FDA.reportPublic FDA data

Clarithromycin

Product NDC
68788-8480
11-digit product format
687888480
Labeler code
68788
Product ID
68788-8480_e91d16a6-1d59-4cd6-842d-b75fa5839b4f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clarithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA065489
Marketing category
ANDA
Marketing start
2023-07-13
Substance
CLARITHROMYCIN
Active strength
500 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
CLARITHROMYCIN500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiH1250JIK0A
Rxcui197517

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
68788-8480-2Clarithromycin20 in 1 BOTTLETABLET, FILM COATED204
68788-8480-8Clarithromycin28 in 1 BOTTLETABLET, FILM COATED284

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8480-2EA - Each68788-8480abcb3b13-2a07-42b5-a937-72a7be2bfc6f12023-08-08
68788-8480-8EA - Each68788-8480732ba457-b639-42e5-9dea-eef86663fe9712023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8480CLARITHROMYCIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]3Current NDC, 2 package rows20250305_81c0c69e-b1ae-42f3-9e85-09b8daa75d8d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197517clarithromycin 500 MG Oral TabletPSN81c0c69e-b1ae-42f3-9e85-09b8daa75d8d4
197517clarithromycin 500 MG Oral TabletSCD81c0c69e-b1ae-42f3-9e85-09b8daa75d8d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8480-26878884800220 TABLET, FILM COATED in 1 BOTTLE (68788-8480-2) 2023-07-13NoNoHistorical
68788-8480-86878884800828 TABLET, FILM COATED in 1 BOTTLE (68788-8480-8) 2023-07-13NoNoHistorical