FDA.reportPublic FDA data

ACYCLOVIR

Product NDC
23155-227
11-digit product format
231550227
Labeler code
23155
Product ID
23155-227_6e0a075f-822f-457d-8ccc-e63a16746d76
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ACYCLOVIR
Dosage form
TABLET
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA074891
Marketing category
ANDA
Marketing start
2013-08-08
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, 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
23155-227-01ACYCLOVIR100 in 1 BOTTLETABLET1005
23155-227-05ACYCLOVIR500 in 1 BOTTLETABLET5005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-227-01EA - Each23155-227ae1224bf-817b-426e-ae90-18891462db1b12013-11-04
23155-227-05EA - Each23155-227a5c8999b-2645-4747-a839-bd9d41246cf012013-11-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACYCLOVIRACTIVE INGREDIENTX4HES1O11FACYCLOVIR TABLET [HERITAGE PHARMACEUTICALS INC.]1
ACYCLOVIRACTIVE MOIETYX4HES1O11FACYCLOVIR TABLET [HERITAGE PHARMACEUTICALS INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACYCLOVIR TABLET [HERITAGE PHARMACEUTICALS INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACYCLOVIR TABLET [HERITAGE PHARMACEUTICALS INC.]1
POVIDONE K25INACTIVE INGREDIENTK0KQV10C35ACYCLOVIR TABLET [HERITAGE PHARMACEUTICALS INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ACYCLOVIR TABLET [HERITAGE PHARMACEUTICALS INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ACYCLOVIR TABLET [HERITAGE PHARMACEUTICALS INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-227ACYCLOVIR TABLET [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]5Current NDC, Legacy NDC, 2 package rows20230727_0de2f5c7-9e75-4bdf-9c28-e026cc6694b4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197311acyclovir 400 MG Oral TabletPSNc0e41bf9-e141-404e-9952-aeeb705958b4102
197311acyclovir 400 MG Oral TabletSCDc0e41bf9-e141-404e-9952-aeeb705958b4102
197311acycycloguanosine 400 MG Oral TabletSYc0e41bf9-e141-404e-9952-aeeb705958b4102
197311acyclovir 400 MG Oral TabletPSN331fe0bd-6bb2-4337-8faa-d0c82ff54dc76
197311acyclovir 400 MG Oral TabletSCD331fe0bd-6bb2-4337-8faa-d0c82ff54dc76
197311acycycloguanosine 400 MG Oral TabletSY331fe0bd-6bb2-4337-8faa-d0c82ff54dc76
197311acyclovir 400 MG Oral TabletPSN05f42300-2a06-45f1-a9b9-6e5c84ae58ec5
197311acyclovir 400 MG Oral TabletPSN0de2f5c7-9e75-4bdf-9c28-e026cc6694b45
197313acyclovir 800 MG Oral TabletPSN05f42300-2a06-45f1-a9b9-6e5c84ae58ec5
197313acyclovir 800 MG Oral TabletPSN0de2f5c7-9e75-4bdf-9c28-e026cc6694b45
197311acyclovir 400 MG Oral TabletSCD05f42300-2a06-45f1-a9b9-6e5c84ae58ec5
197311acyclovir 400 MG Oral TabletSCD0de2f5c7-9e75-4bdf-9c28-e026cc6694b45
197313acyclovir 800 MG Oral TabletSCD05f42300-2a06-45f1-a9b9-6e5c84ae58ec5
197313acyclovir 800 MG Oral TabletSCD0de2f5c7-9e75-4bdf-9c28-e026cc6694b45
197311acycycloguanosine 400 MG Oral TabletSY0de2f5c7-9e75-4bdf-9c28-e026cc6694b45
197311acycycloguanosine 400 MG Oral TabletSY05f42300-2a06-45f1-a9b9-6e5c84ae58ec5
197313acycycloguanosine 800 MG Oral TabletSY0de2f5c7-9e75-4bdf-9c28-e026cc6694b45
197313acycycloguanosine 800 MG Oral TabletSY05f42300-2a06-45f1-a9b9-6e5c84ae58ec5
197311acyclovir 400 MG Oral TabletPSNb1b999a9-11cc-d6e5-e053-2995a90a54783
197311acyclovir 400 MG Oral TabletSCDb1b999a9-11cc-d6e5-e053-2995a90a54783
197311acycycloguanosine 400 MG Oral TabletSYb1b999a9-11cc-d6e5-e053-2995a90a54783
197311acyclovir 400 MG Oral TabletPSN32aa3f42-23a1-4867-8228-e6e76cf9f1351
197313acyclovir 800 MG Oral TabletPSN32aa3f42-23a1-4867-8228-e6e76cf9f1351
197311acyclovir 400 MG Oral TabletSCD32aa3f42-23a1-4867-8228-e6e76cf9f1351
197313acyclovir 800 MG Oral TabletSCD32aa3f42-23a1-4867-8228-e6e76cf9f1351
197311acycycloguanosine 400 MG Oral TabletSY32aa3f42-23a1-4867-8228-e6e76cf9f1351
197313acycycloguanosine 800 MG Oral TabletSY32aa3f42-23a1-4867-8228-e6e76cf9f1351

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
23155-227-0123155022701100 TABLET in 1 BOTTLE (23155-227-01) 100 tablet2013-08-080000-00-00NoNoCurrent
23155-227-0523155022705500 TABLET in 1 BOTTLE (23155-227-05) 500 tablet2013-08-080000-00-00NoNoCurrent