0093-7445 : Budesonide (Enteric Coated) 3 mg Oral Capsule, Delayed Release Pellets

NDC:	0093-7445
Labeler:	Teva Pharmaceuticals USA, Inc.
Product Type:	Human Prescription Drug
Drug Name:	Budesonide (Enteric Coated)
Dosage Form:	Oral Capsule, Delayed Release Pellets
Application #:	ANDA090379
Rev. Date:	Jun 23, 2016

Appearance:

Markings:	TEVA;7445
Shapes:	Capsule
Colors:	Orange / White
Size (mm):	20
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:

• 0093-7445-01: 100 CAPSULE, DELAYED RELEASE PELLETS IN 1 BOTTLE (0093‑7445‑01)

Active Ingredients:

• Budesonide

Inactive Ingredients:

• Acetyltributyl Citrate
• Ethylcelluloses
• Acetic Acid
• Lactose Monohydrate
• Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type a
• Polysorbate 80
• Dimethicone
• Sodium Hydroxide
• Sucrose
• Starch, Corn
• Talc
• Triethyl Citrate
• Fd&c Yellow No. 6
• Fd&c Red No. 40
• Gelatin, Unspecified
• Titanium Dioxide
• D&c Yellow No. 10
• Fd&c Blue No. 1
• Fd&c Blue No. 2
• Indigotindisulfonate Sodium
• Shellac
• Ferrosoferric Oxide
• Propylene Glycol

Pharmaceutical Classes:

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

Related Products:

• 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.
• 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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