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United States · US · US:17772-170_4af3ee09-faf9-9840-e063-6394a90aafdc

GOCOVRI

In shortageOrange BookUNIISPLATC N04BB01

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

Identification

ManufacturerSupernus Pharmaceuticals
CountryUS (United States)
ATC codeN04BB01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    1777217021
    21 CAPSULE, COATED PELLETS in 1 BOTTLE (17772-170-21)
  • ndc11
    1777217060
    60 CAPSULE, COATED PELLETS in 1 BOTTLE (17772-170-60)

Annotations

UNII (FDA Substance ID)
BF4C9Z1J53
AMANTADINE
RxCUI 620
Orange Book
N208944
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Amantadine Hydrochloride Capsule
Raw payload (JSON)
{
  "unii": {
    "unii": "BF4C9Z1J53",
    "rxcui": "620",
    "inchikey": "DKNWSYNQZKUICI-UHFFFAOYSA-N",
    "display_name": "AMANTADINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "2bee0631-0028-1314-e063-6394a90aaaed": {
      "match": "brand_token",
      "title": "GOCOVRI (AMANTADINE) CAPSULE, COATED PELLETS [SUPERNUS PHARMACEUTICALS]",
      "spl_version": "6",
      "published_date": "2026-02-18"
    }
  },
  "productid": "17772-170_4af3ee09-faf9-9840-e063-6394a90aafdc",
  "productndc": "17772-170",
  "dosage_form": "CAPSULE, COATED PELLETS",
  "orange_book": {
    "appl_no": "208944",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "EQ 68.5MG BASE",
        "product_no": "001",
        "approval_date": "Aug 24, 2017"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 137MG BASE",
        "product_no": "002",
        "approval_date": "Aug 24, 2017"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "AMANTADINE",
  "shortage_reason": "Amantadine Hydrochloride Capsule",
  "shortage_status": "current",
  "proprietary_name": "GOCOVRI",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA208944",
  "marketing_category": "NDA",
  "nonproprietary_name": "AMANTADINE",
  "start_marketing_date": "20170824",
  "active_numerator_strength": "137"
}

Related drugs

Other records sharing ATC code N04BB01.

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