Phytonadione
- Product NDC
- 25021-505
- 11-digit product format
- 250210505
- Labeler code
- 25021
- Product ID
- 25021-505_ba507639-69c8-4451-ac5c-b5bc64f297ca
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Phytonadione
- Dosage form
- INJECTION, EMULSION
- Route
- INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Sagent Pharmaceuticals
- Application
- ANDA216444
- Marketing category
- ANDA
- Marketing start
- 2026-02-01
- Substance
- PHYTONADIONE
- Active strength
- 1 mg/.5mL
- 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
- Phytonadione
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PHYTONADIONE | 1 mg/.5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | A034SE7857 |
| Rxcui | 727625 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 25021-505-70 | Phytonadione | 10 in 1 CARTON | INJECTION, EMULSION | 10 | | 1 |
| 25021-505-70 | Phytonadione | 0.5 mL in 1 SYRINGE | INJECTION, EMULSION | 0.5 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 25021-505-70 | 25021050570 | 10 SYRINGE in 1 CARTON (25021-505-70) / .5 mL in 1 SYRINGE | 10 syringe | 2026-02-01 | No | No | Historical |