Tegretol

Product NDC
70518-3266
11-digit product format
705183266
Labeler code
70518
Product ID
70518-3266_d0759daf-d590-62e6-e053-2a95a90adf94
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
carbamazepine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
NDA020234
Marketing category
NDA
Marketing start
2021-11-09
Marketing end
0000-00-00
Substance
CARBAMAZEPINE
Active strength
400 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-3266-02023-03-23C16284748780-1f386c64a-3e67-0266-e053-dadaa90a7c1a56dea03d-f61b-43c8-bf34-86651defed90
70518-3266-02023-01-30C16284748780-1f386c64a-3e67-0266-e053-dadaa90a7c1a56dea03d-f61b-43c8-bf34-86651defed90

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3266-070518326600100 POUCH in 1 BOX (70518-3266-0) > 1 TABLET, EXTENDED RELEASE in 1 POUCH (70518-3266-1) 100 pouch2021-11-090000-00-00NoNoCurrent