FDA.reportPublic FDA data

Topiramate

Product NDC
70748-277
11-digit product format
707480277
Labeler code
70748
Product ID
70748-277_68180c67-ab30-49d0-aece-5a8d476097e2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Topiramate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA215561
Marketing category
ANDA
Marketing start
2026-02-03
Substance
TOPIRAMATE
Active strength
100 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
TOPIRAMATE100 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
70748-277-06Topiramate30 in 1 BOTTLECAPSULE, EXTENDED RELEASE309

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1437283topiramate 100 MG 24HR Extended Release Oral CapsulePSNe310afcd-1260-434e-a994-34549c789d999
1437288topiramate 200 MG 24HR Extended Release Oral CapsulePSNe310afcd-1260-434e-a994-34549c789d999
1437278topiramate 25 MG 24HR Extended Release Oral CapsulePSNe310afcd-1260-434e-a994-34549c789d999
1436239topiramate 50 MG 24HR Extended Release Oral CapsulePSNe310afcd-1260-434e-a994-34549c789d999
143728324 HR topiramate 100 MG Extended Release Oral CapsuleSCDe310afcd-1260-434e-a994-34549c789d999
143728824 HR topiramate 200 MG Extended Release Oral CapsuleSCDe310afcd-1260-434e-a994-34549c789d999
143727824 HR topiramate 25 MG Extended Release Oral CapsuleSCDe310afcd-1260-434e-a994-34549c789d999
143623924 HR topiramate 50 MG Extended Release Oral CapsuleSCDe310afcd-1260-434e-a994-34549c789d999
1437283topiramate 100 MG 24 HR Extended Release Oral CapsuleSYe310afcd-1260-434e-a994-34549c789d999
1437288topiramate 200 MG 24 HR Extended Release Oral CapsuleSYe310afcd-1260-434e-a994-34549c789d999
1437278topiramate 25 MG 24 HR Extended Release Oral CapsuleSYe310afcd-1260-434e-a994-34549c789d999
1436239topiramate 50 MG 24 HR Extended Release Oral CapsuleSYe310afcd-1260-434e-a994-34549c789d999

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70748-277-067074802770630 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70748-277-06) 2026-02-03NoNoCurrent