PHYTONADIONE
- Product NDC
- 0404-9969
- 11-digit product format
- 004049969
- Labeler code
- 0404
- Product ID
- 0404-9969_219e0da6-2fee-450f-ba9c-ff2595f90b69
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- phytonadione
- Dosage form
- INJECTION, EMULSION
- Route
- INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Henry Schein, Inc.
- Application
- ANDA207719
- Marketing category
- ANDA
- Marketing start
- 2022-01-10
- 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 |
|---|
| 0404-9969-01 | PHYTONADIONE | 1 mL in 1 AMPULE | INJECTION, EMULSION | 1 | | 5 |
| 0404-9969-01 | PHYTONADIONE | 1 in 1 BAG | INJECTION, EMULSION | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0404-9969 | PHYTONADIONE INJECTION, EMULSION [HENRY SCHEIN, INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20241018_1cf90be3-a744-4db5-999d-a84c67372304.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0404-9969-01 | 00404996901 | 1 AMPULE in 1 BAG (0404-9969-01) / 1 mL in 1 AMPULE | 1 ampule | 2022-01-10 | 0000-00-00 | No | No | Current |