FDA.reportPublic FDA data

Clarithromycin

Product NDC
85766-197
11-digit product format
857660197
Labeler code
85766
Product ID
85766-197_4fa17015-6060-4973-e063-6394a90a798d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clarithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sportpharm LLC
Application
ANDA210459
Marketing category
ANDA
Marketing start
2022-02-01
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
85766-197-01Clarithromycin100 in 1 BOTTLETABLET, FILM COATED1001
85766-197-05Clarithromycin5 in 1 BOTTLETABLET, FILM COATED51
85766-197-07Clarithromycin7 in 1 BOTTLETABLET, FILM COATED71
85766-197-10Clarithromycin10 in 1 BOTTLETABLET, FILM COATED101
85766-197-15Clarithromycin15 in 1 BOTTLETABLET, FILM COATED151
85766-197-20Clarithromycin20 in 1 BOTTLETABLET, FILM COATED201
85766-197-30Clarithromycin30 in 1 BOTTLETABLET, FILM COATED301
85766-197-60Clarithromycin60 in 1 BOTTLETABLET, FILM COATED601
85766-197-90Clarithromycin90 in 1 BOTTLETABLET, FILM COATED901

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197516clarithromycin 250 MG Oral TabletPSNde33ba3a-9df1-4076-8d5f-b603d26980961
197517clarithromycin 500 MG Oral TabletPSNde33ba3a-9df1-4076-8d5f-b603d26980961
197516clarithromycin 250 MG Oral TabletSCDde33ba3a-9df1-4076-8d5f-b603d26980961
197517clarithromycin 500 MG Oral TabletSCDde33ba3a-9df1-4076-8d5f-b603d26980961

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
85766-197-0185766019701100 TABLET, FILM COATED in 1 BOTTLE (85766-197-01) 2026-04-17NoNoCurrent
85766-197-05857660197055 TABLET, FILM COATED in 1 BOTTLE (85766-197-05) 2026-04-17NoNoCurrent
85766-197-07857660197077 TABLET, FILM COATED in 1 BOTTLE (85766-197-07) 2026-04-17NoNoCurrent
85766-197-108576601971010 TABLET, FILM COATED in 1 BOTTLE (85766-197-10) 2026-04-17NoNoCurrent
85766-197-158576601971515 TABLET, FILM COATED in 1 BOTTLE (85766-197-15) 2026-04-17NoNoCurrent
85766-197-208576601972020 TABLET, FILM COATED in 1 BOTTLE (85766-197-20) 2026-04-17NoNoCurrent
85766-197-308576601973030 TABLET, FILM COATED in 1 BOTTLE (85766-197-30) 2026-04-17NoNoCurrent
85766-197-608576601976060 TABLET, FILM COATED in 1 BOTTLE (85766-197-60) 2026-04-17NoNoCurrent
85766-197-908576601979090 TABLET, FILM COATED in 1 BOTTLE (85766-197-90) 2026-04-17NoNoCurrent