51862-582 : Budesonide (Enteric Coated) (Enteric Coated) 3 mg Oral Capsule, Delayed Release Pellets


NDC51862-582
Labeler: Mayne Pharma Inc.
Product Type: Human Prescription Drug
Drug Name:  Budesonide (Enteric Coated)
Dosage Form: Oral Capsule, Delayed Release Pellets
Application #: ANDA206623
Rev. Date: 


Appearance:


Markings: 0495
Shapes:  Capsule
Colors:  Pink / White
Size (mm): 19
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:

  • 51862-582-01: 100 CAPSULE, DELAYED RELEASE PELLETS IN 1 BOTTLE (51862‑582‑01)

Active Ingredients:

  • Budesonide

Dosage Strength:

  • 3 mg

Inactive Ingredients:

  • Acetyltributyl Citrate
  • Ethylcellulose (10 Mpa.s)
  • Hypromellose, Unspecified
  • Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type a
  • Polyethylene Glycol, Unspecified
  • Polysorbate 80
  • Sodium Lauryl Sulfate
  • Sucrose
  • Starch, Corn
  • Talc
  • Triethyl Citrate
  • Gelatin, Unspecified
  • D&c Red No. 28
  • D&c Red No. 33
  • Titanium Dioxide
  • Ferrosoferric Oxide
  • D&c Yellow No. 10
  • Fd&c Blue No. 1
  • Fd&c Blue No. 2
  • Fd&c Red No. 40
  • Propylene Glycol
  • Shellac

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 51862-580 Budesonide (Enteric Coated) (Enteric Coated) 3 mg Oral Capsule, Delayed Release Pellets by Mayne Pharma Inc.
  • 0093-7445 Budesonide (Enteric Coated) 3 mg Oral Capsule, Delayed Release Pellets by Teva Pharmaceuticals USA, Inc.
  • 47781-146 Budesonide (Enteric Coated) (Enteric Coated) 3 mg Oral Capsule by Alvogen, Inc.
  • 51407-128 Budesonide (Enteric Coated) (Enteric Coated) 3 mg Oral Capsule, Delayed Release Pellets by Golden State Medical Supply, Inc.
  • 55700-590 Budesonide (Enteric Coated) (Enteric Coated) 3 mg Oral Capsule, Delayed Release Pellets by Lake Erie Medical Dba Quality Care Products LLC

NDC 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.