PROPRANOLOL HYDROCHLORIDE - propranolol hydrochloride capsule, extended release 
Zydus Lifesciences Limited

----------

Propranolol Hydrochloride Extended-release Capsules, USP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-745-01 in bottle of 100 Capsules

Propranolol Hydrochloride Extended-release Capsules USP, 60 mg

Rx only

100 CAPSULES

Structured formula for propranolol

NDC 65841-746-01 in bottle of 100 Capsules

Propranolol Hydrochloride Extended-release Capsules USP, 80 mg

Rx only

100 CAPSULES

Structured formula for propranolol

NDC 65841-747-01 in bottle of 100 Capsules

Propranolol Hydrochloride Extended-release Capsules USP, 120 mg

Rx only

100 CAPSULES

Structured formula for propranolol

NDC 65841-748-01 in bottle of 100 Capsules

Propranolol Hydrochloride Extended-release Capsules USP, 160 mg

Rx only

100 CAPSULES

Structural formula for propranolol
PROPRANOLOL HYDROCHLORIDE 
propranolol hydrochloride capsule, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-745
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PROPRANOLOL HYDROCHLORIDE (UNII: F8A3652H1V) (PROPRANOLOL - UNII:9Y8NXQ24VQ) PROPRANOLOL HYDROCHLORIDE60 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GELATIN (UNII: 2G86QN327L)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
Product Characteristics
ColorWHITE (WHITE) , BLUE (LIGHT BLUE) Scoreno score
ShapeCAPSULE (CAPSULE) Size16mm
FlavorImprint Code ZA;57;60;mg
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-745-1690 in 1 BOTTLE; Type 0: Not a Combination Product04/15/2014
2NDC:65841-745-01100 in 1 BOTTLE; Type 0: Not a Combination Product04/15/2014
3NDC:65841-745-05500 in 1 BOTTLE; Type 0: Not a Combination Product04/15/2014
4NDC:65841-745-101000 in 1 BOTTLE; Type 0: Not a Combination Product04/15/2014
5NDC:65841-745-77100 in 1 CARTON04/15/2014
5NDC:65841-745-301 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09032104/15/2014
PROPRANOLOL HYDROCHLORIDE 
propranolol hydrochloride capsule, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-746
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PROPRANOLOL HYDROCHLORIDE (UNII: F8A3652H1V) (PROPRANOLOL - UNII:9Y8NXQ24VQ) PROPRANOLOL HYDROCHLORIDE80 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GELATIN (UNII: 2G86QN327L)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
Product Characteristics
ColorBLUE (LIGHT BLUE) , BLUE (LIGHT BLUE) Scoreno score
ShapeCAPSULE (CAPSULE) Size16mm
FlavorImprint Code ZA;58;80;mg
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-746-1690 in 1 BOTTLE; Type 0: Not a Combination Product04/15/2014
2NDC:65841-746-01100 in 1 BOTTLE; Type 0: Not a Combination Product04/15/2014
3NDC:65841-746-05500 in 1 BOTTLE; Type 0: Not a Combination Product04/15/2014
4NDC:65841-746-101000 in 1 BOTTLE; Type 0: Not a Combination Product04/15/2014
5NDC:65841-746-77100 in 1 CARTON04/15/2014
5NDC:65841-746-301 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09032104/15/2014
PROPRANOLOL HYDROCHLORIDE 
propranolol hydrochloride capsule, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-747
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PROPRANOLOL HYDROCHLORIDE (UNII: F8A3652H1V) (PROPRANOLOL - UNII:9Y8NXQ24VQ) PROPRANOLOL HYDROCHLORIDE120 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GELATIN (UNII: 2G86QN327L)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
Product Characteristics
ColorBLUE (DARK BLUE) , BLUE (LIGHT BLUE) Scoreno score
ShapeCAPSULE (CAPSULE) Size18mm
FlavorImprint Code ZA;59;120;mg
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-747-1690 in 1 BOTTLE; Type 0: Not a Combination Product04/15/2014
2NDC:65841-747-01100 in 1 BOTTLE; Type 0: Not a Combination Product04/15/2014
3NDC:65841-747-05500 in 1 BOTTLE; Type 0: Not a Combination Product04/15/2014
4NDC:65841-747-101000 in 1 BOTTLE; Type 0: Not a Combination Product04/15/2014
5NDC:65841-747-77100 in 1 CARTON04/15/2014
5NDC:65841-747-301 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09032104/15/2014
PROPRANOLOL HYDROCHLORIDE 
propranolol hydrochloride capsule, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-748
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PROPRANOLOL HYDROCHLORIDE (UNII: F8A3652H1V) (PROPRANOLOL - UNII:9Y8NXQ24VQ) PROPRANOLOL HYDROCHLORIDE160 mg
Inactive Ingredients
Ingredient NameStrength
ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GELATIN (UNII: 2G86QN327L)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
Product Characteristics
ColorBLUE (DARK BLUE) , BLUE (DARK BLUE) Scoreno score
ShapeCAPSULE (CAPSULE) Size19mm
FlavorImprint Code ZA;60;160;mg
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-748-1690 in 1 BOTTLE; Type 0: Not a Combination Product04/15/2014
2NDC:65841-748-01100 in 1 BOTTLE; Type 0: Not a Combination Product04/15/2014
3NDC:65841-748-05500 in 1 BOTTLE; Type 0: Not a Combination Product04/15/2014
4NDC:65841-748-101000 in 1 BOTTLE; Type 0: Not a Combination Product04/15/2014
5NDC:65841-748-77100 in 1 CARTON04/15/2014
5NDC:65841-748-301 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09032104/15/2014
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited918596198ANALYSIS(65841-745, 65841-746, 65841-747, 65841-748) , MANUFACTURE(65841-745, 65841-746, 65841-747, 65841-748)

Revised: 10/2022
Document Id: aa9c5856-379d-49b0-90b7-a16dc636d6d7
Set id: fa1ec93e-35b0-43c9-81ee-69f7e8abea87
Version: 4
Effective Time: 20221014
 
Zydus Lifesciences Limited