FDA.reportPublic FDA data

Clarithromycin

Product NDC
71335-0017
11-digit product format
713350017
Labeler code
71335
Product ID
71335-0017_d0282505-f559-492d-a071-5a5d8385fd8d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clarithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
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
71335-0017-1Clarithromycin20 in 1 BOTTLETABLET, FILM COATED208
71335-0017-2Clarithromycin14 in 1 BOTTLETABLET, FILM COATED148
71335-0017-3Clarithromycin30 in 1 BOTTLETABLET, FILM COATED308
71335-0017-4Clarithromycin21 in 1 BOTTLETABLET, FILM COATED218
71335-0017-5Clarithromycin28 in 1 BOTTLETABLET, FILM COATED288
71335-0017-6Clarithromycin60 in 1 BOTTLETABLET, FILM COATED608
71335-0017-7Clarithromycin90 in 1 BOTTLETABLET, FILM COATED908
71335-0017-8Clarithromycin10 in 1 BOTTLETABLET, FILM COATED108
71335-0017-9Clarithromycin180 in 1 BOTTLETABLET, FILM COATED1808

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0017-1EA - Each71335-0017d29fdfbc-28bb-41b9-8e2f-65c6f3de789512018-03-08
71335-0017-2EA - Each71335-00177b7b2368-0f23-49f1-92fb-f8603cc6b8a312018-03-08
71335-0017-3EA - Each71335-00174596bbec-d6c5-4c67-801a-9a6d76d8b39212018-03-08
71335-0017-4EA - Each71335-001734875bd1-b1be-4fe5-ac80-e7b959697b2212018-03-08
71335-0017-5EA - Each71335-0017d62d45d6-fea2-4aa3-b239-02685c5fea2812018-03-08
71335-0017-6EA - Each71335-001734c25ebd-7a2d-42ca-882c-ffd9bd6390dd12018-03-08
71335-0017-7EA - Each71335-001710948cba-35d2-4c00-bd1a-7fd1d698d18412018-03-08
71335-0017-8EA - Each71335-0017c4b9e033-e8ea-4df5-8731-2ec74afa2cf512018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0017CLARITHROMYCIN TABLET, FILM COATED [BRYANT RANCH PREPACK]8Current NDC, Legacy NDC, 9 package rows20250315_0c7d8391-50ef-4827-abe6-e0fc0c2f1636.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197517clarithromycin 500 MG Oral TabletPSN0c7d8391-50ef-4827-abe6-e0fc0c2f16368
197517clarithromycin 500 MG Oral TabletSCD0c7d8391-50ef-4827-abe6-e0fc0c2f16368

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0017-17133500170120 TABLET, FILM COATED in 1 BOTTLE (71335-0017-1) 2018-09-040000-00-00NoNoCurrent
71335-0017-27133500170214 TABLET, FILM COATED in 1 BOTTLE (71335-0017-2) 2018-11-120000-00-00NoNoCurrent
71335-0017-37133500170330 TABLET, FILM COATED in 1 BOTTLE (71335-0017-3) 2018-05-090000-00-00NoNoCurrent
71335-0017-47133500170421 TABLET, FILM COATED in 1 BOTTLE (71335-0017-4) 2022-03-090000-00-00NoNoCurrent
71335-0017-57133500170528 TABLET, FILM COATED in 1 BOTTLE (71335-0017-5) 2018-03-010000-00-00NoNoCurrent
71335-0017-67133500170660 TABLET, FILM COATED in 1 BOTTLE (71335-0017-6) 2022-03-090000-00-00NoNoCurrent
71335-0017-77133500170790 TABLET, FILM COATED in 1 BOTTLE (71335-0017-7) 2022-03-090000-00-00NoNoCurrent
71335-0017-87133500170810 TABLET, FILM COATED in 1 BOTTLE (71335-0017-8) 2022-03-090000-00-00NoNoCurrent
71335-0017-971335001709180 TABLET, FILM COATED in 1 BOTTLE (71335-0017-9) 2022-03-090000-00-00NoNoCurrent