Back to search
🇺🇸

United States · US · US:58151-285_dfbc1443-0ba8-479b-8590-32bd942732d4

Neurontin

Orange BookUNIISPLATC N02BF01

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

Identification

ManufacturerViatris Specialty LLC
CountryUS (United States)
ATC codeN02BF01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5815128501
    100 TABLET, FILM COATED in 1 BOTTLE (58151-285-01)

Annotations

UNII (FDA Substance ID)
6CW7F3G59X
GABAPENTIN
RxCUI 25480
Orange Book
N020882
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": {
    "97935fd9-1d4a-43b6-a5d9-de994591187b": {
      "match": "brand_token",
      "title": "NEURONTIN (GABAPENTIN) CAPSULE NEURONTIN (GABAPENTIN) TABLET, FILM COATED NEURONTIN (GABAPENTIN) SOLUTION [VIATRIS SPECIALTY LLC]",
      "spl_version": "47",
      "published_date": "2026-04-10"
    }
  },
  "productid": "58151-285_dfbc1443-0ba8-479b-8590-32bd942732d4",
  "productndc": "58151-285",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "020882",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB1",
        "strength": "600MG",
        "product_no": "001",
        "approval_date": "Oct 9, 1998"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB1",
        "strength": "800MG",
        "product_no": "002",
        "approval_date": "Oct 9, 1998"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GABAPENTIN",
  "proprietary_name": "Neurontin",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA020882",
  "marketing_category": "NDA",
  "nonproprietary_name": "gabapentin",
  "start_marketing_date": "20250919",
  "active_numerator_strength": "800"
}

Related drugs

Other records sharing ATC code N02BF01.

Access this data programmatically

Query Neurontin 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.