NDC Code(s) : 0574-9855-10
Packager : Padagis US LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

budesonidebudesonide CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0574-9855
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BUDESONIDE(UNII: Q3OKS62Q6X)
(BUDESONIDE - UNII:Q3OKS62Q6X) 		BUDESONIDE3 mg
Inactive Ingredients
Ingredient Name Strength
ETHYLCELLULOSE, UNSPECIFIED(UNII: 7Z8S9VYZ4B)
ACETYLTRIBUTYL CITRATE(UNII: 0ZBX0N59RZ)
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER(UNII: NX76LV5T8J)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
TALC(UNII: 7SEV7J4R1U)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
FERRIC OXIDE RED(UNII: 1K09F3G675)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color GRAY (opaque light gray) Score no score
Shape CAPSULE Size 7 mm
Flavor Imprint Code ENTOCORT;EC;3mg
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0574-9855-101 in 1 CARTON 29/06/2018
1100 in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021324 06/29/2018

LABELER - Padagis US LLC(967694121)

PRINCIPAL DISPLAY PANEL

NDC 0574-9855-10

Rx Only

Budesonide Delayed-Release Capsules 3mg

100 Capsules

carton

The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation.

carton