FDA.reportPublic FDA data

Clarithromycin

Product NDC
50090-0994
11-digit product format
500900994
Labeler code
50090
Product ID
50090-0994_b17c8e0b-5db9-4116-9073-8e8fac3459dc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clarithromycin
Dosage form
FOR SUSPENSION
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA065283
Marketing category
ANDA
Marketing start
2007-09-04
Substance
CLARITHROMYCIN
Active strength
250 mg/5mL
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Clarithromycin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLARITHROMYCIN250 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiH1250JIK0A
Rxcui309322

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
50090-0994-02023-02-07C16284748780-1f386c649-ab14-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CLARITHROMYCIN FOR ORAL SUSPENSION safely and effectively. See full prescribing information for CLARITHROMYCIN FOR ORAL SUSPENSION. CLARITHROMYCIN for oral suspension, for oral use Initial U.S. Approval: 1991
50090-0994-02023-01-30C16284748780-1f386c649-ab14-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CLARITHROMYCIN FOR ORAL SUSPENSION safely and effectively. See full prescribing information for CLARITHROMYCIN FOR ORAL SUSPENSION. CLARITHROMYCIN for oral suspension, for oral use Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0994-0Clarithromycin50 mL in 1 BOTTLEFOR SUSPENSION5019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0994-0ML - Milliliter50090-099418e3ad50-7de1-4f5c-883d-4e9c1484abee12018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0994CLARITHROMYCIN FOR SUSPENSION [A-S MEDICATION SOLUTIONS]17Current NDC, Legacy NDC, 1 package rows20240113_fad1e5a3-59f9-4868-9937-d3b061ab8f00.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309322clarithromycin 250 MG in 5 mL Oral SuspensionPSNfad1e5a3-59f9-4868-9937-d3b061ab8f0019
309322clarithromycin 50 MG/ML Oral SuspensionSCDfad1e5a3-59f9-4868-9937-d3b061ab8f0019
309322clarithromycin 250 MG per 5 ML Oral SuspensionSYfad1e5a3-59f9-4868-9937-d3b061ab8f0019

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0994-05009009940050 mL in 1 BOTTLE (50090-0994-0) 50 ml2014-11-280000-00-00NoNoCurrent