topiramate

Product NDC
60760-514
11-digit product format
607600514
Labeler code
60760
Product ID
60760-514_92211f5f-fdcb-cc94-e053-2995a90a22ee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
topiramate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
St. Mary's Medical Park Pharmacy
Application
ANDA078235
Marketing category
ANDA
Marketing start
2009-03-27
Marketing end
0000-00-00
Substance
TOPIRAMATE
Active strength
100 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60760-514-602024-12-18C16284748780-1f386c64a-214b-0266-e053-dadaa90a7c1a92211f5f-fdca-cc94-e053-2995a90a22ee
60760-514-602023-01-30C16284748780-1f386c64a-214b-0266-e053-dadaa90a7c1a92211f5f-fdca-cc94-e053-2995a90a22ee

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-514-60EA - Each60760-51423a925b1-bc8b-4ca0-987e-752e4c02193e12019-10-07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60760-514-606076005146060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-514-60) 2019-09-050000-00-00NoNoCurrent