bicalutamide

Generic: bicalutamide

Labeler: accord healthcare inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name bicalutamide
Generic Name bicalutamide
Labeler accord healthcare inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

bicalutamide 50 mg/1

Manufacturer
Accord Healthcare Inc.

Identifiers & Regulatory

Product NDC 16729-023
Product ID 16729-023_0f1d66dd-3a8d-73a9-e063-6394a90ab5e2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078917
Listing Expiration 2026-12-31
Marketing Start 2009-07-06

Pharmacologic Class

Established (EPC)
androgen receptor inhibitor [epc]
Mechanism of Action
androgen receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16729023
Hyphenated Format 16729-023

Supplemental Identifiers

RxCUI
199123
UNII
A0Z3NAU9DP
NUI
N0000000243 N0000175560

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 bicalutamide (source: ndc)
Generic Name bicalutamide (source: ndc)
Application Number ANDA078917 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (16729-023-01)
  • 30 TABLET in 1 BOTTLE (16729-023-10)
source: ndc

Packages (2)

16729-023-01 100 TABLET in 1 BOTTLE (16729-023-01) 16729-023-10 30 TABLET in 1 BOTTLE (16729-023-10)

Ingredients (1)

bicalutamide (50 mg/1)

Linked Drug Pages (1)

Bicalutamide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0f1d66dd-3a8d-73a9-e063-6394a90ab5e2", "openfda": {"nui": ["N0000000243", "N0000175560"], "unii": ["A0Z3NAU9DP"], "rxcui": ["199123"], "spl_set_id": ["7c295b64-ec39-42ec-9f02-da5b42e775e1"], "pharm_class_epc": ["Androgen Receptor Inhibitor [EPC]"], "pharm_class_moa": ["Androgen Receptor Antagonists [MoA]"], "manufacturer_name": ["Accord Healthcare Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (16729-023-01)", "package_ndc": "16729-023-01", "marketing_start_date": "20090706"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (16729-023-10)", "package_ndc": "16729-023-10", "marketing_start_date": "20090706"}], "brand_name": "Bicalutamide", "product_id": "16729-023_0f1d66dd-3a8d-73a9-e063-6394a90ab5e2", "dosage_form": "TABLET", "pharm_class": ["Androgen Receptor Antagonists [MoA]", "Androgen Receptor Inhibitor [EPC]"], "product_ndc": "16729-023", "generic_name": "Bicalutamide", "labeler_name": "Accord Healthcare Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bicalutamide", "active_ingredients": [{"name": "BICALUTAMIDE", "strength": "50 mg/1"}], "application_number": "ANDA078917", "marketing_category": "ANDA", "marketing_start_date": "20090706", "listing_expiration_date": "20261231"}