Home NDC 63323-325 Acyclovir
Product NDC 63323-325
11-digit product format 633230325
Labeler code 63323
Product ID 63323-325_5913c199-275d-40b3-a249-050106e058de
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name acyclovir
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA074930
Marketing category ANDA
Marketing start 2000-10-17
Substance ACYCLOVIR SODIUM
Active strength 50 mg/mL
Pharmacologic classes DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Acyclovir
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACYCLOVIR SODIUM 50 mg/mL
Harmonized Identifiers# Field, Values table Field Values Unii 927L42J563 Rxcui 1734932, 1734934
DailyMed Product Concepts# 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 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
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 RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63323-325-03 63323032503 10 mL in 1 VIAL, SINGLE-DOSE 10 ml Historical 63323-325-09 63323032509 20 mL in 1 VIAL, SINGLE-DOSE 20 ml Historical 63323-325-10 63323032510 10 VIAL, SINGLE-DOSE in 1 TRAY (63323-325-10) / 10 mL in 1 VIAL, SINGLE-DOSE (63323-325-03) 2000-10-17 0000-00-00 No No Current 63323-325-14 63323032514 10 VIAL, SINGLE-DOSE in 1 TRAY (63323-325-14) / 10 mL in 1 VIAL, SINGLE-DOSE (63323-325-41) 2000-10-17 0000-00-00 No No Current 63323-325-20 63323032520 10 VIAL, SINGLE-DOSE in 1 TRAY (63323-325-20) / 20 mL in 1 VIAL, SINGLE-DOSE (63323-325-09) 2000-10-17 0000-00-00 No No Current 63323-325-24 63323032524 10 VIAL, SINGLE-DOSE in 1 TRAY (63323-325-24) / 20 mL in 1 VIAL, SINGLE-DOSE (63323-325-43) 2000-10-17 0000-00-00 No No Current 63323-325-41 63323032541 10 mL in 1 VIAL, SINGLE-DOSE 10 ml Historical 63323-325-43 63323032543 20 mL in 1 VIAL, SINGLE-DOSE 20 ml Historical