FDA.reportPublic FDA data

Acyclovir

Product NDC
85957-036
11-digit product format
859570036
Labeler code
85957
Product ID
85957-036_50c132f3-95be-0da8-e063-6294a90a46c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acyclovir
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Aryeh Pharma Corp
Application
ANDA202459
Marketing category
ANDA
Marketing start
2026-04-10
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Acyclovir
Listing expiration
2027-12-31

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
85957-036-01Acyclovir5 g in 1 TUBEOINTMENT52
85957-036-01Acyclovir2 in 1 CARTONOINTMENT22
85957-036-02Acyclovir15 g in 1 TUBEOINTMENT152
85957-036-02Acyclovir1 in 1 CARTONOINTMENT12
85957-036-03Acyclovir30 g in 1 TUBEOINTMENT302
85957-036-03Acyclovir1 in 1 CARTONOINTMENT12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197312acyclovir 5 % Topical OintmentPSNf60cc0c2-e0fe-406a-b5c0-90bc4b566bb32
197312acyclovir 0.05 MG/MG Topical OintmentSCDf60cc0c2-e0fe-406a-b5c0-90bc4b566bb32
197312acyclovir 5 % Topical OintmentSYf60cc0c2-e0fe-406a-b5c0-90bc4b566bb32
197312acyclovir 50 MG per 1 GM Topical OintmentSYf60cc0c2-e0fe-406a-b5c0-90bc4b566bb32
197312acycycloguanosine 0.05 MG/MG Topical OintmentSYf60cc0c2-e0fe-406a-b5c0-90bc4b566bb32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85957-036-01859570036012 TUBE in 1 CARTON (85957-036-01) / 5 g in 1 TUBE2 tube2026-04-10NoNoHistorical
85957-036-02859570036021 TUBE in 1 CARTON (85957-036-02) / 15 g in 1 TUBE1 tube2026-04-10NoNoHistorical
85957-036-03859570036031 TUBE in 1 CARTON (85957-036-03) / 30 g in 1 TUBE1 tube2026-04-10NoNoHistorical