VITAMIN K1 PHYTONADIONE
- Product NDC
- 51662-1537
- 11-digit product format
- 516621537
- Labeler code
- 51662
- Product ID
- 51662-1537_1034dbd2-6cd0-dd97-e063-6294a90a19b1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- VITAMIN K1, PHYTONADIONE
- Dosage form
- INJECTION, EMULSION
- Route
- INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- HF Acquisition Co LLC, DBA HealthFirst
- Application
- ANDA087954
- Marketing category
- ANDA
- Marketing start
- 2021-11-01
- Substance
- PHYTONADIONE
- Active strength
- 2 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- VITAMIN K1 PHYTONADIONE
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PHYTONADIONE | 2 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | A034SE7857 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51662-1537-2 | VITAMIN K1 PHYTONADIONE | 0.5 mL in 1 AMPULE | INJECTION, EMULSION | 0.5 | | 3 |
| 51662-1537-2 | VITAMIN K1 PHYTONADIONE | 1 in 1 POUCH | INJECTION, EMULSION | 1 | | 3 |
| 51662-1537-3 | VITAMIN K1 PHYTONADIONE | 25 in 1 BOX | INJECTION, EMULSION | 25 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51662-1537 | VITAMIN K1 PHYTONADIONE (VITAMIN K1, PHYTONADIONE) INJECTION, EMULSION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] | 3 | Current NDC, Legacy NDC, 3 package rows | 20240201_cfc0df9f-ee59-9e30-e053-2995a90ad449.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 |
|---|
| 51662-1537-2 | 51662153702 | 0.5 mL in 1 AMPULE | 0.5 ml | | | | | Historical |
| 51662-1537-3 | 51662153703 | 25 POUCH in 1 BOX (51662-1537-3) / 1 AMPULE in 1 POUCH (51662-1537-2) / .5 mL in 1 AMPULE | 25 pouch | 2021-11-01 | 0000-00-00 | No | No | Current |