Neurontin

Orange BookUNIISPLATC N02BF01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

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
5815128201
100 CAPSULE in 1 BOTTLE (58151-282-01)

Annotations

UNII (FDA Substance ID)

6CW7F3G59X

GABAPENTIN

RxCUI 25480

Orange Book

N020235

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": {
    "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": "58151-282_dfbc1443-0ba8-479b-8590-32bd942732d4",
  "productndc": "58151-282",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "020235",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Dec 30, 1993"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "002",
        "approval_date": "Dec 30, 1993"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "400MG",
        "product_no": "003",
        "approval_date": "Dec 30, 1993"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GABAPENTIN",
  "proprietary_name": "Neurontin",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA020235",
  "marketing_category": "NDA",
  "nonproprietary_name": "gabapentin",
  "start_marketing_date": "20260409",
  "active_numerator_strength": "300"
}

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