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United States · US · US:59651-300_a596c715-8e30-43c1-aba3-4fe5de6729fa
Tamoxifen Citrate
Orange BookUNIISPLATC L02BA01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeL02BA01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11596513003030 TABLET, FILM COATED in 1 BOTTLE (59651-300-30)
- ndc11596513009090 TABLET, FILM COATED in 1 BOTTLE (59651-300-90)
Annotations
UNII (FDA Substance ID)
7FRV7310N6
TAMOXIFEN CITRATE
RxCUI 40137
Orange Book
A213358
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "7FRV7310N6",
"rxcui": "40137",
"inchikey": "FQZYTYWMLGAPFJ-OQKDUQJOSA-N",
"display_name": "TAMOXIFEN CITRATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"509f8ba3-214d-aec8-e063-6294a90af498": {
"match": "brand_token",
"title": "TAMOXIFEN CITRATE TABLET, FILM COATED [NUCARE PHARMACEUTICALS, INC.]",
"spl_version": "2",
"published_date": "2026-05-04"
}
},
"productid": "59651-300_a596c715-8e30-43c1-aba3-4fe5de6729fa",
"productndc": "59651-300",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "213358",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 10MG BASE",
"product_no": "001",
"approval_date": "Aug 14, 2020"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "EQ 20MG BASE",
"product_no": "002",
"approval_date": "Aug 14, 2020"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "TAMOXIFEN CITRATE",
"proprietary_name": "Tamoxifen Citrate",
"active_ingred_unit": "mg/1",
"application_number": "ANDA213358",
"marketing_category": "ANDA",
"nonproprietary_name": "Tamoxifen Citrate",
"start_marketing_date": "20200814",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code L02BA01.
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