Cefadroxil

Product NDC
21695-427
11-digit product format
216950427
Labeler code
21695
Product ID
21695-427_b757af04-e516-4ac7-8a2f-45fffab86c5d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefadroxil
Dosage form
CAPSULE
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA065311
Marketing category
ANDA
Marketing start
2006-02-07
Marketing end
0000-00-00
Substance
CEFADROXIL
Active strength
500 mg/1
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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct21695-427IInactivated by FDA2026-08-03
excluded packagepackage21695-42721695-427-10IInactivated by FDA2026-08-03
excluded packagepackage21695-42721695-427-20IInactivated by FDA2026-08-03
excluded packagepackage21695-42721695-427-28IInactivated by FDA2026-08-03
excluded packagepackage21695-42721695-427-50IInactivated 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 2 · 110 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 packagepackage21695-427-20d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage21695-427-28d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage21695-427-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage21695-427-50d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-427-20f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-427-28f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-427-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-427-50f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-427-202ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-427-282ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-427-102ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-427-502ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-427-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-427-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-427-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-427-50a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-427-20cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-427-28cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-427-10cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-427-50cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-427-20cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-427-28cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-427-10cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-427-50cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-427-20302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-427-28302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-427-10302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-427-50302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-427-20ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-427-28ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-427-10ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-427-50ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-427-200efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-427-280efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-427-100efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-427-500efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage21695-427-20ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage21695-427-28ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage21695-427-10ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage21695-427-50ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage21695-427-20367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage21695-427-28367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage21695-427-10367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage21695-427-50367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage21695-427-20557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage21695-427-28557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage21695-427-10557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage21695-427-50557ba5c1ecfa…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
A065311-001CEFADROXILCEFADROXIL/CEFADROXIL HEMIHYDRATEEQ 500MG BASECAPSULE / ORAL2006-02-07

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 UTC2026-02A065311-001CEFADROXILEQ 500MG BASECAPSULE / ORAL2006-02-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065311-001CEFADROXILEQ 500MG BASECAPSULE / ORAL2006-02-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A065311-001CEFADROXILEQ 500MG BASECAPSULE / ORAL2006-02-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065311-001CEFADROXILEQ 500MG BASECAPSULE / ORAL2006-02-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065311-001CEFADROXILEQ 500MG BASECAPSULE / ORAL2006-02-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065311-001CEFADROXILEQ 500MG BASECAPSULE / ORAL2006-02-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065311-001CEFADROXILEQ 500MG BASECAPSULE / ORAL2006-02-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065311-001CEFADROXILEQ 500MG BASECAPSULE / ORAL2006-02-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065311-001CEFADROXILEQ 500MG BASECAPSULE / ORAL2006-02-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065311-001CEFADROXILEQ 500MG BASECAPSULE / ORAL2006-02-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065311-001CEFADROXILEQ 500MG BASECAPSULE / ORAL2006-02-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065311-001CEFADROXILEQ 500MG BASECAPSULE / ORAL2006-02-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065311-001CEFADROXILEQ 500MG BASECAPSULE / ORAL2006-02-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065311-001CEFADROXILEQ 500MG BASECAPSULE / ORAL2006-02-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065311-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2006-02-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065311-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2006-02-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065311-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2006-02-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065311-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2006-02-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065311-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2006-02-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065311-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2006-02-07782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065311-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2006-02-0787673890dc5c…
2021-03-12 10:30 UTC2021-03A065311-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2006-02-075aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065311-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2006-02-078869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065311-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2006-02-07c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065311-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2006-02-073f01610625f2…
2019-09-15 20:21 UTC2019-09A065311-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2006-02-07b00525d2431f…
2019-07-19 19:46 UTC2019-07A065311-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2006-02-07ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065311-001CEFADROXILEQ 500MG BASECAPSULE / ORAL2006-02-076a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065311-001CEFADROXILEQ 500MG BASECAPSULE / ORAL2006-02-071c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065311-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2006-02-07ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065311-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2006-02-07a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065311-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2006-02-079b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065311-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2006-02-07a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065311-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2006-02-073f0d92c62455…
2023-05-13 08:27 UTC2023-05A065311-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2006-02-07053a50430f4f…
2023-01-26 05:58 UTC2023-01A065311-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2006-02-073bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065311-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2006-02-073a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065311-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2006-02-07f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065311-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2006-02-07e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065311-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2006-02-07cb3db0bc1861…

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 ZIP2022-06A065311-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065311-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065311-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065311-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065311-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065311-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065311-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A065311-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065311-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065311-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065311-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A065311-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A065311-001AB1ea99ee380514…
2023-12-20 04:57 UTC2023-12A065311-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065311-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065311-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065311-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065311-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A065311-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A065311-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065311-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065311-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065311-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065311-001AB1cb3db0bc1861…

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-427-10Cefadroxil10 in 1 BOTTLECAPSULE101
21695-427-20Cefadroxil20 in 1 BOTTLECAPSULE201
21695-427-28Cefadroxil28 in 1 BOTTLECAPSULE281
21695-427-50Cefadroxil50 in 1 BOTTLECAPSULE501

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-427-10EA - Each21695-42762b32ad6-baa1-4296-b346-5c09753f85ef12013-02-13
21695-427-20EA - Each21695-427703d3b4c-1f1f-4a48-80d8-cde94739ce3e12013-02-13
21695-427-28EA - Each21695-427c7367914-6efd-4156-814e-b672233c59b312013-02-13
21695-427-50EA - Each21695-4274ab800f3-4be8-4203-bc78-a6af71d61ab312013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFADROXILACTIVE INGREDIENT280111G160CEFADROXIL CAPSULE [REBEL DISTRIBUTORS CORP]1
CEFADROXILACTIVE MOIETY280111G160CEFADROXIL CAPSULE [REBEL DISTRIBUTORS CORP]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CEFADROXIL CAPSULE [REBEL DISTRIBUTORS CORP]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CEFADROXIL CAPSULE [REBEL DISTRIBUTORS CORP]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CEFADROXIL CAPSULE [REBEL DISTRIBUTORS CORP]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CEFADROXIL CAPSULE [REBEL DISTRIBUTORS CORP]1
GELATININACTIVE INGREDIENT2G86QN327LCEFADROXIL CAPSULE [REBEL DISTRIBUTORS CORP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCEFADROXIL CAPSULE [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEFADROXIL 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
21695-427CEFADROXIL CAPSULE [REBEL DISTRIBUTORS CORP]1Legacy NDC, 4 package rows20110201_b757af04-e516-4ac7-8a2f-45fffab86c5d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309049cefadroxil 500 MG Oral CapsulePSNb757af04-e516-4ac7-8a2f-45fffab86c5d1
309049cefadroxil 500 MG Oral CapsuleSCDb757af04-e516-4ac7-8a2f-45fffab86c5d1
309049cefadroxil (as cefadroxil monohydrate) 500 MG Oral CapsuleSYb757af04-e516-4ac7-8a2f-45fffab86c5d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-427-102169504271010 in 1 BOTTLEHistorical
21695-427-202169504272020 in 1 BOTTLEHistorical
21695-427-282169504272828 in 1 BOTTLEHistorical
21695-427-502169504275050 in 1 BOTTLEHistorical