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United States · US · US:68382-395_5b244567-d037-4fbd-9e2b-ed394e1c07b4

RIBAVIRIN

Orange BookUNIISPLATC J05AP01

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

Identification

ManufacturerZydus Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeJ05AP01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6838239504
    4 VIAL in 1 CARTON (68382-395-04) / 1 POWDER, FOR SOLUTION in 1 VIAL

Annotations

UNII (FDA Substance ID)
49717AWG6K
RIBAVIRIN
RxCUI 9344
Orange Book
A207366
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "49717AWG6K",
    "rxcui": "9344",
    "inchikey": "IWUCXVSUMQZMFG-AFCXAGJDSA-N",
    "display_name": "RIBAVIRIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "RESPIRATORY (INHALATION)",
  "spl_meta": {
    "7ea8dafa-d3d8-493e-a0db-e783d92fb13f": {
      "match": "brand_token",
      "title": "RIBAVIRIN POWDER, FOR SOLUTION [CAMERON PHARMACEUTICALS]",
      "spl_version": "3",
      "published_date": "2026-04-15"
    }
  },
  "productid": "68382-395_5b244567-d037-4fbd-9e2b-ed394e1c07b4",
  "productndc": "68382-395",
  "dosage_form": "POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "207366",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "6GM/VIAL",
        "product_no": "001",
        "approval_date": "Oct 6, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "RIBAVIRIN",
  "proprietary_name": "RIBAVIRIN",
  "active_ingred_unit": "g/1",
  "application_number": "ANDA207366",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ribavirin",
  "start_marketing_date": "20161215",
  "active_numerator_strength": "6"
}

Related drugs

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