Cefadroxil

Product NDC
0093-4059
11-digit product format
000934059
Labeler code
0093
Product ID
0093-4059_980978a7-5c16-4350-add2-dd7c88ecb91b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefadroxil
Dosage form
TABLET
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA062774
Marketing category
ANDA
Marketing start
2007-01-31
Substance
CEFADROXIL
Active strength
1000 mg/1
Pharmacologic classes
Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
A062774-001CEFADROXILCEFADROXIL/CEFADROXIL HEMIHYDRATEEQ 1GM BASETABLET / ORALRS1987-04-08

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 UTC2026-02A062774-001CEFADROXILEQ 1GM BASETABLET / ORALRS1987-04-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A062774-001CEFADROXILEQ 1GM BASETABLET / ORALRS1987-04-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A062774-001CEFADROXILEQ 1GM BASETABLET / ORALRS1987-04-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A062774-001CEFADROXILEQ 1GM BASETABLET / ORALRS1987-04-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A062774-001CEFADROXILEQ 1GM BASETABLET / ORALRS1987-04-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A062774-001CEFADROXILEQ 1GM BASETABLET / ORALRS1987-04-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A062774-001CEFADROXILEQ 1GM BASETABLET / ORALRS1987-04-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A062774-001CEFADROXILEQ 1GM BASETABLET / ORALRS1987-04-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A062774-001CEFADROXILEQ 1GM BASETABLET / ORALRS1987-04-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A062774-001CEFADROXILEQ 1GM BASETABLET / ORALRS1987-04-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A062774-001CEFADROXILEQ 1GM BASETABLET / ORALRS1987-04-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A062774-001CEFADROXILEQ 1GM BASETABLET / ORALRS1987-04-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A062774-001CEFADROXILEQ 1GM BASETABLET / ORALRS1987-04-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05A062774-001CEFADROXILEQ 1GM BASETABLET / ORALRS1987-04-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A062774-001CEFADROXILEQ 1GM BASETABLET / ORALABRS1987-04-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A062774-001CEFADROXILEQ 1GM BASETABLET / ORALABRS1987-04-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A062774-001CEFADROXILEQ 1GM BASETABLET / ORALRS1987-04-084b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A062774-001CEFADROXILEQ 1GM BASETABLET / ORALRS1987-04-0874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A062774-001CEFADROXILEQ 1GM BASETABLET / ORALRS1987-04-08bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A062774-001CEFADROXILEQ 1GM BASETABLET / ORALRS1987-04-08782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A062774-001CEFADROXILEQ 1GM BASETABLET / ORALRS1987-04-0887673890dc5c…
2021-03-12 10:30 UTC2021-03A062774-001CEFADROXILEQ 1GM BASETABLET / ORALRS1987-04-085aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A062774-001CEFADROXILEQ 1GM BASETABLET / ORALRS1987-04-088869cabd3fbd…
2020-11-12 02:37 UTC2020-11A062774-001CEFADROXILEQ 1GM BASETABLET / ORALRS1987-04-08c0c555d07b60…
2019-12-14 00:12 UTC2019-12A062774-001CEFADROXILEQ 1GM BASETABLET / ORALRS1987-04-083f01610625f2…
2019-09-15 20:21 UTC2019-09A062774-001CEFADROXILEQ 1GM BASETABLET / ORALRS1987-04-08b00525d2431f…
2019-07-19 19:46 UTC2019-07A062774-001CEFADROXILEQ 1GM BASETABLET / ORALRS1987-04-08ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A062774-001CEFADROXILEQ 1GM BASETABLET / ORALRS1987-04-086a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A062774-001CEFADROXILEQ 1GM BASETABLET / ORALRS1987-04-081c564ffb4f44…
2023-12-20 04:57 UTC2023-12A062774-001CEFADROXILEQ 1GM BASETABLET / ORALABRS1987-04-08ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A062774-001CEFADROXILEQ 1GM BASETABLET / ORALABRS1987-04-08a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A062774-001CEFADROXILEQ 1GM BASETABLET / ORALABRS1987-04-089b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A062774-001CEFADROXILEQ 1GM BASETABLET / ORALABRS1987-04-08a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A062774-001CEFADROXILEQ 1GM BASETABLET / ORALABRS1987-04-083f0d92c62455…
2023-05-13 08:27 UTC2023-05A062774-001CEFADROXILEQ 1GM BASETABLET / ORALABRS1987-04-08053a50430f4f…
2023-01-26 05:58 UTC2023-01A062774-001CEFADROXILEQ 1GM BASETABLET / ORALABRS1987-04-083bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A062774-001CEFADROXILEQ 1GM BASETABLET / ORALABRS1987-04-083a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A062774-001CEFADROXILEQ 1GM BASETABLET / ORALABRS1987-04-08f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A062774-001CEFADROXILEQ 1GM BASETABLET / ORALABRS1987-04-08e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A062774-001CEFADROXILEQ 1GM BASETABLET / ORALABRS1987-04-08cb3db0bc1861…

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 ZIP2022-06A062774-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A062774-001AB15d02ea3f76ae…
2023-12-20 04:57 UTC2023-12A062774-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A062774-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A062774-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A062774-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A062774-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A062774-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A062774-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A062774-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A062774-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A062774-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A062774-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Cefadroxil
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CEFADROXIL1000 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
280111G160Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
309047Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4674a05c-fdef-4737-a4b8-e3229bdada9dAvailable on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0093-4059-53Cefadroxil50 in 1 BOTTLETABLET507

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-4059-53EA - Each0093-4059462d4bad-3c3b-459a-a1fc-f6f417dd197812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CEFADROXILACTIVE INGREDIENT280111G160CEFADROXIL TABLET [TEVA PHARMACEUTICALS USA INC]4
CEFADROXIL ANHYDROUSACTIVE MOIETYQ525PA8JJBCEFADROXIL TABLET [TEVA PHARMACEUTICALS USA INC]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCEFADROXIL TABLET [TEVA PHARMACEUTICALS USA INC]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CEFADROXIL TABLET [TEVA PHARMACEUTICALS USA INC]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEFADROXIL TABLET [TEVA PHARMACEUTICALS USA INC]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CEFADROXIL TABLET [TEVA PHARMACEUTICALS USA INC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-4059CEFADROXIL TABLET [TEVA PHARMACEUTICALS USA, INC.]7Current NDC, Legacy NDC, 1 package rows20250306_4674a05c-fdef-4737-a4b8-e3229bdada9d.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CefadroxilCEFADROXILTeva Pharmaceuticals USA, Inc.4674a05c-fdef-4737-a4b8-e3229bdada9d2024-12-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 062774
application number: ANDA062774
ndc (product): 0093-4059

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309047cefadroxil 1000 MG Oral TabletPSN4674a05c-fdef-4737-a4b8-e3229bdada9d7
309047cefadroxil 1000 MG Oral TabletSCD4674a05c-fdef-4737-a4b8-e3229bdada9d7
309047cefadroxil 1 GM Oral TabletSY4674a05c-fdef-4737-a4b8-e3229bdada9d7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-4059-530009340595350 TABLET in 1 BOTTLE (0093-4059-53) 50 tablet2007-01-310000-00-00NoNoCurrent