NDC 0121-0862

Carbamazepine

Carbamazepine

Carbamazepine is a Oral Suspension in the Human Prescription Drug category. It is labeled and distributed by Pai Holdings, Llc. The primary component is Carbamazepine.

Product ID0121-0862_6480cf3e-b4a0-4dfc-b505-6c74bcddcdff
NDC0121-0862
Product TypeHuman Prescription Drug
Proprietary NameCarbamazepine
Generic NameCarbamazepine
Dosage FormSuspension
Route of AdministrationORAL
Marketing Start Date2002-06-05
Marketing CategoryANDA / ANDA
Application NumberANDA075714
Labeler NamePAI Holdings, LLC
Substance NameCARBAMAZEPINE
Active Ingredient Strength100 mg/5mL
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 0121-0862-30

3 TRAY in 1 CASE (0121-0862-30) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (0121-0862-05)
Marketing Start Date2020-05-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0121-0862-40 [00121086240]

Carbamazepine SUSPENSION
Marketing CategoryANDA
Application NumberANDA075714
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-10-21
Marketing End Date2020-05-06

NDC 0121-0862-05 [00121086205]

Carbamazepine SUSPENSION
Marketing CategoryANDA
Application NumberANDA075714
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2002-06-05

NDC 0121-0862-30 [00121086230]

Carbamazepine SUSPENSION
Marketing CategoryANDA
Application NumberANDA075714
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-05-14

Drug Details

Active Ingredients

IngredientStrength
CARBAMAZEPINE100 mg/5mL

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
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