FDA.reportPublic FDA data

Acyclovir

Product NDC
72162-1735
11-digit product format
721621735
Labeler code
72162
Product ID
72162-1735_8c615600-bebe-4c68-8803-8100d5260676
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075382
Marketing category
ANDA
Marketing start
2009-10-22
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
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
ACYCLOVIR400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX4HES1O11F
Rxcui197311

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
72162-1735-1Acyclovir120 in 1 BOTTLE, PLASTICTABLET120102
72162-1735-2Acyclovir20 in 1 BOTTLE, PLASTICTABLET20102
72162-1735-3Acyclovir30 in 1 BOTTLE, PLASTICTABLET30102
72162-1735-4Acyclovir28 in 1 BOTTLE, PLASTICTABLET28102
72162-1735-5Acyclovir10 in 1 BOTTLE, PLASTICTABLET10102
72162-1735-6Acyclovir60 in 1 BOTTLE, PLASTICTABLET60102
72162-1735-7Acyclovir50 in 1 BOTTLE, PLASTICTABLET50102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1735-1EA - Each72162-1735bf807b4a-bf13-47b0-92f0-62c6bc84e4db12023-10-16
72162-1735-2EA - Each72162-1735999a483e-5326-4ee8-87e6-8fd123c683a912023-10-16
72162-1735-3EA - Each72162-173538ad4994-e407-46b8-9f2b-ed6e1e7914bc12023-10-16
72162-1735-4EA - Each72162-173560b855ee-7970-4008-a5fb-103c4ae7ea3a12023-10-16
72162-1735-5EA - Each72162-173544fa26cf-3c82-408f-a845-49cec7cb696a12023-10-16
72162-1735-6EA - Each72162-1735b231becf-f4b5-4705-8b28-6f8972065e5c12023-10-16
72162-1735-7EA - Each72162-1735a8a2b11d-7516-4dab-bb64-cf00cb211cf712023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1735ACYCLOVIR TABLET [BRYANT RANCH PREPACK]102Current NDC, 7 package rows20240919_f09cdb3f-dfd2-4e47-bb5e-a5d26d8bcc89.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197311acyclovir 400 MG Oral TabletPSNf09cdb3f-dfd2-4e47-bb5e-a5d26d8bcc89102
197311acyclovir 400 MG Oral TabletSCDf09cdb3f-dfd2-4e47-bb5e-a5d26d8bcc89102
197311acycycloguanosine 400 MG Oral TabletSYf09cdb3f-dfd2-4e47-bb5e-a5d26d8bcc89102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-1735-172162173501120 TABLET in 1 BOTTLE, PLASTIC (72162-1735-1) 120 tablet2024-09-06NoNoHistorical
72162-1735-27216217350220 TABLET in 1 BOTTLE, PLASTIC (72162-1735-2) 20 tablet2024-09-06NoNoHistorical
72162-1735-37216217350330 TABLET in 1 BOTTLE, PLASTIC (72162-1735-3) 30 tablet2024-08-15NoNoHistorical
72162-1735-47216217350428 TABLET in 1 BOTTLE, PLASTIC (72162-1735-4) 28 tablet2024-09-06NoNoHistorical
72162-1735-57216217350510 TABLET in 1 BOTTLE, PLASTIC (72162-1735-5) 10 tablet2024-09-06NoNoHistorical
72162-1735-67216217350660 TABLET in 1 BOTTLE, PLASTIC (72162-1735-6) 60 tablet2024-09-06NoNoHistorical
72162-1735-77216217350750 TABLET in 1 BOTTLE, PLASTIC (72162-1735-7) 50 tablet2024-09-06NoNoHistorical