FDA.reportPublic FDA data

Marcaine

Product NDC
0404-9768
11-digit product format
004049768
Labeler code
0404
Product ID
0404-9768_fc5fd272-2b75-47c6-a1cd-7201ca102030
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupivacine hydrochloride
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL; INTRACAUDAL; PERINEURAL
Labeler
Henry Schein, Inc.
Application
NDA016964
Marketing category
NDA
Marketing start
2026-01-26
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Marcaine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPIVACAINE HYDROCHLORIDE5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7TQO7W3VT8
Rxcui1724884, 1725046

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
0404-9768-30Marcaine1 in 1 BAGINJECTION, SOLUTION11
0404-9768-30Marcaine30 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1724884BUPivacaine HCl 0.5 % in 30 ML InjectionPSN7d94e8e0-0d1e-4af3-973a-a480d7d517371
1725046Marcaine 0.5 % in 30 ML InjectionPSN7d94e8e0-0d1e-4af3-973a-a480d7d517371
172504630 ML bupivacaine hydrochloride 5 MG/ML Injection [Marcaine]SBD7d94e8e0-0d1e-4af3-973a-a480d7d517371
172488430 ML bupivacaine hydrochloride 5 MG/ML InjectionSCD7d94e8e0-0d1e-4af3-973a-a480d7d517371
172504630 ML Marcaine 5 MG/ML InjectionSY7d94e8e0-0d1e-4af3-973a-a480d7d517371
1724884bupivacaine HCl 0.5 % in 30 ML InjectionSY7d94e8e0-0d1e-4af3-973a-a480d7d517371
1725046Marcaine 0.5 % in 30 ML InjectionSY7d94e8e0-0d1e-4af3-973a-a480d7d517371

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0404-9768-30004049768301 VIAL, SINGLE-DOSE in 1 BAG (0404-9768-30) / 30 mL in 1 VIAL, SINGLE-DOSE2026-01-26NoNoHistorical