Clarithromycin

Product NDC
73473-911
11-digit product format
734730911
Labeler code
73473
Product ID
73473-911_4d4303a8-74ef-6e98-e063-6394a90a47d6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clarithromycin
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Solaris Pharma Corporation
Application
ANDA208987
Marketing category
ANDA
Marketing start
2019-09-10
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
Rxcui359385

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
73473-911-60Clarithromycin60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE601

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359385clarithromycin 500 MG 24HR Extended Release Oral TabletPSN4d4303f8-88dd-8b88-e063-6394a90ab48f1
35938524 HR clarithromycin 500 MG Extended Release Oral TabletSCD4d4303f8-88dd-8b88-e063-6394a90ab48f1
359385clarithromycin 500 MG 24 HR Extended Release Oral TabletSY4d4303f8-88dd-8b88-e063-6394a90ab48f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
73473-911-607347309116060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (73473-911-60) 2019-09-10NoNoCurrent