NDC 59630-821
Cedax
Ceftibuten Dihydrate
Cedax is a Oral Suspension in the Human Prescription Drug category. It is labeled and distributed by Sciele Pharma, Inc.. The primary component is Ceftibuten Dihydrate.
| Product ID | 59630-821_d1672f05-b1ee-40f9-9b4c-7ba2fad264fc |
| NDC | 59630-821 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Cedax |
| Generic Name | Ceftibuten Dihydrate |
| Dosage Form | Suspension |
| Route of Administration | ORAL |
| Marketing Start Date | 1995-12-20 |
| Marketing Category | NDA / NDA |
| Application Number | NDA050686 |
| Labeler Name | Sciele Pharma, Inc. |
| Substance Name | CEFTIBUTEN DIHYDRATE |
| Active Ingredient Strength | 18 mg/mL |
| Pharm Classes | Cephalosporin Antibacterial [EPC],Cephalosporins [CS] |
| NDC Exclude Flag | E |
| Listing Certified Through | 2017-12-31 |
Packaging
NDC 59630-821-90
1 BOTTLE in 1 CARTON (59630-821-90) > 90 mL in 1 BOTTLE
| Marketing Start Date | 1995-12-20 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 59630-821-90 [59630082190]
Cedax SUSPENSION
| Marketing Category | NDA |
| Application Number | NDA050686 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1995-12-20 |
| Inactivation Date | 2019-10-21 |
NDC 59630-821-12 [59630082112]
Cedax SUSPENSION
| Marketing Category | NDA |
| Application Number | NDA050686 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1995-12-20 |
| Inactivation Date | 2019-10-21 |
NDC 59630-821-60 [59630082160]
Cedax SUSPENSION
| Marketing Category | NDA |
| Application Number | NDA050686 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 1995-12-20 |
| Inactivation Date | 2019-10-21 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| CEFTIBUTEN DIHYDRATE | 18 mg/mL |
OpenFDA Data
| SPL SET ID: | 2dd58c88-142f-41ad-bc31-0a4fff074970 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- Cephalosporin Antibacterial [EPC]
- Cephalosporins [CS]
NDC Crossover Matching brand name "Cedax" or generic name "Ceftibuten Dihydrate"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 59630-820 | Cedax | Ceftibuten dihydrate |
| 59630-821 | Cedax | Ceftibuten dihydrate |
Trademark Results [Cedax]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CEDAX 73825904 1610363 Live/Registered |
LABORATOIRES UNICET 1989-09-18 |
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