Piperacillin and Tazobactam

Product NDC
22607-034
11-digit product format
226070034
Labeler code
22607
Product ID
22607-034_59c0c9d5-2a0a-4591-984a-039b3fdc6194
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
piperacillin sodium and tazobactam sodium
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Mitim S.r.l.
Application
ANDA206996
Marketing category
ANDA
Marketing start
2017-03-22
Marketing end
0000-00-00
Substance
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
Active strength
2 g/10mL; g/10mL
Pharmacologic classes
Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitors [MoA],beta Lactamase Inhibitor [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

Additional Listing Data#

Finished product
No
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PIPERACILLIN SODIUM2 g/10mL
TAZOBACTAM SODIUM.25 g/10mL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
22607-034-012020-01-31C16284748780-19d75b9d0-282a-f424-e053-dadaa90a57ce8fd74a6a-63d4-457d-ac5f-4cf8b5eb3b0b