FDA.reportPublic FDA data

Bupivacaine hydrochloride

Product NDC
70069-753
11-digit product format
700690753
Labeler code
70069
Product ID
70069-753_2b24af95-6f20-4945-bf8c-742f1d6f2721
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupivacaine hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INFILTRATION; PERINEURAL
Labeler
Somerset Therapeutics, LLC
Application
ANDA217792
Marketing category
ANDA
Marketing start
2023-11-27
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPIVACAINE HYDROCHLORIDE5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7TQO7W3VT8
Rxcui1012396, 1012404

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
70069-753-01Bupivacaine hydrochloride50 mL in 1 VIALINJECTION, SOLUTION504
70069-753-01Bupivacaine hydrochloride1 in 1 CARTONINJECTION, SOLUTION14
70069-753-10Bupivacaine hydrochloride10 in 1 CARTONINJECTION, SOLUTION104
70069-753-10Bupivacaine hydrochloride50 mL in 1 VIALINJECTION, SOLUTION504
70069-753-25Bupivacaine hydrochloride25 in 1 CARTONINJECTION, SOLUTION254
70069-753-25Bupivacaine hydrochloride50 mL in 1 VIALINJECTION, SOLUTION504

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70069-753-01ML - Milliliter70069-7539c216b3b-039c-4850-9a33-b3157c57cf7e12024-07-12
70069-753-10ML - Milliliter70069-75357d4bba8-323c-475f-b890-a53e2e51722b12024-07-12
70069-753-25ML - Milliliter70069-7535cb03865-fe5d-4af9-9a79-3f33149552a312023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70069-753BUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTION [SOMERSET THERAPEUTICS, LLC]4Current NDC, 6 package rows20240621_bcaab86f-20f0-4482-8d73-e29b36dced58.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1012396BUPivacaine HCl 0.25 % Injectable SolutionPSNbcaab86f-20f0-4482-8d73-e29b36dced584
1012404BUPivacaine HCl 0.5 % Injectable SolutionPSNbcaab86f-20f0-4482-8d73-e29b36dced584
1012396bupivacaine hydrochloride 2.5 MG/ML Injectable SolutionSCDbcaab86f-20f0-4482-8d73-e29b36dced584
1012404bupivacaine hydrochloride 5 MG/ML Injectable SolutionSCDbcaab86f-20f0-4482-8d73-e29b36dced584
1012396bupivacaine hydrochloride 0.25 % Injectable SolutionSYbcaab86f-20f0-4482-8d73-e29b36dced584
1012404bupivacaine hydrochloride 0.5 % Injectable SolutionSYbcaab86f-20f0-4482-8d73-e29b36dced584

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70069-753-01700690753011 VIAL in 1 CARTON (70069-753-01) / 50 mL in 1 VIAL1 vial2024-05-29NoNoHistorical
70069-753-107006907531010 VIAL in 1 CARTON (70069-753-10) / 50 mL in 1 VIAL10 vial2024-05-30NoNoHistorical
70069-753-257006907532525 VIAL in 1 CARTON (70069-753-25) / 50 mL in 1 VIAL25 vial2023-11-27NoNoHistorical