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United States · US · US:16714-662_2f6c168b-aaf3-4a6a-b8a0-5be6b5f81d7e

Gabapentin

Orange BookUNIISPLATC N02BF01

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

Identification

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

Packs · 3

  • ndc11
    1671466201
    100 CAPSULE in 1 BOTTLE (16714-662-01)
  • ndc11
    1671466202
    500 CAPSULE in 1 BOTTLE (16714-662-02)
  • ndc11
    1671466203
    1000 CAPSULE in 1 BOTTLE (16714-662-03)

Annotations

UNII (FDA Substance ID)
6CW7F3G59X
GABAPENTIN
RxCUI 25480
Orange Book
A078787
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": "16714-662_2f6c168b-aaf3-4a6a-b8a0-5be6b5f81d7e",
  "productndc": "16714-662",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "078787",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Jan 31, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "002",
        "approval_date": "Jan 31, 2008"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG",
        "product_no": "003",
        "approval_date": "Jan 31, 2008"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GABAPENTIN",
  "proprietary_name": "Gabapentin",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA078787",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Gabapentin",
  "start_marketing_date": "20080131",
  "active_numerator_strength": "300"
}

Related drugs

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