FDA.reportPublic FDA data

Acyclovir

Product NDC
0143-9657
11-digit product format
001439657
Labeler code
0143
Product ID
0143-9657_dbf69540-34d6-423d-a06a-e5eddfd40ae3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA205771
Marketing category
ANDA
Marketing start
2016-02-29
Substance
ACYCLOVIR SODIUM
Active strength
500 mg/1
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 SODIUM500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii927L42J563
Rxcui2263503, 2263505

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
0143-9657-01Acyclovir1 in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,15
0143-9657-10Acyclovir10 in 1 BOXINJECTION, POWDER, LYOPHILIZED,105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9657ACYCLOVIR INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.]5Current NDC, Legacy NDC, 2 package rows20240413_babdbce2-5cbd-4943-bc38-9ebdd696a77a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2263503acyclovir 1000 MG InjectionPSNbabdbce2-5cbd-4943-bc38-9ebdd696a77a5
2263505acyclovir 500 MG InjectionPSNbabdbce2-5cbd-4943-bc38-9ebdd696a77a5
2263503acyclovir 1000 MG InjectionSCDbabdbce2-5cbd-4943-bc38-9ebdd696a77a5
2263505acyclovir 500 MG InjectionSCDbabdbce2-5cbd-4943-bc38-9ebdd696a77a5
2263503acyclovir (as acyclovir sodium) 1000 MG InjectionSYbabdbce2-5cbd-4943-bc38-9ebdd696a77a5
2263505acyclovir (as acyclovir sodium) 500 MG InjectionSYbabdbce2-5cbd-4943-bc38-9ebdd696a77a5
2263503acycycloguanosine 1000 MG InjectionSYbabdbce2-5cbd-4943-bc38-9ebdd696a77a5
2263505acycycloguanosine 500 MG InjectionSYbabdbce2-5cbd-4943-bc38-9ebdd696a77a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0143-9657-01001439657011 in 1 VIAL, SINGLE-DOSEHistorical
0143-9657-100014396571010 VIAL, SINGLE-DOSE in 1 BOX (0143-9657-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (0143-9657-01) 2016-02-290000-00-00NoNoCurrent