NDC 43598-405 – Phytonadione Phytonadione
Phytonadione 10 mg/mL · Injection, Emulsion · Intramuscular, Intravenous, Subcutaneous
Product NDC43598-405
Product details
- Brand name
- Phytonadione Phytonadione
- Generic name
- Phytonadione
- Labeler
- Dr.Reddy's Laboratories Inc
- Dosage form
- Injection, Emulsion
- Route
- Intramuscular, Intravenous, Subcutaneous
- Marketing category
- ANDA · ANDA207719
- Marketed since
- May 31, 2019
- Listing expires
- December 31, 2026
- Pharmacologic class
- Vitamin K; Warfarin Reversal Agent
Active ingredients
- Phytonadione 10 mg/mL
Package NDC codes (1)
| Package NDC | Description | Since |
|---|---|---|
| 43598-405-16 | 25 AMPULE in 1 CARTON (43598-405-16) / 1 mL in 1 AMPULE (43598-405-11) | May 31, 2019 |
Recalls mentioning this NDC
- D-0007-2023 Oct 12, 2022 · Class III
Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content. - D-1094-2020 Apr 8, 2020 · Class I
Defective Container: Recall is due to breaking and shattering of ampules upon opening
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