PHYTONADIONE
- Product NDC
- 52584-405
- 11-digit product format
- 525840405
- Labeler code
- 52584
- Product ID
- 52584-405_b3a5d989-e368-4b24-8385-baa1900f7325
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- phytonadione
- Dosage form
- INJECTION, EMULSION
- Route
- INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- General Injectables & Vaccines, Inc.
- Application
- ANDA207719
- Marketing category
- ANDA
- Marketing start
- 2019-08-20
- Marketing end
- 2023-11-30
- 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
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 52584-405-11 | 52584040511 | 1 AMPULE in 1 BAG (52584-405-11) > 1 mL in 1 AMPULE | 1 ampule | 2019-08-20 | 0000-00-00 | No | No | Current |