FDA.reportPublic FDA data

Bupivacaine Hydrochloride

Product NDC
83270-166
11-digit product format
832700166
Labeler code
83270
Product ID
83270-166_4ab4435e-7ee9-628a-e063-6294a90ad2b5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Bupivacaine Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL
Labeler
ONESOURCE SPECIALTY PHARMA LIMITED
Application
ANDA091487
Marketing category
ANDA
Marketing start
2026-01-29
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Bupivacaine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUPIVACAINE HYDROCHLORIDE5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7TQO7W3VT8
Rxcui1724786, 1724787, 1724880, 1724884, 1725078, 1725082

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
83270-166-01Bupivacaine Hydrochloride30 mL in 1 VIALINJECTION, SOLUTION301
83270-166-01Bupivacaine Hydrochloride1 in 1 CARTONINJECTION, SOLUTION11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1725078BUPivacaine HCl 0.25 % in 10 ML InjectionPSN5c10e3a1-7806-40c7-afd2-4c420e1418231
1725082BUPivacaine HCl 0.25 % in 30 ML InjectionPSN5c10e3a1-7806-40c7-afd2-4c420e1418231
1724880BUPivacaine HCl 0.5 % in 10 ML InjectionPSN5c10e3a1-7806-40c7-afd2-4c420e1418231
1724884BUPivacaine HCl 0.5 % in 30 ML InjectionPSN5c10e3a1-7806-40c7-afd2-4c420e1418231
1724787BUPivacaine HCl 0.75 % in 10 ML InjectionPSN5c10e3a1-7806-40c7-afd2-4c420e1418231
1724786BUPivacaine HCl 0.75 % in 30 ML InjectionPSN5c10e3a1-7806-40c7-afd2-4c420e1418231
172507810 ML bupivacaine hydrochloride 2.5 MG/ML InjectionSCD5c10e3a1-7806-40c7-afd2-4c420e1418231
172488010 ML bupivacaine hydrochloride 5 MG/ML InjectionSCD5c10e3a1-7806-40c7-afd2-4c420e1418231
172478710 ML bupivacaine hydrochloride 7.5 MG/ML InjectionSCD5c10e3a1-7806-40c7-afd2-4c420e1418231
172508230 ML bupivacaine hydrochloride 2.5 MG/ML InjectionSCD5c10e3a1-7806-40c7-afd2-4c420e1418231
172488430 ML bupivacaine hydrochloride 5 MG/ML InjectionSCD5c10e3a1-7806-40c7-afd2-4c420e1418231
172478630 ML bupivacaine hydrochloride 7.5 MG/ML InjectionSCD5c10e3a1-7806-40c7-afd2-4c420e1418231
1725078bupivacaine HCl 0.25 % in 10 ML InjectionSY5c10e3a1-7806-40c7-afd2-4c420e1418231
1725082bupivacaine HCl 0.25 % per 30 ML InjectionSY5c10e3a1-7806-40c7-afd2-4c420e1418231
1724880bupivacaine HCl 0.5 % in 10 ML InjectionSY5c10e3a1-7806-40c7-afd2-4c420e1418231
1724884bupivacaine HCl 0.5 % in 30 ML InjectionSY5c10e3a1-7806-40c7-afd2-4c420e1418231
1724787bupivacaine HCl 0.75 % in 10 ML InjectionSY5c10e3a1-7806-40c7-afd2-4c420e1418231
1724786bupivacaine HCl 0.75 % in 30 ML InjectionSY5c10e3a1-7806-40c7-afd2-4c420e1418231
1724786bupivacaine HCl 225 MG per 30 ML InjectionSY5c10e3a1-7806-40c7-afd2-4c420e1418231
1724787bupivacaine HCl 75 MG per 10 ML InjectionSY5c10e3a1-7806-40c7-afd2-4c420e1418231

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83270-166-01832700166011 VIAL in 1 CARTON (83270-166-01) / 30 mL in 1 VIAL1 vial2026-01-29NoNoCurrent