Clarithromycin

Product NDC
70934-507
11-digit product format
709340507
Labeler code
70934
Product ID
70934-507_ba0d460e-fc4b-58fd-e053-2a95a90a4595
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clarithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA203584
Marketing category
ANDA
Marketing start
2021-01-29
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70934-507IInactivated by FDA2026-08-10
excluded packagepackage70934-50770934-507-14IInactivated by FDA2026-08-10

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 packagepackage70934-507-14d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70934-507-14f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70934-507-142ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70934-507-14a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70934-507-14cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70934-507-14cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70934-507-14302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70934-507-14ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70934-507-140efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70934-507-14ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70934-507-14367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70934-507-14557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage70934-507-148af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage70934-507-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage70934-507-141332a3947898…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
A203584-001CLARITHROMYCINCLARITHROMYCIN250MGTABLET / ORALAB2015-09-28
A203584-002CLARITHROMYCINCLARITHROMYCIN500MGTABLET / ORALAB2015-09-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203584-001AB
A203584-002AB

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 UTC2026-02A203584-001CLARITHROMYCIN250MGTABLET / ORALAB2015-09-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203584-002CLARITHROMYCIN500MGTABLET / ORALAB2015-09-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203584-001CLARITHROMYCIN250MGTABLET / ORALAB2015-09-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203584-002CLARITHROMYCIN500MGTABLET / ORALAB2015-09-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A203584-001CLARITHROMYCIN250MGTABLET / ORALAB2015-09-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203584-002CLARITHROMYCIN500MGTABLET / ORALAB2015-09-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203584-001CLARITHROMYCIN250MGTABLET / ORALAB2015-09-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203584-002CLARITHROMYCIN500MGTABLET / ORALAB2015-09-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203584-001CLARITHROMYCIN250MGTABLET / ORALAB2015-09-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203584-002CLARITHROMYCIN500MGTABLET / ORALAB2015-09-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203584-001CLARITHROMYCIN250MGTABLET / ORALAB2015-09-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203584-002CLARITHROMYCIN500MGTABLET / ORALAB2015-09-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203584-001CLARITHROMYCIN250MGTABLET / ORALAB2015-09-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203584-002CLARITHROMYCIN500MGTABLET / ORALAB2015-09-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203584-001CLARITHROMYCIN250MGTABLET / ORALAB2015-09-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203584-002CLARITHROMYCIN500MGTABLET / ORALAB2015-09-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203584-001CLARITHROMYCIN250MGTABLET / ORALAB2015-09-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203584-002CLARITHROMYCIN500MGTABLET / ORALAB2015-09-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203584-001CLARITHROMYCIN250MGTABLET / ORALAB2015-09-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A203584-002CLARITHROMYCIN500MGTABLET / ORALAB2015-09-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203584-001CLARITHROMYCIN250MGTABLET / ORALAB2015-09-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203584-002CLARITHROMYCIN500MGTABLET / ORALAB2015-09-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203584-001CLARITHROMYCIN250MGTABLET / ORALAB2015-09-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203584-002CLARITHROMYCIN500MGTABLET / ORALAB2015-09-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203584-001CLARITHROMYCIN250MGTABLET / ORALAB2015-09-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203584-002CLARITHROMYCIN500MGTABLET / ORALAB2015-09-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203584-001CLARITHROMYCIN250MGTABLET / ORALAB2015-09-288072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203584-002CLARITHROMYCIN500MGTABLET / ORALAB2015-09-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203584-001CLARITHROMYCIN250MGTABLET / ORALAB2015-09-285c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203584-002CLARITHROMYCIN500MGTABLET / ORALAB2015-09-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203584-001CLARITHROMYCIN250MGTABLET / ORALAB2015-09-285d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203584-002CLARITHROMYCIN500MGTABLET / ORALAB2015-09-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203584-001CLARITHROMYCIN250MGTABLET / ORALAB2015-09-284b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203584-002CLARITHROMYCIN500MGTABLET / ORALAB2015-09-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203584-001CLARITHROMYCIN250MGTABLET / ORALAB2015-09-2874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203584-002CLARITHROMYCIN500MGTABLET / ORALAB2015-09-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203584-001CLARITHROMYCIN250MGTABLET / ORALAB2015-09-28bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203584-002CLARITHROMYCIN500MGTABLET / ORALAB2015-09-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203584-001CLARITHROMYCIN250MGTABLET / ORALAB2015-09-28782e0a99824c…
2021-12-28 21:50 UTC2021-12A203584-002CLARITHROMYCIN500MGTABLET / ORALAB2015-09-28782e0a99824c…

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 UTC2026-02A203584-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203584-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203584-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203584-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203584-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203584-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203584-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203584-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203584-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203584-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203584-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203584-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203584-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203584-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203584-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203584-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203584-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203584-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203584-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203584-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203584-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203584-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203584-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203584-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203584-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203584-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203584-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203584-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203584-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203584-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203584-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203584-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203584-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203584-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203584-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203584-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203584-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203584-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203584-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A203584-002AB1782e0a99824c…

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70934-507-14Clarithromycin14 in 1 BOTTLE, PLASTICTABLET, FILM COATED141

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70934-507CLARITHROMYCIN TABLET, FILM COATED [DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS]1Legacy NDC, 1 package rows20210201_ba0d460e-fc4a-58fd-e053-2a95a90a4595.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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ClarithromycinCLARITHROMYCINSolaris Pharma Corporation4d42821d-ce7a-7d64-e063-6294a90a08752026-04-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203584
application number: ANDA203584
ClarithromycinCLARITHROMYCINAmerican Health Packaging59ebe6cb-c830-45c7-8242-52f9f42a90a02026-03-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203584
application number: ANDA203584
ClarithromycinCLARITHROMYCINProficient Rx LP9eb306e0-ccfb-418c-82ca-204f20a788f72025-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203584
application number: ANDA203584
ClarithromycinCLARITHROMYCINPD-Rx Pharmaceuticals, Inc.1cb8a78a-0f07-49e8-a23e-a776280062092025-10-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203584
application number: ANDA203584
ClarithromycinCLARITHROMYCINLannett Company, Inc.9bf207c0-86eb-4f3b-92e7-f65f3fccd5a72023-11-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203584
application number: ANDA203584

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197517clarithromycin 500 MG Oral TabletPSNba0d460e-fc4a-58fd-e053-2a95a90a45951
197517clarithromycin 500 MG Oral TabletSCDba0d460e-fc4a-58fd-e053-2a95a90a45951

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70934-507-147093405071414 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70934-507-14) 2021-01-290000-00-00NoNoCurrent