NDC Code(s) : 71288-007-75
Packager : Meitheal Pharmaceuticals Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Ampicillin and SulbactamAmpicillin Sodium and Sulbactam Sodium INJECTION, POWDER, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71288-007
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ampicillin sodium(UNII: JFN36L5S8K)
(ampicillin - UNII:7C782967RD) 		ampicillin10 g
sulbactam sodium(UNII: DKQ4T82YE6)
(sulbactam - UNII:S4TF6I2330) 		sulbactam5 g
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:71288-007-751 in 1 CARTON 17/12/2018
11 in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090578 12/17/2018 07/31/2024

LABELER - Meitheal Pharmaceuticals Inc.(080548348)

PRINCIPAL DISPLAY PANEL

NDC 71288-007-75

Rx only

Ampicillin and Sulbactam for Injection, USP

15 grams* per Pharmacy Bulk Package

PHARMACY BULK PACKAGE –

NOT FOR DIRECT INFUSION

Equivalent to 10 grams of ampicillin

plus 5 grams of sulbactam

For Intravenous Use

Principal Display Panel – Ampicillin and Sulbactam for Injection, USP 15 gram Bottle Label

PRINCIPAL DISPLAY PANEL

NDC 71288-007-75

1 Bottle

Ampicillin and Sulbactam for Injection, USP

15 grams* per Pharmacy Bulk Package

PHARMACY BULK PACKAGE –

NOT FOR DIRECT INFUSION

Equivalent to 10 grams of ampicillin

plus 5 grams of sulbactam

Rx only

For Intravenous Use

Principal Display Panel – Ampicillin and Sulbactam for Injection, USP 15 gram Carton