piperacillin and tazobactam

Generic: piperacillin and tazobactam

Labeler: sandoz inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name piperacillin and tazobactam
Generic Name piperacillin and tazobactam
Labeler sandoz inc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS PARENTERAL
Active Ingredients

piperacillin sodium 12 g/100mL, tazobactam sodium 1.5 g/100mL

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 0781-3117
Product ID 0781-3117_27be0ff3-ee57-4d56-a73b-ca773d763a1e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203557
Listing Expiration 2026-12-31
Marketing Start 2014-10-29

Pharmacologic Class

Classes
penicillin-class antibacterial [epc] penicillins [cs] beta lactamase inhibitor [epc] beta lactamase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 07813117
Hyphenated Format 0781-3117

Supplemental Identifiers

RxCUI
312447
UNII
UXA545ABTT M98T69Q7HP

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name piperacillin and tazobactam (source: ndc)
Generic Name piperacillin and tazobactam (source: ndc)
Application Number ANDA203557 (source: ndc)
Routes
INTRAVENOUS PARENTERAL
source: ndc

Resolved Composition

Strengths
  • 12 g/100mL
  • 1.5 g/100mL
source: ndc
Packaging
  • 16 HOW SUPPLIED/STORAGE AND HANDLING Piperacillin and tazobactam for injection, USP is supplied as a powder in the pharmacy bulk bottle as follows: Piperacillin and tazobactam for injection, USP 13.5 g pharmacy bulk bottle containing piperacillin sodium equivalent to 12 grams of piperacillin, tazobactam sodium equivalent to 1.5 grams tazobactam and 28.2 mEq (648 mg) of sodium. Supplied as 1 pharmacy bulk package bottle per box – NDC 0781-3117-46 Piperacillin and tazobactam for injection, USP 40.5 g pharmacy bulk bottle containing piperacillin sodium equivalent to 36 grams of piperacillin, tazobactam sodium equivalent to 4.5 grams tazobactam and 84.5 mEq (1,944 mg) of sodium. Supplied as 1 pharmacy bulk package bottle per box – NDC 0781-3180-94 Piperacillin and tazobactam for injection, USP pharmacy bulk bottles should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] prior to reconstitution.
  • 13.5 grams Carton NDC 0781-3117-46 Piperacillin and Tazobactam for Injection, USP 13.5 grams – per Pharmacy Bulk Package PHARMACY BULK PACKAGE – NOT FOR DIRECT INFUSION Rx Only RECONSTITUTED STOCK SOLUTION MUST BE TRANSFERRED AND FURTHER DILUTED FOR I.V. INFUSION 1 Bottle Sandoz 13.5g-carton
  • 40.5 grams Carton NDC 0781-3180-94 Piperacillin and Tazobactam for Injection, USP 40.5 grams per Pharmacy Bulk Package PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION Rx Only RECONSTITUTED STOCK SOLUTION MUST BE TRANSFERRED AND FURTHER DILUTED FOR INTRAVENOUS INFUSION 1 Bottle Sandoz 40.5g-carton
source: label

Packages (0)

No package records.

Ingredients (2)

piperacillin sodium (12 g/100mL) tazobactam sodium (1.5 g/100mL)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS", "PARENTERAL"], "spl_id": "27be0ff3-ee57-4d56-a73b-ca773d763a1e", "openfda": {"unii": ["UXA545ABTT", "M98T69Q7HP"], "rxcui": ["312447"], "spl_set_id": ["b1cb1314-d3e0-4b44-a1df-de14c32e8cc6"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "Piperacillin and Tazobactam", "product_id": "0781-3117_27be0ff3-ee57-4d56-a73b-ca773d763a1e", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Penicillin-class Antibacterial [EPC]", "Penicillins [CS]", "beta Lactamase Inhibitor [EPC]", "beta Lactamase Inhibitors [MoA]"], "product_ndc": "0781-3117", "generic_name": "Piperacillin and Tazobactam", "labeler_name": "Sandoz Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Piperacillin and Tazobactam", "active_ingredients": [{"name": "PIPERACILLIN SODIUM", "strength": "12 g/100mL"}, {"name": "TAZOBACTAM SODIUM", "strength": "1.5 g/100mL"}], "application_number": "ANDA203557", "marketing_category": "ANDA", "marketing_start_date": "20141029", "listing_expiration_date": "20261231"}