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United States · US · US:72865-256_96acc27b-7400-480e-b79a-baa8ac3ab801

GABAPENTIN

Orange BookUNIISPLATC N02BF01

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerXLCare Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeN02BF01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7286525605
    500 TABLET in 1 BOTTLE (72865-256-05)
  • ndc11
    7286525690
    90 TABLET in 1 BOTTLE (72865-256-90)

Annotations

UNII (FDA Substance ID)
6CW7F3G59X
GABAPENTIN
RxCUI 25480
Orange Book
A214957
AB1AB1
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": {
    "798575b9-ddfa-4915-9574-626abbaf025f": {
      "match": "brand_token",
      "title": "GABAPENTIN CAPSULE [STRIDES PHARMA SCIENCE LIMITED]",
      "spl_version": "3",
      "published_date": "2026-06-02"
    }
  },
  "productid": "72865-256_96acc27b-7400-480e-b79a-baa8ac3ab801",
  "productndc": "72865-256",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "214957",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "600MG",
        "product_no": "001",
        "approval_date": "Oct 1, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "800MG",
        "product_no": "002",
        "approval_date": "Oct 1, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GABAPENTIN",
  "proprietary_name": "GABAPENTIN",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA214957",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Gabapentin",
  "start_marketing_date": "20211001",
  "active_numerator_strength": "800"
}

Related drugs

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