FDA.reportPublic FDA data

Acyclovir

Product NDC
69367-138
11-digit product format
693670138
Labeler code
69367
Product ID
69367-138_629d8ddb-bba0-4dd8-8621-1bd2a7b129dc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
Westminster Pharmaceuticals, LLC
Application
ANDA210401
Marketing category
ANDA
Marketing start
2023-06-20
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
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
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
69367-138-01Acyclovir100 in 1 BOTTLETABLET1005
69367-138-05Acyclovir500 in 1 BOTTLETABLET5005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69367-138-01EA - Each69367-138cb3b43c1-9493-4c3d-8872-b045e982940c12023-07-06
69367-138-05EA - Each69367-138cd7af76e-819f-43de-ab7c-d24a7853837312023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69367-138ACYCLOVIR TABLET [WESTMINSTER PHARMACEUTICALS, LLC]2Current NDC, 2 package rows20230629_f352a641-988e-4878-8016-2b69cd6ee548.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197311acyclovir 400 MG Oral TabletPSNf352a641-988e-4878-8016-2b69cd6ee5485
197313acyclovir 800 MG Oral TabletPSNf352a641-988e-4878-8016-2b69cd6ee5485
197311acyclovir 400 MG Oral TabletSCDf352a641-988e-4878-8016-2b69cd6ee5485
197313acyclovir 800 MG Oral TabletSCDf352a641-988e-4878-8016-2b69cd6ee5485
197311acycycloguanosine 400 MG Oral TabletSYf352a641-988e-4878-8016-2b69cd6ee5485
197313acycycloguanosine 800 MG Oral TabletSYf352a641-988e-4878-8016-2b69cd6ee5485
197313acyclovir 800 MG Oral TabletPSN2e6a3667-af06-40de-80c0-8c4346e0671f3
197313acyclovir 800 MG Oral TabletPSNd0908b3c-f5dd-4113-9080-bb01abe13c9c3
197313acyclovir 800 MG Oral TabletSCD2e6a3667-af06-40de-80c0-8c4346e0671f3
197313acyclovir 800 MG Oral TabletSCDd0908b3c-f5dd-4113-9080-bb01abe13c9c3
197313acycycloguanosine 800 MG Oral TabletSY2e6a3667-af06-40de-80c0-8c4346e0671f3
197313acycycloguanosine 800 MG Oral TabletSYd0908b3c-f5dd-4113-9080-bb01abe13c9c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69367-138-0169367013801100 TABLET in 1 BOTTLE (69367-138-01) 100 tablet2023-06-20NoNoCurrent
69367-138-0569367013805500 TABLET in 1 BOTTLE (69367-138-05) 500 tablet2023-06-20NoNoCurrent