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United States · US · US:49702-212_01ba4f9b-3d72-4bc2-bae1-ecb13a8b845a

RETROVIR

Orange BookUNIISPLATC J05AF01

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerViiV Healthcare Company
CountryUS (United States)
ATC codeJ05AF01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4970221248
    240 mL in 1 BOTTLE (49702-212-48)

Annotations

UNII (FDA Substance ID)
4B9XT59T7S
ZIDOVUDINE
RxCUI 11413
Orange Book
N019910
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": {
    "6df09f15-b102-431c-adde-d7aeef6f5d84": {
      "match": "brand_token",
      "title": "RETROVIR (ZIDOVUDINE) CAPSULE RETROVIR (ZIDOVUDINE) SOLUTION RETROVIR (ZIDOVUDINE) INJECTION, SOLUTION [VIIV HEALTHCARE COMPANY]",
      "spl_version": "32",
      "published_date": "2025-09-25"
    }
  },
  "productid": "49702-212_01ba4f9b-3d72-4bc2-bae1-ecb13a8b845a",
  "productndc": "49702-212",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "019910",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AA",
        "strength": "50MG/5ML",
        "product_no": "001",
        "approval_date": "Sep 28, 1989"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ZIDOVUDINE",
  "proprietary_name": "RETROVIR",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA019910",
  "marketing_category": "NDA",
  "nonproprietary_name": "zidovudine",
  "start_marketing_date": "20101028",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code J05AF01.

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