BUDESONIDE (ENTERIC COATED) (Page 8 of 8)

PRINCIPAL DISPLAY PANEL — 3 mg Capsule Bottle Label

NDC 51407-128-01

Budesonide
Capsules
(Enteric Coated)

3 mg

PHARMACIST: Dispense the accompanying
Patient Information leaflet to each patient.

Rx Only 100 Capsules

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BUDESONIDE (ENTERIC COATED) budesonide capsule, delayed release pellets
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51407-128(NDC:51862-580)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUDESONIDE (BUDESONIDE) BUDESONIDE 3 mg
Inactive Ingredients
Ingredient Name Strength
ACETYLTRIBUTYL CITRATE
ETHYLCELLULOSE (10 MPA.S)
HYPROMELLOSE, UNSPECIFIED
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER
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
Product Characteristics
Color pink (pink opaque cap) , white (white opaque body) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code m580
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51407-128-01 100 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206623 04/08/2016
Labeler — Golden State Medical Supply, Inc. (603184490)
Establishment
Name Address ID/FEI Operations
Golden State Medical Supply, Inc. 603184490 relabel (51407-128), repack (51407-128)

Revised: 03/2023 Golden State Medical Supply, Inc.

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