Acyclovir

Product NDC
54348-627
11-digit product format
543480627
Labeler code
54348
Product ID
54348-627_ea937906-dba1-207f-e053-2a95a90a111e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
PharmPak, Inc.
Application
ANDA203834
Marketing category
ANDA
Marketing start
2013-11-29
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
A203834-001ACYCLOVIRACYCLOVIR400MGTABLET / ORALAB2013-10-29
A203834-002ACYCLOVIRACYCLOVIR800MGTABLET / ORALABRS2013-10-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203834-001AB
A203834-002AB

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 UTC2026-02A203834-001ACYCLOVIR400MGTABLET / ORALAB2013-10-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203834-002ACYCLOVIR800MGTABLET / ORALABRS2013-10-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203834-001ACYCLOVIR400MGTABLET / ORALAB2013-10-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203834-002ACYCLOVIR800MGTABLET / ORALABRS2013-10-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A203834-001ACYCLOVIR400MGTABLET / ORALAB2013-10-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203834-002ACYCLOVIR800MGTABLET / ORALABRS2013-10-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203834-001ACYCLOVIR400MGTABLET / ORALAB2013-10-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203834-002ACYCLOVIR800MGTABLET / ORALABRS2013-10-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203834-001ACYCLOVIR400MGTABLET / ORALAB2013-10-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203834-002ACYCLOVIR800MGTABLET / ORALABRS2013-10-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203834-001ACYCLOVIR400MGTABLET / ORALAB2013-10-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203834-002ACYCLOVIR800MGTABLET / ORALABRS2013-10-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203834-001ACYCLOVIR400MGTABLET / ORALAB2013-10-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203834-002ACYCLOVIR800MGTABLET / ORALABRS2013-10-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203834-001ACYCLOVIR400MGTABLET / ORALAB2013-10-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203834-002ACYCLOVIR800MGTABLET / ORALABRS2013-10-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203834-001ACYCLOVIR400MGTABLET / ORALAB2013-10-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203834-002ACYCLOVIR800MGTABLET / ORALABRS2013-10-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203834-001ACYCLOVIR400MGTABLET / ORALAB2013-10-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A203834-002ACYCLOVIR800MGTABLET / ORALABRS2013-10-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203834-001ACYCLOVIR400MGTABLET / ORALAB2013-10-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203834-002ACYCLOVIR800MGTABLET / ORALABRS2013-10-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203834-001ACYCLOVIR400MGTABLET / ORALAB2013-10-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203834-002ACYCLOVIR800MGTABLET / ORALABRS2013-10-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203834-001ACYCLOVIR400MGTABLET / ORALAB2013-10-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203834-002ACYCLOVIR800MGTABLET / ORALABRS2013-10-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203834-001ACYCLOVIR400MGTABLET / ORALAB2013-10-298072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203834-002ACYCLOVIR800MGTABLET / ORALABRS2013-10-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203834-001ACYCLOVIR400MGTABLET / ORALAB2013-10-295c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203834-002ACYCLOVIR800MGTABLET / ORALABRS2013-10-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203834-001ACYCLOVIR400MGTABLET / ORALAB2013-10-295d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203834-002ACYCLOVIR800MGTABLET / ORALABRS2013-10-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203834-001ACYCLOVIR400MGTABLET / ORALAB2013-10-294b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203834-002ACYCLOVIR800MGTABLET / ORALABRS2013-10-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203834-001ACYCLOVIR400MGTABLET / ORALAB2013-10-2974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203834-002ACYCLOVIR800MGTABLET / ORALAB2013-10-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203834-001ACYCLOVIR400MGTABLET / ORALAB2013-10-29bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203834-002ACYCLOVIR800MGTABLET / ORALABRS2013-10-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203834-001ACYCLOVIR400MGTABLET / ORALAB2013-10-29782e0a99824c…
2021-12-28 21:50 UTC2021-12A203834-002ACYCLOVIR800MGTABLET / ORALABRS2013-10-29782e0a99824c…

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 UTC2026-02A203834-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203834-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203834-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203834-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203834-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203834-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203834-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203834-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203834-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203834-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203834-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203834-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203834-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203834-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203834-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203834-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203834-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203834-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203834-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203834-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203834-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203834-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203834-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203834-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203834-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203834-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203834-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203834-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203834-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203834-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203834-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203834-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203834-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203834-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203834-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203834-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203834-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203834-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203834-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A203834-002AB1782e0a99824c…

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
8fb01f23-e2bd-6850-e053-2995a90a7cc5Available 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
54348-627-10Acyclovir1 in 1 BOXTABLET12
54348-627-10Acyclovir10 in 1 BOTTLETABLET102
54348-627-15Acyclovir1 in 1 BOXTABLET12
54348-627-15Acyclovir15 in 1 BOTTLETABLET152
54348-627-20Acyclovir20 in 1 BOTTLETABLET202
54348-627-20Acyclovir1 in 1 BOXTABLET12
54348-627-21Acyclovir21 in 1 BOTTLETABLET212
54348-627-21Acyclovir1 in 1 BOXTABLET12
54348-627-25Acyclovir25 in 1 BOTTLETABLET252
54348-627-25Acyclovir1 in 1 BOXTABLET12
54348-627-30Acyclovir30 in 1 BOTTLETABLET302
54348-627-30Acyclovir1 in 1 BOXTABLET12
54348-627-60Acyclovir60 in 1 BOTTLETABLET602
54348-627-60Acyclovir1 in 1 BOXTABLET12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54348-627ACYCLOVIR TABLET [PHARMPAK, INC.]2Current NDC, Legacy NDC, 14 package rows20221011_8fb01f23-e2bd-6850-e053-2995a90a7cc5.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 2 · 22 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcyclovirACYCLOVIRREMEDYREPACK INC.6d0e492e-5359-49e8-812d-8c8e2e5d42f82026-07-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203834
application number: ANDA203834
AcyclovirACYCLOVIRREMEDYREPACK INC.736679be-469e-4bdb-8e15-b10751c3dd602026-07-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203834
application number: ANDA203834
AcyclovirACYCLOVIRREMEDYREPACK INC.38547daa-7d2f-4a7b-84d3-6e164984f9582026-07-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203834
application number: ANDA203834
AcyclovirACYCLOVIRSt. Mary's Medical Park Pharmacy1493e22d-455d-b613-e063-6294a90afede2026-06-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203834
application number: ANDA203834
AcyclovirACYCLOVIRBryant Ranch Prepackdbdb7903-0991-413d-b1ad-ab0f1ae2d8f42026-06-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203834
application number: ANDA203834
AcyclovirACYCLOVIRPD-Rx Pharmaceuticals, Inc.db0a0ce5-dc39-4bd3-8b97-21ce9c9999f02026-05-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203834
application number: ANDA203834
AcyclovirACYCLOVIRBryant Ranch Prepack0e78d5e8-ae2d-4e84-b8c2-6765b1299c122026-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203834
application number: ANDA203834
AcyclovirACYCLOVIRPD-Rx Pharmaceuticals, Inc.e8a0f9f8-294f-4dd6-bd55-10a6253f1aa82026-04-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203834
application number: ANDA203834
AcyclovirACYCLOVIRMajor Pharmaceuticals46150f19-ce5d-42a0-80a7-f96fda2b98792026-02-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203834
application number: ANDA203834
AcyclovirACYCLOVIRPreferred Pharmaceuticals, Inc.b6d69697-12bb-4548-a6c3-2463cbf54f8f2026-02-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203834
application number: ANDA203834
AcyclovirACYCLOVIRCamber Pharmaceuticals, Inc.0910335b-6796-459f-b97e-d7ef5439a0602026-02-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203834
application number: ANDA203834
AcyclovirACYCLOVIRNorthwind Health Company, LLC5dcfd21c-43f0-469c-be70-a4e74e6ccf882026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203834
application number: ANDA203834
AcyclovirACYCLOVIRNorthwind Health Company, LLCf6f56143-ea74-af87-e053-6394a90ae3462026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203834
application number: ANDA203834
AcyclovirACYCLOVIRAdvanced Rx Pharmacy of Tennessee, LLCf4c5779d-e4bf-4f2b-e053-2995a90a91872024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203834
application number: ANDA203834
AcyclovirACYCLOVIRNuCare Pharmaceuticals,Inc.638803d2-a172-486d-e053-2991aa0ab0742024-07-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203834
application number: ANDA203834
AcyclovirACYCLOVIRNuCare Pharmaceuticals, Inc.5176c7f9-9076-4797-e054-00144ff8d46c2024-07-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203834
application number: ANDA203834
AcyclovirACYCLOVIRNuCare Pharmaceuticals,Inc.83e82707-85b6-2fea-e053-2991aa0a99ef2024-06-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203834
application number: ANDA203834
AcyclovirACYCLOVIRA-S Medication Solutionse4f91376-9e18-41a4-aa5e-adcea0c625d92023-12-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203834
application number: ANDA203834
AcyclovirACYCLOVIRPharmPak, Inc.d824fc07-9f03-4cb2-9bf8-ff7cc29552552022-10-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203834
application number: ANDA203834
AcyclovirACYCLOVIRPharmPak, Inc.8fb01f23-e2bd-6850-e053-2995a90a7cc52022-10-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203834
application number: ANDA203834
ndc (product): 54348-627

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197311acyclovir 400 MG Oral TabletPSN8fb01f23-e2bd-6850-e053-2995a90a7cc52
197311acyclovir 400 MG Oral TabletSCD8fb01f23-e2bd-6850-e053-2995a90a7cc52
197311acycycloguanosine 400 MG Oral TabletSY8fb01f23-e2bd-6850-e053-2995a90a7cc52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54348-627-10543480627101 BOTTLE in 1 BOX (54348-627-10) / 10 TABLET in 1 BOTTLE1 bottle2019-08-080000-00-00NoNoCurrent
54348-627-15543480627151 BOTTLE in 1 BOX (54348-627-15) / 15 TABLET in 1 BOTTLE1 bottle2019-08-080000-00-00NoNoCurrent
54348-627-20543480627201 BOTTLE in 1 BOX (54348-627-20) / 20 TABLET in 1 BOTTLE1 bottle2019-08-080000-00-00NoNoCurrent
54348-627-21543480627211 BOTTLE in 1 BOX (54348-627-21) / 21 TABLET in 1 BOTTLE1 bottle2019-08-080000-00-00NoNoCurrent
54348-627-25543480627251 BOTTLE in 1 BOX (54348-627-25) / 25 TABLET in 1 BOTTLE1 bottle2019-08-080000-00-00NoNoCurrent
54348-627-30543480627301 BOTTLE in 1 BOX (54348-627-30) / 30 TABLET in 1 BOTTLE1 bottle2019-08-080000-00-00NoNoCurrent
54348-627-60543480627601 BOTTLE in 1 BOX (54348-627-60) / 60 TABLET in 1 BOTTLE1 bottle2019-08-080000-00-00NoNoCurrent