Back to search
🇺🇸

United States · US · US:76420-235_e347fcb2-dba9-193d-e053-2995a90a4784

Gabapentin

Orange BookUNIISPLATC N02BF01

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

Identification

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

Packs · 5

  • ndc11
    7642023512
    120 TABLET in 1 BOTTLE (76420-235-12)
  • ndc11
    7642023524
    240 TABLET in 1 BOTTLE (76420-235-24)
  • ndc11
    7642023530
    30 TABLET in 1 BOTTLE (76420-235-30)
  • ndc11
    7642023560
    60 TABLET in 1 BOTTLE (76420-235-60)
  • ndc11
    7642023590
    90 TABLET in 1 BOTTLE (76420-235-90)

Annotations

UNII (FDA Substance ID)
6CW7F3G59X
GABAPENTIN
RxCUI 25480
Orange Book
A205101
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": "76420-235_e347fcb2-dba9-193d-e053-2995a90a4784",
  "productndc": "76420-235",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "205101",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "600MG",
        "product_no": "001",
        "approval_date": "Feb 4, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "800MG",
        "product_no": "002",
        "approval_date": "Feb 4, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GABAPENTIN",
  "proprietary_name": "Gabapentin",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA205101",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Gabapentin",
  "start_marketing_date": "20160204",
  "active_numerator_strength": "600"
}

Related drugs

Other records sharing ATC code N02BF01.

Access this data programmatically

Query Gabapentin and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.