Clarithromycin

Product NDC
50090-4059
11-digit product format
500904059
Labeler code
50090
Product ID
50090-4059_0e626c42-d14a-4319-a0a0-c2f5319e8078
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clarithromycin
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA208987
Marketing category
ANDA
Marketing start
2018-07-23
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
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50090-4059IInactivated by FDA2026-08-07
excluded packagepackage50090-405950090-4059-0IInactivated by FDA2026-08-07

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 30 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-4059-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-4059-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-4059-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-4059-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-4059-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-4059-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-4059-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-4059-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-4059-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-4059-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-4059-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-4059-0557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50090-4059-08af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50090-4059-0834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50090-4059-01332a3947898…d4bfe170f9cd…

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A208987-001CLARITHROMYCINCLARITHROMYCIN500MGTABLET, EXTENDED RELEASE / ORALAB2018-07-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A208987-001AB

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 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A208987-001CLARITHROMYCIN500MGTABLET, EXTENDED RELEASE / ORALAB2018-07-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208987-001CLARITHROMYCIN500MGTABLET, EXTENDED RELEASE / ORALAB2018-07-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A208987-001CLARITHROMYCIN500MGTABLET, EXTENDED RELEASE / ORALAB2018-07-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208987-001CLARITHROMYCIN500MGTABLET, EXTENDED RELEASE / ORALAB2018-07-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208987-001CLARITHROMYCIN500MGTABLET, EXTENDED RELEASE / ORALAB2018-07-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208987-001CLARITHROMYCIN500MGTABLET, EXTENDED RELEASE / ORALAB2018-07-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208987-001CLARITHROMYCIN500MGTABLET, EXTENDED RELEASE / ORALAB2018-07-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208987-001CLARITHROMYCIN500MGTABLET, EXTENDED RELEASE / ORALAB2018-07-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208987-001CLARITHROMYCIN500MGTABLET, EXTENDED RELEASE / ORALAB2018-07-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208987-001CLARITHROMYCIN500MGTABLET, EXTENDED RELEASE / ORALAB2018-07-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208987-001CLARITHROMYCIN500MGTABLET, EXTENDED RELEASE / ORALAB2018-07-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208987-001CLARITHROMYCIN500MGTABLET, EXTENDED RELEASE / ORALAB2018-07-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208987-001CLARITHROMYCIN500MGTABLET, EXTENDED RELEASE / ORALAB2018-07-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208987-001CLARITHROMYCIN500MGTABLET, EXTENDED RELEASE / ORALAB2018-07-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208987-001CLARITHROMYCIN500MGTABLET, EXTENDED RELEASE / ORALAB2018-07-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208987-001CLARITHROMYCIN500MGTABLET, EXTENDED RELEASE / ORALAB2018-07-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208987-001CLARITHROMYCIN500MGTABLET, EXTENDED RELEASE / ORALAB2018-07-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208987-001CLARITHROMYCIN500MGTABLET, EXTENDED RELEASE / ORALAB2018-07-0974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208987-001CLARITHROMYCIN500MGTABLET, EXTENDED RELEASE / ORALAB2018-07-09bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208987-001CLARITHROMYCIN500MGTABLET, EXTENDED RELEASE / ORALAB2018-07-09782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208987-001CLARITHROMYCIN500MGTABLET, EXTENDED RELEASE / ORALAB2018-07-0987673890dc5c…
2021-03-12 10:30 UTC2021-03A208987-001CLARITHROMYCIN500MGTABLET, EXTENDED RELEASE / ORALAB2018-07-095aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208987-001CLARITHROMYCIN500MGTABLET, EXTENDED RELEASE / ORALAB2018-07-098869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208987-001CLARITHROMYCIN500MGTABLET, EXTENDED RELEASE / ORALAB2018-07-09c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208987-001CLARITHROMYCIN500MGTABLET, EXTENDED RELEASE / ORALAB2018-07-093f01610625f2…
2019-09-15 20:21 UTC2019-09A208987-001CLARITHROMYCIN500MGTABLET, EXTENDED RELEASE / ORALAB2018-07-09b00525d2431f…
2019-07-19 19:46 UTC2019-07A208987-001CLARITHROMYCIN500MGTABLET, EXTENDED RELEASE / ORALAB2018-07-09ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208987-001CLARITHROMYCIN500MGTABLET, EXTENDED RELEASE / ORALAB2018-07-096a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208987-001CLARITHROMYCIN500MGTABLET, EXTENDED RELEASE / ORALAB2018-07-091c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208987-001CLARITHROMYCIN500MGTABLET, EXTENDED RELEASE / ORALAB2018-07-09ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208987-001CLARITHROMYCIN500MGTABLET, EXTENDED RELEASE / ORALAB2018-07-09a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208987-001CLARITHROMYCIN500MGTABLET, EXTENDED RELEASE / ORALAB2018-07-099b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208987-001CLARITHROMYCIN500MGTABLET, EXTENDED RELEASE / ORALAB2018-07-09a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208987-001CLARITHROMYCIN500MGTABLET, EXTENDED RELEASE / ORALAB2018-07-093f0d92c62455…
2023-05-13 08:27 UTC2023-05A208987-001CLARITHROMYCIN500MGTABLET, EXTENDED RELEASE / ORALAB2018-07-09053a50430f4f…
2023-01-26 05:58 UTC2023-01A208987-001CLARITHROMYCIN500MGTABLET, EXTENDED RELEASE / ORALAB2018-07-093bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208987-001CLARITHROMYCIN500MGTABLET, EXTENDED RELEASE / ORALAB2018-07-093a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A208987-001CLARITHROMYCIN500MGTABLET, EXTENDED RELEASE / ORALAB2018-07-09f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A208987-001CLARITHROMYCIN500MGTABLET, EXTENDED RELEASE / ORALAB2018-07-09e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A208987-001CLARITHROMYCIN500MGTABLET, EXTENDED RELEASE / ORALAB2018-07-09cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A208987-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208987-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208987-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208987-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208987-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208987-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208987-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208987-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208987-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208987-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208987-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208987-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208987-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208987-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208987-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208987-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208987-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208987-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208987-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208987-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208987-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A208987-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208987-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208987-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208987-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A208987-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A208987-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208987-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208987-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208987-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208987-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208987-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208987-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208987-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A208987-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A208987-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208987-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A208987-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A208987-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A208987-001AB1cb3db0bc1861…

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4059-0Clarithromycin14 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE141

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4059CLARITHROMYCIN TABLET, FILM COATED, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]1Legacy NDC, 1 package rows20190201_2e467e89-66c3-4690-8ebd-5ce51e1a8c38.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ClarithromycinCLARITHROMYCINSolaris Pharma Corporation4d4303f8-88dd-8b88-e063-6394a90ab48f2026-03-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208987
application number: ANDA208987
CLARITHROMYCINCLARITHROMYCINChartwell RX, LLCdea5bd78-7f93-4bc4-a2e4-1b021f5fe0982025-12-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208987
application number: ANDA208987
ClarithromycinCLARITHROMYCINPD-Rx Pharmaceuticals, Inc.1d328f5d-73c1-4df7-a3df-71d0e02211812025-10-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208987
application number: ANDA208987
ClarithromycinCLARITHROMYCINLannett Company, Inc.71a836d0-d60f-6418-e053-2a95a90aa6ef2023-09-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208987
application number: ANDA208987

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359385clarithromycin 500 MG 24HR Extended Release Oral TabletPSN2e467e89-66c3-4690-8ebd-5ce51e1a8c381
35938524 HR clarithromycin 500 MG Extended Release Oral TabletSCD2e467e89-66c3-4690-8ebd-5ce51e1a8c381
359385clarithromycin 500 MG 24 HR Extended Release Oral TabletSY2e467e89-66c3-4690-8ebd-5ce51e1a8c381

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4059-05009040590014 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-4059-0) 2019-01-160000-00-00NoNoCurrent