CLARITHROMYCIN

Product NDC
62135-615
11-digit product format
621350615
Labeler code
62135
Product ID
62135-615_f08573c8-02d4-3717-e053-2a95a90a2dda
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clarithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Chartwell RX, LLC.
Application
ANDA065384
Marketing category
ANDA
Marketing start
2007-08-20
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
A065384-001CLARITHROMYCINCLARITHROMYCIN250MGTABLET / ORALAB2007-08-20
A065384-002CLARITHROMYCINCLARITHROMYCIN500MGTABLET / ORALAB2007-08-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065384-001AB
A065384-002AB

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 UTC2026-02A065384-001CLARITHROMYCIN250MGTABLET / ORALAB2007-08-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065384-002CLARITHROMYCIN500MGTABLET / ORALAB2007-08-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065384-001CLARITHROMYCIN250MGTABLET / ORALAB2007-08-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065384-002CLARITHROMYCIN500MGTABLET / ORALAB2007-08-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A065384-001CLARITHROMYCIN250MGTABLET / ORALAB2007-08-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065384-002CLARITHROMYCIN500MGTABLET / ORALAB2007-08-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065384-001CLARITHROMYCIN250MGTABLET / ORALAB2007-08-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065384-002CLARITHROMYCIN500MGTABLET / ORALAB2007-08-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065384-001CLARITHROMYCIN250MGTABLET / ORALAB2007-08-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065384-002CLARITHROMYCIN500MGTABLET / ORALAB2007-08-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065384-001CLARITHROMYCIN250MGTABLET / ORALAB2007-08-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065384-002CLARITHROMYCIN500MGTABLET / ORALAB2007-08-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065384-001CLARITHROMYCIN250MGTABLET / ORALAB2007-08-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065384-002CLARITHROMYCIN500MGTABLET / ORALAB2007-08-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065384-001CLARITHROMYCIN250MGTABLET / ORALAB2007-08-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065384-002CLARITHROMYCIN500MGTABLET / ORALAB2007-08-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065384-001CLARITHROMYCIN250MGTABLET / ORALAB2007-08-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065384-002CLARITHROMYCIN500MGTABLET / ORALAB2007-08-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065384-001CLARITHROMYCIN250MGTABLET / ORALAB2007-08-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A065384-002CLARITHROMYCIN500MGTABLET / ORALAB2007-08-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065384-001CLARITHROMYCIN250MGTABLET / ORALAB2007-08-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065384-002CLARITHROMYCIN500MGTABLET / ORALAB2007-08-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065384-001CLARITHROMYCIN250MGTABLET / ORALAB2007-08-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065384-002CLARITHROMYCIN500MGTABLET / ORALAB2007-08-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065384-001CLARITHROMYCIN250MGTABLET / ORALAB2007-08-201e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065384-002CLARITHROMYCIN500MGTABLET / ORALAB2007-08-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065384-001CLARITHROMYCIN250MGTABLET / ORALAB2007-08-208072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065384-002CLARITHROMYCIN500MGTABLET / ORALAB2007-08-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065384-001CLARITHROMYCIN250MGTABLET / ORALAB2007-08-205c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065384-002CLARITHROMYCIN500MGTABLET / ORALAB2007-08-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065384-001CLARITHROMYCIN250MGTABLET / ORALAB2007-08-205d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065384-002CLARITHROMYCIN500MGTABLET / ORALAB2007-08-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065384-001CLARITHROMYCIN250MGTABLET / ORALAB2007-08-204b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065384-002CLARITHROMYCIN500MGTABLET / ORALAB2007-08-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065384-001CLARITHROMYCIN250MGTABLET / ORALAB2007-08-2074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065384-002CLARITHROMYCIN500MGTABLET / ORALAB2007-08-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065384-001CLARITHROMYCIN250MGTABLET / ORALAB2007-08-20bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065384-002CLARITHROMYCIN500MGTABLET / ORALAB2007-08-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065384-001CLARITHROMYCIN250MGTABLET / ORALAB2007-08-20782e0a99824c…
2021-12-28 21:50 UTC2021-12A065384-002CLARITHROMYCIN500MGTABLET / ORALAB2007-08-20782e0a99824c…

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 UTC2026-02A065384-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065384-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065384-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065384-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065384-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065384-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065384-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065384-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065384-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065384-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065384-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065384-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065384-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065384-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065384-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065384-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065384-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065384-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065384-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A065384-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065384-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065384-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065384-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065384-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065384-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065384-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065384-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065384-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065384-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065384-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065384-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065384-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065384-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065384-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065384-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065384-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065384-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065384-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065384-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A065384-002AB1782e0a99824c…

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
99d2fd6b-39ca-42f9-ad06-30e7fbc22c47Available 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
62135-615-60CLARITHROMYCIN60 in 1 BOTTLE, PLASTICTABLET, FILM COATED602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-615-60EA - Each62135-6159783389e-5d39-42f6-8443-6f565603a39412021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-615CLARITHROMYCIN TABLET, FILM COATED [CHARTWELL RX, LLC.]2Current NDC, Legacy NDC, 1 package rows20221224_99d2fd6b-39ca-42f9-ad06-30e7fbc22c47.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CLARITHROMYCINCLARITHROMYCINChartwell RX, LLC.99d2fd6b-39ca-42f9-ad06-30e7fbc22c472022-12-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065384
application number: ANDA065384
ndc (product): 62135-615

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197516clarithromycin 250 MG Oral TabletPSN99d2fd6b-39ca-42f9-ad06-30e7fbc22c472
197517clarithromycin 500 MG Oral TabletPSN99d2fd6b-39ca-42f9-ad06-30e7fbc22c472
197516clarithromycin 250 MG Oral TabletSCD99d2fd6b-39ca-42f9-ad06-30e7fbc22c472
197517clarithromycin 500 MG Oral TabletSCD99d2fd6b-39ca-42f9-ad06-30e7fbc22c472

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62135-615-606213506156060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (62135-615-60) 2021-02-010000-00-00NoNoCurrent