Clarithromycin

Product NDC
67296-1632
Requested package NDC
67296-1632-2
11-digit product format
672961632
Labeler code
67296
Product ID
67296-1632_b8d0796c-80c6-1386-e053-2a95a90a676f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clarithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA065489
Marketing category
ANDA
Marketing start
2019-01-01
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
2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage67296-163267296-1632-2IInactivated by FDA2026-08-03

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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
A065489-001CLARITHROMYCINCLARITHROMYCIN250MGTABLET / ORALABRS2012-07-25
A065489-002CLARITHROMYCINCLARITHROMYCIN500MGTABLET / ORALABRS2012-07-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A065489-001AB
A065489-002AB

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 UTC2026-02A065489-001CLARITHROMYCIN250MGTABLET / ORALABRS2012-07-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065489-002CLARITHROMYCIN500MGTABLET / ORALABRS2012-07-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065489-001CLARITHROMYCIN250MGTABLET / ORALABRS2012-07-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065489-002CLARITHROMYCIN500MGTABLET / ORALABRS2012-07-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A065489-001CLARITHROMYCIN250MGTABLET / ORALABRS2012-07-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065489-002CLARITHROMYCIN500MGTABLET / ORALABRS2012-07-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065489-001CLARITHROMYCIN250MGTABLET / ORALABRS2012-07-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065489-002CLARITHROMYCIN500MGTABLET / ORALABRS2012-07-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065489-001CLARITHROMYCIN250MGTABLET / ORALABRS2012-07-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065489-002CLARITHROMYCIN500MGTABLET / ORALABRS2012-07-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065489-001CLARITHROMYCIN250MGTABLET / ORALABRS2012-07-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065489-002CLARITHROMYCIN500MGTABLET / ORALABRS2012-07-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065489-001CLARITHROMYCIN250MGTABLET / ORALABRS2012-07-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065489-002CLARITHROMYCIN500MGTABLET / ORALABRS2012-07-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065489-001CLARITHROMYCIN250MGTABLET / ORALABRS2012-07-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065489-002CLARITHROMYCIN500MGTABLET / ORALABRS2012-07-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065489-001CLARITHROMYCIN250MGTABLET / ORALABRS2012-07-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065489-002CLARITHROMYCIN500MGTABLET / ORALABRS2012-07-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065489-001CLARITHROMYCIN250MGTABLET / ORALABRS2012-07-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A065489-002CLARITHROMYCIN500MGTABLET / ORALABRS2012-07-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065489-001CLARITHROMYCIN250MGTABLET / ORALABRS2012-07-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065489-002CLARITHROMYCIN500MGTABLET / ORALABRS2012-07-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065489-001CLARITHROMYCIN250MGTABLET / ORALABRS2012-07-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065489-002CLARITHROMYCIN500MGTABLET / ORALABRS2012-07-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065489-001CLARITHROMYCIN250MGTABLET / ORALABRS2012-07-251e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065489-002CLARITHROMYCIN500MGTABLET / ORALABRS2012-07-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065489-001CLARITHROMYCIN250MGTABLET / ORALABRS2012-07-258072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065489-002CLARITHROMYCIN500MGTABLET / ORALABRS2012-07-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065489-001CLARITHROMYCIN250MGTABLET / ORALABRS2012-07-255c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065489-002CLARITHROMYCIN500MGTABLET / ORALABRS2012-07-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065489-001CLARITHROMYCIN250MGTABLET / ORALABRS2012-07-255d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065489-002CLARITHROMYCIN500MGTABLET / ORALABRS2012-07-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065489-001CLARITHROMYCIN250MGTABLET / ORALABRS2012-07-254b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065489-002CLARITHROMYCIN500MGTABLET / ORALABRS2012-07-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065489-001CLARITHROMYCIN250MGTABLET / ORALABRS2012-07-2574a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065489-002CLARITHROMYCIN500MGTABLET / ORALABRS2012-07-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065489-001CLARITHROMYCIN250MGTABLET / ORALABRS2012-07-25bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065489-002CLARITHROMYCIN500MGTABLET / ORALABRS2012-07-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065489-001CLARITHROMYCIN250MGTABLET / ORALABRS2012-07-25782e0a99824c…
2021-12-28 21:50 UTC2021-12A065489-002CLARITHROMYCIN500MGTABLET / ORALABRS2012-07-25782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A065489-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065489-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065489-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065489-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065489-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065489-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065489-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065489-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065489-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065489-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065489-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065489-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065489-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065489-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065489-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065489-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065489-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065489-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065489-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065489-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065489-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065489-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065489-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065489-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065489-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065489-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065489-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065489-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065489-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065489-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065489-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065489-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065489-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065489-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065489-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065489-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065489-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065489-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065489-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A065489-002AB1782e0a99824c…

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
67296-1632-22023-01-30C16284748780-1f386c649-fe79-0266-e053-dadaa90a7c1aClarithromycin 500mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1632-2Clarithromycin20 in 1 BOTTLETABLET, FILM COATED208

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1632CLARITHROMYCIN TABLET, FILM COATED [REDPHARM DRUG, INC.]8Legacy NDC, 1 package rows20210114_888d5192-8ff7-41bd-e053-2a95a90ac970.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 · 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ClarithromycinCLARITHROMYCINSportpharm LLCd836ae7e-fdbf-4dcb-a90d-ede1dcbc3e672026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065489
application number: ANDA065489
ClarithromycinCLARITHROMYCINREMEDYREPACK INC.9d5848f0-e9f0-4112-a7ca-bcc8ea2e69c62026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065489
application number: ANDA065489
ClarithromycinCLARITHROMYCINProficient Rx LP88c7ded8-333c-408d-b693-a72881710f592026-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065489
application number: ANDA065489
ClarithromycinCLARITHROMYCINPreferred Pharmaceuticals Inc.81c0c69e-b1ae-42f3-9e85-09b8daa75d8d2026-03-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065489
application number: ANDA065489
ClarithromycinCLARITHROMYCINMajor Pharmaceuticalsd0a66646-6774-4fc6-9b26-a98c3a5df2742026-03-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065489
application number: ANDA065489
ClarithromycinCLARITHROMYCINAmerican Health Packagingfa69ea92-0b41-43fb-918f-ed80e0dedf042026-03-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065489
application number: ANDA065489
ClarithromycinCLARITHROMYCINAvPAK1920f943-bbf1-cfd9-7475-96a35680a9e02026-02-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065489
application number: ANDA065489
ClarithromycinCLARITHROMYCINNorthwind Health Company, LLC471f638a-9dd1-09d3-e063-6294a90a2d4f2026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065489
application number: ANDA065489
ClarithromycinCLARITHROMYCINDirect_Rx3ba1da51-ba5b-323f-e063-6294a90a03332025-09-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065489
application number: ANDA065489
ClarithromycinCLARITHROMYCINPD-Rx Pharmaceuticals, Inc.ba216276-b0bd-420a-9e0d-090bdfcc24602025-08-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065489
application number: ANDA065489
ClarithromycinCLARITHROMYCINA-S Medication Solutions25debd85-0840-4f8d-9898-027772061dd22025-06-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065489
application number: ANDA065489
ClarithromycinCLARITHROMYCINNuCare Pharmaceuticals,Inc.9143b79c-4c79-43ac-e053-2995a90ad7082025-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065489
application number: ANDA065489
ClarithromycinCLARITHROMYCINBryant Ranch Prepack0c7d8391-50ef-4827-abe6-e0fc0c2f16362024-01-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065489
application number: ANDA065489
ClarithromycinCLARITHROMYCINRising Pharma Holdings, Inc.0c4db97f-f4c9-4cac-9f12-9db1d967ebeb2024-01-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065489
application number: ANDA065489
ClarithromycinCLARITHROMYCINAurobindo Pharma Limited9aaffb41-408c-4372-8fd5-1d649450c0e92023-10-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065489
application number: ANDA065489
ClarithromycinCLARITHROMYCINA-S Medication Solutions1d6f5a9d-51b2-4e0d-b573-ccf08fe6ea232023-07-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065489
application number: ANDA065489
ClarithromycinCLARITHROMYCINProficient Rx LPb1bdf526-4f16-4130-b614-4cb678f060d72021-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065489
application number: ANDA065489

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197517clarithromycin 500 MG Oral TabletPSN888d5192-8ff7-41bd-e053-2a95a90ac9708
197517clarithromycin 500 MG Oral TabletSCD888d5192-8ff7-41bd-e053-2a95a90ac9708

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67296-1632-26729616320220 TABLET, FILM COATED in 1 BOTTLE (67296-1632-2) 2019-01-010000-00-00NoNoCurrent