Home NDC 55289-589 Cefadroxil
Product NDC 55289-589
11-digit product format 552890589
Labeler code 55289
Product ID 55289-589_da31fb95-ea07-1fd9-e053-2995a90ad99b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cefadroxil
Dosage form CAPSULE
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA065282
Marketing category ANDA
Marketing start 2007-01-31
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 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 · 5 matching rows.
View current auxiliary records. · View the auxiliary file history.
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A065282-001 CEFADROXIL CEFADROXIL/CEFADROXIL HEMIHYDRATE EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A065282-001 AB
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CEFADROXIL ACTIVE INGREDIENT 280111G160 CEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.] 3 CEFADROXIL ANHYDROUS ACTIVE MOIETY Q525PA8JJB CEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.] 3 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 CEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.] 3 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 CEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.] 3 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G CEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.] 3 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD CEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.] 3 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK CEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.] 3 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA CEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.] 3 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 CEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.] 3 GELATIN INACTIVE INGREDIENT 2G86QN327L CEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.] 3 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 CEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.] 3 SHELLAC INACTIVE INGREDIENT 46N107B71O CEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.] 3 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J CEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55289-589 CEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.] 17 Legacy NDC 20250322_88c7119e-404f-4718-b81f-d77d5eceb8f5.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 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55289-589-10 55289058910 10 CAPSULE in 1 BOTTLE, PLASTIC (55289-589-10) 10 capsule 2010-09-21 0000-00-00 No No Current 55289-589-14 55289058914 14 CAPSULE in 1 BOTTLE, PLASTIC (55289-589-14) 14 capsule 2010-09-21 0000-00-00 No No Current 55289-589-20 55289058920 20 CAPSULE in 1 BOTTLE, PLASTIC (55289-589-20) 20 capsule 2010-09-21 0000-00-00 No No Current 55289-589-28 55289058928 28 CAPSULE in 1 BOTTLE, PLASTIC (55289-589-28) 28 capsule 2010-09-21 0000-00-00 No No Current