51862-580 : Budesonide (Enteric Coated) (Enteric Coated) 3 mg Oral Capsule, Delayed Release Pellets

NDC:	51862-580
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:	Oct 31, 2019

Appearance:

Markings:	m580
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:

• 51862-580-01: 100 CAPSULE, DELAYED RELEASE PELLETS IN 1 BOTTLE (51862‑580‑01)

Active Ingredients:

• Budesonide

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 Hormone Receptor Agonists [MoA]
• Corticosteroid [EPC]

Related Products:

• 51862-582 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

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