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United States · US · US:72162-1813_e8a268d7-a080-4540-8ac9-63201fd965e4

Gabapentin

Orange BookUNIISPLATC N02BF01

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeN02BF01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 7

  • ndc11
    7216218131
    100 CAPSULE in 1 BOTTLE (72162-1813-1)
  • ndc11
    7216218132
    120 CAPSULE in 1 BOTTLE (72162-1813-2)
  • ndc11
    7216218134
    20 CAPSULE in 1 BOTTLE (72162-1813-4)
  • ndc11
    7216218136
    60 CAPSULE in 1 BOTTLE (72162-1813-6)
  • ndc11
    7216218137
    180 CAPSULE in 1 BOTTLE (72162-1813-7)
  • ndc11
    7216218138
    84 CAPSULE in 1 BOTTLE (72162-1813-8)
  • ndc11
    7216218139
    90 CAPSULE in 1 BOTTLE (72162-1813-9)

Annotations

UNII (FDA Substance ID)
6CW7F3G59X
GABAPENTIN
RxCUI 25480
Orange Book
A078428
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": "72162-1813_e8a268d7-a080-4540-8ac9-63201fd965e4",
  "productndc": "72162-1813",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "078428",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Jul 25, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "002",
        "approval_date": "Jul 25, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG",
        "product_no": "003",
        "approval_date": "Jul 25, 2007"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GABAPENTIN",
  "proprietary_name": "Gabapentin",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA078428",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Gabapentin",
  "start_marketing_date": "20091124",
  "active_numerator_strength": "300"
}

Related drugs

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