LYVISPAH

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
6489607809
90 PACKET in 1 CARTON (64896-078-09) / 1 GRANULE in 1 PACKET

Annotations

UNII (FDA Substance ID)

H789N3FKE8

BACLOFEN

RxCUI 1292

Orange Book

N215422

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": "ORAL",
  "spl_meta": {
    "f8992a56-9010-4c4b-84d5-ddcc3e2c3317": {
      "match": "brand_token",
      "title": "LYVISPAH (BACLOFEN) GRANULE [AMNEAL PHARMACEUTICALS LLC]",
      "spl_version": "5",
      "published_date": "2024-10-25"
    }
  },
  "productid": "64896-078_d042d45f-7097-47e0-921f-0442e00d47e0",
  "productndc": "64896-078",
  "dosage_form": "GRANULE",
  "orange_book": {
    "appl_no": "215422",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "5MG/PACKET",
        "product_no": "001",
        "approval_date": "Nov 22, 2021"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "10MG/PACKET",
        "product_no": "002",
        "approval_date": "Nov 22, 2021"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "20MG/PACKET",
        "product_no": "003",
        "approval_date": "Nov 22, 2021"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BACLOFEN",
  "proprietary_name": "LYVISPAH",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA215422",
  "marketing_category": "NDA",
  "nonproprietary_name": "baclofen",
  "start_marketing_date": "20230601",
  "active_numerator_strength": "20"
}

Related drugs

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