FDA.reportPublic FDA data

Trokendi XR

Product NDC
17772-102
11-digit product format
177720102
Labeler code
17772
Product ID
17772-102_4d7bcc14-c816-0b67-e063-6394a90a1097
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
topiramate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Supernus Pharmaceuticals, Inc.
Application
NDA201635
Marketing category
NDA
Marketing start
2013-08-16
Substance
TOPIRAMATE
Active strength
50 mg/1
Pharmacologic classes
Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOPIRAMATE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0H73WJJ391
Rxcui1436239, 1436245, 1437278, 1437280, 1437283, 1437285, 1437288, 1437290

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e5b1b0ba-27f8-4d5d-8943-8aed080fdedcProduct name420260306
6c26dd6d-01b5-4a80-b096-b3a6f7ca6077Product name220250623
cb966f54-bbf0-40fb-b581-80c6648d510cProduct name420250623
6e2fb0d7-40d7-e97c-1375-fa022ff20193Product name420250305
3d272a3f-17c0-421d-bc43-3cbdb719258dProduct name120250303
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17772-102-01Trokendi XR100 in 1 BOTTLECAPSULE, EXTENDED RELEASE10029
17772-102-07Trokendi XR7 in 1 BOTTLECAPSULE, EXTENDED RELEASE729
17772-102-10Trokendi XR5 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE529
17772-102-12Trokendi XR7 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE729
17772-102-15Trokendi XR30 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE3029
17772-102-30Trokendi XR30 in 1 BOTTLECAPSULE, EXTENDED RELEASE3029
17772-102-70Trokendi XR7 in 1 BOTTLECAPSULE, EXTENDED RELEASE729

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17772-102-01EA - Each17772-102b50aa032-0ece-4054-9431-844df08cefa912014-11-05
17772-102-15EA - Each17772-102b3a4ef7e-904e-4dd4-be63-e034773a1b0712013-10-17
17772-102-30EA - Each17772-102a47ac3e6-e8a3-4d17-bc57-aaf64f4a30db12017-12-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
topiramateACTIVE INGREDIENT0H73WJJ391TROKENDI XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [SUPERNUS PHARMACEUTICALS, INC.]2
topiramateACTIVE MOIETY0H73WJJ391TROKENDI XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [SUPERNUS PHARMACEUTICALS, INC.]2
docusate sodium/sodium benzoateINACTIVE INGREDIENT656HXR6YXNTROKENDI XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [SUPERNUS PHARMACEUTICALS, INC.]2
EthylcellulosesINACTIVE INGREDIENT7Z8S9VYZ4BTROKENDI XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [SUPERNUS PHARMACEUTICALS, INC.]2
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDTROKENDI XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [SUPERNUS PHARMACEUTICALS, INC.]2
FD&C Red No. 3INACTIVE INGREDIENTPN2ZH5LOQYTROKENDI XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [SUPERNUS PHARMACEUTICALS, INC.]2
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8TROKENDI XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [SUPERNUS PHARMACEUTICALS, INC.]2
Ferric Oxide YellowINACTIVE INGREDIENTEX438O2MRTTROKENDI XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [SUPERNUS PHARMACEUTICALS, INC.]2
gelatinINACTIVE INGREDIENT2G86QN327LTROKENDI XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [SUPERNUS PHARMACEUTICALS, INC.]2
MannitolINACTIVE INGREDIENT3OWL53L36ATROKENDI XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [SUPERNUS PHARMACEUTICALS, INC.]2
Medium-Chain TriglyceridesINACTIVE INGREDIENTC9H2L21V7UTROKENDI XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [SUPERNUS PHARMACEUTICALS, INC.]2
Oleic AcidINACTIVE INGREDIENT2UMI9U37CPTROKENDI XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [SUPERNUS PHARMACEUTICALS, INC.]2
Polyethylene GlycolsINACTIVE INGREDIENT3WJQ0SDW1ATROKENDI XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [SUPERNUS PHARMACEUTICALS, INC.]2
Polyvinyl AlcoholINACTIVE INGREDIENT532B59J990TROKENDI XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [SUPERNUS PHARMACEUTICALS, INC.]2
RiboflavinINACTIVE INGREDIENTTLM2976OFRTROKENDI XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [SUPERNUS PHARMACEUTICALS, INC.]2
TalcINACTIVE INGREDIENT7SEV7J4R1UTROKENDI XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [SUPERNUS PHARMACEUTICALS, INC.]2
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPTROKENDI XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [SUPERNUS PHARMACEUTICALS, INC.]2
Xanthan GumINACTIVE INGREDIENTTTV12P4NEETROKENDI XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [SUPERNUS PHARMACEUTICALS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17772-102TROKENDI XR (TOPIRAMATE) CAPSULE, EXTENDED RELEASE [SUPERNUS PHARMACEUTICALS]25Current NDC, Legacy NDC, 7 package rows20250316_2dc7957e-a3e5-46bb-aa66-f3250f872f5e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1437283topiramate 100 MG 24HR Extended Release Oral CapsulePSN2dc7957e-a3e5-46bb-aa66-f3250f872f5e29
1437288topiramate 200 MG 24HR Extended Release Oral CapsulePSN2dc7957e-a3e5-46bb-aa66-f3250f872f5e29
1437278topiramate 25 MG 24HR Extended Release Oral CapsulePSN2dc7957e-a3e5-46bb-aa66-f3250f872f5e29
1436239topiramate 50 MG 24HR Extended Release Oral CapsulePSN2dc7957e-a3e5-46bb-aa66-f3250f872f5e29
1436245Trokendi 50 MG 24HR Extended Release Oral CapsulePSN2dc7957e-a3e5-46bb-aa66-f3250f872f5e29
1437285Trokendi XR 100 MG 24HR Extended Release Oral CapsulePSN2dc7957e-a3e5-46bb-aa66-f3250f872f5e29
1437290Trokendi XR 200 MG 24HR Extended Release Oral CapsulePSN2dc7957e-a3e5-46bb-aa66-f3250f872f5e29
1437280Trokendi XR 25 MG 24HR Extended Release Oral CapsulePSN2dc7957e-a3e5-46bb-aa66-f3250f872f5e29
143728524 HR topiramate 100 MG Extended Release Oral Capsule [Trokendi]SBD2dc7957e-a3e5-46bb-aa66-f3250f872f5e29
143729024 HR topiramate 200 MG Extended Release Oral Capsule [Trokendi]SBD2dc7957e-a3e5-46bb-aa66-f3250f872f5e29
143728024 HR topiramate 25 MG Extended Release Oral Capsule [Trokendi]SBD2dc7957e-a3e5-46bb-aa66-f3250f872f5e29
143624524 HR topiramate 50 MG Extended Release Oral Capsule [Trokendi]SBD2dc7957e-a3e5-46bb-aa66-f3250f872f5e29
143728324 HR topiramate 100 MG Extended Release Oral CapsuleSCD2dc7957e-a3e5-46bb-aa66-f3250f872f5e29
143728824 HR topiramate 200 MG Extended Release Oral CapsuleSCD2dc7957e-a3e5-46bb-aa66-f3250f872f5e29
143727824 HR topiramate 25 MG Extended Release Oral CapsuleSCD2dc7957e-a3e5-46bb-aa66-f3250f872f5e29
143623924 HR topiramate 50 MG Extended Release Oral CapsuleSCD2dc7957e-a3e5-46bb-aa66-f3250f872f5e29
143728524 HR Trokendi 100 MG Extended Release Oral CapsuleSY2dc7957e-a3e5-46bb-aa66-f3250f872f5e29
143729024 HR Trokendi 200 MG Extended Release Oral CapsuleSY2dc7957e-a3e5-46bb-aa66-f3250f872f5e29
143728024 HR Trokendi 25 MG Extended Release Oral CapsuleSY2dc7957e-a3e5-46bb-aa66-f3250f872f5e29
143624524 HR Trokendi XR 50 MG Extended Release Oral CapsuleSY2dc7957e-a3e5-46bb-aa66-f3250f872f5e29
1437283topiramate 100 MG 24 HR Extended Release Oral CapsuleSY2dc7957e-a3e5-46bb-aa66-f3250f872f5e29
1437288topiramate 200 MG 24 HR Extended Release Oral CapsuleSY2dc7957e-a3e5-46bb-aa66-f3250f872f5e29
1437278topiramate 25 MG 24 HR Extended Release Oral CapsuleSY2dc7957e-a3e5-46bb-aa66-f3250f872f5e29
1436239topiramate 50 MG 24 HR Extended Release Oral CapsuleSY2dc7957e-a3e5-46bb-aa66-f3250f872f5e29
1437285Trokendi XR 100 MG 24 HR Extended Release Oral CapsuleSY2dc7957e-a3e5-46bb-aa66-f3250f872f5e29
1437290Trokendi XR 200 MG 24 HR Extended Release Oral CapsuleSY2dc7957e-a3e5-46bb-aa66-f3250f872f5e29
1437280Trokendi XR 25 MG 24 HR Extended Release Oral CapsuleSY2dc7957e-a3e5-46bb-aa66-f3250f872f5e29
1436245Trokendi XR 50 MG 24 HR Extended Release Oral CapsuleSY2dc7957e-a3e5-46bb-aa66-f3250f872f5e29

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
17772-102-0117772010201100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-102-01) 2013-08-160000-00-00NoNoCurrent
17772-102-07177720102077 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-102-07) 2020-06-230000-00-00YesNoCurrent
17772-102-10177720102105 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (17772-102-10) 2013-08-160000-00-00YesNoCurrent
17772-102-12177720102127 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (17772-102-12) 2013-08-160000-00-00YesNoCurrent
17772-102-151777201021530 in 1 BLISTER PACKHistorical
17772-102-301777201023030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (17772-102-30) 2013-08-160000-00-00NoNoCurrent
17772-102-70177720102707 in 1 BOTTLEHistorical