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United States · US · US:71335-1007_b749e1c1-83fc-4693-99e8-1341909d80f7

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 · 9

  • ndc11
    7133510071
    30 TABLET, FILM COATED in 1 BOTTLE (71335-1007-1)
  • ndc11
    7133510072
    60 TABLET, FILM COATED in 1 BOTTLE (71335-1007-2)
  • ndc11
    7133510073
    90 TABLET, FILM COATED in 1 BOTTLE (71335-1007-3)
  • ndc11
    7133510074
    180 TABLET, FILM COATED in 1 BOTTLE (71335-1007-4)
  • ndc11
    7133510075
    120 TABLET, FILM COATED in 1 BOTTLE (71335-1007-5)
  • ndc11
    7133510076
    100 TABLET, FILM COATED in 1 BOTTLE (71335-1007-6)
  • ndc11
    7133510077
    84 TABLET, FILM COATED in 1 BOTTLE (71335-1007-7)
  • ndc11
    7133510078
    112 TABLET, FILM COATED in 1 BOTTLE (71335-1007-8)
  • ndc11
    7133510079
    135 TABLET, FILM COATED in 1 BOTTLE (71335-1007-9)

Annotations

UNII (FDA Substance ID)
6CW7F3G59X
GABAPENTIN
RxCUI 25480
Orange Book
A203244
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": "71335-1007_b749e1c1-83fc-4693-99e8-1341909d80f7",
  "productndc": "71335-1007",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "203244",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "800MG",
        "product_no": "001",
        "approval_date": "Jul 12, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "600MG",
        "product_no": "002",
        "approval_date": "Jul 12, 2013"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GABAPENTIN",
  "proprietary_name": "Gabapentin",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA203244",
  "marketing_category": "ANDA",
  "nonproprietary_name": "GABAPENTIN",
  "start_marketing_date": "20140111",
  "active_numerator_strength": "800"
}

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