Topiramate

Product NDC
60760-094
11-digit product format
607600094
Labeler code
60760
Product ID
60760-094_7b2f7a68-8f64-a340-e053-2991aa0a5aeb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Topiramate
Dosage form
TABLET
Route
ORAL
Labeler
St. Mary's Medical Park Pharmacy
Application
ANDA076343
Marketing category
ANDA
Marketing start
2014-06-12
Marketing end
0000-00-00
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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-094-60EA - Each60760-09498d216fd-e29c-46cf-bc85-74e110e33ac412018-02-20
60760-094-90EA - Each60760-094ae0faecf-189c-4d59-9b4a-1ff9c21f6e4712018-02-20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60760-094-606076000946060 TABLET in 1 BOTTLE, PLASTIC (60760-094-60) 60 tablet2017-11-280000-00-00NoNoCurrent
60760-094-906076000949090 TABLET in 1 BOTTLE, PLASTIC (60760-094-90) 90 tablet2017-11-300000-00-00NoNoCurrent