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United States · US · US:65862-024_0f90ebc4-1e78-420b-a2cb-0dc715bdb853

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 · 2

  • ndc11
    6586202410
    6 BLISTER PACK in 1 CARTON (65862-024-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • ndc11
    6586202460
    60 TABLET, FILM COATED in 1 BOTTLE (65862-024-60)

Annotations

UNII (FDA Substance ID)
4B9XT59T7S
ZIDOVUDINE
RxCUI 11413
Orange Book
A077267
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": "65862-024_0f90ebc4-1e78-420b-a2cb-0dc715bdb853",
  "productndc": "65862-024",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "077267",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "300MG",
        "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/1",
  "application_number": "ANDA077267",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Zidovudine",
  "start_marketing_date": "20050919",
  "active_numerator_strength": "300"
}

Related drugs

Other records sharing ATC code J05AF01.

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