Nalbuphine hydrochloride

Orange BookUNIISPLATC N02AF02

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

Identification

ManufacturerSomerset Therapeutics, LLC

CountryUS (United States)

ATC codeN02AF02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7006967110
10 AMPULE in 1 CARTON (70069-671-10) / 1 mL in 1 AMPULE (70069-671-01)

Annotations

UNII (FDA Substance ID)

ZU4275277R

NALBUPHINE HYDROCHLORIDE

RxCUI 154985

Orange Book

A216050

APAP

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": "70069-671_d7e3d7be-ce38-4696-979c-64dd1023a4cd",
  "productndc": "70069-671",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "216050",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "10MG/ML (10MG/ML)",
        "product_no": "001",
        "approval_date": "Sep 19, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "20MG/ML (20MG/ML)",
        "product_no": "002",
        "approval_date": "Sep 19, 2024"
      }
    ],
    "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": "ANDA216050",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Nalbuphine hydrochloride",
  "start_marketing_date": "20240925",
  "active_numerator_strength": "10"
}

Related drugs

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