Clarithromycin

Product NDC
50090-1830
11-digit product format
500901830
Labeler code
50090
Product ID
50090-1830_d98ce2fe-31f9-41d1-9dea-6d5cf2d7e218
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clarithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
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

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…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
ndc (product): 50090-1830
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

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
H1250JIK0AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197517Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
25debd85-0840-4f8d-9898-027772061dd2Available on FDA.report

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
50090-1830-02023-02-06C16284748780-1f386c649-dcaa-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CLARITHROMYCIN TABLETS safely and effectively. See full prescribing information for CLARITHROMYCIN TABLETS. CLARITHROMYCIN tablets, for oral use Initial U.S. Approval: 1991
50090-1830-12023-02-06C16284748780-1f386c649-dcaa-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CLARITHROMYCIN TABLETS safely and effectively. See full prescribing information for CLARITHROMYCIN TABLETS. CLARITHROMYCIN tablets, for oral use Initial U.S. Approval: 1991
50090-1830-22023-02-06C16284748780-1f386c649-dcaa-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CLARITHROMYCIN TABLETS safely and effectively. See full prescribing information for CLARITHROMYCIN TABLETS. CLARITHROMYCIN tablets, for oral use Initial U.S. Approval: 1991
50090-1830-02023-01-30C16284748780-1f386c649-dcaa-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CLARITHROMYCIN TABLETS safely and effectively. See full prescribing information for CLARITHROMYCIN TABLETS. CLARITHROMYCIN tablets, for oral use Initial U.S. Approval: 1991
50090-1830-12023-01-30C16284748780-1f386c649-dcaa-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CLARITHROMYCIN TABLETS safely and effectively. See full prescribing information for CLARITHROMYCIN TABLETS. CLARITHROMYCIN tablets, for oral use Initial U.S. Approval: 1991
50090-1830-22023-01-30C16284748780-1f386c649-dcaa-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CLARITHROMYCIN TABLETS safely and effectively. See full prescribing information for CLARITHROMYCIN TABLETS. CLARITHROMYCIN tablets, for oral use Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1830-0Clarithromycin20 in 1 BOTTLETABLET, FILM COATED2015
50090-1830-1Clarithromycin30 in 1 BOTTLETABLET, FILM COATED3015
50090-1830-2Clarithromycin14 in 1 BOTTLETABLET, FILM COATED1415
50090-1830-3Clarithromycin28 in 1 BOTTLETABLET, FILM COATED2815

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1830-0EA - Each50090-1830558dfd91-cb69-45e6-a8ee-47a410a931ee12018-10-11
50090-1830-1EA - Each50090-18305c9df28b-2802-46b8-8aaf-521135b7d05a12018-09-05
50090-1830-2EA - Each50090-183044c48158-ae09-4b47-aa6f-e99cdba02ac012018-09-05
50090-1830-3EA - Each50090-18305f602713-f63b-4682-89c4-e57d3222dcb312025-07-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1830CLARITHROMYCIN TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]13Current NDC, Legacy NDC, 4 package rows20250430_25debd85-0840-4f8d-9898-027772061dd2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197517clarithromycin 500 MG Oral TabletPSN25debd85-0840-4f8d-9898-027772061dd215
197517clarithromycin 500 MG Oral TabletSCD25debd85-0840-4f8d-9898-027772061dd215

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-1830-05009018300020 TABLET, FILM COATED in 1 BOTTLE (50090-1830-0) 2015-05-180000-00-00NoNoCurrent
50090-1830-15009018300130 TABLET, FILM COATED in 1 BOTTLE (50090-1830-1) 2015-05-180000-00-00NoNoCurrent
50090-1830-25009018300214 TABLET, FILM COATED in 1 BOTTLE (50090-1830-2) 2015-05-180000-00-00NoNoCurrent
50090-1830-35009018300328 TABLET, FILM COATED in 1 BOTTLE (50090-1830-3) 2025-05-22NoNoCurrent