Lioresal (baclofen)

Orange BookUNIISPLATC M03BX01

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

Identification

ManufacturerAmneal Pharmaceuticals LLC

CountryUS (United States)

ATC codeM03BX01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7012124965
5 AMPULE in 1 BOX (70121-2496-5) / 1 mL in 1 AMPULE

Annotations

UNII (FDA Substance ID)

H789N3FKE8

BACLOFEN

RxCUI 1292

Orange Book

N020075

APAPAP

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": {
    "6f3bdcc0-ffc8-4911-8c35-958c8103a2c5": {
      "match": "brand_token",
      "title": "LIORESAL (BACLOFEN) (BACLOFEN) KIT LIORESAL (BACLOFEN) (BACLOFEN) INJECTION [AMNEAL PHARMACEUTICALS LLC]",
      "spl_version": "29",
      "published_date": "2025-11-18"
    }
  },
  "productid": "70121-2496_d68a08e0-d0d9-4144-be01-47b636dfa7e1",
  "productndc": "70121-2496",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "020075",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "0.5MG/ML",
        "product_no": "001",
        "approval_date": "Jun 17, 1992"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "2MG/ML",
        "product_no": "002",
        "approval_date": "Jun 17, 1992"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "0.05MG/ML",
        "product_no": "003",
        "approval_date": "Nov 7, 1996"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BACLOFEN",
  "proprietary_name": "Lioresal (baclofen)",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA020075",
  "marketing_category": "NDA",
  "nonproprietary_name": "baclofen",
  "start_marketing_date": "20220612",
  "active_numerator_strength": ".05"
}

Related drugs

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