NDC 0143-9658-01 - Acyclovir

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
0143-9658
Requested NDC
0143-9658-01
Package NDCs from labels
0143-9658-01, 0143-9658-10
Manufacturer
Hikma Pharmaceuticals USA Inc. | HIKMA FARMACEUTICA (PORTUGAL), S.A
Effective date
2024-04-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Acyclovir - Hikma Pharmaceuticals USA Inc. | HIKMA FARMACEUTICA (PORTUGAL), S.AHikma Pharmaceuticals USA Inc. | HIKMA FARMACEUTICA (PORTUGAL), S.A2024-04-11HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9658-01Acyclovir1 in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,15
0143-9658-10Acyclovir10 in 1 BOXINJECTION, POWDER, LYOPHILIZED,105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9658ACYCLOVIR INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.]5Current NDC, Legacy NDC, 2 package rows20240413_babdbce2-5cbd-4943-bc38-9ebdd696a77a.zip

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 1 ยท 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acyclovir SodiumACYCLOVIR SODIUMProPharma Distribution23a7cf9e-f21b-06c2-e063-6394a90aa6232025-07-18Warnings, Adverse reactionsExact identifier
unii: 927L42J563
acyclovirACYCLOVIRFresenius Kabi USA, LLCb1bb347d-74f4-4976-8450-a375a271718f2024-11-13Warnings, Adverse reactionsExact identifier
unii: 927L42J563
AcyclovirACYCLOVIRFresenius Kabi USA, LLCbadf347b-eeee-4239-9c74-966f262925aa2024-06-30Warnings, Adverse reactionsExact identifier
unii: 927L42J563
AcyclovirACYCLOVIRFresenius Kabi USA, LLCcb64dfab-52ee-4312-bc9c-c3d04efe91092024-06-27Warnings, Adverse reactionsExact identifier
unii: 927L42J563
AcyclovirACYCLOVIRHikma Pharmaceuticals USA Inc.babdbce2-5cbd-4943-bc38-9ebdd696a77a2024-04-11Warnings, Adverse reactionsExact identifier
application number: ANDA205771
ndc (package): 0143-9658-10
ndc (package): 0143-9657-01
ndc (package): 0143-9658-01
ndc (package): 0143-9657-10
ndc (product): 0143-9658
ndc (product): 0143-9657
ndc11 (package): 00143965801
rxcui: 2263505
rxcui: 2263503
spl id: dbf69540-34d6-423d-a06a-e5eddfd40ae3
spl set id: babdbce2-5cbd-4943-bc38-9ebdd696a77a
unii: 927L42J563
acyclovirACYCLOVIRSlate Run Pharmaceuticals, LLC889bccd1-3793-40ce-bca2-c8c9cf6b74882024-02-29Warnings, Adverse reactionsExact identifier
unii: 927L42J563
Acyclovir SodiumACYCLOVIR SODIUMEugia US LLCae921e4e-b8ae-4a45-acc1-32e5e719812b2023-07-05Warnings, Adverse reactionsExact identifier
unii: 927L42J563
acyclovirACYCLOVIRZydus Lifesciences Limited383b930b-6e9c-4ac9-a078-baac6276f3402022-10-17Exact identifier
unii: 927L42J563
acyclovirACYCLOVIRZydus Pharmaceuticals (USA) Inc.69a98000-adef-4323-89a7-09e035a257d42021-11-29Warnings, Adverse reactionsExact identifier
unii: 927L42J563
Acyclovir SodiumACYCLOVIR SODIUMAuroMedics Pharma LLCd3ab226c-677d-4cb7-85cb-1c2e5012f40d2017-09-18Warnings, Adverse reactionsExact identifier
unii: 927L42J563