NDC 0409-7535 – Marcaine
Bupivacaine Hydrochloride 75 mg/30mL · Injection, Solution · Epidural, Infiltration, Intracaudal, Perineural
Product NDC0409-7535
Product details
- Brand name
- Marcaine
- Generic name
- Bupivacaine Hydrochloride
- Labeler
- Hospira, Inc.
- Dosage form
- Injection, Solution
- Route
- Epidural, Infiltration, Intracaudal, Perineural
- Marketing category
- NDA · NDA016964
- Marketed since
- May 27, 2025
- Listing expires
- December 31, 2027
- Pharmacologic class
- Amide Local Anesthetic
Active ingredients
- Bupivacaine Hydrochloride 75 mg/30mL
Package NDC codes (1)
| Package NDC | Description | Since |
|---|---|---|
| 0409-7535-25 | 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-7535-25) / 30 mL in 1 VIAL, SINGLE-DOSE (0409-7535-01) | May 27, 2025 |
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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