NDC 63323-288-25 - Naropin

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
63323-288
Requested NDC
63323-288-25
Package NDCs from labels
63323-288-01, 63323-288-10, 63323-288-06, 63323-288-20, 63323-288-03, 63323-288-11, 63323-288-07, 63323-288-21, 63323-288-23, 63323-288-29, 63323-288-25, 63323-288-27
Manufacturer
Fresenius Kabi USA, LLC | Fresenius Kabi Austria | HP Halden Pharma AS
Effective date
2024-08-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Naropin - Fresenius Kabi USA, LLC | Fresenius Kabi Austria | HP Halden Pharma ASFresenius Kabi USA, LLC | Fresenius Kabi Austria | HP Halden Pharma AS2024-08-06HUMAN PRESCRIPTION DRUG LABEL
Naropin - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2024-07-10HUMAN PRESCRIPTION DRUG LABEL
Naropin - Fresenius Kabi USA, LLC | HP Halden Pharma ASFresenius Kabi USA, LLC | HP Halden Pharma AS2024-05-22HUMAN PRESCRIPTION DRUG LABEL
Naropin - APP Pharmaceuticals, LLC | Fresenius Kabi Norge ASAPP Pharmaceuticals, LLC | Fresenius Kabi Norge AS2011-09-15HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-288-01Naropin10 mL in 1 AMPULEINJECTION, SOLUTION1027
63323-288-03Naropin10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION1027
63323-288-06Naropin20 mL in 1 AMPULEINJECTION, SOLUTION2027
63323-288-07Naropin20 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION2027
63323-288-10Naropin5 in 1 BOXINJECTION, SOLUTION527
63323-288-11Naropin25 in 1 CARTONINJECTION, SOLUTION2527
63323-288-20Naropin5 in 1 BOXINJECTION, SOLUTION527
63323-288-21Naropin25 in 1 CARTONINJECTION, SOLUTION2527
63323-288-23Naropin20 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION208
63323-288-29Naropin25 in 1 TRAYINJECTION, SOLUTION258
63323-288-25Naropin20 mL in 1 AMPULEINJECTION, SOLUTION205
63323-288-27Naropin5 in 1 BOXINJECTION, SOLUTION55

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-288NAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]27Current NDC, Legacy NDC, 8 package rows20240814_23d2d448-a744-4877-9f2d-7e57c198da89.zip
63323-288NAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]8Current NDC, Legacy NDC, 2 package rows20240817_c6613708-c1f7-4f5c-91a3-ebbc1d7905c6.zip
63323-288NAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]5Current NDC, Legacy NDC, 2 package rows20240524_56dfabf7-f7a8-4601-b17a-cb16fb995b0f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-288-01ML - Milliliter63323-28899d30a29-0827-4f56-871e-74fff2b21d2a12025-09-12
63323-288-06ML - Milliliter63323-2880b27ce34-0c40-470b-baa5-cd6d736138a912021-06-02
63323-288-07ML - Milliliter63323-288e450eecd-0e8b-4c29-8b4e-70132736db5612024-08-12
63323-288-10ML - Milliliter63323-2883332880c-79cc-46fc-b3fe-0d5e98caedb912012-07-24
63323-288-11ML - Milliliter63323-288cfbf6146-ab02-4290-b393-9e6cf57f0bdb12013-02-13
63323-288-20ML - Milliliter63323-288d1bf23e5-a796-4fd1-be7d-d04e794afc0212012-07-24
63323-288-21ML - Milliliter63323-28828b72b1c-78b4-463a-baf5-f1249b7071d812013-02-13
63323-288-23ML - Milliliter63323-28857c7d0ae-4b9d-4fa9-a9b4-015794be2d2012024-07-12
63323-288-27ML - Milliliter63323-28867d56f56-df1f-4127-896a-1e29cb3fd63f12014-04-03
63323-288-29ML - Milliliter63323-288f2b1e7d0-d777-41f2-a2a2-b4a33d62a09612014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ROPIVACAINE HYDROCHLORIDEACTIVE INGREDIENTV910P86109NAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]14
ROPIVACAINEACTIVE MOIETY7IO5LYA57NNAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]14
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBNAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]14
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XNAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]14
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32INAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]14
ROPIVACAINE HYDROCHLORIDEACTIVE INGREDIENTV910P86109NAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]4
ROPIVACAINEACTIVE MOIETY7IO5LYA57NNAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]4
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBNAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]4
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XNAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]4
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32INAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]4
ROPIVACAINE HYDROCHLORIDEACTIVE INGREDIENTV910P86109NAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]3
ROPIVACAINEACTIVE MOIETY7IO5LYA57NNAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]3
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBNAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]3
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XNAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]3
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32INAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]3
ROPIVACAINE HYDROCHLORIDEACTIVE INGREDIENTV910P86109NAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION [FRESENIUS KABI USA, LLC]1
ROPIVACAINEACTIVE MOIETY7IO5LYA57NNAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION [FRESENIUS KABI USA, LLC]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBNAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION [FRESENIUS KABI USA, LLC]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XNAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION [FRESENIUS KABI USA, LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32INAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION [FRESENIUS KABI USA, LLC]1

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 1 of 47 · 925 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lymph Tonic IIECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANABioActive Nutritional, Inc.0e3265b0-b210-4a4c-80d2-8a9712981d4e2026-09-17WarningsExact identifier
unii: 451W47IQ8X
SalineNASALRaritan Pharmaceuiticals Inc4b178e4e-a10f-4b75-8140-1f7548e203ad2026-09-09WarningsExact identifier
unii: 451W47IQ8X
Thyroid SupportCALCAREA CARBONICA, CALCAREA IODATA, CAUSTICUM, FERRUM IODATUM, FUCUS VESICULOSUS, KALI IODATUM, NATRUM MURIATICUM, THYROIDINUM (BOVINE)NaturalCare07b4e0ed-2b00-4d0a-ad8f-fc6deff153252026-09-08WarningsExact identifier
unii: 451W47IQ8X
Psoriasis ControlCENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature2db33771-0bb9-49f8-84fa-dddc28e4ba262026-09-04WarningsExact identifier
unii: 451W47IQ8X
KROGER SalineNASALKROGER COMPANYc84b242b-f46e-4ea8-a3c1-109a476446462026-09-02WarningsExact identifier
unii: 451W47IQ8X
Adrenal SupportADRENALINUM, ARGENTUM NITRICUM, BERBERIS VULGARIS, NATRUM MURIATICUM, OLEUM MORRHUAE, PETROLEUM, VANADIUMNaturalCare31a5d522-15cd-432a-bf87-f721bcbe2e312026-09-02WarningsExact identifier
unii: 451W47IQ8X
Xtreme Saline Rinse MixSODIUM BICARBONATE, SODIUM CHLORIDEXtreme Personal Care Inc776f417e-e443-4918-8c7a-1913b7dddcd42026-09-01WarningsExact identifier
unii: 451W47IQ8X
Nacl 0.9% Normal Saline SolutionSODIUM CHLORIDECHI FUNG TECHNOLOGY COMPANY5a53c4c8-c9de-700c-e063-6394a90a3ab52026-08-31WarningsExact identifier
unii: 451W47IQ8X
BMNP Nat MurNATRUM MURIATICUMTotal Operations Management LLC DBA:Bestmade Natural Products Micro5a57ccfd-ab6f-cb2c-e063-6394a90ae9e62026-08-31WarningsExact identifier
unii: 451W47IQ8X
Allergy CareADRENALINUM, RAGWEED, POLLEN (AMBROSIA ARTEMISIAEFOLIA), APIS MELLIFICA, ECHINACEA (ANGUSTIFOLIA), HISTAMINUM HYDROCHLORICUM, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, SULPHURNaturalCaref3ca7f5a-1448-4670-ac02-b47ffb6c55852026-08-27WarningsExact identifier
unii: 451W47IQ8X
SalineSALINE NASAL SPRAYDynarex Corporation3247ae7d-554f-baab-e063-6294a90aa3ec2026-08-25WarningsExact identifier
unii: 451W47IQ8X
Electrolyte PlusKALI MURIATICUM, L-ARGININE, L-CARNITINE, L-LEUCINE, L-ORNITHINE, L-VALINE, MAGNESIA MURIATICA, ASCORBICUM ACIDUM, BORAX, CHROMIUM OXYDATUM, FERRUM MURIATICUM, KALI CARBONICUM, MAGNESIUM GLUCONICUM DIHYDRICUM, NATRUM MURIATICUM, ZINCUM GLUCONICUM, CUPRUM METALLICUM, KALI PHOSPHORICUM, NICCOLUM METALLICUM, SELENIUM METALLICUM, VANADIUM METALLICUM, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, MANGANUM CARBONICUMDeseret Biologicals, Inc.e3564733-8b88-4753-9077-9d74004d8ec92026-08-25WarningsExact identifier
unii: 451W47IQ8X
Aging Eye FormulaCINERARIA MARITIMA, EYE (SUIS), CALCAREA FLUORICA, CAUSTICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUM, GERMANIUM METALLICUM, NATRUM MURIATICUMNutritional Specialties, Inc.d5b44f79-5299-4b31-ba45-0e511cdbe17c2026-08-24WarningsExact identifier
unii: 451W47IQ8X
Bio Combination 28SCHUESSLER SALTSLDD Bioscience Private Limited597caf33-5107-9dec-e063-6294a90a5fcd2026-08-20WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEYYBA CORP597f3347-647c-3545-e063-6294a90abab22026-08-20WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEFresenius Kabi USA, LLC2e5fe9f4-78e5-4af4-8bf9-9680e5dc5e882026-08-20Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sinusforce-HPARSENICUM ALBUM, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SEPIABioActive Nutritional, Inc.53c96680-210b-4426-8b41-3b9a882848dd2026-08-20WarningsExact identifier
unii: 451W47IQ8X
CVS SalineNASALCVS PHARMACYf02c41b0-c78e-41cd-aa4a-2756bbe920872026-08-19WarningsExact identifier
unii: 451W47IQ8X
Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE AND SODIUM CHLORIDEFresenius Kabi USA, LLCdf18a603-ca12-4b26-83b5-9dd07b6453ab2026-08-18Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
DELFLEXDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLCbbc5b820-4973-11e2-a192-0002a5d5c51b2026-08-18Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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