NDC 35561-355

CARBAMAZEPINE ER

Carbamazepine

CARBAMAZEPINE ER is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Austarpharma Llc. The primary component is Carbamazepine.

Product ID35561-355_dc84da79-1dec-755b-e053-2a95a90a973b
NDC35561-355
Product TypeHuman Prescription Drug
Proprietary NameCARBAMAZEPINE ER
Generic NameCarbamazepine
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2021-12-09
Marketing CategoryANDA /
Application NumberANDA215591
Labeler NameAustarPharma LLC
Substance NameCARBAMAZEPINE
Active Ingredient Strength100 mg/1
Pharm ClassesCytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 35561-355-12

100 TABLET, EXTENDED RELEASE in 1 BOTTLE (35561-355-12)
Marketing Start Date2021-12-09
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "CARBAMAZEPINE ER" or generic name "Carbamazepine"

NDCBrand NameGeneric Name
68084-562Carbamazepine ERCarbamazepine ER
68084-561Carbamazepine ERCarbamazepine ER
0781-5988Carbamazepine ERCarbamazepine ER
0781-5987Carbamazepine ERCarbamazepine ER
0781-8016Carbamazepine ERCarbamazepine ER
70518-2653Carbamazepine ERCarbamazepine ER
0093-0109CarbamazepineCarbamazepine
0093-0778CarbamazepineCarbamazepine
0093-0090EpitolCarbamazepine
0078-0508Tegretolcarbamazepine
0078-0509Tegretolcarbamazepine
0078-0510Tegretolcarbamazepine
0078-0511Tegretolcarbamazepine
0078-0512Tegretolcarbamazepine

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