FDA.reportPublic FDA data

Acyclovir

Product NDC
46708-248
11-digit product format
467080248
Labeler code
46708
Product ID
46708-248_f5dd9ff3-9b21-40f8-8abf-ec2f151c90e4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
OINTMENT
Route
CUTANEOUS
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA209000
Marketing category
ANDA
Marketing start
2018-04-16
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
2020-12-31
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
46708-248-302023-01-30C16284748780-1f386c649-bb44-0266-e053-dadaa90a7c1aAcyclovir Ointment USP, 5%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46708-248-30Acyclovir1 in 1 CARTONOINTMENT13
46708-248-30Acyclovir30 g in 1 TUBEOINTMENT303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-248ACYCLOVIR OINTMENT [ALEMBIC PHARMACEUTICALS LIMITED]3Legacy NDC, 2 package rows20191010_2bcc878f-4c86-4a16-85cf-f9963e0f725b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197312acyclovir 5 % Topical OintmentPSN2bcc878f-4c86-4a16-85cf-f9963e0f725b3
197312acyclovir 0.05 MG/MG Topical OintmentSCD2bcc878f-4c86-4a16-85cf-f9963e0f725b3
197312acyclovir 5 % Topical OintmentSY2bcc878f-4c86-4a16-85cf-f9963e0f725b3
197312acyclovir 50 MG per 1 GM Topical OintmentSY2bcc878f-4c86-4a16-85cf-f9963e0f725b3
197312acycycloguanosine 0.05 MG/MG Topical OintmentSY2bcc878f-4c86-4a16-85cf-f9963e0f725b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46708-248-30467080248301 TUBE in 1 CARTON (46708-248-30) > 30 g in 1 TUBE1 tube2018-04-160000-00-00NoNoCurrent