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 · 8

ndc11
7642086800
1000 CAPSULE in 1 BOTTLE (76420-868-00)
ndc11
7642086801
100 CAPSULE in 1 BOTTLE (76420-868-01)
ndc11
7642086805
500 CAPSULE in 1 BOTTLE (76420-868-05)
ndc11
7642086812
120 CAPSULE in 1 BOTTLE (76420-868-12)
ndc11
7642086824
240 CAPSULE in 1 BOTTLE (76420-868-24)
ndc11
7642086830
30 CAPSULE in 1 BOTTLE (76420-868-30)
ndc11
7642086860
60 CAPSULE in 1 BOTTLE (76420-868-60)
ndc11
7642086890
90 CAPSULE in 1 BOTTLE (76420-868-90)

Annotations

UNII (FDA Substance ID)

6CW7F3G59X

GABAPENTIN

RxCUI 25480

Orange Book

A214956

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": "76420-868_26246a5d-24de-ef78-e063-6394a90aff7b",
  "productndc": "76420-868",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "214956",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "May 10, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "002",
        "approval_date": "May 10, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG",
        "product_no": "003",
        "approval_date": "May 10, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GABAPENTIN",
  "proprietary_name": "GABAPENTIN",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA214956",
  "marketing_category": "ANDA",
  "nonproprietary_name": "gabapentin",
  "start_marketing_date": "20210510",
  "active_numerator_strength": "100"
}

Related drugs

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