Clarithromycin

Product NDC
0781-6022
11-digit product format
007816022
Labeler code
0781
Product ID
0781-6022_fcbab0c3-9fdb-40aa-9a17-e53f88a19bbc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clarithromycin
Dosage form
FOR SUSPENSION
Route
ORAL
Labeler
Sandoz Inc
Application
ANDA065283
Marketing category
ANDA
Marketing start
2007-09-04
Substance
CLARITHROMYCIN
Active strength
125 mg/5mL
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
CLARITHROMYCIN125 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiH1250JIK0A
Rxcui240741, 309322

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
0781-6022-46Clarithromycin100 mL in 1 BOTTLEFOR SUSPENSION10015
0781-6022-52Clarithromycin50 mL in 1 BOTTLEFOR SUSPENSION5015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-6022-46ML - Milliliter0781-60229f793f36-cfc3-4cab-99a0-e0c5edacc4e512012-07-24
0781-6022-52ML - Milliliter0781-6022f4a7141b-5c5e-40a7-8fba-809915931bc812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLARITHROMYCINACTIVE INGREDIENTH1250JIK0ACLARITHROMYCIN FOR SUSPENSION [SANDOZ INC]9
CLARITHROMYCINACTIVE MOIETYH1250JIK0ACLARITHROMYCIN FOR SUSPENSION [SANDOZ INC]9
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPCLARITHROMYCIN FOR SUSPENSION [SANDOZ INC]9
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4CLARITHROMYCIN FOR SUSPENSION [SANDOZ INC]9
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCLARITHROMYCIN FOR SUSPENSION [SANDOZ INC]9
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DCLARITHROMYCIN FOR SUSPENSION [SANDOZ INC]9
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JCLARITHROMYCIN FOR SUSPENSION [SANDOZ INC]9
POLOXAMER 188INACTIVE INGREDIENTLQA7B6G8JGCLARITHROMYCIN FOR SUSPENSION [SANDOZ INC]9
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACLARITHROMYCIN FOR SUSPENSION [SANDOZ INC]9
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCLARITHROMYCIN FOR SUSPENSION [SANDOZ INC]9
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4CLARITHROMYCIN FOR SUSPENSION [SANDOZ INC]9
POVIDONESINACTIVE INGREDIENTFZ989GH94ECLARITHROMYCIN FOR SUSPENSION [SANDOZ INC]9
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CLARITHROMYCIN FOR SUSPENSION [SANDOZ INC]9
SUCROSEINACTIVE INGREDIENTC151H8M554CLARITHROMYCIN FOR SUSPENSION [SANDOZ INC]9
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCLARITHROMYCIN FOR SUSPENSION [SANDOZ INC]9
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMCLARITHROMYCIN FOR SUSPENSION [SANDOZ INC]9
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECLARITHROMYCIN FOR SUSPENSION [SANDOZ INC]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-6022CLARITHROMYCIN FOR SUSPENSION [SANDOZ INC]15Current NDC, Legacy NDC, 2 package rows20231102_22457862-0f88-4be8-b507-1c8f264269f2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
240741clarithromycin 125 MG in 5 mL Oral SuspensionPSN22457862-0f88-4be8-b507-1c8f264269f215
309322clarithromycin 250 MG in 5 mL Oral SuspensionPSN22457862-0f88-4be8-b507-1c8f264269f215
240741clarithromycin 25 MG/ML Oral SuspensionSCD22457862-0f88-4be8-b507-1c8f264269f215
309322clarithromycin 50 MG/ML Oral SuspensionSCD22457862-0f88-4be8-b507-1c8f264269f215
240741clarithromycin 125 MG per 5 ML Oral SuspensionSY22457862-0f88-4be8-b507-1c8f264269f215
309322clarithromycin 250 MG per 5 ML Oral SuspensionSY22457862-0f88-4be8-b507-1c8f264269f215

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-6022-4600781602246100 mL in 1 BOTTLE (0781-6022-46) 100 ml2007-09-040000-00-00NoNoCurrent
0781-6022-520078160225250 mL in 1 BOTTLE (0781-6022-52) 50 ml2007-09-040000-00-00NoNoCurrent