FDA.reportPublic FDA data

Acyclovir

Product NDC
69452-290
11-digit product format
694520290
Labeler code
69452
Product ID
69452-290_a0977267-e400-48f6-99fa-dafcc483e96e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
Bionpharma Inc.
Application
ANDA209366
Marketing category
ANDA
Marketing start
2020-08-15
Substance
ACYCLOVIR
Active strength
400 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
ACYCLOVIR400 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
69452-290-20Acyclovir100 in 1 BOTTLETABLET1004
69452-290-30Acyclovir500 in 1 BOTTLETABLET5004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69452-290ACYCLOVIR TABLET [BIONPHARMA INC.]4Current NDC, Legacy NDC, 2 package rows20231211_6f1db9f0-9b41-4fb7-8798-44fdc2c128df.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197311acyclovir 400 MG Oral TabletPSNe73ae5c8-7a77-4330-817d-482d1de4e994103
197311acyclovir 400 MG Oral TabletSCDe73ae5c8-7a77-4330-817d-482d1de4e994103
197311acycycloguanosine 400 MG Oral TabletSYe73ae5c8-7a77-4330-817d-482d1de4e994103
197311acyclovir 400 MG Oral TabletPSNb1033fda-8242-4006-b1cd-23474d70671f6
197311acyclovir 400 MG Oral TabletSCDb1033fda-8242-4006-b1cd-23474d70671f6
197311acycycloguanosine 400 MG Oral TabletSYb1033fda-8242-4006-b1cd-23474d70671f6
197311acyclovir 400 MG Oral TabletPSNe5e99a6b-79a6-7fdb-e053-2a95a90a85634
197311acyclovir 400 MG Oral TabletPSN6f1db9f0-9b41-4fb7-8798-44fdc2c128df4
197313acyclovir 800 MG Oral TabletPSN6f1db9f0-9b41-4fb7-8798-44fdc2c128df4
197311acyclovir 400 MG Oral TabletSCDe5e99a6b-79a6-7fdb-e053-2a95a90a85634
197311acyclovir 400 MG Oral TabletSCD6f1db9f0-9b41-4fb7-8798-44fdc2c128df4
197313acyclovir 800 MG Oral TabletSCD6f1db9f0-9b41-4fb7-8798-44fdc2c128df4
197311acycycloguanosine 400 MG Oral TabletSYe5e99a6b-79a6-7fdb-e053-2a95a90a85634
197311acycycloguanosine 400 MG Oral TabletSY6f1db9f0-9b41-4fb7-8798-44fdc2c128df4
197313acycycloguanosine 800 MG Oral TabletSY6f1db9f0-9b41-4fb7-8798-44fdc2c128df4
197311acyclovir 400 MG Oral TabletPSNfa1ae70c-3372-845c-e053-6394a90ac3d93
197311acyclovir 400 MG Oral TabletSCDfa1ae70c-3372-845c-e053-6394a90ac3d93
197311acycycloguanosine 400 MG Oral TabletSYfa1ae70c-3372-845c-e053-6394a90ac3d93
197311acyclovir 400 MG Oral TabletPSN116f4f0d-66c5-49dd-e063-6394a90ab2b52
197311acyclovir 400 MG Oral TabletPSN7f505e82-d3b3-49d7-b711-2709a4aca5462
197311acyclovir 400 MG Oral TabletSCD7f505e82-d3b3-49d7-b711-2709a4aca5462
197311acyclovir 400 MG Oral TabletSCD116f4f0d-66c5-49dd-e063-6394a90ab2b52
197311acycycloguanosine 400 MG Oral TabletSY7f505e82-d3b3-49d7-b711-2709a4aca5462
197311acycycloguanosine 400 MG Oral TabletSY116f4f0d-66c5-49dd-e063-6394a90ab2b52
197311acyclovir 400 MG Oral TabletPSNa1086845-ba08-4fb2-81dc-aea9c68bf2c31
197311acyclovir 400 MG Oral TabletPSN067109d0-2539-42b6-9e95-102b58ca54dc1
197311acyclovir 400 MG Oral TabletPSNebf418c8-a98c-da82-e053-2995a90a1fb31
197311acyclovir 400 MG Oral TabletPSN266c8441-f178-61f8-e063-6394a90a89c31
197311acyclovir 400 MG Oral TabletPSN387d33ed-45e5-42d6-e063-6294a90afbb71
197311acyclovir 400 MG Oral TabletSCD387d33ed-45e5-42d6-e063-6294a90afbb71
197311acyclovir 400 MG Oral TabletSCD266c8441-f178-61f8-e063-6394a90a89c31
197311acyclovir 400 MG Oral TabletSCD067109d0-2539-42b6-9e95-102b58ca54dc1
197311acyclovir 400 MG Oral TabletSCDebf418c8-a98c-da82-e053-2995a90a1fb31
197311acyclovir 400 MG Oral TabletSCDa1086845-ba08-4fb2-81dc-aea9c68bf2c31
197311acycycloguanosine 400 MG Oral TabletSY266c8441-f178-61f8-e063-6394a90a89c31
197311acycycloguanosine 400 MG Oral TabletSY387d33ed-45e5-42d6-e063-6294a90afbb71
197311acycycloguanosine 400 MG Oral TabletSYebf418c8-a98c-da82-e053-2995a90a1fb31
197311acycycloguanosine 400 MG Oral TabletSYa1086845-ba08-4fb2-81dc-aea9c68bf2c31
197311acycycloguanosine 400 MG Oral TabletSY067109d0-2539-42b6-9e95-102b58ca54dc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69452-290-2069452029020100 TABLET in 1 BOTTLE (69452-290-20) 100 tablet2020-08-150000-00-00NoNoCurrent
69452-290-3069452029030500 TABLET in 1 BOTTLE (69452-290-30) 500 tablet2020-08-150000-00-00NoNoCurrent