Acyclovir

Product NDC
68788-8724
11-digit product format
687888724
Labeler code
68788
Product ID
68788-8724_9ffeaf80-77c0-43c2-9acb-469d537c184a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc
Application
ANDA210401
Marketing category
ANDA
Marketing start
2024-08-16
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
2027-12-31
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
A210401-001ACYCLOVIRACYCLOVIR400MGTABLET / ORALAB2018-03-07
A210401-002ACYCLOVIRACYCLOVIR800MGTABLET / ORALAB2018-03-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A210401-001AB
A210401-002AB

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 22:38:342026-08A210401-001ACYCLOVIR400MGTABLET / ORALAB2018-03-0784e616aacf4f…
2026-09-14 22:38:342026-08A210401-002ACYCLOVIR800MGTABLET / ORALAB2018-03-0784e616aacf4f…
2026-08-18 06:07:402026-07A210401-001ACYCLOVIR400MGTABLET / ORALAB2018-03-07caaa826d4ba7…
2026-08-18 06:07:402026-07A210401-002ACYCLOVIR800MGTABLET / ORALAB2018-03-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210401-001ACYCLOVIR400MGTABLET / ORALAB2018-03-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210401-002ACYCLOVIR800MGTABLET / ORALAB2018-03-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210401-001ACYCLOVIR400MGTABLET / ORALAB2018-03-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210401-002ACYCLOVIR800MGTABLET / ORALAB2018-03-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A210401-001ACYCLOVIR400MGTABLET / ORALAB2018-03-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210401-002ACYCLOVIR800MGTABLET / ORALAB2018-03-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210401-001ACYCLOVIR400MGTABLET / ORALAB2018-03-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210401-002ACYCLOVIR800MGTABLET / ORALAB2018-03-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210401-001ACYCLOVIR400MGTABLET / ORALAB2018-03-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210401-002ACYCLOVIR800MGTABLET / ORALAB2018-03-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210401-001ACYCLOVIR400MGTABLET / ORALAB2018-03-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210401-002ACYCLOVIR800MGTABLET / ORALAB2018-03-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210401-001ACYCLOVIR400MGTABLET / ORALAB2018-03-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210401-002ACYCLOVIR800MGTABLET / ORALAB2018-03-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210401-001ACYCLOVIR400MGTABLET / ORALAB2018-03-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210401-002ACYCLOVIR800MGTABLET / ORALAB2018-03-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210401-001ACYCLOVIR400MGTABLET / ORALAB2018-03-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210401-002ACYCLOVIR800MGTABLET / ORALAB2018-03-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210401-001ACYCLOVIR400MGTABLET / ORALAB2018-03-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A210401-002ACYCLOVIR800MGTABLET / ORALAB2018-03-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210401-001ACYCLOVIR400MGTABLET / ORALAB2018-03-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210401-002ACYCLOVIR800MGTABLET / ORALAB2018-03-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210401-001ACYCLOVIR400MGTABLET / ORALAB2018-03-07301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210401-002ACYCLOVIR800MGTABLET / ORALAB2018-03-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210401-001ACYCLOVIR400MGTABLET / ORALAB2018-03-071e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210401-002ACYCLOVIR800MGTABLET / ORALAB2018-03-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210401-001ACYCLOVIR400MGTABLET / ORALAB2018-03-078072bd15b7f6…
2024-05-31 18:47 UTC2024-05A210401-002ACYCLOVIR800MGTABLET / ORALAB2018-03-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210401-001ACYCLOVIR400MGTABLET / ORALAB2018-03-075c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210401-002ACYCLOVIR800MGTABLET / ORALAB2018-03-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210401-001ACYCLOVIR400MGTABLET / ORALAB2018-03-075d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A210401-002ACYCLOVIR800MGTABLET / ORALAB2018-03-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210401-001ACYCLOVIR400MGTABLET / ORALAB2018-03-074b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A210401-002ACYCLOVIR800MGTABLET / ORALAB2018-03-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210401-001ACYCLOVIR400MGTABLET / ORALAB2018-03-0774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A210401-002ACYCLOVIR800MGTABLET / ORALAB2018-03-0774a2ff9319b5…

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 22:38:342026-08A210401-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A210401-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A210401-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A210401-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210401-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210401-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210401-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210401-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210401-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210401-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210401-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210401-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210401-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210401-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210401-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210401-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210401-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210401-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210401-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210401-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210401-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210401-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210401-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A210401-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210401-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210401-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210401-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210401-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210401-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210401-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210401-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A210401-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210401-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210401-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210401-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A210401-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210401-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A210401-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210401-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A210401-002AB174a2ff9319b5…

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
2027-12-31

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
75334fc5-d236-401a-875c-f4f9c7749c1aAvailable 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
68788-8724-1Acyclovir100 in 1 BOTTLETABLET1003
68788-8724-2Acyclovir21 in 1 BOTTLETABLET213
68788-8724-3Acyclovir30 in 1 BOTTLETABLET303
68788-8724-4Acyclovir40 in 1 BOTTLETABLET403
68788-8724-5Acyclovir50 in 1 BOTTLETABLET503
68788-8724-8Acyclovir35 in 1 BOTTLETABLET353

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8724-1EA - Each68788-8724c704c7e9-de6d-4a82-85e5-ba6b9f4b430d12024-10-04
68788-8724-2EA - Each68788-87242ec1d972-436c-41c9-933e-6385e42a583712024-10-04
68788-8724-3EA - Each68788-872457b21a22-e08e-4bb9-b8cc-d0d1b584bf1b12024-10-04
68788-8724-4EA - Each68788-8724f1733505-8710-4fcd-976f-45fc6595b32c12024-10-04
68788-8724-5EA - Each68788-8724bf9da9fc-6730-47ce-ba98-b9e90231078b12024-10-04
68788-8724-8EA - Each68788-87245e9478ac-35fd-4ddf-b34b-16c95df93ea812024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8724ACYCLOVIR TABLET [PREFERRED PHARMACEUTICALS INC]2Current NDC, 6 package rows20250101_75334fc5-d236-401a-875c-f4f9c7749c1a.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 · 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcyclovirACYCLOVIRPD-Rx Pharmaceuticals, Inc.58dc1402-6098-9cb3-e063-6294a90a062b2026-08-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210401
application number: ANDA210401
AcyclovirACYCLOVIRRedpharm Drug53cbca4d-3ddc-b11e-e063-6394a90a04fa2026-06-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210401
application number: ANDA210401
AcyclovirACYCLOVIRWestminster Pharmaceuticals, LLCf352a641-988e-4878-8016-2b69cd6ee5482026-05-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210401
application number: ANDA210401
AcyclovirACYCLOVIRBryant Ranch Prepack69e5455e-d0be-4c2b-b9ab-458b5480ed572026-03-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210401
application number: ANDA210401
AcyclovirACYCLOVIRA-S Medication Solutions2e6a3667-af06-40de-80c0-8c4346e0671f2026-02-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210401
application number: ANDA210401
AcyclovirACYCLOVIRPreferred Pharmaceuticals Inc75334fc5-d236-401a-875c-f4f9c7749c1a2026-01-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210401
application number: ANDA210401
ndc (product): 68788-8724
AcyclovirACYCLOVIRYILING PHARMACEUTICAL, INC.67e7b340-0635-2595-e053-2a91aa0ad2662025-12-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210401
application number: ANDA210401
AcyclovirACYCLOVIRYILING PHARMACEUTICAL, INC.677edfd5-2d04-b932-e053-2a91aa0a26b02025-12-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210401
application number: ANDA210401
AcyclovirACYCLOVIRRedpharm Drug37453bcd-e34e-5902-e063-6294a90a02452025-12-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210401
application number: ANDA210401
AcyclovirACYCLOVIRChartwell RX, LLC8cd22728-34b4-4e55-8339-580138fe46d82025-12-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210401
application number: ANDA210401
AcyclovirACYCLOVIRProficient Rx LPd0908b3c-f5dd-4113-9080-bb01abe13c9c2025-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210401
application number: ANDA210401
AcyclovirACYCLOVIRBryant Ranch Prepack8d171c3d-de39-4f82-bacb-3e8d71b165402025-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210401
application number: ANDA210401
AcyclovirACYCLOVIRA-S Medication Solutionsb96e44ca-aa54-4a64-89f4-fb5a5932ceae2024-10-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210401
application number: ANDA210401
AcyclovirACYCLOVIRA-S Medication Solutionsc0c29e0f-b6e2-49df-88d1-95b7b625d3562024-10-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210401
application number: ANDA210401
AcyclovirACYCLOVIRA-S Medication Solutions6ea3e3f6-132d-4b15-ac58-336de05201a72024-10-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210401
application number: ANDA210401
AcyclovirACYCLOVIRProficient Rx LP290af212-7332-4914-9ef0-65760478fb322024-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210401
application number: ANDA210401
AcyclovirACYCLOVIRProficient Rx LP97ed8713-4b3e-48a9-92c0-0a98ecf0485c2024-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210401
application number: ANDA210401

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197311acyclovir 400 MG Oral TabletPSN75334fc5-d236-401a-875c-f4f9c7749c1a3
197311acyclovir 400 MG Oral TabletSCD75334fc5-d236-401a-875c-f4f9c7749c1a3
197311acycycloguanosine 400 MG Oral TabletSY75334fc5-d236-401a-875c-f4f9c7749c1a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8724-168788872401100 TABLET in 1 BOTTLE (68788-8724-1) 100 tablet2024-08-16NoNoCurrent
68788-8724-26878887240221 TABLET in 1 BOTTLE (68788-8724-2) 21 tablet2024-08-16NoNoCurrent
68788-8724-36878887240330 TABLET in 1 BOTTLE (68788-8724-3) 30 tablet2024-08-16NoNoCurrent
68788-8724-46878887240440 TABLET in 1 BOTTLE (68788-8724-4) 40 tablet2024-08-16NoNoCurrent
68788-8724-56878887240550 TABLET in 1 BOTTLE (68788-8724-5) 50 tablet2024-08-16NoNoCurrent
68788-8724-86878887240835 TABLET in 1 BOTTLE (68788-8724-8) 35 tablet2024-08-16NoNoCurrent