Home NDC 68289-013 Cefadroxil
Product NDC 68289-013
11-digit product format 682890013
Labeler code 68289
Product ID 68289-013_f219e051-99c0-4142-8bd8-269b049e9722
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cefadroxil
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler Jazeera Pharmaceutical
Application ANDA091036
Marketing category ANDA
Marketing start 2012-11-28
Marketing end 0000-00-00
Substance CEFADROXIL
Active strength 250 mg/5mL
Pharmacologic classes Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag No
Listing certified through 2020-12-31
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 · 51 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 68289-013-50 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 68289-013-01 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 68289-013-50 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 68289-013-01 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 68289-013-50 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 68289-013-01 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 68289-013-50 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 68289-013-01 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 68289-013-50 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 68289-013-01 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 68289-013-50 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 68289-013-01 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 68289-013-50 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 68289-013-01 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 68289-013-50 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 68289-013-01 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 68289-013-50 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 68289-013-01 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 68289-013-50 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 68289-013-01 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 68289-013-50 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 68289-013-01 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 68289-013-50 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 68289-013-01 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 68289-013-50 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 68289-013-01 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 68289-013-50 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 68289-013-01 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 68289-013-50 I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 68289-013-01 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 68289-013-50 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 68289-013-01 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 68289-013-50 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 68289-013-01 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A091036-001 CEFADROXIL CEFADROXIL/CEFADROXIL HEMIHYDRATE EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2012-11-28 A091036-002 CEFADROXIL CEFADROXIL/CEFADROXIL HEMIHYDRATE EQ 500MG BASE/5ML FOR SUSPENSION / ORAL 2012-11-28
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 3 · 82 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 A091036-001 CEFADROXIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2012-11-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091036-002 CEFADROXIL EQ 500MG BASE/5ML FOR SUSPENSION / ORAL 2012-11-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091036-001 CEFADROXIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2012-11-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091036-002 CEFADROXIL EQ 500MG BASE/5ML FOR SUSPENSION / ORAL 2012-11-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091036-001 CEFADROXIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2012-11-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091036-002 CEFADROXIL EQ 500MG BASE/5ML FOR SUSPENSION / ORAL 2012-11-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091036-001 CEFADROXIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2012-11-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091036-002 CEFADROXIL EQ 500MG BASE/5ML FOR SUSPENSION / ORAL 2012-11-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091036-001 CEFADROXIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2012-11-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091036-002 CEFADROXIL EQ 500MG BASE/5ML FOR SUSPENSION / ORAL 2012-11-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091036-001 CEFADROXIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2012-11-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091036-002 CEFADROXIL EQ 500MG BASE/5ML FOR SUSPENSION / ORAL 2012-11-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091036-001 CEFADROXIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2012-11-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091036-002 CEFADROXIL EQ 500MG BASE/5ML FOR SUSPENSION / ORAL 2012-11-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091036-001 CEFADROXIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2012-11-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091036-002 CEFADROXIL EQ 500MG BASE/5ML FOR SUSPENSION / ORAL 2012-11-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091036-001 CEFADROXIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2012-11-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091036-002 CEFADROXIL EQ 500MG BASE/5ML FOR SUSPENSION / ORAL 2012-11-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091036-001 CEFADROXIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2012-11-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091036-002 CEFADROXIL EQ 500MG BASE/5ML FOR SUSPENSION / ORAL 2012-11-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091036-001 CEFADROXIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2012-11-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091036-002 CEFADROXIL EQ 500MG BASE/5ML FOR SUSPENSION / ORAL 2012-11-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091036-001 CEFADROXIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2012-11-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091036-002 CEFADROXIL EQ 500MG BASE/5ML FOR SUSPENSION / ORAL 2012-11-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091036-001 CEFADROXIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2012-11-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091036-002 CEFADROXIL EQ 500MG BASE/5ML FOR SUSPENSION / ORAL 2012-11-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091036-001 CEFADROXIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2012-11-28 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A091036-002 CEFADROXIL EQ 500MG BASE/5ML FOR SUSPENSION / ORAL 2012-11-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091036-001 CEFADROXIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2012-11-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091036-002 CEFADROXIL EQ 500MG BASE/5ML FOR SUSPENSION / ORAL AB 2012-11-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091036-001 CEFADROXIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2012-11-28 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A091036-002 CEFADROXIL EQ 500MG BASE/5ML FOR SUSPENSION / ORAL AB 2012-11-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091036-001 CEFADROXIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2012-11-28 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A091036-002 CEFADROXIL EQ 500MG BASE/5ML FOR SUSPENSION / ORAL AB 2012-11-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091036-001 CEFADROXIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2012-11-28 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A091036-002 CEFADROXIL EQ 500MG BASE/5ML FOR SUSPENSION / ORAL AB 2012-11-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091036-001 CEFADROXIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2012-11-28 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A091036-002 CEFADROXIL EQ 500MG BASE/5ML FOR SUSPENSION / ORAL AB 2012-11-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091036-001 CEFADROXIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2012-11-28 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A091036-002 CEFADROXIL EQ 500MG BASE/5ML FOR SUSPENSION / ORAL AB 2012-11-28 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 48 observed states.
FDA-Initiated Inactive NDC Indexing#