FDA.reportPublic FDA data

Acyclovir

Product NDC
71335-1013
Requested package NDC
71335-1013-8
11-digit product format
713351013
Labeler code
71335
Product ID
71335-1013_1dc4a821-b0d6-433c-94f4-61c1a479102a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA201445
Marketing category
ANDA
Marketing start
2016-10-15
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage71335-101371335-1013-8IInactivated by FDA2026-07-31

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
A201445-001ACYCLOVIRACYCLOVIR200MGCAPSULE / ORALAB2014-03-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A201445-001AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A201445-001ACYCLOVIR200MGCAPSULE / ORALAB2014-03-06a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A201445-001AB1a50c72e98297…

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 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcyclovirACYCLOVIRModavar Pharmaceuticals LLCc7317324-4654-4bcc-8edf-7b7cd8794d2e2026-04-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201445
application number: ANDA201445
AcyclovirACYCLOVIRCadila Pharmaceuticals Limiteddbaf4bf5-57e3-4770-a9b2-d47649e54c1b2026-01-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201445
application number: ANDA201445
AcyclovirACYCLOVIRNivagen Pharmaceuticals, Inc.1b0919aa-0d41-4c91-9ef4-049ac9e27d782022-02-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201445
application number: ANDA201445

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71335-1013-02024-01-30C16284748780-11030e365-14fd-111a-e063-dadaa90a10e2Acyclovir Capsules, USP 200 mg Nivagen Pharmaceuticals, Inc.
71335-1013-12024-01-30C16284748780-11030e365-14fd-111a-e063-dadaa90a10e2Acyclovir Capsules, USP 200 mg Nivagen Pharmaceuticals, Inc.
71335-1013-22024-01-30C16284748780-11030e365-14fd-111a-e063-dadaa90a10e2Acyclovir Capsules, USP 200 mg Nivagen Pharmaceuticals, Inc.
71335-1013-32024-01-30C16284748780-11030e365-14fd-111a-e063-dadaa90a10e2Acyclovir Capsules, USP 200 mg Nivagen Pharmaceuticals, Inc.
71335-1013-42024-01-30C16284748780-11030e365-14fd-111a-e063-dadaa90a10e2Acyclovir Capsules, USP 200 mg Nivagen Pharmaceuticals, Inc.
71335-1013-52024-01-30C16284748780-11030e365-14fd-111a-e063-dadaa90a10e2Acyclovir Capsules, USP 200 mg Nivagen Pharmaceuticals, Inc.
71335-1013-62024-01-30C16284748780-11030e365-14fd-111a-e063-dadaa90a10e2Acyclovir Capsules, USP 200 mg Nivagen Pharmaceuticals, Inc.
71335-1013-72024-01-30C16284748780-11030e365-14fd-111a-e063-dadaa90a10e2Acyclovir Capsules, USP 200 mg Nivagen Pharmaceuticals, Inc.
71335-1013-82024-01-30C16284748780-11030e365-14fd-111a-e063-dadaa90a10e2Acyclovir Capsules, USP 200 mg Nivagen Pharmaceuticals, Inc.
71335-1013-92024-01-30C16284748780-11030e365-14fd-111a-e063-dadaa90a10e2Acyclovir Capsules, USP 200 mg Nivagen Pharmaceuticals, Inc.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1013-0Acyclovir90 in 1 BOTTLECAPSULE904
71335-1013-1Acyclovir30 in 1 BOTTLECAPSULE304
71335-1013-2Acyclovir25 in 1 BOTTLECAPSULE254
71335-1013-3Acyclovir35 in 1 BOTTLECAPSULE354
71335-1013-4Acyclovir50 in 1 BOTTLECAPSULE504
71335-1013-5Acyclovir100 in 1 BOTTLECAPSULE1004
71335-1013-6Acyclovir40 in 1 BOTTLECAPSULE404
71335-1013-7Acyclovir60 in 1 BOTTLECAPSULE604
71335-1013-8Acyclovir120 in 1 BOTTLECAPSULE1204
71335-1013-9Acyclovir20 in 1 BOTTLECAPSULE204

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1013ACYCLOVIR CAPSULE [BRYANT RANCH PREPACK]4Legacy NDC, 10 package rows20220316_1dc4a821-b0d6-433c-94f4-61c1a479102a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197310acyclovir 200 MG Oral CapsulePSN1dc4a821-b0d6-433c-94f4-61c1a479102a4
197310acyclovir 200 MG Oral CapsuleSCD1dc4a821-b0d6-433c-94f4-61c1a479102a4
197310acycycloguanosine 200 MG Oral CapsuleSY1dc4a821-b0d6-433c-94f4-61c1a479102a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1013-871335101308120 CAPSULE in 1 BOTTLE (71335-1013-8) 120 capsule2022-03-090000-00-00NoNoCurrent