NDC 43353-953

CARBAMAZEPINE

Carbamazepine

CARBAMAZEPINE is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, Llc. The primary component is Carbamazepine.

• Product ID: 43353-953_7c7b8491-2291-48de-8b76-bf2eca6c9d9c
• NDC: 43353-953
• Product Type: Human Prescription Drug
• Proprietary Name: CARBAMAZEPINE
• Generic Name: Carbamazepine
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2014-03-07
• Marketing Category: ANDA / ANDA
• Application Number: ANDA075948
• Labeler Name: Aphena Pharma Solutions - Tennessee, LLC
• Substance Name: CARBAMAZEPINE
• Active Ingredient Strength: 200 mg/1
• Pharm Classes: 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 Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 43353-953-53

60 TABLET in 1 BOTTLE (43353-953-53)

• Marketing Start Date: 2014-07-03
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 43353-953-80 [43353095380]

CARBAMAZEPINE TABLET

• Marketing Category: ANDA
• Application Number: ANDA075948
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-07-25

NDC 43353-953-53 [43353095353]

CARBAMAZEPINE TABLET

• Marketing Category: ANDA
• Application Number: ANDA075948
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-07-03

NDC 43353-953-60 [43353095360]

CARBAMAZEPINE TABLET

• Marketing Category: ANDA
• Application Number: ANDA075948
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-07-03

Drug Details

Active Ingredients

Ingredient	Strength
CARBAMAZEPINE	200 mg/1

OpenFDA Data

• SPL SET ID: c1fc31ef-6b2e-4de4-a185-ec44e94e7b40
• Manufacturer:
  • Aphena Pharma Solutions - Tennessee, LLC
• UNII:
  • 33CM23913M
• RxNorm Concept Unique ID - RxCUI:
  • 308979

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"

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