54868-6426 : Zenatane 40 mg Oral Capsule, Gelatin Coated


NDC54868-6426
Labeler: Physicians Total Care, Inc.
Product Type: Human Prescription Drug
Drug Name:  Zenatane
Dosage Form: Oral Capsule, Gelatin Coated
Application #: ANDA202099
Rev. Date: 


Appearance:


Markings: R137
Shapes:  Oval
Colors:  Green
Size (mm): 5
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:

  • 54868-6426-0: 3 BLISTER PACK IN 1 CARTON (54868‑6426‑0) > 10 CAPSULE, GELATIN COATED IN 1 BLISTER PACK

Active Ingredients:

  • Isotretinoin

Dosage Strength:

  • 40 mg

Inactive Ingredients:

  • Butylated Hydroxyanisole
  • Edetate Disodium
  • Hydrogenated Soybean Oil
  • Medium-chain Triglycerides
  • Soybean Oil
  • White Wax
  • Gelatin
  • Glycerin
  • Methylparaben
  • Propylparaben
  • D&c Yellow No. 10
  • Fd&c Blue No. 1
  • Fd&c Blue No. 2
  • Titanium Dioxide
  • Ferrosoferric Oxide
  • Butyl Alcohol
  • Propylene Glycol
  • Shellac

Pharmaceutical Classes:

  • Retinoid [EPC]
  • Retinoids [Chemical/Ingredient]

Related Products:

Based on records with the same trade name.
  • 54868-6425 Zenatane 20 mg Oral Capsule, Gelatin Coated by Physicians Total Care, Inc.
  • 55111-113 Zenatane 30 mg Oral Capsule, Gelatin Coated by Dr. Reddy's Laboratories Limited
  • 55111-135 Zenatane 10 mg Oral Capsule by Dr. Reddy's Laboratories Limited
  • 55111-136 Zenatane 20 mg Oral Capsule by Dr. Reddy's Laboratories Limited
  • 55111-137 Zenatane 40 mg Oral Capsule by Dr. Reddy's Laboratories Limited

NDC QR Code

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NDC 54868-6426 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.