GABAPENTIN

Orange BookUNIISPLATC N02BF01

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

Identification

ManufacturerAsclemed USA, Inc.

CountryUS (United States)

ATC codeN02BF01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
7642061710
100 CAPSULE in 1 BOTTLE (76420-617-10)
ndc11
7642061712
120 CAPSULE in 1 BOTTLE (76420-617-12)
ndc11
7642061724
240 CAPSULE in 1 BOTTLE (76420-617-24)
ndc11
7642061730
30 CAPSULE in 1 BOTTLE (76420-617-30)
ndc11
7642061760
60 CAPSULE in 1 BOTTLE (76420-617-60)
ndc11
7642061790
90 CAPSULE in 1 BOTTLE (76420-617-90)

Annotations

UNII (FDA Substance ID)

6CW7F3G59X

GABAPENTIN

RxCUI 25480

Orange Book

A075360

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": "76420-617_068d23f0-3994-f3d5-e063-6394a90ae9a4",
  "productndc": "76420-617",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "075360",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Apr 6, 2005"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "002",
        "approval_date": "Apr 6, 2005"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG",
        "product_no": "003",
        "approval_date": "Apr 6, 2005"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GABAPENTIN",
  "proprietary_name": "GABAPENTIN",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA075360",
  "marketing_category": "ANDA",
  "nonproprietary_name": "GABAPENTIN",
  "start_marketing_date": "20200907",
  "active_numerator_strength": "300"
}

Related drugs

Other records sharing ATC code N02BF01.

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