NDC 68382-641

Dutasteride

Dutasteride

Dutasteride is a Oral Capsule, Liquid Filled in the Human Prescription Drug category. It is labeled and distributed by Zydus Pharmaceuticals (usa) Inc.. The primary component is Dutasteride.

• Product ID: 68382-641_791e9054-ec90-45b1-bd3e-7dbc689399ac
• NDC: 68382-641
• Product Type: Human Prescription Drug
• Proprietary Name: Dutasteride
• Generic Name: Dutasteride
• Dosage Form: Capsule, Liquid Filled
• Route of Administration: ORAL
• Marketing Start Date: 2018-05-16
• Marketing Category: ANDA / ANDA
• Application Number: ANDA204373
• Labeler Name: Zydus Pharmaceuticals (USA) Inc.
• Substance Name: DUTASTERIDE
• Active Ingredient Strength: 1 mg/1
• Pharm Classes: 5-alpha Reductase Inhibitor [EPC],5-alpha Reductase Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 68382-641-06

30 CAPSULE, LIQUID FILLED in 1 BOTTLE (68382-641-06)

• Marketing Start Date: 2018-05-16
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68382-641-16 [68382064116]

Dutasteride CAPSULE, LIQUID FILLED

• Marketing Category: ANDA
• Application Number: ANDA204373
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-05-16
• Marketing End Date: 2019-04-26

NDC 68382-641-06 [68382064106]

Dutasteride CAPSULE, LIQUID FILLED

• Marketing Category: ANDA
• Application Number: ANDA204373
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-05-16
• Marketing End Date: 2019-04-26

Drug Details

Active Ingredients

Ingredient	Strength
DUTASTERIDE	.5 mg/1

OpenFDA Data

• SPL SET ID: 3676ef86-3195-467d-818e-4f6420fedfb5
• Manufacturer:
  • Zydus Pharmaceuticals (USA) Inc.
• UNII:
  • O0J6XJN02I
• RxNorm Concept Unique ID - RxCUI:
  • 351172

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
0054-0395	Dutasteride	Dutasteride
0115-1438	Dutasteride	Dutasteride
0591-2292	Dutasteride	Dutasteride
25000-011	Dutasteride	Dutasteride
31722-131	Dutasteride	Dutasteride
42543-139	Dutasteride	Dutasteride
42806-549	Dutasteride	Dutasteride
50090-2285	Dutasteride	dutasteride
50090-3040	Dutasteride	Dutasteride
50090-4010	Dutasteride	Dutasteride
50268-282	Dutasteride	Dutasteride
51013-190	Dutasteride	Dutasteride
51407-157	Dutasteride	Dutasteride
51991-749	DUTASTERIDE	DUTASTERIDE
53345-037	Dutasteride	Dutasteride
60429-935	Dutasteride	dutasteride
60505-3877	Dutasteride	dutasteride
62112-8068	Dutasteride	dutasteride
63187-657	Dutasteride	Dutasteride
63629-1222	Dutasteride	Dutasteride
63629-1223	Dutasteride	Dutasteride
63629-8207	Dutasteride	Dutasteride
64380-763	Dutasteride	Dutasteride
64980-224	DUTASTERIDE	dutasteride
68071-4237	Dutasteride	Dutasteride
68071-4609	Dutasteride	Dutasteride
68071-4607	Dutasteride	Dutasteride
68071-4821	Dutasteride	Dutasteride
68382-641	Dutasteride	Dutasteride
70518-1966	Dutasteride	Dutasteride
70771-1347	Dutasteride	Dutasteride
71205-039	Dutasteride	Dutasteride
65162-750	Dutasteride	Dutasteride
72578-019	Dutasteride	Dutasteride
71205-278	Dutasteride	Dutasteride
70518-2256	Dutasteride	Dutasteride
70518-2378	Dutasteride	Dutasteride
72865-140	Dutasteride	Dutasteride
0173-0712	AVODART	dutasteride