Clarithromycin

Product NDC
50090-0927
11-digit product format
500900927
Labeler code
50090
Product ID
50090-0927_00ba1494-ad88-49d5-bb9f-ce0ab6193853
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clarithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA065489
Marketing category
ANDA
Marketing start
2012-07-25
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

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 Identifiers#

Field, Values table
FieldValues
UniiH1250JIK0A
Rxcui197516

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
50090-0927-0Clarithromycin20 in 1 BOTTLETABLET, FILM COATED204

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0927-0EA - Each50090-09272c0d08d1-dc37-4394-be71-6efd7fdda0f912023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0927CLARITHROMYCIN TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]4Current NDC, 1 package rows20230801_1d6f5a9d-51b2-4e0d-b573-ccf08fe6ea23.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197516clarithromycin 250 MG Oral TabletPSN1d6f5a9d-51b2-4e0d-b573-ccf08fe6ea234
197516clarithromycin 250 MG Oral TabletSCD1d6f5a9d-51b2-4e0d-b573-ccf08fe6ea234

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-0927-05009009270020 TABLET, FILM COATED in 1 BOTTLE (50090-0927-0) 2014-11-28NoNoCurrent