FDA.reportPublic FDA data

ACYCLOVIR

Product NDC
71205-388
11-digit product format
712050388
Labeler code
71205
Product ID
71205-388_32aa3f42-23a1-4867-8228-e6e76cf9f135
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ACYCLOVIR
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA074891
Marketing category
ANDA
Marketing start
2013-08-08
Substance
ACYCLOVIR
Active strength
800 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
ACYCLOVIR800 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
71205-388-30ACYCLOVIR30 in 1 BOTTLETABLET301
71205-388-35ACYCLOVIR35 in 1 BOTTLETABLET351
71205-388-60ACYCLOVIR60 in 1 BOTTLETABLET601
71205-388-90ACYCLOVIR90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-388-30EA - Each71205-388dce5ed0f-e0ec-418c-b98f-bf808ce7450f12022-03-09
71205-388-35EA - Each71205-388db1fbd21-a03e-4735-b3b3-05aece38f94e12022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-388ACYCLOVIR TABLET [PROFICIENT RX LP]1Current NDC, Legacy NDC, 4 package rows20220211_32aa3f42-23a1-4867-8228-e6e76cf9f135.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197311acyclovir 400 MG Oral TabletPSN32aa3f42-23a1-4867-8228-e6e76cf9f1351
197313acyclovir 800 MG Oral TabletPSN32aa3f42-23a1-4867-8228-e6e76cf9f1351
197311acyclovir 400 MG Oral TabletSCD32aa3f42-23a1-4867-8228-e6e76cf9f1351
197313acyclovir 800 MG Oral TabletSCD32aa3f42-23a1-4867-8228-e6e76cf9f1351
197311acycycloguanosine 400 MG Oral TabletSY32aa3f42-23a1-4867-8228-e6e76cf9f1351
197313acycycloguanosine 800 MG Oral TabletSY32aa3f42-23a1-4867-8228-e6e76cf9f1351

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-388-307120503883030 TABLET in 1 BOTTLE (71205-388-30) 30 tablet2022-02-080000-00-00NoNoCurrent
71205-388-357120503883535 TABLET in 1 BOTTLE (71205-388-35) 35 tablet2022-02-080000-00-00NoNoCurrent
71205-388-607120503886060 TABLET in 1 BOTTLE (71205-388-60) 60 tablet2022-02-080000-00-00NoNoCurrent
71205-388-907120503889090 TABLET in 1 BOTTLE (71205-388-90) 90 tablet2022-02-080000-00-00NoNoCurrent