NDC 54092-173

Carbatrol

Carbamazepine

Carbatrol is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Takeda Pharmaceuticals America, Inc.. The primary component is Carbamazepine.

• Product ID: 54092-173_14fbfd3d-8615-476d-976c-ca86dd5a9765
• NDC: 54092-173
• Product Type: Human Prescription Drug
• Proprietary Name: Carbatrol
• Generic Name: Carbamazepine
• Dosage Form: Capsule, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 1997-09-30
• Marketing Category: NDA / NDA
• Application Number: NDA020712
• Labeler Name: Takeda Pharmaceuticals America, Inc.
• Substance Name: CARBAMAZEPINE
• Active Ingredient Strength: 300 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 54092-173-12

120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (54092-173-12)

• Marketing Start Date: 1997-09-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 54092-173-12 [54092017312]

Carbatrol CAPSULE, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA020712
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1997-09-30

Drug Details

Active Ingredients

Ingredient	Strength
CARBAMAZEPINE	300 mg/1

OpenFDA Data

• SPL SET ID: bc03e499-5bac-4293-bff4-6864153a624d
• Manufacturer:
  • Shire US Manufacturing Inc.
• UNII:
  • 33CM23913M
• RxNorm Concept Unique ID - RxCUI:
  • 308977
  • 313931
  • 200133
  • 388311
  • 200131
  • 404742
• UPC Code:
  • 0354092171125

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]

Medicade Reported Pricing

54092017312 CARBATROL ER 300 MG CAPSULE

Pricing Unit: EA | Drug Type:

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

NDC	Brand Name	Generic Name
54092-173	Carbatrol	Carbatrol
54092-171	Carbatrol	Carbatrol
54092-172	Carbatrol	Carbatrol
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