Marcaine

Product NDC
0409-7535
11-digit product format
004097535
Labeler code
0409
Product ID
0409-7535_94e0b63b-40eb-4cbf-ae95-99c429816d82
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUPIVACAINE HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL
Labeler
Hospira, Inc.
Application
NDA016964
Marketing category
NDA
Marketing start
2025-05-27
Substance
BUPIVACAINE HYDROCHLORIDE
Active strength
75 mg/30mL
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 14 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0409-7535-252ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0409-7535-25a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0409-7535-25cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0409-7535-25cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0409-7535-25302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0409-7535-25ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0409-7535-250efc9e666f02…f202fb6c5f17…

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 HYDROCHLORIDE75 mg/30mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7TQO7W3VT8Internal UNII lookup
30Q7KI53AKInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 2 · 28 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1012377Internal RxNorm lookup
1012381Internal RxNorm lookup
1012384Internal RxNorm lookup
1012388Internal RxNorm lookup
1012396Internal RxNorm lookup
1012400Internal RxNorm lookup
1012404Internal RxNorm lookup
1012406Internal RxNorm lookup
1672917Internal RxNorm lookup
1672919Internal RxNorm lookup
1673242Internal RxNorm lookup
1673243Internal RxNorm lookup
1724786Internal RxNorm lookup
1724787Internal RxNorm lookup
1724794Internal RxNorm lookup
1724796Internal RxNorm lookup
1724880Internal RxNorm lookup
1724884Internal RxNorm lookup
1725044Internal RxNorm lookup
1725046Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
67578b56-7540-487e-1fba-481255620e78Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0b4ec9ca-d305-43fc-88dd-7a510313efe0Product name120260105
bb209f42-a85f-4fee-9d3d-c9dded168625Product name120251208
49628fc7-2031-4c28-bd31-0ef3aa8f44a3Product name320251118
cbf85893-59ef-423f-87d4-a573c000a8b9Product name820250731
b5b1095b-40cd-8a9e-b111-502545045b07Product name420250325
e190029e-423b-473c-8e04-2ada59b5b711Product name120250314
5dad6767-dcd1-b0da-8727-7f3f7bc3a435Product name220250303
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
e0031c74-3853-42bc-8e10-86dbbe83992eProduct name220231116
f7046b89-2016-499a-adc6-78479172abc6Product name120230425
e3a99641-4540-4894-9108-00cab3c57b7eProduct name120211207
5da98533-f072-406b-9e1b-6ac19eca9926Product name120210622
306b993e-3140-4823-ad5e-88b708f9d2acProduct name120210510
a831e694-3663-4a83-82be-6c309429f750Product name220200608
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
2686d634-e712-4007-8dbf-3d37c6c4d71fProduct name120181121
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
bd49bb86-2d32-4a7a-a594-eeda2e29af42Product name120180118
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
3becbe78-12d9-4ad2-9b4c-1e36f8d1303aProduct name120170815
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-7535-01Marcaine30 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION3037
0409-7535-25Marcaine25 in 1 TRAYINJECTION, SOLUTION2537

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-7535-01ML - Milliliter0409-753580ad93b1-6a1f-47c7-ab02-5ab897e83ae212025-06-13
0409-7535-25ML - Milliliter0409-753586aa74a7-fc3d-4b7c-acb9-30e57c4a9d8812025-06-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUPIVACAINE HYDROCHLORIDEACTIVE INGREDIENT7TQO7W3VT8MARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE WITH EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]13
EPINEPHRINE BITARTRATEACTIVE INGREDIENT30Q7KI53AKMARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE WITH EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]13
BUPIVACAINEACTIVE MOIETYY8335394ROMARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE WITH EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]13
EPINEPHRINEACTIVE MOIETYYKH834O4BHMARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE WITH EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]13
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RMARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE WITH EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]13
EDETATE CALCIUM DISODIUMINACTIVE INGREDIENT25IH6R4SGFMARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE WITH EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]13
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBMARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE WITH EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]13
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TMARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE WITH EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]13
MONOTHIOGLYCEROLINACTIVE INGREDIENTAAO1P0WSXJMARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE WITH EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]13
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XMARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE WITH EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]13
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IMARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE WITH EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]13
SODIUM LACTATEINACTIVE INGREDIENTTU7HW0W0QTMARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE WITH EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]13
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CMARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE WITH EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]13
WATERINACTIVE INGREDIENT059QF0KO0RMARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE WITH EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-7535MARCAINE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION MARCAINE WITH EPINEPHRINE (BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE) INJECTION, SOLUTION [HOSPIRA, INC.]33Current NDC, 2 package rows20250529_67578b56-7540-487e-1fba-481255620e78.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 · 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
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
ndc (product): 0409-7535
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
1867594BUPivacaine HCl 0.25 % / EPINEPHrine 1:200,000 in 10 ML InjectionPSN67578b56-7540-487e-1fba-481255620e7838
1867596BUPivacaine HCl 0.25 % / EPINEPHrine 1:200,000 in 30 ML InjectionPSN67578b56-7540-487e-1fba-481255620e7838
1012377BUPivacaine HCl 0.25 % / EPINEPHrine 1:200,000 Injectable SolutionPSN67578b56-7540-487e-1fba-481255620e7838
1725078BUPivacaine HCl 0.25 % in 10 ML InjectionPSN67578b56-7540-487e-1fba-481255620e7838
1725082BUPivacaine HCl 0.25 % in 30 ML InjectionPSN67578b56-7540-487e-1fba-481255620e7838
1012396BUPivacaine HCl 0.25 % Injectable SolutionPSN67578b56-7540-487e-1fba-481255620e7838
1672917BUPivacaine HCl 0.5 % / EPINEPHrine 1:200,000 in 10 ML InjectionPSN67578b56-7540-487e-1fba-481255620e7838
1672919BUPivacaine HCl 0.5 % / EPINEPHrine 1:200,000 in 30 ML InjectionPSN67578b56-7540-487e-1fba-481255620e7838
1012384BUPivacaine HCl 0.5 % / EPINEPHrine 1:200,000 Injectable SolutionPSN67578b56-7540-487e-1fba-481255620e7838
1724880BUPivacaine HCl 0.5 % in 10 ML InjectionPSN67578b56-7540-487e-1fba-481255620e7838
1724884BUPivacaine HCl 0.5 % in 30 ML InjectionPSN67578b56-7540-487e-1fba-481255620e7838
1012404BUPivacaine HCl 0.5 % Injectable SolutionPSN67578b56-7540-487e-1fba-481255620e7838
1724787BUPivacaine HCl 0.75 % in 10 ML InjectionPSN67578b56-7540-487e-1fba-481255620e7838
1724786BUPivacaine HCl 0.75 % in 30 ML InjectionPSN67578b56-7540-487e-1fba-481255620e7838
1867612Marcaine 0.25 % / EPINEPHrine 1:200,000 in 10 ML InjectionPSN67578b56-7540-487e-1fba-481255620e7838
1867614Marcaine 0.25 % / EPINEPHrine 1:200,000 in 30 ML InjectionPSN67578b56-7540-487e-1fba-481255620e7838
1012381Marcaine 0.25 % / EPINEPHrine 1:200,000 Injectable SolutionPSN67578b56-7540-487e-1fba-481255620e7838
1725079Marcaine 0.25 % in 10 ML InjectionPSN67578b56-7540-487e-1fba-481255620e7838
1725083Marcaine 0.25 % in 30 ML InjectionPSN67578b56-7540-487e-1fba-481255620e7838
1012400Marcaine 0.25 % Injectable SolutionPSN67578b56-7540-487e-1fba-481255620e7838
1673242Marcaine 0.5 % / EPINEPHrine 1:200,000 in 10 ML InjectionPSN67578b56-7540-487e-1fba-481255620e7838
1673243Marcaine 0.5 % / EPINEPHrine 1:200,000 in 30 ML InjectionPSN67578b56-7540-487e-1fba-481255620e7838
1012388Marcaine 0.5 % / EPINEPHrine 1:200,000 Injectable SolutionPSN67578b56-7540-487e-1fba-481255620e7838
1725044Marcaine 0.5 % in 10 ML InjectionPSN67578b56-7540-487e-1fba-481255620e7838
1725046Marcaine 0.5 % in 30 ML InjectionPSN67578b56-7540-487e-1fba-481255620e7838
1012406Marcaine 0.5 % Injectable SolutionPSN67578b56-7540-487e-1fba-481255620e7838
1724796Marcaine 0.75 % in 10 ML InjectionPSN67578b56-7540-487e-1fba-481255620e7838
1724794Marcaine 0.75 % in 30 ML InjectionPSN67578b56-7540-487e-1fba-481255620e7838
186761210 ML bupivacaine hydrochloride 2.5 MG/ML / epinephrine 0.005 MG/ML Injection [Marcaine with Epinephrine]SBD67578b56-7540-487e-1fba-481255620e7838
172507910 ML bupivacaine hydrochloride 2.5 MG/ML Injection [Marcaine]SBD67578b56-7540-487e-1fba-481255620e7838
167324210 ML bupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML Injection [Marcaine with Epinephrine]SBD67578b56-7540-487e-1fba-481255620e7838
172504410 ML bupivacaine hydrochloride 5 MG/ML Injection [Marcaine]SBD67578b56-7540-487e-1fba-481255620e7838
172479610 ML bupivacaine hydrochloride 7.5 MG/ML Injection [Marcaine]SBD67578b56-7540-487e-1fba-481255620e7838
186761430 ML bupivacaine hydrochloride 2.5 MG/ML / epinephrine 0.005 MG/ML Injection [Marcaine with Epinephrine]SBD67578b56-7540-487e-1fba-481255620e7838
172508330 ML bupivacaine hydrochloride 2.5 MG/ML Injection [Marcaine]SBD67578b56-7540-487e-1fba-481255620e7838
167324330 ML bupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML Injection [Marcaine with Epinephrine]SBD67578b56-7540-487e-1fba-481255620e7838
172504630 ML bupivacaine hydrochloride 5 MG/ML Injection [Marcaine]SBD67578b56-7540-487e-1fba-481255620e7838
172479430 ML bupivacaine hydrochloride 7.5 MG/ML Injection [Marcaine]SBD67578b56-7540-487e-1fba-481255620e7838
1012381bupivacaine hydrochloride 2.5 MG/ML / epinephrine 0.005 MG/ML Injectable Solution [Marcaine with Epinephrine]SBD67578b56-7540-487e-1fba-481255620e7838
1012400bupivacaine hydrochloride 2.5 MG/ML Injectable Solution [Marcaine]SBD67578b56-7540-487e-1fba-481255620e7838
1012388bupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML Injectable Solution [Marcaine with Epinephrine]SBD67578b56-7540-487e-1fba-481255620e7838
1012406bupivacaine hydrochloride 5 MG/ML Injectable Solution [Marcaine]SBD67578b56-7540-487e-1fba-481255620e7838
186759410 ML bupivacaine hydrochloride 2.5 MG/ML / epinephrine 0.005 MG/ML InjectionSCD67578b56-7540-487e-1fba-481255620e7838
172507810 ML bupivacaine hydrochloride 2.5 MG/ML InjectionSCD67578b56-7540-487e-1fba-481255620e7838
167291710 ML bupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML InjectionSCD67578b56-7540-487e-1fba-481255620e7838
172488010 ML bupivacaine hydrochloride 5 MG/ML InjectionSCD67578b56-7540-487e-1fba-481255620e7838
172478710 ML bupivacaine hydrochloride 7.5 MG/ML InjectionSCD67578b56-7540-487e-1fba-481255620e7838
186759630 ML bupivacaine hydrochloride 2.5 MG/ML / epinephrine 0.005 MG/ML InjectionSCD67578b56-7540-487e-1fba-481255620e7838
172508230 ML bupivacaine hydrochloride 2.5 MG/ML InjectionSCD67578b56-7540-487e-1fba-481255620e7838
167291930 ML bupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML InjectionSCD67578b56-7540-487e-1fba-481255620e7838
172488430 ML bupivacaine hydrochloride 5 MG/ML InjectionSCD67578b56-7540-487e-1fba-481255620e7838
172478630 ML bupivacaine hydrochloride 7.5 MG/ML InjectionSCD67578b56-7540-487e-1fba-481255620e7838
1012377bupivacaine hydrochloride 2.5 MG/ML / epinephrine 0.005 MG/ML Injectable SolutionSCD67578b56-7540-487e-1fba-481255620e7838
1012396bupivacaine hydrochloride 2.5 MG/ML Injectable SolutionSCD67578b56-7540-487e-1fba-481255620e7838
1012384bupivacaine hydrochloride 5 MG/ML / epinephrine 0.005 MG/ML Injectable SolutionSCD67578b56-7540-487e-1fba-481255620e7838
1012404bupivacaine hydrochloride 5 MG/ML Injectable SolutionSCD67578b56-7540-487e-1fba-481255620e7838
172507910 ML Marcaine 2.5 MG/ML InjectionSY67578b56-7540-487e-1fba-481255620e7838
172504410 ML Marcaine 5 MG/ML InjectionSY67578b56-7540-487e-1fba-481255620e7838
172479610 ML Marcaine 7.5 MG/ML InjectionSY67578b56-7540-487e-1fba-481255620e7838
172508330 ML Marcaine 2.5 MG/ML InjectionSY67578b56-7540-487e-1fba-481255620e7838
172504630 ML Marcaine 5 MG/ML InjectionSY67578b56-7540-487e-1fba-481255620e7838
172479430 ML Marcaine 7.5 MG/ML InjectionSY67578b56-7540-487e-1fba-481255620e7838
1867594bupivacaine HCl 0.25 % / epinephrine (as bitartrate) 1:200,000 per 10 mL InjectionSY67578b56-7540-487e-1fba-481255620e7838
1867596bupivacaine HCl 0.25 % / epinephrine 1:200,000 per 30 ML InjectionSY67578b56-7540-487e-1fba-481255620e7838
1725078bupivacaine HCl 0.25 % in 10 ML InjectionSY67578b56-7540-487e-1fba-481255620e7838
1725082bupivacaine HCl 0.25 % per 30 ML InjectionSY67578b56-7540-487e-1fba-481255620e7838
1672917bupivacaine HCl 0.5 % / epinephrine (as bitartrate) 1:200,000 per 10 ML InjectionSY67578b56-7540-487e-1fba-481255620e7838
1672919bupivacaine HCl 0.5 % / epinephrine (as bitartrate) 1:200,000 per 30 ML InjectionSY67578b56-7540-487e-1fba-481255620e7838
1724880bupivacaine HCl 0.5 % in 10 ML InjectionSY67578b56-7540-487e-1fba-481255620e7838
1724884bupivacaine HCl 0.5 % in 30 ML InjectionSY67578b56-7540-487e-1fba-481255620e7838
1724787bupivacaine HCl 0.75 % in 10 ML InjectionSY67578b56-7540-487e-1fba-481255620e7838
1724786bupivacaine HCl 0.75 % in 30 ML InjectionSY67578b56-7540-487e-1fba-481255620e7838
1724786bupivacaine HCl 225 MG per 30 ML InjectionSY67578b56-7540-487e-1fba-481255620e7838
1724787bupivacaine HCl 75 MG per 10 ML InjectionSY67578b56-7540-487e-1fba-481255620e7838
1012377bupivacaine hydrochloride 0.25 % / epinephrine (as epinephrine bitartrate) 1:200,000 Injectable SolutionSY67578b56-7540-487e-1fba-481255620e7838
1012396bupivacaine hydrochloride 0.25 % Injectable SolutionSY67578b56-7540-487e-1fba-481255620e7838
1012384bupivacaine hydrochloride 0.5 % / epinephrine (as epinephrine bitartrate) 1:200,000 Injectable SolutionSY67578b56-7540-487e-1fba-481255620e7838
1012404bupivacaine hydrochloride 0.5 % Injectable SolutionSY67578b56-7540-487e-1fba-481255620e7838
1867614Marcaine 0.25 % / epinephrine (as epinephrine bitartrate) 1:200,000 per 30 ML InjectionSY67578b56-7540-487e-1fba-481255620e7838
1012381Marcaine 0.25 % / epinephrine 1:200,000 Injectable SolutionSY67578b56-7540-487e-1fba-481255620e7838

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0409-7535-010040975350130 mL in 1 VIAL, SINGLE-DOSE30 mlHistorical
0409-7535-250040975352525 VIAL, SINGLE-DOSE in 1 TRAY (0409-7535-25) / 30 mL in 1 VIAL, SINGLE-DOSE (0409-7535-01) 2025-05-27NoNoCurrent