Budesonide (Page 5 of 5)

Principal Display Panel

NDC 0591-2510-30
Budesonide
Extended-Release Tablets
9 mg
Swallow tablet whole, do not chew or break.
Actavis
30 TabletsRx Only

NDC 0591-2510-30
(click image for full-size original)
BUDESONIDE budesonide tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-2510
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUDESONIDE (BUDESONIDE) BUDESONIDE 9 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
HYDROXYPROPYL CELLULOSE (90000 WAMW)
HYDROXYPROPYL CELLULOSE (110000 WAMW)
HYPROMELLOSE 2910 (3 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
FERROSOFERRIC OXIDE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
METHACRYLIC ACID — METHYL METHACRYLATE COPOLYMER (1:1)
METHACRYLIC ACID — METHYL METHACRYLATE COPOLYMER (1:2)
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL 400
POLYSORBATE 80
PROPYLENE GLYCOL
SODIUM STARCH GLYCOLATE TYPE A POTATO
LECITHIN, SOYBEAN
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 9mm
Flavor Imprint Code WPI;2510
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0591-2510-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205457 07/05/2018
Labeler — Actavis Pharma, Inc. (119723554)

Revised: 06/2020 Actavis Pharma, Inc.

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