54868-4910 : 24 Hr Entocort 3 mg Extended Release Enteric Coated Capsule

Labeler: Physicians Total Care, Inc.
Product Type: Human Prescription Drug
Drug Name:  Entocort Ec
Dosage Form: Oral Capsule
Application #: NDA021324
Rev. Date: 


Markings: ENTOCORT;EC;3;mg
Shapes:  Capsule
Colors:  Gray
Size (mm): 7
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.

ENTOCORT EC 3 mg: (0186-0702) 24 Hr Entocort 3 mg Extended Release Enteric Coated Capsule by Physicians Total Care, Inc.
The above image is provided by the U.S. National Library of Medicine (NLM) and is not part of the official label.

NDC Package Codes:

  • 54868-4910-0: 10 CAPSULE IN 1 BOTTLE, PLASTIC (54868‑4910‑0)
  • 54868-4910-1: 90 CAPSULE IN 1 BOTTLE, PLASTIC (54868‑4910‑1)
  • 54868-4910-2: 100 CAPSULE IN 1 BOTTLE, PLASTIC (54868‑4910‑2)
  • 54868-4910-3: 30 CAPSULE IN 1 BOTTLE, PLASTIC (54868‑4910‑3)

Active Ingredients:

  • Budesonide

Dosage Strength:

  • 3 mg

Inactive Ingredients:

  • Acetyltributyl Citrate
  • Methacrylic Acid
  • Triethyl Citrate
  • Polysorbate 80
  • Talc
  • Gelatin
  • Ferrosoferric Oxide
  • Titanium Dioxide
  • Colloidal Silicon Dioxide
  • Ferric Oxide Yellow
  • Ferric Oxide Red

Pharmaceutical Classes:

  • Corticosteroid [EPC]
  • Corticosteroid Hormone Receptor Agonists [MoA]

Related Products:

Based on records with the same trade name.
  • 0186-0702 24 Hr Entocort 3 mg Extended Release Enteric Coated Capsule by Astrazeneca Lp
  • 65483-702 24 Hr Entocort 3 mg Extended Release Enteric Coated Capsule by Prometheus Laboratories Inc


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