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United States · US · US:71335-2478_2973d72c-9629-418f-8443-47ca3a54d352

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
    7133524780
    180 CAPSULE in 1 BOTTLE (71335-2478-0)
  • ndc11
    7133524781
    20 CAPSULE in 1 BOTTLE (71335-2478-1)
  • ndc11
    7133524782
    90 CAPSULE in 1 BOTTLE (71335-2478-2)
  • ndc11
    7133524783
    60 CAPSULE in 1 BOTTLE (71335-2478-3)
  • ndc11
    7133524784
    30 CAPSULE in 1 BOTTLE (71335-2478-4)
  • ndc11
    7133524785
    120 CAPSULE in 1 BOTTLE (71335-2478-5)
  • ndc11
    7133524786
    21 CAPSULE in 1 BOTTLE (71335-2478-6)
  • ndc11
    7133524787
    84 CAPSULE in 1 BOTTLE (71335-2478-7)
  • ndc11
    7133524788
    112 CAPSULE in 1 BOTTLE (71335-2478-8)
  • ndc11
    7133524789
    28 CAPSULE in 1 BOTTLE (71335-2478-9)

Annotations

UNII (FDA Substance ID)
6CW7F3G59X
GABAPENTIN
RxCUI 25480
Orange Book
A213603
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": "71335-2478_2973d72c-9629-418f-8443-47ca3a54d352",
  "productndc": "71335-2478",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "213603",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Aug 17, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "002",
        "approval_date": "Aug 17, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG",
        "product_no": "003",
        "approval_date": "Aug 17, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GABAPENTIN",
  "proprietary_name": "Gabapentin",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA213603",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Gabapentin",
  "start_marketing_date": "20210503",
  "active_numerator_strength": "400"
}

Related drugs

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