danazol

Generic: danazol

Labeler: lannett company, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name danazol
Generic Name danazol
Labeler lannett company, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

danazol 100 mg/1

Manufacturer
Lannett Company, Inc.

Identifiers & Regulatory

Product NDC 0527-1368
Product ID 0527-1368_399a377e-237d-4939-ad70-805ebd30a1c9
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 05271368
Hyphenated Format 0527-1368

Supplemental Identifiers

RxCUI
197554 197555 197556
UPC
0305271368010 0305271369017 0305271392015
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 ANDA078214 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (0527-1368-01)
source: ndc

Packages (1)

0527-1368-01 100 CAPSULE in 1 BOTTLE (0527-1368-01)

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": "399a377e-237d-4939-ad70-805ebd30a1c9", "openfda": {"nui": ["N0000175824", "N0000000146", "M0001109"], "upc": ["0305271368010", "0305271369017", "0305271392015"], "unii": ["N29QWW3BUO"], "rxcui": ["197554", "197555", "197556"], "spl_set_id": ["f2c9b713-aafc-49ca-866e-334d9b5c2e2d"], "pharm_class_cs": ["Androstanes [CS]"], "pharm_class_epc": ["Androgen [EPC]"], "pharm_class_moa": ["Androgen Receptor Agonists [MoA]"], "manufacturer_name": ["Lannett Company, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (0527-1368-01)", "package_ndc": "0527-1368-01", "marketing_start_date": "20070419"}], "brand_name": "Danazol", "product_id": "0527-1368_399a377e-237d-4939-ad70-805ebd30a1c9", "dosage_form": "CAPSULE", "pharm_class": ["Androgen Receptor Agonists [MoA]", "Androgen [EPC]", "Androstanes [CS]"], "product_ndc": "0527-1368", "generic_name": "Danazol", "labeler_name": "Lannett Company, Inc.", "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"}