Acyclovir

Product NDC
69452-290
11-digit product format
694520290
Labeler code
69452
Product ID
69452-290_a0977267-e400-48f6-99fa-dafcc483e96e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
Bionpharma Inc.
Application
ANDA209366
Marketing category
ANDA
Marketing start
2020-08-15
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 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
A209366-001ACYCLOVIRACYCLOVIR400MGTABLET / ORALAB2019-10-07
A209366-002ACYCLOVIRACYCLOVIR800MGTABLET / ORALAB2019-10-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A209366-001AB
A209366-002AB

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 2 · 78 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A209366-001ACYCLOVIR400MGTABLET / ORALAB2019-10-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209366-002ACYCLOVIR800MGTABLET / ORALAB2019-10-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209366-001ACYCLOVIR400MGTABLET / ORALAB2019-10-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209366-002ACYCLOVIR800MGTABLET / ORALAB2019-10-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A209366-001ACYCLOVIR400MGTABLET / ORALAB2019-10-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209366-002ACYCLOVIR800MGTABLET / ORALAB2019-10-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209366-001ACYCLOVIR400MGTABLET / ORALAB2019-10-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209366-002ACYCLOVIR800MGTABLET / ORALAB2019-10-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209366-001ACYCLOVIR400MGTABLET / ORALAB2019-10-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209366-002ACYCLOVIR800MGTABLET / ORALAB2019-10-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209366-001ACYCLOVIR400MGTABLET / ORALAB2019-10-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209366-002ACYCLOVIR800MGTABLET / ORALAB2019-10-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209366-001ACYCLOVIR400MGTABLET / ORALAB2019-10-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209366-002ACYCLOVIR800MGTABLET / ORALAB2019-10-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209366-001ACYCLOVIR400MGTABLET / ORALAB2019-10-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209366-002ACYCLOVIR800MGTABLET / ORALAB2019-10-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209366-001ACYCLOVIR400MGTABLET / ORALAB2019-10-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209366-002ACYCLOVIR800MGTABLET / ORALAB2019-10-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209366-001ACYCLOVIR400MGTABLET / ORALAB2019-10-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A209366-002ACYCLOVIR800MGTABLET / ORALAB2019-10-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209366-001ACYCLOVIR400MGTABLET / ORALAB2019-10-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209366-002ACYCLOVIR800MGTABLET / ORALAB2019-10-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209366-001ACYCLOVIR400MGTABLET / ORALAB2019-10-07301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209366-002ACYCLOVIR800MGTABLET / ORALAB2019-10-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209366-001ACYCLOVIR400MGTABLET / ORALAB2019-10-071e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209366-002ACYCLOVIR800MGTABLET / ORALAB2019-10-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209366-001ACYCLOVIR400MGTABLET / ORALAB2019-10-078072bd15b7f6…
2024-05-31 18:47 UTC2024-05A209366-002ACYCLOVIR800MGTABLET / ORALAB2019-10-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209366-001ACYCLOVIR400MGTABLET / ORALAB2019-10-075c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209366-002ACYCLOVIR800MGTABLET / ORALAB2019-10-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209366-001ACYCLOVIR400MGTABLET / ORALAB2019-10-075d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A209366-002ACYCLOVIR800MGTABLET / ORALAB2019-10-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209366-001ACYCLOVIR400MGTABLET / ORALAB2019-10-074b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A209366-002ACYCLOVIR800MGTABLET / ORALAB2019-10-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209366-001ACYCLOVIR400MGTABLET / ORALAB2019-10-0774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A209366-002ACYCLOVIR800MGTABLET / ORALAB2019-10-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209366-001ACYCLOVIR400MGTABLET / ORALAB2019-10-07bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A209366-002ACYCLOVIR800MGTABLET / ORALAB2019-10-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209366-001ACYCLOVIR400MGTABLET / ORALAB2019-10-07782e0a99824c…
2021-12-28 21:50 UTC2021-12A209366-002ACYCLOVIR800MGTABLET / ORALAB2019-10-07782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A209366-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209366-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209366-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209366-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209366-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209366-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209366-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209366-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209366-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209366-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209366-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209366-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209366-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209366-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209366-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209366-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209366-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209366-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209366-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A209366-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209366-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209366-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209366-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209366-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209366-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209366-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209366-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A209366-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209366-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209366-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209366-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A209366-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209366-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A209366-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209366-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A209366-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209366-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A209366-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209366-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A209366-002AB1782e0a99824c…

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197311Internal RxNorm lookup
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
6f1db9f0-9b41-4fb7-8798-44fdc2c128dfAvailable 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
69452-290-20Acyclovir100 in 1 BOTTLETABLET1004
69452-290-30Acyclovir500 in 1 BOTTLETABLET5004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69452-290ACYCLOVIR TABLET [BIONPHARMA INC.]4Current NDC, Legacy NDC, 2 package rows20231211_6f1db9f0-9b41-4fb7-8798-44fdc2c128df.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
AcyclovirACYCLOVIRREMEDYREPACK INC.37a51d9c-1f39-4065-8c7d-6528ac6de91c2026-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209366
application number: ANDA209366
AcyclovirACYCLOVIRPreferred Pharmaceuticals Inc.b1033fda-8242-4006-b1cd-23474d70671f2026-01-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209366
application number: ANDA209366
AcyclovirACYCLOVIRREMEDYREPACK INC.a1086845-ba08-4fb2-81dc-aea9c68bf2c32025-08-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209366
application number: ANDA209366
AcyclovirACYCLOVIRDirect_Rx387d33ed-45e5-42d6-e063-6294a90afbb72025-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209366
application number: ANDA209366
AcyclovirACYCLOVIRBryant Ranch Prepack067109d0-2539-42b6-9e95-102b58ca54dc2025-05-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209366
application number: ANDA209366
AcyclovirACYCLOVIRBryant Ranch Prepack713960c2-8278-4778-b781-08ec89a9cfce2025-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209366
application number: ANDA209366
AcyclovirACYCLOVIRNuCare Pharmaceuticals,Inc.116f4f0d-66c5-49dd-e063-6394a90ab2b52025-01-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209366
application number: ANDA209366
AcyclovirACYCLOVIRNuCare Pharmaceuticals,Inc.e5e99a6b-79a6-7fdb-e053-2a95a90a85632024-12-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209366
application number: ANDA209366
AcyclovirACYCLOVIRBryant Ranch Prepacke73ae5c8-7a77-4330-817d-482d1de4e9942024-04-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209366
application number: ANDA209366
AcyclovirACYCLOVIRBionpharma Inc.6f1db9f0-9b41-4fb7-8798-44fdc2c128df2023-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209366
application number: ANDA209366
ndc (product): 69452-290
AcyclovirACYCLOVIRSQUARE PHARMACEUTICALS LIMITEDb24201ea-aeae-4de1-b01b-eee89068e7862023-07-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209366
application number: ANDA209366
AcyclovirACYCLOVIRA-S Medication Solutions34a38cdf-04e8-4006-a9f5-4a0831117d612023-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209366
application number: ANDA209366

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197311acyclovir 400 MG Oral TabletPSNe73ae5c8-7a77-4330-817d-482d1de4e994103
197311acyclovir 400 MG Oral TabletSCDe73ae5c8-7a77-4330-817d-482d1de4e994103
197311acycycloguanosine 400 MG Oral TabletSYe73ae5c8-7a77-4330-817d-482d1de4e994103
197311acyclovir 400 MG Oral TabletPSNb1033fda-8242-4006-b1cd-23474d70671f6
197311acyclovir 400 MG Oral TabletSCDb1033fda-8242-4006-b1cd-23474d70671f6
197311acycycloguanosine 400 MG Oral TabletSYb1033fda-8242-4006-b1cd-23474d70671f6
197311acyclovir 400 MG Oral TabletPSNe5e99a6b-79a6-7fdb-e053-2a95a90a85634
197311acyclovir 400 MG Oral TabletPSN6f1db9f0-9b41-4fb7-8798-44fdc2c128df4
197313acyclovir 800 MG Oral TabletPSN6f1db9f0-9b41-4fb7-8798-44fdc2c128df4
197311acyclovir 400 MG Oral TabletSCDe5e99a6b-79a6-7fdb-e053-2a95a90a85634
197311acyclovir 400 MG Oral TabletSCD6f1db9f0-9b41-4fb7-8798-44fdc2c128df4
197313acyclovir 800 MG Oral TabletSCD6f1db9f0-9b41-4fb7-8798-44fdc2c128df4
197311acycycloguanosine 400 MG Oral TabletSYe5e99a6b-79a6-7fdb-e053-2a95a90a85634
197311acycycloguanosine 400 MG Oral TabletSY6f1db9f0-9b41-4fb7-8798-44fdc2c128df4
197313acycycloguanosine 800 MG Oral TabletSY6f1db9f0-9b41-4fb7-8798-44fdc2c128df4
197311acyclovir 400 MG Oral TabletPSNfa1ae70c-3372-845c-e053-6394a90ac3d93
197311acyclovir 400 MG Oral TabletSCDfa1ae70c-3372-845c-e053-6394a90ac3d93
197311acycycloguanosine 400 MG Oral TabletSYfa1ae70c-3372-845c-e053-6394a90ac3d93
197311acyclovir 400 MG Oral TabletPSN116f4f0d-66c5-49dd-e063-6394a90ab2b52
197311acyclovir 400 MG Oral TabletPSN7f505e82-d3b3-49d7-b711-2709a4aca5462
197311acyclovir 400 MG Oral TabletSCD7f505e82-d3b3-49d7-b711-2709a4aca5462
197311acyclovir 400 MG Oral TabletSCD116f4f0d-66c5-49dd-e063-6394a90ab2b52
197311acycycloguanosine 400 MG Oral TabletSY7f505e82-d3b3-49d7-b711-2709a4aca5462
197311acycycloguanosine 400 MG Oral TabletSY116f4f0d-66c5-49dd-e063-6394a90ab2b52
197311acyclovir 400 MG Oral TabletPSNa1086845-ba08-4fb2-81dc-aea9c68bf2c31
197311acyclovir 400 MG Oral TabletPSN067109d0-2539-42b6-9e95-102b58ca54dc1
197311acyclovir 400 MG Oral TabletPSNebf418c8-a98c-da82-e053-2995a90a1fb31
197311acyclovir 400 MG Oral TabletPSN266c8441-f178-61f8-e063-6394a90a89c31
197311acyclovir 400 MG Oral TabletPSN387d33ed-45e5-42d6-e063-6294a90afbb71
197311acyclovir 400 MG Oral TabletSCD387d33ed-45e5-42d6-e063-6294a90afbb71
197311acyclovir 400 MG Oral TabletSCD266c8441-f178-61f8-e063-6394a90a89c31
197311acyclovir 400 MG Oral TabletSCD067109d0-2539-42b6-9e95-102b58ca54dc1
197311acyclovir 400 MG Oral TabletSCDebf418c8-a98c-da82-e053-2995a90a1fb31
197311acyclovir 400 MG Oral TabletSCDa1086845-ba08-4fb2-81dc-aea9c68bf2c31
197311acycycloguanosine 400 MG Oral TabletSY266c8441-f178-61f8-e063-6394a90a89c31
197311acycycloguanosine 400 MG Oral TabletSY387d33ed-45e5-42d6-e063-6294a90afbb71
197311acycycloguanosine 400 MG Oral TabletSYebf418c8-a98c-da82-e053-2995a90a1fb31
197311acycycloguanosine 400 MG Oral TabletSYa1086845-ba08-4fb2-81dc-aea9c68bf2c31
197311acycycloguanosine 400 MG Oral TabletSY067109d0-2539-42b6-9e95-102b58ca54dc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69452-290-2069452029020100 TABLET in 1 BOTTLE (69452-290-20) 100 tablet2020-08-150000-00-00NoNoCurrent
69452-290-3069452029030500 TABLET in 1 BOTTLE (69452-290-30) 500 tablet2020-08-150000-00-00NoNoCurrent