Acyclovir

Product NDC
63629-1678
11-digit product format
636291678
Labeler code
63629
Product ID
63629-1678_493fe3ca-2fb6-43a4-8bfd-44e53804d6f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075382
Marketing category
ANDA
Marketing start
2009-10-22
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 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
A075382-001ACYCLOVIRACYCLOVIR400MGTABLET / ORALAB1999-04-30
A075382-002ACYCLOVIRACYCLOVIR800MGTABLET / ORALAB1999-04-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075382-001AB
A075382-002AB

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 UTC2026-02A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-308072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-305c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-305d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-304b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-3074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-30bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075382-001ACYCLOVIR400MGTABLET / ORALAB1999-04-30782e0a99824c…
2021-12-28 21:50 UTC2021-12A075382-002ACYCLOVIR800MGTABLET / ORALAB1999-04-30782e0a99824c…

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 UTC2026-02A075382-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075382-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075382-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075382-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075382-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075382-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075382-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075382-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075382-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075382-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075382-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075382-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075382-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075382-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075382-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075382-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075382-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075382-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075382-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075382-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075382-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075382-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075382-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075382-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075382-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075382-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075382-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075382-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075382-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075382-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075382-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075382-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075382-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075382-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075382-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075382-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075382-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075382-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075382-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A075382-002AB1782e0a99824c…

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
f3cbd634-77c8-3306-bdbd-a4598b20603eAvailable 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
63629-1678-0Acyclovir500 in 1 BOTTLETABLET50022
63629-1678-1Acyclovir25 in 1 BOTTLETABLET2522
63629-1678-2Acyclovir35 in 1 BOTTLETABLET3522
63629-1678-3Acyclovir30 in 1 BOTTLETABLET3022
63629-1678-4Acyclovir60 in 1 BOTTLETABLET6022
63629-1678-5Acyclovir50 in 1 BOTTLETABLET5022
63629-1678-6Acyclovir10 in 1 BOTTLETABLET1022
63629-1678-7Acyclovir40 in 1 BOTTLETABLET4022
63629-1678-8Acyclovir21 in 1 BOTTLETABLET2122
63629-1678-9Acyclovir90 in 1 BOTTLETABLET9022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1678-1EA - Each63629-16783ed69acc-6e7e-4626-a190-62589f6fae8612012-07-24
63629-1678-2EA - Each63629-1678bf0cda76-c198-4f44-ad18-e10ac8a7c52912012-07-24
63629-1678-3EA - Each63629-16787da81c29-fa81-4e69-98e1-4d123b70c64412012-07-24
63629-1678-4EA - Each63629-1678754681ec-7109-4998-ab6d-9d7addb72cde12012-07-24
63629-1678-5EA - Each63629-167813c0e740-7146-4428-bf9e-e52d408a498c12012-07-24
63629-1678-7EA - Each63629-167850eef86f-78ed-4cd7-a285-a17f5230e61412020-09-14
63629-1678-8EA - Each63629-167894021499-6e61-41cf-8479-7937d5e2d45c12020-09-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACYCLOVIRACTIVE INGREDIENTX4HES1O11FACYCLOVIR TABLET [BRYANT RANCH PREPACK]2
ACYCLOVIRACTIVE MOIETYX4HES1O11FACYCLOVIR TABLET [BRYANT RANCH PREPACK]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACYCLOVIR TABLET [BRYANT RANCH PREPACK]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACYCLOVIR TABLET [BRYANT RANCH PREPACK]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ACYCLOVIR TABLET [BRYANT RANCH PREPACK]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJACYCLOVIR TABLET [BRYANT RANCH PREPACK]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1678ACYCLOVIR TABLET [BRYANT RANCH PREPACK]22Current NDC, Legacy NDC, 10 package rows20241108_f3cbd634-77c8-3306-bdbd-a4598b20603e.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
AcyclovirACYCLOVIRCardinal Health 107, LLCd8004652-86fe-4714-81d4-5e1dd2585bb42026-04-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075382
application number: ANDA075382
AcyclovirACYCLOVIRNuCare Pharmaceuticals,Inc.c2d9940a-ce88-5fd0-e053-2a95a90a4bc82026-03-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075382
application number: ANDA075382
AcyclovirACYCLOVIRAvPAK6e203fa9-ee97-1e08-8d6a-fb57cfa13e192026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075382
application number: ANDA075382
AcyclovirACYCLOVIRBryant Ranch Prepackf3cbd634-77c8-3306-bdbd-a4598b20603e2024-10-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075382
application number: ANDA075382
ndc (product): 63629-1678
AcyclovirACYCLOVIRBryant Ranch Prepacke0f17e6f-63c7-4828-8585-91fc582df30b2024-09-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075382
application number: ANDA075382
AcyclovirACYCLOVIRBryant Ranch Prepackf09cdb3f-dfd2-4e47-bb5e-a5d26d8bcc892024-09-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075382
application number: ANDA075382
AcyclovirACYCLOVIRBryant Ranch Prepack8c5d1f30-2d31-417d-860b-7228b7baaa642024-09-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075382
application number: ANDA075382
AcyclovirACYCLOVIRGolden State Medical Supply, Inc.785d68bc-0bbf-b69d-e053-2991aa0ac0d52024-09-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075382
application number: ANDA075382
AcyclovirACYCLOVIRBryant Ranch Prepack89583890-186b-4a7a-8741-41f6c5f0a99d2024-09-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075382
application number: ANDA075382
AcyclovirACYCLOVIRCarlsbad Technology, Inc.a68e610a-841c-4b69-9233-673d060561e82024-08-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075382
application number: ANDA075382
AcyclovirACYCLOVIRNuCare Pharmaceuticals,Inc.c46d5033-b1b2-e213-e053-2995a90ae6a32024-08-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075382
application number: ANDA075382
AcyclovirACYCLOVIRProficient Rx LP33630a35-346e-43b6-9286-89e28ac0094a2022-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075382
application number: ANDA075382

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197313acyclovir 800 MG Oral TabletPSNf3cbd634-77c8-3306-bdbd-a4598b20603e22
197313acyclovir 800 MG Oral TabletSCDf3cbd634-77c8-3306-bdbd-a4598b20603e22
197313acycycloguanosine 800 MG Oral TabletSYf3cbd634-77c8-3306-bdbd-a4598b20603e22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1678-063629167800500 TABLET in 1 BOTTLE (63629-1678-0) 500 tablet2018-05-210000-00-00NoNoCurrent
63629-1678-16362916780125 TABLET in 1 BOTTLE (63629-1678-1) 25 tablet2024-10-290000-00-00NoNoCurrent
63629-1678-26362916780235 TABLET in 1 BOTTLE (63629-1678-2) 35 tablet2024-10-290000-00-00NoNoCurrent
63629-1678-36362916780330 TABLET in 1 BOTTLE (63629-1678-3) 30 tablet2024-10-290000-00-00NoNoCurrent
63629-1678-46362916780460 TABLET in 1 BOTTLE (63629-1678-4) 60 tablet2024-10-290000-00-00NoNoCurrent
63629-1678-56362916780550 TABLET in 1 BOTTLE (63629-1678-5) 50 tablet2024-10-290000-00-00NoNoCurrent
63629-1678-66362916780610 TABLET in 1 BOTTLE (63629-1678-6) 10 tablet2013-03-280000-00-00NoNoCurrent
63629-1678-76362916780740 TABLET in 1 BOTTLE (63629-1678-7) 40 tablet2011-06-090000-00-00NoNoCurrent
63629-1678-86362916780821 TABLET in 1 BOTTLE (63629-1678-8) 21 tablet2011-11-170000-00-00NoNoCurrent
63629-1678-96362916780990 TABLET in 1 BOTTLE (63629-1678-9) 90 tablet2020-06-040000-00-00NoNoCurrent