UNASYN (Page 5 of 5)

Animal Pharmacology

While reversible glycogenosis was observed in laboratory animals, this phenomenon was dose- and time-dependent and is not expected to develop at the therapeutic doses and corresponding plasma levels attained during the relatively short periods of combined ampicillin/sulbactam therapy in man.

HOW SUPPLIED

UNASYN (ampicillin sodium/sulbactam sodium), a sterile off-white dry powder, is available in Pharmacy Bulk Package containing ampicillin sodium and sulbactam sodium equivalent to 10 g ampicillin and 5 g sulbactam × 1 (NDC 0049-0024-28).

UNASYN sterile powder is to be stored at or below 30°C (86°F) prior to reconstitution.

OTHER SIZE PACKAGES AVAILABLE

UNASYN is also supplied in glass vial and piggyback bottles in the following package sizes:

Vials containing 1.5 g (NDC 0049-0013-83) equivalent of UNASYN (1 g ampicillin as the sodium salt plus 0.5 g sulbactam as the sodium salt)

Vials containing 3 g (NDC 0049-0014-83) equivalent of UNASYN (2 g ampicillin as the sodium salt plus 1 g sulbactam as the sodium salt)

ADD-Vantage® package of 5 vials (NDC 0049-0031-02). Each vial containing 1.5 g (NDC 0049-0031-01) equivalent of UNASYN (1 g ampicillin as the sodium salt plus 0.5 g sulbactam as the sodium salt) are distributed by Pfizer Inc.

ADD-Vantage package of 5 vials (NDC 0049-0032-02). Each vial containing 3 g (NDC 0049-0032-01) equivalent of UNASYN (2 g ampicillin as the sodium salt plus 1 g sulbactam as the sodium salt) are distributed by Pfizer Inc.

The 1.5 g UNASYN ADD-Vantage vials are only to be used with the ADD-Vantage Flexible Diluent Container containing 0.9% Sodium Chloride Injection, USP, 50 mL, 100 mL, or 250 mL sizes.

The 3 g UNASYN ADD-Vantage vials are only to be used with the ADD-Vantage Flexible Diluent Container containing 0.9% Sodium Chloride Injection, USP, 100 mL or 250 mL sizes.

ADD-Vantage is a registered trademark of Hospira Inc., a Pfizer company.

To report SUSPECTED ADVERSE EVENTS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or http://www.fda.gov/ for voluntary reporting of adverse reactions.

This product’s label may have been updated. For current full prescribing information, please visit www.pfizer.com.

Rx only

Logo

LAB-0018-19.0
Revised October 2019

PRINCIPAL DISPLAY PANEL — 15 g Bulk Vial Label

Pfizer Injectables

NDC 0049-0024-28
Rx only

Unasyn®
(ampicillin sodium/
sulbactam sodium)

15 g*

Sterile
For Intravenous Use

PHARMACY BULK PACKAGENOT FOR DIRECT INFUSION

PRINCIPAL DISPLAY PANEL -- 15 g Bulk Vial Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 15 g Bulk Carton

NDC 0049-0024-28
Rx only

1 Bottle

Unasyn®
(ampicillin sodium/
sulbactam sodium)

15 g*

PHARMACY BULK PACKAGENOT FOR DIRECT INFUSION

Sterile

For Intravenous Use

Pfizer Injectables

PRINCIPAL DISPLAY PANEL -- 15 g Bottle Carton
(click image for full-size original)
UNASYN ampicillin sodium and sulbactam sodium injection, powder, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0049-0024
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMPICILLIN SODIUM (AMPICILLIN) AMPICILLIN 100 mg in 1 mL
SULBACTAM SODIUM (SULBACTAM) SULBACTAM 50 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0049-0024-28 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON contains a VIAL, PHARMACY BULK PACKAGE
1 100 mL in 1 VIAL, PHARMACY BULK PACKAGE This package is contained within the CARTON (0049-0024-28)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050608 11/22/1991
Labeler — Roerig (829076996)
Establishment
Name Address ID/FEI Operations
Haupt Pharma Latina Srl 338690598 MANUFACTURE (0049-0024)
Establishment
Name Address ID/FEI Operations
Pfizer Global Supply Japan Inc. 691715758 API MANUFACTURE (0049-0024), MANUFACTURE (0049-0024)

Revised: 10/2019 Roerig

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