NDC 0555-0633

Danazol

Danazol

Danazol is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Teva Pharmaceuticals Usa, Inc.. The primary component is Danazol.

• Product ID: 0555-0633_22654f9f-0307-48aa-a28e-43ff43f86c94
• NDC: 0555-0633
• Product Type: Human Prescription Drug
• Proprietary Name: Danazol
• Generic Name: Danazol
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 1998-06-25
• Marketing Category: ANDA / ANDA
• Application Number: ANDA074582
• Labeler Name: Teva Pharmaceuticals USA, Inc.
• Substance Name: DANAZOL
• Active Ingredient Strength: 50 mg/1
• Pharm Classes: Androgen Receptor Agonists [MoA],Androstanes [CS],Androgen [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 0555-0633-02

100 CAPSULE in 1 BOTTLE (0555-0633-02)

• Marketing Start Date: 1998-06-25
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0555-0633-02 [00555063302]

Danazol CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA074582
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1998-06-25

Drug Details

Active Ingredients

Ingredient	Strength
DANAZOL	50 mg/1

OpenFDA Data

• SPL SET ID: e19acee5-ff33-45a5-bbbf-801756bc59b4
• Manufacturer:
  • Teva Pharmaceuticals USA, Inc.
• UNII:
  • N29QWW3BUO
• RxNorm Concept Unique ID - RxCUI:
  • 197556
  • 197555
  • 197554

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
0527-1368	Danazol	Danazol
0527-1369	Danazol	Danazol
0527-1392	Danazol	Danazol
0555-0633	Danazol	Danazol
0555-0634	Danazol	Danazol
0555-0635	Danazol	Danazol
42291-243	Danazol	Danazol
68151-2298	Danazol	Danazol
71205-861	Danazol	Danazol
71205-862	Danazol	Danazol