Phytonadione
- Product NDC
- 76282-740
- 11-digit product format
- 762820740
- Labeler code
- 76282
- Product ID
- 76282-740_1c09ec9b-5913-42d4-92e2-34d26682556a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Phytonadione
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Exelan Pharmaceuticals, Inc.
- Application
- ANDA213329
- Marketing category
- ANDA
- Marketing start
- 2023-12-01
- 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 |
|---|
| 76282-740-30 | Phytonadione | 30 in 1 BOTTLE | TABLET | 30 | | 1 |
| 76282-740-30 | 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 |
|---|
| 76282-740 | PHYTONADIONE TABLET [EXELAN PHARMACEUTICALS, INC.] | 1 | Current NDC, 2 package rows | 20240110_63771c95-d4f5-42eb-b591-4df146f18cb0.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 |
|---|
| 76282-740-30 | 76282074030 | 1 BOTTLE in 1 CARTON (76282-740-30) / 30 TABLET in 1 BOTTLE | 1 bottle | 2023-12-01 | No | No | Current |