NDC 0615-8125

Carbamazepine

Carbamazepine

Carbamazepine is a Oral Tablet, Chewable in the Human Prescription Drug category. It is labeled and distributed by Ncs Healthcare Of Ky, Inc Dba Vangard Labs. The primary component is Carbamazepine.

Product ID0615-8125_17434f46-d421-4fcb-a3cd-0b911c96e830
NDC0615-8125
Product TypeHuman Prescription Drug
Proprietary NameCarbamazepine
Generic NameCarbamazepine
Dosage FormTablet, Chewable
Route of AdministrationORAL
Marketing Start Date2000-10-24
Marketing CategoryANDA / ANDA
Application NumberANDA075687
Labeler NameNCS HealthCare of KY, Inc dba Vangard Labs
Substance NameCARBAMAZEPINE
Active Ingredient Strength100 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 Through2020-12-31

Packaging

NDC 0615-8125-39

30 TABLET, CHEWABLE in 1 BLISTER PACK (0615-8125-39)
Marketing Start Date2019-06-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0615-8125-39 [00615812539]

Carbamazepine TABLET, CHEWABLE
Marketing CategoryANDA
Application NumberANDA075687
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-06-06

Drug Details

Active Ingredients

IngredientStrength
CARBAMAZEPINE100 mg/1

OpenFDA Data

SPL SET ID:963db7cf-e9f5-496c-816e-626e89bc839e
Manufacturer
UNII

Pharmacological Class

  • 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]
  • 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 Crossover Matching brand name "Carbamazepine" or generic name "Carbamazepine"

NDCBrand NameGeneric Name
0093-0109CarbamazepineCarbamazepine
0093-0778CarbamazepineCarbamazepine
68071-3282CarbamazepineCarbamazepine
68071-4313CARBAMAZEPINECARBAMAZEPINE
68084-444CarbamazepineCarbamazepine
68094-007CarbamazepineCarbamazepine
68094-008CarbamazepineCarbamazepine
68382-555carbamazepinecarbamazepine
68382-556carbamazepinecarbamazepine
68382-557carbamazepinecarbamazepine
68788-7210CARBAMAZEPINECARBAMAZEPINE
68788-9492CARBAMAZEPINECARBAMAZEPINE
68788-9812CarbamazepineCarbamazepine
69189-0410CarbamazepineCarbamazepine
70518-0181CarbamazepineCarbamazepine
70518-0124CarbamazepineCarbamazepine
70518-0902CARBAMAZEPINECARBAMAZEPINE
70518-1769CarbamazepineCarbamazepine
70518-1436CarbamazepineCarbamazepine
70518-1545CarbamazepineCarbamazepine
70518-1433CarbamazepineCarbamazepine
70771-1470carbamazepinecarbamazepine
70771-1469carbamazepinecarbamazepine
70771-1468carbamazepinecarbamazepine
71205-025CARBAMAZEPINECARBAMAZEPINE
71335-0461CarbamazepineCarbamazepine
71335-0462CARBAMAZEPINECARBAMAZEPINE
0615-3505CarbamazepineCarbamazepine
71335-0691CARBAMAZEPINECARBAMAZEPINE
0615-4515CARBAMAZEPINECARBAMAZEPINE
0904-3854CARBAMAZEPINECARBAMAZEPINE
0904-6172CARBAMAZEPINECARBAMAZEPINE
13668-271CARBAMAZEPINECARBAMAZEPINE
13668-268CARBAMAZEPINECARBAMAZEPINE
17856-4047CarbamazepineCarbamazepine
21695-724CarbamazepineCarbamazepine
29033-004CarbamazepineCarbamazepine
33261-676CarbamazepineCarbamazepine
43063-328CarbamazepineCarbamazepine
43353-953CARBAMAZEPINECARBAMAZEPINE
49999-616CARBAMAZEPINECARBAMAZEPINE
50090-2161CARBAMAZEPINECARBAMAZEPINE
51079-385CarbamazepineCarbamazepine
51079-870CarbamazepineCarbamazepine
51655-017CARBAMAZEPINECARBAMAZEPINE
51672-4047CarbamazepineCarbamazepine
51672-4151CarbamazepineCarbamazepine
51672-4124CarbamazepineCarbamazepine
51672-4125CarbamazepineCarbamazepine
51672-4149CarbamazepineCarbamazepine

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