Prescription drug · NDA
Zynrelef (Bupivacaine and meloxicam) NDC 47426-503
Bupivacaine 200 mg/7mL; Meloxicam 6 mg/7mL · Solution · Infiltration · Heron Therapeutics, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 47426-503-01 | 47426050301 | 1 CARTON in 1 KIT (47426-503-01) / 1 VIAL, SINGLE-DOSE in 1 CARTON (47426-503-03) / 2.3 mL in 1 VIAL, SINGLE-DOSEMarketed from Dec 1, 2024 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Zynrelef
- Generic name (nonproprietary)
- bupivacaine and meloxicam
- Active ingredients
- Bupivacaine — 200 mg/7mLMeloxicam — 6 mg/7mL
- Dosage form
- Solution
- Route
- Infiltration
- Labeler
- Heron Therapeutics, Inc.NDC labeler code 47426
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 211988
- Marketing start
- Listing expires
- Other FDA classes
- Amides (Chemical structure)Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Local Anesthesia (Physiologic effect)
- Identifiers
- Product ID 47426-503_ab2a0921-41d7-4b3b-ace9-6adccb12c5e9SPL ID ab2a0921-41d7-4b3b-ace9-6adccb12c5e9SPL set ID dab484a7-9353-43ba-9e74-7fab910c712bRxCUI 2560306, 2560308, 2560309, 2560311, 2560312, 2560315, 2560319, 2560321UNII Y8335394RO, VG2QF83CGL
- Pharmacologic class
- Amide Local Anesthetic; Nonsteroidal Anti-inflammatory Drug
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N447426050301followed by a unit qualifier and the quantityPackage 47426-0503-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
ZYNRELEF is indicated in adults for postsurgical analgesia for up to 72 hours after: soft tissue surgical procedures orthopedic surgical procedures – foot and ankle procedures – other orthopedic surgical procedures (e.g., total joint arthroplasty) in which direct exposure to articular cartilage is avoided [see Warnings and Precautions (5.10) ] ZYNRELEF is indicated in adults for postsurgical analgesia for up to 72 hours after: soft tissue surgical procedures orthopedic surgical procedures – foot and ankle procedures – other orthopedic surgical procedures (e.g., total joint arthroplasty) in which direct exposure to articular cartilage is avoided [see Warnings and Precautions (5.10) ] Limitati…
Excerpt only. Read the full label for complete information.
About NDC 47426-503
- What is NDC 47426-503?
- 47426-503 is the product NDC for Zynrelef, Bupivacaine 200 mg/7mL; Meloxicam 6 mg/7mL solution, listed with the FDA by Heron Therapeutics, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Zynrelef (BUPIVACAINE and MELOXICAM).
- What is the active ingredient?
- Bupivacaine, Meloxicam.
- Who is the labeler?
- Heron Therapeutics, Inc., NDC labeler code 47426. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Zynrelef?
- 1 other product NDC are listed under this name. See all Zynrelef NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Zynrelef products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Zynrelefbupivacaine and meloxicam | Bupivacaine 400 mg/14mL; Meloxicam 12 mg/14mL | SolutionInfiltration | Heron Therapeutics, Inc. | 47426-501 | 47426-0501-02 |
Other NDCs under NDA 211988
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Zynrelefbupivacaine and meloxicam | Bupivacaine 400 mg/14mL; Meloxicam 12 mg/14mL | SolutionInfiltration | Heron Therapeutics, Inc. | 47426-501 |