tamoxifen citrate

Generic: tamoxifen citrate

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tamoxifen citrate
Generic Name tamoxifen citrate
Labeler aurobindo pharma limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

tamoxifen citrate 20 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-300
Product ID 59651-300_a596c715-8e30-43c1-aba3-4fe5de6729fa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213358
Listing Expiration 2026-12-31
Marketing Start 2020-08-14

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59651300
Hyphenated Format 59651-300

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 ANDA213358 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (59651-300-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE (59651-300-90)
source: ndc

Packages (2)

59651-300-30 30 TABLET, FILM COATED in 1 BOTTLE (59651-300-30) 59651-300-90 90 TABLET, FILM COATED in 1 BOTTLE (59651-300-90)

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": "a596c715-8e30-43c1-aba3-4fe5de6729fa", "openfda": {"unii": ["7FRV7310N6"], "rxcui": ["198240", "313195"], "spl_set_id": ["a596c715-8e30-43c1-aba3-4fe5de6729fa"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (59651-300-30)", "package_ndc": "59651-300-30", "marketing_start_date": "20200814"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (59651-300-90)", "package_ndc": "59651-300-90", "marketing_start_date": "20200814"}], "brand_name": "Tamoxifen Citrate", "product_id": "59651-300_a596c715-8e30-43c1-aba3-4fe5de6729fa", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Estrogen Agonist/Antagonist [EPC]", "Selective Estrogen Receptor Modulators [MoA]"], "product_ndc": "59651-300", "generic_name": "Tamoxifen Citrate", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tamoxifen Citrate", "active_ingredients": [{"name": "TAMOXIFEN CITRATE", "strength": "20 mg/1"}], "application_number": "ANDA213358", "marketing_category": "ANDA", "marketing_start_date": "20200814", "listing_expiration_date": "20261231"}