GABARONE

Orange BookUNIISPLATC N02BF01

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

Identification

ManufacturerINA Pharmaceutics Inc.

CountryUS (United States)

ATC codeN02BF01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7415711190
90 TABLET in 1 BOTTLE (74157-111-90)

Annotations

UNII (FDA Substance ID)

6CW7F3G59X

GABAPENTIN

RxCUI 25480

Orange Book

A211313

AB1AB1AB1AB1

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": {
    "0f350a4b-f294-4b98-b69f-3cc789e930ba": {
      "match": "brand_token",
      "title": "GABARONE (GABAPENTIN) TABLET [INA PHARMACEUTICS INC.]",
      "spl_version": "2",
      "published_date": "2026-01-09"
    }
  },
  "productid": "74157-111_47d9ab92-3736-01a7-e063-6394a90a7c55",
  "productndc": "74157-111",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "211313",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "600MG",
        "product_no": "001",
        "approval_date": "Mar 4, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "800MG",
        "product_no": "002",
        "approval_date": "Mar 4, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "100MG",
        "product_no": "003",
        "approval_date": "Dec 20, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "400MG",
        "product_no": "004",
        "approval_date": "Dec 20, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GABAPENTIN",
  "proprietary_name": "GABARONE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA211313",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Gabapentin",
  "start_marketing_date": "20241223",
  "active_numerator_strength": "400"
}

Related drugs

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