FDA.reportPublic FDA data

Acyclovir

Product NDC
71335-1222
11-digit product format
713351222
Labeler code
71335
Product ID
71335-1222_af2a25d9-8333-4f9e-8ff8-36562f8d654f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA210401
Marketing category
ANDA
Marketing start
2018-05-04
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
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
ACYCLOVIR800 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX4HES1O11F
Rxcui197313

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
71335-1222-02024-05-20C16284748780-11030e365-5037-111a-e063-dadaa90a10e2ACYCLOVIR-acyclovir capsule ACYCLOVIR-acyclovir tablet Yiling pharmaceutical Ltd --------------- ACYCLOVIR CAPSULES, USP 200 mg ACYCLOVIR TABLETS, USP 400 mg and 800 mg
71335-1222-12024-05-20C16284748780-11030e365-5037-111a-e063-dadaa90a10e2ACYCLOVIR-acyclovir capsule ACYCLOVIR-acyclovir tablet Yiling pharmaceutical Ltd --------------- ACYCLOVIR CAPSULES, USP 200 mg ACYCLOVIR TABLETS, USP 400 mg and 800 mg
71335-1222-22024-05-20C16284748780-11030e365-5037-111a-e063-dadaa90a10e2ACYCLOVIR-acyclovir capsule ACYCLOVIR-acyclovir tablet Yiling pharmaceutical Ltd --------------- ACYCLOVIR CAPSULES, USP 200 mg ACYCLOVIR TABLETS, USP 400 mg and 800 mg
71335-1222-32024-05-20C16284748780-11030e365-5037-111a-e063-dadaa90a10e2ACYCLOVIR-acyclovir capsule ACYCLOVIR-acyclovir tablet Yiling pharmaceutical Ltd --------------- ACYCLOVIR CAPSULES, USP 200 mg ACYCLOVIR TABLETS, USP 400 mg and 800 mg
71335-1222-42024-05-20C16284748780-11030e365-5037-111a-e063-dadaa90a10e2ACYCLOVIR-acyclovir capsule ACYCLOVIR-acyclovir tablet Yiling pharmaceutical Ltd --------------- ACYCLOVIR CAPSULES, USP 200 mg ACYCLOVIR TABLETS, USP 400 mg and 800 mg
71335-1222-52024-05-20C16284748780-11030e365-5037-111a-e063-dadaa90a10e2ACYCLOVIR-acyclovir capsule ACYCLOVIR-acyclovir tablet Yiling pharmaceutical Ltd --------------- ACYCLOVIR CAPSULES, USP 200 mg ACYCLOVIR TABLETS, USP 400 mg and 800 mg
71335-1222-62024-05-20C16284748780-11030e365-5037-111a-e063-dadaa90a10e2ACYCLOVIR-acyclovir capsule ACYCLOVIR-acyclovir tablet Yiling pharmaceutical Ltd --------------- ACYCLOVIR CAPSULES, USP 200 mg ACYCLOVIR TABLETS, USP 400 mg and 800 mg
71335-1222-72024-05-20C16284748780-11030e365-5037-111a-e063-dadaa90a10e2ACYCLOVIR-acyclovir capsule ACYCLOVIR-acyclovir tablet Yiling pharmaceutical Ltd --------------- ACYCLOVIR CAPSULES, USP 200 mg ACYCLOVIR TABLETS, USP 400 mg and 800 mg
71335-1222-82024-05-20C16284748780-11030e365-5037-111a-e063-dadaa90a10e2ACYCLOVIR-acyclovir capsule ACYCLOVIR-acyclovir tablet Yiling pharmaceutical Ltd --------------- ACYCLOVIR CAPSULES, USP 200 mg ACYCLOVIR TABLETS, USP 400 mg and 800 mg
71335-1222-92024-05-20C16284748780-11030e365-5037-111a-e063-dadaa90a10e2ACYCLOVIR-acyclovir capsule ACYCLOVIR-acyclovir tablet Yiling pharmaceutical Ltd --------------- ACYCLOVIR CAPSULES, USP 200 mg ACYCLOVIR TABLETS, USP 400 mg and 800 mg
71335-1222-02024-01-30C16284748780-11030e365-5037-111a-e063-dadaa90a10e2ACYCLOVIR-acyclovir capsule ACYCLOVIR-acyclovir tablet Yiling pharmaceutical Ltd --------------- ACYCLOVIR CAPSULES, USP 200 mg ACYCLOVIR TABLETS, USP 400 mg and 800 mg
71335-1222-12024-01-30C16284748780-11030e365-5037-111a-e063-dadaa90a10e2ACYCLOVIR-acyclovir capsule ACYCLOVIR-acyclovir tablet Yiling pharmaceutical Ltd --------------- ACYCLOVIR CAPSULES, USP 200 mg ACYCLOVIR TABLETS, USP 400 mg and 800 mg
71335-1222-22024-01-30C16284748780-11030e365-5037-111a-e063-dadaa90a10e2ACYCLOVIR-acyclovir capsule ACYCLOVIR-acyclovir tablet Yiling pharmaceutical Ltd --------------- ACYCLOVIR CAPSULES, USP 200 mg ACYCLOVIR TABLETS, USP 400 mg and 800 mg
71335-1222-32024-01-30C16284748780-11030e365-5037-111a-e063-dadaa90a10e2ACYCLOVIR-acyclovir capsule ACYCLOVIR-acyclovir tablet Yiling pharmaceutical Ltd --------------- ACYCLOVIR CAPSULES, USP 200 mg ACYCLOVIR TABLETS, USP 400 mg and 800 mg
71335-1222-42024-01-30C16284748780-11030e365-5037-111a-e063-dadaa90a10e2ACYCLOVIR-acyclovir capsule ACYCLOVIR-acyclovir tablet Yiling pharmaceutical Ltd --------------- ACYCLOVIR CAPSULES, USP 200 mg ACYCLOVIR TABLETS, USP 400 mg and 800 mg
71335-1222-52024-01-30C16284748780-11030e365-5037-111a-e063-dadaa90a10e2ACYCLOVIR-acyclovir capsule ACYCLOVIR-acyclovir tablet Yiling pharmaceutical Ltd --------------- ACYCLOVIR CAPSULES, USP 200 mg ACYCLOVIR TABLETS, USP 400 mg and 800 mg
71335-1222-62024-01-30C16284748780-11030e365-5037-111a-e063-dadaa90a10e2ACYCLOVIR-acyclovir capsule ACYCLOVIR-acyclovir tablet Yiling pharmaceutical Ltd --------------- ACYCLOVIR CAPSULES, USP 200 mg ACYCLOVIR TABLETS, USP 400 mg and 800 mg
71335-1222-72024-01-30C16284748780-11030e365-5037-111a-e063-dadaa90a10e2ACYCLOVIR-acyclovir capsule ACYCLOVIR-acyclovir tablet Yiling pharmaceutical Ltd --------------- ACYCLOVIR CAPSULES, USP 200 mg ACYCLOVIR TABLETS, USP 400 mg and 800 mg
71335-1222-82024-01-30C16284748780-11030e365-5037-111a-e063-dadaa90a10e2ACYCLOVIR-acyclovir capsule ACYCLOVIR-acyclovir tablet Yiling pharmaceutical Ltd --------------- ACYCLOVIR CAPSULES, USP 200 mg ACYCLOVIR TABLETS, USP 400 mg and 800 mg
71335-1222-92024-01-30C16284748780-11030e365-5037-111a-e063-dadaa90a10e2ACYCLOVIR-acyclovir capsule ACYCLOVIR-acyclovir tablet Yiling pharmaceutical Ltd --------------- ACYCLOVIR CAPSULES, USP 200 mg ACYCLOVIR TABLETS, USP 400 mg and 800 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1222-0Acyclovir500 in 1 BOTTLETABLET5006
71335-1222-1Acyclovir25 in 1 BOTTLETABLET256
71335-1222-2Acyclovir35 in 1 BOTTLETABLET356
71335-1222-3Acyclovir30 in 1 BOTTLETABLET306
71335-1222-4Acyclovir60 in 1 BOTTLETABLET606
71335-1222-5Acyclovir50 in 1 BOTTLETABLET506
71335-1222-6Acyclovir10 in 1 BOTTLETABLET106
71335-1222-7Acyclovir40 in 1 BOTTLETABLET406
71335-1222-8Acyclovir21 in 1 BOTTLETABLET216
71335-1222-9Acyclovir90 in 1 BOTTLETABLET906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1222ACYCLOVIR TABLET [BRYANT RANCH PREPACK]6Current NDC, Legacy NDC, 10 package rows20250224_8d171c3d-de39-4f82-bacb-3e8d71b16540.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197313acyclovir 800 MG Oral TabletPSN8d171c3d-de39-4f82-bacb-3e8d71b165406
197313acyclovir 800 MG Oral TabletSCD8d171c3d-de39-4f82-bacb-3e8d71b165406
197313acycycloguanosine 800 MG Oral TabletSY8d171c3d-de39-4f82-bacb-3e8d71b165406

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1222-071335122200500 TABLET in 1 BOTTLE (71335-1222-0) 500 tablet2025-01-300000-00-00NoNoCurrent
71335-1222-17133512220125 TABLET in 1 BOTTLE (71335-1222-1) 25 tablet2019-06-070000-00-00NoNoCurrent
71335-1222-27133512220235 TABLET in 1 BOTTLE (71335-1222-2) 35 tablet2019-06-030000-00-00NoNoCurrent
71335-1222-37133512220330 TABLET in 1 BOTTLE (71335-1222-3) 30 tablet2019-05-130000-00-00NoNoCurrent
71335-1222-47133512220460 TABLET in 1 BOTTLE (71335-1222-4) 60 tablet2025-01-300000-00-00NoNoCurrent
71335-1222-57133512220550 TABLET in 1 BOTTLE (71335-1222-5) 50 tablet2019-05-060000-00-00NoNoCurrent
71335-1222-67133512220610 TABLET in 1 BOTTLE (71335-1222-6) 10 tablet2025-01-300000-00-00NoNoCurrent
71335-1222-77133512220740 TABLET in 1 BOTTLE (71335-1222-7) 40 tablet2019-05-230000-00-00NoNoCurrent
71335-1222-87133512220821 TABLET in 1 BOTTLE (71335-1222-8) 21 tablet2025-01-300000-00-00NoNoCurrent
71335-1222-97133512220990 TABLET in 1 BOTTLE (71335-1222-9) 90 tablet2025-01-300000-00-00NoNoCurrent