Ampicillin and Sulbactam

Product NDC
0641-6120
11-digit product format
006416120
Labeler code
0641
Product ID
0641-6120_92aca661-65af-4b86-a95c-ca9e2f7afd4a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ampicillin and Sulbactam
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA065406
Marketing category
ANDA
Marketing start
2009-12-22
Marketing end
0000-00-00
Substance
AMPICILLIN SODIUM; SULBACTAM SODIUM
Active strength
2 g/3g; g/3g
Pharmacologic classes
beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA],Penicillin-class Antibacterial [EPC],Penicillins [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0641-6120-102025-03-12C16284748780-12cef2736-82c7-d83d-e063-dadaa90ab31ff8e534d8-5bb8-47c4-a11e-ec67f0609d1d
0641-6120-102025-01-30C16284748780-12cef2736-82c7-d83d-e063-dadaa90ab31ff8e534d8-5bb8-47c4-a11e-ec67f0609d1d

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-6120-01EA - Each0641-612048bef9ab-977e-4bf9-a18a-168fa40b5e1912012-07-24
0641-6120-10EA - Each0641-6120e82ec28b-e40f-40f7-8215-f15a4c5e6a3612012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0641-6120-100064161201010 VIAL in 1 CARTON (0641-6120-10) > 3 g in 1 VIAL (0641-6120-01) 10 vial2009-12-220000-00-00NoNoCurrent