FDA.reportPublic FDA data

ACYCLOVIR

Product NDC
50090-0595
11-digit product format
500900595
Labeler code
50090
Product ID
50090-0595_52cce24f-88b0-4da9-86b5-2a718e5d3c5a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ACYCLOVIR
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA075677
Marketing category
ANDA
Marketing start
2006-03-20
Marketing end
0000-00-00
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
2020-12-31
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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
5518bf13-db2f-2e9c-3679-e70ecf03752cProduct name920210614
27897900-0e40-497b-97e1-88057e68fe6cProduct name420200710
ca834e59-e669-229c-9288-0ccb76dc373eProduct name920200220
d7f95c49-d3e1-4bbc-a389-e9cd73f59a28Product name120190702
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
fb15b394-3715-4c87-a447-421489aa8739Product name320170727
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-0595-02023-01-30C16284748780-1f386c649-a0dc-0266-e053-dadaa90a7c1aACYCLOVIR CAPSULES USP 200 mg
50090-0595-12023-01-30C16284748780-1f386c649-a0dc-0266-e053-dadaa90a7c1aACYCLOVIR CAPSULES USP 200 mg
50090-0595-72023-01-30C16284748780-1f386c649-a0dc-0266-e053-dadaa90a7c1aACYCLOVIR CAPSULES USP 200 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0595-0ACYCLOVIR25 in 1 BOTTLECAPSULE259
50090-0595-1ACYCLOVIR50 in 1 BOTTLECAPSULE509
50090-0595-7ACYCLOVIR30 in 1 BOTTLECAPSULE309

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0595-0EA - Each50090-0595ca1db555-891b-4cf5-a655-860d31fd221e12018-08-13
50090-0595-1EA - Each50090-0595f5f49240-7239-4407-9712-83530885260b12018-09-05
50090-0595-7EA - Each50090-0595d9cb9225-6106-4d73-976d-eef7e2945ad612018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0595ACYCLOVIR CAPSULE [A-S MEDICATION SOLUTIONS]9Legacy NDC, 3 package rows20190125_0fbc0612-0249-481d-8198-0e810423f875.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197310acyclovir 200 MG Oral CapsulePSN0fbc0612-0249-481d-8198-0e810423f8759
197310acyclovir 200 MG Oral CapsuleSCD0fbc0612-0249-481d-8198-0e810423f8759
197310acycycloguanosine 200 MG Oral CapsuleSY0fbc0612-0249-481d-8198-0e810423f8759

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0595-05009005950025 CAPSULE in 1 BOTTLE (50090-0595-0) 25 capsule2014-11-280000-00-00NoNoCurrent
50090-0595-15009005950150 CAPSULE in 1 BOTTLE (50090-0595-1) 50 capsule2014-11-280000-00-00NoNoCurrent
50090-0595-75009005950730 CAPSULE in 1 BOTTLE (50090-0595-7) 30 capsule2014-11-280000-00-00NoNoCurrent