Clarithromycin

Product NDC
0781-1962
11-digit product format
007811962
Labeler code
0781
Product ID
0781-1962_a18fa357-b294-48b9-aabe-dad7d6259ba3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clarithromycin
Dosage form
TABLET
Route
ORAL
Labeler
Sandoz Inc
Application
ANDA065136
Marketing category
ANDA
Marketing start
2005-08-25
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

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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0781-19620781-1962-01DDiscontinued by firm2026-08-11
excluded packagepackage0781-19620781-1962-05DDiscontinued by firm2026-08-11
excluded packagepackage0781-19620781-1962-31DDiscontinued by firm2026-08-11

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 · 36 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-050781-1962-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-050781-1962-31d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-050781-1962-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-260781-1962-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-260781-1962-31f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-260781-1962-05f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-310781-1962-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-310781-1962-312ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-310781-1962-052ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-280781-1962-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-280781-1962-31a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-280781-1962-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-210781-1962-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-210781-1962-31cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-210781-1962-05cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-100781-1962-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-100781-1962-31cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-100781-1962-05cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-310781-1962-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-310781-1962-31302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-310781-1962-05302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-200781-1962-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-200781-1962-31ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-200781-1962-05ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100781-1962-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-100781-1962-310efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-100781-1962-050efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-080781-1962-01ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-080781-1962-31ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-080781-1962-05ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-030781-1962-01367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-030781-1962-31367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-030781-1962-05367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-090781-1962-01557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-090781-1962-31557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-090781-1962-05557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065136-001CLARITHROMYCINCLARITHROMYCIN500MGTABLET / ORALAB2005-08-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065136-001AB

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 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A065136-001CLARITHROMYCIN500MGTABLET / ORALAB2005-08-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065136-001CLARITHROMYCIN500MGTABLET / ORALAB2005-08-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A065136-001CLARITHROMYCIN500MGTABLET / ORALAB2005-08-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065136-001CLARITHROMYCIN500MGTABLET / ORALAB2005-08-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065136-001CLARITHROMYCIN500MGTABLET / ORALAB2005-08-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065136-001CLARITHROMYCIN500MGTABLET / ORALAB2005-08-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065136-001CLARITHROMYCIN500MGTABLET / ORALAB2005-08-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065136-001CLARITHROMYCIN500MGTABLET / ORALAB2005-08-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065136-001CLARITHROMYCIN500MGTABLET / ORALAB2005-08-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065136-001CLARITHROMYCIN500MGTABLET / ORALAB2005-08-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065136-001CLARITHROMYCIN500MGTABLET / ORALAB2005-08-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065136-001CLARITHROMYCIN500MGTABLET / ORALAB2005-08-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065136-001CLARITHROMYCIN500MGTABLET / ORALAB2005-08-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065136-001CLARITHROMYCIN500MGTABLET / ORALAB2005-08-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065136-001CLARITHROMYCIN500MGTABLET / ORALAB2005-08-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065136-001CLARITHROMYCIN500MGTABLET / ORALAB2005-08-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065136-001CLARITHROMYCIN500MGTABLET / ORALAB2005-08-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065136-001CLARITHROMYCIN500MGTABLET / ORALAB2005-08-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065136-001CLARITHROMYCIN500MGTABLET / ORALAB2005-08-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065136-001CLARITHROMYCIN500MGTABLET / ORALAB2005-08-25782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065136-001CLARITHROMYCIN500MGTABLET / ORALAB2005-08-2587673890dc5c…
2021-03-12 10:30 UTC2021-03A065136-001CLARITHROMYCIN500MGTABLET / ORALAB2005-08-255aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065136-001CLARITHROMYCIN500MGTABLET / ORALAB2005-08-258869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065136-001CLARITHROMYCIN500MGTABLET / ORALAB2005-08-25c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065136-001CLARITHROMYCIN500MGTABLET / ORALAB2005-08-253f01610625f2…
2019-09-15 20:21 UTC2019-09A065136-001CLARITHROMYCIN500MGTABLET / ORALAB2005-08-25b00525d2431f…
2019-07-19 19:46 UTC2019-07A065136-001CLARITHROMYCIN500MGTABLET / ORALAB2005-08-25ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065136-001CLARITHROMYCIN500MGTABLET / ORALAB2005-08-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065136-001CLARITHROMYCIN500MGTABLET / ORALAB2005-08-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065136-001CLARITHROMYCIN500MGTABLET / ORALAB2005-08-25ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065136-001CLARITHROMYCIN500MGTABLET / ORALAB2005-08-25a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065136-001CLARITHROMYCIN500MGTABLET / ORALAB2005-08-259b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065136-001CLARITHROMYCIN500MGTABLET / ORALAB2005-08-25a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065136-001CLARITHROMYCIN500MGTABLET / ORALAB2005-08-253f0d92c62455…
2023-05-13 08:27 UTC2023-05A065136-001CLARITHROMYCIN500MGTABLET / ORALAB2005-08-25053a50430f4f…
2023-01-26 05:58 UTC2023-01A065136-001CLARITHROMYCIN500MGTABLET / ORALAB2005-08-253bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065136-001CLARITHROMYCIN500MGTABLET / ORALAB2005-08-253a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065136-001CLARITHROMYCIN500MGTABLET / ORALAB2005-08-25f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065136-001CLARITHROMYCIN500MGTABLET / ORALAB2005-08-25e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065136-001CLARITHROMYCIN500MGTABLET / ORALAB2005-08-25cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A065136-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065136-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065136-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065136-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065136-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065136-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065136-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065136-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065136-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065136-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065136-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065136-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065136-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065136-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065136-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065136-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065136-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065136-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065136-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065136-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065136-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A065136-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065136-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065136-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065136-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A065136-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A065136-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065136-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065136-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065136-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065136-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065136-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065136-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065136-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A065136-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A065136-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065136-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065136-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065136-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065136-001AB1cb3db0bc1861…

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
b98b02bb-2609-49a0-b29f-e5911aa0cbc1Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
0781-1962-01Clarithromycin100 in 1 BOTTLETABLET10023
0781-1962-05Clarithromycin500 in 1 BOTTLETABLET50023
0781-1962-31Clarithromycin30 in 1 BOTTLETABLET3023
0781-1962-60Clarithromycin60 in 1 BOTTLETABLET6023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-1962-60EA - Each0781-196262606abb-9b9c-4257-94dc-2d661592cab812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLARITHROMYCINACTIVE INGREDIENTH1250JIK0ACLARITHROMYCIN TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3350
CLARITHROMYCINACTIVE MOIETYH1250JIK0ACLARITHROMYCIN TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3350
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCLARITHROMYCIN TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3350
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CLARITHROMYCIN TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3350
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCLARITHROMYCIN TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3350
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLARITHROMYCIN TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3350
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACLARITHROMYCIN TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3350
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCLARITHROMYCIN TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3350
POVIDONEINACTIVE INGREDIENTFZ989GH94ECLARITHROMYCIN TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3350
TALCINACTIVE INGREDIENT7SEV7J4R1UCLARITHROMYCIN TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3350
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCLARITHROMYCIN TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3350
CLARITHROMYCINACTIVE INGREDIENTH1250JIK0ACLARITHROMYCIN TABLET [PD-RX PHARMACEUTICALS, INC.]15
CLARITHROMYCINACTIVE INGREDIENTH1250JIK0ACLARITHROMYCIN TABLET [SANDOZ INC]15
CLARITHROMYCINACTIVE MOIETYH1250JIK0ACLARITHROMYCIN TABLET [PD-RX PHARMACEUTICALS, INC.]15
CLARITHROMYCINACTIVE MOIETYH1250JIK0ACLARITHROMYCIN TABLET [SANDOZ INC]15
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCLARITHROMYCIN TABLET [SANDOZ INC]15
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCLARITHROMYCIN TABLET [PD-RX PHARMACEUTICALS, INC.]15
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CLARITHROMYCIN TABLET [PD-RX PHARMACEUTICALS, INC.]15
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CLARITHROMYCIN TABLET [SANDOZ INC]15
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82CLARITHROMYCIN TABLET [PD-RX PHARMACEUTICALS, INC.]15
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82CLARITHROMYCIN TABLET [SANDOZ INC]15
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6CLARITHROMYCIN TABLET [PD-RX PHARMACEUTICALS, INC.]15
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6CLARITHROMYCIN TABLET [SANDOZ INC]15
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLARITHROMYCIN TABLET [SANDOZ INC]15
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLARITHROMYCIN TABLET [PD-RX PHARMACEUTICALS, INC.]15
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCLARITHROMYCIN TABLET [PD-RX PHARMACEUTICALS, INC.]15
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCLARITHROMYCIN TABLET [SANDOZ INC]15
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCLARITHROMYCIN TABLET [PD-RX PHARMACEUTICALS, INC.]15
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCLARITHROMYCIN TABLET [SANDOZ INC]15
POVIDONESINACTIVE INGREDIENTFZ989GH94ECLARITHROMYCIN TABLET [PD-RX PHARMACEUTICALS, INC.]15
POVIDONESINACTIVE INGREDIENTFZ989GH94ECLARITHROMYCIN TABLET [SANDOZ INC]15
TALCINACTIVE INGREDIENT7SEV7J4R1UCLARITHROMYCIN TABLET [PD-RX PHARMACEUTICALS, INC.]15
TALCINACTIVE INGREDIENT7SEV7J4R1UCLARITHROMYCIN TABLET [SANDOZ INC]15
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCLARITHROMYCIN TABLET [PD-RX PHARMACEUTICALS, INC.]15
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCLARITHROMYCIN TABLET [SANDOZ INC]15
CLARITHROMYCINACTIVE INGREDIENTH1250JIK0ACLARITHROMYCIN TABLET [PHYSICIANS TOTAL CARE, INC.]3
CLARITHROMYCINACTIVE MOIETYH1250JIK0ACLARITHROMYCIN TABLET [PHYSICIANS TOTAL CARE, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCLARITHROMYCIN TABLET [PHYSICIANS TOTAL CARE, INC.]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CLARITHROMYCIN TABLET [PHYSICIANS TOTAL CARE, INC.]3
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82CLARITHROMYCIN TABLET [PHYSICIANS TOTAL CARE, INC.]3
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6CLARITHROMYCIN TABLET [PHYSICIANS TOTAL CARE, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLARITHROMYCIN TABLET [PHYSICIANS TOTAL CARE, INC.]3
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCLARITHROMYCIN TABLET [PHYSICIANS TOTAL CARE, INC.]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCLARITHROMYCIN TABLET [PHYSICIANS TOTAL CARE, INC.]3
POVIDONEINACTIVE INGREDIENTFZ989GH94ECLARITHROMYCIN TABLET [PHYSICIANS TOTAL CARE, INC.]3
TALCINACTIVE INGREDIENT7SEV7J4R1UCLARITHROMYCIN TABLET [PHYSICIANS TOTAL CARE, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCLARITHROMYCIN TABLET [PHYSICIANS TOTAL CARE, INC.]3
CLARITHROMYCINACTIVE INGREDIENTH1250JIK0ACLARITHROMYCIN TABLET [AMERICAN HEALTH PACKAGING]2
CLARITHROMYCINACTIVE MOIETYH1250JIK0ACLARITHROMYCIN TABLET [AMERICAN HEALTH PACKAGING]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCLARITHROMYCIN TABLET [AMERICAN HEALTH PACKAGING]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CLARITHROMYCIN TABLET [AMERICAN HEALTH PACKAGING]2
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82CLARITHROMYCIN TABLET [AMERICAN HEALTH PACKAGING]2
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6CLARITHROMYCIN TABLET [AMERICAN HEALTH PACKAGING]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLARITHROMYCIN TABLET [AMERICAN HEALTH PACKAGING]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCLARITHROMYCIN TABLET [AMERICAN HEALTH PACKAGING]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCLARITHROMYCIN TABLET [AMERICAN HEALTH PACKAGING]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ECLARITHROMYCIN TABLET [AMERICAN HEALTH PACKAGING]2
TALCINACTIVE INGREDIENT7SEV7J4R1UCLARITHROMYCIN TABLET [AMERICAN HEALTH PACKAGING]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCLARITHROMYCIN TABLET [AMERICAN HEALTH PACKAGING]2
CLARITHROMYCINACTIVE INGREDIENTH1250JIK0ACLARITHROMYCIN TABLET [LIFE LINE HOME CARE SERVICES, INC.]1
clarithromycinACTIVE INGREDIENTH1250JIK0ACLARITHROMYCIN TABLET [REBEL DISTRIBUTORS CORP.]1
CLARITHROMYCINACTIVE MOIETYH1250JIK0ACLARITHROMYCIN TABLET [LIFE LINE HOME CARE SERVICES, INC.]1
clarithromycinACTIVE MOIETYH1250JIK0ACLARITHROMYCIN TABLET [REBEL DISTRIBUTORS CORP.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCLARITHROMYCIN TABLET [LIFE LINE HOME CARE SERVICES, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCLARITHROMYCIN TABLET [REBEL DISTRIBUTORS CORP.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CLARITHROMYCIN TABLET [REBEL DISTRIBUTORS CORP.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CLARITHROMYCIN TABLET [LIFE LINE HOME CARE SERVICES, INC.]1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOCLARITHROMYCIN TABLET [REBEL DISTRIBUTORS CORP.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCLARITHROMYCIN TABLET [LIFE LINE HOME CARE SERVICES, INC.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30CLARITHROMYCIN TABLET [REBEL DISTRIBUTORS CORP.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLARITHROMYCIN TABLET [LIFE LINE HOME CARE SERVICES, INC.]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ACLARITHROMYCIN TABLET [LIFE LINE HOME CARE SERVICES, INC.]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ACLARITHROMYCIN TABLET [REBEL DISTRIBUTORS CORP.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCLARITHROMYCIN TABLET [REBEL DISTRIBUTORS CORP.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCLARITHROMYCIN TABLET [LIFE LINE HOME CARE SERVICES, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ECLARITHROMYCIN TABLET [LIFE LINE HOME CARE SERVICES, INC.]1
povidoneINACTIVE INGREDIENTFZ989GH94ECLARITHROMYCIN TABLET [REBEL DISTRIBUTORS CORP.]1
talcINACTIVE INGREDIENT7SEV7J4R1UCLARITHROMYCIN TABLET [REBEL DISTRIBUTORS CORP.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UCLARITHROMYCIN TABLET [LIFE LINE HOME CARE SERVICES, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCLARITHROMYCIN TABLET [LIFE LINE HOME CARE SERVICES, INC.]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPCLARITHROMYCIN TABLET [REBEL DISTRIBUTORS CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-1962CLARITHROMYCIN TABLET [SANDOZ INC]23Current NDC, Legacy NDC, 4 package rows20231102_b98b02bb-2609-49a0-b29f-e5911aa0cbc1.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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ClarithromycinCLARITHROMYCINNorthwind Health Company, LLCf98aacb4-2f01-3e94-e053-6294a90a9aa02026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065136
application number: ANDA065136
ClarithromycinCLARITHROMYCINPD-Rx Pharmaceuticals, Inc.0be243c6-de02-45dd-8210-cab1bbc8dfa72025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065136
application number: ANDA065136
ClarithromycinCLARITHROMYCINCoupler LLC2d6cfd87-9b8c-bba9-e063-6294a90aff5a2025-02-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065136
application number: ANDA065136
ClarithromycinCLARITHROMYCINDirectRxd22bd12c-737b-4aab-e053-2995a90aff602025-01-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065136
application number: ANDA065136
ClarithromycinCLARITHROMYCINBryant Ranch Prepack27e02b77-4332-49e0-8d0c-a072cf5dff922024-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065136
application number: ANDA065136
ClarithromycinCLARITHROMYCINProficient Rx LP28f60574-4ecd-441c-aebe-5b1d18033ef62024-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065136
application number: ANDA065136
ClarithromycinCLARITHROMYCINA-S Medication Solutionsadba78c2-9e51-4bed-8c6a-6f977f79c40c2023-12-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065136
application number: ANDA065136
ClarithromycinCLARITHROMYCINSandoz Incb98b02bb-2609-49a0-b29f-e5911aa0cbc12023-05-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065136
application number: ANDA065136
ndc (product): 0781-1962
ClarithromycinCLARITHROMYCINAsclemed USA, Inc.a12e4d38-e0f8-4467-a26c-bb25a342aa922020-10-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065136
application number: ANDA065136

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197517clarithromycin 500 MG Oral TabletPSN0be243c6-de02-45dd-8210-cab1bbc8dfa729
197517clarithromycin 500 MG Oral TabletSCD0be243c6-de02-45dd-8210-cab1bbc8dfa729
197516clarithromycin 250 MG Oral TabletPSNb98b02bb-2609-49a0-b29f-e5911aa0cbc123
197517clarithromycin 500 MG Oral TabletPSNb98b02bb-2609-49a0-b29f-e5911aa0cbc123
197516clarithromycin 250 MG Oral TabletSCDb98b02bb-2609-49a0-b29f-e5911aa0cbc123
197517clarithromycin 500 MG Oral TabletSCDb98b02bb-2609-49a0-b29f-e5911aa0cbc123
197517clarithromycin 500 MG Oral TabletPSNadba78c2-9e51-4bed-8c6a-6f977f79c40c8
197517clarithromycin 500 MG Oral TabletSCDadba78c2-9e51-4bed-8c6a-6f977f79c40c8
197517clarithromycin 500 MG Oral TabletPSN3fdb8746-395f-1123-e054-00144ff88e887
197517clarithromycin 500 MG Oral TabletSCD3fdb8746-395f-1123-e054-00144ff88e887
197517clarithromycin 500 MG Oral TabletPSN27e02b77-4332-49e0-8d0c-a072cf5dff926
197517clarithromycin 500 MG Oral TabletSCD27e02b77-4332-49e0-8d0c-a072cf5dff926
197517clarithromycin 500 MG Oral TabletPSNf98aacb4-2f01-3e94-e053-6294a90a9aa04
197517clarithromycin 500 MG Oral TabletPSNd22bd12c-737b-4aab-e053-2995a90aff604
197517clarithromycin 500 MG Oral TabletSCDf98aacb4-2f01-3e94-e053-6294a90a9aa04
197517clarithromycin 500 MG Oral TabletSCDd22bd12c-737b-4aab-e053-2995a90aff604
197517clarithromycin 500 MG Oral TabletPSN92ae2611-637c-4a9e-8e95-2d8fa8191f033
197517clarithromycin 500 MG Oral TabletSCD92ae2611-637c-4a9e-8e95-2d8fa8191f033
197517clarithromycin 500 MG Oral TabletPSN146e570b-c0d0-4879-9f58-8cf6287af9a62
197517clarithromycin 500 MG Oral TabletSCD146e570b-c0d0-4879-9f58-8cf6287af9a62
197516clarithromycin 250 MG Oral TabletPSNf3a50f13-b028-4135-8f20-bfb62a9bc0a91
197517clarithromycin 500 MG Oral TabletPSN28f60574-4ecd-441c-aebe-5b1d18033ef61
197517clarithromycin 500 MG Oral TabletPSNc14051fd-deeb-4340-b9a9-9482ef6c198c1
197517clarithromycin 500 MG Oral TabletPSNa12e4d38-e0f8-4467-a26c-bb25a342aa921
197517clarithromycin 500 MG Oral TabletPSNece57ade-11e0-7057-e053-2a95a90a26d71
197517clarithromycin 500 MG Oral TabletPSNf3a50f13-b028-4135-8f20-bfb62a9bc0a91
197517clarithromycin 500 MG Oral TabletPSN2d6cfd87-9b8c-bba9-e063-6294a90aff5a1
197516clarithromycin 250 MG Oral TabletSCDf3a50f13-b028-4135-8f20-bfb62a9bc0a91
197517clarithromycin 500 MG Oral TabletSCD28f60574-4ecd-441c-aebe-5b1d18033ef61
197517clarithromycin 500 MG Oral TabletSCDc14051fd-deeb-4340-b9a9-9482ef6c198c1
197517clarithromycin 500 MG Oral TabletSCDa12e4d38-e0f8-4467-a26c-bb25a342aa921
197517clarithromycin 500 MG Oral TabletSCDece57ade-11e0-7057-e053-2a95a90a26d71
197517clarithromycin 500 MG Oral TabletSCDf3a50f13-b028-4135-8f20-bfb62a9bc0a91
197517clarithromycin 500 MG Oral TabletSCD2d6cfd87-9b8c-bba9-e063-6294a90aff5a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-1962-0100781196201100 in 1 BOTTLEHistorical
0781-1962-0500781196205500 in 1 BOTTLEHistorical
0781-1962-310078119623130 in 1 BOTTLEHistorical
0781-1962-600078119626060 TABLET in 1 BOTTLE (0781-1962-60) 60 tablet2005-08-250000-00-00NoNoCurrent