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United States · US · US:62756-139_aff50a15-df39-495f-a145-0ba59660eed8

gabapentin

Orange BookUNIISPLATC N02BF01

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeN02BF01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 5

  • ndc11
    6275613901
    50 CAPSULE in 1 BOX, UNIT-DOSE (62756-139-01)
  • ndc11
    6275613902
    100 CAPSULE in 1 BOTTLE (62756-139-02)
  • ndc11
    6275613903
    100 CAPSULE in 1 BOTTLE (62756-139-03)
  • ndc11
    6275613904
    1000 CAPSULE in 1 BOTTLE (62756-139-04)
  • ndc11
    6275613905
    500 CAPSULE in 1 BOTTLE (62756-139-05)

Annotations

UNII (FDA Substance ID)
6CW7F3G59X
GABAPENTIN
RxCUI 25480
Orange Book
A077242
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": "62756-139_aff50a15-df39-495f-a145-0ba59660eed8",
  "productndc": "62756-139",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "077242",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Aug 24, 2006"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "300MG",
        "product_no": "002",
        "approval_date": "Aug 24, 2006"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "400MG",
        "product_no": "003",
        "approval_date": "Aug 24, 2006"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GABAPENTIN",
  "proprietary_name": "gabapentin",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA077242",
  "marketing_category": "ANDA",
  "nonproprietary_name": "gabapentin",
  "start_marketing_date": "20220201",
  "active_numerator_strength": "400"
}

Related drugs

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