NDC 0054-0395

Dutasteride

Dutasteride

Dutasteride is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by West-ward Pharmaceuticals Corp.. The primary component is Dutasteride.

• Product ID: 0054-0395_6f137001-db0e-4fcb-913a-c4c8a9a602e1
• NDC: 0054-0395
• Product Type: Human Prescription Drug
• Proprietary Name: Dutasteride
• Generic Name: Dutasteride
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2013-08-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA202204
• Labeler Name: West-Ward Pharmaceuticals Corp.
• 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: 2020-12-31

Packaging

NDC 0054-0395-13

30 CAPSULE in 1 BOTTLE (0054-0395-13)

• Marketing Start Date: 2013-08-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0054-0395-13 [00054039513]

Dutasteride CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA202204
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-11-23
• Marketing End Date: 2020-01-02

NDC 0054-0395-22 [00054039522]

Dutasteride CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA202204
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-11-23
• Marketing End Date: 2020-01-02

Drug Details

Active Ingredients

Ingredient	Strength
DUTASTERIDE	.5 mg/1

OpenFDA Data

• SPL SET ID: c3759886-6d13-43c5-a35b-558368154d96
• Manufacturer:
  • West-Ward Pharmaceuticals Corp.
• UNII:
  • O0J6XJN02I
• RxNorm Concept Unique ID - RxCUI:
  • 351172
• UPC Code:
  • 0300540395131

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