Marcaine

Product NDC
0404-9907
11-digit product format
004049907
Labeler code
0404
Product ID
0404-9907_d507a686-a77e-4e61-b7c8-018a42d63f31
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupivacaine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL; INTRACAUDAL; PERINEURAL
Labeler
Henry Schein, Inc.
Application
NDA016964
Marketing category
NDA
Marketing start
2022-01-19
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

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 Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0404-9907MARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [HENRY SCHEIN, INC.]6Legacy NDC20240323_76bb1e84-6032-4bb4-9b79-596542f5d05d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0404-9907-10004049907101 VIAL, SINGLE-DOSE in 1 BAG (0404-9907-10) > 10 mL in 1 VIAL, SINGLE-DOSE2022-01-190000-00-00NoNoCurrent
0404-9907-30004049907301 PACKAGE in 1 BAG (0404-9907-30) > 30 mL in 1 PACKAGE1 package2022-01-190000-00-00NoNoCurrent