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United States · US · US:70518-2614_4a7a1b4f-bbe0-2c4f-e063-6294a90a1879

Gabapentin

Orange BookUNIISPLATC N02BF01

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

Identification

ManufacturerREMEDYREPACK INC.
CountryUS (United States)
ATC codeN02BF01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 5

  • ndc11
    7051826140
    90 CAPSULE in 1 BOTTLE, PLASTIC (70518-2614-0)
  • ndc11
    7051826142
    30 CAPSULE in 1 BLISTER PACK (70518-2614-2)
  • ndc11
    7051826143
    30 CAPSULE in 1 BOTTLE, PLASTIC (70518-2614-3)
  • ndc11
    7051826146
    60 CAPSULE in 1 BOTTLE, PLASTIC (70518-2614-6)
  • ndc11
    7051826147
    100 POUCH in 1 BOX (70518-2614-7) / 1 CAPSULE in 1 POUCH (70518-2614-8)

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": "70518-2614_4a7a1b4f-bbe0-2c4f-e063-6294a90a1879",
  "productndc": "70518-2614",
  "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": "20200306",
  "active_numerator_strength": "100"
}

Related drugs

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