FDA.reportPublic FDA data

acyclovir

Product NDC
72578-082
11-digit product format
725780082
Labeler code
72578
Product ID
72578-082_ccf3671e-924e-466b-932e-f8e7ebacd4a4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acyclovir
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Viona Pharmaceuticals Inc
Application
ANDA205974
Marketing category
ANDA
Marketing start
2020-06-08
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
72578-082-01acyclovir1 in 1 CARTONOINTMENT13
72578-082-01acyclovir15 g in 1 TUBEOINTMENT153
72578-082-06acyclovir30 g in 1 TUBEOINTMENT303
72578-082-06acyclovir1 in 1 CARTONOINTMENT13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72578-082-01GM - Gram72578-082fa52958e-83f8-4a91-8623-fc186b31102e12020-08-06
72578-082-06GM - Gram72578-082484dac64-513f-48be-a8df-6cd3ff433d3812020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72578-082ACYCLOVIR OINTMENT [VIONA PHARMACEUTICALS INC]3Current NDC, Legacy NDC, 4 package rows20221007_12df1991-fb1c-45df-acf3-706b1e8ecfc3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197312acyclovir 5 % Topical OintmentPSNc11c1136-7421-48ff-86d2-39507e80a04c5
197312acyclovir 0.05 MG/MG Topical OintmentSCDc11c1136-7421-48ff-86d2-39507e80a04c5
197312acyclovir 5 % Topical OintmentSYc11c1136-7421-48ff-86d2-39507e80a04c5
197312acyclovir 50 MG per 1 GM Topical OintmentSYc11c1136-7421-48ff-86d2-39507e80a04c5
197312acycycloguanosine 0.05 MG/MG Topical OintmentSYc11c1136-7421-48ff-86d2-39507e80a04c5
197312acyclovir 5 % Topical OintmentPSN12df1991-fb1c-45df-acf3-706b1e8ecfc33
197312acyclovir 0.05 MG/MG Topical OintmentSCD12df1991-fb1c-45df-acf3-706b1e8ecfc33
197312acyclovir 5 % Topical OintmentSY12df1991-fb1c-45df-acf3-706b1e8ecfc33
197312acyclovir 50 MG per 1 GM Topical OintmentSY12df1991-fb1c-45df-acf3-706b1e8ecfc33
197312acycycloguanosine 0.05 MG/MG Topical OintmentSY12df1991-fb1c-45df-acf3-706b1e8ecfc33
197312acyclovir 5 % Topical OintmentPSNc561bf77-5b26-4f23-9d49-9d964b48f7722
197312acyclovir 0.05 MG/MG Topical OintmentSCDc561bf77-5b26-4f23-9d49-9d964b48f7722
197312acyclovir 5 % Topical OintmentSYc561bf77-5b26-4f23-9d49-9d964b48f7722
197312acyclovir 50 MG per 1 GM Topical OintmentSYc561bf77-5b26-4f23-9d49-9d964b48f7722
197312acycycloguanosine 0.05 MG/MG Topical OintmentSYc561bf77-5b26-4f23-9d49-9d964b48f7722

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72578-082-01725780082011 TUBE in 1 CARTON (72578-082-01) / 15 g in 1 TUBE1 tube2020-06-080000-00-00NoNoCurrent
72578-082-06725780082061 TUBE in 1 CARTON (72578-082-06) / 30 g in 1 TUBE1 tube2020-06-080000-00-00NoNoCurrent