NDC 68382-074

Finasteride

Finasteride

Finasteride is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Zydus Pharmaceuticals (usa) Inc.. The primary component is Finasteride.

• Product ID: 68382-074_c8f04aaf-7ee2-4d41-92b2-072e9a500581
• NDC: 68382-074
• Product Type: Human Prescription Drug
• Proprietary Name: Finasteride
• Generic Name: Finasteride
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2017-12-05
• Marketing Category: ANDA / ANDA
• Application Number: ANDA078900
• Labeler Name: Zydus Pharmaceuticals (USA) Inc.
• Substance Name: FINASTERIDE
• Active Ingredient Strength: 5 mg/1
• Pharm Classes: 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 68382-074-01

100 TABLET, FILM COATED in 1 BOTTLE (68382-074-01)

• Marketing Start Date: 2017-12-05
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68382-074-77 [68382007477]

Finasteride TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA078900
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-12-05

NDC 68382-074-06 [68382007406]

Finasteride TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA078900
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-12-05

NDC 68382-074-10 [68382007410]

Finasteride TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA078900
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-12-05

NDC 68382-074-01 [68382007401]

Finasteride TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA078900
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-12-05

NDC 68382-074-30 [68382007430]

Finasteride TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA078900
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-12-05
• Marketing End Date: 2019-12-03

Drug Details

Active Ingredients

Ingredient	Strength
FINASTERIDE	5 mg/1

OpenFDA Data

• SPL SET ID: c3b1ea5f-5d84-4f6f-b1bb-0be087bd7768
• Manufacturer:
  • Zydus Pharmaceuticals (USA) Inc.
• UNII:
  • 57GNO57U7G
• RxNorm Concept Unique ID - RxCUI:
  • 310346

Pharmacological Class

• 5-alpha Reductase Inhibitor [EPC]
• 5-alpha Reductase Inhibitors [MoA]

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

NDC	Brand Name	Generic Name
0093-7355	Finasteride	Finasteride
0179-0175	Finasteride	Finasteride
0378-5036	Finasteride	finasteride
0904-6830	Finasteride	Finasteride
16729-089	Finasteride	Finasteride
16729-090	Finasteride	finasteride
17856-0090	Finasteride	finasteride
31722-525	Finasteride	Finasteride
31722-526	Finasteride	Finasteride
33261-833	Finasteride	Finasteride
35573-400	Finasteride	Finasteride
42291-280	Finasteride	Finasteride
43598-303	Finasteride	Finasteride
43598-390	Finasteride	Finasteride
45963-500	Finasteride	Finasteride
45963-600	FINASTERIDE	FINASTERIDE
47335-714	Finasteride	Finasteride
47335-715	FINASTERIDE	FINASTERIDE
50090-1718	Finasteride	finasteride
67877-288	Finasteride	Finasteride
67877-455	Finasteride	Finasteride
68071-1648	Finasteride	Finasteride
68071-1710	Finasteride	Finasteride
68071-3234	Finasteride	Finasteride
68071-3306	Finasteride	Finasteride
68071-4044	Finasteride	Finasteride
68071-3354	Finasteride	Finasteride
68071-3380	Finasteride	Finasteride
68071-4167	Finasteride	Finasteride
68071-4541	Finasteride	Finasteride
68071-4808	Finasteride	Finasteride
68084-399	Finasteride	Finasteride
68382-074	Finasteride	Finasteride
68645-541	Finasteride	Finasteride
68554-3026	Finasteride	Finasteride
68554-3025	Finasteride	Finasteride
68788-6976	Finasteride	Finasteride
68788-6875	Finasteride	Finasteride
68788-9519	Finasteride	Finasteride
68788-9249	Finasteride	Finasteride
68788-9517	Finasteride	Finasteride
69097-112	Finasteride	Finasteride
70518-0397	Finasteride	Finasteride
70518-1704	Finasteride	Finasteride
70771-1152	Finasteride	Finasteride
71335-0433	Finasteride	Finasteride
71335-0281	Finasteride	Finasteride
71335-0235	Finasteride	Finasteride
76282-412	Finasteride	Finasteride
76519-1204	FINASTERIDE	FINASTERIDE