Carbamazepine

Product NDC
71930-072
11-digit product format
719300072
Labeler code
71930
Product ID
71930-072_fe788fd8-8083-4201-af83-010af795d108
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbamazepine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Eywa Pharma Inc
Application
ANDA212948
Marketing category
ANDA
Marketing start
2021-10-15
Marketing end
0000-00-00
Substance
CARBAMAZEPINE
Active strength
100 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71930-072-12EA - Each71930-072cb86dc76-33bc-4c72-a1da-651f91a9060b12021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71930-072CARBAMAZEPINE ER (CARBAMAZEPINE) TABLET, EXTENDED RELEASE [EYWA PHARMA INC]1Legacy NDC20211016_48010b2b-526b-4bd6-87fd-87745c22cb8f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71930-072-1271930007212100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71930-072-12) 2021-10-150000-00-00NoNoCurrent