FDA.reportPublic FDA data

ACYCLOVIR

Product NDC
61919-331
11-digit product format
619190331
Labeler code
61919
Product ID
61919-331_8e6e3ffb-a885-ec6b-e053-2a95a90a6dda
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ACYCLOVIR
Dosage form
CAPSULE
Route
ORAL
Labeler
Direct_Rx
Application
ANDA075677
Marketing category
ANDA
Marketing start
2019-07-24
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
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
61919-331-302023-01-30C16284748780-1f386c64a-1264-0266-e053-dadaa90a7c1aACYCLOVIR

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-331-30ACYCLOVIR30 in 1 BOTTLECAPSULE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-331-30EA - Each61919-331d36ec2c5-e140-44e7-85a3-628b272d074312019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-331ACYCLOVIR CAPSULE [DIRECT_RX]1Legacy NDC, 1 package rows20190724_8e6e3ffb-a884-ec6b-e053-2a95a90a6dda.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197310acyclovir 200 MG Oral CapsulePSN8e6e3ffb-a884-ec6b-e053-2a95a90a6dda1
197310acyclovir 200 MG Oral CapsuleSCD8e6e3ffb-a884-ec6b-e053-2a95a90a6dda1
197310acycycloguanosine 200 MG Oral CapsuleSY8e6e3ffb-a884-ec6b-e053-2a95a90a6dda1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-331-306191903313030 CAPSULE in 1 BOTTLE (61919-331-30) 30 capsule2019-07-240000-00-00NoNoCurrent