Home NDC 23594-250 Cefaclor
Product NDC 23594-250
11-digit product format 235940250
Labeler code 23594
Product ID 23594-250_ed37ca15-9a37-73c4-e053-2995a90a34f3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name cefaclor
Dosage form FOR SUSPENSION
Route ORAL
Labeler Aytu Therapeutics, LLC
Application ANDA065412
Marketing category ANDA
Marketing start 2015-10-26
Marketing end 0000-00-00
Substance CEFACLOR
Active strength 250 mg/5mL
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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 23594-250-01 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 23594-250-01 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 23594-250-01 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 23594-250-01 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 23594-250-01 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 23594-250-01 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 23594-250-01 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 23594-250-01 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 23594-250-01 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 23594-250-01 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 23594-250-01 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 23594-250-01 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A065412-001 CEFACLOR CEFACLOR EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2012-02-17 A065412-002 CEFACLOR CEFACLOR EQ 187MG BASE/5ML FOR SUSPENSION / ORAL 2012-02-17 A065412-003 CEFACLOR CEFACLOR EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2012-02-17 A065412-004 CEFACLOR CEFACLOR EQ 375MG BASE/5ML FOR SUSPENSION / ORAL RS 2012-02-17
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 5 · 168 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 A065412-001 CEFACLOR EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2012-02-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065412-002 CEFACLOR EQ 187MG BASE/5ML FOR SUSPENSION / ORAL 2012-02-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065412-003 CEFACLOR EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2012-02-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065412-004 CEFACLOR EQ 375MG BASE/5ML FOR SUSPENSION / ORAL RS 2012-02-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065412-001 CEFACLOR EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2012-02-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065412-002 CEFACLOR EQ 187MG BASE/5ML FOR SUSPENSION / ORAL 2012-02-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065412-003 CEFACLOR EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2012-02-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065412-004 CEFACLOR EQ 375MG BASE/5ML FOR SUSPENSION / ORAL RS 2012-02-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065412-001 CEFACLOR EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2012-02-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065412-002 CEFACLOR EQ 187MG BASE/5ML FOR SUSPENSION / ORAL 2012-02-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065412-003 CEFACLOR EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2012-02-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065412-004 CEFACLOR EQ 375MG BASE/5ML FOR SUSPENSION / ORAL RS 2012-02-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065412-001 CEFACLOR EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2012-02-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065412-002 CEFACLOR EQ 187MG BASE/5ML FOR SUSPENSION / ORAL 2012-02-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065412-003 CEFACLOR EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2012-02-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065412-004 CEFACLOR EQ 375MG BASE/5ML FOR SUSPENSION / ORAL RS 2012-02-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065412-001 CEFACLOR EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2012-02-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065412-002 CEFACLOR EQ 187MG BASE/5ML FOR SUSPENSION / ORAL 2012-02-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065412-003 CEFACLOR EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2012-02-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065412-004 CEFACLOR EQ 375MG BASE/5ML FOR SUSPENSION / ORAL RS 2012-02-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065412-001 CEFACLOR EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2012-02-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065412-002 CEFACLOR EQ 187MG BASE/5ML FOR SUSPENSION / ORAL 2012-02-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065412-003 CEFACLOR EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2012-02-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065412-004 CEFACLOR EQ 375MG BASE/5ML FOR SUSPENSION / ORAL RS 2012-02-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065412-001 CEFACLOR EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2012-02-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065412-002 CEFACLOR EQ 187MG BASE/5ML FOR SUSPENSION / ORAL 2012-02-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065412-003 CEFACLOR EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2012-02-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065412-004 CEFACLOR EQ 375MG BASE/5ML FOR SUSPENSION / ORAL RS 2012-02-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065412-001 CEFACLOR EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2012-02-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065412-002 CEFACLOR EQ 187MG BASE/5ML FOR SUSPENSION / ORAL 2012-02-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065412-003 CEFACLOR EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2012-02-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065412-004 CEFACLOR EQ 375MG BASE/5ML FOR SUSPENSION / ORAL RS 2012-02-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065412-001 CEFACLOR EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2012-02-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065412-002 CEFACLOR EQ 187MG BASE/5ML FOR SUSPENSION / ORAL 2012-02-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065412-003 CEFACLOR EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2012-02-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065412-004 CEFACLOR EQ 375MG BASE/5ML FOR SUSPENSION / ORAL RS 2012-02-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065412-001 CEFACLOR EQ 125MG BASE/5ML FOR SUSPENSION / ORAL 2012-02-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065412-002 CEFACLOR EQ 187MG BASE/5ML FOR SUSPENSION / ORAL 2012-02-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065412-003 CEFACLOR EQ 250MG BASE/5ML FOR SUSPENSION / ORAL 2012-02-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065412-004 CEFACLOR EQ 375MG BASE/5ML FOR SUSPENSION / ORAL RS 2012-02-17 d8e5a09893c0…
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 23594-250-01 23594025001 150 mL in 1 BOTTLE, PLASTIC (23594-250-01) 150 ml 2015-10-26 0000-00-00 No No Current