Cedax

Product NDC: 59630-821
11-digit product format: 596300821
Labeler code: 59630
Product ID: 59630-821_d1672f05-b1ee-40f9-9b4c-7ba2fad264fc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ceftibuten dihydrate
Dosage form: SUSPENSION
Route: ORAL
Labeler: Sciele Pharma, Inc.
Application: NDA050686
Marketing category: NDA
Marketing start: 1995-12-20
Marketing end: 0000-00-00
Substance: CEFTIBUTEN DIHYDRATE
Active strength: 18 mg/mL
Pharmacologic classes: Cephalosporin Antibacterial [EPC],Cephalosporins [CS]
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	59630-821		I	Inactivated by FDA	2026-10-15
excluded package	package	59630-821	59630-821-12	I	Inactivated by FDA	2026-10-15
excluded package	package	59630-821	59630-821-60	I	Inactivated by FDA	2026-10-15
excluded package	package	59630-821	59630-821-90	I	Inactivated by FDA	2026-10-15

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 · 88 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	59630-821-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	59630-821-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	59630-821-90	`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	59630-821-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	59630-821-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	59630-821-90	`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	59630-821-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	59630-821-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	59630-821-90	`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	59630-821-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	59630-821-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	59630-821-90	`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	59630-821-12	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	59630-821-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	59630-821-90	`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	59630-821-12	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	59630-821-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	59630-821-90	`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	59630-821-12	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	59630-821-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	59630-821-90	`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	59630-821-12	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	59630-821-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	59630-821-90	`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	59630-821-12	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	59630-821-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	59630-821-90	`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	59630-821-12	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	59630-821-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	59630-821-90	`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	59630-821-12	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	59630-821-60	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	59630-821-90	`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	59630-821-12	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	59630-821-60	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	59630-821-90	`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	59630-821-12	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	59630-821-60	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	59630-821-90	`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	59630-821-12	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	59630-821-60	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	59630-821-90	`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	59630-821-12	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	59630-821-60	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	59630-821-90	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N050686-001	CEDAX	CEFTIBUTEN DIHYDRATE	EQ 90MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD	1995-12-20
N050686-002	CEDAX	CEFTIBUTEN DIHYDRATE	EQ 180MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD	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 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N050686-001	CEDAX	EQ 90MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1995-12-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N050686-002	CEDAX	EQ 180MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1995-12-20	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N050686-001	CEDAX	EQ 90MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1995-12-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N050686-002	CEDAX	EQ 180MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1995-12-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N050686-001	CEDAX	EQ 90MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1995-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N050686-002	CEDAX	EQ 180MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1995-12-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050686-001	CEDAX	EQ 90MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1995-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N050686-002	CEDAX	EQ 180MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1995-12-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050686-001	CEDAX	EQ 90MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1995-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050686-002	CEDAX	EQ 180MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1995-12-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050686-001	CEDAX	EQ 90MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1995-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N050686-002	CEDAX	EQ 180MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1995-12-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050686-001	CEDAX	EQ 90MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1995-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050686-002	CEDAX	EQ 180MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1995-12-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050686-001	CEDAX	EQ 90MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1995-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050686-002	CEDAX	EQ 180MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1995-12-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050686-001	CEDAX	EQ 90MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1995-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050686-002	CEDAX	EQ 180MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1995-12-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050686-001	CEDAX	EQ 90MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1995-12-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050686-002	CEDAX	EQ 180MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1995-12-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050686-001	CEDAX	EQ 90MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1995-12-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050686-002	CEDAX	EQ 180MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1995-12-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050686-001	CEDAX	EQ 90MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1995-12-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050686-002	CEDAX	EQ 180MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1995-12-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050686-001	CEDAX	EQ 90MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1995-12-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N050686-002	CEDAX	EQ 180MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1995-12-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050686-001	CEDAX	EQ 90MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1995-12-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050686-002	CEDAX	EQ 180MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1995-12-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050686-001	CEDAX	EQ 90MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1995-12-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050686-002	CEDAX	EQ 180MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1995-12-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050686-001	CEDAX	EQ 90MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1995-12-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050686-002	CEDAX	EQ 180MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1995-12-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050686-001	CEDAX	EQ 90MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1995-12-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N050686-002	CEDAX	EQ 180MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1995-12-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050686-001	CEDAX	EQ 90MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1995-12-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050686-002	CEDAX	EQ 180MG BASE/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1995-12-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050686-001	CEDAX	EQ 90MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1995-12-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050686-002	CEDAX	EQ 180MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1995-12-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050686-001	CEDAX	EQ 90MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1995-12-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050686-002	CEDAX	EQ 180MG BASE/5ML	FOR SUSPENSION / ORAL	RLD	1995-12-20	`4b0b4de00fa7…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
777d68c6-a5ab-e06c-d314-677b0b9af0c8	Product name	2	20240508
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
59630-821-12	2019-10-21	C162847	48780-1	956f9ecf-ddac-621f-e053-dbdaa90a74ad	CEDAX ® (ceftibuten capsules) and (ceftibuten for oral suspension)
59630-821-60	2019-10-21	C162847	48780-1	956f9ecf-ddac-621f-e053-dbdaa90a74ad	CEDAX ® (ceftibuten capsules) and (ceftibuten for oral suspension)
59630-821-90	2019-10-21	C162847	48780-1	956f9ecf-ddac-621f-e053-dbdaa90a74ad	CEDAX ® (ceftibuten capsules) and (ceftibuten for oral suspension)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
59630-821-12	Cedax	1 in 1 CARTON	SUSPENSION	1	1
59630-821-12	Cedax	120 mL in 1 BOTTLE	SUSPENSION	120	1
59630-821-60	Cedax	1 in 1 CARTON	SUSPENSION	1	1
59630-821-60	Cedax	60 mL in 1 BOTTLE	SUSPENSION	60	1
59630-821-90	Cedax	1 in 1 CARTON	SUSPENSION	1	1
59630-821-90	Cedax	90 mL in 1 BOTTLE	SUSPENSION	90	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59630-821-12	ML - Milliliter	59630-821	89716a7b-d37b-4e98-a43d-eda3d212d452	1	2012-07-24
59630-821-60	ML - Milliliter	59630-821	70e6c5fd-e9d9-454d-85a6-dd849ee76ce8	1	2012-07-24
59630-821-90	ML - Milliliter	59630-821	cfa8f4dd-9dbc-477d-8982-fafc86577c91	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
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
59630-821	CEDAX (CEFTIBUTEN DIHYDRATE) CAPSULE CEDAX (CEFTIBUTEN DIHYDRATE) SUSPENSION [SCIELE PHARMA, INC.]	1	Legacy NDC, 6 package rows	20100115_2dd58c88-142f-41ad-bc31-0a4fff074970.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
62F4443RWP	CEFTIBUTEN DIHYDRATE	118081-34-8	CEFTIBUTEN DIHYDRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
108395	Cedax 400 MG Oral Capsule	PSN	2dd58c88-142f-41ad-bc31-0a4fff074970	1
581580	CEDAX 90 MG in 5 mL Oral Suspension	PSN	2dd58c88-142f-41ad-bc31-0a4fff074970	1
309086	ceftibuten 400 MG Oral Capsule	PSN	2dd58c88-142f-41ad-bc31-0a4fff074970	1
309087	ceftibuten 90 MG in 5 mL Oral Suspension	PSN	2dd58c88-142f-41ad-bc31-0a4fff074970	1
581580	ceftibuten 18 MG/ML Oral Suspension [Cedax]	SBD	2dd58c88-142f-41ad-bc31-0a4fff074970	1
108395	ceftibuten 400 MG Oral Capsule [Cedax]	SBD	2dd58c88-142f-41ad-bc31-0a4fff074970	1
309087	ceftibuten 18 MG/ML Oral Suspension	SCD	2dd58c88-142f-41ad-bc31-0a4fff074970	1
309086	ceftibuten 400 MG Oral Capsule	SCD	2dd58c88-142f-41ad-bc31-0a4fff074970	1
581580	Cedax 18 MG/ML Oral Suspension	SY	2dd58c88-142f-41ad-bc31-0a4fff074970	1
108395	Cedax 400 MG Oral Capsule	SY	2dd58c88-142f-41ad-bc31-0a4fff074970	1
581580	Cedax 90 MG per 5 ML Oral Suspension	SY	2dd58c88-142f-41ad-bc31-0a4fff074970	1
309086	ceftibuten (as ceftibuten dihydrate) 400 mg Oral Capsule	SY	2dd58c88-142f-41ad-bc31-0a4fff074970	1
309087	ceftibuten 90 MG per 5 ML Oral Suspension	SY	2dd58c88-142f-41ad-bc31-0a4fff074970	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
59630-821-12	59630082112	1 in 1 CARTON	Historical
59630-821-60	59630082160	1 in 1 CARTON	Historical
59630-821-90	59630082190	1 in 1 CARTON	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CEDAX ® (ceftibuten capsules) and (ceftibuten for oral suspension)	Sciele Pharma, Inc.	2010-01-12	HUMAN PRESCRIPTION DRUG LABEL	1