gabapentin

Orange BookUNIISPLATC N02BF01

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

Identification

ManufacturerZydus Pharmaceuticals USA Inc.

CountryUS (United States)

ATC codeN02BF01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
6838260705
500 TABLET in 1 BOTTLE (68382-607-05)
ndc11
6838260716
90 TABLET in 1 BOTTLE (68382-607-16)
ndc11
6838260777
10 BLISTER PACK in 1 CARTON (68382-607-77) / 10 TABLET in 1 BLISTER PACK (68382-607-30)

Annotations

UNII (FDA Substance ID)

6CW7F3G59X

GABAPENTIN

RxCUI 25480

Orange Book

A203934

AB2AB2ABABAB

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": "68382-607_898c1710-d86c-4fbe-9a53-34661fcdb63a",
  "productndc": "68382-607",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "203934",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB2",
        "strength": "300MG",
        "product_no": "001",
        "approval_date": "Jan 24, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB2",
        "strength": "600MG",
        "product_no": "002",
        "approval_date": "Jan 24, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "450MG",
        "product_no": "003",
        "approval_date": "Aug 25, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "750MG",
        "product_no": "004",
        "approval_date": "Aug 25, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "900MG",
        "product_no": "005",
        "approval_date": "Aug 25, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GABAPENTIN",
  "proprietary_name": "gabapentin",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA203934",
  "marketing_category": "ANDA",
  "nonproprietary_name": "gabapentin",
  "start_marketing_date": "20240125",
  "active_numerator_strength": "600"
}

Related drugs

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