NALBUPHINE HCI

Orange BookUNIISPLATC N02AF02

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerHF Acquisition Co LLC, DBA HealthFirst

CountryUS (United States)

ATC codeN02AF02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5166214181
1 VIAL, MULTI-DOSE in 1 CARTON (51662-1418-1) / 10 mL in 1 VIAL, MULTI-DOSE

Annotations

UNII (FDA Substance ID)

ZU4275277R

NALBUPHINE HYDROCHLORIDE

RxCUI 154985

Orange Book

A070918

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": "51662-1418_2b37c24d-1ab8-34d6-e063-6294a90abf70",
  "productndc": "51662-1418",
  "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 HCI",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA070918",
  "marketing_category": "ANDA",
  "nonproprietary_name": "NALBUPHINE HCI",
  "start_marketing_date": "20191029",
  "active_numerator_strength": "20"
}

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