Label: CARVEDILOL tablet, film coated
-
NDC Code(s):
65841-616-01,
65841-616-05,
65841-616-17,
65841-617-01, view more65841-617-05, 65841-617-17, 65841-618-01, 65841-618-05, 65841-618-17, 65841-619-01, 65841-619-05, 65841-619-17
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 31, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
-
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 65841-616-01 in bottle of 100 Tablets
Carvedilol Tablets USP, 3.125 mg
Rx only
100 Tablets
NDC 65841-617-01 in bottle of 100 Tablets
Carvedilol Tablets USP, 6.25 mg
Rx only
100 Tablets
NDC 65841-618-01 in bottle of 100 Tablets
Carvedilol Tablets USP, 12.5 mg
Rx only
100 Tablets
NDC 65841-619-01 in bottle of 100 Tablets
Carvedilol Tablets USP, 25 mg
Rx only
100 Tablets
-
INGREDIENTS AND APPEARANCE
CARVEDILOL
carvedilol tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-616 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CARVEDILOL (UNII: 0K47UL67F2) (CARVEDILOL - UNII:0K47UL67F2) CARVEDILOL 3.125 mg Inactive Ingredients Ingredient Name Strength CROSPOVIDONE (12 MPA.S AT 5%) (UNII: 40UAA97IT9) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE K30 (UNII: U725QWY32X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score no score Shape ROUND (ROUND) Size 4mm Flavor Imprint Code Z;1 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-616-17 28 in 1 BOTTLE; Type 0: Not a Combination Product 09/05/2007 2 NDC:65841-616-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 09/05/2007 3 NDC:65841-616-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 09/05/2007 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077614 09/05/2007 CARVEDILOL
carvedilol tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-617 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CARVEDILOL (UNII: 0K47UL67F2) (CARVEDILOL - UNII:0K47UL67F2) CARVEDILOL 6.25 mg Inactive Ingredients Ingredient Name Strength CROSPOVIDONE (12 MPA.S AT 5%) (UNII: 40UAA97IT9) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE K30 (UNII: U725QWY32X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score no score Shape ROUND (ROUND) Size 6mm Flavor Imprint Code ZC40 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-617-17 28 in 1 BOTTLE; Type 0: Not a Combination Product 09/05/2007 2 NDC:65841-617-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 09/05/2007 3 NDC:65841-617-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 09/05/2007 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077614 09/05/2007 CARVEDILOL
carvedilol tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-618 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CARVEDILOL (UNII: 0K47UL67F2) (CARVEDILOL - UNII:0K47UL67F2) CARVEDILOL 12.5 mg Inactive Ingredients Ingredient Name Strength CROSPOVIDONE (12 MPA.S AT 5%) (UNII: 40UAA97IT9) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE K30 (UNII: U725QWY32X) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score no score Shape ROUND (ROUND) Size 8mm Flavor Imprint Code ZC41 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-618-17 28 in 1 BOTTLE; Type 0: Not a Combination Product 09/05/2007 2 NDC:65841-618-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 09/05/2007 3 NDC:65841-618-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 09/05/2007 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077614 09/05/2007 CARVEDILOL
carvedilol tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-619 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CARVEDILOL (UNII: 0K47UL67F2) (CARVEDILOL - UNII:0K47UL67F2) CARVEDILOL 25 mg Inactive Ingredients Ingredient Name Strength CROSPOVIDONE (12 MPA.S AT 5%) (UNII: 40UAA97IT9) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE K30 (UNII: U725QWY32X) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Product Characteristics Color WHITE (WHITE TO OFF-WHITE) Score no score Shape ROUND (ROUND) Size 10mm Flavor Imprint Code ZC42 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-619-17 28 in 1 BOTTLE; Type 0: Not a Combination Product 09/05/2007 2 NDC:65841-619-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 09/05/2007 3 NDC:65841-619-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 09/05/2007 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077614 09/05/2007 Labeler - Zydus Lifesciences Limited (918596198) Registrant - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 918596198 ANALYSIS(65841-616, 65841-617, 65841-618, 65841-619) , MANUFACTURE(65841-616, 65841-617, 65841-618, 65841-619) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 677605858 ANALYSIS(65841-616, 65841-617, 65841-618, 65841-619) , MANUFACTURE(65841-616, 65841-617, 65841-618, 65841-619)