Marcaine

Product NDC
0404-9770
11-digit product format
004049770
Labeler code
0404
Product ID
0404-9770_dba40c2a-6967-4b86-a56d-e933f23f4ea3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bupivacaine hydrochloride
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL
Labeler
Henry Schein, Inc.
Application
NDA016964
Marketing category
NDA
Marketing start
2025-12-02
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
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 10 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N016964-001MARCAINE HYDROCHLORIDEBUPIVACAINE HYDROCHLORIDE0.25%INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982
N016964-004MARCAINE HYDROCHLORIDE W/ EPINEPHRINEBUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE0.25%;0.0091MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982
N016964-005MARCAINE HYDROCHLORIDE PRESERVATIVE FREEBUPIVACAINE HYDROCHLORIDE0.5%INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982
N016964-006MARCAINE HYDROCHLORIDEBUPIVACAINE HYDROCHLORIDE0.5%INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982
N016964-007MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREEBUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE0.5%;0.0091MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982
N016964-008MARCAINE HYDROCHLORIDE W/ EPINEPHRINEBUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE0.5%;0.0091MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982
N016964-009MARCAINE HYDROCHLORIDE PRESERVATIVE FREEBUPIVACAINE HYDROCHLORIDE0.75%INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982
N016964-010MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREEBUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE0.75%;0.0091MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982
N016964-012MARCAINE HYDROCHLORIDE PRESERVATIVE FREEBUPIVACAINE HYDROCHLORIDE0.25%INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982
N016964-013MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREEBUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE0.25%;0.0091MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 10 matching rows.

Application-product, TE code table
Application-productTE code
N016964-001AP
N016964-004AP
N016964-005AP
N016964-006AP
N016964-007AP
N016964-008AP
N016964-009AP
N016964-010AP
N016964-012AP
N016964-013AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 11 · 420 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N016964-001MARCAINE HYDROCHLORIDE0.25%INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N016964-004MARCAINE HYDROCHLORIDE W/ EPINEPHRINE0.25%;0.0091MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N016964-005MARCAINE HYDROCHLORIDE PRESERVATIVE FREE0.5%INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N016964-006MARCAINE HYDROCHLORIDE0.5%INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N016964-007MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE0.5%;0.0091MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N016964-008MARCAINE HYDROCHLORIDE W/ EPINEPHRINE0.5%;0.0091MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N016964-009MARCAINE HYDROCHLORIDE PRESERVATIVE FREE0.75%INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N016964-010MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE0.75%;0.0091MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N016964-012MARCAINE HYDROCHLORIDE PRESERVATIVE FREE0.25%INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N016964-013MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE0.25%;0.0091MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N016964-001MARCAINE HYDROCHLORIDE0.25%INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N016964-004MARCAINE HYDROCHLORIDE W/ EPINEPHRINE0.25%;0.0091MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N016964-005MARCAINE HYDROCHLORIDE PRESERVATIVE FREE0.5%INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N016964-006MARCAINE HYDROCHLORIDE0.5%INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N016964-007MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE0.5%;0.0091MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N016964-008MARCAINE HYDROCHLORIDE W/ EPINEPHRINE0.5%;0.0091MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N016964-009MARCAINE HYDROCHLORIDE PRESERVATIVE FREE0.75%INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N016964-010MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE0.75%;0.0091MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N016964-012MARCAINE HYDROCHLORIDE PRESERVATIVE FREE0.25%INJECTABLE / INJECTIONAPRLD, RS, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N016964-013MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE0.25%;0.0091MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N016964-001MARCAINE HYDROCHLORIDE0.25%INJECTABLE / INJECTIONAPRLD, RS, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N016964-004MARCAINE HYDROCHLORIDE W/ EPINEPHRINE0.25%;0.0091MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N016964-005MARCAINE HYDROCHLORIDE PRESERVATIVE FREE0.5%INJECTABLE / INJECTIONAPRLD, RS, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N016964-006MARCAINE HYDROCHLORIDE0.5%INJECTABLE / INJECTIONAPRLD, RS, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N016964-007MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE0.5%;0.0091MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N016964-008MARCAINE HYDROCHLORIDE W/ EPINEPHRINE0.5%;0.0091MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N016964-009MARCAINE HYDROCHLORIDE PRESERVATIVE FREE0.75%INJECTABLE / INJECTIONAPRLD, RS, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N016964-010MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE0.75%;0.0091MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N016964-012MARCAINE HYDROCHLORIDE PRESERVATIVE FREE0.25%INJECTABLE / INJECTIONAPRLD, RS, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N016964-013MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE0.25%;0.0091MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N016964-001MARCAINE HYDROCHLORIDE0.25%INJECTABLE / INJECTIONAPRLD, RS, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N016964-004MARCAINE HYDROCHLORIDE W/ EPINEPHRINE0.25%;0.0091MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N016964-005MARCAINE HYDROCHLORIDE PRESERVATIVE FREE0.5%INJECTABLE / INJECTIONAPRLD, RS, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N016964-006MARCAINE HYDROCHLORIDE0.5%INJECTABLE / INJECTIONAPRLD, RS, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N016964-007MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE0.5%;0.0091MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N016964-008MARCAINE HYDROCHLORIDE W/ EPINEPHRINE0.5%;0.0091MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N016964-009MARCAINE HYDROCHLORIDE PRESERVATIVE FREE0.75%INJECTABLE / INJECTIONAPRLD, RS, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N016964-010MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE0.75%;0.0091MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N016964-012MARCAINE HYDROCHLORIDE PRESERVATIVE FREE0.25%INJECTABLE / INJECTIONAPRLD, RS, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N016964-013MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE0.25%;0.0091MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 19826a471c1ec25d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 11 · 420 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N016964-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07N016964-004AP1caaa826d4ba7…
2026-08-18 06:07:402026-07N016964-005AP1caaa826d4ba7…
2026-08-18 06:07:402026-07N016964-006AP1caaa826d4ba7…
2026-08-18 06:07:402026-07N016964-007AP1caaa826d4ba7…
2026-08-18 06:07:402026-07N016964-008AP1caaa826d4ba7…
2026-08-18 06:07:402026-07N016964-009AP1caaa826d4ba7…
2026-08-18 06:07:402026-07N016964-010AP1caaa826d4ba7…
2026-08-18 06:07:402026-07N016964-012AP1caaa826d4ba7…
2026-08-18 06:07:402026-07N016964-013AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N016964-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N016964-004AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N016964-005AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N016964-006AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N016964-007AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N016964-008AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N016964-009AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N016964-010AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N016964-012AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N016964-013AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N016964-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N016964-004AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N016964-005AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N016964-006AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N016964-007AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N016964-008AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N016964-009AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N016964-010AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N016964-012AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N016964-013AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N016964-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N016964-004AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N016964-005AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N016964-006AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N016964-007AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N016964-008AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N016964-009AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N016964-010AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N016964-012AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N016964-013AP16a471c1ec25d…

Additional Listing Data#

Finished product
Yes
Brand name base
Marcaine
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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1725078Internal RxNorm lookup
1725079Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
562f4499-f3b7-4d9e-b022-61172176c883Available 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
0404-9770-10Marcaine10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION101
0404-9770-10Marcaine1 in 1 BAGINJECTION, SOLUTION11

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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MarcaineBUPIVACAINE HYDROCHLORIDEHenry Schein, Inc.562f4499-f3b7-4d9e-b022-61172176c8832026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 016964
application number: NDA016964
ndc (product): 0404-9770
MarcaineBUPIVACAINE HYDROCHLORIDEHenry Schein, Inc.2c6f9b85-e783-4ad4-a804-a0ff1a32ec2c2026-06-24Warnings, Adverse reactionsExact identifier
application applno (NDA): 016964
application number: NDA016964
MarcaineBUPIVACAINE HYDROCHLORIDEHospira, Inc.67578b56-7540-487e-1fba-481255620e782026-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 016964
application number: NDA016964
MARCAINE WITH EPINEPHRINEBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEHenry Schein, Inc.d0d51133-882c-4f9e-ba1c-f037226305a12026-01-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 016964
application number: NDA016964
MarcaineBUPIVACINE HYDROCHLORIDEHenry Schein, Inc.7d94e8e0-0d1e-4af3-973a-a480d7d517372026-01-26Warnings, Adverse reactionsExact identifier
application applno (NDA): 016964
application number: NDA016964
Marcaine with EpinephrineBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINEHospira, Inc.93cf0914-de08-4ec6-8f8c-d663243b99582024-02-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 016964
application number: NDA016964

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1725078BUPivacaine HCl 0.25 % in 10 ML InjectionPSN562f4499-f3b7-4d9e-b022-61172176c8831
1725079Marcaine 0.25 % in 10 ML InjectionPSN562f4499-f3b7-4d9e-b022-61172176c8831
172507910 ML bupivacaine hydrochloride 2.5 MG/ML Injection [Marcaine]SBD562f4499-f3b7-4d9e-b022-61172176c8831
172507810 ML bupivacaine hydrochloride 2.5 MG/ML InjectionSCD562f4499-f3b7-4d9e-b022-61172176c8831
172507910 ML Marcaine 2.5 MG/ML InjectionSY562f4499-f3b7-4d9e-b022-61172176c8831
1725078bupivacaine HCl 0.25 % in 10 ML InjectionSY562f4499-f3b7-4d9e-b022-61172176c8831
1725079Marcaine 0.25 % in 10 ML InjectionSY562f4499-f3b7-4d9e-b022-61172176c8831

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0404-9770-10004049770101 VIAL, SINGLE-DOSE in 1 BAG (0404-9770-10) / 10 mL in 1 VIAL, SINGLE-DOSE2025-12-02NoNoCurrent