NDC 63323-412 – Midazolam
Midazolam Hydrochloride 5 mg/mL · Injection, Solution · Intramuscular, Intravenous
Product NDC63323-412
Product details
- Brand name
- Midazolam
- Generic name
- Midazolam Hydrochloride
- Labeler
- Fresenius Kabi USA, LLC
- Dosage form
- Injection, Solution
- Route
- Intramuscular, Intravenous
- Marketing category
- ANDA · ANDA075154
- Marketed since
- July 10, 2000
- Listing expires
- December 31, 2026
- Pharmacologic class
- Benzodiazepine
Active ingredients
- Midazolam Hydrochloride 5 mg/mL
Package NDC codes (3)
| Package NDC | Description | Since |
|---|---|---|
| 63323-412-02 | 10 VIAL in 1 TRAY (63323-412-02) / 2 mL in 1 VIAL (63323-412-03) | Jul 10, 2000 |
| 63323-412-10 | 10 VIAL in 1 TRAY (63323-412-10) / 10 mL in 1 VIAL (63323-412-13) | Jul 10, 2000 |
| 63323-412-25 | 25 VIAL in 1 TRAY (63323-412-25) / 1 mL in 1 VIAL (63323-412-18) | Jul 10, 2000 |
Recalls mentioning this NDC
- D-0456-2017 Feb 8, 2017 · Class II
Failed Impurities/Degradation Specifications - D-0295-2015 Dec 17, 2014 · Class II
Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.
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