danazol

Generic: danazol

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name danazol
Generic Name danazol
Labeler proficient rx lp
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

danazol 100 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 71205-861
Product ID 71205-861_9e103cf9-f075-48ba-8913-2e44f9442781
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078214
Listing Expiration 2026-12-31
Marketing Start 2007-04-19

Pharmacologic Class

Established (EPC)
androgen [epc]
Mechanism of Action
androgen receptor agonists [moa]
Chemical Structure
androstanes [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71205861
Hyphenated Format 71205-861

Supplemental Identifiers

RxCUI
197554 197555
UPC
0371205861308
UNII
N29QWW3BUO
NUI
N0000175824 N0000000146 M0001109

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name danazol (source: ndc)
Generic Name danazol (source: ndc)
Application Number ANDA078214 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (71205-861-00)
  • 30 CAPSULE in 1 BOTTLE (71205-861-30)
  • 500 CAPSULE in 1 BOTTLE (71205-861-55)
  • 60 CAPSULE in 1 BOTTLE (71205-861-60)
  • 120 CAPSULE in 1 BOTTLE (71205-861-72)
  • 90 CAPSULE in 1 BOTTLE (71205-861-90)
source: ndc

Packages (6)

71205-861-00 100 CAPSULE in 1 BOTTLE (71205-861-00) 71205-861-30 30 CAPSULE in 1 BOTTLE (71205-861-30) 71205-861-55 500 CAPSULE in 1 BOTTLE (71205-861-55) 71205-861-60 60 CAPSULE in 1 BOTTLE (71205-861-60) 71205-861-72 120 CAPSULE in 1 BOTTLE (71205-861-72) 71205-861-90 90 CAPSULE in 1 BOTTLE (71205-861-90)

Ingredients (1)

danazol (100 mg/1)

Linked Drug Pages (1)

Danazol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "9e103cf9-f075-48ba-8913-2e44f9442781", "openfda": {"nui": ["N0000175824", "N0000000146", "M0001109"], "upc": ["0371205861308"], "unii": ["N29QWW3BUO"], "rxcui": ["197554", "197555"], "spl_set_id": ["9e103cf9-f075-48ba-8913-2e44f9442781"], "pharm_class_cs": ["Androstanes [CS]"], "pharm_class_epc": ["Androgen [EPC]"], "pharm_class_moa": ["Androgen Receptor Agonists [MoA]"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (71205-861-00)", "package_ndc": "71205-861-00", "marketing_start_date": "20220401"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (71205-861-30)", "package_ndc": "71205-861-30", "marketing_start_date": "20220401"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (71205-861-55)", "package_ndc": "71205-861-55", "marketing_start_date": "20220401"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (71205-861-60)", "package_ndc": "71205-861-60", "marketing_start_date": "20220401"}, {"sample": false, "description": "120 CAPSULE in 1 BOTTLE (71205-861-72)", "package_ndc": "71205-861-72", "marketing_start_date": "20220401"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (71205-861-90)", "package_ndc": "71205-861-90", "marketing_start_date": "20220401"}], "brand_name": "Danazol", "product_id": "71205-861_9e103cf9-f075-48ba-8913-2e44f9442781", "dosage_form": "CAPSULE", "pharm_class": ["Androgen Receptor Agonists [MoA]", "Androgen [EPC]", "Androstanes [CS]"], "product_ndc": "71205-861", "generic_name": "Danazol", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Danazol", "active_ingredients": [{"name": "DANAZOL", "strength": "100 mg/1"}], "application_number": "ANDA078214", "marketing_category": "ANDA", "marketing_start_date": "20070419", "listing_expiration_date": "20261231"}