Cefadroxil

Product NDC
68071-2752
Requested package NDC
68071-2752-1
11-digit product format
680712752
Labeler code
68071
Product ID
68071-2752_e09261c7-1818-3042-e053-2a95a90aef90
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefadroxil
Dosage form
CAPSULE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA065352
Marketing category
ANDA
Marketing start
2007-01-25
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
2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68071-275268071-2752-1IInactivated 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 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded 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
A065352-001CEFADROXILCEFADROXIL/CEFADROXIL HEMIHYDRATEEQ 500MG BASECAPSULE / ORALAB2007-01-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A065352-001AB

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 UTC2026-02A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-25782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-2587673890dc5c…
2021-03-12 10:30 UTC2021-03A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-255aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-258869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-25c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-253f01610625f2…
2019-09-15 20:21 UTC2019-09A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-25b00525d2431f…
2019-07-19 19:46 UTC2019-07A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-25ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-25ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-25a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-259b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-25a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-253f0d92c62455…
2023-05-13 08:27 UTC2023-05A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-25053a50430f4f…
2023-01-26 05:58 UTC2023-01A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-253bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-253a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-25f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-25e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065352-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-01-25cb3db0bc1861…

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 UTC2026-02A065352-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065352-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A065352-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065352-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065352-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065352-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065352-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065352-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065352-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065352-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065352-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065352-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065352-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065352-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065352-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065352-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065352-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065352-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065352-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065352-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065352-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A065352-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065352-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065352-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065352-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A065352-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A065352-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065352-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065352-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065352-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065352-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065352-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065352-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065352-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A065352-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A065352-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065352-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065352-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065352-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065352-001AB1cb3db0bc1861…

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
68071-2752-12025-01-30C16284748780-12cef2736-862c-d83d-e063-dadaa90ab31fCefadroxil Capsules, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2752-1Cefadroxil100 in 1 BOTTLECAPSULE1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2752CEFADROXIL CAPSULE [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC, 1 package rows20220604_e09261f8-e8e3-89cb-e053-2995a90a0cc0.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 · 19 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CefadroxilCEFADROXILRedpharm Drug4fb524c1-f985-2a8f-e063-6394a90aab7f2026-04-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065352
application number: ANDA065352
CefadroxilCEFADROXILPreferred Pharmaceuticals Inc.41bc5f5a-5e1d-4cb6-a795-9f1756a8f0742026-03-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065352
application number: ANDA065352
CefadroxilCEFADROXILRedPharm Drug, Inc.97193a92-12ff-cfab-e053-2a95a90a9f142026-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065352
application number: ANDA065352
CefadroxilCEFADROXILPD-Rx Pharmaceuticals, Inc.ab9cf28c-7c16-4bfa-879d-c360b4d1d5a62025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065352
application number: ANDA065352
CEFADROXILCEFADROXILDIRECT RXa7e74b63-9d5c-7baa-e053-2a95a90a98b22025-01-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065352
application number: ANDA065352
CefadroxilCEFADROXILDirect_Rx02566385-46f3-255a-e063-6294a90a1d1c2024-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065352
application number: ANDA065352
CefadroxilCEFADROXILNuCare Pharmaceuticals,Inc.a218d8d3-af90-4599-e053-2995a90a0ede2024-06-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065352
application number: ANDA065352
CefadroxilCEFADROXILNuCare Pharmaceuticals,Inc.8bdd68a4-4e2e-0170-e053-2a95a90adb782024-06-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065352
application number: ANDA065352
CefadroxilCEFADROXILNuCare Pharmaceuticals,Inc.7278a39f-9de1-c9e2-e053-2a91aa0aea342024-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065352
application number: ANDA065352
CefadroxilCEFADROXILAdvanced Rx Pharmacy of Tennessee, LLC1a50b564-b00f-58e4-e063-6294a90af2c62024-06-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065352
application number: ANDA065352
CefadroxilCEFADROXILNuCare Pharmaceuticals,Inc.16f3dd01-650a-2426-e063-6394a90a1b4b2024-04-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065352
application number: ANDA065352
CefadroxilCEFADROXILBryant Ranch Prepack672519a7-11a1-4d8e-b2ca-dc9598c2f1792024-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065352
application number: ANDA065352
CefadroxilCEFADROXILBryant Ranch Prepack9c3bed82-6df0-4643-944a-a826f7dc018f2024-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065352
application number: ANDA065352
CefadroxilCEFADROXILBryant Ranch Prepack8cdaac56-b84a-4b6b-b94d-cab15d5961c52024-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065352
application number: ANDA065352
CefadroxilCEFADROXILA-S Medication Solutions41ab333a-fafb-4647-844e-f3b2a76723cb2024-02-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065352
application number: ANDA065352
CefadroxilCEFADROXILAdvanced Rx Pharmacy of Tennessee, LLCec836a53-7ed1-79b9-e053-2a95a90a9c362024-02-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065352
application number: ANDA065352
CefadroxilCEFADROXILRising Pharma Holdings, Inc.74c99fd8-16d1-4d2c-9158-42ff5eed2b7c2024-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065352
application number: ANDA065352
CefadroxilCEFADROXILAurobindo Pharma Limited7bb90096-14d3-400e-94d3-048bff6b12922024-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065352
application number: ANDA065352
CefadroxilCEFADROXILNorthStar Rx LLC17123057-58c7-401a-b87d-8c4c0764bbf62024-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065352
application number: ANDA065352

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309049cefadroxil 500 MG Oral CapsulePSNe09261f8-e8e3-89cb-e053-2995a90a0cc01
309049cefadroxil 500 MG Oral CapsuleSCDe09261f8-e8e3-89cb-e053-2995a90a0cc01
309049cefadroxil (as cefadroxil monohydrate) 500 MG Oral CapsuleSYe09261f8-e8e3-89cb-e053-2995a90a0cc01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2752-168071275201100 CAPSULE in 1 BOTTLE (68071-2752-1) 100 capsule2022-06-030000-00-00NoNoCurrent