FDA.reportPublic FDA data

BUPIVACAINE HYDROCHLORIDE

Product NDC
72603-327
11-digit product format
726030327
Labeler code
72603
Product ID
72603-327_415a95a7-6a83-fcf0-e063-6294a90a266b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BUPIVACAINE HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL
Labeler
NorthStar RxLLC
Application
ANDA217821
Marketing category
ANDA
Marketing start
2024-10-01
Substance
BUPIVACAINE HYDROCHLORIDE
Active strength
2.5 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 HYDROCHLORIDE2.5 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
72603-327-01BUPIVACAINE HYDROCHLORIDE10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION102
72603-327-10BUPIVACAINE HYDROCHLORIDE10 in 1 CARTONINJECTION, SOLUTION102
72603-327-25BUPIVACAINE HYDROCHLORIDE25 in 1 CARTONINJECTION, SOLUTION252

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-327-01ML - Milliliter72603-327c161109a-24dd-471a-a21c-3e62632d4ce012025-02-10
72603-327-10ML - Milliliter72603-327b666ba9e-f486-4669-b2e4-b48a84e5f4a112025-02-10
72603-327-25ML - Milliliter72603-3276b83330e-fde9-4375-9ef4-2c8b0e6c09b012025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-327BUPIVACAINE HYDROCHLORIDE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [NORTHSTAR RXLLC]1Current NDC, 3 package rows20241006_ee3b5bbe-4013-4682-b6ee-db86e7788077.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1725078BUPivacaine HCl 0.25 % in 10 ML InjectionPSNee3b5bbe-4013-4682-b6ee-db86e77880772
1725082BUPivacaine HCl 0.25 % in 30 ML InjectionPSNee3b5bbe-4013-4682-b6ee-db86e77880772
1724880BUPivacaine HCl 0.5 % in 10 ML InjectionPSNee3b5bbe-4013-4682-b6ee-db86e77880772
1724884BUPivacaine HCl 0.5 % in 30 ML InjectionPSNee3b5bbe-4013-4682-b6ee-db86e77880772
1724787BUPivacaine HCl 0.75 % in 10 ML InjectionPSNee3b5bbe-4013-4682-b6ee-db86e77880772
1724786BUPivacaine HCl 0.75 % in 30 ML InjectionPSNee3b5bbe-4013-4682-b6ee-db86e77880772
172507810 ML bupivacaine hydrochloride 2.5 MG/ML InjectionSCDee3b5bbe-4013-4682-b6ee-db86e77880772
172488010 ML bupivacaine hydrochloride 5 MG/ML InjectionSCDee3b5bbe-4013-4682-b6ee-db86e77880772
172478710 ML bupivacaine hydrochloride 7.5 MG/ML InjectionSCDee3b5bbe-4013-4682-b6ee-db86e77880772
172508230 ML bupivacaine hydrochloride 2.5 MG/ML InjectionSCDee3b5bbe-4013-4682-b6ee-db86e77880772
172488430 ML bupivacaine hydrochloride 5 MG/ML InjectionSCDee3b5bbe-4013-4682-b6ee-db86e77880772
172478630 ML bupivacaine hydrochloride 7.5 MG/ML InjectionSCDee3b5bbe-4013-4682-b6ee-db86e77880772
1725078bupivacaine HCl 0.25 % in 10 ML InjectionSYee3b5bbe-4013-4682-b6ee-db86e77880772
1725082bupivacaine HCl 0.25 % per 30 ML InjectionSYee3b5bbe-4013-4682-b6ee-db86e77880772
1724880bupivacaine HCl 0.5 % in 10 ML InjectionSYee3b5bbe-4013-4682-b6ee-db86e77880772
1724884bupivacaine HCl 0.5 % in 30 ML InjectionSYee3b5bbe-4013-4682-b6ee-db86e77880772
1724787bupivacaine HCl 0.75 % in 10 ML InjectionSYee3b5bbe-4013-4682-b6ee-db86e77880772
1724786bupivacaine HCl 0.75 % in 30 ML InjectionSYee3b5bbe-4013-4682-b6ee-db86e77880772
1724786bupivacaine HCl 225 MG per 30 ML InjectionSYee3b5bbe-4013-4682-b6ee-db86e77880772
1724787bupivacaine HCl 75 MG per 10 ML InjectionSYee3b5bbe-4013-4682-b6ee-db86e77880772

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72603-327-017260303270110 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical
72603-327-107260303271010 VIAL, SINGLE-DOSE in 1 CARTON (72603-327-10) / 10 mL in 1 VIAL, SINGLE-DOSE (72603-327-01) 2024-10-01NoNoHistorical
72603-327-257260303272525 VIAL, SINGLE-DOSE in 1 CARTON (72603-327-25) / 10 mL in 1 VIAL, SINGLE-DOSE (72603-327-01) 2024-10-01NoNoHistorical