Cefditoren Pivoxil
- Product NDC
- 44009-802
- 11-digit product format
- 440090802
- Labeler code
- 44009
- Product ID
- 44009-802_edeaf75d-92f5-4fef-a127-ad200561aa71
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- cefditoren pivoxil
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Pharma RomLev Inc.
- Application
- NDA021222
- Marketing category
- NDA
- Marketing start
- 2010-01-01
- 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#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 44009-802-20 | Cefditoren Pivoxil | 20 in 1 BLISTER PACK | TABLET, FILM COATED | 20 | | 2 |
| 44009-802-28 | Cefditoren Pivoxil | 28 in 1 BLISTER PACK | TABLET, FILM COATED | 28 | | 2 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| CEFDITOREN PIVOXIL | ACTIVE INGREDIENT | 78THA212DH | CEFDITOREN PIVOXIL TABLET, FILM COATED [PHARMA ROMLEV INC.] | 2 | |
| CEFDITOREN | ACTIVE MOIETY | 81QS09V3YW | CEFDITOREN PIVOXIL TABLET, FILM COATED [PHARMA ROMLEV INC.] | 2 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | CEFDITOREN PIVOXIL TABLET, FILM COATED [PHARMA ROMLEV INC.] | 2 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | CEFDITOREN PIVOXIL TABLET, FILM COATED [PHARMA ROMLEV INC.] | 2 | |
| D&C RED NO. 27 | INACTIVE INGREDIENT | 2LRS185U6K | CEFDITOREN PIVOXIL TABLET, FILM COATED [PHARMA ROMLEV INC.] | 2 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | CEFDITOREN PIVOXIL TABLET, FILM COATED [PHARMA ROMLEV INC.] | 2 | |
| HYDROXYPROPYL CELLULOSE | INACTIVE INGREDIENT | RFW2ET671P | CEFDITOREN PIVOXIL TABLET, FILM COATED [PHARMA ROMLEV INC.] | 2 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | CEFDITOREN PIVOXIL TABLET, FILM COATED [PHARMA ROMLEV INC.] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | CEFDITOREN PIVOXIL TABLET, FILM COATED [PHARMA ROMLEV INC.] | 2 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | CEFDITOREN PIVOXIL TABLET, FILM COATED [PHARMA ROMLEV INC.] | 2 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | CEFDITOREN PIVOXIL TABLET, FILM COATED [PHARMA ROMLEV INC.] | 2 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | CEFDITOREN PIVOXIL TABLET, FILM COATED [PHARMA ROMLEV INC.] | 2 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | CEFDITOREN PIVOXIL TABLET, FILM COATED [PHARMA ROMLEV INC.] | 2 | |
| SODIUM CASEINATE | INACTIVE INGREDIENT | 7473P66J9E | CEFDITOREN PIVOXIL TABLET, FILM COATED [PHARMA ROMLEV INC.] | 2 | |
| SODIUM TRIPOLYPHOSPHATE | INACTIVE INGREDIENT | 5HK03SA80J | CEFDITOREN PIVOXIL TABLET, FILM COATED [PHARMA ROMLEV INC.] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | CEFDITOREN PIVOXIL TABLET, FILM COATED [PHARMA ROMLEV INC.] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 44009-802 | CEFDITOREN PIVOXIL TABLET, FILM COATED [PHARMA ROMLEV INC.] | 2 | Legacy NDC, 2 package rows | 20130606_d5050d0e-81d1-4707-a38a-e80de2aebf09.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 44009-802-20 | 44009080220 | 20 in 1 BLISTER PACK | Historical |
| 44009-802-28 | 44009080228 | 28 in 1 BLISTER PACK | Historical |