acyclovir

Product NDC
72578-002
11-digit product format
725780002
Labeler code
72578
Product ID
72578-002_b797bf2f-d83c-413a-90bf-63c3a0eabf89
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acyclovir
Dosage form
CAPSULE
Route
ORAL
Labeler
Viona Pharmaceuticals Inc
Application
ANDA204313
Marketing category
ANDA
Marketing start
2019-08-23
Substance
ACYCLOVIR
Active strength
200 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204313-001ACYCLOVIRACYCLOVIR200MGCAPSULE / ORALAB2016-03-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204313-001AB

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A204313-001ACYCLOVIR200MGCAPSULE / ORALAB2016-03-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204313-001ACYCLOVIR200MGCAPSULE / ORALAB2016-03-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A204313-001ACYCLOVIR200MGCAPSULE / ORALAB2016-03-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204313-001ACYCLOVIR200MGCAPSULE / ORALAB2016-03-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204313-001ACYCLOVIR200MGCAPSULE / ORALAB2016-03-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204313-001ACYCLOVIR200MGCAPSULE / ORALAB2016-03-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204313-001ACYCLOVIR200MGCAPSULE / ORALAB2016-03-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204313-001ACYCLOVIR200MGCAPSULE / ORALAB2016-03-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204313-001ACYCLOVIR200MGCAPSULE / ORALAB2016-03-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204313-001ACYCLOVIR200MGCAPSULE / ORALAB2016-03-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204313-001ACYCLOVIR200MGCAPSULE / ORALAB2016-03-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204313-001ACYCLOVIR200MGCAPSULE / ORALAB2016-03-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204313-001ACYCLOVIR200MGCAPSULE / ORALAB2016-03-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204313-001ACYCLOVIR200MGCAPSULE / ORALAB2016-03-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204313-001ACYCLOVIR200MGCAPSULE / ORALAB2016-03-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204313-001ACYCLOVIR200MGCAPSULE / ORALAB2016-03-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204313-001ACYCLOVIR200MGCAPSULE / ORALAB2016-03-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A204313-001ACYCLOVIR200MGCAPSULE / ORALAB2016-03-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A204313-001ACYCLOVIR200MGCAPSULE / ORALAB2016-03-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A204313-001ACYCLOVIR200MGCAPSULE / ORALAB2016-03-25782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A204313-001ACYCLOVIR200MGCAPSULE / ORALAB2016-03-2587673890dc5c…
2021-03-12 10:30 UTC2021-03A204313-001ACYCLOVIR200MGCAPSULE / ORALAB2016-03-255aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A204313-001ACYCLOVIR200MGCAPSULE / ORALAB2016-03-258869cabd3fbd…
2020-11-12 02:37 UTC2020-11A204313-001ACYCLOVIR200MGCAPSULE / ORALAB2016-03-25c0c555d07b60…
2019-12-14 00:12 UTC2019-12A204313-001ACYCLOVIR200MGCAPSULE / ORALAB2016-03-253f01610625f2…
2019-09-15 20:21 UTC2019-09A204313-001ACYCLOVIR200MGCAPSULE / ORALAB2016-03-25b00525d2431f…
2019-07-19 19:46 UTC2019-07A204313-001ACYCLOVIR200MGCAPSULE / ORALAB2016-03-25ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A204313-001ACYCLOVIR200MGCAPSULE / ORALAB2016-03-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A204313-001ACYCLOVIR200MGCAPSULE / ORALAB2016-03-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12A204313-001ACYCLOVIR200MGCAPSULE / ORALAB2016-03-25ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A204313-001ACYCLOVIR200MGCAPSULE / ORALAB2016-03-25a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A204313-001ACYCLOVIR200MGCAPSULE / ORALAB2016-03-259b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A204313-001ACYCLOVIR200MGCAPSULE / ORALAB2016-03-25a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A204313-001ACYCLOVIR200MGCAPSULE / ORALAB2016-03-253f0d92c62455…
2023-05-13 08:27 UTC2023-05A204313-001ACYCLOVIR200MGCAPSULE / ORALAB2016-03-25053a50430f4f…
2023-01-26 05:58 UTC2023-01A204313-001ACYCLOVIR200MGCAPSULE / ORALAB2016-03-253bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A204313-001ACYCLOVIR200MGCAPSULE / ORALAB2016-03-253a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A204313-001ACYCLOVIR200MGCAPSULE / ORALAB2016-03-25f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A204313-001ACYCLOVIR200MGCAPSULE / ORALAB2016-03-25e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A204313-001ACYCLOVIR200MGCAPSULE / ORALAB2016-03-25cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A204313-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204313-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204313-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204313-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204313-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204313-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204313-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204313-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204313-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204313-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204313-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204313-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204313-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204313-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204313-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204313-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204313-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A204313-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A204313-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A204313-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A204313-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A204313-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A204313-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A204313-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A204313-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A204313-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A204313-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A204313-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A204313-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A204313-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A204313-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A204313-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A204313-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A204313-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A204313-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A204313-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A204313-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A204313-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A204313-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A204313-001AB1cb3db0bc1861…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACYCLOVIR200 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
197310Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e580b7e9-9060-43f5-9b58-33998078d7e4Available 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
72578-002-01acyclovir100 in 1 BOTTLECAPSULE1005
72578-002-05acyclovir500 in 1 BOTTLECAPSULE5005
72578-002-06acyclovir30 in 1 BOTTLECAPSULE305
72578-002-10acyclovir1000 in 1 BOTTLECAPSULE10005
72578-002-16acyclovir90 in 1 BOTTLECAPSULE905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72578-002-01EA - Each72578-002f08917d2-e772-4702-bf5c-32379ec5b07112021-02-05
72578-002-05EA - Each72578-00214e14538-73b3-4116-87d9-8fe3743d6ba412021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72578-002ACYCLOVIR CAPSULE [VIONA PHARMACEUTICALS INC]4Current NDC, Legacy NDC, 5 package rows20231101_e580b7e9-9060-43f5-9b58-33998078d7e4.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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
acyclovirACYCLOVIRPD-Rx Pharmaceuticals, Inc.86c43bdf-c5bf-47cd-8dfd-8112638258782026-07-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204313
application number: ANDA204313
acyclovirACYCLOVIRProficient Rx LPd4729677-164b-41b8-bbc4-4e47346b0f722026-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204313
application number: ANDA204313
acyclovirACYCLOVIRREMEDYREPACK INC.0990b625-5dfe-4810-b5b4-ac5948599e792026-04-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204313
application number: ANDA204313
acyclovirACYCLOVIRA-S Medication Solutionsa0ed999f-7366-42c3-a6f5-3c239215a99c2026-03-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204313
application number: ANDA204313
acyclovirACYCLOVIRNorthwind Health Company, LLCff9776b3-a248-e1ea-e053-6294a90aeb7b2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204313
application number: ANDA204313
acyclovirACYCLOVIRViona Pharmaceuticals Ince580b7e9-9060-43f5-9b58-33998078d7e42025-12-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204313
application number: ANDA204313
ndc (product): 72578-002
acyclovirACYCLOVIRZydus Lifesciences Limited395cd839-21e1-43e2-a8ce-078f07bc76682025-11-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204313
application number: ANDA204313
acyclovirACYCLOVIRBryant Ranch Prepackc818e86c-a4d0-48cd-a888-fa1ee9e2aa192025-09-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204313
application number: ANDA204313
AcyclovirACYCLOVIRNuCare Pharmaceuticals,Inc.cacaeb2a-6d3b-cf3e-e053-2a95a90a6ce42025-01-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204313
application number: ANDA204313

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197310acyclovir 200 MG Oral CapsulePSNc818e86c-a4d0-48cd-a888-fa1ee9e2aa19101
197310acyclovir 200 MG Oral CapsuleSCDc818e86c-a4d0-48cd-a888-fa1ee9e2aa19101
197310acycycloguanosine 200 MG Oral CapsuleSYc818e86c-a4d0-48cd-a888-fa1ee9e2aa19101
197310acyclovir 200 MG Oral CapsulePSN0990b625-5dfe-4810-b5b4-ac5948599e797
197310acyclovir 200 MG Oral CapsuleSCD0990b625-5dfe-4810-b5b4-ac5948599e797
197310acycycloguanosine 200 MG Oral CapsuleSY0990b625-5dfe-4810-b5b4-ac5948599e797
197310acyclovir 200 MG Oral CapsulePSNe580b7e9-9060-43f5-9b58-33998078d7e45
197310acyclovir 200 MG Oral CapsuleSCDe580b7e9-9060-43f5-9b58-33998078d7e45
197310acycycloguanosine 200 MG Oral CapsuleSYe580b7e9-9060-43f5-9b58-33998078d7e45
197310acyclovir 200 MG Oral CapsulePSNff9776b3-a248-e1ea-e053-6294a90aeb7b3
197310acyclovir 200 MG Oral CapsulePSNcacaeb2a-6d3b-cf3e-e053-2a95a90a6ce43
197310acyclovir 200 MG Oral CapsulePSNa0ed999f-7366-42c3-a6f5-3c239215a99c3
197310acyclovir 200 MG Oral CapsuleSCDa0ed999f-7366-42c3-a6f5-3c239215a99c3
197310acyclovir 200 MG Oral CapsuleSCDcacaeb2a-6d3b-cf3e-e053-2a95a90a6ce43
197310acyclovir 200 MG Oral CapsuleSCDff9776b3-a248-e1ea-e053-6294a90aeb7b3
197310acycycloguanosine 200 MG Oral CapsuleSYa0ed999f-7366-42c3-a6f5-3c239215a99c3
197310acycycloguanosine 200 MG Oral CapsuleSYcacaeb2a-6d3b-cf3e-e053-2a95a90a6ce43
197310acycycloguanosine 200 MG Oral CapsuleSYff9776b3-a248-e1ea-e053-6294a90aeb7b3
197310acyclovir 200 MG Oral CapsulePSNfcc7fd8f-b361-463e-90ae-59397e48866e2
197310acyclovir 200 MG Oral CapsulePSNd4729677-164b-41b8-bbc4-4e47346b0f722
197310acyclovir 200 MG Oral CapsulePSNf4c224c8-c28c-254c-e053-2a95a90a9cda2
197310acyclovir 200 MG Oral CapsuleSCDd4729677-164b-41b8-bbc4-4e47346b0f722
197310acyclovir 200 MG Oral CapsuleSCDfcc7fd8f-b361-463e-90ae-59397e48866e2
197310acyclovir 200 MG Oral CapsuleSCDf4c224c8-c28c-254c-e053-2a95a90a9cda2
197310acycycloguanosine 200 MG Oral CapsuleSYf4c224c8-c28c-254c-e053-2a95a90a9cda2
197310acycycloguanosine 200 MG Oral CapsuleSYd4729677-164b-41b8-bbc4-4e47346b0f722
197310acycycloguanosine 200 MG Oral CapsuleSYfcc7fd8f-b361-463e-90ae-59397e48866e2
197310acyclovir 200 MG Oral CapsulePSN266bb8b5-f762-e84d-e063-6394a90ae1b91
197310acyclovir 200 MG Oral CapsulePSN86c43bdf-c5bf-47cd-8dfd-8112638258781
197310acyclovir 200 MG Oral CapsuleSCD266bb8b5-f762-e84d-e063-6394a90ae1b91
197310acyclovir 200 MG Oral CapsuleSCD86c43bdf-c5bf-47cd-8dfd-8112638258781
197310acycycloguanosine 200 MG Oral CapsuleSY266bb8b5-f762-e84d-e063-6394a90ae1b91
197310acycycloguanosine 200 MG Oral CapsuleSY86c43bdf-c5bf-47cd-8dfd-8112638258781

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72578-002-0172578000201100 CAPSULE in 1 BOTTLE (72578-002-01) 100 capsule2019-08-230000-00-00NoNoCurrent
72578-002-0572578000205500 CAPSULE in 1 BOTTLE (72578-002-05) 500 capsule2019-08-230000-00-00NoNoCurrent
72578-002-067257800020630 CAPSULE in 1 BOTTLE (72578-002-06) 30 capsule2019-08-230000-00-00NoNoCurrent
72578-002-10725780002101000 CAPSULE in 1 BOTTLE (72578-002-10) 1000 capsule2019-08-230000-00-00NoNoCurrent
72578-002-167257800021690 CAPSULE in 1 BOTTLE (72578-002-16) 90 capsule2019-08-230000-00-00NoNoCurrent