Phytonadione
- Product NDC
- 68083-606
- 11-digit product format
- 680830606
- Labeler code
- 68083
- Product ID
- 68083-606_1d345aaf-a506-4d73-a0ac-41c41675cebf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Phytonadione
- Dosage form
- INJECTION, EMULSION
- Route
- INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA217386
- Marketing category
- ANDA
- Marketing start
- 2024-12-10
- 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
- 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 | 10 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | A034SE7857 |
| Rxcui | 1670192 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68083-606-05 | Phytonadione | 5 in 1 TRAY | INJECTION, EMULSION | 5 | | 4 |
| 68083-606-05 | Phytonadione | 1 mL in 1 AMPULE | INJECTION, EMULSION | 1 | | 4 |
| 68083-606-25 | Phytonadione | 5 in 1 CARTON | INJECTION, EMULSION | 5 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-606 | PHYTONADIONE INJECTION, EMULSION [GLAND PHARMA LIMITED] | 4 | Current NDC, 3 package rows | 20241215_c375bfab-5a4b-40f3-a783-8372158af860.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68083-606-05 | 68083060605 | 5 in 1 TRAY | | | | | Historical |
| 68083-606-25 | 68083060625 | 5 TRAY in 1 CARTON (68083-606-25) / 5 AMPULE in 1 TRAY (68083-606-05) / 1 mL in 1 AMPULE | 5 tray | 2024-12-10 | No | No | Current |