FDA.reportPublic FDA data

acyclovir

Product NDC
65841-803
11-digit product format
658410803
Labeler code
65841
Product ID
65841-803_b401b7c4-9c22-470f-981e-da74bef39dc6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA204314
Marketing category
ANDA
Marketing start
2014-09-10
Substance
ACYCLOVIR
Active strength
800 mg/1
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
ACYCLOVIR800 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX4HES1O11F
Rxcui197311, 197313

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
65841-803-01acyclovir100 in 1 BOTTLETABLET1005
65841-803-05acyclovir500 in 1 BOTTLETABLET5005
65841-803-06acyclovir30 in 1 BOTTLETABLET305
65841-803-10acyclovir1000 in 1 BOTTLETABLET10005
65841-803-16acyclovir90 in 1 BOTTLETABLET905
65841-803-30acyclovir10 in 1 CARTONTABLET105
65841-803-30acyclovir10 in 1 BLISTER PACKTABLET105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65841-803ACYCLOVIR TABLET [ZYDUS LIFESCIENCES LIMITED]4Current NDC, Legacy NDC, 7 package rows20231025_8d9fea43-6c04-40d7-8aac-398c2de2a558.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197311acyclovir 400 MG Oral TabletPSN8d9fea43-6c04-40d7-8aac-398c2de2a5585
197313acyclovir 800 MG Oral TabletPSN8d9fea43-6c04-40d7-8aac-398c2de2a5585
197311acyclovir 400 MG Oral TabletSCD8d9fea43-6c04-40d7-8aac-398c2de2a5585
197313acyclovir 800 MG Oral TabletSCD8d9fea43-6c04-40d7-8aac-398c2de2a5585
197311acycycloguanosine 400 MG Oral TabletSY8d9fea43-6c04-40d7-8aac-398c2de2a5585
197313acycycloguanosine 800 MG Oral TabletSY8d9fea43-6c04-40d7-8aac-398c2de2a5585

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65841-803-0165841080301100 TABLET in 1 BOTTLE (65841-803-01) 100 tablet2014-09-100000-00-00NoNoCurrent
65841-803-0565841080305500 TABLET in 1 BOTTLE (65841-803-05) 500 tablet2014-09-100000-00-00NoNoCurrent
65841-803-066584108030630 TABLET in 1 BOTTLE (65841-803-06) 30 tablet2014-09-100000-00-00NoNoCurrent
65841-803-10658410803101000 TABLET in 1 BOTTLE (65841-803-10) 1000 tablet2014-09-100000-00-00NoNoCurrent
65841-803-166584108031690 TABLET in 1 BOTTLE (65841-803-16) 90 tablet2014-09-100000-00-00NoNoCurrent
65841-803-306584108033010 BLISTER PACK in 1 CARTON (65841-803-30) / 10 TABLET in 1 BLISTER PACK10 blister pack2014-09-100000-00-00NoNoCurrent