FDA.reportPublic FDA data

Marvona SUIK

Product NDC
76420-230
Requested package NDC
76420-230-01
11-digit product format
764200230
Labeler code
76420
Product ID
76420-230_01491362-9a55-d75a-e063-6294a90a8402
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupivacaine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL; INFILTRATION
Labeler
Asclemed USA, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2009-09-08
Substance
BUPIVACAINE HYDROCHLORIDE
Active strength
5 mg/mL
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
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 SUIK
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPIVACAINE HYDROCHLORIDE5 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
f03f28d9-e42e-404d-9c9c-7707aedb478cAvailable 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
76420-230-01Marvona SUIK10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION1010
76420-230-01Marvona SUIK1 in 1 CARTONINJECTION, SOLUTION110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-230-01EA - Each76420-230cf7ec400-5271-4dd2-b640-49a1bc19cc1b12016-09-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-230MARVONA SUIK (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [ASCLEMED USA, INC.]10Current NDC, Legacy NDC, 2 package rows20230725_f03f28d9-e42e-404d-9c9c-7707aedb478c.zip

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 SUIKBUPIVACAINE HYDROCHLORIDEAsclemed USA, Inc.f03f28d9-e42e-404d-9c9c-7707aedb478c2023-07-19Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (package): 76420-230-01
ndc (product): 76420-230
ndc11 (package): 76420023001

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
76420-230-01764200230011 VIAL, SINGLE-DOSE in 1 CARTON (76420-230-01) / 10 mL in 1 VIAL, SINGLE-DOSE2009-09-080000-00-00NoNoCurrent