FDA.reportPublic FDA data

Clarithromycin

Product NDC
65862-225
11-digit product format
658620225
Labeler code
65862
Product ID
65862-225_4bb3048c-0a75-4818-9be5-4c81cfe9649c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clarithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA065489
Marketing category
ANDA
Marketing start
2012-07-25
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
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
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
65862-225-60Clarithromycin60 in 1 BOTTLETABLET, FILM COATED6021
65862-225-99Clarithromycin1000 in 1 BOTTLETABLET, FILM COATED100021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-225-60EA - Each65862-22517d2f154-09f0-4ac6-9f9f-2c310267610712013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLARITHROMYCINACTIVE INGREDIENTH1250JIK0ACLARITHROMYCIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]8
CLARITHROMYCINACTIVE MOIETYH1250JIK0ACLARITHROMYCIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCLARITHROMYCIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]8
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CLARITHROMYCIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]8
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCLARITHROMYCIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]8
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PCLARITHROMYCIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]8
HYPROMELLOSE 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WCLARITHROMYCIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLARITHROMYCIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]8
POVIDONE K30INACTIVE INGREDIENTU725QWY32XCLARITHROMYCIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]8
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CLARITHROMYCIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]8
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CLARITHROMYCIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]8
SORBIC ACIDINACTIVE INGREDIENTX045WJ989BCLARITHROMYCIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCLARITHROMYCIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]8
VANILLININACTIVE INGREDIENTCHI530446XCLARITHROMYCIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-225CLARITHROMYCIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]21Current NDC, Legacy NDC, 2 package rows20231122_9aaffb41-408c-4372-8fd5-1d649450c0e9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197516clarithromycin 250 MG Oral TabletPSN9aaffb41-408c-4372-8fd5-1d649450c0e921
197517clarithromycin 500 MG Oral TabletPSN9aaffb41-408c-4372-8fd5-1d649450c0e921
197516clarithromycin 250 MG Oral TabletSCD9aaffb41-408c-4372-8fd5-1d649450c0e921
197517clarithromycin 500 MG Oral TabletSCD9aaffb41-408c-4372-8fd5-1d649450c0e921
197516clarithromycin 250 MG Oral TabletPSN1d6f5a9d-51b2-4e0d-b573-ccf08fe6ea234
197516clarithromycin 250 MG Oral TabletSCD1d6f5a9d-51b2-4e0d-b573-ccf08fe6ea234

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65862-225-606586202256060 TABLET, FILM COATED in 1 BOTTLE (65862-225-60) 2012-07-250000-00-00NoNoCurrent
65862-225-99658620225991000 TABLET, FILM COATED in 1 BOTTLE (65862-225-99) 2012-07-250000-00-00NoNoCurrent