FDA.reportPublic FDA data

Acyclovir Sodium

Product NDC
84549-155
11-digit product format
845490155
Labeler code
84549
Product ID
84549-155_3a390591-86f7-b68d-e063-6294a90a8bcc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir Sodium
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
ProPharma Distribution
Application
ANDA203701
Marketing category
ANDA
Marketing start
2013-10-11
Substance
ACYCLOVIR SODIUM
Active strength
1000 mg/20mL
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 Sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACYCLOVIR SODIUM1000 mg/20mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii927L42J563
Rxcui1734934

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
84549-155-20Acyclovir Sodium20 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84549-155ACYCLOVIR SODIUM INJECTION, SOLUTION [PROPHARMA DISTRIBUTION]1Current NDC, 1 package rows20241023_23a7cf9e-f21b-06c2-e063-6394a90aa623.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1734934acyclovir sodium 1000 MG in 20 ML InjectionPSN23a7cf9e-f21b-06c2-e063-6394a90aa6233
173493420 ML acyclovir 50 MG/ML InjectionSCD23a7cf9e-f21b-06c2-e063-6394a90aa6233
173493420 ML acycycloguanosine 50 MG/ML InjectionSY23a7cf9e-f21b-06c2-e063-6394a90aa6233
1734934acyclovir 1000 MG per 20 ML InjectionSY23a7cf9e-f21b-06c2-e063-6394a90aa6233
1734934acyclovir 50 MG/ML (equivalent to acyclovir sodium 54.9 MG/ML) per 20 ML InjectionSY23a7cf9e-f21b-06c2-e063-6394a90aa6233

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84549-155-208454901552020 mL in 1 VIAL, SINGLE-DOSE (84549-155-20) 20 ml2025-08-27NoNoHistorical