Gralise

Orange BookUNIISPLATC N02BF01

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

Identification

ManufacturerAlmatica Pharma LLC

CountryUS (United States)

ATC codeN02BF01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5242780460
60 TABLET, FILM COATED in 1 BOTTLE (52427-804-60)

Annotations

UNII (FDA Substance ID)

6CW7F3G59X

GABAPENTIN

RxCUI 25480

Orange Book

N022544

AB2AB2ABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "6CW7F3G59X",
    "rxcui": "25480",
    "inchikey": "UGJMXCAKCUNAIE-UHFFFAOYSA-N",
    "display_name": "GABAPENTIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "466273b1-c9fc-3930-c94b-aa11394d5140": {
      "match": "brand_token",
      "title": "GRALISE (GABAPENTIN) TABLET, FILM COATED GRALISE (GABAPENTIN) KIT [ALMATICA PHARMA LLC]",
      "spl_version": "6",
      "published_date": "2025-07-02"
    }
  },
  "productid": "52427-804_44a61305-2313-59c4-8a44-98c827461735",
  "productndc": "52427-804",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "022544",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB2",
        "strength": "300MG",
        "product_no": "001",
        "approval_date": "Jan 28, 2011"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB2",
        "strength": "600MG",
        "product_no": "002",
        "approval_date": "Jan 28, 2011"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "450MG",
        "product_no": "003",
        "approval_date": "Apr 18, 2023"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "750MG",
        "product_no": "004",
        "approval_date": "Apr 18, 2023"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "900MG",
        "product_no": "005",
        "approval_date": "Apr 18, 2023"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GABAPENTIN",
  "proprietary_name": "Gralise",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA022544",
  "marketing_category": "NDA",
  "nonproprietary_name": "gabapentin",
  "start_marketing_date": "20231231",
  "active_numerator_strength": "450"
}

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