NDC 70594-082-01 - Ampicillin and Sulbactam

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
70594-082
Requested NDC
70594-082-01
Package NDCs from labels
70594-082-01, 70594-082-02
Manufacturer
Xellia Pharmaceuticals USA LLC | Astral SteriTech Private Limited
Effective date
2024-12-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
AMPICILLIN - Xellia Pharmaceuticals USA LLC | Astral SteriTech Private LimitedXellia Pharmaceuticals USA LLC | Astral SteriTech Private Limited2024-12-10HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70594-082AMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM AND SULBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [XELLIA PHARMACEUTICALS USA LLC]4Legacy NDC20241212_7161f386-6373-4db5-8dfd-d7ddf38ec2f1.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70594-082-01EA - Each70594-08276df4316-2b18-48f9-ae75-11382a11ab5f12021-11-09
70594-082-02EA - Each70594-0825c61e449-ef00-4453-a689-63922f54c1c812021-11-09

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 4 of 4 · 63 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AmpicillinAMPICILLINMedical Purchasing Solutions, LLCbbf118c0-7cd3-5a82-e053-2a95a90ac8c82023-05-08Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
AmpicillinAMPICILLINMedical Purchasing Solutions, LLCc4310ee5-cbd3-99b5-e053-2995a90ae2292023-04-27Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
AmpicillinAMPICILLIN SODIUMFresenius Kabi USA, LLC8dbb4c71-8543-08f1-e053-2995a90af88d2022-10-21Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.