Clarithromycin

Product NDC
50090-0994
11-digit product format
500900994
Labeler code
50090
Product ID
50090-0994_b17c8e0b-5db9-4116-9073-8e8fac3459dc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clarithromycin
Dosage form
FOR SUSPENSION
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA065283
Marketing category
ANDA
Marketing start
2007-09-04
Substance
CLARITHROMYCIN
Active strength
250 mg/5mL
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
2027-12-31
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
A065283-002CLARITHROMYCINCLARITHROMYCIN125MG/5MLFOR SUSPENSION / ORAL2007-09-04
A065283-003CLARITHROMYCINCLARITHROMYCIN250MG/5MLFOR SUSPENSION / ORALRS2007-09-04

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 UTC2026-02A065283-002CLARITHROMYCIN125MG/5MLFOR SUSPENSION / ORAL2007-09-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A065283-003CLARITHROMYCIN250MG/5MLFOR SUSPENSION / ORALRS2007-09-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065283-002CLARITHROMYCIN125MG/5MLFOR SUSPENSION / ORAL2007-09-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065283-003CLARITHROMYCIN250MG/5MLFOR SUSPENSION / ORALRS2007-09-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A065283-002CLARITHROMYCIN125MG/5MLFOR SUSPENSION / ORAL2007-09-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A065283-003CLARITHROMYCIN250MG/5MLFOR SUSPENSION / ORALRS2007-09-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065283-002CLARITHROMYCIN125MG/5MLFOR SUSPENSION / ORAL2007-09-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065283-003CLARITHROMYCIN250MG/5MLFOR SUSPENSION / ORALRS2007-09-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065283-002CLARITHROMYCIN125MG/5MLFOR SUSPENSION / ORAL2007-09-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065283-003CLARITHROMYCIN250MG/5MLFOR SUSPENSION / ORALRS2007-09-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065283-002CLARITHROMYCIN125MG/5MLFOR SUSPENSION / ORAL2007-09-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065283-003CLARITHROMYCIN250MG/5MLFOR SUSPENSION / ORALRS2007-09-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065283-002CLARITHROMYCIN125MG/5MLFOR SUSPENSION / ORAL2007-09-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065283-003CLARITHROMYCIN250MG/5MLFOR SUSPENSION / ORALRS2007-09-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065283-002CLARITHROMYCIN125MG/5MLFOR SUSPENSION / ORAL2007-09-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065283-003CLARITHROMYCIN250MG/5MLFOR SUSPENSION / ORALRS2007-09-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065283-002CLARITHROMYCIN125MG/5MLFOR SUSPENSION / ORAL2007-09-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065283-003CLARITHROMYCIN250MG/5MLFOR SUSPENSION / ORALRS2007-09-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065283-002CLARITHROMYCIN125MG/5MLFOR SUSPENSION / ORAL2007-09-04d06236e962d9…
2024-10-29 15:01 UTC2024-10A065283-003CLARITHROMYCIN250MG/5MLFOR SUSPENSION / ORALRS2007-09-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065283-002CLARITHROMYCIN125MG/5MLFOR SUSPENSION / ORAL2007-09-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065283-003CLARITHROMYCIN250MG/5MLFOR SUSPENSION / ORALRS2007-09-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065283-002CLARITHROMYCIN125MG/5MLFOR SUSPENSION / ORAL2007-09-04301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065283-003CLARITHROMYCIN250MG/5MLFOR SUSPENSION / ORALRS2007-09-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065283-002CLARITHROMYCIN125MG/5MLFOR SUSPENSION / ORAL2007-09-041e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065283-003CLARITHROMYCIN250MG/5MLFOR SUSPENSION / ORALRS2007-09-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065283-002CLARITHROMYCIN125MG/5MLFOR SUSPENSION / ORAL2007-09-048072bd15b7f6…
2024-05-31 18:47 UTC2024-05A065283-003CLARITHROMYCIN250MG/5MLFOR SUSPENSION / ORALRS2007-09-048072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065283-002CLARITHROMYCIN125MG/5MLFOR SUSPENSION / ORALAB2007-09-045c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065283-003CLARITHROMYCIN250MG/5MLFOR SUSPENSION / ORALABRS2007-09-045c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065283-002CLARITHROMYCIN125MG/5MLFOR SUSPENSION / ORALAB2007-09-045d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065283-003CLARITHROMYCIN250MG/5MLFOR SUSPENSION / ORALABRS2007-09-045d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065283-002CLARITHROMYCIN125MG/5MLFOR SUSPENSION / ORALAB2007-09-044b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065283-003CLARITHROMYCIN250MG/5MLFOR SUSPENSION / ORALABRS2007-09-044b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065283-002CLARITHROMYCIN125MG/5MLFOR SUSPENSION / ORALAB2007-09-0474a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065283-003CLARITHROMYCIN250MG/5MLFOR SUSPENSION / ORALABRS2007-09-0474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065283-002CLARITHROMYCIN125MG/5MLFOR SUSPENSION / ORALAB2007-09-04bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065283-003CLARITHROMYCIN250MG/5MLFOR SUSPENSION / ORALABRS2007-09-04bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065283-002CLARITHROMYCIN125MG/5MLFOR SUSPENSION / ORALAB2007-09-04782e0a99824c…
2021-12-28 21:50 UTC2021-12A065283-003CLARITHROMYCIN250MG/5MLFOR SUSPENSION / ORALABRS2007-09-04782e0a99824c…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065283-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065283-003AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065283-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A065283-003AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065283-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A065283-003AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065283-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A065283-003AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065283-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A065283-003AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065283-002AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A065283-003AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065283-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065283-003AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A065283-002AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A065283-003AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065283-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A065283-003AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065283-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A065283-003AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065283-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A065283-003AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A065283-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A065283-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A065283-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A065283-003AB1ea99ee380514…
2023-05-13 08:27 UTC2023-05A065283-002AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A065283-003AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A065283-002AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A065283-003AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065283-002AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065283-003AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065283-002AB1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A065283-003AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065283-002AB1e64feba35796…
2022-09-29 23:25 UTC2022-09A065283-003AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065283-002AB1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065283-003AB1cb3db0bc1861…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ClarithromycinCLARITHROMYCINA-S Medication Solutionsfad1e5a3-59f9-4868-9937-d3b061ab8f002026-02-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065283
application number: ANDA065283
ndc (product): 50090-0994
ClarithromycinCLARITHROMYCINSandoz Inc22457862-0f88-4be8-b507-1c8f264269f22023-09-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065283
application number: ANDA065283

Additional Listing Data#

Finished product
Yes
Brand name base
Clarithromycin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLARITHROMYCIN250 mg/5mL

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
309322Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fad1e5a3-59f9-4868-9937-d3b061ab8f00Available 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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0994-0Clarithromycin50 mL in 1 BOTTLEFOR SUSPENSION5019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0994-0ML - Milliliter50090-099418e3ad50-7de1-4f5c-883d-4e9c1484abee12018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0994CLARITHROMYCIN FOR SUSPENSION [A-S MEDICATION SOLUTIONS]17Current NDC, Legacy NDC, 1 package rows20240113_fad1e5a3-59f9-4868-9937-d3b061ab8f00.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309322clarithromycin 250 MG in 5 mL Oral SuspensionPSNfad1e5a3-59f9-4868-9937-d3b061ab8f0019
309322clarithromycin 50 MG/ML Oral SuspensionSCDfad1e5a3-59f9-4868-9937-d3b061ab8f0019
309322clarithromycin 250 MG per 5 ML Oral SuspensionSYfad1e5a3-59f9-4868-9937-d3b061ab8f0019

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0994-05009009940050 mL in 1 BOTTLE (50090-0994-0) 50 ml2014-11-280000-00-00NoNoCurrent