Home NDC 63304-973 CEFADROXIL
Product NDC 63304-973
11-digit product format 633040973
Labeler code 63304
Product ID 63304-973_a95b07d7-65c1-438d-91e0-0eaca684eccf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name cefadroxil monohydrate
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler Ranbaxy Pharmaceuticals Inc.
Application ANDA065115
Marketing category ANDA
Marketing start 2005-08-30
Marketing end 0000-00-00
Substance CEFADROXIL
Active strength 250 mg/5mL
Pharmacologic classes Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag E
Listing certified through 2017-12-31
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 2 · 66 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A065115-001 CEFADROXIL CEFADROXIL/CEFADROXIL HEMIHYDRATE EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2003-03-26 A065115-002 CEFADROXIL CEFADROXIL/CEFADROXIL HEMIHYDRATE EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2003-03-26 A065115-003 CEFADROXIL CEFADROXIL/CEFADROXIL HEMIHYDRATE EQ 500MG BASE/5ML FOR SUSPENSION / ORAL 2003-03-26
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 4 · 126 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 2026-08-18 06:07:40 2026-07 A065115-001 CEFADROXIL EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2003-03-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065115-002 CEFADROXIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2003-03-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065115-003 CEFADROXIL EQ 500MG BASE/5ML FOR SUSPENSION / ORAL 2003-03-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065115-001 CEFADROXIL EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2003-03-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065115-002 CEFADROXIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2003-03-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065115-003 CEFADROXIL EQ 500MG BASE/5ML FOR SUSPENSION / ORAL 2003-03-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065115-001 CEFADROXIL EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2003-03-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065115-002 CEFADROXIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2003-03-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065115-003 CEFADROXIL EQ 500MG BASE/5ML FOR SUSPENSION / ORAL 2003-03-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065115-001 CEFADROXIL EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2003-03-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065115-002 CEFADROXIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2003-03-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065115-003 CEFADROXIL EQ 500MG BASE/5ML FOR SUSPENSION / ORAL 2003-03-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065115-001 CEFADROXIL EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2003-03-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065115-002 CEFADROXIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2003-03-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065115-003 CEFADROXIL EQ 500MG BASE/5ML FOR SUSPENSION / ORAL 2003-03-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065115-001 CEFADROXIL EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2003-03-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065115-002 CEFADROXIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2003-03-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065115-003 CEFADROXIL EQ 500MG BASE/5ML FOR SUSPENSION / ORAL 2003-03-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065115-001 CEFADROXIL EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2003-03-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065115-002 CEFADROXIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2003-03-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065115-003 CEFADROXIL EQ 500MG BASE/5ML FOR SUSPENSION / ORAL 2003-03-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065115-001 CEFADROXIL EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2003-03-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065115-002 CEFADROXIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2003-03-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065115-003 CEFADROXIL EQ 500MG BASE/5ML FOR SUSPENSION / ORAL 2003-03-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065115-001 CEFADROXIL EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2003-03-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065115-002 CEFADROXIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2003-03-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065115-003 CEFADROXIL EQ 500MG BASE/5ML FOR SUSPENSION / ORAL 2003-03-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065115-001 CEFADROXIL EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2003-03-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065115-002 CEFADROXIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2003-03-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065115-003 CEFADROXIL EQ 500MG BASE/5ML FOR SUSPENSION / ORAL 2003-03-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065115-001 CEFADROXIL EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2003-03-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065115-002 CEFADROXIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2003-03-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065115-003 CEFADROXIL EQ 500MG BASE/5ML FOR SUSPENSION / ORAL 2003-03-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065115-001 CEFADROXIL EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2003-03-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065115-002 CEFADROXIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2003-03-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065115-003 CEFADROXIL EQ 500MG BASE/5ML FOR SUSPENSION / ORAL 2003-03-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065115-001 CEFADROXIL EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2003-03-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065115-002 CEFADROXIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2003-03-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065115-003 CEFADROXIL EQ 500MG BASE/5ML FOR SUSPENSION / ORAL 2003-03-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065115-001 CEFADROXIL EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2003-03-26 1e350fbaab3a…
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63304-973-03 CEFADROXIL 50 mL in 1 BOTTLE POWDER, FOR SUSPENSION 50 2 63304-973-04 CEFADROXIL 100 mL in 1 BOTTLE POWDER, FOR SUSPENSION 100 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CEFADROXIL ACTIVE INGREDIENT 280111G160 CEFADROXIL (CEFADROXIL MONOHYDRATE) POWDER, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.] 2 CEFADROXIL ANHYDROUS ACTIVE MOIETY Q525PA8JJB CEFADROXIL (CEFADROXIL MONOHYDRATE) POWDER, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 CEFADROXIL (CEFADROXIL MONOHYDRATE) POWDER, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.] 2 FRUIT INACTIVE INGREDIENT C2AIY4ERZC CEFADROXIL (CEFADROXIL MONOHYDRATE) POWDER, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.] 2 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H CEFADROXIL (CEFADROXIL MONOHYDRATE) POWDER, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.] 2 RASPBERRY INACTIVE INGREDIENT 4N14V5R27W CEFADROXIL (CEFADROXIL MONOHYDRATE) POWDER, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CEFADROXIL (CEFADROXIL MONOHYDRATE) POWDER, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.] 2 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU CEFADROXIL (CEFADROXIL MONOHYDRATE) POWDER, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.] 2 SUCROSE INACTIVE INGREDIENT C151H8M554 CEFADROXIL (CEFADROXIL MONOHYDRATE) POWDER, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.] 2 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE CEFADROXIL (CEFADROXIL MONOHYDRATE) POWDER, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.] 2 CEFADROXIL ACTIVE INGREDIENT 280111G160 CEFADROXIL (CEFADROXIL MONOHYDRATE) POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 CEFADROXIL ACTIVE MOIETY 280111G160 CEFADROXIL (CEFADROXIL MONOHYDRATE) POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 CEFADROXIL (CEFADROXIL MONOHYDRATE) POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H CEFADROXIL (CEFADROXIL MONOHYDRATE) POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CEFADROXIL (CEFADROXIL MONOHYDRATE) POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU CEFADROXIL (CEFADROXIL MONOHYDRATE) POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 SUCROSE INACTIVE INGREDIENT C151H8M554 CEFADROXIL (CEFADROXIL MONOHYDRATE) POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE CEFADROXIL (CEFADROXIL MONOHYDRATE) POWDER, FOR SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63304-973 CEFADROXIL (CEFADROXIL MONOHYDRATE) POWDER, FOR SUSPENSION [RANBAXY PHARMACEUTICALS INC.] 2 Legacy NDC, 2 package rows 20130321_5fc4f89c-cf94-4e7a-bf31-d3d86a242efa.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 63304-973-03 63304097303 50 mL in 1 BOTTLE 50 ml Historical 63304-973-04 63304097304 100 mL in 1 BOTTLE 100 ml Historical