danazol

Generic: danazol

Labeler: chartwell rx, llc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name danazol
Generic Name danazol
Labeler chartwell rx, llc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

danazol 50 mg/1

Manufacturer
Chartwell RX, LLC.

Identifiers & Regulatory

Product NDC 62135-475
Product ID 62135-475_241f23e1-4b4b-4adb-e063-6394a90adcc5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077246
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 62135475
Hyphenated Format 62135-475

Supplemental Identifiers

RxCUI
197554 197555 197556
UPC
0362135477608 0362135475604 0362135476601
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 ANDA077246 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 60 CAPSULE in 1 BOTTLE (62135-475-60)
source: ndc

Packages (1)

62135-475-60 60 CAPSULE in 1 BOTTLE (62135-475-60)

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": "241f23e1-4b4b-4adb-e063-6394a90adcc5", "openfda": {"nui": ["N0000175824", "N0000000146", "M0001109"], "upc": ["0362135477608", "0362135475604", "0362135476601"], "unii": ["N29QWW3BUO"], "rxcui": ["197554", "197555", "197556"], "spl_set_id": ["55ad6325-16f6-4f0c-a1dc-734847052d0b"], "pharm_class_cs": ["Androstanes [CS]"], "pharm_class_epc": ["Androgen [EPC]"], "pharm_class_moa": ["Androgen Receptor Agonists [MoA]"], "manufacturer_name": ["Chartwell RX, LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE in 1 BOTTLE (62135-475-60)", "package_ndc": "62135-475-60", "marketing_start_date": "20230227"}], "brand_name": "Danazol", "product_id": "62135-475_241f23e1-4b4b-4adb-e063-6394a90adcc5", "dosage_form": "CAPSULE", "pharm_class": ["Androgen Receptor Agonists [MoA]", "Androgen [EPC]", "Androstanes [CS]"], "product_ndc": "62135-475", "generic_name": "Danazol", "labeler_name": "Chartwell RX, LLC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Danazol", "active_ingredients": [{"name": "DANAZOL", "strength": "50 mg/1"}], "application_number": "ANDA077246", "marketing_category": "ANDA", "marketing_start_date": "20070419", "listing_expiration_date": "20261231"}