Enalaprilat (Page 5 of 5)

PRINCIPAL DISPLAY PANEL — 2.5 mg Vial

NDC 0143-9786 -01 Rx only

Enalaprilat

Injection, USP

2.5 mg per 2 mL

(1.25 m/mL)

ANHYDROUS EQUIVALENT

For Intravenous use ONLY

2 mL Single Dose Vial

2.5 unit
(click image for full-size original)

NDC 0143-9786 -10 Rx only

Enalaprilat

Injection, USP

2.5 mg per 2 mL

(1.25 mg/mL)

ANHYDROUS EQUIVALENT

For Intravenous use ONLY

10 x 2 mL Single Dose Vials

2.5 mg carton
(click image for full-size original)

SERIALIZATION IMAGE

Layout 1

ENALAPRILAT
enalaprilat injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0143-9787
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ENALAPRILAT DIHYDRATE (ENALAPRILAT ANHYDROUS) ENALAPRILAT ANHYDROUS 1.25 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
SODIUM HYDROXIDE
WATER
BENZYL ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0143-9787-10 10 VIAL in 1 CARTON contains a VIAL (0143-9787-01)
1 NDC:0143-9787-01 1 mL in 1 VIAL This package is contained within the CARTON (0143-9787-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078687 12/23/2008
ENALAPRILAT
enalaprilat injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0143-9786
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ENALAPRILAT DIHYDRATE (ENALAPRILAT ANHYDROUS) ENALAPRILAT ANHYDROUS 2.5 mg in 2 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
SODIUM HYDROXIDE
WATER
BENZYL ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0143-9786-10 10 VIAL in 1 CARTON contains a VIAL (0143-9786-01)
1 NDC:0143-9786-01 2 mL in 1 VIAL This package is contained within the CARTON (0143-9786-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078687 12/23/2008
Labeler — Hikma Pharmaceuticals USA Inc. (001230762)

Revised: 01/2024 Hikma Pharmaceuticals USA Inc.

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