NDC Code(s) : 0186-0702-10, 0186-0702-94
Packager : AstraZeneca Pharmaceuticals LP

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ENTOCORT Budesonide CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0186-0702
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
ACETYLTRIBUTYL CITRATE(UNII: 0ZBX0N59RZ)
METHACRYLIC ACID(UNII: 1CS02G8656)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
TALC(UNII: 7SEV7J4R1U)
GELATIN(UNII: 2G86QN327L)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERRIC OXIDE RED(UNII: 1K09F3G675)
Product Characteristics
Color GRAY (opaque light gray) Score no score
Shape CAPSULE Size 7 mm
Flavor Imprint Code ENTOCORT;EC;3;mg
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0186-0702-10100 in 1 BOTTLE Type 0: Not a Combination Product29/10/2001
2NDC:0186-0702-946 in 1 BOTTLE Type 0: Not a Combination Product29/10/2001
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021324 10/02/2001 01/31/2019

PRINCIPAL DISPLAY PANEL

NDC 0186-0702-10

ENTOCORT® EC

(budesonide)

3 mg Capsules

Rx Only

Manufactured for AstraZeneca LP

Wilmington, DE 19850

Product of Netherlands

AstraZeneca

ENTOCORT EC 3 mg Capsules - 100 Count Bottle Label