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United States · US · US:0004-0802_94a312ac-c47a-4437-8dd3-6bcd7e08e42c

Tamiflu

In shortageOrange BookUNIISPLATC J05AH02

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

Identification

ManufacturerGenentech, Inc.
CountryUS (United States)
ATC codeJ05AH02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0004080285
    1 BLISTER PACK in 1 CARTON (0004-0802-85) / 10 CAPSULE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
4A3O49NGEZ
OSELTAMIVIR PHOSPHATE
RxCUI 259275
Orange Book
N021087
AB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Oseltamivir Phosphate Capsule
Raw payload (JSON)
{
  "unii": {
    "unii": "4A3O49NGEZ",
    "rxcui": "259275",
    "inchikey": "PGZUMBJQJWIWGJ-ONAKXNSWSA-N",
    "display_name": "OSELTAMIVIR PHOSPHATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "ee3c9555-60f2-4f82-a760-11983c86e97b": {
      "match": "brand_token",
      "title": "TAMIFLU (OSELTAMIVIR PHOSPHATE) CAPSULE TAMIFLU (OSELTAMIVIR PHOSPHATE) POWDER, FOR SUSPENSION [GENENTECH, INC.]",
      "spl_version": "45",
      "published_date": "2025-12-19"
    }
  },
  "productid": "0004-0802_94a312ac-c47a-4437-8dd3-6bcd7e08e42c",
  "productndc": "0004-0802",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "021087",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 75MG BASE",
        "product_no": "001",
        "approval_date": "Oct 27, 1999"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 45MG BASE",
        "product_no": "002",
        "approval_date": "Jul 2, 2007"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 30MG BASE",
        "product_no": "003",
        "approval_date": "Jul 2, 2007"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "OSELTAMIVIR PHOSPHATE",
  "shortage_reason": "Oseltamivir Phosphate Capsule",
  "shortage_status": "current",
  "proprietary_name": "Tamiflu",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021087",
  "marketing_category": "NDA",
  "nonproprietary_name": "oseltamivir phosphate",
  "start_marketing_date": "19991027",
  "active_numerator_strength": "30"
}

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