Acyclovir

Product NDC
72241-027
11-digit product format
722410027
Labeler code
72241
Product ID
72241-027_ea578b6a-2897-45b9-8757-a2d9caf34459
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
Modavar Pharmaceuticals LLC
Application
ANDA202168
Marketing category
ANDA
Marketing start
2021-08-18
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
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A202168-001ACYCLOVIRACYCLOVIR400MGTABLET / ORALAB2013-11-15
A202168-002ACYCLOVIRACYCLOVIR800MGTABLET / ORALAB2013-11-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202168-001AB
A202168-002AB

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A202168-001ACYCLOVIR400MGTABLET / ORALAB2013-11-15caaa826d4ba7…
2026-08-18 06:07:402026-07A202168-002ACYCLOVIR800MGTABLET / ORALAB2013-11-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202168-001ACYCLOVIR400MGTABLET / ORALAB2013-11-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202168-002ACYCLOVIR800MGTABLET / ORALAB2013-11-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202168-001ACYCLOVIR400MGTABLET / ORALAB2013-11-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202168-002ACYCLOVIR800MGTABLET / ORALAB2013-11-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A202168-001ACYCLOVIR400MGTABLET / ORALAB2013-11-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202168-002ACYCLOVIR800MGTABLET / ORALAB2013-11-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202168-001ACYCLOVIR400MGTABLET / ORALAB2013-11-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202168-002ACYCLOVIR800MGTABLET / ORALAB2013-11-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202168-001ACYCLOVIR400MGTABLET / ORALAB2013-11-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202168-002ACYCLOVIR800MGTABLET / ORALAB2013-11-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202168-001ACYCLOVIR400MGTABLET / ORALAB2013-11-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202168-002ACYCLOVIR800MGTABLET / ORALAB2013-11-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202168-001ACYCLOVIR400MGTABLET / ORALAB2013-11-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202168-002ACYCLOVIR800MGTABLET / ORALAB2013-11-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202168-001ACYCLOVIR400MGTABLET / ORALAB2013-11-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202168-002ACYCLOVIR800MGTABLET / ORALAB2013-11-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202168-001ACYCLOVIR400MGTABLET / ORALAB2013-11-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202168-002ACYCLOVIR800MGTABLET / ORALAB2013-11-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202168-001ACYCLOVIR400MGTABLET / ORALAB2013-11-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A202168-002ACYCLOVIR800MGTABLET / ORALAB2013-11-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202168-001ACYCLOVIR400MGTABLET / ORALAB2013-11-1579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202168-002ACYCLOVIR800MGTABLET / ORALAB2013-11-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202168-001ACYCLOVIR400MGTABLET / ORALAB2013-11-15301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202168-002ACYCLOVIR800MGTABLET / ORALAB2013-11-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202168-001ACYCLOVIR400MGTABLET / ORALAB2013-11-151e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202168-002ACYCLOVIR800MGTABLET / ORALAB2013-11-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202168-001ACYCLOVIR400MGTABLET / ORALAB2013-11-158072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202168-002ACYCLOVIR800MGTABLET / ORALAB2013-11-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202168-001ACYCLOVIR400MGTABLET / ORALAB2013-11-155c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202168-002ACYCLOVIR800MGTABLET / ORALAB2013-11-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202168-001ACYCLOVIR400MGTABLET / ORALAB2013-11-155d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202168-002ACYCLOVIR800MGTABLET / ORALAB2013-11-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202168-001ACYCLOVIR400MGTABLET / ORALAB2013-11-154b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202168-002ACYCLOVIR800MGTABLET / ORALAB2013-11-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202168-001ACYCLOVIR400MGTABLET / ORALAB2013-11-1574a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202168-002ACYCLOVIR800MGTABLET / ORALAB2013-11-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202168-001ACYCLOVIR400MGTABLET / ORALAB2013-11-15bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A202168-002ACYCLOVIR800MGTABLET / ORALAB2013-11-15bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A202168-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202168-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202168-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202168-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202168-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202168-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202168-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202168-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202168-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202168-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202168-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202168-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202168-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202168-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202168-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202168-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202168-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202168-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202168-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202168-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202168-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202168-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202168-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202168-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202168-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202168-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202168-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202168-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202168-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A202168-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202168-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202168-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202168-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A202168-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202168-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A202168-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202168-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A202168-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202168-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A202168-002AB1bb7c543d1eb4…

Additional Listing Data#

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

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 · 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
8de9c4f3-b800-4419-a063-8b62a0cba0faAvailable 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
72241-027-05Acyclovir100 in 1 BOTTLETABLET1002
72241-027-10Acyclovir500 in 1 BOTTLETABLET5002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72241-027ACYCLOVIR TABLET [MODAVAR PHARMACEUTICALS LLC]2Current NDC, Legacy NDC, 2 package rows20221230_8de9c4f3-b800-4419-a063-8b62a0cba0fa.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcyclovirACYCLOVIRCadila Pharmaceuticals Limitedacef88f4-6456-4092-993f-27e1496097c72025-12-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202168
application number: ANDA202168
AcyclovirACYCLOVIRModavar Pharmaceuticals LLC8de9c4f3-b800-4419-a063-8b62a0cba0fa2022-12-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202168
application number: ANDA202168
ndc (product): 72241-027

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197311acyclovir 400 MG Oral TabletPSN8de9c4f3-b800-4419-a063-8b62a0cba0fa2
197313acyclovir 800 MG Oral TabletPSN8de9c4f3-b800-4419-a063-8b62a0cba0fa2
197311acyclovir 400 MG Oral TabletSCD8de9c4f3-b800-4419-a063-8b62a0cba0fa2
197313acyclovir 800 MG Oral TabletSCD8de9c4f3-b800-4419-a063-8b62a0cba0fa2
197311acycycloguanosine 400 MG Oral TabletSY8de9c4f3-b800-4419-a063-8b62a0cba0fa2
197313acycycloguanosine 800 MG Oral TabletSY8de9c4f3-b800-4419-a063-8b62a0cba0fa2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72241-027-0572241002705100 TABLET in 1 BOTTLE (72241-027-05) 100 tablet2021-08-180000-00-00NoNoCurrent
72241-027-1072241002710500 TABLET in 1 BOTTLE (72241-027-10) 500 tablet2021-08-180000-00-00NoNoCurrent