Manufacturing Establishments (2)
Corden Pharma Latina S.p.A.
E.R. Squibb & Sons, L.L.C.
339062883
Curia Spain, S.A.U.
E.R. Squibb & Sons, L.L.C.
563371111
Products (2)
AZACTAM
0003-2560
NDA050580
NDA (C73594)
INTRAMUSCULAR, INTRAVENOUS
September 27, 2022
AztreonamActive
Code: G2B4VE5GH8Class: ACTIBQuantity: 1 g in 1 1
arginineInactive
Code: 94ZLA3W45FClass: IACTQuantity: 0.78 g in 1 1
AZACTAM
0003-2570
NDA050580
NDA (C73594)
INTRAMUSCULAR, INTRAVENOUS
September 27, 2022
arginineInactive
Code: 94ZLA3W45FClass: IACTQuantity: 1.54 g in 1 1
AztreonamActive
Code: G2B4VE5GH8Class: ACTIBQuantity: 2 g in 1 1
Drug Labeling Information
HOW SUPPLIED SECTION
HOW SUPPLIED
AZACTAM**®**** (aztreonam for injection, USP)**
Single-dose vials:
|
•** 1 gram/vial:** |
Packages of 10 |
NDC 0003-2560-16 |
|
•** 2 grams/vial:** |
Packages of 10 |
NDC 0003-2570-16 |
Storage
Store in original package at 20°C to 25°C (68°F to 77°F) [see USP controlled room temperature]; avoid excessive heat.