NDC 30698-419

EQUETRO

Carbamazepine

EQUETRO is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Validus Pharmaceuticals Llc. The primary component is Carbamazepine.

• Product ID: 30698-419_414a3f25-2360-4b36-875c-90ec4e5a2dfa
• NDC: 30698-419
• Product Type: Human Prescription Drug
• Proprietary Name: EQUETRO
• Generic Name: Carbamazepine
• Dosage Form: Capsule, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2004-12-10
• Marketing Category: NDA / NDA
• Application Number: NDA021710
• Labeler Name: Validus Pharmaceuticals LLC
• 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 30698-419-12

120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (30698-419-12)

• Marketing Start Date: 2004-12-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 30698-419-12 [30698041912]

EQUETRO CAPSULE, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA021710
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2004-12-10

Drug Details

Active Ingredients

Ingredient	Strength
CARBAMAZEPINE	100 mg/1

OpenFDA Data

• SPL SET ID: be478f3c-40f6-47cc-8ab9-f420a9372b1c
• Manufacturer:
  • Validus Pharmaceuticals LLC
• UNII:
  • 33CM23913M
• RxNorm Concept Unique ID - RxCUI:
  • 672908
  • 672909
  • 200133
  • 388311
  • 200131
  • 672910

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]

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

NDC	Brand Name	Generic Name
30698-423	EQUETRO	EQUETRO
30698-419	EQUETRO	EQUETRO
30698-421	EQUETRO	EQUETRO
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