FDA.reportPublic FDA data

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70594-082-022024-12-10C16284748780-11030e365-55da-111a-e063-dadaa90a10e2Ampicillin and Sulbactam for Injection, USP (For Intramuscular or Intravenous Use)
70594-082-022024-07-30C16284748780-11030e365-55da-111a-e063-dadaa90a10e2Ampicillin and Sulbactam for Injection, USP (For Intramuscular or Intravenous Use)
70594-082-022024-01-30C16284748780-11030e365-55da-111a-e063-dadaa90a10e2Ampicillin and Sulbactam for Injection, USP (For Intramuscular or Intravenous Use)

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 3 of 4 · 63 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AmpicillinAMPICILLIN SODIUMSandoz Inc67dd2930-8482-4da5-b663-b751aff18c612025-05-16Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
Ampicillin and SulbactamAMPICILLIN AND SULBACTAMAvenacy, LLC577dd6f0-d56a-4c82-9f72-274c3a4a0f012025-04-25Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
unii: DKQ4T82YE6
Ampicillin and SulbactamAMPICILLIN AND SULBACTAMAvenacy, LLC4446d4c8-056d-4bc3-8f58-21255b0633982025-04-25Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
unii: DKQ4T82YE6
AmpicillinAMPICILLIN SODIUMSandoz Inc64a04e8c-8f78-46b3-8f45-56ef225a4f742025-02-21Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
AmpicillinAMPICILLIN SODIUMAvenacy Inc.19546563-50b7-4160-8cbe-f8e7079cba692025-02-01Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
AmpicillinAMPICILLINMedical Purchasing Solutions, LLC29675d9c-3248-337a-e063-6294a90a2e202024-12-16Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
ec431dfa-fe17-4e43-acf9-60eee408cc6b7161f386-6373-4db5-8dfd-d7ddf38ec2f12024-12-10Warnings, Adverse reactionsExact identifier
spl id: ec431dfa-fe17-4e43-acf9-60eee408cc6b
spl set id: 7161f386-6373-4db5-8dfd-d7ddf38ec2f1
ampicillin and sulbactamAMPICILLIN AND SULBACTAMSagent Pharmaceuticals35606b43-5914-423c-9bc7-fa3957eb25632024-11-18Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
unii: DKQ4T82YE6
AmpicillinAMPICILLIN SODIUMSandoz Incc2908a44-1da4-4885-ae5a-23f69189d91a2024-10-31Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
AmpicillinAMPICILLIN SODIUMSandoz Incb371e1a5-1fef-4df2-8940-c4fc02b9e2f02024-10-31Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
Ampicillin and SulbactamAMPICILLIN SODIUM AND SULBACTAM SODIUMNorthStar Rx, LLC5e8d35cb-e93d-42ad-a02c-0dbf04910f612024-08-13Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
unii: DKQ4T82YE6
Ampicillin and SulbactamAMPICILLIN SODIUM AND SULBACTAM SODIUMNorthStar Rx, LLC1e5004f1-e79e-4e0b-9f3f-25f6bbc152552024-06-27Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
unii: DKQ4T82YE6
AmpicillinAMPICILLIN SODIUMSandoz Inc5308ddfa-4a5b-4f7b-83ce-9d1b528e050d2024-05-09Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
AmpicillinAMPICILLIN SODIUMSandoz Inc6632a5bd-45f1-422f-80b0-46e5a628969a2024-05-08Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
AmpicillinAMPICILLIN SODIUMSandoz Incf77db491-31c4-4a7c-a114-0f3244c970902024-05-07Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
AmpicillinAMPICILLIN SODIUMNorthStar Rx, LLC6772d650-9814-49e4-a4ec-0b1a97b837d12024-02-22Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
AMPICILLINAMPICILLINHF Acquisition Co LLC, DBA HealthFirste47a21b1-bbdb-4321-e053-2a95a90a3b4a2024-01-28Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
AMPICILLINAMPICILLINHF Acquisition Co LLC, DBA HealthFirste51db6a3-027a-6e24-e053-2a95a90a15872024-01-14Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
AmpicillinAMPICILLIN SODIUMMedical Purchasing Solutions, LLC690f1986-6da9-4787-e053-2a91aa0a26442023-05-23Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
AmpicillinAMPICILLIN SODIUMMedical Purchasing Solutions, LLC70c022b0-ac9a-409b-e053-2a91aa0a757e2023-05-22Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K

Reported adverse events (FAERS/openFDA)#

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