FDA.reportPublic FDA data

NDC 72603-415-01 - BUPIVACAINE HYDROCHLORIDE

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
72603-415
Requested NDC
72603-415-01
Package NDCs from labels
72603-415-01, 72603-415-10, 72603-415-25
Manufacturer
NorthStar RxLLC | Aspiro Pharma Limited
Effective date
2026-07-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
BUPIVACAINE HYDROCHLORIDE - NorthStar RxLLC | Aspiro Pharma LimitedNorthStar RxLLC | Aspiro Pharma Limited2026-07-20HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72603-415-01BUPIVACAINE HYDROCHLORIDE30 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION302
72603-415-10BUPIVACAINE HYDROCHLORIDE10 in 1 CARTONINJECTION, SOLUTION102
72603-415-25BUPIVACAINE HYDROCHLORIDE25 in 1 CARTONINJECTION, SOLUTION252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-415BUPIVACAINE HYDROCHLORIDE (BUPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [NORTHSTAR RXLLC]1Current NDC, 3 package rows20241006_ee3b5bbe-4013-4682-b6ee-db86e7788077.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-415-01ML - Milliliter72603-41529d00fad-7285-4122-8a2c-94a72ee1d8cd12025-02-10
72603-415-10ML - Milliliter72603-4159e9e6cd4-db89-476b-8ada-78351c6ec7e612025-02-10
72603-415-25ML - Milliliter72603-4152d8179b7-ac8d-466a-8d27-b40f1554648f12025-02-10

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 3 of 57 · 1,129 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hypertonic Saline Solution Sodium ChlorideSODIUM CHLORIDENAVEH PHARMA (1996) LTD750ea4b1-de2b-4299-aaa2-331daf383d0d2026-07-30WarningsExact identifier
unii: 451W47IQ8X
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
DelflexDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care de Mexico, S.A. de C.V.a98facd6-9daa-4d37-8209-63a0599dbfaa2026-07-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEFresenius Medical Care de Mexico, S.A. de C.V.9a1220fb-6853-45ae-838c-10d8596e1af72026-07-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLCaf5cdf1a-19f4-11e2-892e-0800200c9a662026-07-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
PEG 3350 and ElectrolytesPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDEA-S Medication Solutions19daf830-7270-4661-81b1-ded38f867f282026-07-24Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Whisidom Saline SolutionSODIUM CHLORIDE 0.9% SALINE SOLUTIONJiangxi Yudexi Pharmaceutical Co., LTD4e4e4169-2a14-3466-e063-6394a90a081b2026-07-20WarningsExact identifier
unii: 451W47IQ8X
BUPIVACAINE HYDROCHLORIDEBUPIVACAINE HYDROCHLORIDENorthStar RxLLCee3b5bbe-4013-4682-b6ee-db86e77880772026-07-20Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA217821
ndc (package): 72603-327-01
ndc (package): 72603-800-25
ndc (package): 72603-700-25
ndc (package): 72603-506-10
ndc (package): 72603-506-25
ndc (package): 72603-700-10
ndc (package): 72603-415-10
ndc (package): 72603-327-25
ndc (package): 72603-415-01
ndc (package): 72603-602-25
ndc (package): 72603-327-10
ndc (package): 72603-415-25
ndc (package): 72603-700-01
ndc (package): 72603-800-01
ndc (package): 72603-506-01
ndc (package): 72603-602-01
ndc (product): 72603-506
ndc (product): 72603-700
ndc (product): 72603-602
ndc (product): 72603-800
ndc (product): 72603-327
ndc (product): 72603-415
ndc11 (package): 72603041501
rxcui: 1724880
rxcui: 1724884
rxcui: 1724787
rxcui: 1725078
rxcui: 1725082
rxcui: 1724786
spl id: 570a9a90-b2e1-2db5-e063-6294a90a1bcb
spl set id: ee3b5bbe-4013-4682-b6ee-db86e7788077
unii: 7TQO7W3VT8
SalineNASALBEST CHOICE (VALU MERCHANDISERS COMPANY)71485e82-bf54-4b8b-8dd2-2a07615345202026-07-17WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDELABORATORIOS GRIFOLS SAeb811d79-fdb8-1f1a-c2ad-1cc4bfc7eadf2026-07-15Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
WHWSWB 0.9% SALINESODIUM CHLORIDEYiwu Huanshu E-commerce Co., Ltd5082b773-79b2-2501-e063-6394a90a170f2026-07-11WarningsExact identifier
unii: 451W47IQ8X
SALINE NASALSODIUM CHLORIDEALAINA HEALTHCARE PRIVATE LIMITEDed30a7f9-7132-42da-9bed-63a9b1c80ab22026-07-07WarningsExact identifier
unii: 451W47IQ8X
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a1d07e-0006-0c75-e063-6394a90a7acc2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 1000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a2f4da-bb1e-8ead-e063-6394a90af72e2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Sterile Eyesaline EyewashSTERILE EYESALINE EYEWASHProtective Industrial Products, Inc.55a290e8-8310-8be4-e063-6394a90abdce2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERProtective Industrial Products, Inc.55a261c2-725d-6765-e063-6294a90a32602026-07-02WarningsExact identifier
unii: 059QF0KO0R
RemodulinTREPROSTINILUnited Therapeutics Corporation6c80bb38-e8db-4138-9f0d-dbbf9c6731852026-07-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.