FDA.reportPublic FDA data

ACYCLOVIR

Product NDC
61919-370
11-digit product format
619190370
Labeler code
61919
Product ID
61919-370_f2134011-7f6b-7b13-e053-2a95a90a5199
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ACYCLOVIR
Dosage form
TABLET
Route
ORAL
Labeler
Direct RX
Application
ANDA075382
Marketing category
ANDA
Marketing start
2014-01-01
Marketing end
0000-00-00
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
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
61919-370-142025-01-30C16284748780-12cef2736-a91b-d83d-e063-dadaa90ab31fACYCLOVIR
61919-370-302025-01-30C16284748780-12cef2736-a91b-d83d-e063-dadaa90ab31fACYCLOVIR
61919-370-402025-01-30C16284748780-12cef2736-a91b-d83d-e063-dadaa90ab31fACYCLOVIR

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-370-14ACYCLOVIR14 in 1 BOTTLETABLET149
61919-370-30ACYCLOVIR30 in 1 BOTTLETABLET309
61919-370-40ACYCLOVIR40 in 1 BOTTLETABLET409

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-370-30EA - Each61919-37034f9d748-6304-4bea-9489-bf2dcc44f2d212015-02-02

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
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACYCLOVIR TABLET [DIRECT RX]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ACYCLOVIR TABLET [DIRECT RX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJACYCLOVIR TABLET [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-370ACYCLOVIR TABLET [DIRECT RX]9Legacy NDC, 3 package rows20230421_5f95a4f4-4822-4502-afbf-b592cafc1ae9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197311acyclovir 400 MG Oral TabletPSN5f95a4f4-4822-4502-afbf-b592cafc1ae99
197311acyclovir 400 MG Oral TabletSCD5f95a4f4-4822-4502-afbf-b592cafc1ae99
197311acycycloguanosine 400 MG Oral TabletSY5f95a4f4-4822-4502-afbf-b592cafc1ae99

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-370-146191903701414 TABLET in 1 BOTTLE (61919-370-14) 14 tablet2014-01-010000-00-00NoNoCurrent
61919-370-306191903703030 TABLET in 1 BOTTLE (61919-370-30) 30 tablet2014-01-010000-00-00NoNoCurrent
61919-370-406191903704040 TABLET in 1 BOTTLE (61919-370-40) 40 tablet2015-01-010000-00-00NoNoCurrent