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United States · US · US:72162-2139_8513f8ab-cf2a-4654-b0b3-91640b319168

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 · 5

  • ndc11
    7216221391
    100 CAPSULE in 1 BOTTLE, PLASTIC (72162-2139-1)
  • ndc11
    7216221392
    270 CAPSULE in 1 BOTTLE, PLASTIC (72162-2139-2)
  • ndc11
    7216221393
    30 CAPSULE in 1 BOTTLE, PLASTIC (72162-2139-3)
  • ndc11
    7216221395
    500 CAPSULE in 1 BOTTLE, PLASTIC (72162-2139-5)
  • ndc11
    7216221399
    90 CAPSULE in 1 BOTTLE, PLASTIC (72162-2139-9)

Annotations

UNII (FDA Substance ID)
6CW7F3G59X
GABAPENTIN
RxCUI 25480
Orange Book
A206943
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": "72162-2139_8513f8ab-cf2a-4654-b0b3-91640b319168",
  "productndc": "72162-2139",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "206943",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "May 14, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "002",
        "approval_date": "May 14, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG",
        "product_no": "003",
        "approval_date": "May 14, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GABAPENTIN",
  "proprietary_name": "Gabapentin",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA206943",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Gabapentin",
  "start_marketing_date": "20180514",
  "active_numerator_strength": "300"
}

Related drugs

Other records sharing ATC code N02BF01.

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