Clarithromycin

Product NDC
10544-522
11-digit product format
105440522
Labeler code
10544
Product ID
10544-522_f6a47a9e-897d-4982-9ee5-fd39f07e3922
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clarithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA065266
Marketing category
ANDA
Marketing start
2012-10-05
Marketing end
0000-00-00
Substance
CLARITHROMYCIN
Active strength
500 mg/1
Pharmacologic classes
Macrolide Antimicrobial [EPC],Macrolides [CS],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct10544-522IInactivated by FDA2026-08-03
excluded packagepackage10544-52210544-522-14IInactivated by FDA2026-08-03
excluded packagepackage10544-52210544-522-20IInactivated by FDA2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 45 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-20 13:05 UTC · source 2025-01-20excluded productproduct10544-522IInactivated by FDAexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage10544-52210544-522-20IInactivated by FDAexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage10544-52210544-522-14IInactivated by FDAexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct10544-522IInactivated by FDAexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage10544-52210544-522-20IInactivated by FDAexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage10544-52210544-522-14IInactivated by FDAexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproduct10544-522IInactivated by FDAexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage10544-52210544-522-20IInactivated by FDAexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage10544-52210544-522-14IInactivated by FDAexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct10544-522IInactivated by FDAexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage10544-52210544-522-20IInactivated by FDAexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage10544-52210544-522-14IInactivated by FDAexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct10544-522IInactivated by FDAexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage10544-52210544-522-20IInactivated by FDAexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage10544-52210544-522-14IInactivated by FDAexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct10544-522IInactivated by FDAexcluded / ndc_excluded.zip8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage10544-52210544-522-20IInactivated by FDAexcluded / ndc_excluded.zip8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage10544-52210544-522-14IInactivated by FDAexcluded / ndc_excluded.zip8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct10544-522IInactivated by FDAexcluded / ndc_excluded.zip834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage10544-52210544-522-20IInactivated by FDAexcluded / ndc_excluded.zip834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage10544-52210544-522-14IInactivated by FDAexcluded / ndc_excluded.zip834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct10544-522IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage10544-52210544-522-20IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage10544-52210544-522-14IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproduct10544-522IInactivated by FDAexcluded / ndc_excluded.zipfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage10544-52210544-522-20IInactivated by FDAexcluded / ndc_excluded.zipfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage10544-52210544-522-14IInactivated by FDAexcluded / ndc_excluded.zipfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct10544-522IInactivated by FDAexcluded / ndc_excluded.zip86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage10544-52210544-522-20IInactivated by FDAexcluded / ndc_excluded.zip86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage10544-52210544-522-14IInactivated by FDAexcluded / ndc_excluded.zip86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproduct10544-522IInactivated by FDAexcluded / ndc_excluded.zipbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage10544-52210544-522-20IInactivated by FDAexcluded / ndc_excluded.zipbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage10544-52210544-522-14IInactivated by FDAexcluded / ndc_excluded.zipbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct10544-522IInactivated by FDAexcluded / ndc_excluded.zip8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage10544-52210544-522-20IInactivated by FDAexcluded / ndc_excluded.zip8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage10544-52210544-522-14IInactivated by FDAexcluded / ndc_excluded.zip8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproduct10544-522IInactivated by FDAexcluded / ndc_excluded.zipe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage10544-52210544-522-20IInactivated by FDAexcluded / ndc_excluded.zipe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage10544-52210544-522-14IInactivated by FDAexcluded / ndc_excluded.zipe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct10544-522IInactivated by FDAexcluded / ndc_excluded.zip9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage10544-52210544-522-20IInactivated by FDAexcluded / ndc_excluded.zip9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage10544-52210544-522-14IInactivated by FDAexcluded / ndc_excluded.zip9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct10544-522EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage10544-52210544-522-20EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage10544-52210544-522-14EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065266-001CLARITHROMYCINCLARITHROMYCIN250MGTABLET / ORAL2006-05-31
A065266-002CLARITHROMYCINCLARITHROMYCIN500MGTABLET / ORAL2006-05-31

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A065266-001CLARITHROMYCIN250MGTABLET / ORAL2006-05-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065266-002CLARITHROMYCIN500MGTABLET / ORAL2006-05-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065266-001CLARITHROMYCIN250MGTABLET / ORAL2006-05-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065266-002CLARITHROMYCIN500MGTABLET / ORAL2006-05-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065266-001CLARITHROMYCIN250MGTABLET / ORAL2006-05-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065266-002CLARITHROMYCIN500MGTABLET / ORAL2006-05-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065266-001CLARITHROMYCIN250MGTABLET / ORAL2006-05-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065266-002CLARITHROMYCIN500MGTABLET / ORAL2006-05-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065266-001CLARITHROMYCIN250MGTABLET / ORAL2006-05-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065266-002CLARITHROMYCIN500MGTABLET / ORAL2006-05-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065266-001CLARITHROMYCIN250MGTABLET / ORAL2006-05-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065266-002CLARITHROMYCIN500MGTABLET / ORAL2006-05-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065266-001CLARITHROMYCIN250MGTABLET / ORAL2006-05-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065266-002CLARITHROMYCIN500MGTABLET / ORAL2006-05-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065266-001CLARITHROMYCIN250MGTABLET / ORAL2006-05-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065266-002CLARITHROMYCIN500MGTABLET / ORAL2006-05-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065266-001CLARITHROMYCIN250MGTABLET / ORAL2006-05-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065266-002CLARITHROMYCIN500MGTABLET / ORAL2006-05-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065266-001CLARITHROMYCIN250MGTABLET / ORAL2006-05-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A065266-002CLARITHROMYCIN500MGTABLET / ORAL2006-05-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065266-001CLARITHROMYCIN250MGTABLET / ORAL2006-05-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065266-002CLARITHROMYCIN500MGTABLET / ORAL2006-05-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065266-001CLARITHROMYCIN250MGTABLET / ORAL2006-05-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065266-002CLARITHROMYCIN500MGTABLET / ORAL2006-05-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065266-001CLARITHROMYCIN250MGTABLET / ORAL2006-05-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065266-002CLARITHROMYCIN500MGTABLET / ORAL2006-05-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065266-001CLARITHROMYCIN250MGTABLET / ORAL2006-05-318072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065266-002CLARITHROMYCIN500MGTABLET / ORAL2006-05-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065266-001CLARITHROMYCIN250MGTABLET / ORAL2006-05-315c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065266-002CLARITHROMYCIN500MGTABLET / ORAL2006-05-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065266-001CLARITHROMYCIN250MGTABLET / ORAL2006-05-315d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065266-002CLARITHROMYCIN500MGTABLET / ORAL2006-05-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065266-001CLARITHROMYCIN250MGTABLET / ORAL2006-05-314b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065266-002CLARITHROMYCIN500MGTABLET / ORAL2006-05-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065266-001CLARITHROMYCIN250MGTABLET / ORALAB2006-05-3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065266-002CLARITHROMYCIN500MGTABLET / ORALAB2006-05-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065266-001CLARITHROMYCIN250MGTABLET / ORAL2006-05-31bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065266-002CLARITHROMYCIN500MGTABLET / ORAL2006-05-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065266-001CLARITHROMYCIN250MGTABLET / ORAL2006-05-31782e0a99824c…
2021-12-28 21:50 UTC2021-12A065266-002CLARITHROMYCIN500MGTABLET / ORAL2006-05-31782e0a99824c…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A065266-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065266-002AB174a2ff9319b5…
2020-12-22 03:56 UTC2020-12A065266-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A065266-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065266-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A065266-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065266-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A065266-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A065266-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A065266-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A065266-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A065266-002AB1ea99ee380514…

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10544-522-142020-01-31C16284748780-19d75b9d0-807d-f424-e053-dadaa90a57ceCLARITHROMYCIN TABLETS, USP
10544-522-202020-01-31C16284748780-19d75b9d0-807d-f424-e053-dadaa90a57ceCLARITHROMYCIN TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-522-14Clarithromycin14 in 1 BOTTLETABLET, FILM COATED141
10544-522-20Clarithromycin20 in 1 BOTTLETABLET, FILM COATED201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10544-522-20EA - Each10544-522b03e6a62-0091-41c0-ab06-a86bdeebd26d12016-01-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-522CLARITHROMYCIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1Legacy NDC, 2 package rows20160113_4452ba66-1d7a-4253-a278-b7775887e6d8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197517clarithromycin 500 MG Oral TabletPSN4452ba66-1d7a-4253-a278-b7775887e6d81
197517clarithromycin 500 MG Oral TabletSCD4452ba66-1d7a-4253-a278-b7775887e6d81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-522-141054405221414 in 1 BOTTLEHistorical
10544-522-201054405222020 in 1 BOTTLEHistorical