FDA.reportPublic FDA data

Clarithromycin

Product NDC
43063-823
11-digit product format
430630823
Labeler code
43063
Product ID
43063-823_3ba20925-0d1d-3712-e063-6394a90aa41b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clarithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA065489
Marketing category
ANDA
Marketing start
2012-07-25
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
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
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
43063-823-20Clarithromycin20 in 1 BOTTLE, PLASTICTABLET, FILM COATED2027
43063-823-28Clarithromycin28 in 1 BOTTLE, PLASTICTABLET, FILM COATED2827

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-823-20EA - Each43063-8236deb23ed-9495-4a53-a7a4-9d13ca018f2512018-02-20
43063-823-28EA - Each43063-82398f74e60-abaa-4871-b8e3-534f1d63ec8b12018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-823CLARITHROMYCIN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]26Current NDC, Legacy NDC, 2 package rows20240703_ba216276-b0bd-420a-9e0d-090bdfcc2460.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197517clarithromycin 500 MG Oral TabletPSNba216276-b0bd-420a-9e0d-090bdfcc246027
197517clarithromycin 500 MG Oral TabletSCDba216276-b0bd-420a-9e0d-090bdfcc246027

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-823-204306308232020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-823-20) 2018-01-080000-00-00NoNoCurrent
43063-823-284306308232828 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-823-28) 2018-02-220000-00-00NoNoCurrent