FDA.reportPublic FDA data

Clarithromycin

Product NDC
50268-178
11-digit product format
502680178
Labeler code
50268
Product ID
50268-178_4a8fd333-72f9-4fae-e063-6394a90af77e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clarithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AvPAK
Application
ANDA065489
Marketing category
ANDA
Marketing start
2016-10-10
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
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/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiH1250JIK0A
Rxcui197516, 197517

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
50268-178-11Clarithromycin1 in 1 BLISTER PACKTABLET, FILM COATED17
50268-178-15Clarithromycin50 in 1 BOX, UNIT-DOSETABLET, FILM COATED507

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-178-11EA - Each50268-178cfd6b24d-bf88-40fd-b84e-fdc29d5c6e7f12016-11-08
50268-178-15EA - Each50268-178f88dcd95-1466-4aa3-afc7-b4ee79b49a8c12016-11-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-178CLARITHROMYCIN TABLET, FILM COATED [AVPAK]6Current NDC, Legacy NDC, 2 package rows20240110_1920f943-bbf1-cfd9-7475-96a35680a9e0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197516clarithromycin 250 MG Oral TabletPSN1920f943-bbf1-cfd9-7475-96a35680a9e07
197517clarithromycin 500 MG Oral TabletPSN1920f943-bbf1-cfd9-7475-96a35680a9e07
197516clarithromycin 250 MG Oral TabletSCD1920f943-bbf1-cfd9-7475-96a35680a9e07
197517clarithromycin 500 MG Oral TabletSCD1920f943-bbf1-cfd9-7475-96a35680a9e07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-178-11502680178111 in 1 BLISTER PACKHistorical
50268-178-155026801781550 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-178-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-178-11) 50 blister pack2016-10-100000-00-00NoNoCurrent