NDC 60687-479

Carbamazepine

Carbamazepine

Carbamazepine is a Oral Tablet, Chewable in the Human Prescription Drug category. It is labeled and distributed by American Health Packaging. The primary component is Carbamazepine.

Product ID60687-479_9b3d77ec-f515-0e30-e053-2995a90a6167
NDC60687-479
Product TypeHuman Prescription Drug
Proprietary NameCarbamazepine
Generic NameCarbamazepine
Dosage FormTablet, Chewable
Route of AdministrationORAL
Marketing Start Date2020-01-03
Marketing CategoryANDA / ANDA
Application NumberANDA075712
Labeler NameAmerican Health Packaging
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 Through2021-12-31

Packaging

NDC 60687-479-01

100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-479-01) > 1 TABLET, CHEWABLE in 1 BLISTER PACK (60687-479-11)
Marketing Start Date2020-01-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 60687-479-11 [60687047911]

Carbamazepine TABLET, CHEWABLE
Marketing CategoryANDA
Application NumberANDA075712
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-01-03

NDC 60687-479-01 [60687047901]

Carbamazepine TABLET, CHEWABLE
Marketing CategoryANDA
Application NumberANDA075712
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-01-03

Drug Details

Active Ingredients

IngredientStrength
CARBAMAZEPINE100 mg/1

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]

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
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.