Home NDC 63323-325-03 NDC 63323-325-03 - 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 63323-325
Requested NDC 63323-325-03
Package NDCs from labels 63323-325-41, 63323-325-14, 63323-325-43, 63323-325-24, 63323-325-03, 63323-325-10, 63323-325-09, 63323-325-20
Manufacturer Fresenius Kabi USA, LLC
Effective date 2024-06-30
Current FDA listing Not matched in FDA.report NDC product tables DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63323-325-03 Acyclovir 10 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 10 6 63323-325-09 Acyclovir 20 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 20 6 63323-325-10 Acyclovir 10 in 1 TRAY INJECTION, SOLUTION 10 6 63323-325-20 Acyclovir 10 in 1 TRAY INJECTION, SOLUTION 10 6 63323-325-14 Acyclovir 10 in 1 TRAY INJECTION, SOLUTION 10 5 63323-325-24 Acyclovir 10 in 1 TRAY INJECTION, SOLUTION 10 5 63323-325-41 Acyclovir 10 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 10 5 63323-325-43 Acyclovir 20 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 20 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-325 ACYCLOVIR (ACYCLOVIR) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC
] 6 Current NDC, Legacy NDC, 4 package rows 20240910_cb64dfab-52ee-4312-bc9c-c3d04efe9109.zip 63323-325 ACYCLOVIR INJECTION, SOLUTION [FRESENIUS KABI USA, LLC
] 5 Current NDC, Legacy NDC, 4 package rows 20240913_badf347b-eeee-4239-9c74-966f262925aa.zip
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACYCLOVIR SODIUM ACTIVE INGREDIENT 927L42J563 ACYCLOVIR (ACYCLOVIR SODIUM) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 3 ACYCLOVIR ACTIVE MOIETY X4HES1O11F ACYCLOVIR (ACYCLOVIR SODIUM) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 3 ACYCLOVIR SODIUM ACTIVE INGREDIENT 927L42J563 ACYCLOVIR (ACYCLOVIR SODIUM) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 1 ACYCLOVIR ACTIVE MOIETY X4HES1O11F ACYCLOVIR (ACYCLOVIR SODIUM) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 1
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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Acyclovir Sodium ACYCLOVIR SODIUM ProPharma Distribution 23a7cf9e-f21b-06c2-e063-6394a90aa623 2025-07-18 Warnings, Adverse reactions Exact identifier rxcui: 1734934 unii: 927L42J563 acyclovir ACYCLOVIR Fresenius Kabi USA, LLC b1bb347d-74f4-4976-8450-a375a271718f 2024-11-13 Warnings, Adverse reactions Exact identifier rxcui: 1734932 rxcui: 1734934 unii: 927L42J563 Acyclovir ACYCLOVIR Fresenius Kabi USA, LLC badf347b-eeee-4239-9c74-966f262925aa 2024-06-30 Warnings, Adverse reactions Exact identifier application number: ANDA074930 ndc (package): 63323-325-41 ndc (package): 63323-325-24 ndc (package): 63323-325-43 ndc (package): 63323-325-14 ndc (product): 63323-325 rxcui: 1734932 rxcui: 1734934 spl id: 5913c199-275d-40b3-a249-050106e058de spl set id: badf347b-eeee-4239-9c74-966f262925aa unii: 927L42J563 Acyclovir ACYCLOVIR Fresenius Kabi USA, LLC cb64dfab-52ee-4312-bc9c-c3d04efe9109 2024-06-27 Warnings, Adverse reactions Exact identifier application number: ANDA074930 ndc (package): 63323-325-10 ndc (package): 63323-325-09 ndc (package): 63323-325-03 ndc (package): 63323-325-20 ndc (product): 63323-325 ndc11 (package): 63323032503 rxcui: 1734932 rxcui: 1734934 spl id: fc30a93e-1fe1-478d-bf68-fe8ab2575279 spl set id: cb64dfab-52ee-4312-bc9c-c3d04efe9109 unii: 927L42J563 Acyclovir ACYCLOVIR Hikma Pharmaceuticals USA Inc. babdbce2-5cbd-4943-bc38-9ebdd696a77a 2024-04-11 Warnings, Adverse reactions Exact identifier unii: 927L42J563 acyclovir ACYCLOVIR Slate Run Pharmaceuticals, LLC 889bccd1-3793-40ce-bca2-c8c9cf6b7488 2024-02-29 Warnings, Adverse reactions Exact identifier rxcui: 1734932 unii: 927L42J563 Acyclovir Sodium ACYCLOVIR SODIUM Eugia US LLC ae921e4e-b8ae-4a45-acc1-32e5e719812b 2023-07-05 Warnings, Adverse reactions Exact identifier rxcui: 1734932 rxcui: 1734934 unii: 927L42J563 acyclovir ACYCLOVIR Zydus Lifesciences Limited 383b930b-6e9c-4ac9-a078-baac6276f340 2022-10-17 Exact identifier rxcui: 1734932 rxcui: 1734934 unii: 927L42J563 acyclovir ACYCLOVIR Zydus Pharmaceuticals (USA) Inc. 69a98000-adef-4323-89a7-09e035a257d4 2021-11-29 Warnings, Adverse reactions Exact identifier rxcui: 1734932 rxcui: 1734934 unii: 927L42J563 Acyclovir Sodium ACYCLOVIR SODIUM AuroMedics Pharma LLC d3ab226c-677d-4cb7-85cb-1c2e5012f40d 2017-09-18 Warnings, Adverse reactions Exact identifier rxcui: 1734932 rxcui: 1734934 unii: 927L42J563
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.