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United States · US · US:71335-1269_6a0627fe-0cbc-4e93-928c-2d4d181b95e0

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 · 8

  • ndc11
    7133512691
    90 CAPSULE in 1 BOTTLE (71335-1269-1)
  • ndc11
    7133512692
    28 CAPSULE in 1 BOTTLE (71335-1269-2)
  • ndc11
    7133512693
    58 CAPSULE in 1 BOTTLE (71335-1269-3)
  • ndc11
    7133512694
    30 CAPSULE in 1 BOTTLE (71335-1269-4)
  • ndc11
    7133512695
    60 CAPSULE in 1 BOTTLE (71335-1269-5)
  • ndc11
    7133512696
    120 CAPSULE in 1 BOTTLE (71335-1269-6)
  • ndc11
    7133512697
    180 CAPSULE in 1 BOTTLE (71335-1269-7)
  • ndc11
    7133512698
    40 CAPSULE in 1 BOTTLE (71335-1269-8)

Annotations

UNII (FDA Substance ID)
6CW7F3G59X
GABAPENTIN
RxCUI 25480
Orange Book
A090858
ABABAB
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": "71335-1269_6a0627fe-0cbc-4e93-928c-2d4d181b95e0",
  "productndc": "71335-1269",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "090858",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Dec 17, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "002",
        "approval_date": "Dec 17, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG",
        "product_no": "003",
        "approval_date": "Dec 17, 2010"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GABAPENTIN",
  "proprietary_name": "Gabapentin",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA090858",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Gabapentin",
  "start_marketing_date": "20110129",
  "active_numerator_strength": "300"
}

Related drugs

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