NDC 0527-1368

Danazol

Danazol

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

• Product ID: 0527-1368_399a377e-237d-4939-ad70-805ebd30a1c9
• NDC: 0527-1368
• Product Type: Human Prescription Drug
• Proprietary Name: Danazol
• Generic Name: Danazol
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2007-04-19
• Marketing Category: ANDA / ANDA
• Application Number: ANDA078214
• Labeler Name: Lannett Company, Inc.
• Substance Name: DANAZOL
• Active Ingredient Strength: 100 mg/1
• Pharm Classes: Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 0527-1368-01

100 CAPSULE in 1 BOTTLE (0527-1368-01)

• Marketing Start Date: 2007-04-19
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0527-1368-01 [00527136801]

Danazol CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA078214
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2007-04-19

Drug Details

Active Ingredients

Ingredient	Strength
DANAZOL	100 mg/1

OpenFDA Data

• SPL SET ID: f2c9b713-aafc-49ca-866e-334d9b5c2e2d
• Manufacturer:
  • Lannett Company, Inc.
• UNII:
  • N29QWW3BUO
• RxNorm Concept Unique ID - RxCUI:
  • 197556
  • 197555
  • 197554
• UPC Code:
  • 0305271369017
  • 0305271368010

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