FDA.reportPublic FDA data

Clarithromycin

Product NDC
43063-530
11-digit product format
430630530
Labeler code
43063
Product ID
43063-530_41392bb7-d916-446c-e063-6294a90a2c5c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clarithromycin
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA065136
Marketing category
ANDA
Marketing start
2005-08-25
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
43063-530-14Clarithromycin14 in 1 BOTTLE, PLASTICTABLET1429
43063-530-20Clarithromycin20 in 1 BOTTLE, PLASTICTABLET2029

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-530-14EA - Each43063-530eff1bb27-53d0-401a-a15b-e7ac6dedc9ef12014-11-05
43063-530-20EA - Each43063-5301d55518f-f209-468f-ba8d-1424fdfe0bec12014-09-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLARITHROMYCINACTIVE INGREDIENTH1250JIK0ACLARITHROMYCIN TABLET [PD-RX PHARMACEUTICALS, INC.]15
CLARITHROMYCINACTIVE MOIETYH1250JIK0ACLARITHROMYCIN TABLET [PD-RX PHARMACEUTICALS, INC.]15
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCLARITHROMYCIN TABLET [PD-RX PHARMACEUTICALS, INC.]15
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CLARITHROMYCIN TABLET [PD-RX PHARMACEUTICALS, INC.]15
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82CLARITHROMYCIN TABLET [PD-RX PHARMACEUTICALS, INC.]15
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6CLARITHROMYCIN TABLET [PD-RX PHARMACEUTICALS, INC.]15
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLARITHROMYCIN TABLET [PD-RX PHARMACEUTICALS, INC.]15
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCLARITHROMYCIN TABLET [PD-RX PHARMACEUTICALS, INC.]15
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCLARITHROMYCIN TABLET [PD-RX PHARMACEUTICALS, INC.]15
POVIDONESINACTIVE INGREDIENTFZ989GH94ECLARITHROMYCIN TABLET [PD-RX PHARMACEUTICALS, INC.]15
TALCINACTIVE INGREDIENT7SEV7J4R1UCLARITHROMYCIN TABLET [PD-RX PHARMACEUTICALS, INC.]15
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCLARITHROMYCIN TABLET [PD-RX PHARMACEUTICALS, INC.]15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-530CLARITHROMYCIN TABLET [PD-RX PHARMACEUTICALS, INC.]28Current NDC, Legacy NDC, 2 package rows20240224_0be243c6-de02-45dd-8210-cab1bbc8dfa7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197517clarithromycin 500 MG Oral TabletPSN0be243c6-de02-45dd-8210-cab1bbc8dfa729
197517clarithromycin 500 MG Oral TabletSCD0be243c6-de02-45dd-8210-cab1bbc8dfa729

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-530-144306305301414 TABLET in 1 BOTTLE, PLASTIC (43063-530-14) 14 tablet2013-09-300000-00-00NoNoCurrent
43063-530-204306305302020 TABLET in 1 BOTTLE, PLASTIC (43063-530-20) 20 tablet2013-09-300000-00-00NoNoCurrent