danazol

Generic: danazol

Labeler: teva pharmaceuticals usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name danazol
Generic Name danazol
Labeler teva pharmaceuticals usa, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

danazol 50 mg/1

Manufacturer
Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 0555-0633
Product ID 0555-0633_012ba27f-5410-4461-bc8a-72004ac311a6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074582
Listing Expiration 2026-12-31
Marketing Start 1998-06-25

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 05550633
Hyphenated Format 0555-0633

Supplemental Identifiers

RxCUI
197554 197555 197556
UNII
N29QWW3BUO
NUI
N0000175824 N0000000146 M0001109

Packaging Origin

Original Packager
true

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 ANDA074582 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (0555-0633-02)
source: ndc

Packages (1)

0555-0633-02 100 CAPSULE in 1 BOTTLE (0555-0633-02)

Ingredients (1)

danazol (50 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": "012ba27f-5410-4461-bc8a-72004ac311a6", "openfda": {"nui": ["N0000175824", "N0000000146", "M0001109"], "unii": ["N29QWW3BUO"], "rxcui": ["197554", "197555", "197556"], "spl_set_id": ["e19acee5-ff33-45a5-bbbf-801756bc59b4"], "pharm_class_cs": ["Androstanes [CS]"], "pharm_class_epc": ["Androgen [EPC]"], "pharm_class_moa": ["Androgen Receptor Agonists [MoA]"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (0555-0633-02)", "package_ndc": "0555-0633-02", "marketing_start_date": "19980625"}], "brand_name": "Danazol", "product_id": "0555-0633_012ba27f-5410-4461-bc8a-72004ac311a6", "dosage_form": "CAPSULE", "pharm_class": ["Androgen Receptor Agonists [MoA]", "Androgen [EPC]", "Androstanes [CS]"], "product_ndc": "0555-0633", "generic_name": "Danazol", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Danazol", "active_ingredients": [{"name": "DANAZOL", "strength": "50 mg/1"}], "application_number": "ANDA074582", "marketing_category": "ANDA", "marketing_start_date": "19980625", "listing_expiration_date": "20261231"}