FDA.reportPublic FDA data

Bupivacaine Hydrochloride

Product NDC
73293-0002
11-digit product format
732930002
Labeler code
73293
Product ID
73293-0002_2e641a0d-4d42-e7cd-e063-6394a90a47d4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupivacaine hydrochloride
Dosage form
INJECTION
Route
SUBARACHNOID
Labeler
Huons Co., Ltd.
Application
ANDA212822
Marketing category
ANDA
Marketing start
2019-12-30
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPIVACAINE HYDROCHLORIDE7.5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7TQO7W3VT8
Rxcui1724784

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
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73293-0002-1Bupivacaine Hydrochloride2 mL in 1 AMPULEINJECTION210
73293-0002-2Bupivacaine Hydrochloride50 in 1 PACKAGEINJECTION5010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73293-0002BUPIVACAINE HYDROCHLORIDE INJECTION [HUONS CO., LTD.]10Current NDC, Legacy NDC, 2 package rows20250221_2dc693df-3218-4a90-b3f7-21e80966a851.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1724784BUPivacaine HCl 0.75 % in 2 ML InjectionPSN2dc693df-3218-4a90-b3f7-21e80966a85110
17247842 ML bupivacaine hydrochloride 7.5 MG/ML InjectionSCD2dc693df-3218-4a90-b3f7-21e80966a85110
1724784bupivacaine HCl 0.75 % per 2 ML InjectionSY2dc693df-3218-4a90-b3f7-21e80966a85110
1724784bupivacaine HCl 15 MG per 2 ML InjectionSY2dc693df-3218-4a90-b3f7-21e80966a85110

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
73293-0002-1732930002012 mL in 1 AMPULE2 mlHistorical
73293-0002-27329300020250 AMPULE in 1 PACKAGE (73293-0002-2) / 2 mL in 1 AMPULE (73293-0002-1) 50 ampule2019-12-300000-00-00NoNoCurrent