FDA.reportPublic FDA data

Acyclovir

Product NDC
31722-968
11-digit product format
317220968
Labeler code
31722
Product ID
31722-968_8a7294a3-588a-4ae1-baaa-4a4402ee3bad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acyclovir
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA212495
Marketing category
ANDA
Marketing start
2020-09-01
Marketing end
0000-00-00
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
2021-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
31722-968-312022-01-28C16284748780-1d6a99b39-e0b4-a426-e053-dadaa90af4c2PRESCRIBING INFORMATION Acyclovir Ointment USP, 5% Rx Only
31722-968-322022-01-28C16284748780-1d6a99b39-e0b4-a426-e053-dadaa90af4c2PRESCRIBING INFORMATION Acyclovir Ointment USP, 5% Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-968-31Acyclovir15 g in 1 TUBEOINTMENT153
31722-968-31Acyclovir1 in 1 CARTONOINTMENT13
31722-968-32Acyclovir30 g in 1 TUBEOINTMENT303
31722-968-32Acyclovir1 in 1 CARTONOINTMENT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-968ACYCLOVIR OINTMENT [CAMBER PHARMACEUTICALS, INC.]3Legacy NDC, 4 package rows20200901_bedf63da-6301-4643-9ac5-fe63eea57215.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197312acyclovir 5 % Topical OintmentPSNbedf63da-6301-4643-9ac5-fe63eea572153
197312acyclovir 0.05 MG/MG Topical OintmentSCDbedf63da-6301-4643-9ac5-fe63eea572153
197312acyclovir 5 % Topical OintmentSYbedf63da-6301-4643-9ac5-fe63eea572153
197312acyclovir 50 MG per 1 GM Topical OintmentSYbedf63da-6301-4643-9ac5-fe63eea572153
197312acycycloguanosine 0.05 MG/MG Topical OintmentSYbedf63da-6301-4643-9ac5-fe63eea572153

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
31722-968-31317220968311 TUBE in 1 CARTON (31722-968-31) > 15 g in 1 TUBE1 tube2020-09-010000-00-00NoNoCurrent
31722-968-32317220968321 TUBE in 1 CARTON (31722-968-32) > 30 g in 1 TUBE1 tube2020-09-010000-00-00NoNoCurrent