FDA.reportPublic FDA data

GOCOVRI

Product NDC
17772-085
11-digit product format
177720085
Labeler code
17772
Product ID
17772-085_4af3ee09-faf9-9840-e063-6394a90aafdc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMANTADINE
Dosage form
CAPSULE, COATED PELLETS
Route
ORAL
Labeler
Supernus Pharmaceuticals
Application
NDA208944
Marketing category
NDA
Marketing start
2017-08-24
Substance
AMANTADINE
Active strength
68.5 mg/1
Pharmacologic classes
Influenza A M2 Protein Inhibitor [EPC], M2 Protein Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
GOCOVRI
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMANTADINE68.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBF4C9Z1J53
Rxcui1944370, 1944376, 1944380, 1944382

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
519d6abc-639d-2962-cced-abbf8b16aad4Product name720250401
82f46845-b4c7-48da-a389-ba5721b956c9Product name220250325
d2c037c0-5ebf-d224-252f-2549922c21c7Product name720240208
b7b57a62-2f7f-1a22-2cb2-eaa5c08d4721Product name220220224
14e11aaf-885f-472f-a02a-c6a3f28df907Product name120180515
82f46845-b4c7-48da-a389-ba5721b956c9Product name120171103

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17772-085-21GOCOVRI21 in 1 BOTTLECAPSULE, COATED PELLETS216
17772-085-60GOCOVRI60 in 1 BOTTLECAPSULE, COATED PELLETS606

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17772-085-60EA - Each17772-0854b6e805e-152d-4c31-b0c4-5bc14f2bcf3f12026-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17772-085GOCOVRI (AMANTADINE) CAPSULE, COATED PELLETS [SUPERNUS PHARMACEUTICALS]1Current NDC, 2 package rows20250119_2bee0631-0028-1314-e063-6394a90aaaed.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1944370amantadine 137 MG 24HR Extended Release Oral CapsulePSN2bee0631-0028-1314-e063-6394a90aaaed6
1944380amantadine 68.5 MG 24HR Extended Release Oral CapsulePSN2bee0631-0028-1314-e063-6394a90aaaed6
1944376GOCOVRI 137 MG 24HR Extended Release Oral CapsulePSN2bee0631-0028-1314-e063-6394a90aaaed6
1944382GOCOVRI 68.5 MG 24HR Extended Release Oral CapsulePSN2bee0631-0028-1314-e063-6394a90aaaed6
194437624 HR amantadine 137 MG Extended Release Oral Capsule [Gocovri]SBD2bee0631-0028-1314-e063-6394a90aaaed6
194438224 HR amantadine 68.5 MG Extended Release Oral Capsule [Gocovri]SBD2bee0631-0028-1314-e063-6394a90aaaed6
194437024 HR amantadine 137 MG Extended Release Oral CapsuleSCD2bee0631-0028-1314-e063-6394a90aaaed6
194438024 HR amantadine 68.5 MG Extended Release Oral CapsuleSCD2bee0631-0028-1314-e063-6394a90aaaed6
194437624 HR Gocovri 137 MG Extended Release Oral CapsuleSY2bee0631-0028-1314-e063-6394a90aaaed6
194438224 HR Gocovri 68.5 MG Extended Release Oral CapsuleSY2bee0631-0028-1314-e063-6394a90aaaed6
1944370amantadine 137 MG (as amantadine HCl 170 MG) 24 HR Extended Release Oral CapsuleSY2bee0631-0028-1314-e063-6394a90aaaed6
1944380amantadine 68.5 MG (as amantadine HCl 85 MG) 24 HR Extended Release Oral CapsuleSY2bee0631-0028-1314-e063-6394a90aaaed6
1944376Gocovri 137 MG (as amantadine HCl 170 MG) 24 HR Extended Release Oral CapsuleSY2bee0631-0028-1314-e063-6394a90aaaed6
1944382Gocovri 68.5 MG (amantadine HCl 85 MG) 24 HR Extended Release Oral CapsuleSY2bee0631-0028-1314-e063-6394a90aaaed6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
17772-085-211777200852121 CAPSULE, COATED PELLETS in 1 BOTTLE (17772-085-21) 2017-08-24YesNoCurrent
17772-085-601777200856060 CAPSULE, COATED PELLETS in 1 BOTTLE (17772-085-60) 2017-08-24NoNoCurrent