Lioresal (baclofen)

Orange BookSPL

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

Identification

ManufacturerAmneal Pharmaceuticals LLC

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7012125052
2 AMPULE in 1 BOX (70121-2505-2) / 1 KIT in 1 AMPULE

Annotations

Orange Book

N020075

APAPAP

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "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": "70121-2505_d68a08e0-d0d9-4144-be01-47b636dfa7e1",
  "productndc": "70121-2505",
  "dosage_form": "KIT",
  "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": null,
  "proprietary_name": "Lioresal (baclofen)",
  "active_ingred_unit": null,
  "application_number": "NDA020075",
  "marketing_category": "NDA",
  "nonproprietary_name": "baclofen",
  "start_marketing_date": "20220612",
  "active_numerator_strength": null
}

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