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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

  • ndc11
    6704616133
    30 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

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