FDA.reportPublic FDA data

acyclovir

Product NDC
13668-515
11-digit product format
136680515
Labeler code
13668
Product ID
13668-515_95f260b9-dd7f-4bd5-af7e-c4f4671ac6bd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acyclovir
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA209971
Marketing category
ANDA
Marketing start
2019-01-11
Substance
ACYCLOVIR
Active strength
50 mg/g
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
ACYCLOVIR50 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX4HES1O11F
Rxcui197312

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
13668-515-01acyclovir15 g in 1 TUBEOINTMENT159
13668-515-02acyclovir30 g in 1 TUBEOINTMENT309

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-515-01GM - Gram13668-51564d21108-be92-4304-b465-cb9ce69b36f712019-04-11
13668-515-02GM - Gram13668-51592ba4514-152b-44f8-bc66-e6d8099bf3f112019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13668-515ACYCLOVIR OINTMENT [TORRENT PHARMACEUTICALS LIMITED]9Current NDC, Legacy NDC, 2 package rows20250119_1c510390-fb00-4271-967d-0883a9d5e1fd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197312acyclovir 5 % Topical OintmentPSN1c510390-fb00-4271-967d-0883a9d5e1fd9
197312acyclovir 0.05 MG/MG Topical OintmentSCD1c510390-fb00-4271-967d-0883a9d5e1fd9
197312acyclovir 5 % Topical OintmentSY1c510390-fb00-4271-967d-0883a9d5e1fd9
197312acyclovir 50 MG per 1 GM Topical OintmentSY1c510390-fb00-4271-967d-0883a9d5e1fd9
197312acycycloguanosine 0.05 MG/MG Topical OintmentSY1c510390-fb00-4271-967d-0883a9d5e1fd9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13668-515-011366805150115 g in 1 TUBE (13668-515-01) 15 g2019-01-110000-00-00NoNoCurrent
13668-515-021366805150230 g in 1 TUBE (13668-515-02) 30 g2019-01-110000-00-00NoNoCurrent