NDC 0591-2924

Testosterone

Testosterone

Testosterone is a Transdermal Gel in the Human Prescription Drug category. It is labeled and distributed by Actavis Pharma, Inc.. The primary component is Testosterone.

• Product ID: 0591-2924_172371b0-3df0-44d3-a8d5-c096386c478e
• NDC: 0591-2924
• Product Type: Human Prescription Drug
• Proprietary Name: Testosterone
• Generic Name: Testosterone
• Dosage Form: Gel
• Route of Administration: TRANSDERMAL
• Marketing Start Date: 2019-04-10
• Marketing Category: ANDA / ANDA
• Application Number: ANDA204570
• Labeler Name: Actavis Pharma, Inc.
• Substance Name: TESTOSTERONE
• Active Ingredient Strength: 16 mg/g
• Pharm Classes: Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [CS]
• DEA Schedule: CIII
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0591-2924-18

1 BOTTLE, PUMP in 1 CARTON (0591-2924-18) > 88 g in 1 BOTTLE, PUMP

• Marketing Start Date: 2019-04-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0591-2924-18 [00591292418]

Testosterone GEL

• Marketing Category: ANDA
• Application Number: ANDA204570
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2019-04-10

Drug Details

Active Ingredients

Ingredient	Strength
TESTOSTERONE	16.2 mg/g

OpenFDA Data

• SPL SET ID: 4f3c2c0a-7dab-4b50-9cae-869c3c2a8498
• Manufacturer:
  • Actavis Pharma, Inc.
• UNII:
  • 3XMK78S47O

Pharmacological Class

• Androgen [EPC]
• Androgen Receptor Agonists [MoA]
• Androstanes [CS]

NDC Crossover Matching brand name "Testosterone" or generic name "Testosterone"

NDC	Brand Name	Generic Name
0254-1012	Testosterone	testosterone
0591-2114	Testosterone	Testosterone
0591-2363	Testosterone	testosterone
0591-2921	Testosterone	Testosterone
0591-2924	Testosterone	Testosterone
0591-2925	Testosterone	Testosterone
0591-2926	Testosterone	Testosterone
0591-3216	Testosterone	Testosterone
68180-943	Testosterone	Testosterone
68382-362	Testosterone	Testosterone
69097-363	Testosterone	Testosterone
0591-3217	Testosterone	Testosterone
70518-1171	Testosterone	Testosterone
0591-3524	Testosterone	Testosterone
0603-7831	Testosterone	Testosterone
0832-1121	Testosterone	Testosterone
0832-1120	Testosterone	Testosterone
43742-1242	Testosterone	Testosterone
43742-0021	Testosterone	Testosterone
43853-0021	Testosterone	Testosterone
43742-0677	Testosterone	Testosterone
44117-0002	Testosterone	Testosterone
43853-0005	Testosterone	Testosterone
44117-0001	Testosterone	Testosterone
45802-116	Testosterone	Testosterone
45802-754	testosterone	testosterone
45802-610	testosterone	testosterone
49884-510	Testosterone	Testosterone
49884-418	Testosterone	Testosterone
50845-0113	Testosterone	Testosterone
57520-0638	Testosterone	Testosterone
68180-941	Testosterone	Testosterone
43598-304	Testosterone	Testosterone
69238-1013	Testosterone	Testosterone
45802-281	testosterone	testosterone
45802-366	testosterone	testosterone
0023-5990	Androderm	Testosterone
0023-5992	Androderm	Testosterone
0051-8425	Androgel	Testosterone
0051-8450	Androgel	Testosterone
0051-8462	Androgel	Testosterone
0245-0871	Vogelxo	Testosterone
0245-0872	Vogelxo	Testosterone