FDA.reportPublic FDA data

Topiramate

Product NDC
70771-1316
11-digit product format
707711316
Labeler code
70771
Product ID
70771-1316_709dd70b-24e1-435f-8373-02e6dd538b2c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Topiramate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA207382
Marketing category
ANDA
Marketing start
2018-04-05
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOPIRAMATE50 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
70771-1316-1Topiramate100 in 1 BOTTLECAPSULE, EXTENDED RELEASE1006
70771-1316-2Topiramate10 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE106
70771-1316-3Topiramate30 in 1 BOTTLECAPSULE, EXTENDED RELEASE306
70771-1316-4Topiramate10 in 1 CARTONCAPSULE, EXTENDED RELEASE106
70771-1316-5Topiramate500 in 1 BOTTLECAPSULE, EXTENDED RELEASE5006
70771-1316-9Topiramate90 in 1 BOTTLECAPSULE, EXTENDED RELEASE906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1316TOPIRAMATE CAPSULE, EXTENDED RELEASE [ZYDUS LIFESCIENCES LIMITED]6Current NDC, Legacy NDC, 6 package rows20231114_9a943af0-1c6d-43c2-830a-f303baa16124.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1437283topiramate 100 MG 24HR Extended Release Oral CapsulePSN9a943af0-1c6d-43c2-830a-f303baa161246
1437288topiramate 200 MG 24HR Extended Release Oral CapsulePSN9a943af0-1c6d-43c2-830a-f303baa161246
1437278topiramate 25 MG 24HR Extended Release Oral CapsulePSN9a943af0-1c6d-43c2-830a-f303baa161246
1436239topiramate 50 MG 24HR Extended Release Oral CapsulePSN9a943af0-1c6d-43c2-830a-f303baa161246
143728324 HR topiramate 100 MG Extended Release Oral CapsuleSCD9a943af0-1c6d-43c2-830a-f303baa161246
143728824 HR topiramate 200 MG Extended Release Oral CapsuleSCD9a943af0-1c6d-43c2-830a-f303baa161246
143727824 HR topiramate 25 MG Extended Release Oral CapsuleSCD9a943af0-1c6d-43c2-830a-f303baa161246
143623924 HR topiramate 50 MG Extended Release Oral CapsuleSCD9a943af0-1c6d-43c2-830a-f303baa161246
1437283topiramate 100 MG 24 HR Extended Release Oral CapsuleSY9a943af0-1c6d-43c2-830a-f303baa161246
1437288topiramate 200 MG 24 HR Extended Release Oral CapsuleSY9a943af0-1c6d-43c2-830a-f303baa161246
1437278topiramate 25 MG 24 HR Extended Release Oral CapsuleSY9a943af0-1c6d-43c2-830a-f303baa161246
1436239topiramate 50 MG 24 HR Extended Release Oral CapsuleSY9a943af0-1c6d-43c2-830a-f303baa161246

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70771-1316-170771131601100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1316-1) 2018-04-050000-00-00NoNoCurrent
70771-1316-27077113160210 in 1 BLISTER PACKHistorical
70771-1316-37077113160330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1316-3) 2018-04-050000-00-00NoNoCurrent
70771-1316-47077113160410 BLISTER PACK in 1 CARTON (70771-1316-4) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (70771-1316-2) 10 blister pack2018-04-050000-00-00NoNoCurrent
70771-1316-570771131605500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1316-5) 2018-04-050000-00-00NoNoCurrent
70771-1316-97077113160990 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1316-9) 2018-04-050000-00-00NoNoCurrent