Gablofen

Orange BookUNIISPLATC M03BX01

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

Identification

ManufacturerPiramal Critical Care Inc

CountryUS (United States)

ATC codeM03BX01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6679415101
1 mL in 1 SYRINGE, GLASS (66794-151-01)

Annotations

UNII (FDA Substance ID)

H789N3FKE8

BACLOFEN

RxCUI 1292

Orange Book

N022462

APAPAPAP

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "H789N3FKE8",
    "rxcui": "1292",
    "inchikey": "KPYSYYIEGFHWSV-UHFFFAOYSA-N",
    "display_name": "BACLOFEN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRATHECAL",
  "spl_meta": {
    "00d3e846-dd92-448d-9ab8-6a07be823cc1": {
      "match": "brand_token",
      "title": "GABLOFEN (BACLOFEN INJECTION) INJECTION, SOLUTION [PIRAMAL CRITICAL CARE INC]",
      "spl_version": "43",
      "published_date": "2026-05-20"
    }
  },
  "productid": "66794-151_5135dfce-e3c4-a382-e063-6394a90a4875",
  "productndc": "66794-151",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "022462",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "0.05MG/ML",
        "product_no": "001",
        "approval_date": "Nov 19, 2010"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "0.5MG/ML",
        "product_no": "002",
        "approval_date": "Nov 19, 2010"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "2MG/ML",
        "product_no": "003",
        "approval_date": "Nov 19, 2010"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "1MG/ML",
        "product_no": "004",
        "approval_date": "Jun 22, 2012"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BACLOFEN",
  "proprietary_name": "Gablofen",
  "active_ingred_unit": "ug/mL",
  "application_number": "NDA022462",
  "marketing_category": "NDA",
  "nonproprietary_name": "Baclofen Injection",
  "start_marketing_date": "20170401",
  "active_numerator_strength": "50"
}

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