FDA.reportPublic FDA data

Acyclovir

Product NDC
71205-056
11-digit product format
712050056
Labeler code
71205
Product ID
71205-056_7fadb9ce-34cc-4b19-9470-15e3a64d9c4f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA075382
Marketing category
ANDA
Marketing start
2009-10-22
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, 197313

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
71205-056-30Acyclovir30 in 1 BOTTLE, PLASTICTABLET305
71205-056-60Acyclovir60 in 1 BOTTLE, PLASTICTABLET605
71205-056-90Acyclovir90 in 1 BOTTLE, PLASTICTABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-056-30EA - Each71205-056fb5befd7-81d9-434d-b354-1af9d373b6ad12018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-056ACYCLOVIR TABLET [PROFICIENT RX LP]5Current NDC, Legacy NDC, 3 package rows20220616_33630a35-346e-43b6-9286-89e28ac0094a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197311acyclovir 400 MG Oral TabletPSN33630a35-346e-43b6-9286-89e28ac0094a5
197313acyclovir 800 MG Oral TabletPSN33630a35-346e-43b6-9286-89e28ac0094a5
197311acyclovir 400 MG Oral TabletSCD33630a35-346e-43b6-9286-89e28ac0094a5
197313acyclovir 800 MG Oral TabletSCD33630a35-346e-43b6-9286-89e28ac0094a5
197311acycycloguanosine 400 MG Oral TabletSY33630a35-346e-43b6-9286-89e28ac0094a5
197313acycycloguanosine 800 MG Oral TabletSY33630a35-346e-43b6-9286-89e28ac0094a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-056-307120500563030 TABLET in 1 BOTTLE, PLASTIC (71205-056-30) 30 tablet2018-06-010000-00-00NoNoCurrent
71205-056-607120500566060 TABLET in 1 BOTTLE, PLASTIC (71205-056-60) 60 tablet2018-06-010000-00-00NoNoCurrent
71205-056-907120500569090 TABLET in 1 BOTTLE, PLASTIC (71205-056-90) 90 tablet2018-06-010000-00-00NoNoCurrent