acyclovir

Product NDC
50090-3250
11-digit product format
500903250
Labeler code
50090
Product ID
50090-3250_0c61c8ca-1f35-4ffa-b0a1-888b08f47f5f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA204314
Marketing category
ANDA
Marketing start
2014-09-10
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
A204314-001ACYCLOVIRACYCLOVIR400MGTABLET / ORALAB2014-08-19
A204314-002ACYCLOVIRACYCLOVIR800MGTABLET / ORALAB2014-08-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204314-001AB
A204314-002AB

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 UTC2026-02A204314-001ACYCLOVIR400MGTABLET / ORALAB2014-08-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204314-002ACYCLOVIR800MGTABLET / ORALAB2014-08-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204314-001ACYCLOVIR400MGTABLET / ORALAB2014-08-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204314-002ACYCLOVIR800MGTABLET / ORALAB2014-08-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A204314-001ACYCLOVIR400MGTABLET / ORALAB2014-08-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204314-002ACYCLOVIR800MGTABLET / ORALAB2014-08-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204314-001ACYCLOVIR400MGTABLET / ORALAB2014-08-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204314-002ACYCLOVIR800MGTABLET / ORALAB2014-08-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204314-001ACYCLOVIR400MGTABLET / ORALAB2014-08-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204314-002ACYCLOVIR800MGTABLET / ORALAB2014-08-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204314-001ACYCLOVIR400MGTABLET / ORALAB2014-08-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204314-002ACYCLOVIR800MGTABLET / ORALAB2014-08-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204314-001ACYCLOVIR400MGTABLET / ORALAB2014-08-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204314-002ACYCLOVIR800MGTABLET / ORALAB2014-08-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204314-001ACYCLOVIR400MGTABLET / ORALAB2014-08-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204314-002ACYCLOVIR800MGTABLET / ORALAB2014-08-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204314-001ACYCLOVIR400MGTABLET / ORALAB2014-08-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204314-002ACYCLOVIR800MGTABLET / ORALAB2014-08-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204314-001ACYCLOVIR400MGTABLET / ORALAB2014-08-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A204314-002ACYCLOVIR800MGTABLET / ORALAB2014-08-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204314-001ACYCLOVIR400MGTABLET / ORALAB2014-08-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204314-002ACYCLOVIR800MGTABLET / ORALAB2014-08-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204314-001ACYCLOVIR400MGTABLET / ORALAB2014-08-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204314-002ACYCLOVIR800MGTABLET / ORALAB2014-08-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204314-001ACYCLOVIR400MGTABLET / ORALAB2014-08-191e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204314-002ACYCLOVIR800MGTABLET / ORALAB2014-08-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204314-001ACYCLOVIR400MGTABLET / ORALAB2014-08-198072bd15b7f6…
2024-05-31 18:47 UTC2024-05A204314-002ACYCLOVIR800MGTABLET / ORALAB2014-08-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204314-001ACYCLOVIR400MGTABLET / ORALAB2014-08-195c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204314-002ACYCLOVIR800MGTABLET / ORALAB2014-08-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204314-001ACYCLOVIR400MGTABLET / ORALAB2014-08-195d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A204314-002ACYCLOVIR800MGTABLET / ORALAB2014-08-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204314-001ACYCLOVIR400MGTABLET / ORALAB2014-08-194b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A204314-002ACYCLOVIR800MGTABLET / ORALAB2014-08-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A204314-001ACYCLOVIR400MGTABLET / ORALAB2014-08-1974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A204314-002ACYCLOVIR800MGTABLET / ORALAB2014-08-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A204314-001ACYCLOVIR400MGTABLET / ORALAB2014-08-19bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A204314-002ACYCLOVIR800MGTABLET / ORALAB2014-08-19bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A204314-001ACYCLOVIR400MGTABLET / ORALAB2014-08-19782e0a99824c…
2021-12-28 21:50 UTC2021-12A204314-002ACYCLOVIR800MGTABLET / ORALAB2014-08-19782e0a99824c…

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 UTC2026-02A204314-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204314-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204314-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204314-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204314-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204314-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204314-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204314-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204314-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204314-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204314-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204314-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204314-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204314-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204314-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204314-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204314-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204314-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204314-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204314-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204314-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204314-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204314-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204314-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204314-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204314-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204314-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A204314-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204314-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204314-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204314-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A204314-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204314-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A204314-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A204314-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A204314-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A204314-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A204314-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A204314-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A204314-002AB1782e0a99824c…

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 · 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
c40a57b9-4cf1-4a69-abf3-eb99a7fcda00Available 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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3250-0acyclovir2 in 1 BOTTLETABLET29
50090-3250-2acyclovir25 in 1 BOTTLETABLET259
50090-3250-3acyclovir50 in 1 BOTTLETABLET509
50090-3250-4acyclovir15 in 1 BOTTLETABLET159
50090-3250-5acyclovir30 in 1 BOTTLETABLET309
50090-3250-6acyclovir60 in 1 BOTTLETABLET609
50090-3250-9acyclovir45 in 1 BOTTLETABLET459

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3250-2EA - Each50090-3250f173f406-8d0a-4455-bf2b-767f97abb7b912019-05-02
50090-3250-3EA - Each50090-3250526d4d56-97d7-4423-ab23-dbb243cc322812020-02-13
50090-3250-4EA - Each50090-3250bd0db342-7397-4871-9e4b-67a4661e8d6612020-02-13
50090-3250-5EA - Each50090-325001b1df88-0274-4c5c-a412-136b7c3158e812020-02-13
50090-3250-6EA - Each50090-3250c8277b90-e618-4491-88d1-ffc0fc27537412020-02-13
50090-3250-9EA - Each50090-3250597b31cf-ee5c-4f08-950d-8f95254e7c0512020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3250ACYCLOVIR TABLET [A-S MEDICATION SOLUTIONS]9Current NDC, Legacy NDC, 7 package rows20230418_c40a57b9-4cf1-4a69-abf3-eb99a7fcda00.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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
acyclovirACYCLOVIRNorthwind Health Company, LLC50c58161-3944-7367-e063-6394a90a62862026-04-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204314
application number: ANDA204314
acyclovirACYCLOVIRREMEDYREPACK INC.960e4ede-692e-4db2-a96e-dc6f4a6190ee2026-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204314
application number: ANDA204314
acyclovirACYCLOVIRREMEDYREPACK INC.8fdabab2-bc93-48ab-9c13-d22ec90fdcfc2026-02-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204314
application number: ANDA204314
acyclovirACYCLOVIRZydus Lifesciences Limited8d9fea43-6c04-40d7-8aac-398c2de2a5582025-11-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204314
application number: ANDA204314
acyclovirACYCLOVIRZydus Pharmaceuticals (USA) Inc.edb0cd28-ee57-4b60-be94-62c797fbf5e62025-11-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204314
application number: ANDA204314
acyclovirACYCLOVIRCoupler LLC2cdbea8d-29df-0045-e063-6294a90a95062025-01-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204314
application number: ANDA204314
acyclovirACYCLOVIRNuCare Pharmaceuticals, Inc.40e5cc54-ed74-3369-e054-00144ff88e882024-08-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204314
application number: ANDA204314
acyclovirACYCLOVIRA-S Medication Solutionsf3e6b1ad-810b-4f53-b92a-b28fc2111f3f2024-01-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204314
application number: ANDA204314
acyclovirACYCLOVIRA-S Medication Solutionsc40a57b9-4cf1-4a69-abf3-eb99a7fcda002023-04-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204314
application number: ANDA204314
ndc (product): 50090-3250
acyclovirACYCLOVIRProficient Rx LP3da54b2d-a206-4ff5-8cc2-90762c4fd70d2021-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204314
application number: ANDA204314

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197311acyclovir 400 MG Oral TabletPSNc40a57b9-4cf1-4a69-abf3-eb99a7fcda009
197311acyclovir 400 MG Oral TabletSCDc40a57b9-4cf1-4a69-abf3-eb99a7fcda009
197311acycycloguanosine 400 MG Oral TabletSYc40a57b9-4cf1-4a69-abf3-eb99a7fcda009

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3250-0500903250002 TABLET in 1 BOTTLE (50090-3250-0) 2 tablet2018-10-15NoNoCurrent
50090-3250-25009032500225 TABLET in 1 BOTTLE (50090-3250-2) 25 tablet2017-11-080000-00-00NoNoCurrent
50090-3250-35009032500350 TABLET in 1 BOTTLE (50090-3250-3) 50 tablet2017-11-080000-00-00NoNoCurrent
50090-3250-45009032500415 TABLET in 1 BOTTLE (50090-3250-4) 15 tablet2017-11-080000-00-00NoNoCurrent
50090-3250-55009032500530 TABLET in 1 BOTTLE (50090-3250-5) 30 tablet2017-11-080000-00-00NoNoCurrent
50090-3250-65009032500660 TABLET in 1 BOTTLE (50090-3250-6) 60 tablet2017-11-080000-00-00NoNoCurrent
50090-3250-95009032500945 TABLET in 1 BOTTLE (50090-3250-9) 45 tablet2017-11-080000-00-00NoNoCurrent