FDA.reportPublic FDA data

ACYCLOVIR

Product NDC
71335-0470
11-digit product format
713350470
Labeler code
71335
Product ID
71335-0470_1848497f-16ba-4911-b27f-a4b5e645767f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ACYCLOVIR
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
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
fb15b394-3715-4c87-a447-421489aa8739Product name320170727
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0470-0ACYCLOVIR90 in 1 BOTTLECAPSULE907
71335-0470-1ACYCLOVIR30 in 1 BOTTLECAPSULE307
71335-0470-2ACYCLOVIR25 in 1 BOTTLECAPSULE257
71335-0470-3ACYCLOVIR35 in 1 BOTTLECAPSULE357
71335-0470-4ACYCLOVIR50 in 1 BOTTLECAPSULE507
71335-0470-5ACYCLOVIR100 in 1 BOTTLECAPSULE1007
71335-0470-6ACYCLOVIR40 in 1 BOTTLECAPSULE407
71335-0470-7ACYCLOVIR60 in 1 BOTTLECAPSULE607
71335-0470-8ACYCLOVIR120 in 1 BOTTLECAPSULE1207
71335-0470-9ACYCLOVIR20 in 1 BOTTLECAPSULE207

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0470-0EA - Each71335-0470396db216-f8fb-4728-9a66-a01562cf00e112018-03-08
71335-0470-1EA - Each71335-04709d7949fe-24e1-44b7-bc59-38d2e7fa9db012018-03-08
71335-0470-2EA - Each71335-0470f1531024-be45-4b30-8180-bf6a6708c28712018-03-08
71335-0470-3EA - Each71335-0470427cafdf-3820-4793-b5c1-d192935188ce12018-03-08
71335-0470-4EA - Each71335-04707969e50c-7b4d-4552-9e4e-f33cfd105a3212018-03-08
71335-0470-5EA - Each71335-047019422067-89be-4d09-980b-a557bbf191eb12018-03-08
71335-0470-6EA - Each71335-047061a672fa-eb0f-49a8-99b5-e4f8fbc4c0c212018-03-08
71335-0470-7EA - Each71335-047060576df0-3bad-4308-be6c-f21fe319aace12018-03-08
71335-0470-8EA - Each71335-0470fe810d25-6fff-4d04-b966-067a2769d8c412018-03-08
71335-0470-9EA - Each71335-04706a55335f-61a0-4d64-b6c7-9e26ee0987d312018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0470ACYCLOVIR CAPSULE [BRYANT RANCH PREPACK]6Current NDC, Legacy NDC, 10 package rows20240724_2b600b5d-ce91-461f-b9d1-75b969daf8e9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0470-07133504700090 CAPSULE in 1 BOTTLE (71335-0470-0) 90 capsule2024-07-092027-04-30NoNoCurrent
71335-0470-17133504700130 CAPSULE in 1 BOTTLE (71335-0470-1) 30 capsule2019-07-112027-04-30NoNoCurrent
71335-0470-27133504700225 CAPSULE in 1 BOTTLE (71335-0470-2) 25 capsule2018-03-282027-04-30NoNoCurrent
71335-0470-37133504700335 CAPSULE in 1 BOTTLE (71335-0470-3) 35 capsule2018-06-222027-04-30NoNoCurrent
71335-0470-47133504700450 CAPSULE in 1 BOTTLE (71335-0470-4) 50 capsule2024-07-092027-04-30NoNoCurrent
71335-0470-571335047005100 CAPSULE in 1 BOTTLE (71335-0470-5) 100 capsule2024-07-092027-04-30NoNoCurrent
71335-0470-67133504700640 CAPSULE in 1 BOTTLE (71335-0470-6) 40 capsule2024-07-092027-04-30NoNoCurrent
71335-0470-77133504700760 CAPSULE in 1 BOTTLE (71335-0470-7) 60 capsule2019-01-042027-04-30NoNoCurrent
71335-0470-871335047008120 CAPSULE in 1 BOTTLE (71335-0470-8) 120 capsule2024-07-092027-04-30NoNoCurrent
71335-0470-97133504700920 CAPSULE in 1 BOTTLE (71335-0470-9) 20 capsule2024-07-092027-04-30NoNoCurrent