PIPERACILLIN SODIUM and TAZOBACTAM SODIUM

Product NDC
70594-080
11-digit product format
705940080
Labeler code
70594
Product ID
70594-080_7b8413a0-a8bd-4899-8567-677034eb0a7d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PIPERACILLIN SODIUM and TAZOBACTAM SODIUM
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Xellia Pharmaceuticals USA LLC
Application
ANDA212287
Marketing category
ANDA
Marketing start
2021-01-10
Marketing end
0000-00-00
Substance
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
Active strength
4 g/150mL; mg/150mL
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#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70594-080-01EA - Each70594-080136e721b-4b8e-46cf-a83b-8c23775a01cf12021-11-09
70594-080-02EA - Each70594-08075acd009-4543-4a82-be00-dc7741a39fef12021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70594-080PIPERACILLIN SODIUM AND TAZOBACTAM SODIUM INJECTION, POWDER, FOR SOLUTION [XELLIA PHARMACEUTICALS USA LLC]4Legacy NDC20241212_184b5961-1ae7-474c-afaa-2a2b2ccfc9cd.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70594-080-027059400800210 VIAL in 1 CARTON (70594-080-02) > 150 mL in 1 VIAL (70594-080-01) 10 vial2021-01-100000-00-00NoNoCurrent