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United States · US · US:71335-1454_eebc392f-b112-477a-af02-59ae539281ab

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 · 8

  • ndc11
    7133514541
    90 CAPSULE in 1 BOTTLE (71335-1454-1)
  • ndc11
    7133514542
    28 CAPSULE in 1 BOTTLE (71335-1454-2)
  • ndc11
    7133514543
    58 CAPSULE in 1 BOTTLE (71335-1454-3)
  • ndc11
    7133514544
    30 CAPSULE in 1 BOTTLE (71335-1454-4)
  • ndc11
    7133514545
    60 CAPSULE in 1 BOTTLE (71335-1454-5)
  • ndc11
    7133514546
    120 CAPSULE in 1 BOTTLE (71335-1454-6)
  • ndc11
    7133514547
    180 CAPSULE in 1 BOTTLE (71335-1454-7)
  • ndc11
    7133514548
    40 CAPSULE in 1 BOTTLE (71335-1454-8)

Annotations

UNII (FDA Substance ID)
6CW7F3G59X
GABAPENTIN
RxCUI 25480
Orange Book
A090705
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": "71335-1454_eebc392f-b112-477a-af02-59ae539281ab",
  "productndc": "71335-1454",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "090705",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Dec 30, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "002",
        "approval_date": "Dec 30, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG",
        "product_no": "003",
        "approval_date": "Dec 30, 2009"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GABAPENTIN",
  "proprietary_name": "GABAPENTIN",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA090705",
  "marketing_category": "ANDA",
  "nonproprietary_name": "GABAPENTIN",
  "start_marketing_date": "20171205",
  "active_numerator_strength": "300"
}

Related drugs

Other records sharing ATC code N02BF01.

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