54868-5043 : Amnesteem 40 mg Oral Capsule

Labeler: Physicians Total Care, Inc.
Product Type: Human Prescription Drug
Drug Name:  Amnesteem
Dosage Form: Oral Capsule
Application #: ANDA075945
Rev. Date: 


Markings: I40
Shapes:  Capsule
Colors:  Orange
Size (mm): 13
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:

  • 54868-5043-0: 3 BLISTER PACK IN 1 CARTON (54868‑5043‑0) > 10 CAPSULE IN 1 BLISTER PACK

Active Ingredients:

  • Isotretinoin

Dosage Strength:

  • 40 mg

Inactive Ingredients:

  • Yellow Wax
  • Butylated Hydroxyanisole
  • Edetate Disodium
  • Soybean Oil
  • Glycerin
  • Ferric Oxide Red
  • Ferric Oxide Yellow
  • Titanium Dioxide

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 54868-5039 Amnesteem 10 mg Oral Capsule by Physicians Total Care, Inc.
  • 54868-5041 Amnesteem 20 mg Oral Capsule by Physicians Total Care, Inc.
  • 0378-6611 Amnesteem 10 mg Oral Capsule by Mylan Pharmaceuticals Inc.
  • 0378-6612 Amnesteem 20 mg Oral Capsule by Mylan Pharmaceuticals Inc.
  • 0378-6614 Amnesteem 40 mg Oral Capsule by Mylan Pharmaceuticals Inc.


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