BUDESONIDE- budesonide capsule, coated pellets 
Zydus Lifesciences Limited

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BUDESONIDE DELAYED-RELEASE CAPSULES

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1075-1 in bottle of 100 capsules

Budesonide Delayed-Release Capsules 3 mg

100 capsules

Rx only

Budesonide Capsules label
BUDESONIDE 
budesonide capsule, coated pellets
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1075
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BUDESONIDE (UNII: Q3OKS62Q6X) (BUDESONIDE - UNII:Q3OKS62Q6X) BUDESONIDE3 mg
Inactive Ingredients
Ingredient NameStrength
ACETYLTRIBUTYL CITRATE (UNII: 0ZBX0N59RZ)  
ALCOHOL (UNII: 3K9958V90M)  
AMMONIA (UNII: 5138Q19F1X)  
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GELATIN (UNII: 2G86QN327L)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
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)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorORANGE (OPAQUE LIGHT-ORANGE) , WHITE (OPAQUE WHITE) Scoreno score
ShapeCAPSULE (CAPSULE) Size19mm
FlavorImprint Code 720
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1075-330 in 1 BOTTLE; Type 0: Not a Combination Product06/08/2017
2NDC:70771-1075-990 in 1 BOTTLE; Type 0: Not a Combination Product06/08/2017
3NDC:70771-1075-1100 in 1 BOTTLE; Type 0: Not a Combination Product06/08/2017
4NDC:70771-1075-5500 in 1 BOTTLE; Type 0: Not a Combination Product06/08/2017
5NDC:70771-1075-01000 in 1 BOTTLE; Type 0: Not a Combination Product06/08/2017
6NDC:70771-1075-410 in 1 CARTON06/08/2017
610 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20613406/08/2017
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited863362789ANALYSIS(70771-1075) , MANUFACTURE(70771-1075)

Revised: 2/2025
Document Id: bfde9c2e-2ff5-4258-91bc-78a48b228d14
Set id: d645a346-c99b-4de7-9bca-69e73266d6b4
Version: 8
Effective Time: 20250212
 
Zydus Lifesciences Limited