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United States · US · US:76420-789_227219b4-ec12-cb15-e063-6394a90acd32

Gabapentin

Orange BookUNIISPLATC N02BF01

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

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
    7642078901
    100 CAPSULE in 1 BOTTLE, PLASTIC (76420-789-01)
  • ndc11
    7642078905
    500 CAPSULE in 1 BOTTLE, PLASTIC (76420-789-05)
  • ndc11
    7642078912
    120 CAPSULE in 1 BOTTLE, PLASTIC (76420-789-12)
  • ndc11
    7642078930
    30 CAPSULE in 1 BOTTLE, PLASTIC (76420-789-30)
  • ndc11
    7642078960
    60 CAPSULE in 1 BOTTLE, PLASTIC (76420-789-60)
  • ndc11
    7642078990
    90 CAPSULE in 1 BOTTLE, PLASTIC (76420-789-90)

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": "76420-789_227219b4-ec12-cb15-e063-6394a90acd32",
  "productndc": "76420-789",
  "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": "20160218",
  "active_numerator_strength": "300"
}

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