phytonadione
- Product NDC
- 70121-1682
- 11-digit product format
- 701211682
- Labeler code
- 70121
- Product ID
- 70121-1682_a2f87d42-33cd-4706-bd3c-8b15c8095617
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PHYTONADIONE
- Dosage form
- INJECTION, EMULSION
- Route
- INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA216601
- Marketing category
- ANDA
- Marketing start
- 2025-11-04
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- phytonadione
- Listing expiration
- 2026-12-31
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 |
|---|
| 70121-1682-1 | phytonadione | 1 in 1 TRAY | INJECTION, EMULSION | 1 | | 6 |
| 70121-1682-1 | phytonadione | 0.5 mL in 1 SYRINGE, GLASS | INJECTION, EMULSION | 0.5 | | 6 |
| 70121-1682-7 | phytonadione | 10 in 1 CARTON | INJECTION, EMULSION | 10 | | 6 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70121-1682-1 | 70121168201 | 1 in 1 TRAY | | | | | Historical |
| 70121-1682-7 | 70121168207 | 10 TRAY in 1 CARTON (70121-1682-7) / 1 SYRINGE, GLASS in 1 TRAY (70121-1682-1) / .5 mL in 1 SYRINGE, GLASS | 10 tray | 2025-11-04 | No | No | Current |