Ampicillin and Sulbactam

Product NDC
71288-007
11-digit product format
712880007
Labeler code
71288
Product ID
71288-007_3c1d3466-581c-466e-bb5b-256c294c8218
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ampicillin Sodium and Sulbactam Sodium
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Meitheal Pharmaceuticals Inc.
Application
ANDA090578
Marketing category
ANDA
Marketing start
2018-12-17
Marketing end
0000-00-00
Substance
AMPICILLIN SODIUM; SULBACTAM SODIUM
Active strength
10 g/1; g/1
Pharmacologic classes
Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71288-007-752024-01-30C16284748780-11030e365-1d5c-111a-e063-dadaa90a10e281ec59a2-aca3-4546-b7e8-4f676073ab71

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-007-75EA - Each71288-0077188f48b-f47e-4944-907d-94fd0f69d8cd12019-01-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71288-007-75712880007751 BOTTLE in 1 CARTON (71288-007-75) > 1 INJECTION, POWDER, FOR SOLUTION in 1 BOTTLE1 bottle2018-12-170000-00-00NoNoCurrent