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United States · US · US:71205-619_185f264e-db32-41cd-b90d-519717b97850

GABAPENTIN

Orange BookUNIISPLATC N02BF01

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeN02BF01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    7120561930
    30 CAPSULE in 1 BOTTLE (71205-619-30)
  • ndc11
    7120561960
    60 CAPSULE in 1 BOTTLE (71205-619-60)
  • ndc11
    7120561972
    120 CAPSULE in 1 BOTTLE (71205-619-72)
  • ndc11
    7120561990
    90 CAPSULE in 1 BOTTLE (71205-619-90)

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": "71205-619_185f264e-db32-41cd-b90d-519717b97850",
  "productndc": "71205-619",
  "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": "400"
}

Related drugs

Other records sharing ATC code N02BF01.

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