PHYTONADIONE
- Product NDC
- 81607-020
- 11-digit product format
- 816070020
- Labeler code
- 81607
- Product ID
- 81607-020_1a12da69-249c-42d2-8cde-1f0ecfbc299c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Phytonadione
- Dosage form
- INJECTION, EMULSION
- Route
- INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Orbicular Pharmaceutical Technologies Private Limited
- Application
- ANDA216298
- Marketing category
- ANDA
- Marketing start
- 2026-03-24
- 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 |
|---|
| 81607-020-01 | PHYTONADIONE | 1 in 1 BLISTER PACK | INJECTION, EMULSION | 1 | | 1 |
| 81607-020-01 | PHYTONADIONE | 1 in 1 CARTON | INJECTION, EMULSION | 1 | | 1 |
| 81607-020-02 | PHYTONADIONE | 10 in 1 CARTON | INJECTION, EMULSION | 10 | | 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 |
|---|
| 81607-020-01 | 81607002001 | 1 in 1 BLISTER PACK | | | | | Historical |
| 81607-020-02 | 81607002002 | 10 CARTON in 1 CARTON (81607-020-02) / 1 BLISTER PACK in 1 CARTON (81607-020-01) / 1 SYRINGE in 1 BLISTER PACK / .5 mL in 1 SYRINGE | 10 carton | 2026-03-24 | No | No | Current |