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United States · US · US:65862-048_19584bb3-e849-4839-961f-c38bb07a4e8c
Zidovudine
Orange BookUNIISPLATC J05AF01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeJ05AF01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc116586204824240 mL in 1 BOTTLE (65862-048-24)
Annotations
UNII (FDA Substance ID)
4B9XT59T7S
ZIDOVUDINE
RxCUI 11413
Orange Book
A077268
AA
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": "65862-048_19584bb3-e849-4839-961f-c38bb07a4e8c",
"productndc": "65862-048",
"dosage_form": "SYRUP",
"orange_book": {
"appl_no": "077268",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "50MG/5ML",
"product_no": "001",
"approval_date": "Sep 19, 2005"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ZIDOVUDINE",
"proprietary_name": "Zidovudine",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA077268",
"marketing_category": "ANDA",
"nonproprietary_name": "Zidovudine",
"start_marketing_date": "20050919",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code J05AF01.
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