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United States · US · US:67046-1613_48c0ccac-2fe3-0fe2-e063-6294a90a2a9c
Zidovudine
Orange BookUNIISPLATC J05AF01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCoupler LLC
CountryUS (United States)
ATC codeJ05AF01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11670461613330 TABLET in 1 BLISTER PACK (67046-1613-3)
Annotations
UNII (FDA Substance ID)
4B9XT59T7S
ZIDOVUDINE
RxCUI 11413
Orange Book
A090092
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "4B9XT59T7S",
"rxcui": "11413",
"inchikey": "HBOMLICNUCNMMY-XLPZGREQSA-N",
"display_name": "ZIDOVUDINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"437f55b2-f6d9-0065-e063-6294a90ab929": {
"match": "brand_token",
"title": "ZIDOVUDINE TABLET [COUPLER LLC]",
"spl_version": "2",
"published_date": "2026-01-21"
}
},
"productid": "67046-1613_48c0ccac-2fe3-0fe2-e063-6294a90a2a9c",
"productndc": "67046-1613",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "090092",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "300MG",
"product_no": "001",
"approval_date": "Apr 25, 2008"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ZIDOVUDINE",
"proprietary_name": "Zidovudine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA090092",
"marketing_category": "ANDA",
"nonproprietary_name": "Zidovudine",
"start_marketing_date": "20251113",
"active_numerator_strength": "300"
}Related drugs
Other records sharing ATC code J05AF01.
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