FDA.reportPublic FDA data

ACYCLOVIR

Product NDC
55154-7629
11-digit product format
551547629
Labeler code
55154
Product ID
55154-7629_9534442e-046a-4f0e-a938-c49cd1481bbf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ACYCLOVIR
Dosage form
CAPSULE
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA075677
Marketing category
ANDA
Marketing start
2007-04-19
Marketing end
2026-08-31
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ACYCLOVIR

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
55154-7629-0ACYCLOVIR1 in 1 BLISTER PACKCAPSULE115
55154-7629-0ACYCLOVIR10 in 1 BAGCAPSULE1015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-7629ACYCLOVIR CAPSULE [CARDINAL HEALTH 107, LLC]13Current NDC, Legacy NDC, 2 package rows20240606_7484b631-18f9-440d-bb11-a44932fec6e7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197310acyclovir 200 MG Oral CapsulePSN7484b631-18f9-440d-bb11-a44932fec6e715
197310acyclovir 200 MG Oral CapsuleSCD7484b631-18f9-440d-bb11-a44932fec6e715
197310acycycloguanosine 200 MG Oral CapsuleSY7484b631-18f9-440d-bb11-a44932fec6e715

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-7629-05515476290010 BLISTER PACK in 1 BAG (55154-7629-0) / 1 CAPSULE in 1 BLISTER PACK10 blister pack2007-04-192026-08-31NoNoCurrent