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United States · US · US:71335-1997_8b321864-f57b-49e4-8eb0-748af0b2b96f

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 · 10

  • ndc11
    7133519970
    20 CAPSULE in 1 BOTTLE (71335-1997-0)
  • ndc11
    7133519971
    30 CAPSULE in 1 BOTTLE (71335-1997-1)
  • ndc11
    7133519972
    90 CAPSULE in 1 BOTTLE (71335-1997-2)
  • ndc11
    7133519973
    60 CAPSULE in 1 BOTTLE (71335-1997-3)
  • ndc11
    7133519974
    120 CAPSULE in 1 BOTTLE (71335-1997-4)
  • ndc11
    7133519975
    100 CAPSULE in 1 BOTTLE (71335-1997-5)
  • ndc11
    7133519976
    28 CAPSULE in 1 BOTTLE (71335-1997-6)
  • ndc11
    7133519977
    112 CAPSULE in 1 BOTTLE (71335-1997-7)
  • ndc11
    7133519978
    84 CAPSULE in 1 BOTTLE (71335-1997-8)
  • ndc11
    7133519979
    180 CAPSULE in 1 BOTTLE (71335-1997-9)

Annotations

UNII (FDA Substance ID)
6CW7F3G59X
GABAPENTIN
RxCUI 25480
Orange Book
A075360
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": "71335-1997_8b321864-f57b-49e4-8eb0-748af0b2b96f",
  "productndc": "71335-1997",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "075360",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Apr 6, 2005"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "002",
        "approval_date": "Apr 6, 2005"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG",
        "product_no": "003",
        "approval_date": "Apr 6, 2005"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GABAPENTIN",
  "proprietary_name": "GABAPENTIN",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA075360",
  "marketing_category": "ANDA",
  "nonproprietary_name": "GABAPENTIN",
  "start_marketing_date": "20200907",
  "active_numerator_strength": "300"
}

Related drugs

Other records sharing ATC code N02BF01.

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