FDA.reportPublic FDA data

Topiramate

Product NDC
70710-1043
11-digit product format
707101043
Labeler code
70710
Product ID
70710-1043_bb736981-167f-4de6-a285-0e840ae37fc7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Topiramate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA208949
Marketing category
ANDA
Marketing start
2023-01-17
Substance
TOPIRAMATE
Active strength
200 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
TOPIRAMATE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0H73WJJ391
Rxcui1494769, 1812419, 1812421, 1812425, 1812427

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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70710-1043-3Topiramate30 in 1 BOTTLECAPSULE, EXTENDED RELEASE307
70710-1043-9Topiramate90 in 1 BOTTLECAPSULE, EXTENDED RELEASE907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70710-1043-3EA - Each70710-10431fac1ef5-133e-4df4-920b-9b26ffc97a6e12023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1043TOPIRAMATE CAPSULE, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS USA INC.]6Current NDC, 2 package rows20250411_a5ca2fce-bd2d-40db-b963-e3ec27c8bf23.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1812427topiramate 100 MG Sprinkle 24HR Extended Release Oral CapsulePSNa5ca2fce-bd2d-40db-b963-e3ec27c8bf237
1494769topiramate 150 MG Sprinkle 24HR Extended Release Oral CapsulePSNa5ca2fce-bd2d-40db-b963-e3ec27c8bf237
1812419topiramate 200 MG Sprinkle 24HR Extended Release Oral CapsulePSNa5ca2fce-bd2d-40db-b963-e3ec27c8bf237
1812421topiramate 25 MG Sprinkle 24HR Extended Release Oral CapsulePSNa5ca2fce-bd2d-40db-b963-e3ec27c8bf237
1812425topiramate 50 MG Sprinkle 24HR Extended Release Oral CapsulePSNa5ca2fce-bd2d-40db-b963-e3ec27c8bf237
1812427Sprinkle 24 HR topiramate 100 MG Extended Release Oral CapsuleSCDa5ca2fce-bd2d-40db-b963-e3ec27c8bf237
1494769Sprinkle 24 HR topiramate 150 MG Extended Release Oral CapsuleSCDa5ca2fce-bd2d-40db-b963-e3ec27c8bf237
1812419Sprinkle 24 HR topiramate 200 MG Extended Release Oral CapsuleSCDa5ca2fce-bd2d-40db-b963-e3ec27c8bf237
1812421Sprinkle 24 HR topiramate 25 MG Extended Release Oral CapsuleSCDa5ca2fce-bd2d-40db-b963-e3ec27c8bf237
1812425Sprinkle 24 HR topiramate 50 MG Extended Release Oral CapsuleSCDa5ca2fce-bd2d-40db-b963-e3ec27c8bf237
1812427topiramate 100 MG Sprinkle 24 HR Extended Release Oral CapsuleSYa5ca2fce-bd2d-40db-b963-e3ec27c8bf237
1494769topiramate 150 MG Sprinkle 24 HR Extended Release Oral CapsuleSYa5ca2fce-bd2d-40db-b963-e3ec27c8bf237
1812419topiramate 200 MG Sprinkle 24 HR Extended Release Oral CapsuleSYa5ca2fce-bd2d-40db-b963-e3ec27c8bf237
1812421topiramate 25 MG Sprinkle 24HR Extended Release Oral CapsuleSYa5ca2fce-bd2d-40db-b963-e3ec27c8bf237
1812425topiramate 50 MG Sprinkle 24HR Extended Release Oral CapsuleSYa5ca2fce-bd2d-40db-b963-e3ec27c8bf237

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70710-1043-37071010430330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70710-1043-3) 2023-01-17NoNoCurrent
70710-1043-97071010430990 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70710-1043-9) 2023-01-17NoNoCurrent