SIVEXTRO
- Product NDC
- 67919-040
- 11-digit product format
- 679190040
- Labeler code
- 67919
- Product ID
- 67919-040_340a4655-ccf2-4c0f-a305-7576c06f4518
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tedizolid phosphate
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Merck Sharp & Dohme LLC
- Application
- NDA205436
- Marketing category
- NDA
- Marketing start
- 2014-06-20
- Substance
- TEDIZOLID PHOSPHATE
- Active strength
- 200 mg/4mL
- Pharmacologic classes
- Breast Cancer Resistance Protein Inhibitors [MoA], Oxazolidinone Antibacterial [EPC], Oxazolidinones [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- SIVEXTRO
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TEDIZOLID PHOSPHATE | 200 mg/4mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | O7DRJ6R4DW |
| Rxcui | 1540862, 1540868, 1540886, 1540890 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67919-040-02 | SIVEXTRO | 10 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 10 | | 34 |
| 67919-040-02 | SIVEXTRO | 4 mL in 1 VIAL, GLASS | INJECTION, POWDER, LYOPHILIZED, | 4 | | 34 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| tedizolid phosphate | ACTIVE INGREDIENT | O7DRJ6R4DW | SIVEXTRO (TEDIZOLID PHOSPHATE) TABLET, FILM COATED SIVEXTRO (TEDIZOLID PHOSPHATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.] | 6 | |
| tedizolid | ACTIVE MOIETY | 97HLQ82NGL | SIVEXTRO (TEDIZOLID PHOSPHATE) TABLET, FILM COATED SIVEXTRO (TEDIZOLID PHOSPHATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.] | 6 | |
| cellulose, microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | SIVEXTRO (TEDIZOLID PHOSPHATE) TABLET, FILM COATED SIVEXTRO (TEDIZOLID PHOSPHATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.] | 6 | |
| crospovidone (15 MPA.S AT 5%) | INACTIVE INGREDIENT | 68401960MK | SIVEXTRO (TEDIZOLID PHOSPHATE) TABLET, FILM COATED SIVEXTRO (TEDIZOLID PHOSPHATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.] | 6 | |
| ferric oxide yellow | INACTIVE INGREDIENT | EX438O2MRT | SIVEXTRO (TEDIZOLID PHOSPHATE) TABLET, FILM COATED SIVEXTRO (TEDIZOLID PHOSPHATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.] | 6 | |
| hydrochloric acid | INACTIVE INGREDIENT | QTT17582CB | SIVEXTRO (TEDIZOLID PHOSPHATE) TABLET, FILM COATED SIVEXTRO (TEDIZOLID PHOSPHATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.] | 6 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | SIVEXTRO (TEDIZOLID PHOSPHATE) TABLET, FILM COATED SIVEXTRO (TEDIZOLID PHOSPHATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.] | 6 | |
| mannitol | INACTIVE INGREDIENT | 3OWL53L36A | SIVEXTRO (TEDIZOLID PHOSPHATE) TABLET, FILM COATED SIVEXTRO (TEDIZOLID PHOSPHATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.] | 6 | |
| polyethylene glycols | INACTIVE INGREDIENT | 3WJQ0SDW1A | SIVEXTRO (TEDIZOLID PHOSPHATE) TABLET, FILM COATED SIVEXTRO (TEDIZOLID PHOSPHATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.] | 6 | |
| polyvinyl alcohol | INACTIVE INGREDIENT | 532B59J990 | SIVEXTRO (TEDIZOLID PHOSPHATE) TABLET, FILM COATED SIVEXTRO (TEDIZOLID PHOSPHATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.] | 6 | |
| povidones | INACTIVE INGREDIENT | FZ989GH94E | SIVEXTRO (TEDIZOLID PHOSPHATE) TABLET, FILM COATED SIVEXTRO (TEDIZOLID PHOSPHATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.] | 6 | |
| sodium hydroxide | INACTIVE INGREDIENT | 55X04QC32I | SIVEXTRO (TEDIZOLID PHOSPHATE) TABLET, FILM COATED SIVEXTRO (TEDIZOLID PHOSPHATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.] | 6 | |
| talc | INACTIVE INGREDIENT | 7SEV7J4R1U | SIVEXTRO (TEDIZOLID PHOSPHATE) TABLET, FILM COATED SIVEXTRO (TEDIZOLID PHOSPHATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.] | 6 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | SIVEXTRO (TEDIZOLID PHOSPHATE) TABLET, FILM COATED SIVEXTRO (TEDIZOLID PHOSPHATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.] | 6 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67919-040 | SIVEXTRO (TEDIZOLID PHOSPHATE) TABLET, FILM COATED SIVEXTRO (TEDIZOLID PHOSPHATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME LLC] | 31 | Current NDC, Legacy NDC, 2 package rows | 20250419_75672079-589f-451a-bdbf-eaebcfcc80a9.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 67919-040-01 | 67919004001 | 10 VIAL, GLASS in 1 CARTON (67919-040-01) > 4 mL in 1 VIAL, GLASS | 2014-06-20 | 0000-00-00 | No | No | Current |
| 67919-040-02 | 67919004002 | 10 VIAL, GLASS in 1 CARTON (67919-040-02) / 4 mL in 1 VIAL, GLASS | 2014-06-20 | | No | No | Historical |