FDA.reportPublic FDA data

Acyclovir

Product NDC
72241-028
11-digit product format
722410028
Labeler code
72241
Product ID
72241-028_d0f2dc6f-5436-4306-8e1f-df80c89e1309
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
CAPSULE
Route
ORAL
Labeler
Modavar Pharmaceuticals LLC
Application
ANDA201445
Marketing category
ANDA
Marketing start
2021-08-18
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
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
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
72241-028-05Acyclovir100 in 1 BOTTLECAPSULE1004
72241-028-10Acyclovir500 in 1 BOTTLECAPSULE5004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72241-028-05EA - Each72241-028ad1943a5-9e45-44db-a6fb-94d7f85e367312023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72241-028ACYCLOVIR CAPSULE [MODAVAR PHARMACEUTICALS LLC]3Current NDC, Legacy NDC, 2 package rows20230306_c7317324-4654-4bcc-8edf-7b7cd8794d2e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197310acyclovir 200 MG Oral CapsulePSNc7317324-4654-4bcc-8edf-7b7cd8794d2e4
197310acyclovir 200 MG Oral CapsuleSCDc7317324-4654-4bcc-8edf-7b7cd8794d2e4
197310acycycloguanosine 200 MG Oral CapsuleSYc7317324-4654-4bcc-8edf-7b7cd8794d2e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72241-028-0572241002805100 CAPSULE in 1 BOTTLE (72241-028-05) 100 capsule2021-08-180000-00-00NoNoCurrent
72241-028-1072241002810500 CAPSULE in 1 BOTTLE (72241-028-10) 500 capsule2021-08-180000-00-00NoNoCurrent