FDA.reportPublic FDA data

Clarithromycin

Product NDC
33261-618
11-digit product format
332610618
Labeler code
33261
Product ID
33261-618_c32a755e-ce62-4ae6-a581-e1f2f26e65ed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clarithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA065266
Marketing category
ANDA
Marketing start
2006-05-31
Marketing end
0000-00-00
Substance
CLARITHROMYCIN
Active strength
500 mg/1
Pharmacologic classes
Macrolide Antimicrobial [EPC],Macrolides [CS],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct33261-618IInactivated by FDA2026-08-03
excluded packagepackage33261-61833261-618-10IInactivated by FDA2026-08-03
excluded packagepackage33261-61833261-618-14IInactivated by FDA2026-08-03
excluded packagepackage33261-61833261-618-20IInactivated by FDA2026-08-03

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
A065266-001CLARITHROMYCINCLARITHROMYCIN250MGTABLET / ORAL2006-05-31
A065266-002CLARITHROMYCINCLARITHROMYCIN500MGTABLET / ORAL2006-05-31

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 22:54:322026-06A065266-001CLARITHROMYCIN250MGTABLET / ORAL2006-05-31a50c72e98297…
2026-08-01 22:54:322026-06A065266-002CLARITHROMYCIN500MGTABLET / ORAL2006-05-31a50c72e98297…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2bb254ff-3d7f-4bdb-abf9-476506008c55Product name120230117
e3d1ac4d-bee8-bcec-c4e6-12004dcb6ab2Product name720221114
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
33261-618-102020-01-31C16284748780-19d75b9d1-24c0-f424-e053-dadaa90a57ceCLARITHROMYCIN TABLETS, USP
33261-618-142020-01-31C16284748780-19d75b9d1-24c0-f424-e053-dadaa90a57ceCLARITHROMYCIN TABLETS, USP
33261-618-202020-01-31C16284748780-19d75b9d1-24c0-f424-e053-dadaa90a57ceCLARITHROMYCIN TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-618-10Clarithromycin10 in 1 BOTTLE, PLASTICTABLET, FILM COATED101
33261-618-14Clarithromycin14 in 1 BOTTLE, PLASTICTABLET, FILM COATED141
33261-618-20Clarithromycin20 in 1 BOTTLE, PLASTICTABLET, FILM COATED201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-618-10EA - Each33261-618a964b058-a8d9-45f5-9baf-278d91e4df0612016-09-02
33261-618-14EA - Each33261-618dd37ab3c-247b-43d7-8285-177c5c02c60c12015-10-02
33261-618-20EA - Each33261-61839ce88ff-e3eb-4eb9-b80b-52b7e7cf69f812015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLARITHROMYCINACTIVE INGREDIENTH1250JIK0ACLARITHROMYCIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
CLARITHROMYCINACTIVE MOIETYH1250JIK0ACLARITHROMYCIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCLARITHROMYCIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PCLARITHROMYCIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCLARITHROMYCIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCLARITHROMYCIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLARITHROMYCIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACLARITHROMYCIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CLARITHROMYCIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CLARITHROMYCIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UCLARITHROMYCIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCLARITHROMYCIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-618CLARITHROMYCIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 3 package rows20140102_b333961e-22af-41de-9fad-192d56af8d38.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197516clarithromycin 250 MG Oral TabletPSNb333961e-22af-41de-9fad-192d56af8d381
197517clarithromycin 500 MG Oral TabletPSNb333961e-22af-41de-9fad-192d56af8d381
197516clarithromycin 250 MG Oral TabletSCDb333961e-22af-41de-9fad-192d56af8d381
197517clarithromycin 500 MG Oral TabletSCDb333961e-22af-41de-9fad-192d56af8d381

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-618-103326106181010 in 1 BOTTLE, PLASTICHistorical
33261-618-143326106181414 in 1 BOTTLE, PLASTICHistorical
33261-618-203326106182020 in 1 BOTTLE, PLASTICHistorical