Phytonadione
- Product NDC
- 50228-333
- 11-digit product format
- 502280333
- Labeler code
- 50228
- Product ID
- 50228-333_02ae977c-f584-4433-e063-6394a90a1290
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Phytonadione
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- ScieGen Pharmaceuticals Inc
- Application
- ANDA213329
- Marketing category
- ANDA
- Marketing start
- 2023-07-28
- Substance
- PHYTONADIONE
- Active strength
- 5 mg/1
- 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 | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | A034SE7857 |
| Rxcui | 198102 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50228-333-01 | Phytonadione | 1 in 1 CARTON | TABLET | 1 | | 1 |
| 50228-333-01 | Phytonadione | 100 in 1 BOTTLE | TABLET | 100 | | 1 |
| 50228-333-30 | Phytonadione | 30 in 1 BOTTLE | TABLET | 30 | | 1 |
| 50228-333-30 | Phytonadione | 1 in 1 CARTON | TABLET | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50228-333 | PHYTONADIONE TABLET [SCIEGEN PHARMACEUTICALS INC] | 1 | Current NDC, 4 package rows | 20230812_c0e38a20-7225-46a5-9730-924cbd08dbee.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 |
|---|
| 50228-333-01 | 50228033301 | 1 BOTTLE in 1 CARTON (50228-333-01) / 100 TABLET in 1 BOTTLE | 1 bottle | 2023-07-28 | No | No | Historical |
| 50228-333-30 | 50228033330 | 1 BOTTLE in 1 CARTON (50228-333-30) / 30 TABLET in 1 BOTTLE | 1 bottle | 2023-07-28 | No | No | Historical |