NDC 0409-1582 – Marcaine
Bupivacaine Hydrochloride 7.5 mg/mL · Injection, Solution · Epidural, Retrobulbar
Product NDC0409-1582
Product details
- Brand name
- Marcaine
- Generic name
- Bupivacaine Hydrochloride
- Labeler
- Hospira, Inc.
- Dosage form
- Injection, Solution
- Route
- Epidural, Retrobulbar
- Marketing category
- NDA · NDA016964
- Marketed since
- July 27, 2005
- Listing expires
- December 31, 2027
- Pharmacologic class
- Amide Local Anesthetic
Active ingredients
- Bupivacaine Hydrochloride 7.5 mg/mL
Package NDC codes (2)
| Package NDC | Description | Since |
|---|---|---|
| 0409-1582-10 | 10 VIAL, SINGLE-DOSE in 1 TRAY (0409-1582-10) / 10 mL in 1 VIAL, SINGLE-DOSE (0409-1582-18) | Jul 27, 2005 |
| 0409-1582-29 | 10 VIAL, SINGLE-DOSE in 1 CARTON (0409-1582-29) / 30 mL in 1 VIAL, SINGLE-DOSE (0409-1582-19) | Aug 8, 2005 |
Recalls mentioning this NDC
- D-0097-2017 Oct 19, 2016 · Class II
Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the labeled… - D-0096-2017 Oct 19, 2016 · Class II
Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the labeled… - D-0002-2015 Oct 8, 2014 · Class I
Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible metal particles embedded in the glass vial and visible in the solution. - D-1358-2014 Jun 11, 2014 · Class I
Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible metal particles embedded in the glass vial and visible in the solution. - D-1161-2014 Mar 26, 2014 · Class I
Presence of Particulate Matter: Units of this lot may have visible metal particles embedded in the vial and in the solution causing the product to be discolored.
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