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United States · US · US:0409-1467_cbcbf107-67c0-4a8a-a25d-5a05c43a0bfd

Nalbuphine Hydrochloride

Orange BookUNIISPLATC N02AF02

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

Identification

ManufacturerHospira, Inc.
CountryUS (United States)
ATC codeN02AF02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0409146701
    25 CARTON in 1 CASE (0409-1467-01) / 1 VIAL, MULTI-DOSE in 1 CARTON (0409-1467-61) / 10 mL in 1 VIAL, MULTI-DOSE

Annotations

UNII (FDA Substance ID)
ZU4275277R
NALBUPHINE HYDROCHLORIDE
RxCUI 154985
Orange Book
A070918
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "ZU4275277R",
    "rxcui": "154985",
    "inchikey": "YZLZPSJXMWGIFH-BCXQGASESA-N",
    "display_name": "NALBUPHINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
  "spl_meta": {
    "dd621bfa-ce48-4c27-b247-a6d885f70b72": {
      "match": "brand_token",
      "title": "NALBUPHINE HYDROCHLORIDE INJECTION [HENRY SCHEIN, INC.]",
      "spl_version": "2",
      "published_date": "2026-04-28"
    }
  },
  "productid": "0409-1467_cbcbf107-67c0-4a8a-a25d-5a05c43a0bfd",
  "productndc": "0409-1467",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "070918",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "200MG/10ML (20MG/ML)",
        "product_no": "001",
        "approval_date": "Feb 3, 1989"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "NALBUPHINE HYDROCHLORIDE",
  "proprietary_name": "Nalbuphine Hydrochloride",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA070918",
  "marketing_category": "ANDA",
  "nonproprietary_name": "NALBUPHINE HYDROCHLORIDE",
  "start_marketing_date": "20050516",
  "active_numerator_strength": "20"
}

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