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United States · US · US:68071-4784_1adbfbb6-92bf-3288-e063-6394a90a6f29

GABAPENTIN

Orange BookUNIISPLATC N02BF01

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

Identification

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

Packs · 1

  • ndc11
    6807147841
    100 CAPSULE in 1 BOTTLE (68071-4784-1)

Annotations

UNII (FDA Substance ID)
6CW7F3G59X
GABAPENTIN
RxCUI 25480
Orange Book
A090007
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": "68071-4784_1adbfbb6-92bf-3288-e063-6394a90a6f29",
  "productndc": "68071-4784",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "090007",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Jul 21, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "002",
        "approval_date": "Jul 21, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG",
        "product_no": "003",
        "approval_date": "Jul 21, 2011"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GABAPENTIN",
  "proprietary_name": "GABAPENTIN",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA090007",
  "marketing_category": "ANDA",
  "nonproprietary_name": "GABAPENTIN",
  "start_marketing_date": "20151230",
  "active_numerator_strength": "300"
}

Related drugs

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