Home NDC 59630-820 Cedax
Product NDC 59630-820
11-digit product format 596300820
Labeler code 59630
Product ID 59630-820_d1672f05-b1ee-40f9-9b4c-7ba2fad264fc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ceftibuten dihydrate
Dosage form CAPSULE
Route ORAL
Labeler Sciele Pharma, Inc.
Application NDA050685
Marketing category NDA
Marketing start 1995-12-20
Marketing end 0000-00-00
Substance CEFTIBUTEN DIHYDRATE
Active strength 400 mg/1
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 1 · 44 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 59630-820-20 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 59630-820-20 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 59630-820-20 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 59630-820-20 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 59630-820-20 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 59630-820-20 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 59630-820-20 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 59630-820-20 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 59630-820-20 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 59630-820-20 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 59630-820-20 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 59630-820-20 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 59630-820-20 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 59630-820-20 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 59630-820-20 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 59630-820-20 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 59630-820-20 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 59630-820-20 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 59630-820-20 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 59630-820-20 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 59630-820-20 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 59630-820-20 110d247fa046…a55b01930146…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 N050685-002 CEDAX CEFTIBUTEN DIHYDRATE EQ 400MG BASE CAPSULE / ORAL 1995-12-20
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 · 44 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 2026-10-15 13:18:30 2026-09 N050685-002 CEDAX EQ 400MG BASE CAPSULE / ORAL 1995-12-20 c2088c7a36db…2026-09-14 22:38:34 2026-08 N050685-002 CEDAX EQ 400MG BASE CAPSULE / ORAL 1995-12-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 N050685-002 CEDAX EQ 400MG BASE CAPSULE / ORAL 1995-12-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N050685-002 CEDAX EQ 400MG BASE CAPSULE / ORAL 1995-12-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050685-002 CEDAX EQ 400MG BASE CAPSULE / ORAL 1995-12-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N050685-002 CEDAX EQ 400MG BASE CAPSULE / ORAL 1995-12-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050685-002 CEDAX EQ 400MG BASE CAPSULE / ORAL 1995-12-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050685-002 CEDAX EQ 400MG BASE CAPSULE / ORAL 1995-12-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050685-002 CEDAX EQ 400MG BASE CAPSULE / ORAL 1995-12-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050685-002 CEDAX EQ 400MG BASE CAPSULE / ORAL 1995-12-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050685-002 CEDAX EQ 400MG BASE CAPSULE / ORAL 1995-12-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050685-002 CEDAX EQ 400MG BASE CAPSULE / ORAL 1995-12-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N050685-002 CEDAX EQ 400MG BASE CAPSULE / ORAL 1995-12-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050685-002 CEDAX EQ 400MG BASE CAPSULE / ORAL 1995-12-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050685-002 CEDAX EQ 400MG BASE CAPSULE / ORAL 1995-12-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050685-002 CEDAX EQ 400MG BASE CAPSULE / ORAL 1995-12-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N050685-002 CEDAX EQ 400MG BASE CAPSULE / ORAL 1995-12-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050685-002 CEDAX EQ 400MG BASE CAPSULE / ORAL 1995-12-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N050685-002 CEDAX EQ 400MG BASE CAPSULE / ORAL 1995-12-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N050685-002 CEDAX EQ 400MG BASE CAPSULE / ORAL 1995-12-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N050685-002 CEDAX EQ 400MG BASE CAPSULE / ORAL 1995-12-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N050685-002 CEDAX EQ 400MG BASE CAPSULE / ORAL 1995-12-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N050685-002 CEDAX EQ 400MG BASE CAPSULE / ORAL 1995-12-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N050685-002 CEDAX EQ 400MG BASE CAPSULE / ORAL 1995-12-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N050685-002 CEDAX EQ 400MG BASE CAPSULE / ORAL 1995-12-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N050685-002 CEDAX EQ 400MG BASE CAPSULE / ORAL 1995-12-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N050685-002 CEDAX EQ 400MG BASE CAPSULE / ORAL 1995-12-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N050685-002 CEDAX EQ 400MG BASE CAPSULE / ORAL 1995-12-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N050685-002 CEDAX EQ 400MG BASE CAPSULE / ORAL 1995-12-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N050685-002 CEDAX EQ 400MG BASE CAPSULE / ORAL 1995-12-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N050685-002 CEDAX EQ 400MG BASE CAPSULE / ORAL 1995-12-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N050685-002 CEDAX EQ 400MG BASE CAPSULE / ORAL 1995-12-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N050685-002 CEDAX EQ 400MG BASE CAPSULE / ORAL 1995-12-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N050685-002 CEDAX EQ 400MG BASE CAPSULE / ORAL 1995-12-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N050685-002 CEDAX EQ 400MG BASE CAPSULE / ORAL 1995-12-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N050685-002 CEDAX EQ 400MG BASE CAPSULE / ORAL 1995-12-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N050685-002 CEDAX EQ 400MG BASE CAPSULE / ORAL 1995-12-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N050685-002 CEDAX EQ 400MG BASE CAPSULE / ORAL 1995-12-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N050685-002 CEDAX EQ 400MG BASE CAPSULE / ORAL 1995-12-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N050685-002 CEDAX EQ 400MG BASE CAPSULE / ORAL 1995-12-20 3a93d1ddd44b…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 59630-820-20 Cedax 20 in 1 BOTTLE CAPSULE 20 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Ceftibuten dihydrate ACTIVE INGREDIENT 62F4443RWP CEDAX (CEFTIBUTEN DIHYDRATE) CAPSULE CEDAX (CEFTIBUTEN DIHYDRATE) SUSPENSION [SCIELE PHARMA, INC.] 1 Ceftibuten ACTIVE MOIETY IW71N46B4Y CEDAX (CEFTIBUTEN DIHYDRATE) CAPSULE CEDAX (CEFTIBUTEN DIHYDRATE) SUSPENSION [SCIELE PHARMA, INC.] 1 benzyl alcohol INACTIVE INGREDIENT LKG8494WBH CEDAX (CEFTIBUTEN DIHYDRATE) CAPSULE CEDAX (CEFTIBUTEN DIHYDRATE) SUSPENSION [SCIELE PHARMA, INC.] 1 butylparaben INACTIVE INGREDIENT 3QPI1U3FV8 CEDAX (CEFTIBUTEN DIHYDRATE) CAPSULE CEDAX (CEFTIBUTEN DIHYDRATE) SUSPENSION [SCIELE PHARMA, INC.] 1 edetate calcium disodium INACTIVE INGREDIENT 25IH6R4SGF CEDAX (CEFTIBUTEN DIHYDRATE) CAPSULE CEDAX (CEFTIBUTEN DIHYDRATE) SUSPENSION [SCIELE PHARMA, INC.] 1 gelatin INACTIVE INGREDIENT 2G86QN327L CEDAX (CEFTIBUTEN DIHYDRATE) CAPSULE CEDAX (CEFTIBUTEN DIHYDRATE) SUSPENSION [SCIELE PHARMA, INC.] 1 methylparaben INACTIVE INGREDIENT A2I8C7HI9T CEDAX (CEFTIBUTEN DIHYDRATE) CAPSULE CEDAX (CEFTIBUTEN DIHYDRATE) SUSPENSION [SCIELE PHARMA, INC.] 1 polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H CEDAX (CEFTIBUTEN DIHYDRATE) CAPSULE CEDAX (CEFTIBUTEN DIHYDRATE) SUSPENSION [SCIELE PHARMA, INC.] 1 propylparaben INACTIVE INGREDIENT Z8IX2SC1OH CEDAX (CEFTIBUTEN DIHYDRATE) CAPSULE CEDAX (CEFTIBUTEN DIHYDRATE) SUSPENSION [SCIELE PHARMA, INC.] 1 silicon dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 CEDAX (CEFTIBUTEN DIHYDRATE) CAPSULE CEDAX (CEFTIBUTEN DIHYDRATE) SUSPENSION [SCIELE PHARMA, INC.] 1 sodium benzoate INACTIVE INGREDIENT OJ245FE5EU CEDAX (CEFTIBUTEN DIHYDRATE) CAPSULE CEDAX (CEFTIBUTEN DIHYDRATE) SUSPENSION [SCIELE PHARMA, INC.] 1 sodium lauryl sulfate INACTIVE INGREDIENT 368GB5141J CEDAX (CEFTIBUTEN DIHYDRATE) CAPSULE CEDAX (CEFTIBUTEN DIHYDRATE) SUSPENSION [SCIELE PHARMA, INC.] 1 sodium propionate INACTIVE INGREDIENT DK6Y9P42IN CEDAX (CEFTIBUTEN DIHYDRATE) CAPSULE CEDAX (CEFTIBUTEN DIHYDRATE) SUSPENSION [SCIELE PHARMA, INC.] 1 sucrose INACTIVE INGREDIENT C151H8M554 CEDAX (CEFTIBUTEN DIHYDRATE) CAPSULE CEDAX (CEFTIBUTEN DIHYDRATE) SUSPENSION [SCIELE PHARMA, INC.] 1 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP CEDAX (CEFTIBUTEN DIHYDRATE) CAPSULE CEDAX (CEFTIBUTEN DIHYDRATE) SUSPENSION [SCIELE PHARMA, INC.] 1 xanthan gum INACTIVE INGREDIENT TTV12P4NEE CEDAX (CEFTIBUTEN DIHYDRATE) CAPSULE CEDAX (CEFTIBUTEN DIHYDRATE) SUSPENSION [SCIELE PHARMA, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59630-820 CEDAX (CEFTIBUTEN DIHYDRATE) CAPSULE CEDAX (CEFTIBUTEN DIHYDRATE) SUSPENSION [SCIELE PHARMA, INC.] 1 Legacy NDC, 1 package rows 20100115_2dd58c88-142f-41ad-bc31-0a4fff074970.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 59630-820-20 59630082020 20 in 1 BOTTLE Historical