FDA.reportPublic FDA data

GOCOVRI

Product NDC
70482-085
11-digit product format
704820085
Labeler code
70482
Product ID
70482-085_41c15d67-44b5-5c87-e063-6294a90adcc8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMANTADINE
Dosage form
CAPSULE, COATED PELLETS
Route
ORAL
Labeler
Adamas Pharma, LLC
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
GOCOVRI
Listing expiration
2026-12-31

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70482-085-212024-02-08C16284748780-11030e365-2f06-111a-e063-dadaa90a10e2GOCOVRI ® - These highlights do not include all the information needed to use GOCOVRI ® safely and effectively. See full prescribing information for GOCOVRI. GOCOVRI ® (amantadine) extended-release capsules, for oral use Initial U.S. Approval: 1968
70482-085-212024-02-08C16284748780-11030e365-2f06-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use GOCOVRI ® safely and effectively. See full prescribing information for GOCOVRI ® . GOCOVRI ® (amantadine) extended-release capsules, for oral use Initial U.S. Approval: 1968
70482-085-602024-02-08C16284748780-11030e365-2f06-111a-e063-dadaa90a10e2GOCOVRI ® - These highlights do not include all the information needed to use GOCOVRI ® safely and effectively. See full prescribing information for GOCOVRI. GOCOVRI ® (amantadine) extended-release capsules, for oral use Initial U.S. Approval: 1968
70482-085-602024-02-08C16284748780-11030e365-2f06-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use GOCOVRI ® safely and effectively. See full prescribing information for GOCOVRI ® . GOCOVRI ® (amantadine) extended-release capsules, for oral use Initial U.S. Approval: 1968
70482-085-612024-02-08C16284748780-11030e365-2f06-111a-e063-dadaa90a10e2GOCOVRI ® - These highlights do not include all the information needed to use GOCOVRI ® safely and effectively. See full prescribing information for GOCOVRI. GOCOVRI ® (amantadine) extended-release capsules, for oral use Initial U.S. Approval: 1968
70482-085-612024-02-08C16284748780-11030e365-2f06-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use GOCOVRI ® safely and effectively. See full prescribing information for GOCOVRI ® . GOCOVRI ® (amantadine) extended-release capsules, for oral use Initial U.S. Approval: 1968
70482-085-212024-01-30C16284748780-11030e365-2f06-111a-e063-dadaa90a10e2GOCOVRI ® - These highlights do not include all the information needed to use GOCOVRI ® safely and effectively. See full prescribing information for GOCOVRI. GOCOVRI ® (amantadine) extended-release capsules, for oral use Initial U.S. Approval: 1968
70482-085-212024-01-30C16284748780-11030e365-2f06-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use GOCOVRI ® safely and effectively. See full prescribing information for GOCOVRI ® . GOCOVRI ® (amantadine) extended-release capsules, for oral use Initial U.S. Approval: 1968
70482-085-602024-01-30C16284748780-11030e365-2f06-111a-e063-dadaa90a10e2GOCOVRI ® - These highlights do not include all the information needed to use GOCOVRI ® safely and effectively. See full prescribing information for GOCOVRI. GOCOVRI ® (amantadine) extended-release capsules, for oral use Initial U.S. Approval: 1968
70482-085-602024-01-30C16284748780-11030e365-2f06-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use GOCOVRI ® safely and effectively. See full prescribing information for GOCOVRI ® . GOCOVRI ® (amantadine) extended-release capsules, for oral use Initial U.S. Approval: 1968
70482-085-612024-01-30C16284748780-11030e365-2f06-111a-e063-dadaa90a10e2GOCOVRI ® - These highlights do not include all the information needed to use GOCOVRI ® safely and effectively. See full prescribing information for GOCOVRI. GOCOVRI ® (amantadine) extended-release capsules, for oral use Initial U.S. Approval: 1968
70482-085-612024-01-30C16284748780-11030e365-2f06-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use GOCOVRI ® safely and effectively. See full prescribing information for GOCOVRI ® . GOCOVRI ® (amantadine) extended-release capsules, for oral use Initial U.S. Approval: 1968

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70482-085-21GOCOVRI21 in 1 BOTTLECAPSULE, COATED PELLETS2117
70482-085-60GOCOVRI60 in 1 BOTTLECAPSULE, COATED PELLETS6017
70482-085-61GOCOVRI60 in 1 BOTTLECAPSULE, COATED PELLETS6017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70482-085-60EA - Each70482-08503ed5b83-ee9a-410d-8aef-60997dd00cf212017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70482-085GOCOVRI (AMANTADINE) CAPSULE, COATED PELLETS [ADAMAS PHARMA, LLC]13Current NDC, Legacy NDC, 3 package rows20241012_82ff865f-78f3-4c94-b6a9-727a54944b28.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1944370amantadine 137 MG 24HR Extended Release Oral CapsulePSN82ff865f-78f3-4c94-b6a9-727a54944b2817
1944380amantadine 68.5 MG 24HR Extended Release Oral CapsulePSN82ff865f-78f3-4c94-b6a9-727a54944b2817
1944376GOCOVRI 137 MG 24HR Extended Release Oral CapsulePSN82ff865f-78f3-4c94-b6a9-727a54944b2817
1944382GOCOVRI 68.5 MG 24HR Extended Release Oral CapsulePSN82ff865f-78f3-4c94-b6a9-727a54944b2817
194437624 HR amantadine 137 MG Extended Release Oral Capsule [Gocovri]SBD82ff865f-78f3-4c94-b6a9-727a54944b2817
194438224 HR amantadine 68.5 MG Extended Release Oral Capsule [Gocovri]SBD82ff865f-78f3-4c94-b6a9-727a54944b2817
194437024 HR amantadine 137 MG Extended Release Oral CapsuleSCD82ff865f-78f3-4c94-b6a9-727a54944b2817
194438024 HR amantadine 68.5 MG Extended Release Oral CapsuleSCD82ff865f-78f3-4c94-b6a9-727a54944b2817
194437624 HR Gocovri 137 MG Extended Release Oral CapsuleSY82ff865f-78f3-4c94-b6a9-727a54944b2817
194438224 HR Gocovri 68.5 MG Extended Release Oral CapsuleSY82ff865f-78f3-4c94-b6a9-727a54944b2817
1944370amantadine 137 MG (as amantadine HCl 170 MG) 24 HR Extended Release Oral CapsuleSY82ff865f-78f3-4c94-b6a9-727a54944b2817
1944380amantadine 68.5 MG (as amantadine HCl 85 MG) 24 HR Extended Release Oral CapsuleSY82ff865f-78f3-4c94-b6a9-727a54944b2817
1944376Gocovri 137 MG (as amantadine HCl 170 MG) 24 HR Extended Release Oral CapsuleSY82ff865f-78f3-4c94-b6a9-727a54944b2817
1944382Gocovri 68.5 MG (amantadine HCl 85 MG) 24 HR Extended Release Oral CapsuleSY82ff865f-78f3-4c94-b6a9-727a54944b2817

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70482-085-217048200852121 CAPSULE, COATED PELLETS in 1 BOTTLE (70482-085-21) 2017-08-240000-00-00YesNoCurrent
70482-085-607048200856060 CAPSULE, COATED PELLETS in 1 BOTTLE (70482-085-60) 2017-08-240000-00-00NoNoCurrent
70482-085-617048200856160 CAPSULE, COATED PELLETS in 1 BOTTLE (70482-085-61) 2017-08-240000-00-00YesNoCurrent