NDC 0781-8016

Carbamazepine ER

Carbamazepine

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

• Product ID: 0781-8016_546468c0-441c-4689-889c-c0c01e9c279f
• NDC: 0781-8016
• Product Type: Human Prescription Drug
• Proprietary Name: Carbamazepine ER
• Generic Name: Carbamazepine
• Dosage Form: Tablet, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 1996-03-25
• Marketing Category: NDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
• Application Number: NDA020234
• Labeler Name: Sandoz Inc
• Substance Name: CARBAMAZEPINE
• Active Ingredient Strength: 100 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: 2021-12-31

Packaging

NDC 0781-8016-01

100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0781-8016-01)

• Marketing Start Date: 2018-01-09
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0781-8016-01 [00781801601]

Carbamazepine ER TABLET, EXTENDED RELEASE

• Marketing Category: NDA authorized generic
• Application Number: NDA020234
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-01-09

Drug Details

Active Ingredients

Ingredient	Strength
CARBAMAZEPINE	100 mg/1

OpenFDA Data

• SPL SET ID: 3a3344dc-9cc8-41da-859e-295d053597c1
• Manufacturer:
  • Sandoz Inc
• UNII:
  • 33CM23913M
• RxNorm Concept Unique ID - RxCUI:
  • 199378
  • 402505
  • 402506

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 ER" or generic name "Carbamazepine"

NDC	Brand Name	Generic Name
68084-562	Carbamazepine ER	Carbamazepine ER
68084-561	Carbamazepine ER	Carbamazepine ER
0781-5988	Carbamazepine ER	Carbamazepine ER
0781-5987	Carbamazepine ER	Carbamazepine ER
0781-8016	Carbamazepine ER	Carbamazepine ER
70518-2653	Carbamazepine ER	Carbamazepine ER
0093-0109	Carbamazepine	Carbamazepine
0093-0778	Carbamazepine	Carbamazepine
0093-0090	Epitol	Carbamazepine
0078-0508	Tegretol	carbamazepine
0078-0509	Tegretol	carbamazepine
0078-0510	Tegretol	carbamazepine
0078-0511	Tegretol	carbamazepine
0078-0512	Tegretol	carbamazepine