NDC 0527-1392

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 ID0527-1392_399a377e-237d-4939-ad70-805ebd30a1c9
NDC0527-1392
Product TypeHuman Prescription Drug
Proprietary NameDanazol
Generic NameDanazol
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2007-04-19
Marketing CategoryANDA / ANDA
Application NumberANDA078214
Labeler NameLannett Company, Inc.
Substance NameDANAZOL
Active Ingredient Strength50 mg/1
Pharm ClassesAndrogen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0527-1392-01

100 CAPSULE in 1 BOTTLE (0527-1392-01)
Marketing Start Date2007-04-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0527-1392-01 [00527139201]

Danazol CAPSULE
Marketing CategoryANDA
Application NumberANDA078214
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-04-19

Drug Details

Active Ingredients

IngredientStrength
DANAZOL50 mg/1

OpenFDA Data

SPL SET ID:f2c9b713-aafc-49ca-866e-334d9b5c2e2d
Manufacturer
UNII
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"

    NDCBrand NameGeneric Name
    0527-1368DanazolDanazol
    0527-1369DanazolDanazol
    0527-1392DanazolDanazol
    0555-0633DanazolDanazol
    0555-0634DanazolDanazol
    0555-0635DanazolDanazol
    42291-243DanazolDanazol
    68151-2298DanazolDanazol
    71205-861DanazolDanazol
    71205-862DanazolDanazol

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.