FDA.reportPublic FDA data

ACYCLOVIR

Product NDC
61919-003
11-digit product format
619190003
Labeler code
61919
Product ID
61919-003_f21b560f-f5c1-2bfb-e053-2a95a90aa353
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ACYCLOVIR
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA077309
Marketing category
ANDA
Marketing start
2014-01-01
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
2024-12-31
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
61919-003-302025-01-30C16284748780-12cef2736-6357-d83d-e063-dadaa90ab31fACYCLOVIR
61919-003-352025-01-30C16284748780-12cef2736-6357-d83d-e063-dadaa90ab31fACYCLOVIR

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-003-30ACYCLOVIR30 in 1 BOTTLETABLET307
61919-003-35ACYCLOVIR35 in 1 BOTTLETABLET357

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-003-35EA - Each61919-00313a299f5-bdc7-408f-9712-72912ba11f9d12014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACYCLOVIRACTIVE INGREDIENTX4HES1O11FACYCLOVIR TABLET [DIRECT RX]1
ACYCLOVIRACTIVE MOIETYX4HES1O11FACYCLOVIR TABLET [DIRECT RX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACYCLOVIR TABLET [DIRECT RX]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ACYCLOVIR TABLET [DIRECT RX]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ACYCLOVIR TABLET [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACYCLOVIR TABLET [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-003ACYCLOVIR TABLET [DIRECT RX]7Legacy NDC, 2 package rows20230331_d92e83ee-b513-487d-b0b2-8287ffd2bc26.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197313acyclovir 800 MG Oral TabletPSNd92e83ee-b513-487d-b0b2-8287ffd2bc267
197313acyclovir 800 MG Oral TabletSCDd92e83ee-b513-487d-b0b2-8287ffd2bc267
197313acycycloguanosine 800 MG Oral TabletSYd92e83ee-b513-487d-b0b2-8287ffd2bc267

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-003-306191900033030 TABLET in 1 BOTTLE (61919-003-30) 30 tablet2014-01-010000-00-00NoNoCurrent
61919-003-356191900033535 TABLET in 1 BOTTLE (61919-003-35) 35 tablet2014-01-010000-00-00NoNoCurrent