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United States · US · US:63187-810_bd1a42c2-a627-4f3b-ba8c-bb1877f99ca0

Gabapentin

Orange BookUNIISPLATC N02BF01

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

Identification

ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeN02BF01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 6

  • ndc11
    6318781000
    100 CAPSULE in 1 BOTTLE (63187-810-00)
  • ndc11
    6318781015
    15 CAPSULE in 1 BOTTLE (63187-810-15)
  • ndc11
    6318781030
    30 CAPSULE in 1 BOTTLE (63187-810-30)
  • ndc11
    6318781060
    60 CAPSULE in 1 BOTTLE (63187-810-60)
  • ndc11
    6318781072
    120 CAPSULE in 1 BOTTLE (63187-810-72)
  • ndc11
    6318781090
    90 CAPSULE in 1 BOTTLE (63187-810-90)

Annotations

UNII (FDA Substance ID)
6CW7F3G59X
GABAPENTIN
RxCUI 25480
Orange Book
A090858
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": "63187-810_bd1a42c2-a627-4f3b-ba8c-bb1877f99ca0",
  "productndc": "63187-810",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "090858",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Dec 17, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "002",
        "approval_date": "Dec 17, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG",
        "product_no": "003",
        "approval_date": "Dec 17, 2010"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GABAPENTIN",
  "proprietary_name": "Gabapentin",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA090858",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Gabapentin",
  "start_marketing_date": "20110129",
  "active_numerator_strength": "300"
}

Related drugs

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