FDA.reportPublic FDA data

Acyclovir

Product NDC
69076-146
11-digit product format
690760146
Labeler code
69076
Product ID
69076-146_f03d714d-ed3a-60fc-e053-2995a90a3153
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
CAPSULE
Route
ORAL
Labeler
Quinn Pharmaceuticals
Application
ANDA075090
Marketing category
ANDA
Marketing start
2021-05-27
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
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
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
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
69076-146-01Acyclovir100 in 1 BOTTLECAPSULE1007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69076-146-01EA - Each69076-146f15830c4-4385-4048-9629-f9a162d0f7e212015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AcyclovirACTIVE INGREDIENTX4HES1O11FACYCLOVIR CAPSULE [QUINN PHARMACEUTICALS, LLC]1
AcyclovirACTIVE MOIETYX4HES1O11FACYCLOVIR CAPSULE [QUINN PHARMACEUTICALS, LLC]1
Lactose MonohydrateINACTIVE INGREDIENTEWQ57Q8I5XACYCLOVIR CAPSULE [QUINN PHARMACEUTICALS, LLC]1
Magnesium StearateINACTIVE INGREDIENT70097M6I30ACYCLOVIR CAPSULE [QUINN PHARMACEUTICALS, LLC]1
Sodium Lauryl SulfateINACTIVE INGREDIENT368GB5141JACYCLOVIR CAPSULE [QUINN PHARMACEUTICALS, LLC]1
Sodium Starch Glycolate Type A PotatoINACTIVE INGREDIENT5856J3G2A2ACYCLOVIR CAPSULE [QUINN PHARMACEUTICALS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69076-146ACYCLOVIR CAPSULE [QUINN PHARMACEUTICALS]7Current NDC, Legacy NDC, 1 package rows20221221_9ad711e4-003d-4b58-8177-32928bc42aa9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197310acyclovir 200 MG Oral CapsulePSNe8433261-07f1-448b-aaf4-631414598c08100
197310acyclovir 200 MG Oral CapsuleSCDe8433261-07f1-448b-aaf4-631414598c08100
197310acycycloguanosine 200 MG Oral CapsuleSYe8433261-07f1-448b-aaf4-631414598c08100
197310acyclovir 200 MG Oral CapsulePSNf87c2c1e-568f-49e1-979e-fce80086fe0811
197310acyclovir 200 MG Oral CapsuleSCDf87c2c1e-568f-49e1-979e-fce80086fe0811
197310acycycloguanosine 200 MG Oral CapsuleSYf87c2c1e-568f-49e1-979e-fce80086fe0811
197310acyclovir 200 MG Oral CapsulePSN9ad711e4-003d-4b58-8177-32928bc42aa97
197310acyclovir 200 MG Oral CapsuleSCD9ad711e4-003d-4b58-8177-32928bc42aa97
197310acycycloguanosine 200 MG Oral CapsuleSY9ad711e4-003d-4b58-8177-32928bc42aa97
197310acyclovir 200 MG Oral CapsulePSN6e813b35-4ead-42d6-bc51-9d7caf1db1ef5
197310acyclovir 200 MG Oral CapsulePSN57eab132-77fc-4282-e053-2a91aa0a23275
197310acyclovir 200 MG Oral CapsuleSCD6e813b35-4ead-42d6-bc51-9d7caf1db1ef5
197310acyclovir 200 MG Oral CapsuleSCD57eab132-77fc-4282-e053-2a91aa0a23275
197310acycycloguanosine 200 MG Oral CapsuleSY6e813b35-4ead-42d6-bc51-9d7caf1db1ef5
197310acycycloguanosine 200 MG Oral CapsuleSY57eab132-77fc-4282-e053-2a91aa0a23275
197310acyclovir 200 MG Oral CapsulePSN6714cfd9-97d3-4290-b618-54594d89cf4e3
197310acyclovir 200 MG Oral CapsuleSCD6714cfd9-97d3-4290-b618-54594d89cf4e3
197310acycycloguanosine 200 MG Oral CapsuleSY6714cfd9-97d3-4290-b618-54594d89cf4e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69076-146-0169076014601100 CAPSULE in 1 BOTTLE (69076-146-01) 100 capsule2021-05-270000-00-00NoNoCurrent