FDA.reportPublic FDA data

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

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 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
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

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 vial2023-06-01NoNoHistorical