Cefadroxil

Product NDC
33261-018
11-digit product format
332610018
Labeler code
33261
Product ID
33261-018_6b12226c-28cd-4448-9b95-242fd0cc761e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefadroxil
Dosage form
CAPSULE
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
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
2019-12-31
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 · 6 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct33261-018IInactivated by FDA2026-08-17
excluded packagepackage33261-01833261-018-14IInactivated by FDA2026-08-17
excluded packagepackage33261-01833261-018-20IInactivated by FDA2026-08-17
excluded packagepackage33261-01833261-018-28IInactivated by FDA2026-08-17
excluded packagepackage33261-01833261-018-30IInactivated by FDA2026-08-17
excluded packagepackage33261-01833261-018-40IInactivated 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 3 · 126 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 packagepackage33261-018-40d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage33261-018-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage33261-018-14d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage33261-018-20d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage33261-018-28d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage33261-018-40f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage33261-018-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage33261-018-14f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage33261-018-20f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage33261-018-28f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage33261-018-402ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage33261-018-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage33261-018-142ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage33261-018-202ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage33261-018-282ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage33261-018-40a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage33261-018-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage33261-018-14a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage33261-018-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage33261-018-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage33261-018-40cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage33261-018-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage33261-018-14cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage33261-018-20cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage33261-018-28cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage33261-018-40cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage33261-018-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage33261-018-14cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage33261-018-20cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage33261-018-28cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage33261-018-40302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage33261-018-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage33261-018-14302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage33261-018-20302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage33261-018-28302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage33261-018-40ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage33261-018-30ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage33261-018-14ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage33261-018-20ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage33261-018-28ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage33261-018-400efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage33261-018-300efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage33261-018-140efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage33261-018-200efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage33261-018-280efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage33261-018-40ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage33261-018-30ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage33261-018-14ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage33261-018-20ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage33261-018-28ad56d346431e…cc804d4bbf1e…

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-018-14Cefadroxil14 in 1 BOTTLECAPSULE141
33261-018-20Cefadroxil20 in 1 BOTTLECAPSULE201
33261-018-28Cefadroxil28 in 1 BOTTLECAPSULE281
33261-018-30Cefadroxil30 in 1 BOTTLECAPSULE301
33261-018-40Cefadroxil40 in 1 BOTTLECAPSULE401

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-018-14EA - Each33261-01833e933e3-7c66-427f-aff7-acf1c5e9e62312017-06-15
33261-018-20EA - Each33261-018f0f1929e-2794-4db9-877f-0ee627a1574612017-06-15

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-018CEFADROXIL CAPSULE [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 5 package rows20140102_d433e4e8-9f38-405e-ac80-bc8dfcba0649.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 CapsulePSNd433e4e8-9f38-405e-ac80-bc8dfcba06491
309049cefadroxil 500 MG Oral CapsuleSCDd433e4e8-9f38-405e-ac80-bc8dfcba06491
309049cefadroxil (as cefadroxil monohydrate) 500 MG Oral CapsuleSYd433e4e8-9f38-405e-ac80-bc8dfcba06491

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-018-143326100181414 in 1 BOTTLEHistorical
33261-018-203326100182020 in 1 BOTTLEHistorical
33261-018-283326100182828 in 1 BOTTLEHistorical
33261-018-303326100183030 in 1 BOTTLEHistorical
33261-018-403326100184040 in 1 BOTTLEHistorical