NDC 70518-3266

Tegretol XR

Carbamazepine

Tegretol XR is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Carbamazepine.

Product ID70518-3266_d0759daf-d590-62e6-e053-2a95a90adf94
NDC70518-3266
Product TypeHuman Prescription Drug
Proprietary NameTegretol XR
Generic NameCarbamazepine
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2021-11-09
Marketing CategoryNDA /
Application NumberNDA020234
Labeler NameREMEDYREPACK INC.
Substance NameCARBAMAZEPINE
Active Ingredient Strength400 mg/1
Pharm ClassesDecreased 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 FlagN
Listing Certified Through2022-12-31

Packaging

NDC 70518-3266-0

100 POUCH in 1 BOX (70518-3266-0) > 1 TABLET, EXTENDED RELEASE in 1 POUCH (70518-3266-1)
Marketing Start Date2021-11-09
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Tegretol XR" or generic name "Carbamazepine"

NDCBrand NameGeneric Name
70518-0337Tegretol XRTegretol XR
0093-0109CarbamazepineCarbamazepine
0093-0778CarbamazepineCarbamazepine
0121-0862CarbamazepineCarbamazepine
0093-0090EpitolCarbamazepine
0078-0508Tegretolcarbamazepine
0078-0509Tegretolcarbamazepine
0078-0510Tegretolcarbamazepine
0078-0511Tegretolcarbamazepine
0078-0512Tegretolcarbamazepine

Trademark Results [Tegretol]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TEGRETOL
TEGRETOL
72201286 0788091 Live/Registered
GEIGY CHEMICAL CORPORTION
1964-09-04

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.