NDC 0555-0635

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 ID0555-0635_22654f9f-0307-48aa-a28e-43ff43f86c94
NDC0555-0635
Product TypeHuman Prescription Drug
Proprietary NameDanazol
Generic NameDanazol
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date1996-08-09
Marketing CategoryANDA / ANDA
Application NumberANDA074582
Labeler NameTeva Pharmaceuticals USA, Inc.
Substance NameDANAZOL
Active Ingredient Strength200 mg/1
Pharm ClassesAndrogen Receptor Agonists [MoA],Androstanes [CS],Androgen [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0555-0635-02

100 CAPSULE in 1 BOTTLE (0555-0635-02)
Marketing Start Date1996-08-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0555-0635-04 [00555063504]

Danazol CAPSULE
Marketing CategoryANDA
Application NumberANDA074582
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1996-08-09
Marketing End Date2012-02-14

NDC 0555-0635-02 [00555063502]

Danazol CAPSULE
Marketing CategoryANDA
Application NumberANDA074582
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1996-08-09

NDC 0555-0635-09 [00555063509]

Danazol CAPSULE
Marketing CategoryANDA
Application NumberANDA074582
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1996-08-09

Drug Details

Active Ingredients

IngredientStrength
DANAZOL200 mg/1

OpenFDA Data

SPL SET ID:e19acee5-ff33-45a5-bbbf-801756bc59b4
Manufacturer
UNII
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"

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

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