FDA.reportPublic FDA data

Acyclovir

Product NDC
0591-1159
11-digit product format
005911159
Labeler code
0591
Product ID
0591-1159_9a0c599a-742a-48f5-ae69-cd9e8cbaa604
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acyclovir
Dosage form
OINTMENT
Route
TOPICAL
Labeler
ACTAVIS PHARMA, INC.
Application
NDA018604
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2014-04-11
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
0591-1159-30Acyclovir30 g in 1 TUBEOINTMENT307
0591-1159-30Acyclovir1 in 1 CARTONOINTMENT17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-1159-30GM - Gram0591-11593b3647f6-b771-4b90-911e-63e19576ecff12014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
acyclovirACTIVE INGREDIENTX4HES1O11FACYCLOVIR OINTMENT [ACTAVIS PHARMA, INC.]3
acyclovirACTIVE MOIETYX4HES1O11FACYCLOVIR OINTMENT [ACTAVIS PHARMA, INC.]3
Polyethylene GlycolsINACTIVE INGREDIENT3WJQ0SDW1AACYCLOVIR OINTMENT [ACTAVIS PHARMA, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-1159ACYCLOVIR OINTMENT [ACTAVIS PHARMA, INC.]7Current NDC, Legacy NDC, 2 package rows20210112_b360a808-a24d-4f3c-89a7-9941422d17d6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197312acyclovir 5 % Topical OintmentPSNb360a808-a24d-4f3c-89a7-9941422d17d67
197312acyclovir 0.05 MG/MG Topical OintmentSCDb360a808-a24d-4f3c-89a7-9941422d17d67
197312acyclovir 5 % Topical OintmentSYb360a808-a24d-4f3c-89a7-9941422d17d67
197312acyclovir 50 MG per 1 GM Topical OintmentSYb360a808-a24d-4f3c-89a7-9941422d17d67
197312acycycloguanosine 0.05 MG/MG Topical OintmentSYb360a808-a24d-4f3c-89a7-9941422d17d67

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0591-1159-30005911159301 TUBE in 1 CARTON (0591-1159-30) / 30 g in 1 TUBE1 tube2014-04-110000-00-00NoNoCurrent