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United States · US · US:71335-0351_165c2908-0442-46aa-82e6-4c4ad348a0d1

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
    7133503510
    180 CAPSULE in 1 BOTTLE (71335-0351-0)
  • ndc11
    7133503511
    20 CAPSULE in 1 BOTTLE (71335-0351-1)
  • ndc11
    7133503512
    90 CAPSULE in 1 BOTTLE (71335-0351-2)
  • ndc11
    7133503513
    60 CAPSULE in 1 BOTTLE (71335-0351-3)
  • ndc11
    7133503514
    30 CAPSULE in 1 BOTTLE (71335-0351-4)
  • ndc11
    7133503515
    120 CAPSULE in 1 BOTTLE (71335-0351-5)
  • ndc11
    7133503516
    21 CAPSULE in 1 BOTTLE (71335-0351-6)
  • ndc11
    7133503517
    84 CAPSULE in 1 BOTTLE (71335-0351-7)
  • ndc11
    7133503518
    112 CAPSULE in 1 BOTTLE (71335-0351-8)
  • ndc11
    7133503519
    28 CAPSULE in 1 BOTTLE (71335-0351-9)

Annotations

UNII (FDA Substance ID)
6CW7F3G59X
GABAPENTIN
RxCUI 25480
Orange Book
A075350
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": "71335-0351_165c2908-0442-46aa-82e6-4c4ad348a0d1",
  "productndc": "71335-0351",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "075350",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Sep 12, 2003"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "002",
        "approval_date": "Sep 12, 2003"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG",
        "product_no": "003",
        "approval_date": "Sep 12, 2003"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GABAPENTIN",
  "proprietary_name": "Gabapentin",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA075350",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Gabapentin",
  "start_marketing_date": "20140403",
  "active_numerator_strength": "400"
}

Related drugs

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