FDA.reportPublic FDA data

acyclovir

Product NDC
50090-3250
11-digit product format
500903250
Labeler code
50090
Product ID
50090-3250_0c61c8ca-1f35-4ffa-b0a1-888b08f47f5f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA204314
Marketing category
ANDA
Marketing start
2014-09-10
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

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-3250-22023-02-07C16284748780-1f386c649-ef06-0266-e053-dadaa90a7c1aAcyclovir Tablets, USP Rx only
50090-3250-32023-02-07C16284748780-1f386c649-ef06-0266-e053-dadaa90a7c1aAcyclovir Tablets, USP Rx only
50090-3250-42023-02-07C16284748780-1f386c649-ef06-0266-e053-dadaa90a7c1aAcyclovir Tablets, USP Rx only
50090-3250-52023-02-07C16284748780-1f386c649-ef06-0266-e053-dadaa90a7c1aAcyclovir Tablets, USP Rx only
50090-3250-62023-02-07C16284748780-1f386c649-ef06-0266-e053-dadaa90a7c1aAcyclovir Tablets, USP Rx only
50090-3250-92023-02-07C16284748780-1f386c649-ef06-0266-e053-dadaa90a7c1aAcyclovir Tablets, USP Rx only
50090-3250-22023-01-30C16284748780-1f386c649-ef06-0266-e053-dadaa90a7c1aAcyclovir Tablets, USP Rx only
50090-3250-32023-01-30C16284748780-1f386c649-ef06-0266-e053-dadaa90a7c1aAcyclovir Tablets, USP Rx only
50090-3250-42023-01-30C16284748780-1f386c649-ef06-0266-e053-dadaa90a7c1aAcyclovir Tablets, USP Rx only
50090-3250-52023-01-30C16284748780-1f386c649-ef06-0266-e053-dadaa90a7c1aAcyclovir Tablets, USP Rx only
50090-3250-62023-01-30C16284748780-1f386c649-ef06-0266-e053-dadaa90a7c1aAcyclovir Tablets, USP Rx only
50090-3250-92023-01-30C16284748780-1f386c649-ef06-0266-e053-dadaa90a7c1aAcyclovir Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3250-0acyclovir2 in 1 BOTTLETABLET29
50090-3250-2acyclovir25 in 1 BOTTLETABLET259
50090-3250-3acyclovir50 in 1 BOTTLETABLET509
50090-3250-4acyclovir15 in 1 BOTTLETABLET159
50090-3250-5acyclovir30 in 1 BOTTLETABLET309
50090-3250-6acyclovir60 in 1 BOTTLETABLET609
50090-3250-9acyclovir45 in 1 BOTTLETABLET459

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3250-2EA - Each50090-3250f173f406-8d0a-4455-bf2b-767f97abb7b912019-05-02
50090-3250-3EA - Each50090-3250526d4d56-97d7-4423-ab23-dbb243cc322812020-02-13
50090-3250-4EA - Each50090-3250bd0db342-7397-4871-9e4b-67a4661e8d6612020-02-13
50090-3250-5EA - Each50090-325001b1df88-0274-4c5c-a412-136b7c3158e812020-02-13
50090-3250-6EA - Each50090-3250c8277b90-e618-4491-88d1-ffc0fc27537412020-02-13
50090-3250-9EA - Each50090-3250597b31cf-ee5c-4f08-950d-8f95254e7c0512020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3250ACYCLOVIR TABLET [A-S MEDICATION SOLUTIONS]9Current NDC, Legacy NDC, 7 package rows20230418_c40a57b9-4cf1-4a69-abf3-eb99a7fcda00.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197311acyclovir 400 MG Oral TabletPSNc40a57b9-4cf1-4a69-abf3-eb99a7fcda009
197311acyclovir 400 MG Oral TabletSCDc40a57b9-4cf1-4a69-abf3-eb99a7fcda009
197311acycycloguanosine 400 MG Oral TabletSYc40a57b9-4cf1-4a69-abf3-eb99a7fcda009

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3250-0500903250002 TABLET in 1 BOTTLE (50090-3250-0) 2 tablet2018-10-15NoNoCurrent
50090-3250-25009032500225 TABLET in 1 BOTTLE (50090-3250-2) 25 tablet2017-11-080000-00-00NoNoCurrent
50090-3250-35009032500350 TABLET in 1 BOTTLE (50090-3250-3) 50 tablet2017-11-080000-00-00NoNoCurrent
50090-3250-45009032500415 TABLET in 1 BOTTLE (50090-3250-4) 15 tablet2017-11-080000-00-00NoNoCurrent
50090-3250-55009032500530 TABLET in 1 BOTTLE (50090-3250-5) 30 tablet2017-11-080000-00-00NoNoCurrent
50090-3250-65009032500660 TABLET in 1 BOTTLE (50090-3250-6) 60 tablet2017-11-080000-00-00NoNoCurrent
50090-3250-95009032500945 TABLET in 1 BOTTLE (50090-3250-9) 45 tablet2017-11-080000-00-00NoNoCurrent