Ramipril

RAMIPRIL — ramipril capsule
Zydus Lifesciences Limited

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-655-06 in bottle of 30 Capsules

Ramipril Capsules, 1.25 mg

R_x only

30 Capsules

NDC 65841-656-01 in bottle of 100 Capsules

Ramipril Capsules, 2.5 mg

R_x only

100 Capsules

NDC 65841-657-01 in bottle of 100 Capsules

Ramipril Capsules, 5 mg

R_x only

100 Capsules

NDC 65841-658-01 in bottle of 100 Capsules

Ramipril Capsules, 10 mg

R_x only

100 Capsules

RAMIPRIL ramipril capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-655 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RAMIPRIL (RAMIPRILAT) RAMIPRIL 1.25 mg

Inactive Ingredients Ingredient Name Strength FD&C RED NO. 40 FD&C YELLOW NO. 5 FD&C YELLOW NO. 6 GELATIN TITANIUM DIOXIDE STARCH, CORN FERROSOFERRIC OXIDE

Product Characteristics Color WHITE (WHITE) , YELLOW (YELLOW) Score no score Shape CAPSULE (CAPSULE) Size 14mm Flavor Imprint Code ZA;43;1;25mg Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:65841-655-06 30 CAPSULE in 1 BOTTLE None 2 NDC:65841-655-16 90 CAPSULE in 1 BOTTLE None 3 NDC:65841-655-01 100 CAPSULE in 1 BOTTLE None 4 NDC:65841-655-05 500 CAPSULE in 1 BOTTLE None 5 NDC:65841-655-30 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK 5 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (65841-655-30)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078832 11/20/2010

RAMIPRIL ramipril capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-656 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RAMIPRIL (RAMIPRILAT) RAMIPRIL 2.5 mg

Inactive Ingredients Ingredient Name Strength D&C YELLOW NO. 10 FD&C RED NO. 40 GELATIN TITANIUM DIOXIDE STARCH, CORN FERROSOFERRIC OXIDE

Product Characteristics Color WHITE (WHITE) , ORANGE (ORANGE) Score no score Shape CAPSULE (CAPSULE) Size 14mm Flavor Imprint Code ZA;44;2;5mg Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:65841-656-06 30 CAPSULE in 1 BOTTLE None 2 NDC:65841-656-16 90 CAPSULE in 1 BOTTLE None 3 NDC:65841-656-01 100 CAPSULE in 1 BOTTLE None 4 NDC:65841-656-05 500 CAPSULE in 1 BOTTLE None 5 NDC:65841-656-30 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK 5 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (65841-656-30)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078832 11/20/2010

RAMIPRIL ramipril capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-657 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RAMIPRIL (RAMIPRILAT) RAMIPRIL 5 mg

Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 FD&C RED NO. 40 FD&C YELLOW NO. 6 GELATIN TITANIUM DIOXIDE STARCH, CORN FERROSOFERRIC OXIDE

Product Characteristics Color WHITE (WHITE) , RED (RED) Score no score Shape CAPSULE (CAPSULE) Size 14mm Flavor Imprint Code ZA;45;5mg Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:65841-657-06 30 CAPSULE in 1 BOTTLE None 2 NDC:65841-657-16 90 CAPSULE in 1 BOTTLE None 3 NDC:65841-657-01 100 CAPSULE in 1 BOTTLE None 4 NDC:65841-657-05 500 CAPSULE in 1 BOTTLE None 5 NDC:65841-657-30 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK 5 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (65841-657-30)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078832 11/20/2010

RAMIPRIL ramipril capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-658 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RAMIPRIL (RAMIPRILAT) RAMIPRIL 10 mg

Inactive Ingredients Ingredient Name Strength D&C RED NO. 28 D&C YELLOW NO. 10 FD&C BLUE NO. 1 GELATIN TITANIUM DIOXIDE STARCH, CORN FERROSOFERRIC OXIDE

Product Characteristics Color WHITE (WHITE) , BLUE (BLUE) Score no score Shape CAPSULE (CAPSULE) Size 14mm Flavor Imprint Code ZA;46;10mg Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:65841-658-06 30 CAPSULE in 1 BOTTLE None 2 NDC:65841-658-16 90 CAPSULE in 1 BOTTLE None 3 NDC:65841-658-01 100 CAPSULE in 1 BOTTLE None 4 NDC:65841-658-05 500 CAPSULE in 1 BOTTLE None 5 NDC:65841-658-30 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK 5 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (65841-658-30)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078832 11/20/2010

Labeler — Zydus Lifesciences Limited (918596198)

Registrant — Zydus Lifesciences Limited (918596198)

Establishment
Name	Address	ID/FEI	Operations
Zydus Lifesciences Limited		918596198	ANALYSIS (65841-655), ANALYSIS (65841-656), ANALYSIS (65841-657), ANALYSIS (65841-658), MANUFACTURE (65841-655), MANUFACTURE (65841-656), MANUFACTURE (65841-657), MANUFACTURE (65841-658)

Revised: 10/2022 Zydus Lifesciences Limited