NDC 63402-208

Aptiom

Eslicarbazepine Acetate

Aptiom is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Sunovion Pharmaceuticals Inc.. The primary component is Eslicarbazepine Acetate.

• Product ID: 63402-208_05e586b4-1a22-4825-90e8-21053a1b570a
• NDC: 63402-208
• Product Type: Human Prescription Drug
• Proprietary Name: Aptiom
• Generic Name: Eslicarbazepine Acetate
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2014-04-07
• Marketing Category: NDA / NDA
• Application Number: NDA022416
• Labeler Name: Sunovion Pharmaceuticals Inc.
• Substance Name: ESLICARBAZEPINE ACETATE
• Active Ingredient Strength: 800 mg/1
• Pharm Classes: Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 63402-208-28

4 BLISTER PACK in 1 CARTON (63402-208-28) > 7 TABLET in 1 BLISTER PACK (63402-208-07)

• Marketing Start Date: 2014-04-07
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63402-208-28 [63402020828]

Aptiom TABLET

• Marketing Category: NDA
• Application Number: NDA022416
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-04-07

NDC 63402-208-07 [63402020807]

Aptiom TABLET

• Marketing Category: NDA
• Application Number: NDA022416
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-04-07

NDC 63402-208-30 [63402020830]

Aptiom TABLET

• Marketing Category: NDA
• Application Number: NDA022416
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-04-07

NDC 63402-208-90 [63402020890]

Aptiom TABLET

• Marketing Category: NDA
• Application Number: NDA022416
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-04-07
• Marketing End Date: 2019-03-28

Drug Details

Active Ingredients

Ingredient	Strength
ESLICARBAZEPINE ACETATE	800 mg/1

OpenFDA Data

• SPL SET ID: 3d0c9554-eaeb-4694-8089-00133fcadce3
• Manufacturer:
  • Sunovion Pharmaceuticals Inc.
• UNII:
  • BEA68ZVB2K
• RxNorm Concept Unique ID - RxCUI:
  • 1482523
  • 1482521
  • 1482527
  • 1482525
  • 1491643
  • 1491642
  • 1482513
  • 1482507
  • 1482517
  • 1482515

Pharmacological Class

• Decreased Central Nervous System Disorganized Electrical Activity [PE]
• Cytochrome P450 3A4 Inducers [MoA]
• Cytochrome P450 2C19 Inhibitors [MoA]
• Decreased Central Nervous System Disorganized Electrical Activity [PE]
• Cytochrome P450 3A4 Inducers [MoA]
• Cytochrome P450 2C19 Inhibitors [MoA]

Medicade Reported Pricing

63402020830 APTIOM 800 MG TABLET

Pricing Unit: EA | Drug Type:

NDC Crossover Matching brand name "Aptiom" or generic name "Eslicarbazepine Acetate"

NDC	Brand Name	Generic Name
63402-202	Aptiom	ESLICARBAZEPINE ACETATE
63402-204	Aptiom	ESLICARBAZEPINE ACETATE
63402-206	Aptiom	ESLICARBAZEPINE ACETATE
63402-208	Aptiom	ESLICARBAZEPINE ACETATE
63402-248	Aptiom	ESLICARBAZEPINE ACETATE