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 — 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
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: 04/2022 Golden State Medical Supply, Inc.

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