zynrelef

Generic: bupivacaine and meloxicam

Labeler: heron therapeutics, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name zynrelef
Generic Name bupivacaine and meloxicam
Labeler heron therapeutics, inc.
Dosage Form SOLUTION
Routes
INFILTRATION
Active Ingredients

bupivacaine 200 mg/7mL, meloxicam 6 mg/7mL

Manufacturer
Heron Therapeutics, Inc.

Identifiers & Regulatory

Product NDC 47426-503
Product ID 47426-503_44cabd7f-3a81-4749-b523-655d188b83cf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA211988
Listing Expiration 2026-12-31
Marketing Start 2024-12-01

Pharmacologic Class

Established (EPC)
nonsteroidal anti-inflammatory drug [epc] amide local anesthetic [epc]
Mechanism of Action
cyclooxygenase inhibitors [moa]
Chemical Structure
anti-inflammatory agents, non-steroidal [cs] amides [cs]
Physiologic Effect
local anesthesia [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 47426503
Hyphenated Format 47426-503

Supplemental Identifiers

RxCUI
2560306 2560308 2560309 2560311 2560312 2560315 2560319 2560321
UNII
VG2QF83CGL Y8335394RO
NUI
N0000000160 M0001335 N0000175722 N0000175682 M0000897 N0000175976

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name zynrelef (source: ndc)
Generic Name bupivacaine and meloxicam (source: ndc)
Application Number NDA211988 (source: ndc)
Routes
INFILTRATION
source: ndc

Resolved Composition

Strengths
  • 200 mg/7mL
  • 6 mg/7mL
source: ndc
Packaging
  • 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-DOSE
source: ndc

Packages (1)

47426-503-01 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-DOSE

Ingredients (2)

bupivacaine (200 mg/7mL) meloxicam (6 mg/7mL)

Linked Drug Pages (1)

ZYNRELEF ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INFILTRATION"], "spl_id": "44cabd7f-3a81-4749-b523-655d188b83cf", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722", "N0000175682", "M0000897", "N0000175976"], "unii": ["VG2QF83CGL", "Y8335394RO"], "rxcui": ["2560306", "2560308", "2560309", "2560311", "2560312", "2560315", "2560319", "2560321"], "spl_set_id": ["dab484a7-9353-43ba-9e74-7fab910c712b"], "pharm_class_cs": ["Anti-Inflammatory Agents, Non-Steroidal [CS]", "Amides [CS]"], "pharm_class_pe": ["Local Anesthesia [PE]"], "pharm_class_epc": ["Nonsteroidal Anti-inflammatory Drug [EPC]", "Amide Local Anesthetic [EPC]"], "pharm_class_moa": ["Cyclooxygenase Inhibitors [MoA]"], "manufacturer_name": ["Heron Therapeutics, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "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-DOSE", "package_ndc": "47426-503-01", "marketing_start_date": "20241201"}], "brand_name": "ZYNRELEF", "product_id": "47426-503_44cabd7f-3a81-4749-b523-655d188b83cf", "dosage_form": "SOLUTION", "pharm_class": ["Amide Local Anesthetic [EPC]", "Amides [CS]", "Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Local Anesthesia [PE]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "47426-503", "generic_name": "BUPIVACAINE and MELOXICAM", "labeler_name": "Heron Therapeutics, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ZYNRELEF", "active_ingredients": [{"name": "BUPIVACAINE", "strength": "200 mg/7mL"}, {"name": "MELOXICAM", "strength": "6 mg/7mL"}], "application_number": "NDA211988", "marketing_category": "NDA", "marketing_start_date": "20241201", "listing_expiration_date": "20261231"}