FDA.reportPublic FDA data

Acyclovir

Product NDC
71205-472
11-digit product format
712050472
Labeler code
71205
Product ID
71205-472_17c98e9b-bcc4-4909-b6ce-0e11d786081a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA210401
Marketing category
ANDA
Marketing start
2018-05-04
Substance
ACYCLOVIR
Active strength
400 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
ACYCLOVIR400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX4HES1O11F
Rxcui197311

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
71205-472-15Acyclovir15 in 1 BOTTLETABLET153
71205-472-30Acyclovir30 in 1 BOTTLETABLET303
71205-472-60Acyclovir60 in 1 BOTTLETABLET603
71205-472-90Acyclovir90 in 1 BOTTLETABLET903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-472ACYCLOVIR TABLET [PROFICIENT RX LP]3Current NDC, Legacy NDC, 4 package rows20241024_290af212-7332-4914-9ef0-65760478fb32.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197311acyclovir 400 MG Oral TabletPSN290af212-7332-4914-9ef0-65760478fb323
197311acyclovir 400 MG Oral TabletSCD290af212-7332-4914-9ef0-65760478fb323
197311acycycloguanosine 400 MG Oral TabletSY290af212-7332-4914-9ef0-65760478fb323

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-472-157120504721515 TABLET in 1 BOTTLE (71205-472-15) 15 tablet2020-08-210000-00-00NoNoCurrent
71205-472-307120504723030 TABLET in 1 BOTTLE (71205-472-30) 30 tablet2020-08-210000-00-00NoNoCurrent
71205-472-607120504726060 TABLET in 1 BOTTLE (71205-472-60) 60 tablet2020-08-210000-00-00NoNoCurrent
71205-472-907120504729090 TABLET in 1 BOTTLE (71205-472-90) 90 tablet2020-08-210000-00-00NoNoCurrent