Budesonide

BUDESONIDE — budesonide capsule, coated pellets
Cadila Healthcare Limited

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1075-1 in bottle of 100 capsules

Budesonide Delayed-Release Capsules (Enteric Coated) 3 mg

100 capsules

Rx only

Budesonide Capsules label
(click image for full-size original)
BUDESONIDE
budesonide capsule, coated pellets
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1075
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
ALCOHOL
AMMONIA
BUTYL ALCOHOL
DIMETHICONE
ETHYLCELLULOSES
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
GELATIN
ISOPROPYL ALCOHOL
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER
POLYSORBATE 80
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
SODIUM LAURYL SULFATE
SUCROSE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
WATER
Product Characteristics
Color ORANGE (OPAQUE LIGHT-ORANGE) , WHITE (OPAQUE WHITE) Score no score
Shape CAPSULE (CAPSULE) Size 19mm
Flavor Imprint Code 720
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1075-3 30 CAPSULE, COATED PELLETS in 1 BOTTLE None
2 NDC:70771-1075-9 90 CAPSULE, COATED PELLETS in 1 BOTTLE None
3 NDC:70771-1075-1 100 CAPSULE, COATED PELLETS in 1 BOTTLE None
4 NDC:70771-1075-5 500 CAPSULE, COATED PELLETS in 1 BOTTLE None
5 NDC:70771-1075-0 1000 CAPSULE, COATED PELLETS in 1 BOTTLE None
6 NDC:70771-1075-4 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK
6 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK This package is contained within the CARTON (70771-1075-4)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206134 06/08/2017
Labeler — Cadila Healthcare Limited (918596198)
Registrant — Cadila Healthcare Limited (918596198)
Establishment
Name Address ID/FEI Operations
Cadila Healthcare Limited 863362789 ANALYSIS (70771-1075), MANUFACTURE (70771-1075)

Revised: 10/2021 Cadila Healthcare Limited

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