acyclovir

Product NDC
66267-399
11-digit product format
662670399
Labeler code
66267
Product ID
66267-399_1fa6dc86-6637-c362-e063-6394a90a4c03
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
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
Rxcui197313

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66267-399-15acyclovir15 in 1 BOTTLETABLET155
66267-399-21acyclovir21 in 1 BOTTLETABLET215
66267-399-25acyclovir25 in 1 BOTTLETABLET255
66267-399-30acyclovir30 in 1 BOTTLETABLET305
66267-399-35acyclovir35 in 1 BOTTLETABLET355
66267-399-50acyclovir50 in 1 BOTTLETABLET505

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66267-399-30EA - Each66267-399423537f3-aa8b-4dc2-82c5-2a88a5d9116712017-03-06
66267-399-35EA - Each66267-3990ccca00b-ff07-4eeb-9771-f1eeb20d5f4e12017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66267-399ACYCLOVIR TABLET [NUCARE PHARMACEUTICALS, INC.]5Current NDC, Legacy NDC, 6 package rows20240815_40e5cc54-ed74-3369-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197313acyclovir 800 MG Oral TabletPSN40e5cc54-ed74-3369-e054-00144ff88e885
197313acyclovir 800 MG Oral TabletSCD40e5cc54-ed74-3369-e054-00144ff88e885
197313acycycloguanosine 800 MG Oral TabletSY40e5cc54-ed74-3369-e054-00144ff88e885

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66267-399-156626703991515 TABLET in 1 BOTTLE (66267-399-15) 15 tablet2016-11-090000-00-00NoNoCurrent
66267-399-216626703992121 TABLET in 1 BOTTLE (66267-399-21) 21 tablet2016-11-090000-00-00NoNoCurrent
66267-399-256626703992525 TABLET in 1 BOTTLE (66267-399-25) 25 tablet2016-11-090000-00-00NoNoCurrent
66267-399-306626703993030 TABLET in 1 BOTTLE (66267-399-30) 30 tablet2016-11-090000-00-00NoNoCurrent
66267-399-356626703993535 TABLET in 1 BOTTLE (66267-399-35) 35 tablet2016-11-090000-00-00NoNoCurrent
66267-399-506626703995050 TABLET in 1 BOTTLE (66267-399-50) 50 tablet2016-11-090000-00-00NoNoCurrent