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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077309-001ACYCLOVIRACYCLOVIR400MGTABLET / ORALAB2005-09-29
A077309-002ACYCLOVIRACYCLOVIR800MGTABLET / ORALAB2005-09-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A077309-001AB
A077309-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A077309-001ACYCLOVIR400MGTABLET / ORALAB2005-09-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077309-002ACYCLOVIR800MGTABLET / ORALAB2005-09-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077309-001ACYCLOVIR400MGTABLET / ORALAB2005-09-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077309-002ACYCLOVIR800MGTABLET / ORALAB2005-09-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A077309-001ACYCLOVIR400MGTABLET / ORALAB2005-09-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077309-002ACYCLOVIR800MGTABLET / ORALAB2005-09-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077309-001ACYCLOVIR400MGTABLET / ORALAB2005-09-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077309-002ACYCLOVIR800MGTABLET / ORALAB2005-09-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077309-001ACYCLOVIR400MGTABLET / ORALAB2005-09-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077309-002ACYCLOVIR800MGTABLET / ORALAB2005-09-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077309-001ACYCLOVIR400MGTABLET / ORALAB2005-09-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077309-002ACYCLOVIR800MGTABLET / ORALAB2005-09-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077309-001ACYCLOVIR400MGTABLET / ORALAB2005-09-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077309-002ACYCLOVIR800MGTABLET / ORALAB2005-09-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077309-001ACYCLOVIR400MGTABLET / ORALAB2005-09-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077309-002ACYCLOVIR800MGTABLET / ORALAB2005-09-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077309-001ACYCLOVIR400MGTABLET / ORALAB2005-09-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077309-002ACYCLOVIR800MGTABLET / ORALAB2005-09-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077309-001ACYCLOVIR400MGTABLET / ORALAB2005-09-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A077309-002ACYCLOVIR800MGTABLET / ORALAB2005-09-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077309-001ACYCLOVIR400MGTABLET / ORALAB2005-09-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077309-002ACYCLOVIR800MGTABLET / ORALAB2005-09-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077309-001ACYCLOVIR400MGTABLET / ORALAB2005-09-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077309-002ACYCLOVIR800MGTABLET / ORALAB2005-09-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077309-001ACYCLOVIR400MGTABLET / ORALAB2005-09-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077309-002ACYCLOVIR800MGTABLET / ORALAB2005-09-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077309-001ACYCLOVIR400MGTABLET / ORALAB2005-09-298072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077309-002ACYCLOVIR800MGTABLET / ORALAB2005-09-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077309-001ACYCLOVIR400MGTABLET / ORALAB2005-09-295c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077309-002ACYCLOVIR800MGTABLET / ORALAB2005-09-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077309-001ACYCLOVIR400MGTABLET / ORALAB2005-09-295d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077309-002ACYCLOVIR800MGTABLET / ORALAB2005-09-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077309-001ACYCLOVIR400MGTABLET / ORALAB2005-09-294b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077309-002ACYCLOVIR800MGTABLET / ORALAB2005-09-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077309-001ACYCLOVIR400MGTABLET / ORALAB2005-09-2974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077309-002ACYCLOVIR800MGTABLET / ORALAB2005-09-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077309-001ACYCLOVIR400MGTABLET / ORALAB2005-09-29bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077309-002ACYCLOVIR800MGTABLET / ORALAB2005-09-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077309-001ACYCLOVIR400MGTABLET / ORALAB2005-09-29782e0a99824c…
2021-12-28 21:50 UTC2021-12A077309-002ACYCLOVIR800MGTABLET / ORALAB2005-09-29782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A077309-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077309-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077309-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077309-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077309-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077309-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077309-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077309-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077309-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077309-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077309-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077309-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077309-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077309-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077309-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077309-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077309-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077309-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077309-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077309-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077309-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077309-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077309-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077309-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077309-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077309-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077309-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077309-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077309-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077309-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077309-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077309-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077309-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077309-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077309-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077309-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077309-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077309-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077309-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A077309-002AB1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
acyclovir

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACYCLOVIR800 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
X4HES1O11FInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197313Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
db35fce0-d7a3-4589-ba60-d78cdb1119cbAvailable on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
acyclovirACYCLOVIRREMEDYREPACK INC.499c6a98-0614-4ded-8526-909942bae8a42026-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077309
application number: ANDA077309
acyclovirACYCLOVIRBryant Ranch Prepackdb35fce0-d7a3-4589-ba60-d78cdb1119cb2026-06-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077309
application number: ANDA077309
ndc (product): 71335-1381
acyclovirACYCLOVIRApotex Corp.7fdeb609-24c4-5024-52c3-6a32bc7f3fcc2025-11-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077309
application number: ANDA077309
acyclovirACYCLOVIRBryant Ranch Prepacka7fd298b-3914-4316-8484-2d3ae188221a2024-08-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077309
application number: ANDA077309
acyclovirACYCLOVIRNuCare Pharmaceuticals,Inc.ada4004a-c10a-6190-e053-2a95a90a5e672024-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077309
application number: ANDA077309
acyclovirACYCLOVIRNuCare Pharmaceuticals,Inc.b2ae0432-bd2a-1480-e053-2a95a90a6fc82024-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077309
application number: ANDA077309
acyclovirACYCLOVIRNuCare Pharmaceuticals,Inc.968800dc-9456-a45f-e053-2995a90aa15e2024-06-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077309
application number: ANDA077309
acyclovirACYCLOVIRBryant Ranch Prepackbf1b4142-c5f3-4147-8224-bf63445666942024-05-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077309
application number: ANDA077309
acyclovirACYCLOVIRProficient Rx LP4c5a75fa-73db-4f48-895f-de1635d33f492021-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077309
application number: ANDA077309
acyclovirACYCLOVIRAsclemed USA, Inc.e186fdc9-b60e-4280-8d60-36cae9f2838f2020-09-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077309
application number: ANDA077309
acyclovirACYCLOVIRProficient Rx LP51052f0e-1a07-405a-a962-981ce9439e022020-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077309
application number: ANDA077309

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