47781-146 : Budesonide (Enteric Coated) (Enteric Coated) 3 mg Oral Capsule

NDC:	47781-146
Labeler:	Alvogen, Inc.
Product Type:	Human Prescription Drug
Drug Name:	Budesonide (Enteric Coated)
Dosage Form:	Oral Capsule
Application #:	ANDA206724
Rev. Date:	Nov 28, 2016

Appearance:

Markings:	NATCO;3mg
Shapes:	Capsule
Colors:	Gray / Pink
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:

• 47781-146-01: 100 CAPSULE IN 1 BOTTLE (47781‑146‑01)

Active Ingredients:

• Budesonide

Inactive Ingredients:

• Acetyltributyl Citrate
• Cetyl Alcohol
• Ethylcelluloses
• Ferric Oxide Red
• Ferrosoferric Oxide
• Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type a
• Polysorbate 80
• Sodium Lauryl Sulfate
• Starch, Corn
• Sucrose
• Talc
• Titanium Dioxide
• Triethyl Citrate
• Water
• Ethyl Acrylate
• Gelatin
• Potassium Hydroxide
• Propylene Glycol
• Ammonia
• Shellac

Pharmaceutical Classes:

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

Related Products:

• 0093-7445 Budesonide (Enteric Coated) 3 mg Oral Capsule, Delayed Release Pellets by Teva Pharmaceuticals USA, Inc.
• 51407-128 Budesonide (Enteric Coated) (Enteric Coated) 3 mg Oral Capsule, Delayed Release Pellets by Golden State Medical Supply, Inc.
• 51862-580 Budesonide (Enteric Coated) (Enteric Coated) 3 mg Oral Capsule, Delayed Release Pellets by Mayne Pharma Inc.
• 51862-582 Budesonide (Enteric Coated) (Enteric Coated) 3 mg Oral Capsule, Delayed Release Pellets by Mayne Pharma 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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