PRIMAXIN IV (Page 7 of 7)

PRINCIPAL DISPLAY PANEL 250 mg Vial Label

NDC 0006-3514-58

250
PRIMAXIN® I.V.
(IMIPENEM AND CILASTATIN FOR INJECTION)

IMIPENEM 250 mg (Anhydrous Equivalent)
CILASTATIN EQUIVALENT 250 mg
CAUTION: SINGLE DOSE VIAL / FOR I.V. USE ONLY
NOT FOR DIRECT INFUSION

Rx only
250 mg

Merck Sharp & Dohme Corp., a subsidiary ofMERCK & CO., INC., Whitehouse Station, NJ 08889, USA

3514

PRINCIPAL DISPLAY PANEL 250 mg Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL 500 mg Vial Label

NDC 0006-3516-59

500
PRIMAXIN® I.V.
(IMIPENEM AND CILASTATIN FOR INJECTION)

Each vial contains 500 mg imipenem (equivalent to 530 mg
imipenem monohydrate), 500 mg cilastatin (equivalent to 531 mg
cilastatin sodium), and 20 mg sodium bicarbonate (used as a buffer).

CAUTION: SINGLE DOSE VIAL / FOR I.V. USE ONLY
NOT FOR DIRECT INFUSION

Rx only 500 mg

PRINCIPAL DISPLAY PANEL 500 mg Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 500 mg Vial Package

1 PACKAGE (25 VIALS)
NDC 0006-3516-59

500
PRIMAXIN® I.V.
(IMIPENEM AND CILASTATIN FOR INJECTION)

Not to be divided.

Each vial contains 500 mg imipenem (equivalent to 530 mg imipenem monohydrate), 500 mg cilastatin
(equivalent to 531 mg cilastatin sodium), and 20 mg sodium bicarbonate (used as a buffer).
CAUTION: SINGLE DOSE VIAL / FOR I.V. USE ONLY / NOT FOR DIRECT INFUSION
For the Preparation of Intravenous Solutions and USUAL ADULT DOSAGE: See
accompanying circular. Color changes in solution from colorless to
yellow do not affect potency. Store dry material below 25ºC.

Rx only

Merck Sharp & Dohme LLC
Rahway, NJ 07065, USA

Copyright © 2022 Merck & Co., Inc.
Rahway, NJ, USA, and its affiliates.All rights reserved.

PRINCIPAL DISPLAY PANEL -- 500 mg Vial Package
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — Single-Dose ADD-Vantage Vial 250 mg

NDC 0006-3551-58

Single-dose ADD-Vantage® vial

250

PRIMAXIN® I.V.

(IMIPENEM AND CILASTATIN FOR INJECTION)

IMIPENEM 250 mg (Anhydrous Equivalent)
CILASTATIN EQUIVALENT 250 mg

CAUTION: SINGLE DOSE VIAL / FOR I.V. USE ONLY
NOT FOR DIRECT INFUSION

PRIMAXIN is a registered trademark of Merck Sharp & Dohme Corp.

ADD-Vantage is a registered trademark of ABBOTT LABORATORIES, Inc.

9960800

For the Preparation of Intravenous Solutions and USUAL ADULT DOSAGE: See accompanying circular.

Store dry material below 25°C.

After constitution as directed, the solution maintains satisfactory potency for 4 hours at room temperature.

Consult accompanying INSTRUCTIONS FOR USE.

Use only with ADD-Vantage® Diluent Containers.

Rx only

250 mg | No. 3551

Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC.Whitehouse Station, NJ 08889, USA

Single-Dose ADD-Vantage Vial 250 mg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — Single-Dose ADD-Vantage Vial 500 mg

NDC 0006-3552-59

Single-dose ADD-Vantage® vial

500

PRIMAXIN® I.V.

(IMIPENEM AND CILASTATIN FOR INJECTION)

IMIPENEM 500 mg (Anhydrous Equivalent)
CILASTATIN EQUIVALENT 500 mg

CAUTION: SINGLE DOSE VIAL / FOR I.V. USE ONLY
NOT FOR DIRECT INFUSION

PRIMAXIN is a registered trademark of Merck Sharp & Dohme Corp.

ADD-Vantage is a registered trademark of ABBOTT LABORATORIES, Inc.

9940700

For the Preparation of Intravenous Solutions and USUAL ADULT DOSAGE: See accompanying circular.

Store dry material below 25°C.

After constitution as directed, the solution maintains satisfactory potency for 4 hours at room temperature.

Consult accompanying INSTRUCTIONS FOR USE.

Use only with ADD-Vantage® Diluent Containers.

Rx only

500 mg | No. 3552

Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC.Whitehouse Station, NJ 08889, USA

Single-Dose ADD-Vantage Vial 500 mg
(click image for full-size original)
PRIMAXIN IV imipenem and cilastatin sodium injection, powder, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0006-3514
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IMIPENEM (IMIPENEM ANHYDROUS) IMIPENEM ANHYDROUS 250 mg in 100 mL
CILASTATIN SODIUM (CILASTATIN) CILASTATIN 250 mg in 100 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM BICARBONATE 10 mg in 100 mL
Product Characteristics
Color YELLOW (colorless to yellow) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0006-3514-58 25 VIAL, SINGLE-DOSE in 1 TRAY contains a VIAL, SINGLE-DOSE
1 100 mL in 1 VIAL, SINGLE-DOSE This package is contained within the TRAY (0006-3514-58)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050587 11/26/1985 05/01/2017
PRIMAXIN IV imipenem and cilastatin sodium injection, powder, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0006-3516
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IMIPENEM (IMIPENEM ANHYDROUS) IMIPENEM ANHYDROUS 500 mg in 100 mL
CILASTATIN SODIUM (CILASTATIN) CILASTATIN 500 mg in 100 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM BICARBONATE 20 mg in 100 mL
Product Characteristics
Color YELLOW (colorless to yellow) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0006-3516-59 25 VIAL, SINGLE-DOSE in 1 TRAY contains a VIAL, SINGLE-DOSE
1 100 mL in 1 VIAL, SINGLE-DOSE This package is contained within the TRAY (0006-3516-59)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050587 11/26/1985
PRIMAXIN IV imipenem and cilastatin sodium injection, powder, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0006-3551
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IMIPENEM (IMIPENEM ANHYDROUS) IMIPENEM ANHYDROUS 250 mg in 100 mL
CILASTATIN SODIUM (CILASTATIN) CILASTATIN 250 mg in 100 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM BICARBONATE 10 mg in 100 mL
Product Characteristics
Color YELLOW (colorless to yellow) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0006-3551-58 25 VIAL, PHARMACY BULK PACKAGE in 1 TRAY contains a VIAL, PHARMACY BULK PACKAGE
1 100 mL in 1 VIAL, PHARMACY BULK PACKAGE This package is contained within the TRAY (0006-3551-58)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA062756 01/08/1987 05/31/2016
PRIMAXIN IV imipenem and cilastatin sodium injection, powder, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0006-3552
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IMIPENEM (IMIPENEM ANHYDROUS) IMIPENEM ANHYDROUS 500 mg in 100 mL
CILASTATIN SODIUM (CILASTATIN) CILASTATIN 500 mg in 100 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM BICARBONATE 20 mg in 100 mL
Product Characteristics
Color YELLOW (colorless to yellow) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0006-3552-59 25 VIAL, PHARMACY BULK PACKAGE in 1 TRAY contains a VIAL, PHARMACY BULK PACKAGE
1 100 mL in 1 VIAL, PHARMACY BULK PACKAGE This package is contained within the TRAY (0006-3552-59)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA062756 01/08/1987 05/31/2016
Labeler — Merck Sharp & Dohme LLC (118446553)

Revised: 12/2023 Merck Sharp & Dohme LLC

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