FDA.reportPublic FDA data

ACYCLOVIR

Product NDC
60505-0042
11-digit product format
605050042
Labeler code
60505
Product ID
60505-0042_ca931d58-7d38-8516-2997-f61253819cb9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ACYCLOVIR
Dosage form
CAPSULE
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA075677
Marketing category
ANDA
Marketing start
2006-03-20
Marketing end
2027-04-30
Substance
ACYCLOVIR
Active strength
200 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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ACYCLOVIR

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACYCLOVIR200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX4HES1O11F
Rxcui197310

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
33190c02-82e1-0a4d-d716-9ccd23588463Product name520250225
c367d1da-5a72-8966-6d11-1eb9a73ae758Product name320231115
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
5518bf13-db2f-2e9c-3679-e70ecf03752cProduct name920210614
27897900-0e40-497b-97e1-88057e68fe6cProduct name420200710
ca834e59-e669-229c-9288-0ccb76dc373eProduct name920200220
d7f95c49-d3e1-4bbc-a389-e9cd73f59a28Product name120190702
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
fb15b394-3715-4c87-a447-421489aa8739Product name320170727
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60505-0042-5ACYCLOVIR500 in 1 BOTTLECAPSULE5008
60505-0042-6ACYCLOVIR100 in 1 BOTTLECAPSULE1008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-0042-6EA - Each60505-0042acc06317-f0ea-434e-8d73-02361df4747312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACYCLOVIRACTIVE INGREDIENTX4HES1O11FACYCLOVIR CAPSULE [APOTEX CORP.]2
ACYCLOVIRACTIVE MOIETYX4HES1O11FACYCLOVIR CAPSULE [APOTEX CORP.]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MACYCLOVIR CAPSULE [APOTEX CORP.]2
AMMONIAINACTIVE INGREDIENT5138Q19F1XACYCLOVIR CAPSULE [APOTEX CORP.]2
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3ACYCLOVIR CAPSULE [APOTEX CORP.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACYCLOVIR CAPSULE [APOTEX CORP.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ACYCLOVIR CAPSULE [APOTEX CORP.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDACYCLOVIR CAPSULE [APOTEX CORP.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ACYCLOVIR CAPSULE [APOTEX CORP.]2
GELATININACTIVE INGREDIENT2G86QN327LACYCLOVIR CAPSULE [APOTEX CORP.]2
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302ACYCLOVIR CAPSULE [APOTEX CORP.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACYCLOVIR CAPSULE [APOTEX CORP.]2
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TACYCLOVIR CAPSULE [APOTEX CORP.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ACYCLOVIR CAPSULE [APOTEX CORP.]2
SHELLACINACTIVE INGREDIENT46N107B71OACYCLOVIR CAPSULE [APOTEX CORP.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ACYCLOVIR CAPSULE [APOTEX CORP.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPACYCLOVIR CAPSULE [APOTEX CORP.]2
ACYCLOVIRACTIVE INGREDIENTX4HES1O11FACYCLOVIR CAPSULE [MAJOR PHARMACEUTICALS]1
ACYCLOVIRACTIVE MOIETYX4HES1O11FACYCLOVIR CAPSULE [MAJOR PHARMACEUTICALS]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MACYCLOVIR CAPSULE [MAJOR PHARMACEUTICALS]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XACYCLOVIR CAPSULE [MAJOR PHARMACEUTICALS]1
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3ACYCLOVIR CAPSULE [MAJOR PHARMACEUTICALS]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACYCLOVIR CAPSULE [MAJOR PHARMACEUTICALS]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ACYCLOVIR CAPSULE [MAJOR PHARMACEUTICALS]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDACYCLOVIR CAPSULE [MAJOR PHARMACEUTICALS]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ACYCLOVIR CAPSULE [MAJOR PHARMACEUTICALS]1
GELATININACTIVE INGREDIENT2G86QN327LACYCLOVIR CAPSULE [MAJOR PHARMACEUTICALS]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302ACYCLOVIR CAPSULE [MAJOR PHARMACEUTICALS]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACYCLOVIR CAPSULE [MAJOR PHARMACEUTICALS]1
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TACYCLOVIR CAPSULE [MAJOR PHARMACEUTICALS]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ACYCLOVIR CAPSULE [MAJOR PHARMACEUTICALS]1
SHELLACINACTIVE INGREDIENT46N107B71OACYCLOVIR CAPSULE [MAJOR PHARMACEUTICALS]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ACYCLOVIR CAPSULE [MAJOR PHARMACEUTICALS]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPACYCLOVIR CAPSULE [MAJOR PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-0042ACYCLOVIR CAPSULE [APOTEX CORP.]7Current NDC, Legacy NDC, 2 package rows20240516_41bea43a-f58c-2c6f-4d31-406ceb456077.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197310acyclovir 200 MG Oral CapsulePSNe5356160-cb35-4ff6-91d5-2ade594e0279102
197310acyclovir 200 MG Oral CapsuleSCDe5356160-cb35-4ff6-91d5-2ade594e0279102
197310acycycloguanosine 200 MG Oral CapsuleSYe5356160-cb35-4ff6-91d5-2ade594e0279102
197310acyclovir 200 MG Oral CapsulePSN0fbc0612-0249-481d-8198-0e810423f8759
197310acyclovir 200 MG Oral CapsulePSN864d96b9-e2de-45a8-850b-6f7b72ceefe19
197310acyclovir 200 MG Oral CapsuleSCD0fbc0612-0249-481d-8198-0e810423f8759
197310acyclovir 200 MG Oral CapsuleSCD864d96b9-e2de-45a8-850b-6f7b72ceefe19
197310acycycloguanosine 200 MG Oral CapsuleSY0fbc0612-0249-481d-8198-0e810423f8759
197310acycycloguanosine 200 MG Oral CapsuleSY864d96b9-e2de-45a8-850b-6f7b72ceefe19
197310acyclovir 200 MG Oral CapsulePSN41bea43a-f58c-2c6f-4d31-406ceb4560778
197310acyclovir 200 MG Oral CapsuleSCD41bea43a-f58c-2c6f-4d31-406ceb4560778
197310acycycloguanosine 200 MG Oral CapsuleSY41bea43a-f58c-2c6f-4d31-406ceb4560778
197310acyclovir 200 MG Oral CapsulePSN2b600b5d-ce91-461f-b9d1-75b969daf8e97
197310acyclovir 200 MG Oral CapsuleSCD2b600b5d-ce91-461f-b9d1-75b969daf8e97
197310acycycloguanosine 200 MG Oral CapsuleSY2b600b5d-ce91-461f-b9d1-75b969daf8e97
197310acyclovir 200 MG Oral CapsulePSN7ee2d439-e78d-42ac-b93e-aa5e2656fb825
197310acyclovir 200 MG Oral CapsulePSN4e8f535c-057d-0ddf-e054-00144ff8d46c5
197310acyclovir 200 MG Oral CapsuleSCD7ee2d439-e78d-42ac-b93e-aa5e2656fb825
197310acyclovir 200 MG Oral CapsuleSCD4e8f535c-057d-0ddf-e054-00144ff8d46c5
197310acycycloguanosine 200 MG Oral CapsuleSY7ee2d439-e78d-42ac-b93e-aa5e2656fb825
197310acycycloguanosine 200 MG Oral CapsuleSY4e8f535c-057d-0ddf-e054-00144ff8d46c5
197310acyclovir 200 MG Oral CapsulePSN8d7994a6-5bd2-494d-89c1-b03755d4f2c33
197310acyclovir 200 MG Oral CapsuleSCD8d7994a6-5bd2-494d-89c1-b03755d4f2c33
197310acycycloguanosine 200 MG Oral CapsuleSY8d7994a6-5bd2-494d-89c1-b03755d4f2c33
197310acyclovir 200 MG Oral CapsulePSN8e6e3ffb-a884-ec6b-e053-2a95a90a6dda1
197310acyclovir 200 MG Oral CapsuleSCD8e6e3ffb-a884-ec6b-e053-2a95a90a6dda1
197310acycycloguanosine 200 MG Oral CapsuleSY8e6e3ffb-a884-ec6b-e053-2a95a90a6dda1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60505-0042-560505004205500 CAPSULE in 1 BOTTLE (60505-0042-5) 500 capsule2006-03-200000-00-00NoNoCurrent
60505-0042-660505004206100 CAPSULE in 1 BOTTLE (60505-0042-6) 100 capsule2006-03-202027-04-30NoNoCurrent