Gabapentin

Orange BookUNIISPLATC N02BF01

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

Identification

ManufacturerPreferred Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeN02BF01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 8

ndc11
6878887120
100 CAPSULE in 1 BOTTLE, PLASTIC (68788-8712-0)
ndc11
6878887122
20 CAPSULE in 1 BOTTLE, PLASTIC (68788-8712-2)
ndc11
6878887123
30 CAPSULE in 1 BOTTLE, PLASTIC (68788-8712-3)
ndc11
6878887124
28 CAPSULE in 1 BOTTLE, PLASTIC (68788-8712-4)
ndc11
6878887125
15 CAPSULE in 1 BOTTLE, PLASTIC (68788-8712-5)
ndc11
6878887126
60 CAPSULE in 1 BOTTLE, PLASTIC (68788-8712-6)
ndc11
6878887128
120 CAPSULE in 1 BOTTLE, PLASTIC (68788-8712-8)
ndc11
6878887129
90 CAPSULE in 1 BOTTLE, PLASTIC (68788-8712-9)

Annotations

UNII (FDA Substance ID)

6CW7F3G59X

GABAPENTIN

RxCUI 25480

Orange Book

A204989

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": {
    "798575b9-ddfa-4915-9574-626abbaf025f": {
      "match": "brand_token",
      "title": "GABAPENTIN CAPSULE [STRIDES PHARMA SCIENCE LIMITED]",
      "spl_version": "3",
      "published_date": "2026-06-02"
    }
  },
  "productid": "68788-8712_c22a5d36-9f6e-41bf-8703-7364aaa84715",
  "productndc": "68788-8712",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "204989",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Feb 18, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "002",
        "approval_date": "Feb 18, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG",
        "product_no": "003",
        "approval_date": "Feb 18, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "200MG",
        "product_no": "004",
        "approval_date": "Mar 6, 2026"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GABAPENTIN",
  "proprietary_name": "Gabapentin",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA204989",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Gabapentin",
  "start_marketing_date": "20240709",
  "active_numerator_strength": "300"
}

Related drugs

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