List of Excipients in API testosterone undecanoate

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Excipients in NDA-approved (novel) drugs containing testosterone undecanoate

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Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Antares Pharma Inc	TLANDO	testosterone undecanoate	54436-112	AMMONIA	2025-03-28
Antares Pharma Inc	TLANDO	testosterone undecanoate	54436-112	ASCORBYL PALMITATE	2025-03-28
Antares Pharma Inc	TLANDO	testosterone undecanoate	54436-112	FERROSOFERRIC OXIDE	2025-03-28
>Company	>Tradename	>Ingredient	>NDC	>Excipient	>Potential Generic Entry

Detailed excipient profiles for testosterone undecanoate

Excipient focus: .ALPHA.-TOCOPHEROL

testosterone undecanoate drug variants containing .ALPHA.-TOCOPHEROL

Glossary

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Company	Ingredient	NDC
Marius Pharmaceuticals	testosterone undecanoate	80603-101
>Company	>Ingredient	>NDC

testosterone undecanoate drug variants not containing .ALPHA.-TOCOPHEROL

Glossary

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Company	Ingredient	NDC
Antares Pharma Inc	testosterone undecanoate	54436-112
Endo Pharmaceuticals Inc	testosterone undecanoate	67979-511
TOLMAR Inc	testosterone undecanoate	69087-158
>Company	>Ingredient	>NDC

Excipient focus: AMMONIA

testosterone undecanoate drug variants containing AMMONIA

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Company	Ingredient	NDC
Antares Pharma Inc	testosterone undecanoate	54436-112
Verity Pharmaceuticals Inc	testosterone undecanoate	74676-0112
>Company	>Ingredient	>NDC

testosterone undecanoate drug variants not containing AMMONIA

Glossary

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Company	Ingredient	NDC
Endo Pharmaceuticals Inc	testosterone undecanoate	67979-511
TOLMAR Inc	testosterone undecanoate	69087-158
Marius Pharmaceuticals	testosterone undecanoate	80603-101
>Company	>Ingredient	>NDC

Excipient focus: ASCORBYL PALMITATE

testosterone undecanoate drug variants containing ASCORBYL PALMITATE

Glossary

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Company	Ingredient	NDC
Antares Pharma Inc	testosterone undecanoate	54436-112
Verity Pharmaceuticals Inc	testosterone undecanoate	74676-0112
>Company	>Ingredient	>NDC

testosterone undecanoate drug variants not containing ASCORBYL PALMITATE

Glossary

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Company	Ingredient	NDC
Endo Pharmaceuticals Inc	testosterone undecanoate	67979-511
TOLMAR Inc	testosterone undecanoate	69087-158
Marius Pharmaceuticals	testosterone undecanoate	80603-101
>Company	>Ingredient	>NDC

Excipient focus: BENZYL BENZOATE

testosterone undecanoate drug variants containing BENZYL BENZOATE

Glossary

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Company	Ingredient	NDC
Endo Pharmaceuticals Inc	testosterone undecanoate	67979-511
>Company	>Ingredient	>NDC

testosterone undecanoate drug variants not containing BENZYL BENZOATE

Glossary

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Company	Ingredient	NDC
Antares Pharma Inc	testosterone undecanoate	54436-112
TOLMAR Inc	testosterone undecanoate	69087-158
Verity Pharmaceuticals Inc	testosterone undecanoate	74676-0112
>Company	>Ingredient	>NDC

Excipient focus: BORAGE OIL

testosterone undecanoate drug variants containing BORAGE OIL

Glossary

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Company	Ingredient	NDC
TOLMAR Inc	testosterone undecanoate	69087-158
>Company	>Ingredient	>NDC

testosterone undecanoate drug variants not containing BORAGE OIL

Glossary

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Company	Ingredient	NDC
Antares Pharma Inc	testosterone undecanoate	54436-112
Endo Pharmaceuticals Inc	testosterone undecanoate	67979-511
Verity Pharmaceuticals Inc	testosterone undecanoate	74676-0112
>Company	>Ingredient	>NDC

Excipient focus: BUTYLATED HYDROXYTOLUENE

testosterone undecanoate drug variants containing BUTYLATED HYDROXYTOLUENE

Glossary

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Company	Ingredient	NDC
TOLMAR Inc	testosterone undecanoate	69087-158
>Company	>Ingredient	>NDC

testosterone undecanoate drug variants not containing BUTYLATED HYDROXYTOLUENE

Glossary

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Company	Ingredient	NDC
Antares Pharma Inc	testosterone undecanoate	54436-112
Endo Pharmaceuticals Inc	testosterone undecanoate	67979-511
Verity Pharmaceuticals Inc	testosterone undecanoate	74676-0112
>Company	>Ingredient	>NDC

Excipient focus: CASTOR OIL

testosterone undecanoate drug variants containing CASTOR OIL

Glossary

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Company	Ingredient	NDC
Endo Pharmaceuticals Inc	testosterone undecanoate	67979-511
>Company	>Ingredient	>NDC

testosterone undecanoate drug variants not containing CASTOR OIL

Glossary

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Company	Ingredient	NDC
Antares Pharma Inc	testosterone undecanoate	54436-112
TOLMAR Inc	testosterone undecanoate	69087-158
Verity Pharmaceuticals Inc	testosterone undecanoate	74676-0112
>Company	>Ingredient	>NDC

Excipient focus: FD&C YELLOW NO. 6

testosterone undecanoate drug variants containing FD&C YELLOW NO. 6

Glossary

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Company	Ingredient	NDC
TOLMAR Inc	testosterone undecanoate	69087-158
>Company	>Ingredient	>NDC

testosterone undecanoate drug variants not containing FD&C YELLOW NO. 6

Glossary

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Company	Ingredient	NDC
Antares Pharma Inc	testosterone undecanoate	54436-112
Endo Pharmaceuticals Inc	testosterone undecanoate	67979-511
Verity Pharmaceuticals Inc	testosterone undecanoate	74676-0112
>Company	>Ingredient	>NDC

Excipient focus: FERRIC OXIDE RED

testosterone undecanoate drug variants containing FERRIC OXIDE RED

Glossary

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Company	Ingredient	NDC
TOLMAR Inc	testosterone undecanoate	69087-158
>Company	>Ingredient	>NDC

testosterone undecanoate drug variants not containing FERRIC OXIDE RED

Glossary

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Company	Ingredient	NDC
Antares Pharma Inc	testosterone undecanoate	54436-112
Endo Pharmaceuticals Inc	testosterone undecanoate	67979-511
Verity Pharmaceuticals Inc	testosterone undecanoate	74676-0112
>Company	>Ingredient	>NDC

Excipient focus: FERROSOFERRIC OXIDE

testosterone undecanoate drug variants containing FERROSOFERRIC OXIDE

Glossary

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Company	Ingredient	NDC
Antares Pharma Inc	testosterone undecanoate	54436-112
Verity Pharmaceuticals Inc	testosterone undecanoate	74676-0112
>Company	>Ingredient	>NDC

testosterone undecanoate drug variants not containing FERROSOFERRIC OXIDE

Glossary

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Company	Ingredient	NDC
Endo Pharmaceuticals Inc	testosterone undecanoate	67979-511
TOLMAR Inc	testosterone undecanoate	69087-158
Marius Pharmaceuticals	testosterone undecanoate	80603-101
>Company	>Ingredient	>NDC

Excipient focus: GELATIN

testosterone undecanoate drug variants containing GELATIN

Glossary

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Company	Ingredient	NDC
TOLMAR Inc	testosterone undecanoate	69087-158
Marius Pharmaceuticals	testosterone undecanoate	80603-101
>Company	>Ingredient	>NDC

testosterone undecanoate drug variants not containing GELATIN

Glossary

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Company	Ingredient	NDC
Antares Pharma Inc	testosterone undecanoate	54436-112
Endo Pharmaceuticals Inc	testosterone undecanoate	67979-511
Verity Pharmaceuticals Inc	testosterone undecanoate	74676-0112
>Company	>Ingredient	>NDC

Excipient focus: GLYCERIN

testosterone undecanoate drug variants containing GLYCERIN

Glossary

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Company	Ingredient	NDC
Antares Pharma Inc	testosterone undecanoate	54436-112
TOLMAR Inc	testosterone undecanoate	69087-158
Verity Pharmaceuticals Inc	testosterone undecanoate	74676-0112
>Company	>Ingredient	>NDC

testosterone undecanoate drug variants not containing GLYCERIN

Glossary

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Company	Ingredient	NDC
Endo Pharmaceuticals Inc	testosterone undecanoate	67979-511
>Company	>Ingredient	>NDC

Excipient focus: GLYCERYL MONOLINOLEATE

testosterone undecanoate drug variants containing GLYCERYL MONOLINOLEATE

Glossary

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Company	Ingredient	NDC
Antares Pharma Inc	testosterone undecanoate	54436-112
Verity Pharmaceuticals Inc	testosterone undecanoate	74676-0112
>Company	>Ingredient	>NDC

testosterone undecanoate drug variants not containing GLYCERYL MONOLINOLEATE

Glossary

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Company	Ingredient	NDC
Endo Pharmaceuticals Inc	testosterone undecanoate	67979-511
TOLMAR Inc	testosterone undecanoate	69087-158
Marius Pharmaceuticals	testosterone undecanoate	80603-101
>Company	>Ingredient	>NDC

Excipient focus: OLEIC ACID

testosterone undecanoate drug variants containing OLEIC ACID

Glossary

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Company	Ingredient	NDC
TOLMAR Inc	testosterone undecanoate	69087-158
>Company	>Ingredient	>NDC

testosterone undecanoate drug variants not containing OLEIC ACID

Glossary

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Company	Ingredient	NDC
Antares Pharma Inc	testosterone undecanoate	54436-112
Endo Pharmaceuticals Inc	testosterone undecanoate	67979-511
Verity Pharmaceuticals Inc	testosterone undecanoate	74676-0112
>Company	>Ingredient	>NDC

Excipient focus: PEPPERMINT OIL

testosterone undecanoate drug variants containing PEPPERMINT OIL

Glossary

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Company	Ingredient	NDC
TOLMAR Inc	testosterone undecanoate	69087-158
>Company	>Ingredient	>NDC

testosterone undecanoate drug variants not containing PEPPERMINT OIL

Glossary

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Company	Ingredient	NDC
Antares Pharma Inc	testosterone undecanoate	54436-112
Endo Pharmaceuticals Inc	testosterone undecanoate	67979-511
Verity Pharmaceuticals Inc	testosterone undecanoate	74676-0112
>Company	>Ingredient	>NDC

Excipient focus: POLYETHYLENE GLYCOL 8000

testosterone undecanoate drug variants containing POLYETHYLENE GLYCOL 8000

Glossary

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Company	Ingredient	NDC
Antares Pharma Inc	testosterone undecanoate	54436-112
Verity Pharmaceuticals Inc	testosterone undecanoate	74676-0112
>Company	>Ingredient	>NDC

testosterone undecanoate drug variants not containing POLYETHYLENE GLYCOL 8000

Glossary

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Company	Ingredient	NDC
Endo Pharmaceuticals Inc	testosterone undecanoate	67979-511
TOLMAR Inc	testosterone undecanoate	69087-158
Marius Pharmaceuticals	testosterone undecanoate	80603-101
>Company	>Ingredient	>NDC

Excipient focus: POLYOXYL 40 HYDROGENATED CASTOR OIL

testosterone undecanoate drug variants containing POLYOXYL 40 HYDROGENATED CASTOR OIL

Glossary

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Company	Ingredient	NDC
Antares Pharma Inc	testosterone undecanoate	54436-112
TOLMAR Inc	testosterone undecanoate	69087-158
Verity Pharmaceuticals Inc	testosterone undecanoate	74676-0112
>Company	>Ingredient	>NDC

testosterone undecanoate drug variants not containing POLYOXYL 40 HYDROGENATED CASTOR OIL

Glossary

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Company	Ingredient	NDC
Endo Pharmaceuticals Inc	testosterone undecanoate	67979-511
>Company	>Ingredient	>NDC

Excipient focus: PROPYLENE GLYCOL

testosterone undecanoate drug variants containing PROPYLENE GLYCOL

Glossary

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Company	Ingredient	NDC
Antares Pharma Inc	testosterone undecanoate	54436-112
Verity Pharmaceuticals Inc	testosterone undecanoate	74676-0112
>Company	>Ingredient	>NDC

testosterone undecanoate drug variants not containing PROPYLENE GLYCOL

Glossary

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Company	Ingredient	NDC
Endo Pharmaceuticals Inc	testosterone undecanoate	67979-511
TOLMAR Inc	testosterone undecanoate	69087-158
Marius Pharmaceuticals	testosterone undecanoate	80603-101
>Company	>Ingredient	>NDC

Excipient focus: PROPYLENE GLYCOL MONOLAURATE

testosterone undecanoate drug variants containing PROPYLENE GLYCOL MONOLAURATE

Glossary

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Company	Ingredient	NDC
Marius Pharmaceuticals	testosterone undecanoate	80603-101
>Company	>Ingredient	>NDC

testosterone undecanoate drug variants not containing PROPYLENE GLYCOL MONOLAURATE

Glossary

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Company	Ingredient	NDC
Antares Pharma Inc	testosterone undecanoate	54436-112
Endo Pharmaceuticals Inc	testosterone undecanoate	67979-511
TOLMAR Inc	testosterone undecanoate	69087-158
>Company	>Ingredient	>NDC

Excipient focus: SHELLAC

testosterone undecanoate drug variants containing SHELLAC

Glossary

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Company	Ingredient	NDC
Antares Pharma Inc	testosterone undecanoate	54436-112
Verity Pharmaceuticals Inc	testosterone undecanoate	74676-0112
>Company	>Ingredient	>NDC

testosterone undecanoate drug variants not containing SHELLAC

Glossary

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Company	Ingredient	NDC
Endo Pharmaceuticals Inc	testosterone undecanoate	67979-511
TOLMAR Inc	testosterone undecanoate	69087-158
Marius Pharmaceuticals	testosterone undecanoate	80603-101
>Company	>Ingredient	>NDC

Excipient focus: SORBITOL

testosterone undecanoate drug variants containing SORBITOL

Glossary

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Company	Ingredient	NDC
TOLMAR Inc	testosterone undecanoate	69087-158
Marius Pharmaceuticals	testosterone undecanoate	80603-101
>Company	>Ingredient	>NDC

testosterone undecanoate drug variants not containing SORBITOL

Glossary

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Company	Ingredient	NDC
Antares Pharma Inc	testosterone undecanoate	54436-112
Endo Pharmaceuticals Inc	testosterone undecanoate	67979-511
Verity Pharmaceuticals Inc	testosterone undecanoate	74676-0112
>Company	>Ingredient	>NDC

Excipient focus: TITANIUM DIOXIDE

testosterone undecanoate drug variants containing TITANIUM DIOXIDE

Glossary

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Company	Ingredient	NDC
Antares Pharma Inc	testosterone undecanoate	54436-112
TOLMAR Inc	testosterone undecanoate	69087-158
Verity Pharmaceuticals Inc	testosterone undecanoate	74676-0112
>Company	>Ingredient	>NDC

testosterone undecanoate drug variants not containing TITANIUM DIOXIDE

Glossary

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Company	Ingredient	NDC
Endo Pharmaceuticals Inc	testosterone undecanoate	67979-511
>Company	>Ingredient	>NDC

Excipient focus: WATER

testosterone undecanoate drug variants containing WATER

Glossary

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Company	Ingredient	NDC
TOLMAR Inc	testosterone undecanoate	69087-158
Marius Pharmaceuticals	testosterone undecanoate	80603-101
>Company	>Ingredient	>NDC

testosterone undecanoate drug variants not containing WATER

Glossary

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Company	Ingredient	NDC
Antares Pharma Inc	testosterone undecanoate	54436-112
Endo Pharmaceuticals Inc	testosterone undecanoate	67979-511
Verity Pharmaceuticals Inc	testosterone undecanoate	74676-0112
>Company	>Ingredient	>NDC

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