BUPIVACAINE HYDROCHLORIDE injection, solution

Product NDC
51662-1638
11-digit product format
516621638
Labeler code
51662
Product ID
51662-1638_0f952dd8-92a8-2eb0-e063-6394a90a8c35
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUPIVACAINE HYDROCHLORIDE injection, solution
Dosage form
INJECTION, SOLUTION
Route
PERINEURAL
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
ANDA207183
Marketing category
ANDA
Marketing start
2016-05-13
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
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207183-001BUPIVACAINE HYDROCHLORIDEBUPIVACAINE HYDROCHLORIDE0.25%INJECTABLE / INJECTIONAP2016-05-13
A207183-002BUPIVACAINE HYDROCHLORIDEBUPIVACAINE HYDROCHLORIDE0.5%INJECTABLE / INJECTIONAP2016-05-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A207183-001AP
A207183-002AP

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 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A207183-001BUPIVACAINE HYDROCHLORIDE0.25%INJECTABLE / INJECTIONAP2016-05-13caaa826d4ba7…
2026-08-18 06:07:402026-07A207183-002BUPIVACAINE HYDROCHLORIDE0.5%INJECTABLE / INJECTIONAP2016-05-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207183-001BUPIVACAINE HYDROCHLORIDE0.25%INJECTABLE / INJECTIONAP2016-05-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207183-002BUPIVACAINE HYDROCHLORIDE0.5%INJECTABLE / INJECTIONAP2016-05-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207183-001BUPIVACAINE HYDROCHLORIDE0.25%INJECTABLE / INJECTIONAP2016-05-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207183-002BUPIVACAINE HYDROCHLORIDE0.5%INJECTABLE / INJECTIONAP2016-05-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A207183-001BUPIVACAINE HYDROCHLORIDE0.25%INJECTABLE / INJECTIONAP2016-05-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207183-002BUPIVACAINE HYDROCHLORIDE0.5%INJECTABLE / INJECTIONAP2016-05-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207183-001BUPIVACAINE HYDROCHLORIDE0.25%INJECTABLE / INJECTIONAP2016-05-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207183-002BUPIVACAINE HYDROCHLORIDE0.5%INJECTABLE / INJECTIONAP2016-05-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207183-001BUPIVACAINE HYDROCHLORIDE0.25%INJECTABLE / INJECTIONAP2016-05-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207183-002BUPIVACAINE HYDROCHLORIDE0.5%INJECTABLE / INJECTIONAP2016-05-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207183-001BUPIVACAINE HYDROCHLORIDE0.25%INJECTABLE / INJECTIONAP2016-05-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207183-002BUPIVACAINE HYDROCHLORIDE0.5%INJECTABLE / INJECTIONAP2016-05-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207183-001BUPIVACAINE HYDROCHLORIDE0.25%INJECTABLE / INJECTIONAP2016-05-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207183-002BUPIVACAINE HYDROCHLORIDE0.5%INJECTABLE / INJECTIONAP2016-05-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207183-001BUPIVACAINE HYDROCHLORIDE0.25%INJECTABLE / INJECTIONAP2016-05-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207183-002BUPIVACAINE HYDROCHLORIDE0.5%INJECTABLE / INJECTIONAP2016-05-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207183-001BUPIVACAINE HYDROCHLORIDE0.25%INJECTABLE / INJECTIONAP2016-05-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207183-002BUPIVACAINE HYDROCHLORIDE0.5%INJECTABLE / INJECTIONAP2016-05-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207183-001BUPIVACAINE HYDROCHLORIDE0.25%INJECTABLE / INJECTIONAP2016-05-13d06236e962d9…
2024-10-29 15:01 UTC2024-10A207183-002BUPIVACAINE HYDROCHLORIDE0.5%INJECTABLE / INJECTIONAP2016-05-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207183-001BUPIVACAINE HYDROCHLORIDE0.25%INJECTABLE / INJECTIONAP2016-05-1379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207183-002BUPIVACAINE HYDROCHLORIDE0.5%INJECTABLE / INJECTIONAP2016-05-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207183-001BUPIVACAINE HYDROCHLORIDE0.25%INJECTABLE / INJECTIONAP2016-05-13301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207183-002BUPIVACAINE HYDROCHLORIDE0.5%INJECTABLE / INJECTIONAP2016-05-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207183-001BUPIVACAINE HYDROCHLORIDE0.25%INJECTABLE / INJECTIONAP2016-05-131e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207183-002BUPIVACAINE HYDROCHLORIDE0.5%INJECTABLE / INJECTIONAP2016-05-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207183-001BUPIVACAINE HYDROCHLORIDE0.25%INJECTABLE / INJECTIONAP2016-05-138072bd15b7f6…
2024-05-31 18:47 UTC2024-05A207183-002BUPIVACAINE HYDROCHLORIDE0.5%INJECTABLE / INJECTIONAP2016-05-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207183-001BUPIVACAINE HYDROCHLORIDE0.25%INJECTABLE / INJECTIONAP2016-05-135c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207183-002BUPIVACAINE HYDROCHLORIDE0.5%INJECTABLE / INJECTIONAP2016-05-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207183-001BUPIVACAINE HYDROCHLORIDE0.25%INJECTABLE / INJECTIONAP2016-05-135d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A207183-002BUPIVACAINE HYDROCHLORIDE0.5%INJECTABLE / INJECTIONAP2016-05-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207183-001BUPIVACAINE HYDROCHLORIDE0.25%INJECTABLE / INJECTIONAP2016-05-134b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A207183-002BUPIVACAINE HYDROCHLORIDE0.5%INJECTABLE / INJECTIONAP2016-05-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207183-001BUPIVACAINE HYDROCHLORIDE0.25%INJECTABLE / INJECTIONAP2016-05-1374a2ff9319b5…
2019-12-13 00:20 UTC2019-12A207183-002BUPIVACAINE HYDROCHLORIDE0.5%INJECTABLE / INJECTIONAP2016-05-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207183-001BUPIVACAINE HYDROCHLORIDE0.25%INJECTABLE / INJECTIONAP2016-05-13bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A207183-002BUPIVACAINE HYDROCHLORIDE0.5%INJECTABLE / INJECTIONAP2016-05-13bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A207183-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A207183-002AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207183-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207183-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207183-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207183-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207183-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207183-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207183-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207183-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207183-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207183-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207183-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207183-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207183-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207183-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207183-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207183-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207183-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207183-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207183-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207183-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207183-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207183-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207183-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207183-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207183-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207183-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207183-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A207183-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207183-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207183-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207183-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A207183-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207183-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A207183-002AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207183-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A207183-002AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207183-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A207183-002AP1bb7c543d1eb4…

Additional Listing Data#

Finished product
Yes
Brand name base
BUPIVACAINE HYDROCHLORIDE injection, solution
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPIVACAINE HYDROCHLORIDE5 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1012404Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
06c15208-c600-7173-e063-6394a90a2f94Available 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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
e3a99641-4540-4894-9108-00cab3c57b7eProduct name120211207
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
5da98533-f072-406b-9e1b-6ac19eca9926Product name120210622
306b993e-3140-4823-ad5e-88b708f9d2acProduct name120210510
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
a831e694-3663-4a83-82be-6c309429f750Product name220200608
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51662-1638-2BUPIVACAINE HYDROCHLORIDE injection, solution50 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION502
51662-1638-2BUPIVACAINE HYDROCHLORIDE injection, solution1 in 1 POUCHINJECTION, SOLUTION12
51662-1638-3BUPIVACAINE HYDROCHLORIDE injection, solution25 in 1 CASEINJECTION, SOLUTION252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1638BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]2Current NDC, 3 package rows20240123_06c15208-c600-7173-e063-6394a90a2f94.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
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEEugia US LLCffecf450-1f01-4721-8e10-2513858526122025-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207183
application number: ANDA207183
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEA-S Medication Solutions1091d4d8-5dad-46e1-8f26-7bc0c5dd833f2024-05-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207183
application number: ANDA207183
BUPIVACAINE HCIBUPIVACAINE HCIHF Acquisition Co LLC, DBA HealthFirste37e1599-db88-2fcd-e053-2995a90a00e52024-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207183
application number: ANDA207183
BUPIVACAINE HYDROCHLORIDE injection, solutionBUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTIONHF Acquisition Co LLC, DBA HealthFirst06c15208-c600-7173-e063-6394a90a2f942024-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207183
application number: ANDA207183
ndc (product): 51662-1638
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEMedical Purchasing Solutions, LLC694926ac-aff0-aa1f-e053-2991aa0a95882023-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207183
application number: ANDA207183
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEMedical Purchasing Solutions, LLCd1642239-4230-b679-e053-2a95a90a3b7c2023-05-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207183
application number: ANDA207183

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1012404BUPivacaine HCl 0.5 % Injectable SolutionPSN06c15208-c600-7173-e063-6394a90a2f942
1012404bupivacaine hydrochloride 5 MG/ML Injectable SolutionSCD06c15208-c600-7173-e063-6394a90a2f942
1012404bupivacaine hydrochloride 0.5 % Injectable SolutionSY06c15208-c600-7173-e063-6394a90a2f942

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51662-1638-25166216380250 mL in 1 VIAL, MULTI-DOSE50 mlHistorical
51662-1638-35166216380325 POUCH in 1 CASE (51662-1638-3) / 1 VIAL, MULTI-DOSE in 1 POUCH (51662-1638-2) / 50 mL in 1 VIAL, MULTI-DOSE25 pouch2023-10-02NoNoCurrent