FDA.reportPublic FDA data

acyclovir

Product NDC
71335-1381
11-digit product format
713351381
Labeler code
71335
Product ID
71335-1381_ab6cd5b2-f2ba-43b6-99f5-aeedd8a8a069
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077309
Marketing category
ANDA
Marketing start
2006-03-13
Marketing end
2026-12-31
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
acyclovir

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1381-0acyclovir500 in 1 BOTTLETABLET5003
71335-1381-1acyclovir25 in 1 BOTTLETABLET253
71335-1381-2acyclovir35 in 1 BOTTLETABLET353
71335-1381-3acyclovir30 in 1 BOTTLETABLET303
71335-1381-4acyclovir60 in 1 BOTTLETABLET603
71335-1381-5acyclovir50 in 1 BOTTLETABLET503
71335-1381-6acyclovir10 in 1 BOTTLETABLET103
71335-1381-7acyclovir40 in 1 BOTTLETABLET403
71335-1381-8acyclovir21 in 1 BOTTLETABLET213
71335-1381-9acyclovir90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1381-0EA - Each71335-1381b6fbcdcf-fe80-4164-89c6-542715086c3e12020-09-14
71335-1381-1EA - Each71335-13811b6589da-f949-4377-9628-0e236da80d4b12020-09-14
71335-1381-2EA - Each71335-13818c7a3119-5bd4-4730-832b-093743e7769a12020-09-14
71335-1381-3EA - Each71335-138111151fb6-2ed9-4f9d-9831-cec118fc4f1f12020-09-14
71335-1381-4EA - Each71335-1381453f0077-4241-4523-a202-6fbebc16d4d812020-09-14
71335-1381-5EA - Each71335-1381dd51b8e8-313a-4c74-b306-2dfa3bb719fe12020-09-14
71335-1381-6EA - Each71335-138144fe4936-6139-4c8c-9734-229083fcebe112020-09-14
71335-1381-7EA - Each71335-1381f6e0a295-514c-4c50-990a-e4eceec1c1f812020-09-14
71335-1381-8EA - Each71335-138155c458af-f088-4398-ab8b-0e1d37a0b0de12020-09-14
71335-1381-9EA - Each71335-13817a202e1d-9837-4536-a047-fac665ccf7bb12020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1381ACYCLOVIR TABLET [BRYANT RANCH PREPACK]3Current NDC, Legacy NDC, 10 package rows20240725_db35fce0-d7a3-4589-ba60-d78cdb1119cb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197313acyclovir 800 MG Oral TabletPSNdb35fce0-d7a3-4589-ba60-d78cdb1119cb3
197313acyclovir 800 MG Oral TabletSCDdb35fce0-d7a3-4589-ba60-d78cdb1119cb3
197313acycycloguanosine 800 MG Oral TabletSYdb35fce0-d7a3-4589-ba60-d78cdb1119cb3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1381-071335138100500 TABLET in 1 BOTTLE (71335-1381-0) 500 tablet2024-07-092026-12-31NoNoCurrent
71335-1381-17133513810125 TABLET in 1 BOTTLE (71335-1381-1) 25 tablet2024-07-092026-12-31NoNoCurrent
71335-1381-27133513810235 TABLET in 1 BOTTLE (71335-1381-2) 35 tablet2019-10-312026-12-31NoNoCurrent
71335-1381-37133513810330 TABLET in 1 BOTTLE (71335-1381-3) 30 tablet2019-10-282026-12-31NoNoCurrent
71335-1381-47133513810460 TABLET in 1 BOTTLE (71335-1381-4) 60 tablet2024-07-092026-12-31NoNoCurrent
71335-1381-57133513810550 TABLET in 1 BOTTLE (71335-1381-5) 50 tablet2024-07-092026-12-31NoNoCurrent
71335-1381-67133513810610 TABLET in 1 BOTTLE (71335-1381-6) 10 tablet2024-07-092026-12-31NoNoCurrent
71335-1381-77133513810740 TABLET in 1 BOTTLE (71335-1381-7) 40 tablet2024-07-092026-12-31NoNoCurrent
71335-1381-87133513810821 TABLET in 1 BOTTLE (71335-1381-8) 21 tablet2020-05-192026-12-31NoNoCurrent
71335-1381-97133513810990 TABLET in 1 BOTTLE (71335-1381-9) 90 tablet2024-07-092026-12-31NoNoCurrent