Acyclovir

Product NDC
33261-227
11-digit product format
332610227
Labeler code
33261
Product ID
33261-227_7a30fb41-2a84-4afb-a155-46dba2cfb76a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA074556
Marketing category
ANDA
Marketing start
1997-04-30
Marketing end
0000-00-00
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
2019-12-31
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
33261-227-16Acyclovir16 in 1 BOTTLETABLET163
33261-227-30Acyclovir30 in 1 BOTTLETABLET303
33261-227-35Acyclovir35 in 1 BOTTLETABLET353
33261-227-40Acyclovir40 in 1 BOTTLETABLET403

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-227-16EA - Each33261-227ec5730fa-bd12-4211-abda-a7f37201ad2812015-10-02
33261-227-30EA - Each33261-227ac0aa71d-29ca-4e61-bf60-21d2f366cf4512015-10-02
33261-227-35EA - Each33261-2276ae08737-2b87-469c-95d7-4789951ed76b12015-10-02
33261-227-40EA - Each33261-2275f800923-bd5d-4255-9965-5979accb286012015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACYCLOVIRACTIVE INGREDIENTX4HES1O11FACYCLOVIR CAPSULE ACYCLOVIR TABLET [AIDAREX PHARMACEUTICALS LLC]3
ACYCLOVIRACTIVE MOIETYX4HES1O11FACYCLOVIR CAPSULE ACYCLOVIR TABLET [AIDAREX PHARMACEUTICALS LLC]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACYCLOVIR CAPSULE ACYCLOVIR TABLET [AIDAREX PHARMACEUTICALS LLC]3
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHACYCLOVIR CAPSULE ACYCLOVIR TABLET [AIDAREX PHARMACEUTICALS LLC]3
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LACYCLOVIR CAPSULE ACYCLOVIR TABLET [AIDAREX PHARMACEUTICALS LLC]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GACYCLOVIR CAPSULE ACYCLOVIR TABLET [AIDAREX PHARMACEUTICALS LLC]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDACYCLOVIR CAPSULE ACYCLOVIR TABLET [AIDAREX PHARMACEUTICALS LLC]3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKACYCLOVIR CAPSULE ACYCLOVIR TABLET [AIDAREX PHARMACEUTICALS LLC]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAACYCLOVIR CAPSULE ACYCLOVIR TABLET [AIDAREX PHARMACEUTICALS LLC]3
GELATININACTIVE INGREDIENT2G86QN327LACYCLOVIR CAPSULE ACYCLOVIR TABLET [AIDAREX PHARMACEUTICALS LLC]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XACYCLOVIR CAPSULE ACYCLOVIR TABLET [AIDAREX PHARMACEUTICALS LLC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACYCLOVIR CAPSULE ACYCLOVIR TABLET [AIDAREX PHARMACEUTICALS LLC]3
POVIDONESINACTIVE INGREDIENTFZ989GH94EACYCLOVIR CAPSULE ACYCLOVIR TABLET [AIDAREX PHARMACEUTICALS LLC]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ACYCLOVIR CAPSULE ACYCLOVIR TABLET [AIDAREX PHARMACEUTICALS LLC]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JACYCLOVIR CAPSULE ACYCLOVIR TABLET [AIDAREX PHARMACEUTICALS LLC]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ACYCLOVIR CAPSULE ACYCLOVIR TABLET [AIDAREX PHARMACEUTICALS LLC]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJACYCLOVIR CAPSULE ACYCLOVIR TABLET [AIDAREX PHARMACEUTICALS LLC]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPACYCLOVIR CAPSULE ACYCLOVIR TABLET [AIDAREX PHARMACEUTICALS LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-227ACYCLOVIR CAPSULE ACYCLOVIR TABLET [AIDAREX PHARMACEUTICALS LLC]3Legacy NDC, 4 package rows20120913_68227df2-cac6-4799-8dcd-8c2f42204315.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197310acyclovir 200 MG Oral CapsulePSN68227df2-cac6-4799-8dcd-8c2f422043153
197311acyclovir 400 MG Oral TabletPSN68227df2-cac6-4799-8dcd-8c2f422043153
197313acyclovir 800 MG Oral TabletPSN68227df2-cac6-4799-8dcd-8c2f422043153
197310acyclovir 200 MG Oral CapsuleSCD68227df2-cac6-4799-8dcd-8c2f422043153
197311acyclovir 400 MG Oral TabletSCD68227df2-cac6-4799-8dcd-8c2f422043153
197313acyclovir 800 MG Oral TabletSCD68227df2-cac6-4799-8dcd-8c2f422043153
197310acycycloguanosine 200 MG Oral CapsuleSY68227df2-cac6-4799-8dcd-8c2f422043153
197311acycycloguanosine 400 MG Oral TabletSY68227df2-cac6-4799-8dcd-8c2f422043153
197313acycycloguanosine 800 MG Oral TabletSY68227df2-cac6-4799-8dcd-8c2f422043153

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-227-163326102271616 in 1 BOTTLEHistorical
33261-227-303326102273030 in 1 BOTTLEHistorical
33261-227-353326102273535 in 1 BOTTLEHistorical
33261-227-403326102274040 in 1 BOTTLEHistorical