NDC Code(s) : 68382-720-06, 68382-720-16, 68382-720-01, 68382-720-05, 68382-720-10, 68382-720-30, 68382-720-77
Packager : Zydus Pharmaceuticals USA Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

budesonidebudesonide CAPSULE, COATED PELLETS
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68382-720
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)
DIMETHICONE(UNII: 92RU3N3Y1O)
ETHYLCELLULOSES(UNII: 7Z8S9VYZ4B)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
GELATIN(UNII: 2G86QN327L)
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER(UNII: NX76LV5T8J)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
SUCROSE(UNII: C151H8M554)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
Product Characteristics
Color ORANGE (OPAQUE LIGHT-ORANGE), WHITE (OPAQUE WHITE) Score no score
Shape CAPSULE (CAPSULE) Size 19 mm
Flavor Imprint Code 720
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68382-720-0630 in 1 BOTTLE Type 0: Not a Combination Product06/08/2017
2NDC:68382-720-1690 in 1 BOTTLE Type 0: Not a Combination Product06/08/2017
3NDC:68382-720-01100 in 1 BOTTLE Type 0: Not a Combination Product06/08/2017
4NDC:68382-720-05500 in 1 BOTTLE Type 0: Not a Combination Product06/08/2017
5NDC:68382-720-101000 in 1 BOTTLE Type 0: Not a Combination Product06/08/2017
6NDC:68382-720-7710 in 1 CARTON 06/08/2017
6NDC:68382-720-3010 in 1 BLISTER PACK Type 0: Not a Combination Product06/08/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206134 06/08/2017

LABELER - Zydus Pharmaceuticals USA Inc.(156861945)

REGISTRANT - Zydus Pharmaceuticals USA Inc.(156861945)

Establishment
Name Address ID/FEI Business Operations
Zydus Lifesciences Limited 863362789 ANALYSIS(68382-720), MANUFACTURE(68382-720)

PRINCIPAL DISPLAY PANEL

NDC 68382-720-01 in bottle of 100 capsules

Budesonide Delayed-Release capsules (Enteric Coated) 3 mg

Rx only

Budesonide Capsules label