NDC 0093-0090

Epitol

Carbamazepine

Epitol is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Teva Pharmaceuticals Usa, Inc.. The primary component is Carbamazepine.

• Product ID: 0093-0090_2a6353f7-c318-4543-b64e-b2f58cb777dd
• NDC: 0093-0090
• Product Type: Human Prescription Drug
• Proprietary Name: Epitol
• Generic Name: Carbamazepine
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 1990-09-30
• Marketing Category: ANDA / ANDA
• Application Number: ANDA070541
• Labeler Name: Teva Pharmaceuticals USA, Inc.
• 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: 2021-12-31

Packaging

NDC 0093-0090-01

100 TABLET in 1 BOTTLE (0093-0090-01)

• Marketing Start Date: 1990-09-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0093-0090-83 [00093009083]

Epitol TABLET

• Marketing Category: ANDA
• Application Number: ANDA070541
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2011-05-06
• Marketing End Date: 2013-02-19

NDC 0093-0090-01 [00093009001]

Epitol TABLET

• Marketing Category: ANDA
• Application Number: ANDA070541
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1990-09-30

Drug Details

Active Ingredients

Ingredient	Strength
CARBAMAZEPINE	200 mg/1

OpenFDA Data

• SPL SET ID: 32bbe864-7374-44da-8c6e-e733f0648243
• Manufacturer:
  • Teva Pharmaceuticals USA, Inc.
• UNII:
  • 33CM23913M
• RxNorm Concept Unique ID - RxCUI:
  • 308979
  • 211817
• UPC Code:
  • 0300930090011

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 "Epitol" or generic name "Carbamazepine"

NDC	Brand Name	Generic Name
0093-0090	Epitol	Carbamazepine
0093-0109	Carbamazepine	Carbamazepine
0093-0778	Carbamazepine	Carbamazepine
0078-0508	Tegretol	carbamazepine
0078-0509	Tegretol	carbamazepine
0078-0510	Tegretol	carbamazepine
0078-0511	Tegretol	carbamazepine
0078-0512	Tegretol	carbamazepine