Acyclovir

Product NDC
71335-1053
11-digit product format
713351053
Labeler code
71335
Product ID
71335-1053_93537a74-6bc3-4da2-865f-73752bf24e54
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075382
Marketing category
ANDA
Marketing start
2009-10-22
Substance
ACYCLOVIR
Active strength
400 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A075382-001ACYCLOVIRACYCLOVIR400MGTABLET / ORALAB1999-04-30
A075382-002ACYCLOVIRACYCLOVIR800MGTABLET / ORALAB1999-04-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075382-001AB
A075382-002AB

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 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-3084e616aacf4f…
2026-09-14 22:38:342026-08A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-3084e616aacf4f…
2026-08-18 06:07:402026-07A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-30caaa826d4ba7…
2026-08-18 06:07:402026-07A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-308072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-305c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-305d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-304b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-3074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-3074a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A075382-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A075382-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A075382-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075382-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075382-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075382-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075382-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075382-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075382-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075382-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075382-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075382-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075382-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075382-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075382-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075382-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075382-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075382-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075382-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075382-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075382-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075382-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075382-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075382-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075382-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075382-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075382-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075382-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075382-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075382-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075382-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075382-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075382-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075382-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075382-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075382-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075382-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075382-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075382-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075382-002AB174a2ff9319b5…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Acyclovir
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACYCLOVIR400 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
197311Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
89583890-186b-4a7a-8741-41f6c5f0a99dAvailable 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
71335-1053-0Acyclovir120 in 1 BOTTLETABLET1208
71335-1053-1Acyclovir20 in 1 BOTTLETABLET208
71335-1053-2Acyclovir28 in 1 BOTTLETABLET288
71335-1053-3Acyclovir30 in 1 BOTTLETABLET308
71335-1053-4Acyclovir50 in 1 BOTTLETABLET508
71335-1053-5Acyclovir15 in 1 BOTTLETABLET158
71335-1053-6Acyclovir60 in 1 BOTTLETABLET608
71335-1053-7Acyclovir25 in 1 BOTTLETABLET258
71335-1053-8Acyclovir10 in 1 BOTTLETABLET108
71335-1053-9Acyclovir40 in 1 BOTTLETABLET408

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1053-0EA - Each71335-105349696220-b55c-408b-9fd0-25b7df63c65212020-09-14
71335-1053-1EA - Each71335-1053f58c2bd3-8f91-4055-8890-ca125dd3a24612020-09-14
71335-1053-2EA - Each71335-105349b19d5c-106d-4ca2-b915-bdacb5dd1d3012020-09-14
71335-1053-3EA - Each71335-10531553f3d8-73aa-48aa-9221-e9bb0a08b67b12020-09-14
71335-1053-4EA - Each71335-10538710c334-7b2b-4ba4-9a13-b9661a33b78b12020-09-14
71335-1053-6EA - Each71335-1053cbc1a761-4526-4d05-8569-5af6773a644f12020-09-14
71335-1053-8EA - Each71335-1053479ea726-b56c-49dd-93dc-053f654cfdc712020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1053ACYCLOVIR TABLET [BRYANT RANCH PREPACK]8Current NDC, Legacy NDC, 10 package rows20240913_89583890-186b-4a7a-8741-41f6c5f0a99d.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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcyclovirACYCLOVIRCardinal Health 107, LLCd8004652-86fe-4714-81d4-5e1dd2585bb42026-04-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075382
application number: ANDA075382
AcyclovirACYCLOVIRNuCare Pharmaceuticals,Inc.c2d9940a-ce88-5fd0-e053-2a95a90a4bc82026-03-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075382
application number: ANDA075382
AcyclovirACYCLOVIRAvPAK6e203fa9-ee97-1e08-8d6a-fb57cfa13e192026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075382
application number: ANDA075382
AcyclovirACYCLOVIRBryant Ranch Prepackf3cbd634-77c8-3306-bdbd-a4598b20603e2024-10-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075382
application number: ANDA075382
AcyclovirACYCLOVIRBryant Ranch Prepacke0f17e6f-63c7-4828-8585-91fc582df30b2024-09-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075382
application number: ANDA075382
AcyclovirACYCLOVIRBryant Ranch Prepackf09cdb3f-dfd2-4e47-bb5e-a5d26d8bcc892024-09-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075382
application number: ANDA075382
AcyclovirACYCLOVIRBryant Ranch Prepack8c5d1f30-2d31-417d-860b-7228b7baaa642024-09-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075382
application number: ANDA075382
AcyclovirACYCLOVIRGolden State Medical Supply, Inc.785d68bc-0bbf-b69d-e053-2991aa0ac0d52024-09-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075382
application number: ANDA075382
AcyclovirACYCLOVIRBryant Ranch Prepack89583890-186b-4a7a-8741-41f6c5f0a99d2024-09-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075382
application number: ANDA075382
ndc (product): 71335-1053
AcyclovirACYCLOVIRCarlsbad Technology, Inc.a68e610a-841c-4b69-9233-673d060561e82024-08-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075382
application number: ANDA075382
AcyclovirACYCLOVIRNuCare Pharmaceuticals,Inc.c46d5033-b1b2-e213-e053-2995a90ae6a32024-08-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075382
application number: ANDA075382
AcyclovirACYCLOVIRProficient Rx LP33630a35-346e-43b6-9286-89e28ac0094a2022-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075382
application number: ANDA075382

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197311acyclovir 400 MG Oral TabletPSN89583890-186b-4a7a-8741-41f6c5f0a99d8
197311acyclovir 400 MG Oral TabletSCD89583890-186b-4a7a-8741-41f6c5f0a99d8
197311acycycloguanosine 400 MG Oral TabletSY89583890-186b-4a7a-8741-41f6c5f0a99d8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1053-071335105300120 TABLET in 1 BOTTLE (71335-1053-0) 120 tablet2019-11-130000-00-00NoNoCurrent
71335-1053-17133510530120 TABLET in 1 BOTTLE (71335-1053-1) 20 tablet2019-02-190000-00-00NoNoCurrent
71335-1053-27133510530228 TABLET in 1 BOTTLE (71335-1053-2) 28 tablet2020-02-060000-00-00NoNoCurrent
71335-1053-37133510530330 TABLET in 1 BOTTLE (71335-1053-3) 30 tablet2019-01-280000-00-00NoNoCurrent
71335-1053-47133510530450 TABLET in 1 BOTTLE (71335-1053-4) 50 tablet2019-01-150000-00-00NoNoCurrent
71335-1053-57133510530515 TABLET in 1 BOTTLE (71335-1053-5) 15 tablet2020-06-010000-00-00NoNoCurrent
71335-1053-67133510530660 TABLET in 1 BOTTLE (71335-1053-6) 60 tablet2019-01-080000-00-00NoNoCurrent
71335-1053-77133510530725 TABLET in 1 BOTTLE (71335-1053-7) 25 tablet2021-03-020000-00-00NoNoCurrent
71335-1053-87133510530810 TABLET in 1 BOTTLE (71335-1053-8) 10 tablet2020-01-030000-00-00NoNoCurrent
71335-1053-97133510530940 TABLET in 1 BOTTLE (71335-1053-9) 40 tablet2022-08-240000-00-00NoNoCurrent