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United States · US · US:71335-3060_5d28b44b-1f62-4868-8345-acdf1df41481

Gabapentin

Orange BookUNIISPLATC N02BF01

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeN02BF01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 10

  • ndc11
    7133530600
    28 TABLET in 1 BOTTLE (71335-3060-0)
  • ndc11
    7133530601
    30 TABLET in 1 BOTTLE (71335-3060-1)
  • ndc11
    7133530602
    60 TABLET in 1 BOTTLE (71335-3060-2)
  • ndc11
    7133530603
    180 TABLET in 1 BOTTLE (71335-3060-3)
  • ndc11
    7133530604
    90 TABLET in 1 BOTTLE (71335-3060-4)
  • ndc11
    7133530605
    100 TABLET in 1 BOTTLE (71335-3060-5)
  • ndc11
    7133530606
    120 TABLET in 1 BOTTLE (71335-3060-6)
  • ndc11
    7133530607
    500 TABLET in 1 BOTTLE (71335-3060-7)
  • ndc11
    7133530608
    84 TABLET in 1 BOTTLE (71335-3060-8)
  • ndc11
    7133530609
    112 TABLET in 1 BOTTLE (71335-3060-9)

Annotations

UNII (FDA Substance ID)
6CW7F3G59X
GABAPENTIN
RxCUI 25480
Orange Book
A217995
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": "71335-3060_5d28b44b-1f62-4868-8345-acdf1df41481",
  "productndc": "71335-3060",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "217995",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "600MG",
        "product_no": "001",
        "approval_date": "Jul 19, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "800MG",
        "product_no": "002",
        "approval_date": "Jul 19, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GABAPENTIN",
  "proprietary_name": "Gabapentin",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA217995",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Gabapentin",
  "start_marketing_date": "20240404",
  "active_numerator_strength": "600"
}

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