FDA.reportPublic FDA data

Topiramate

Product NDC
68382-863
11-digit product format
683820863
Labeler code
68382
Product ID
68382-863_2535bcc8-fac7-4b15-8c6f-fd6675655fd3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Topiramate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA207382
Marketing category
ANDA
Marketing start
2024-09-10
Substance
TOPIRAMATE
Active strength
25 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
Topiramate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOPIRAMATE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0H73WJJ391
Rxcui1436239, 1437278, 1437283, 1437288

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68382-863-01Topiramate100 in 1 BOTTLECAPSULE, EXTENDED RELEASE10010
68382-863-05Topiramate500 in 1 BOTTLECAPSULE, EXTENDED RELEASE50010
68382-863-06Topiramate30 in 1 BOTTLECAPSULE, EXTENDED RELEASE3010
68382-863-16Topiramate90 in 1 BOTTLECAPSULE, EXTENDED RELEASE9010
68382-863-30Topiramate10 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE1010
68382-863-78Topiramate3 in 1 CARTONCAPSULE, EXTENDED RELEASE310

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-863-06EA - Each68382-8639d2c073b-abe6-4e7c-b893-0bc35c98764912023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-863TOPIRAMATE CAPSULE, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS USA INC.]9Current NDC, Legacy NDC, 6 package rows20250406_f72774dd-c7eb-41f9-9837-02baf77cc523.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1437283topiramate 100 MG 24HR Extended Release Oral CapsulePSNf72774dd-c7eb-41f9-9837-02baf77cc52310
1437288topiramate 200 MG 24HR Extended Release Oral CapsulePSNf72774dd-c7eb-41f9-9837-02baf77cc52310
1437278topiramate 25 MG 24HR Extended Release Oral CapsulePSNf72774dd-c7eb-41f9-9837-02baf77cc52310
1436239topiramate 50 MG 24HR Extended Release Oral CapsulePSNf72774dd-c7eb-41f9-9837-02baf77cc52310
143728324 HR topiramate 100 MG Extended Release Oral CapsuleSCDf72774dd-c7eb-41f9-9837-02baf77cc52310
143728824 HR topiramate 200 MG Extended Release Oral CapsuleSCDf72774dd-c7eb-41f9-9837-02baf77cc52310
143727824 HR topiramate 25 MG Extended Release Oral CapsuleSCDf72774dd-c7eb-41f9-9837-02baf77cc52310
143623924 HR topiramate 50 MG Extended Release Oral CapsuleSCDf72774dd-c7eb-41f9-9837-02baf77cc52310
1437283topiramate 100 MG 24 HR Extended Release Oral CapsuleSYf72774dd-c7eb-41f9-9837-02baf77cc52310
1437288topiramate 200 MG 24 HR Extended Release Oral CapsuleSYf72774dd-c7eb-41f9-9837-02baf77cc52310
1437278topiramate 25 MG 24 HR Extended Release Oral CapsuleSYf72774dd-c7eb-41f9-9837-02baf77cc52310
1436239topiramate 50 MG 24 HR Extended Release Oral CapsuleSYf72774dd-c7eb-41f9-9837-02baf77cc52310

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-863-0168382086301100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-863-01) 2024-09-100000-00-00NoNoCurrent
68382-863-0568382086305500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-863-05) 2024-09-100000-00-00NoNoCurrent
68382-863-066838208630630 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-863-06) 2024-09-100000-00-00NoNoCurrent
68382-863-166838208631690 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-863-16) 2024-09-100000-00-00NoNoCurrent
68382-863-306838208633010 in 1 BLISTER PACKHistorical
68382-863-776838208637710 BLISTER PACK in 1 CARTON (68382-863-77) > 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (68382-863-30) 10 blister pack2018-04-050000-00-00NoNoCurrent
68382-863-78683820863783 BLISTER PACK in 1 CARTON (68382-863-78) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (68382-863-30) 3 blister pack2024-09-10NoNoHistorical