FDA.reportPublic FDA data

Clarithromycin

Product NDC
0781-1961
11-digit product format
007811961
Labeler code
0781
Product ID
0781-1961_a18fa357-b294-48b9-aabe-dad7d6259ba3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clarithromycin
Dosage form
TABLET
Route
ORAL
Labeler
Sandoz Inc
Application
ANDA065144
Marketing category
ANDA
Marketing start
2005-10-18
Substance
CLARITHROMYCIN
Active strength
250 mg/1
Pharmacologic classes
Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0781-19610781-1961-01DDiscontinued by firm2026-07-31
excluded packagepackage0781-19610781-1961-10DDiscontinued by firm2026-07-31
excluded packagepackage0781-19610781-1961-31DDiscontinued by firm2026-07-31

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
A065144-001CLARITHROMYCINCLARITHROMYCIN250MGTABLET / ORALAB2005-10-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065144-001AB

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 22:54:322026-06A065144-001CLARITHROMYCIN250MGTABLET / ORALAB2005-10-18a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A065144-001AB1a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ClarithromycinCLARITHROMYCINSandoz Incb98b02bb-2609-49a0-b29f-e5911aa0cbc12023-05-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065144
application number: ANDA065144
ndc (product): 0781-1961

Additional Listing Data#

Finished product
Yes
Brand name base
Clarithromycin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLARITHROMYCIN250 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
H1250JIK0AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197516Internal RxNorm lookup
197517Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b98b02bb-2609-49a0-b29f-e5911aa0cbc1Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0781-1961-01Clarithromycin100 in 1 BOTTLETABLET10023
0781-1961-10Clarithromycin1000 in 1 BOTTLETABLET100023
0781-1961-31Clarithromycin30 in 1 BOTTLETABLET3023
0781-1961-60Clarithromycin60 in 1 BOTTLETABLET6023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-1961-60EA - Each0781-19617b7bb0aa-65e8-4f77-9744-f7621a19e12412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLARITHROMYCINACTIVE INGREDIENTH1250JIK0ACLARITHROMYCIN TABLET [SANDOZ INC]15
CLARITHROMYCINACTIVE MOIETYH1250JIK0ACLARITHROMYCIN TABLET [SANDOZ INC]15
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCLARITHROMYCIN TABLET [SANDOZ INC]15
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CLARITHROMYCIN TABLET [SANDOZ INC]15
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82CLARITHROMYCIN TABLET [SANDOZ INC]15
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6CLARITHROMYCIN TABLET [SANDOZ INC]15
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLARITHROMYCIN TABLET [SANDOZ INC]15
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCLARITHROMYCIN TABLET [SANDOZ INC]15
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCLARITHROMYCIN TABLET [SANDOZ INC]15
POVIDONESINACTIVE INGREDIENTFZ989GH94ECLARITHROMYCIN TABLET [SANDOZ INC]15
TALCINACTIVE INGREDIENT7SEV7J4R1UCLARITHROMYCIN TABLET [SANDOZ INC]15
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCLARITHROMYCIN TABLET [SANDOZ INC]15
clarithromycinACTIVE INGREDIENTH1250JIK0ACLARITHROMYCIN TABLET [REBEL DISTRIBUTORS CORP.]1
clarithromycinACTIVE MOIETYH1250JIK0ACLARITHROMYCIN TABLET [REBEL DISTRIBUTORS CORP.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCLARITHROMYCIN TABLET [REBEL DISTRIBUTORS CORP.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CLARITHROMYCIN TABLET [REBEL DISTRIBUTORS CORP.]1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOCLARITHROMYCIN TABLET [REBEL DISTRIBUTORS CORP.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30CLARITHROMYCIN TABLET [REBEL DISTRIBUTORS CORP.]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ACLARITHROMYCIN TABLET [REBEL DISTRIBUTORS CORP.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCLARITHROMYCIN TABLET [REBEL DISTRIBUTORS CORP.]1
povidoneINACTIVE INGREDIENTFZ989GH94ECLARITHROMYCIN TABLET [REBEL DISTRIBUTORS CORP.]1
talcINACTIVE INGREDIENT7SEV7J4R1UCLARITHROMYCIN TABLET [REBEL DISTRIBUTORS CORP.]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPCLARITHROMYCIN TABLET [REBEL DISTRIBUTORS CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-1961CLARITHROMYCIN TABLET [SANDOZ INC]23Current NDC, Legacy NDC, 4 package rows20231102_b98b02bb-2609-49a0-b29f-e5911aa0cbc1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197516clarithromycin 250 MG Oral TabletPSNb98b02bb-2609-49a0-b29f-e5911aa0cbc123
197517clarithromycin 500 MG Oral TabletPSNb98b02bb-2609-49a0-b29f-e5911aa0cbc123
197516clarithromycin 250 MG Oral TabletSCDb98b02bb-2609-49a0-b29f-e5911aa0cbc123
197517clarithromycin 500 MG Oral TabletSCDb98b02bb-2609-49a0-b29f-e5911aa0cbc123
197516clarithromycin 250 MG Oral TabletPSNf3a50f13-b028-4135-8f20-bfb62a9bc0a91
197517clarithromycin 500 MG Oral TabletPSNf3a50f13-b028-4135-8f20-bfb62a9bc0a91
197516clarithromycin 250 MG Oral TabletSCDf3a50f13-b028-4135-8f20-bfb62a9bc0a91
197517clarithromycin 500 MG Oral TabletSCDf3a50f13-b028-4135-8f20-bfb62a9bc0a91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-1961-0100781196101100 in 1 BOTTLEHistorical
0781-1961-10007811961101000 in 1 BOTTLEHistorical
0781-1961-310078119613130 in 1 BOTTLEHistorical
0781-1961-600078119616060 TABLET in 1 BOTTLE (0781-1961-60) 60 tablet2005-10-180000-00-00NoNoCurrent