tamoxifen citrate

Generic: tamoxifen citrate

Labeler: mayne pharma commercial llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tamoxifen citrate
Generic Name tamoxifen citrate
Labeler mayne pharma commercial llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

tamoxifen citrate 20 mg/1

Manufacturer
Mayne Pharma Commercial LLC

Identifiers & Regulatory

Product NDC 51862-643
Product ID 51862-643_433f16e8-7df7-8a6e-e063-6394a90a7c4c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075797
Listing Expiration 2026-12-31
Marketing Start 2021-08-27

Pharmacologic Class

Classes
estrogen agonist/antagonist [epc] selective estrogen receptor modulators [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51862643
Hyphenated Format 51862-643

Supplemental Identifiers

RxCUI
198240 313195
UNII
7FRV7310N6

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 tamoxifen citrate (source: ndc)
Generic Name tamoxifen citrate (source: ndc)
Application Number ANDA075797 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 1000 TABLET, FILM COATED in 1 BOTTLE (51862-643-10)
  • 30 TABLET, FILM COATED in 1 BOTTLE (51862-643-30)
source: ndc

Packages (2)

51862-643-10 1000 TABLET, FILM COATED in 1 BOTTLE (51862-643-10) 51862-643-30 30 TABLET, FILM COATED in 1 BOTTLE (51862-643-30)

Ingredients (1)

tamoxifen citrate (20 mg/1)

Linked Drug Pages (1)

Tamoxifen Citrate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "433f16e8-7df7-8a6e-e063-6394a90a7c4c", "openfda": {"unii": ["7FRV7310N6"], "rxcui": ["198240", "313195"], "spl_set_id": ["c82205a3-ae0c-4ce5-b04b-9581cd8c70d4"], "manufacturer_name": ["Mayne Pharma Commercial LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (51862-643-10)", "package_ndc": "51862-643-10", "marketing_start_date": "20210827"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (51862-643-30)", "package_ndc": "51862-643-30", "marketing_start_date": "20210827"}], "brand_name": "Tamoxifen Citrate", "product_id": "51862-643_433f16e8-7df7-8a6e-e063-6394a90a7c4c", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Estrogen Agonist/Antagonist [EPC]", "Selective Estrogen Receptor Modulators [MoA]"], "product_ndc": "51862-643", "generic_name": "Tamoxifen Citrate", "labeler_name": "Mayne Pharma Commercial LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tamoxifen Citrate", "active_ingredients": [{"name": "TAMOXIFEN CITRATE", "strength": "20 mg/1"}], "application_number": "ANDA075797", "marketing_category": "ANDA", "marketing_start_date": "20210827", "listing_expiration_date": "20261231"}