FDA.reportPublic FDA data

acyclovir

Product NDC
50090-0637
11-digit product format
500900637
Labeler code
50090
Product ID
50090-0637_417f3d6d-aa1b-48df-aaa3-1f640d83b14b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA077309
Marketing category
ANDA
Marketing start
2006-03-13
Marketing end
0000-00-00
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
2022-12-31
Current FDA listing
Historical FDA.report record

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
50090-0637-02023-01-30C16284748780-1f386c64a-1145-0266-e053-dadaa90a7c1aACYCLOVIR TABLETS, USP 400 mg and 800 mg
50090-0637-22023-01-30C16284748780-1f386c64a-1145-0266-e053-dadaa90a7c1aACYCLOVIR TABLETS, USP 400 mg and 800 mg
50090-0637-32023-01-30C16284748780-1f386c64a-1145-0266-e053-dadaa90a7c1aACYCLOVIR TABLETS, USP 400 mg and 800 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0637-0acyclovir35 in 1 BOTTLETABLET3510
50090-0637-2acyclovir70 in 1 BOTTLETABLET7010
50090-0637-3acyclovir40 in 1 BOTTLETABLET4010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0637-0EA - Each50090-0637c90f39a2-28d2-4799-8510-f754d0c102f912021-08-05
50090-0637-3EA - Each50090-0637d66c9f92-b628-470d-958d-d369689f7d7212021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0637ACYCLOVIR TABLET [A-S MEDICATION SOLUTIONS]10Legacy NDC, 3 package rows20210402_6952db57-c3a3-46a4-828c-21e9eccd22f0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197313acyclovir 800 MG Oral TabletPSN6952db57-c3a3-46a4-828c-21e9eccd22f010
197313acyclovir 800 MG Oral TabletSCD6952db57-c3a3-46a4-828c-21e9eccd22f010
197313acycycloguanosine 800 MG Oral TabletSY6952db57-c3a3-46a4-828c-21e9eccd22f010

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0637-05009006370035 TABLET in 1 BOTTLE (50090-0637-0) 35 tablet2014-11-280000-00-00NoNoCurrent
50090-0637-25009006370270 TABLET in 1 BOTTLE (50090-0637-2) 70 tablet2014-11-280000-00-00NoNoCurrent
50090-0637-35009006370340 TABLET in 1 BOTTLE (50090-0637-3) 40 tablet2019-11-250000-00-00NoNoCurrent