Diltiazem Hydrochloride (Page 6 of 6)

PRINCIPAL DISPLAY PANEL — 5 mL Vial Label

5 mL Single-dose Fliptop Vial

Diltiazem
HCl Injection

25 mg/5 mL
(5 mg/mL)

Rx only

For Direct Intravenous Bolus Injectionand Continuous Intravenous Infusion.

PRINCIPAL DISPLAY PANEL — 5 mL Vial Carton

10 X 5 mL Single-dose Fliptop Vials
NDC 0409-1171 -01
Rx only

Diltiazem Hydrochloride Injection
25 mg/5 mL
(5 mg/mL)

For Direct Intravenous Bolus Injection and Continuous Intravenous Infusion.

Store Under Refrigeration(For full storage information, see back panel.)

Hospira

PRINCIPAL DISPLAY PANEL — 10 mL Vial Label

10 mL Single-dose Fliptop Vial

Diltiazem
HCl Injection

50 mg/10 mL
(5 mg/mL)

For Direct Intravenous
Bolus Injection and ContinuousIntravenous Infusion.

PRINCIPAL DISPLAY PANEL — 10 mL Vial Carton

10 X 10 mL Single-dose Fliptop Vials
NDC 0409-1171 -02
Rx only

Diltiazem Hydrochloride Injection
50 mg/10 mL
(5 mg/mL)

For Direct Intravenous Bolus Injection and Continuous Intravenous Infusion.

Store Under Refrigeration(For full storage information, see back panel.)

Hospira

PRINCIPAL DISPLAY PANEL — 100 mg Vial Label

Single-dose
ADD-Vantage™ Vial

Sterile Powder

Diltiazem HCl for Injection

For Continuous Intravenous Infusion
Not For Bolus

Equivalent to 100 mg Diltiazem HCl

Usual dosage: See insert.
Each vial contains lyophilized powder comprised
of 100 mg diltiazem hydrochloride and 75 mgMannitol USP.

PRINCIPAL DISPLAY PANEL — 100 mg Vial Tray

10 Single-dose ADD-Vantage™ Vials
Sterile Powder
Rx only
NDC 0409-4350-03
Contains 10 of NDC 0409-4350-13

Diltiazem HCl for Injection

For Continuous Intravenous Infusion
Not For Bolus Usual Dosage: See insert.

Equivalent to 100 mg Diltiazem HCl

Hospira

DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-1171 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DILTIAZEM HYDROCHLORIDE (DILTIAZEM) DILTIAZEM HYDROCHLORIDE 5 mg in 1 mL

Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE 0.75 mg in 1 mL TRISODIUM CITRATE DIHYDRATE 0.65 mg in 1 mL SORBITOL 50 mg in 1 mL WATER SODIUM HYDROXIDE HYDROCHLORIC ACID

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0409-1171-01 10 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (0409-1171-11) 1 NDC:0409-1171-11 5 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (0409-1171-01) 2 NDC:0409-1171-02 10 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (0409-1171-12) 2 NDC:0409-1171-12 10 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (0409-1171-02)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA074941 05/05/2006

DILTIAZEM HYDROCHLORIDE diltiazem hydrochloride injection, powder, lyophilized, for solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-4350 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DILTIAZEM HYDROCHLORIDE (DILTIAZEM) DILTIAZEM HYDROCHLORIDE 100 mg

Inactive Ingredients Ingredient Name Strength MANNITOL 75 mg

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0409-4350-03 10 VIAL, PATENT DELIVERY SYSTEM in 1 TRAY contains a VIAL, PATENT DELIVERY SYSTEM (0409-4350-13) 1 NDC:0409-4350-13 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, PATENT DELIVERY SYSTEM This package is contained within the TRAY (0409-4350-03)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075853 04/30/2005

Labeler — Hospira, Inc. (141588017)

Establishment
Name	Address	ID/FEI	Operations
Hospira, Inc.		030606222	ANALYSIS (0409-1171), ANALYSIS (0409-4350), MANUFACTURE (0409-1171), MANUFACTURE (0409-4350), PACK (0409-1171), PACK (0409-4350), LABEL (0409-1171), LABEL (0409-4350)

Establishment
Name	Address	ID/FEI	Operations
Hospira, Inc.		827731089	ANALYSIS (0409-1171), ANALYSIS (0409-4350)

Revised: 04/2021 Hospira, Inc.