Ampicillin and Sulbactam

Product NDC
71288-005
11-digit product format
712880005
Labeler code
71288
Product ID
71288-005_0478d88f-efdc-479a-bd7d-b1f49e5de1e2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ampicillin sodium and Sulbactam sodium
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Meitheal Pharmaceuticals Inc.
Application
ANDA090579
Marketing category
ANDA
Marketing start
2022-01-17
Marketing end
0000-00-00
Substance
AMPICILLIN SODIUM; SULBACTAM SODIUM
Active strength
1 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
71288-005-202024-01-30C16284748780-11030e365-3b7a-111a-e063-dadaa90a10e26ae2c4a1-f704-4642-bbdd-f69a9ef07605

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-005-20EA - Each71288-005c9e8bd6c-1b08-4e12-9c6d-8bc21355e75612019-01-24
71288-005-21EA - Each71288-0051e21a4da-6f84-4050-bfbb-cca09fca4d3412019-10-07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71288-005-207128800052010 VIAL, SINGLE-DOSE in 1 CARTON (71288-005-20) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (71288-005-21) 2022-01-170000-00-00NoNoCurrent