Topiramate

Product NDC
60429-770
11-digit product format
604290770
Labeler code
60429
Product ID
60429-770_be4e1a6e-ecdf-eb94-e053-2995a90a8a0f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
topiramate
Dosage form
TABLET
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA079162
Marketing category
ANDA
Marketing start
2011-07-08
Marketing end
2022-05-31
Substance
TOPIRAMATE
Active strength
50 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60429-770-05EA - Each60429-7701f2f1c74-dea0-49ca-9f8c-0e7e4b8a291512012-07-24
60429-770-10EA - Each60429-770558a47bd-a1b5-4846-bfeb-bd05f7d6b2d812012-07-24
60429-770-60EA - Each60429-7704e264fe7-6815-42ab-a4cf-9e8dde8846b812012-07-24

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
151226topiramate 50 MG Oral TabletPSN7b630268-906b-4c75-bb98-99957e3a70722
151226topiramate 50 MG Oral TabletSCD7b630268-906b-4c75-bb98-99957e3a70722

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60429-770-10604290770101000 TABLET in 1 BOTTLE (60429-770-10) 1000 tablet2011-07-080000-00-00NoNoCurrent
60429-770-606042907706060 TABLET in 1 BOTTLE (60429-770-60) 60 tablet2011-07-080000-00-00NoNoCurrent