63402-208 : Aptiom 800 mg/1 Oral Tablet


NDC: 63402-208
Labeler: Sunovion Pharmaceuticals Inc.
Product Type: Human Prescription Drug
Drug Name:  Aptiom
Dosage Form: Oral Tablet
Application #: NDA022416
Rev. Date: 


Appearance:


Markings: ESL;800
Shapes:  Oval
Colors:  White
Size (mm): 19
Segments: * 2

* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 2 indicates a scored pill which can be broken into 2 equal pieces.

NDC Package Codes:

  • 63402-208-28: 4 BLISTER PACK IN 1 CARTON (63402‑208‑28) > 7 TABLET IN 1 BLISTER PACK (63402‑208‑07)
  • 63402-208-30: 30 TABLET IN 1 BOTTLE (63402‑208‑30)
  • 63402-208-90: 90 TABLET IN 1 BOTTLE (63402‑208‑90)

Active Ingredients:

  • Eslicarbazepine Acetate

Dosage Strength:

  • 800 mg

Inactive Ingredients:

  • Povidone K29/32
  • Croscarmellose Sodium
  • Magnesium Stearate

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 63402-202 Aptiom 200 mg/1 Oral Tablet by Sunovion Pharmaceuticals Inc.
  • 63402-204 Aptiom 400 mg/1 Oral Tablet by Sunovion Pharmaceuticals Inc.
  • 63402-206 Aptiom 600 mg/1 Oral Tablet by Sunovion Pharmaceuticals Inc.
  • 63402-248 Aptiom Oral Kit by Sunovion Pharmaceuticals Inc.

NDC QR Code

Scan the QR code below to easily reference this data in the future:

NDC 63402-208 QR Code

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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.