FDA.reportPublic FDA data

Acyclovir

Product NDC
33261-491
11-digit product format
332610491
Labeler code
33261
Product ID
33261-491_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
1997-04-23
Marketing end
0000-00-00
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
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
33261-491-212020-01-31C16284748780-19d75b9d0-2ec9-f424-e053-dadaa90a57ceACYCLOVIR CAPSULES USP ACYCLOVIR TABLETS USP 8940 8943 8947 Rx only
33261-491-252020-01-31C16284748780-19d75b9d0-2ec9-f424-e053-dadaa90a57ceACYCLOVIR CAPSULES USP ACYCLOVIR TABLETS USP 8940 8943 8947 Rx only
33261-491-282020-01-31C16284748780-19d75b9d0-2ec9-f424-e053-dadaa90a57ceACYCLOVIR CAPSULES USP ACYCLOVIR TABLETS USP 8940 8943 8947 Rx only
33261-491-302020-01-31C16284748780-19d75b9d0-2ec9-f424-e053-dadaa90a57ceACYCLOVIR CAPSULES USP ACYCLOVIR TABLETS USP 8940 8943 8947 Rx only
33261-491-602020-01-31C16284748780-19d75b9d0-2ec9-f424-e053-dadaa90a57ceACYCLOVIR CAPSULES USP ACYCLOVIR TABLETS USP 8940 8943 8947 Rx only
33261-491-902020-01-31C16284748780-19d75b9d0-2ec9-f424-e053-dadaa90a57ceACYCLOVIR CAPSULES USP ACYCLOVIR TABLETS USP 8940 8943 8947 Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-491-21Acyclovir21 in 1 BOTTLETABLET213
33261-491-25Acyclovir25 in 1 BLISTER PACKTABLET253
33261-491-28Acyclovir28 in 1 BOTTLETABLET283
33261-491-30Acyclovir30 in 1 BOTTLETABLET303
33261-491-60Acyclovir60 in 1 BOTTLETABLET603
33261-491-90Acyclovir90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-491-28EA - Each33261-4917a43c7c5-e456-4d32-bcfe-b443de85916212015-10-02
33261-491-30EA - Each33261-49109e6dbd6-100c-43e6-ac2f-0ef81e486ae212015-10-02
33261-491-60EA - Each33261-4915a680a4a-5df8-45cb-94f9-b7e0b522989012015-10-02
33261-491-90EA - Each33261-4913418d1c6-e483-412a-ada2-8c65176833e512015-10-02

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
33261-491ACYCLOVIR CAPSULE ACYCLOVIR TABLET [AIDAREX PHARMACEUTICALS LLC]3Legacy NDC, 6 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
33261-491-213326104912121 in 1 BOTTLEHistorical
33261-491-253326104912525 in 1 BLISTER PACKHistorical
33261-491-283326104912828 in 1 BOTTLEHistorical
33261-491-303326104913030 in 1 BOTTLEHistorical
33261-491-603326104916060 in 1 BOTTLEHistorical
33261-491-903326104919090 in 1 BOTTLEHistorical