Cefadroxil

Product NDC
45865-503
11-digit product format
458650503
Labeler code
45865
Product ID
45865-503_7df08284-2357-0914-e053-2991aa0aa0fa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefadroxil
Dosage form
CAPSULE
Route
ORAL
Labeler
medsource pharmaceutocals
Application
ANDA065392
Marketing category
ANDA
Marketing start
2008-04-23
Marketing end
0000-00-00
Substance
CEFADROXIL
Active strength
500 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct45865-503IInactivated by FDA2026-08-03
excluded packagepackage45865-50345865-503-28IInactivated by FDA2026-08-03

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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage45865-503-28IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage45865-503-28IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage45865-503-28IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage45865-503-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage45865-503-28IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage45865-503-28IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage45865-503-28UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage45865-503-28UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage45865-503-28UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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
A065392-001CEFADROXILCEFADROXIL/CEFADROXIL HEMIHYDRATEEQ 500MG BASECAPSULE / ORALAB2007-05-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065392-001AB

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 UTC2026-02A065392-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-05-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065392-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-05-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A065392-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-05-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065392-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-05-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065392-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-05-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065392-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-05-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065392-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-05-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065392-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-05-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065392-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-05-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065392-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-05-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065392-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-05-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065392-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-05-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065392-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-05-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065392-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-05-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065392-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-05-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065392-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-05-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065392-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-05-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065392-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-05-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065392-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-05-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065392-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-05-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065392-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-05-2987673890dc5c…
2021-03-12 10:30 UTC2021-03A065392-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-05-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065392-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-05-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065392-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-05-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065392-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-05-293f01610625f2…
2019-09-15 20:21 UTC2019-09A065392-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-05-29b00525d2431f…
2019-07-19 19:46 UTC2019-07A065392-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-05-29ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065392-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-05-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065392-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-05-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065392-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-05-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065392-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-05-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065392-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-05-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065392-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-05-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065392-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-05-293f0d92c62455…
2023-05-13 08:27 UTC2023-05A065392-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-05-29053a50430f4f…
2023-01-26 05:58 UTC2023-01A065392-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-05-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065392-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-05-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065392-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-05-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065392-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-05-29e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065392-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-05-29cb3db0bc1861…

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 UTC2026-02A065392-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065392-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065392-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065392-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065392-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065392-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065392-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065392-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065392-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065392-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065392-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065392-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065392-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065392-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065392-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065392-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065392-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065392-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065392-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065392-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065392-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A065392-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065392-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065392-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065392-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A065392-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A065392-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065392-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065392-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065392-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065392-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065392-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065392-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065392-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A065392-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A065392-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065392-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065392-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065392-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065392-001AB1cb3db0bc1861…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
560bed03-0257-a1db-0638-2c46fc35054cProduct name220170824
34f1b9ee-0673-df8c-ddae-36eaf4c48382Product name120140508
3793572a-4958-68b2-f923-8cf695ec1cc1Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
45865-503-282025-01-30C16284748780-12cef2736-78c7-d83d-e063-dadaa90ab31fCefadroxil Capsules USP 500 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-503-28Cefadroxil28 in 1 BOTTLECAPSULE281

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-503CEFADROXIL CAPSULE [MEDSOURCE PHARMACEUTOCALS]1Legacy NDC, 1 package rows20181227_7df07f19-1eb2-6894-e053-2991aa0a8d41.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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CefadroxilCEFADROXILProficient Rx LP57eebea5-28b6-44a3-888b-76950f6038f42026-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065392
application number: ANDA065392
CefadroxilCEFADROXILREMEDYREPACK INC.eb365f05-1c8f-4495-b443-abb0580b39fb2026-04-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065392
application number: ANDA065392
CefadroxilCEFADROXILPreferred Pharmaceuticals, Inc.485bc35b-637a-426b-aaa2-023c664914ae2026-03-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065392
application number: ANDA065392
CefadroxilCEFADROXILRedpharm Drug1c50c0db-ca03-6217-e063-6294a90a89fa2025-12-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065392
application number: ANDA065392
CefadroxilCEFADROXILNuCare Pharmaceuticals,Inc.7e931c7e-5ab6-c39c-e053-2a91aa0a59d92025-11-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065392
application number: ANDA065392
CefadroxilCEFADROXILLupin Pharmaceuticals, Inc.5fe066ce-2f97-49d7-81bd-a672be1ebecd2025-10-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065392
application number: ANDA065392
CefadroxilCEFADROXILBryant Ranch Prepackcaee9515-9a10-4020-af47-e9833aa69ef82025-06-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065392
application number: ANDA065392
CefadroxilCEFADROXILPD-Rx Pharmaceuticals, Inc.f5bbbf87-f059-4bbd-aea9-27d31462654f2025-02-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065392
application number: ANDA065392
CefadroxilCEFADROXILDirect_Rxf6ddd84a-4a44-7035-e053-6294a90a66062025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065392
application number: ANDA065392
CefadroxilCEFADROXILAdvanced Rx of Tennessee, LLC205cb17b-6fbf-e147-e063-6294a90a608e2024-08-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065392
application number: ANDA065392

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309049cefadroxil 500 MG Oral CapsulePSN7df07f19-1eb2-6894-e053-2991aa0a8d411
309049cefadroxil 500 MG Oral CapsuleSCD7df07f19-1eb2-6894-e053-2991aa0a8d411
309049cefadroxil (as cefadroxil monohydrate) 500 MG Oral CapsuleSY7df07f19-1eb2-6894-e053-2991aa0a8d411

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45865-503-284586505032828 CAPSULE in 1 BOTTLE (45865-503-28) 28 capsule2018-06-010000-00-00NoNoCurrent