FDA.reportPublic FDA data

acyclovir

Product NDC
71205-391
11-digit product format
712050391
Labeler code
71205
Product ID
71205-391_51052f0e-1a07-405a-a962-981ce9439e02
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA077309
Marketing category
ANDA
Marketing start
2007-06-09
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
71205-391-25acyclovir25 in 1 BOTTLETABLET251
71205-391-30acyclovir30 in 1 BOTTLETABLET301
71205-391-60acyclovir60 in 1 BOTTLETABLET601
71205-391-90acyclovir90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-391-25EA - Each71205-3918a29b0bf-f710-4e62-bfff-3fba00c072ed12020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-391ACYCLOVIR TABLET [PROFICIENT RX LP]1Current NDC, Legacy NDC, 4 package rows20200206_51052f0e-1a07-405a-a962-981ce9439e02.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197311acyclovir 400 MG Oral TabletPSN51052f0e-1a07-405a-a962-981ce9439e021
197311acyclovir 400 MG Oral TabletSCD51052f0e-1a07-405a-a962-981ce9439e021
197311acycycloguanosine 400 MG Oral TabletSY51052f0e-1a07-405a-a962-981ce9439e021

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-391-257120503912525 TABLET in 1 BOTTLE (71205-391-25) 25 tablet2020-01-280000-00-00NoNoCurrent
71205-391-307120503913030 TABLET in 1 BOTTLE (71205-391-30) 30 tablet2020-01-280000-00-00NoNoCurrent
71205-391-607120503916060 TABLET in 1 BOTTLE (71205-391-60) 60 tablet2020-01-280000-00-00NoNoCurrent
71205-391-907120503919090 TABLET in 1 BOTTLE (71205-391-90) 90 tablet2020-01-280000-00-00NoNoCurrent