NDC 70518-1452

Tegretol

Carbamazepine

Tegretol is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Carbamazepine.

• Product ID: 70518-1452_774aba77-e770-0e0a-e053-2991aa0a8083
• NDC: 70518-1452
• Product Type: Human Prescription Drug
• Proprietary Name: Tegretol
• Generic Name: Carbamazepine
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2018-10-02
• Marketing Category: NDA / NDA
• Application Number: NDA016608
• Labeler Name: REMEDYREPACK 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: 2019-12-31

Packaging

NDC 70518-1452-0

30 TABLET in 1 BLISTER PACK (70518-1452-0)

• Marketing Start Date: 2018-10-02
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70518-1452-0 [70518145200]

Tegretol TABLET

• Marketing Category: NDA
• Application Number: NDA016608
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-10-02
• Marketing End Date: 2020-05-21

Drug Details

Active Ingredients

Ingredient	Strength
CARBAMAZEPINE	200 mg/1

OpenFDA Data

• SPL SET ID: 572954c3-4948-4e0a-8acd-ead8d0831649
• Manufacturer:
  • REMEDYREPACK INC.
• UNII:
  • 33CM23913M
• RxNorm Concept Unique ID - RxCUI:
  • 308972
  • 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]

NDC Crossover Matching brand name "Tegretol" or generic name "Carbamazepine"

NDC	Brand Name	Generic Name
0078-0508	Tegretol	carbamazepine
0078-0509	Tegretol	carbamazepine
0078-0510	Tegretol	carbamazepine
0078-0511	Tegretol	carbamazepine
0078-0512	Tegretol	carbamazepine
70518-1452	Tegretol	Tegretol
0093-0109	Carbamazepine	Carbamazepine
0093-0778	Carbamazepine	Carbamazepine
0093-0090	Epitol	Carbamazepine