Spectracef
- Product NDC
- 44004-802
- 11-digit product format
- 440040802
- Labeler code
- 44004
- Product ID
- 44004-802_f99cc35f-6ffa-4f2e-bcdf-e51bb9a17c0d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Cefditoren Pivoxil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Vansen Pharma Inc.
- Application
- NDA021222
- Marketing category
- NDA
- Marketing start
- 2013-02-05
- Marketing end
- 0000-00-00
- Substance
- CEFDITOREN PIVOXIL
- 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
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| a62a50ac-1535-4461-9768-8ae703e2e9fb | Product name | 1 | 20210525 |
| 735c6807-7b6d-31b0-8032-5eb0f5889757 | Product name | 1 | 20140508 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
| bc07ef78-e82d-0c19-31f4-31f263780582 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 44004-802-20 | 2019-11-27 | C162847 | 48780-1 | 9855d018-e309-cd31-e053-dbdaa90ab51a | Spectracef® (cefditoren pivoxil) Tablets 200 mg and 400 mg |
| 44004-802-28 | 2019-11-27 | C162847 | 48780-1 | 9855d018-e309-cd31-e053-dbdaa90ab51a | Spectracef® (cefditoren pivoxil) Tablets 200 mg and 400 mg |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 44004-802-20 | Spectracef | 20 in 1 BLISTER PACK | TABLET, FILM COATED | 20 | 2 | |
| 44004-802-28 | Spectracef | 28 in 1 BLISTER PACK | TABLET, FILM COATED | 28 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 44004-802 | SPECTRACEF (CEFDITOREN PIVOXIL) TABLET, FILM COATED SPECTRACEF (CEFDITOREN PIVOXIL) TABLET, FILM COATED [VANSEN PHARMA INC.] | 2 | Legacy NDC, 2 package rows | 20130605_1c90b649-5536-417c-82cb-89663137f14f.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 351127 | cefditoren pivoxil 200 MG Oral Tablet | PSN | 1c90b649-5536-417c-82cb-89663137f14f | 2 |
| 847360 | cefditoren pivoxil 400 MG Oral Tablet | PSN | 1c90b649-5536-417c-82cb-89663137f14f | 2 |
| 847365 | Spectracef 200 MG Oral Tablet | PSN | 1c90b649-5536-417c-82cb-89663137f14f | 2 |
| 847362 | Spectracef 400 MG Oral Tablet | PSN | 1c90b649-5536-417c-82cb-89663137f14f | 2 |
| 847365 | cefditoren pivoxil 200 MG Oral Tablet [Spectracef] | SBD | 1c90b649-5536-417c-82cb-89663137f14f | 2 |
| 847362 | cefditoren pivoxil 400 MG Oral Tablet [Spectracef] | SBD | 1c90b649-5536-417c-82cb-89663137f14f | 2 |
| 351127 | cefditoren pivoxil 200 MG Oral Tablet | SCD | 1c90b649-5536-417c-82cb-89663137f14f | 2 |
| 847360 | cefditoren pivoxil 400 MG Oral Tablet | SCD | 1c90b649-5536-417c-82cb-89663137f14f | 2 |
| 847365 | Spectracef 200 MG Oral Tablet | SY | 1c90b649-5536-417c-82cb-89663137f14f | 2 |
| 847362 | Spectracef 400 MG Oral Tablet | SY | 1c90b649-5536-417c-82cb-89663137f14f | 2 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 44004-802-20 | 44004080220 | 20 in 1 BLISTER PACK | Historical |
| 44004-802-28 | 44004080228 | 28 in 1 BLISTER PACK | Historical |