Acyclovir

Product NDC
62135-019
11-digit product format
621350019
Labeler code
62135
Product ID
62135-019_458baf7d-dea5-aa22-e063-6394a90a8ae5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA210401
Marketing category
ANDA
Marketing start
2018-05-04
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Acyclovir
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACYCLOVIR800 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX4HES1O11F
Rxcui197310, 197313

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62135-019-50Acyclovir50 in 1 BOTTLETABLET504

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-019-50EA - Each62135-0198aba693d-db7f-48a5-a94b-9e3846848e6512022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-019ACYCLOVIR CAPSULE ACYCLOVIR TABLET [CHARTWELL RX, LLC]3Current NDC, Legacy NDC, 1 package rows20241012_8cd22728-34b4-4e55-8339-580138fe46d8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197310acyclovir 200 MG Oral CapsulePSN8cd22728-34b4-4e55-8339-580138fe46d84
197313acyclovir 800 MG Oral TabletPSN8cd22728-34b4-4e55-8339-580138fe46d84
197310acyclovir 200 MG Oral CapsuleSCD8cd22728-34b4-4e55-8339-580138fe46d84
197313acyclovir 800 MG Oral TabletSCD8cd22728-34b4-4e55-8339-580138fe46d84
197310acycycloguanosine 200 MG Oral CapsuleSY8cd22728-34b4-4e55-8339-580138fe46d84
197313acycycloguanosine 800 MG Oral TabletSY8cd22728-34b4-4e55-8339-580138fe46d84

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62135-019-506213500195050 TABLET in 1 BOTTLE (62135-019-50) 50 tablet2022-07-010000-00-00NoNoCurrent