FDA.reportPublic FDA data

acyclovir

Product NDC
68462-746
11-digit product format
684620746
Labeler code
68462
Product ID
68462-746_091cd2ff-6773-415a-9529-4f8386512c41
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acyclovir
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA205510
Marketing category
ANDA
Marketing start
2017-07-31
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
68462-746-17acyclovir15 g in 1 TUBEOINTMENT157
68462-746-17acyclovir1 in 1 CARTONOINTMENT17
68462-746-35acyclovir1 in 1 CARTONOINTMENT17
68462-746-35acyclovir30 g in 1 TUBEOINTMENT307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-746-17GM - Gram68462-746d3f04db8-047c-4278-bb66-fbad44f4ddfe12017-10-13
68462-746-35GM - Gram68462-74627082f9c-0aa9-4213-9bde-ce8e8b7b78ca12017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-746ACYCLOVIR OINTMENT [GLENMARK PHARMACEUTICALS INC., USA]6Current NDC, Legacy NDC, 4 package rows20240104_149f4418-7668-4d34-a6f9-69bf3a9c5049.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197312acyclovir 5 % Topical OintmentPSN149f4418-7668-4d34-a6f9-69bf3a9c50497
197312acyclovir 0.05 MG/MG Topical OintmentSCD149f4418-7668-4d34-a6f9-69bf3a9c50497
197312acyclovir 5 % Topical OintmentSY149f4418-7668-4d34-a6f9-69bf3a9c50497
197312acyclovir 50 MG per 1 GM Topical OintmentSY149f4418-7668-4d34-a6f9-69bf3a9c50497
197312acycycloguanosine 0.05 MG/MG Topical OintmentSY149f4418-7668-4d34-a6f9-69bf3a9c50497

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-746-17684620746171 TUBE in 1 CARTON (68462-746-17) / 15 g in 1 TUBE1 tube2017-07-310000-00-00NoNoCurrent
68462-746-35684620746351 TUBE in 1 CARTON (68462-746-35) / 30 g in 1 TUBE1 tube2017-07-310000-00-00NoNoCurrent