Gabapentin

Orange BookUNIISPLATC N02BF01

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

Identification

ManufacturerLaurus Labs Limited

CountryUS (United States)

ATC codeN02BF01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
4238598001
100 TABLET, FILM COATED in 1 BOTTLE (42385-980-01)
ndc11
4238598005
500 TABLET, FILM COATED in 1 BOTTLE (42385-980-05)
ndc11
4238598011
1000 TABLET, FILM COATED in 1 BOTTLE (42385-980-11)
ndc11
4238598030
30 TABLET, FILM COATED in 1 BOTTLE (42385-980-30)
ndc11
4238598072
10 BLISTER PACK in 1 CARTON (42385-980-72) / 10 TABLET, FILM COATED in 1 BLISTER PACK
ndc11
4238598090
90 TABLET, FILM COATED in 1 BOTTLE (42385-980-90)

Annotations

UNII (FDA Substance ID)

6CW7F3G59X

GABAPENTIN

RxCUI 25480

Orange Book

A217965

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": "42385-980_5fd82a02-46ac-4312-a008-fa17e5cd3ffd",
  "productndc": "42385-980",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "217965",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "600MG",
        "product_no": "001",
        "approval_date": "Apr 8, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "800MG",
        "product_no": "002",
        "approval_date": "Apr 8, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GABAPENTIN",
  "proprietary_name": "Gabapentin",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA217965",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Gabapentin",
  "start_marketing_date": "20240409",
  "active_numerator_strength": "800"
}

Related drugs

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