FDA.reportPublic FDA data

acyclovir

Product NDC
65219-622
11-digit product format
652190622
Labeler code
65219
Product ID
65219-622_a2fee863-ed62-4501-881d-eab609ebd51d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ACYCLOVIR
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA215404
Marketing category
ANDA
Marketing start
2024-12-16
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
IngredientStrength
ACYCLOVIR SODIUM50 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii927L42J563
Rxcui1734932, 1734934

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
33190c02-82e1-0a4d-d716-9ccd23588463Product name520250225
c367d1da-5a72-8966-6d11-1eb9a73ae758Product name320231115
5518bf13-db2f-2e9c-3679-e70ecf03752cProduct name920210614
27897900-0e40-497b-97e1-88057e68fe6cProduct name420200710
ca834e59-e669-229c-9288-0ccb76dc373eProduct name920200220
d7f95c49-d3e1-4bbc-a389-e9cd73f59a28Product name120190702
fb15b394-3715-4c87-a447-421489aa8739Product name320170727
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65219-622-02acyclovir10 mL in 1 VIALINJECTION, SOLUTION101
65219-622-10acyclovir10 in 1 CARTONINJECTION, SOLUTION101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65219-622-02ML - Milliliter65219-62210910075-6a5f-4427-9746-9a3fb457cbdb12025-06-13
65219-622-10ML - Milliliter65219-6220768026e-8ce8-4048-b66f-c996415fa38312025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65219-622ACYCLOVIR INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1Current NDC, 2 package rows20241217_b1bb347d-74f4-4976-8450-a375a271718f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1734934acyclovir sodium 1000 MG in 20 ML InjectionPSNb1bb347d-74f4-4976-8450-a375a271718f1
1734932acyclovir sodium 500 MG in 10 ML InjectionPSNb1bb347d-74f4-4976-8450-a375a271718f1
173493210 ML acyclovir 50 MG/ML InjectionSCDb1bb347d-74f4-4976-8450-a375a271718f1
173493420 ML acyclovir 50 MG/ML InjectionSCDb1bb347d-74f4-4976-8450-a375a271718f1
173493210 ML acycycloguanosine 50 MG/ML InjectionSYb1bb347d-74f4-4976-8450-a375a271718f1
173493420 ML acycycloguanosine 50 MG/ML InjectionSYb1bb347d-74f4-4976-8450-a375a271718f1
1734934acyclovir 1000 MG per 20 ML InjectionSYb1bb347d-74f4-4976-8450-a375a271718f1
1734932acyclovir 50 MG/ML (equivalent to acyclovir sodium 54.9 MG/ML) per 10 ML InjectionSYb1bb347d-74f4-4976-8450-a375a271718f1
1734934acyclovir 50 MG/ML (equivalent to acyclovir sodium 54.9 MG/ML) per 20 ML InjectionSYb1bb347d-74f4-4976-8450-a375a271718f1
1734932acyclovir 500 MG per 10 ML InjectionSYb1bb347d-74f4-4976-8450-a375a271718f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65219-622-026521906220210 mL in 1 VIAL10 mlHistorical
65219-622-106521906221010 VIAL in 1 CARTON (65219-622-10) / 10 mL in 1 VIAL (65219-622-02) 10 vial2024-12-16NoNoHistorical