FDA.reportPublic FDA data

Acyclovir

Product NDC
80425-0270
11-digit product format
804250270
Labeler code
80425
Product ID
80425-0270_2a9bad62-b2ff-697c-e063-6294a90aa395
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA203834
Marketing category
ANDA
Marketing start
2023-02-15
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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A203834-001ACYCLOVIR400MGTABLET / ORALAB2013-10-29a50c72e98297…
2026-08-01 22:54:322026-06A203834-002ACYCLOVIR800MGTABLET / ORALABRS2013-10-29a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A203834-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A203834-002AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
ndc (product): 80425-0270
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

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
f4c5779d-e4bf-4f2b-e053-2995a90a9187Available 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
80425-0270-1Acyclovir40 in 1 BOTTLETABLET402

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0270-1EA - Each80425-027057230474-f987-412a-8a38-afa6e635dd9b12023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0270ACYCLOVIR TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 1 package rows20250102_f4c5779d-e4bf-4f2b-e053-2995a90a9187.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197311acyclovir 400 MG Oral TabletPSNf4c5779d-e4bf-4f2b-e053-2995a90a91872
197311acyclovir 400 MG Oral TabletSCDf4c5779d-e4bf-4f2b-e053-2995a90a91872
197311acycycloguanosine 400 MG Oral TabletSYf4c5779d-e4bf-4f2b-e053-2995a90a91872

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0270-18042502700140 TABLET in 1 BOTTLE (80425-0270-1) 40 tablet2023-02-15NoNoCurrent