NDC 42291-243

Danazol

Danazol

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

Product ID42291-243_63254869-67d3-0900-e053-2a91aa0af95c
NDC42291-243
Product TypeHuman Prescription Drug
Proprietary NameDanazol
Generic NameDanazol
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2016-02-23
Marketing CategoryANDA / ANDA
Application NumberANDA074582
Labeler NameAvKARE, Inc.
Substance NameDANAZOL
Active Ingredient Strength200 mg/1
Pharm ClassesAndrogen Receptor Agonists [MoA],Androstanes [CS],Androgen [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 42291-243-01

100 CAPSULE in 1 BOTTLE (42291-243-01)
Marketing Start Date2016-02-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42291-243-01 [42291024301]

Danazol CAPSULE
Marketing CategoryANDA
Application NumberANDA074582
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-02-23

Drug Details

Active Ingredients

IngredientStrength
DANAZOL200 mg/1

OpenFDA Data

SPL SET ID:7f5374f9-66bb-7e32-ffe6-61a7ddeb37c1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197555
  • UPC Code
  • 0342291243019
  • Pharmacological Class

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