Cefadroxil

Product NDC
42254-146
11-digit product format
422540146
Labeler code
42254
Product ID
42254-146_42f92a36-4c11-44f6-8f82-716a8b7a3f08
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefadroxil
Dosage form
CAPSULE
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA065392
Marketing category
ANDA
Marketing start
2008-04-01
Marketing end
0000-00-00
Substance
CEFADROXIL
Active strength
500 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
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 productproduct42254-146IInactivated by FDA2026-08-17
excluded packagepackage42254-14642254-146-28IInactivated by FDA2026-08-17

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage42254-146-28d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage42254-146-28f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage42254-146-282ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage42254-146-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage42254-146-28cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage42254-146-28cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage42254-146-28302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage42254-146-28ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage42254-146-280efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage42254-146-28ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage42254-146-28367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage42254-146-28557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage42254-146-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage42254-146-28834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage42254-146-281332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage42254-146-28fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage42254-146-2886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage42254-146-28bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage42254-146-288dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage42254-146-28e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage42254-146-289bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage42254-146-28110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A065392-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-05-29caaa826d4ba7…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A065392-001AB1caaa826d4ba7…
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…

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
42254-146-282019-09-24C16284748780-19350213a-3d9a-c013-e053-90daa90a1393Cefadroxil Capsules USP 500 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42254-146-28Cefadroxil28 in 1 BOTTLECAPSULE281

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42254-146-28EA - Each42254-1466bc1e426-0cc9-4dc1-8dd1-f1e820bd6a5512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFADROXILACTIVE INGREDIENT280111G160CEFADROXIL CAPSULE [REBEL DISTRIBUTORS CORP]1
CEFADROXIL ANHYDROUSACTIVE MOIETYQ525PA8JJBCEFADROXIL CAPSULE [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCEFADROXIL CAPSULE [REBEL DISTRIBUTORS CORP]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCEFADROXIL CAPSULE [REBEL DISTRIBUTORS CORP]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHCEFADROXIL CAPSULE [REBEL DISTRIBUTORS CORP]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCEFADROXIL CAPSULE [REBEL DISTRIBUTORS CORP]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACEFADROXIL CAPSULE [REBEL DISTRIBUTORS CORP]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CEFADROXIL CAPSULE [REBEL DISTRIBUTORS CORP]1
GELATININACTIVE INGREDIENT2G86QN327LCEFADROXIL CAPSULE [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEFADROXIL CAPSULE [REBEL DISTRIBUTORS CORP]1
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TCEFADROXIL CAPSULE [REBEL DISTRIBUTORS CORP]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CEFADROXIL CAPSULE [REBEL DISTRIBUTORS CORP]1
SHELLACINACTIVE INGREDIENT46N107B71OCEFADROXIL CAPSULE [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEFADROXIL CAPSULE [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42254-146CEFADROXIL CAPSULE [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20120420_42f92a36-4c11-44f6-8f82-716a8b7a3f08.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 CapsulePSN42f92a36-4c11-44f6-8f82-716a8b7a3f081
309049cefadroxil 500 MG Oral CapsuleSCD42f92a36-4c11-44f6-8f82-716a8b7a3f081
309049cefadroxil (as cefadroxil monohydrate) 500 MG Oral CapsuleSY42f92a36-4c11-44f6-8f82-716a8b7a3f081

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
42254-146-284225401462828 in 1 BOTTLEHistorical