ACYCLOVIR

Product NDC
53002-2450
11-digit product format
530022450
Labeler code
53002
Product ID
53002-2450_b35886fc-3d80-41e7-ad02-1addacdfa5d3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ACYCLOVIR
Dosage form
CAPSULE
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
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
2021-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-2450-1ACYCLOVIR25 in 1 BOTTLECAPSULE255
53002-2450-2ACYCLOVIR50 in 1 BOTTLECAPSULE505

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-2450ACYCLOVIR CAPSULE [RPK PHARMACEUTICALS, INC.]5Legacy NDC, 2 package rows20230609_7ee2d439-e78d-42ac-b93e-aa5e2656fb82.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197310acyclovir 200 MG Oral CapsulePSN7ee2d439-e78d-42ac-b93e-aa5e2656fb825
197310acyclovir 200 MG Oral CapsuleSCD7ee2d439-e78d-42ac-b93e-aa5e2656fb825
197310acycycloguanosine 200 MG Oral CapsuleSY7ee2d439-e78d-42ac-b93e-aa5e2656fb825

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-2450-15300224500125 CAPSULE in 1 BOTTLE (53002-2450-1) 25 capsule2018-10-010000-00-00NoNoCurrent
53002-2450-25300224500250 CAPSULE in 1 BOTTLE (53002-2450-2) 50 capsule2018-10-010000-00-00NoNoCurrent