Clarithromycin

Product NDC
0527-1932
11-digit product format
005271932
Labeler code
0527
Product ID
0527-1932_0a136962-d1f1-f728-e063-6394a90a01b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clarithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Lannett Company, Inc.
Application
ANDA203584
Marketing category
ANDA
Marketing start
2019-11-23
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
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…

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 · 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
ndc (product): 0527-1932

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197516Internal RxNorm lookup
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
9bf207c0-86eb-4f3b-92e7-f65f3fccd5a7Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0527-1932-06Clarithromycin60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0527-1932-06EA - Each0527-1932594a826f-e5ea-4992-b168-4778ce1a1d4612016-02-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0527-1932CLARITHROMYCIN TABLET, FILM COATED [LANNETT COMPANY, INC.]19Current NDC, Legacy NDC, 1 package rows20231115_9bf207c0-86eb-4f3b-92e7-f65f3fccd5a7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197517clarithromycin 500 MG Oral TabletPSN1cb8a78a-0f07-49e8-a23e-a7762800620923
197517clarithromycin 500 MG Oral TabletSCD1cb8a78a-0f07-49e8-a23e-a7762800620923
197516clarithromycin 250 MG Oral TabletPSN9bf207c0-86eb-4f3b-92e7-f65f3fccd5a719
197517clarithromycin 500 MG Oral TabletPSN9bf207c0-86eb-4f3b-92e7-f65f3fccd5a719
197516clarithromycin 250 MG Oral TabletSCD9bf207c0-86eb-4f3b-92e7-f65f3fccd5a719
197517clarithromycin 500 MG Oral TabletSCD9bf207c0-86eb-4f3b-92e7-f65f3fccd5a719
197516clarithromycin 250 MG Oral TabletPSN2a7bb675-0ef5-44c0-a8c2-72aa3334f29d9
197517clarithromycin 500 MG Oral TabletPSN2a7bb675-0ef5-44c0-a8c2-72aa3334f29d9
197516clarithromycin 250 MG Oral TabletSCD2a7bb675-0ef5-44c0-a8c2-72aa3334f29d9
197517clarithromycin 500 MG Oral TabletSCD2a7bb675-0ef5-44c0-a8c2-72aa3334f29d9
197517clarithromycin 500 MG Oral TabletPSN4a3febd5-8cf4-5306-e054-00144ff8d46c8
197517clarithromycin 500 MG Oral TabletSCD4a3febd5-8cf4-5306-e054-00144ff8d46c8
197517clarithromycin 500 MG Oral TabletPSN59ebe6cb-c830-45c7-8242-52f9f42a90a06
197517clarithromycin 500 MG Oral TabletPSN9eb306e0-ccfb-418c-82ca-204f20a788f76
197517clarithromycin 500 MG Oral TabletSCD9eb306e0-ccfb-418c-82ca-204f20a788f76
197517clarithromycin 500 MG Oral TabletSCD59ebe6cb-c830-45c7-8242-52f9f42a90a06
197517clarithromycin 500 MG Oral TabletPSN8ff1fc34-9cd8-ea26-e053-2995a90a06164
197517clarithromycin 500 MG Oral TabletPSN5047246b-310f-5ae0-e054-00144ff8d46c4
197517clarithromycin 500 MG Oral TabletSCD8ff1fc34-9cd8-ea26-e053-2995a90a06164
197517clarithromycin 500 MG Oral TabletSCD5047246b-310f-5ae0-e054-00144ff8d46c4
197517clarithromycin 500 MG Oral TabletPSN07b6fad2-cae6-43e1-850b-202126eb2abd3
197517clarithromycin 500 MG Oral TabletSCD07b6fad2-cae6-43e1-850b-202126eb2abd3
197517clarithromycin 500 MG Oral TabletPSN876b7723-ff80-7ccf-e053-2995a90a6fc31
197517clarithromycin 500 MG Oral TabletPSNba0d460e-fc4a-58fd-e053-2a95a90a45951
197517clarithromycin 500 MG Oral TabletSCD876b7723-ff80-7ccf-e053-2995a90a6fc31
197517clarithromycin 500 MG Oral TabletSCDba0d460e-fc4a-58fd-e053-2a95a90a45951

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0527-1932-060052719320660 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0527-1932-06) 2019-11-230000-00-00NoNoCurrent