Vitamin K1
- Product NDC
- 0409-9158
- 11-digit product format
- 004099158
- Labeler code
- 0409
- Product ID
- 0409-9158_42b6397b-1ec3-4182-95cf-e2dfe5c19a28
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PHYTONADIONE
- Dosage form
- INJECTION, EMULSION
- Route
- INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Hospira, Inc.
- Application
- ANDA087955
- Marketing category
- ANDA
- Marketing start
- 2005-07-27
- Substance
- PHYTONADIONE
- Active strength
- 10 mg/mL
- Pharmacologic classes
- Increased Prothrombin Activity [PE], Reversed Anticoagulation Activity [PE], Vitamin K [CS], Vitamin K [EPC], Warfarin Reversal Agent [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Vitamin K1
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PHYTONADIONE | 10 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | A034SE7857 |
| Rxcui | 312424, 1670192 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0409-9158-01 | Vitamin K1 | 5 in 1 CONTAINER | INJECTION, EMULSION | 5 | | 22 |
| 0409-9158-11 | Vitamin K1 | 1 mL in 1 AMPULE | INJECTION, EMULSION | 1 | | 22 |
| 0409-9158-25 | Vitamin K1 | 5 in 1 CONTAINER | INJECTION, EMULSION | 5 | | 22 |
| 0409-9158-31 | Vitamin K1 | 1 mL in 1 AMPULE | INJECTION, EMULSION | 1 | | 22 |
| 0409-9158-50 | Vitamin K1 | 5 in 1 TRAY | INJECTION, EMULSION | 5 | | 22 |
| 0409-9158-55 | Vitamin K1 | 5 in 1 TRAY | INJECTION, EMULSION | 5 | | 22 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| PHYTONADIONE | ACTIVE INGREDIENT | A034SE7857 | VITAMIN K1 (PHYTONADIONE) INJECTION, EMULSION [HOSPIRA, INC.] | 12 | |
| PHYTONADIONE | ACTIVE MOIETY | A034SE7857 | VITAMIN K1 (PHYTONADIONE) INJECTION, EMULSION [HOSPIRA, INC.] | 12 | |
| BENZYL ALCOHOL | INACTIVE INGREDIENT | LKG8494WBH | VITAMIN K1 (PHYTONADIONE) INJECTION, EMULSION [HOSPIRA, INC.] | 12 | |
| DEXTROSE MONOHYDRATE | INACTIVE INGREDIENT | LX22YL083G | VITAMIN K1 (PHYTONADIONE) INJECTION, EMULSION [HOSPIRA, INC.] | 12 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | VITAMIN K1 (PHYTONADIONE) INJECTION, EMULSION [HOSPIRA, INC.] | 12 | |
| POLYOXYL 35 CASTOR OIL | INACTIVE INGREDIENT | 6D4M1DAL6O | VITAMIN K1 (PHYTONADIONE) INJECTION, EMULSION [HOSPIRA, INC.] | 12 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | VITAMIN K1 (PHYTONADIONE) INJECTION, EMULSION [HOSPIRA, INC.] | 12 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0409-9158 | VITAMIN K1 (PHYTONADIONE) INJECTION, EMULSION [HOSPIRA, INC.] | 20 | Current NDC, Legacy NDC, 6 package rows | 20241207_e8808230-2c44-44c6-8cab-8f29b6b34051.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0409-9158-01 | 00409915801 | 5 TRAY in 1 CONTAINER (0409-9158-01) / 5 AMPULE in 1 TRAY (0409-9158-50) / 1 mL in 1 AMPULE (0409-9158-31) | 5 tray | 2005-07-27 | 0000-00-00 | No | No | Current |
| 0409-9158-11 | 00409915811 | 1 mL in 1 AMPULE | 1 ml | | | | | Historical |
| 0409-9158-25 | 00409915825 | 5 TRAY in 1 CONTAINER (0409-9158-25) / 5 AMPULE in 1 TRAY (0409-9158-55) / 1 mL in 1 AMPULE (0409-9158-11) | 5 tray | 2021-01-15 | 0000-00-00 | No | No | Current |
| 0409-9158-31 | 00409915831 | 1 mL in 1 AMPULE | 1 ml | | | | | Historical |
| 0409-9158-50 | 00409915850 | 5 in 1 TRAY | | | | | | Historical |
| 0409-9158-55 | 00409915855 | 5 in 1 TRAY | | | | | | Historical |