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United States · US · US:71335-2048_c8480861-4d12-4b83-abe8-3a6f182de239

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 · 6

  • ndc11
    7133520481
    90 TABLET in 1 BOTTLE (71335-2048-1)
  • ndc11
    7133520482
    58 TABLET in 1 BOTTLE (71335-2048-2)
  • ndc11
    7133520483
    100 TABLET in 1 BOTTLE (71335-2048-3)
  • ndc11
    7133520484
    120 TABLET in 1 BOTTLE (71335-2048-4)
  • ndc11
    7133520485
    60 TABLET in 1 BOTTLE (71335-2048-5)
  • ndc11
    7133520486
    30 TABLET in 1 BOTTLE (71335-2048-6)

Annotations

UNII (FDA Substance ID)
6CW7F3G59X
GABAPENTIN
RxCUI 25480
Orange Book
A206402
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": "71335-2048_c8480861-4d12-4b83-abe8-3a6f182de239",
  "productndc": "71335-2048",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "206402",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "600MG",
        "product_no": "001",
        "approval_date": "Dec 23, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "800MG",
        "product_no": "002",
        "approval_date": "Dec 23, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GABAPENTIN",
  "proprietary_name": "Gabapentin",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA206402",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Gabapentin",
  "start_marketing_date": "20151101",
  "active_numerator_strength": "600"
}

Related drugs

Other records sharing ATC code N02BF01.

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