FDA.reportPublic FDA data

NDC 71288-031-20 - 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
71288-031
Requested NDC
71288-031-20
Package NDCs from labels
71288-031-91, 71288-031-92, 71288-031-20, 71288-031-21
Manufacturer
Meitheal Pharmaceuticals Inc.
Effective date
2026-07-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ampicillin and Sulbactam - Meitheal Pharmaceuticals Inc.Meitheal Pharmaceuticals Inc.2026-07-22HUMAN PRESCRIPTION DRUG LABEL
Ampicillin and Sulbactam - Meitheal Pharmaceuticals Inc.Meitheal Pharmaceuticals Inc.2026-06-10HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71288-031-20Ampicillin and Sulbactam1 in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION16
71288-031-21Ampicillin and Sulbactam10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION106
71288-031-91Ampicillin and Sulbactam1 in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION12
71288-031-92Ampicillin and Sulbactam10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-031AMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM AND SULBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [MEITHEAL PHARMACEUTICALS INC.]6Current NDC, 2 package rows20250323_e6cf14a8-3ed9-4a7a-ba69-be0b794cbdc4.zip
71288-031AMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM AND SULBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [MEITHEAL PHARMACEUTICALS INC.]1Current NDC, 2 package rows20240524_006f9a3f-b4e3-4aa5-ac65-6cc3d3e2582d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-031-20EA - Each71288-031c929ba34-0c4d-4f42-ab1a-f71c6e3106f712023-09-05
71288-031-21EA - Each71288-031aa6724ba-18bc-43a8-87b1-b47fc15d79fb12023-09-05
71288-031-91EA - Each71288-0310b923ff9-c34b-4b6d-8ed6-5af31642e20012024-09-09
71288-031-92EA - Each71288-031a8cb77d6-6828-44f4-90b3-68b30e469df912024-09-09

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 1 of 4 · 62 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AMPICILLINAMPICILLIN SODIUMHenry Schein, Inc.78988f6a-a73b-4d3b-9a76-d61a748c3c162026-07-31Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
Ampicillin SodiumAMPICILLIN SODIUMSagent Pharmaceuticals5b3796dd-6f81-4999-ae2b-a13a727957292026-07-27Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
ampicillinAMPICILLINSagent Pharmaceuticals9d2aebe8-4f04-49dd-b1e5-80b962868dc32026-07-27Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
Ampicillin and SulbactamAMPICILLIN SODIUM AND SULBACTAM SODIUMMeitheal Pharmaceuticals Inc.139b4b2e-46f7-44a8-9cc1-774afa463b802026-07-23Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
unii: DKQ4T82YE6
Ampicillin and SulbactamAMPICILLIN SODIUM AND SULBACTAM SODIUMMeitheal Pharmaceuticals Inc.006f9a3f-b4e3-4aa5-ac65-6cc3d3e2582d2026-07-22Warnings, Adverse reactionsExact identifier
application number: ANDA065406
ndc (package): 71288-032-92
ndc (package): 71288-031-92
ndc (package): 71288-031-91
ndc (package): 71288-032-91
ndc (product): 71288-032
ndc (product): 71288-031
rxcui: 1659592
rxcui: 1659598
spl id: 13827c0d-189b-468c-be84-a183793dd8a3
spl set id: 006f9a3f-b4e3-4aa5-ac65-6cc3d3e2582d
unii: JFN36L5S8K
unii: DKQ4T82YE6
UNASYNAMPICILLIN SODIUM AND SULBACTAM SODIUMRoerig155c7ec0-5862-404f-b1d0-f278f8a8bbda2026-07-10Warnings, Adverse reactionsExact identifier
rxcui: 1659592
rxcui: 1659598
unii: JFN36L5S8K
unii: DKQ4T82YE6
UNASYNAMPICILLIN SODIUM AND SULBACTAM SODIUMRoerig12eeb72a-403d-41be-bae4-4cb9308628842026-07-09Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
unii: DKQ4T82YE6
Ampicillin and SulbactamAMPICILLIN AND SULBACTAMWG Critical Care, LLC72a37674-8cb2-4b40-aac8-d345ffcf22f22026-06-23Warnings, Adverse reactionsExact identifier
rxcui: 1659598
unii: JFN36L5S8K
unii: DKQ4T82YE6
Ampicillin and SulbactamAMPICILLIN AND SULBACTAMWG Critical Care, LLC9a722de6-9dc0-4fb9-b63a-225385aa33142026-06-23Warnings, Adverse reactionsExact identifier
rxcui: 1659592
rxcui: 1659598
unii: JFN36L5S8K
unii: DKQ4T82YE6
Ampicillin and SulbactamAMPICILLIN AND SULBACTAMWG Critical Care, LLC77158167-0c1e-4f01-a5b0-a3df8ad121f52026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
unii: DKQ4T82YE6
AmpicillinAMPICILLINWG Critical Care, LLC12b6ac82-ca74-4f88-99ea-ae4a1c419b702026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
AmpicillinAMPICILLINWG Critical Care, LLC38ec7b7a-9caf-45f2-88a1-0f78f089a1e42026-06-22Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
AmpicillinAMPICILLIN SODIUMNorthStar Rx, LLC3b683547-48ac-48ca-8fd4-6866fd17be342026-06-15Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
Ampicillin and SulbactamAMPICILLIN SODIUM AND SULBACTAM SODIUMMeitheal Pharmaceuticals Inc.e6cf14a8-3ed9-4a7a-ba69-be0b794cbdc42026-06-10Warnings, Adverse reactionsExact identifier
application number: ANDA065406
ndc (package): 71288-031-21
ndc (package): 71288-032-21
ndc (package): 71288-031-20
ndc (package): 71288-032-20
ndc (product): 71288-032
ndc (product): 71288-031
ndc11 (package): 71288003120
rxcui: 1659592
rxcui: 1659598
spl id: 321dbb78-6419-46a7-b462-5cab5c732924
spl set id: e6cf14a8-3ed9-4a7a-ba69-be0b794cbdc4
unii: JFN36L5S8K
unii: DKQ4T82YE6
AmpicillinAMPICILLINONESOURCE SPECIALTY PHARMA LIMITED519f3ba6-606f-bfc4-e063-6294a90af8842026-05-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
AMPICILLINAMPICILLIN SODIUMHenry Schein, Inc.06ca924c-5f3a-4924-90f4-5ba623daaa0e2026-04-30Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
Ampicillin and SulbactamAMPICILLIN SODIUM AND SULBACTAM SODIUMMedical Purchasing Solutions, LLC.4e81c215-2ab6-87c6-e063-6294a90ac28c2026-04-02Warnings, Adverse reactionsExact identifier
rxcui: 1659592
unii: JFN36L5S8K
unii: DKQ4T82YE6
Ampicillin and SulbactamAMPICILLIN AND SULBACTAMHikma Pharmaceuticals USA Inc.a65a70bf-4283-4bc0-b576-00c9ab29bd642026-03-25Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
unii: DKQ4T82YE6
Ampicillin and SulbactamAMPICILLIN AND SULBACTAMHikma Pharmaceuticals USA Inc.d3026cc0-95d8-44cf-be47-b5ebb8fd45682026-03-25Warnings, Adverse reactionsExact identifier
application number: ANDA065406
rxcui: 1659592
rxcui: 1659598
unii: JFN36L5S8K
unii: DKQ4T82YE6
AmpicillinAMPICILLINONESOURCE SPECIALTY PHARMA LIMITED519f2131-79e7-569f-e063-6394a90a2f932026-02-27Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K

Reported adverse events (FAERS/openFDA)#

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