FDA.reportPublic FDA data

acyclovir

Product NDC
65841-829
11-digit product format
658410829
Labeler code
65841
Product ID
65841-829_60403e35-9772-472d-ba86-f4f373060ee9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acyclovir
Dosage form
CAPSULE
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA204313
Marketing category
ANDA
Marketing start
2016-05-03
Substance
ACYCLOVIR
Active strength
200 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
ACYCLOVIR200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX4HES1O11F
Rxcui197310

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
65841-829-01acyclovir100 in 1 BOTTLECAPSULE1005
65841-829-05acyclovir500 in 1 BOTTLECAPSULE5005
65841-829-06acyclovir30 in 1 BOTTLECAPSULE305
65841-829-10acyclovir1000 in 1 BOTTLECAPSULE10005
65841-829-16acyclovir90 in 1 BOTTLECAPSULE905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65841-829ACYCLOVIR CAPSULE [ZYDUS LIFESCIENCES LIMITED]4Current NDC, Legacy NDC, 5 package rows20231101_395cd839-21e1-43e2-a8ce-078f07bc7668.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197310acyclovir 200 MG Oral CapsulePSN395cd839-21e1-43e2-a8ce-078f07bc76685
197310acyclovir 200 MG Oral CapsuleSCD395cd839-21e1-43e2-a8ce-078f07bc76685
197310acycycloguanosine 200 MG Oral CapsuleSY395cd839-21e1-43e2-a8ce-078f07bc76685

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65841-829-0165841082901100 CAPSULE in 1 BOTTLE (65841-829-01) 100 capsule2016-05-030000-00-00NoNoCurrent
65841-829-0565841082905500 CAPSULE in 1 BOTTLE (65841-829-05) 500 capsule2016-05-030000-00-00NoNoCurrent
65841-829-066584108290630 CAPSULE in 1 BOTTLE (65841-829-06) 30 capsule2016-05-030000-00-00NoNoCurrent
65841-829-10658410829101000 CAPSULE in 1 BOTTLE (65841-829-10) 1000 capsule2016-05-030000-00-00NoNoCurrent
65841-829-166584108291690 CAPSULE in 1 BOTTLE (65841-829-16) 90 capsule2016-05-030000-00-00NoNoCurrent