54868-5432 : Carbatrol 300 mg 12 Hr Extended Release Capsule


NDC: 54868-5432
Labeler: Physicians Total Care, Inc.
Product Type: Human Prescription Drug
Drug Name:  Carbatrol
Dosage Form: Oral Capsule, Extended Release
Application #: NDA020712
Rev. Date: 


Appearance:


Shapes:  Capsule
Colors:  Black / Green
Size (mm): 22
Segments: * 1

* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

NDC Package Codes:

  • 54868-5432-0: 120 CAPSULE, EXTENDED RELEASE IN 1 BOTTLE (54868‑5432‑0)

Active Ingredients:

  • Carbamazepine

Dosage Strength:

  • 300 mg

Inactive Ingredients:

  • Citric Acid Monohydrate
  • Silicon Dioxide
  • Lactose Monohydrate
  • Cellulose, Microcrystalline
  • Polyethylene Glycol
  • Povidone
  • Sodium Lauryl Sulfate
  • Talc
  • Triethyl Citrate
  • Gelatin
  • Fd&c Blue No. 2
  • Fd&c Yellow No. 6
  • Ferric Oxide Red
  • Ferric Oxide Yellow
  • Titanium Dioxide

Pharmaceutical 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]

Related Products:

Based on records with the same trade name.
  • 54092-171 12 Hr Carbatrol 100 mg Extended Release Capsule by Shire Us Manufacturing Inc.
  • 54092-172 12 Hr Carbatrol 200 mg Extended Release Capsule by Shire Us Manufacturing Inc.
  • 54092-173 Carbatrol 300 mg 12 Hr Extended Release Capsule by Shire Us Manufacturing Inc.

NDC QR Code

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NDC 54868-5432 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.