Neurontin

Orange BookUNIISPLATC N02BF01

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

Identification

ManufacturerParke-Davis Div of Pfizer Inc

CountryUS (United States)

ATC codeN02BF01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0071080524
100 CAPSULE in 1 BOTTLE (0071-0805-24)

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": "0071-0805_e730d5df-d47b-4d7f-ae3b-bd449f6b1213",
  "productndc": "0071-0805",
  "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": "19931230",
  "active_numerator_strength": "300"
}

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