FDA.reportPublic FDA data

ZYNRELEF

Product NDC
47426-301
11-digit product format
474260301
Labeler code
47426
Product ID
47426-301_c89236a8-214c-4de1-b60c-9284efeabe58
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUPIVACAINE and MELOXICAM
Dosage form
SOLUTION
Route
INFILTRATION
Labeler
Heron Therapeutics, Inc.
Application
NDA211988
Marketing category
NDA
Marketing start
2021-07-01
Marketing end
0000-00-00
Substance
BUPIVACAINE; MELOXICAM
Active strength
400 mg/14mL; mg/14mL
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Local Anesthesia [PE], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bdef11ce-16e2-4690-96a3-597bcf5cc738Product name120260130
f2791553-0b76-42f4-8d49-af3eda072bfbProduct name120251117
cbf85893-59ef-423f-87d4-a573c000a8b9Product name820250731
5dad6767-dcd1-b0da-8727-7f3f7bc3a435Product name220250303
e3a99641-4540-4894-9108-00cab3c57b7eProduct name120211207
3e9b4ed6-844c-4725-9d19-cceb5c823572Product name220210903
5da98533-f072-406b-9e1b-6ac19eca9926Product name120210622
306b993e-3140-4823-ad5e-88b708f9d2acProduct name120210510
b21a682e-c765-4e26-9bb2-dbb8c7b38ef7Product name120200623
a831e694-3663-4a83-82be-6c309429f750Product name220200608
a428d1db-64d7-4fc3-8d13-832b1e84b683Product name120190201
96649a58-aac8-401c-be00-450b4335f7e7Product name120161116
f0761cb7-8207-3a19-2ca3-ecbb559b04e1Product name220161116

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
47426-301-022024-09-18C16284748780-11e7a6dab-1ec9-a2ce-e063-dadaa90aadf7These highlights do not include all the information needed to use ZYNRELEF ® safely and effectively. See full prescribing information for ZYNRELEF. ZYNRELEF (bupivacaine and meloxicam) extended-release solution, for instillation use Initial U.S. Approval: 2021
47426-301-022024-07-30C16284748780-11e7a6dab-1ec9-a2ce-e063-dadaa90aadf7These highlights do not include all the information needed to use ZYNRELEF ® safely and effectively. See full prescribing information for ZYNRELEF. ZYNRELEF (bupivacaine and meloxicam) extended-release solution, for instillation use Initial U.S. Approval: 2021

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47426-301-02ZYNRELEF1 in 1 KITSOLUTION116
47426-301-04ZYNRELEF1 in 1 CARTONSOLUTION116
47426-301-06ZYNRELEF14 mL in 1 VIAL, SINGLE-DOSESOLUTION1416

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47426-301-02ML - Milliliter47426-30121902a12-b0dc-42ed-8875-b27d1b2a718912021-07-15
47426-301-06ML - Milliliter47426-301de149819-b34f-4a60-8c7b-91fd546ac6e712023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47426-301ZYNRELEF (BUPIVACAINE AND MELOXICAM) SOLUTION [HERON THERAPEUTICS, INC.]13Legacy NDC, 3 package rows20241206_dab484a7-9353-43ba-9e74-7fab910c712b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2560321BUPivacaine 200 MG / meloxicam 6 MG in 7 ML Extended Release SolutionPSNdab484a7-9353-43ba-9e74-7fab910c712b16
2560315BUPivacaine 300 MG / meloxicam 9 MG in 10.5 ML Extended Release SolutionPSNdab484a7-9353-43ba-9e74-7fab910c712b16
2560312BUPivacaine 400 MG / meloxicam 12 MG in 14 ML Extended Release SolutionPSNdab484a7-9353-43ba-9e74-7fab910c712b16
2560319BUPivacaine 60 MG / meloxicam 1.8 MG in 2.3 ML Extended Release SolutionPSNdab484a7-9353-43ba-9e74-7fab910c712b16
2560306ZYNRELEF (BUPivacaine 200 MG / meloxicam 6 MG) in 7 ML Extended Release SolutionPSNdab484a7-9353-43ba-9e74-7fab910c712b16
2560309ZYNRELEF (BUPivacaine 300 MG / meloxicam 9 MG) in 10.5 ML Extended Release SolutionPSNdab484a7-9353-43ba-9e74-7fab910c712b16
2560308ZYNRELEF (BUPivacaine 400 MG / meloxicam 12 MG) in 14 ML Extended Release SolutionPSNdab484a7-9353-43ba-9e74-7fab910c712b16
2560311ZYNRELEF (BUPivacaine 60 MG / meloxicam 1.8 MG) in 2.3 ML Extended Release SolutionPSNdab484a7-9353-43ba-9e74-7fab910c712b16
256030910.5 ML bupivacaine 29.3 MG/ML / meloxicam 0.88 MG/ML Injection [Zynrelef]SBDdab484a7-9353-43ba-9e74-7fab910c712b16
256030814 ML bupivacaine 29.3 MG/ML / meloxicam 0.88 MG/ML Injection [Zynrelef]SBDdab484a7-9353-43ba-9e74-7fab910c712b16
25603112.3 ML bupivacaine 29.3 MG/ML / meloxicam 0.88 MG/ML Injection [Zynrelef]SBDdab484a7-9353-43ba-9e74-7fab910c712b16
25603067 ML bupivacaine 29.3 MG/ML / meloxicam 0.88 MG/ML Injection [Zynrelef]SBDdab484a7-9353-43ba-9e74-7fab910c712b16
256031510.5 ML bupivacaine 29.3 MG/ML / meloxicam 0.88 MG/ML InjectionSCDdab484a7-9353-43ba-9e74-7fab910c712b16
256031214 ML bupivacaine 29.3 MG/ML / meloxicam 0.88 MG/ML InjectionSCDdab484a7-9353-43ba-9e74-7fab910c712b16
25603192.3 ML bupivacaine 29.3 MG/ML / meloxicam 0.88 MG/ML InjectionSCDdab484a7-9353-43ba-9e74-7fab910c712b16
25603217 ML bupivacaine 29.3 MG/ML / meloxicam 0.88 MG/ML InjectionSCDdab484a7-9353-43ba-9e74-7fab910c712b16
2560321bupivacaine 200 MG / meloxicam 6 MG per 7 ML Extended Release SolutionSYdab484a7-9353-43ba-9e74-7fab910c712b16
2560315bupivacaine 300 MG / meloxicam 9 MG per 10.5 ML Extended Release SolutionSYdab484a7-9353-43ba-9e74-7fab910c712b16
2560312bupivacaine 400 MG / meloxicam 12 MG per 14 ML Extended Release SolutionSYdab484a7-9353-43ba-9e74-7fab910c712b16
2560319bupivacaine 60 MG / meloxicam 1.8 MG per 2.3 ML Extended Release SolutionSYdab484a7-9353-43ba-9e74-7fab910c712b16
2560306Zynrelef (bupivacaine 200 MG / meloxicam 6 MG) per 7 ML Extended Release SolutionSYdab484a7-9353-43ba-9e74-7fab910c712b16
2560309Zynrelef (bupivacaine 300 MG / meloxicam 9 MG) per 10.5 ML Extended Release SolutionSYdab484a7-9353-43ba-9e74-7fab910c712b16
2560308Zynrelef (bupivacaine 400 MG / meloxicam 12 MG) per 14 ML Extended Release SolutionSYdab484a7-9353-43ba-9e74-7fab910c712b16
2560311Zynrelef (bupivacaine 60 MG / meloxicam 1.8 MG) per 2.3 ML Extended Release SolutionSYdab484a7-9353-43ba-9e74-7fab910c712b16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47426-301-02474260301021 CARTON in 1 KIT (47426-301-02) > 1 VIAL, SINGLE-DOSE in 1 CARTON > 14 mL in 1 VIAL, SINGLE-DOSE1 carton2021-07-010000-00-00NoNoCurrent
47426-301-04474260301041 in 1 CARTONHistorical
47426-301-064742603010614 mL in 1 VIAL, SINGLE-DOSE14 mlHistorical