FDA.reportPublic FDA data

Marvona-25 SUIK

Product NDC
87063-079
Requested package NDC
87063-079-01
11-digit product format
870630079
Labeler code
87063
Product ID
87063-079_491b452c-8e01-dfc0-e063-6394a90a3427
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupivacaine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL
Labeler
Asclemed USA, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2026-01-24
Substance
BUPIVACAINE HYDROCHLORIDE
Active strength
2.5 mg/mL
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Marvona-25 SUIK
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPIVACAINE HYDROCHLORIDE2.5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7TQO7W3VT8Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
cb71b757-057e-42d4-8a12-8fd8e69a9124Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cbf85893-59ef-423f-87d4-a573c000a8b9Product name820250731
5dad6767-dcd1-b0da-8727-7f3f7bc3a435Product name220250303
e3a99641-4540-4894-9108-00cab3c57b7eProduct name120211207
5da98533-f072-406b-9e1b-6ac19eca9926Product name120210622
306b993e-3140-4823-ad5e-88b708f9d2acProduct name120210510
a831e694-3663-4a83-82be-6c309429f750Product name220200608

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87063-079-01Marvona-25 SUIK10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION101
87063-079-01Marvona-25 SUIK1 in 1 CARTONINJECTION, SOLUTION11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
87063-079-01EA - Each87063-0797ec97ff6-c8de-47cc-b868-989de8f88e1e12026-03-17

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Marvona-25 SUIKBUPIVACAINE HYDROCHLORIDEAsclemed USA, Inc.cb71b757-057e-42d4-8a12-8fd8e69a91242026-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 87063-079-01
ndc (product): 87063-079
ndc11 (package): 87063007901

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
87063-079-01870630079011 VIAL, SINGLE-DOSE in 1 CARTON (87063-079-01) / 10 mL in 1 VIAL, SINGLE-DOSE2026-01-24NoNoCurrent