Label: BUDESONIDE capsule, coated pellets
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NDC Code(s):
70771-1075-0,
70771-1075-1,
70771-1075-3,
70771-1075-4, view more70771-1075-5, 70771-1075-9
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated July 27, 2022
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- SPL UNCLASSIFIED SECTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BUDESONIDE
budesonide capsule, coated pelletsProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1075 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BUDESONIDE (UNII: Q3OKS62Q6X) (BUDESONIDE - UNII:Q3OKS62Q6X) BUDESONIDE 3 mg Inactive Ingredients Ingredient Name Strength 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 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 Marketing Start Date Marketing End Date 1 NDC:70771-1075-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 06/08/2017 2 NDC:70771-1075-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 06/08/2017 3 NDC:70771-1075-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 06/08/2017 4 NDC:70771-1075-5 500 in 1 BOTTLE; Type 0: Not a Combination Product 06/08/2017 5 NDC:70771-1075-0 1000 in 1 BOTTLE; Type 0: Not a Combination Product 06/08/2017 6 NDC:70771-1075-4 10 in 1 CARTON 06/08/2017 6 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA206134 06/08/2017 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 863362789 ANALYSIS(70771-1075) , MANUFACTURE(70771-1075)
