NDC 44004-802
Spectracef
Cefditoren Pivoxil
Spectracef is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Vansen Pharma Inc.. The primary component is Cefditoren Pivoxil.
| Product ID | 44004-802_f99cc35f-6ffa-4f2e-bcdf-e51bb9a17c0d |
| NDC | 44004-802 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Spectracef |
| Generic Name | Cefditoren Pivoxil |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2013-02-05 |
| Marketing Category | NDA / NDA |
| Application Number | NDA021222 |
| Labeler Name | Vansen Pharma Inc. |
| Substance Name | CEFDITOREN PIVOXIL |
| Active Ingredient Strength | 400 mg/1 |
| Pharm Classes | Cephalosporin Antibacterial [EPC],Cephalosporins [CS] |
| NDC Exclude Flag | E |
| Listing Certified Through | 2017-12-31 |
Packaging
NDC 44004-802-28
28 TABLET, FILM COATED in 1 BLISTER PACK (44004-802-28)
| Marketing Start Date | 2013-02-05 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 44004-802-28 [44004080228]
Spectracef TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA021222 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2013-02-05 |
| Inactivation Date | 2019-11-27 |
NDC 44004-802-20 [44004080220]
Spectracef TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA021222 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2013-02-05 |
| Inactivation Date | 2019-11-27 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| CEFDITOREN PIVOXIL | 400 mg/1 |
OpenFDA Data
| SPL SET ID: | 1c90b649-5536-417c-82cb-89663137f14f |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- Cephalosporin Antibacterial [EPC]
- Cephalosporins [CS]
NDC Crossover Matching brand name "Spectracef" or generic name "Cefditoren Pivoxil"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 44004-801 | Spectracef | cefditoren pivoxil |
| 44004-802 | Spectracef | Cefditoren Pivoxil |
| 44009-801 | Cefditoren Pivoxil | cefditoren pivoxil |
| 44009-802 | Cefditoren Pivoxil | cefditoren pivoxil |
Trademark Results [Spectracef]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SPECTRACEF 75641053 2635805 Live/Registered |
MEIJI SEIKA PHARMA CO., LTD. 1999-02-16 |
 SPECTRACEF 74356411 not registered Dead/Abandoned |
Bristol-Myers Squibb Company 1993-02-08 |
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