Bupivacaine HCl

Product NDC
70594-120
11-digit product format
705940120
Labeler code
70594
Product ID
70594-120_afc179ac-71b9-4021-8b71-3372bf590e4a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupivacaine hydrochloride
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL; INTRACAUDAL; PERINEURAL
Labeler
Xellia Pharmaceuticals USA LLC
Application
ANDA091487
Marketing category
ANDA
Marketing start
2023-06-01
Substance
BUPIVACAINE HYDROCHLORIDE
Active strength
7.5 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091487-001BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREEBUPIVACAINE HYDROCHLORIDE0.5%INJECTABLE / INJECTIONAP2011-10-18
A091487-002BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREEBUPIVACAINE HYDROCHLORIDE0.25%INJECTABLE / INJECTIONAP2011-10-18
A091487-003BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREEBUPIVACAINE HYDROCHLORIDE0.75%INJECTABLE / INJECTIONAP2011-10-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A091487-001AP
A091487-002AP
A091487-003AP

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 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A091487-001BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.5%INJECTABLE / INJECTIONAP2011-10-18caaa826d4ba7…
2026-08-18 06:07:402026-07A091487-002BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.25%INJECTABLE / INJECTIONAP2011-10-18caaa826d4ba7…
2026-08-18 06:07:402026-07A091487-003BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.75%INJECTABLE / INJECTIONAP2011-10-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091487-001BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.5%INJECTABLE / INJECTIONAP2011-10-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091487-002BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.25%INJECTABLE / INJECTIONAP2011-10-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091487-003BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.75%INJECTABLE / INJECTIONAP2011-10-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091487-001BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.5%INJECTABLE / INJECTIONAP2011-10-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091487-002BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.25%INJECTABLE / INJECTIONAP2011-10-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091487-003BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.75%INJECTABLE / INJECTIONAP2011-10-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A091487-001BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.5%INJECTABLE / INJECTIONAP2011-10-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091487-002BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.25%INJECTABLE / INJECTIONAP2011-10-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091487-003BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.75%INJECTABLE / INJECTIONAP2011-10-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091487-001BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.5%INJECTABLE / INJECTIONAP2011-10-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091487-002BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.25%INJECTABLE / INJECTIONAP2011-10-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091487-003BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.75%INJECTABLE / INJECTIONAP2011-10-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091487-001BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.5%INJECTABLE / INJECTIONAP2011-10-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091487-002BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.25%INJECTABLE / INJECTIONAP2011-10-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091487-003BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.75%INJECTABLE / INJECTIONAP2011-10-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091487-001BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.5%INJECTABLE / INJECTIONAP2011-10-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091487-002BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.25%INJECTABLE / INJECTIONAP2011-10-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091487-003BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.75%INJECTABLE / INJECTIONAP2011-10-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091487-001BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.5%INJECTABLE / INJECTIONAP2011-10-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091487-002BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.25%INJECTABLE / INJECTIONAP2011-10-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091487-003BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.75%INJECTABLE / INJECTIONAP2011-10-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091487-001BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.5%INJECTABLE / INJECTIONAP2011-10-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091487-002BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.25%INJECTABLE / INJECTIONAP2011-10-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091487-003BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.75%INJECTABLE / INJECTIONAP2011-10-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091487-001BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.5%INJECTABLE / INJECTIONAP2011-10-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091487-002BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.25%INJECTABLE / INJECTIONAP2011-10-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091487-003BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.75%INJECTABLE / INJECTIONAP2011-10-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091487-001BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.5%INJECTABLE / INJECTIONAP2011-10-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A091487-002BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.25%INJECTABLE / INJECTIONAP2011-10-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A091487-003BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.75%INJECTABLE / INJECTIONAP2011-10-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091487-001BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.5%INJECTABLE / INJECTIONAP2011-10-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091487-002BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.25%INJECTABLE / INJECTIONAP2011-10-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091487-003BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.75%INJECTABLE / INJECTIONAP2011-10-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091487-001BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.5%INJECTABLE / INJECTIONAP2011-10-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091487-002BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.25%INJECTABLE / INJECTIONAP2011-10-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091487-003BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.75%INJECTABLE / INJECTIONAP2011-10-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091487-001BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE0.5%INJECTABLE / INJECTIONAP2011-10-181e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 72 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A091487-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A091487-002AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A091487-003AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091487-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091487-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091487-003AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091487-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091487-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091487-003AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091487-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091487-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091487-003AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091487-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091487-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091487-003AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091487-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091487-002AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091487-003AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091487-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091487-002AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091487-003AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091487-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091487-002AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091487-003AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091487-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091487-002AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091487-003AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091487-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091487-002AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091487-003AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091487-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091487-002AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A091487-003AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091487-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091487-002AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091487-003AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091487-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091487-002AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091487-003AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091487-001AP11e350fbaab3a…

Additional Listing Data#

Finished product
Yes
Brand name base
Bupivacaine HCl
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPIVACAINE HYDROCHLORIDE7.5 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 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1724786Internal RxNorm lookup
1724787Internal RxNorm lookup
1724880Internal RxNorm lookup
1724884Internal RxNorm lookup
1725078Internal RxNorm lookup
1725082Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f29c905e-9a55-446f-a89d-860ad9ade7adAvailable 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
70594-120-01Bupivacaine HCl10 mL in 1 VIALINJECTION, SOLUTION102
70594-120-02Bupivacaine HCl10 in 1 CARTONINJECTION, SOLUTION102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70594-120-01ML - Milliliter70594-120caa2c45e-8375-4c95-b187-d0c3540fcc0b12023-08-08
70594-120-02ML - Milliliter70594-120514767d6-72a1-4045-a5c6-2ba65579489c12023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70594-120BUPIVACAINE HCL (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION BUPIVACAINE HCL (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION BUPIVACINE HCL (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [XELLIA PHARMACEUTICALS USA LLC]2Current NDC, 2 package rows20230622_f29c905e-9a55-446f-a89d-860ad9ade7ad.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEONESOURCE SPECIALTY PHARMA LIMITED5c10e3a1-7806-40c7-afd2-4c420e1418232025-11-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091487
application number: ANDA091487
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEFosun Pharma USA Inc.3a996abe-0bb9-4590-e063-6394a90a0b602025-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091487
application number: ANDA091487
Bupivacaine HClBUPIVACAINE HYDROCHLORIDEXellia Pharmaceuticals USA LLCf29c905e-9a55-446f-a89d-860ad9ade7ad2023-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091487
application number: ANDA091487
ndc (product): 70594-120

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1725078BUPivacaine HCl 0.25 % in 10 ML InjectionPSNf29c905e-9a55-446f-a89d-860ad9ade7ad2
1725082BUPivacaine HCl 0.25 % in 30 ML InjectionPSNf29c905e-9a55-446f-a89d-860ad9ade7ad2
1724880BUPivacaine HCl 0.5 % in 10 ML InjectionPSNf29c905e-9a55-446f-a89d-860ad9ade7ad2
1724884BUPivacaine HCl 0.5 % in 30 ML InjectionPSNf29c905e-9a55-446f-a89d-860ad9ade7ad2
1724787BUPivacaine HCl 0.75 % in 10 ML InjectionPSNf29c905e-9a55-446f-a89d-860ad9ade7ad2
1724786BUPivacaine HCl 0.75 % in 30 ML InjectionPSNf29c905e-9a55-446f-a89d-860ad9ade7ad2
172507810 ML bupivacaine hydrochloride 2.5 MG/ML InjectionSCDf29c905e-9a55-446f-a89d-860ad9ade7ad2
172488010 ML bupivacaine hydrochloride 5 MG/ML InjectionSCDf29c905e-9a55-446f-a89d-860ad9ade7ad2
172478710 ML bupivacaine hydrochloride 7.5 MG/ML InjectionSCDf29c905e-9a55-446f-a89d-860ad9ade7ad2
172508230 ML bupivacaine hydrochloride 2.5 MG/ML InjectionSCDf29c905e-9a55-446f-a89d-860ad9ade7ad2
172488430 ML bupivacaine hydrochloride 5 MG/ML InjectionSCDf29c905e-9a55-446f-a89d-860ad9ade7ad2
172478630 ML bupivacaine hydrochloride 7.5 MG/ML InjectionSCDf29c905e-9a55-446f-a89d-860ad9ade7ad2
1725078bupivacaine HCl 0.25 % in 10 ML InjectionSYf29c905e-9a55-446f-a89d-860ad9ade7ad2
1725082bupivacaine HCl 0.25 % per 30 ML InjectionSYf29c905e-9a55-446f-a89d-860ad9ade7ad2
1724880bupivacaine HCl 0.5 % in 10 ML InjectionSYf29c905e-9a55-446f-a89d-860ad9ade7ad2
1724884bupivacaine HCl 0.5 % in 30 ML InjectionSYf29c905e-9a55-446f-a89d-860ad9ade7ad2
1724787bupivacaine HCl 0.75 % in 10 ML InjectionSYf29c905e-9a55-446f-a89d-860ad9ade7ad2
1724786bupivacaine HCl 0.75 % in 30 ML InjectionSYf29c905e-9a55-446f-a89d-860ad9ade7ad2
1724786bupivacaine HCl 225 MG per 30 ML InjectionSYf29c905e-9a55-446f-a89d-860ad9ade7ad2
1724787bupivacaine HCl 75 MG per 10 ML InjectionSYf29c905e-9a55-446f-a89d-860ad9ade7ad2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70594-120-017059401200110 mL in 1 VIAL10 mlHistorical
70594-120-027059401200210 VIAL in 1 CARTON (70594-120-02) / 10 mL in 1 VIAL (70594-120-01) 10 vial2023-06-01NoNoCurrent