FDA.reportPublic FDA data

Cefadroxil

Product NDC
63629-1358
Requested package NDC
63629-1358-4
11-digit product format
636291358
Labeler code
63629
Product ID
63629-1358_4e03c51e-a386-424c-998e-08b9b2ede0f4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cefadroxil
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
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
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63629-135863629-1358-4DDiscontinued by firm2026-08-03

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
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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A065392-001CEFADROXILEQ 500MG BASECAPSULE / ORALAB2007-05-29a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A065392-001AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1358-1EA - Each63629-1358079a1fb2-0cc1-48e1-a907-9f2adc49550212017-06-15
63629-1358-2EA - Each63629-1358103d85b8-3e0c-46c2-b95c-e7cc6809f54212017-06-15
63629-1358-3EA - Each63629-135807e61b6c-4e6d-4973-9270-99419d7604b712017-06-15
63629-1358-4EA - Each63629-13587cdf1604-f1c6-4dfe-af33-e0b2dbc7f11212017-06-15
63629-1358-5EA - Each63629-1358fe3acfe1-bc87-4210-a80c-69f4d7fb01c112017-06-15
63629-1358-6EA - Each63629-1358ac7f0e24-5aee-4eb4-a658-b06e018a134012017-06-15
63629-1358-7EA - Each63629-13585bb88658-8cc2-41ac-9396-a97c778cb08912017-06-15
63629-1358-8EA - Each63629-1358fc41e637-d154-4a78-8d4e-d95628a0030012017-06-15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1358-46362913580430 CAPSULE in 1 BOTTLE (63629-1358-4) 30 capsule2008-04-230000-00-00NoNoCurrent