NDC 70518-0337

Tegretol XR

Carbamazepine

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

• Product ID: 70518-0337_83d35f16-305e-7350-e053-2991aa0a94d3
• NDC: 70518-0337
• Product Type: Human Prescription Drug
• Proprietary Name: Tegretol XR
• Generic Name: Carbamazepine
• Dosage Form: Tablet, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2017-03-20
• Marketing Category: NDA / NDA
• Application Number: NDA020234
• Labeler Name: REMEDYREPACK 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: 2020-12-31

Packaging

NDC 70518-0337-0

30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-0337-0)

• Marketing Start Date: 2017-03-20
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70518-0337-1 [70518033701]

Tegretol XR TABLET, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA020234
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-07-31

NDC 70518-0337-0 [70518033700]

Tegretol XR TABLET, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA020234
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-03-20
• Marketing End Date: 2018-08-09

Drug Details

Active Ingredients

Ingredient	Strength
CARBAMAZEPINE	100 mg/1

OpenFDA Data

• SPL SET ID: 9528e07a-c386-4d07-bd57-9ca3e1a59ec6
• Manufacturer:
  • REMEDYREPACK INC.
• UNII:
  • 33CM23913M
• RxNorm Concept Unique ID - RxCUI:
  • 199378
  • 866303

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 XR" or generic name "Carbamazepine"

NDC	Brand Name	Generic Name
70518-0337	Tegretol XR	Tegretol XR
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