NDC 63323-285-01 - 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
63323-285
Requested NDC
63323-285-01
Package NDCs from labels
63323-285-41, 63323-285-28, 63323-285-53, 63323-285-68, 63323-285-59, 63323-285-73, 63323-285-01, 63323-285-10, 63323-285-06, 63323-285-20, 63323-285-03, 63323-285-13, 63323-285-07, 63323-285-23, 63323-285-57, 63323-285-64, 63323-285-51, 63323-285-65, 63323-285-02, 63323-285-61, 63323-285-04, 63323-285-63, 63323-285-55, 63323-285-67
Manufacturer
Fresenius Kabi USA, LLC
Effective date
2024-08-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Naropin - Fresenius Kabi USA, LLCFresenius Kabi USA, LLC2024-08-15HUMAN PRESCRIPTION DRUG LABEL
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 - 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
63323-285-01Naropin10 mL in 1 AMPULEINJECTION, SOLUTION1027
63323-285-02Naropin100 mL in 1 BAGINJECTION, SOLUTION10027
63323-285-03Naropin10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION1027
63323-285-04Naropin200 mL in 1 BAGINJECTION, SOLUTION20027
63323-285-06Naropin20 mL in 1 AMPULEINJECTION, SOLUTION2027
63323-285-07Naropin20 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION2027
63323-285-10Naropin5 in 1 BOXINJECTION, SOLUTION527
63323-285-13Naropin25 in 1 CARTONINJECTION, SOLUTION2527
63323-285-20Naropin5 in 1 BOXINJECTION, SOLUTION527
63323-285-23Naropin25 in 1 CARTONINJECTION, SOLUTION2527
63323-285-51Naropin100 mL in 1 BOTTLEINJECTION, SOLUTION10027
63323-285-57Naropin200 mL in 1 BOTTLEINJECTION, SOLUTION20027
63323-285-61Naropin24 in 1 CASEINJECTION, SOLUTION2427
63323-285-63Naropin24 in 1 CASEINJECTION, SOLUTION2427
63323-285-64Naropin12 in 1 CASEINJECTION, SOLUTION1227
63323-285-65Naropin12 in 1 CASEINJECTION, SOLUTION1227
63323-285-55Naropin100 mL in 1 BOTTLEINJECTION, SOLUTION1008
63323-285-67Naropin12 in 1 CASEINJECTION, SOLUTION128
63323-285-28Naropin25 in 1 CARTONINJECTION, SOLUTION256
63323-285-41Naropin20 mL in 1 VIAL, SINGLE-USEINJECTION, SOLUTION206
63323-285-53Naropin100 mL in 1 BOTTLEINJECTION, SOLUTION1006
63323-285-59Naropin200 mL in 1 BOTTLEINJECTION, SOLUTION2006
63323-285-68Naropin12 in 1 CASEINJECTION, SOLUTION126
63323-285-73Naropin12 in 1 CASEINJECTION, SOLUTION126

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-285NAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]27Current NDC, Legacy NDC, 16 package rows20240814_23d2d448-a744-4877-9f2d-7e57c198da89.zip
63323-285NAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]8Current NDC, Legacy NDC, 2 package rows20240817_c6613708-c1f7-4f5c-91a3-ebbc1d7905c6.zip
63323-285NAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]6Current NDC, Legacy NDC, 6 package rows20240829_dff4a1e4-4b2a-4a64-b6d8-ea470dee88f7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-285-01ML - Milliliter63323-285893d30d3-b6d5-462c-bc51-8cbf1886c25512021-09-07
63323-285-02ML - Milliliter63323-2859bdc252f-940e-4528-8b2b-4da77d9ecc3a12021-09-07
63323-285-03ML - Milliliter63323-285da85634f-61af-4b22-a40e-ba62d9a6edad12024-05-16
63323-285-04ML - Milliliter63323-28581a7042a-f052-49fa-b262-8d24da6883c412025-09-12
63323-285-06ML - Milliliter63323-285d741087a-35e2-410e-b6f6-83dd30872f5712021-10-08
63323-285-07ML - Milliliter63323-28589f2db61-bda6-46e6-b177-6bc7a355a88c12019-12-10
63323-285-10ML - Milliliter63323-285a00fb96b-a729-4e34-9f7c-df4846da95cd12012-07-24
63323-285-13ML - Milliliter63323-28537cc6a92-bef0-483c-b9a3-f4151a5c6ea812013-02-13
63323-285-20ML - Milliliter63323-285ee701e17-d341-42b2-98fd-4132ce75af2912012-07-24
63323-285-23ML - Milliliter63323-28580084105-4a41-47e9-b0eb-642c4886b0ce12013-02-13
63323-285-28ML - Milliliter63323-28500d04aec-77b7-47e9-af8a-c646c87ae74112013-12-02
63323-285-41ML - Milliliter63323-28597920a89-34e5-4b22-96ee-46acd0c8cbc812024-07-12
63323-285-61ML - Milliliter63323-2859ced10cb-e20a-4f51-9c40-0bb690ae40d612014-12-01
63323-285-63ML - Milliliter63323-285bf1577aa-f242-4c8a-af89-6e0799cf40aa12014-12-01
63323-285-64ML - Milliliter63323-2855c072df3-66ab-48c5-b8a2-1466693b4f1712012-07-24
63323-285-65ML - Milliliter63323-285e2abc321-1532-41d0-886c-bf58d34a7d1312012-07-24
63323-285-67ML - Milliliter63323-285782ee9c8-c46c-428f-9158-37e1f61cf8a212012-07-24
63323-285-68ML - Milliliter63323-285e3bc0528-9df1-4dbc-8c8a-81e01f68c8bb12013-12-02
63323-285-73ML - Milliliter63323-28587b770ee-12e2-482b-ba6c-566687bea3e112014-07-02

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, SOLUTION [FRESENIUS KABI USA, LLC]2
ROPIVACAINEACTIVE MOIETY7IO5LYA57NNAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBNAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XNAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32INAROPIN (ROPIVACAINE HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2

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 5 of 46 · 915 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VirilBENZOICUM ACIDUM, CALADIUM SEGUINUM, CHIMAPHILA UMBELLATA, CLEMATIS ERECTA, RHODODENDRON, SABAL SERRULATA, NATRUM MURIATICUM, CORTISONE ACETICUM, HYPOTHALAMUS SUIS, PROSTATE (SUIS), TESTOSTERONE, AGNUS CASTUS, AURUM METALLICUM, BRYONIA (ALBA), CONIUM MACULATUM, LYCOPODIUM CLAVATUM, SELENIUM METALLICUM, SEPIA, THUJA OCCIDENTALIS, KALI ARSENICOSUM, BUFO RANADeseret Biologicals, Inc.3701cc0d-91ed-45fd-98b8-9d8cfba9c7872026-05-06WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDESportpharm LLCa2c111f6-74d5-4a5d-82ac-d0f237488cb82026-04-24Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Ropivacaine HydrochlorideROPIVACAINE HYDROCHLORIDESportpharm LLC56b664ad-03e0-4bf3-8efa-40ce3e8d34982026-04-24Warnings, Adverse reactionsExact identifier
rxcui: 1734475
unii: V910P86109
Ropivacaine HydrochlorideROPIVACAINE HYDROCHLORIDESportpharm LLC7327766c-19f0-4d83-89c6-eb685e0d286c2026-04-24Warnings, Adverse reactionsExact identifier
rxcui: 1734475
unii: V910P86109
Sodium ChlorideSODIUM CHLORIDEMethod Pharmaceuticals, LLC4b08859e-65bd-8255-e063-6394a90af6142026-04-23WarningsExact identifier
unii: 451W47IQ8X
Ropivacaine HydrochlorideROPIVACAINE HYDROCHLORIDEEugia US LLC3763b7b6-da49-4658-b93d-28f5da24d09e2026-04-21Warnings, Adverse reactionsExact identifier
rxcui: 1734090
rxcui: 1734483
rxcui: 1734207
rxcui: 1734475
rxcui: 1734084
rxcui: 1734347
rxcui: 905189
unii: V910P86109
RingersSODIUM CHLORIDE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDEICU Medical, Inc.a926f913-18fa-4a3e-bfd6-210e1e4279602026-04-20Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Cardioforce IIABROTANUM, BOLDO, CIMICIFUGA RACEMOSA, KALI PHOSPHORICUM, TARAXACUM OFFICINALE, CONVALLARIA MAJALIS, MAGNESIA SULPHURICA, OLEANDER, NATRUM MURIATICUM, BELLIS PERENNISBioActive Nutritional, Inc.733bbb26-7698-4a1b-9dc8-7e3490ffc92b2026-04-17WarningsExact identifier
unii: 451W47IQ8X
Thyroid HPBARYTA CARBONICA, CALCAREA CARBONICA, FUCUS VESICULOSUS, IODIUM, NATRUM MURIATICUM, PULSATILLA, SPONGIA TOSTA, THYROIDINUM (SUIS)BioActive Nutritional, Inc.3795820a-cf2a-4094-9a02-70e3757b75102026-04-17WarningsExact identifier
unii: 451W47IQ8X
DIANEAL Low Calcium with DextroseSODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSEVantive US Healthcare LLCaa268d3f-7389-4f25-801f-5d4825495f082026-04-16Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
PEG 3350 and ElectrolytesPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDEWilshire Pharmaceuticals, Inc.b251752d-7750-482a-9364-0acf4ad47cc82026-04-16Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE AND SODIUM CHLORIDEFresenius Kabi USA, LLC99c6a1a9-cadf-435b-a332-ccc189afdfa92026-04-16Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
GoLYTELYPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDEAzurity Pharmaceuticals, Inc.7609ecf7-0ce0-4fbb-9c27-30987f6895752026-04-15Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
TRILYTEPOLYETHYLENE GLYOCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDEAurobindo Pharma Limited79f5e596-8d51-4227-afcc-f5e3411509572026-04-15Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Anxiety ReliefACONITUM NAPELLUS, ARGENTUM NITRICUM, ARSENICUM ALBUM, AURUM METALLICUM, GELSEMIUM SEMPERVIRENS, HYOSCYAMUS NIGER, IGNATIA AMARA, KALI CARBONICUM, MOSCHUS, NATRUM MURIATICUM, PIPER METHYSTICUMNaturalCare9f982e89-655c-49be-85d8-4099a02ed0212026-04-15WarningsExact identifier
unii: 451W47IQ8X
PEG 3350, sodium chloride, sodium bicarbonate and potassium chloridePOLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDEWilshire Pharmaceuticals, Inc.4e442a72-b13b-4869-8a1d-59356095b0912026-04-14Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
SODIUM CHLORIDE 1 GRAMSODIUM CHLORIDEGendose Pharmaceuticals, LLCce988ae5-61c6-4324-90e1-a94c8a54d0d02026-04-13WarningsExact identifier
unii: 451W47IQ8X
Quantum ResonanceALCOHOLUS, ALUMINA SILICATA, ANACARDIUM ORIENTALE, AQUA MARINA, BAPTISIA TINCTORIA, CANDIDA ALBICANS, COLLAGEN, DNA, LAVANDULA OFFICINALIS, MEDULLA OSSIS SUIS, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NUX MOSCHATA, PHOSPHORUS, QUARTZ, SILICEA, TELA ARANEA, VALERIANA OFFICINALIS, VISCUM ALBUMDeseret Biologicals, Inc.f94a10bd-1c40-42c7-b458-b580706145492026-04-10WarningsExact identifier
unii: 451W47IQ8X
Quantum ResonanceALCOHOLUS, ALUMINA SILICATA, ANACARDIUM ORIENTALE, AQUA MARINA, BAPTISIA TINCTORIA, CANDIDA ALBICANS, COLLAGEN, DNA, LAVANDULA OFFICINALIS, MEDULLA OSSIS SUIS, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NUX MOSCHATA, PHOSPHORUS, QUARTZ, SILICEA, TELA ARANEA, VALERIANA OFFICINALIS, VISCUM ALBUMDeseret Biologicals, Inc.1467111a-bef6-473d-b7f2-3309a9bb72ce2026-04-10WarningsExact identifier
unii: 451W47IQ8X
H-Focus FormulaAGNUS CASTUS, AVENA SATIVA, BARYTA CARBONICA, IGNATIA AMARA, LYCOPODIUM CLAVATUM, NATRUM CARBONICUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, SILICEA, ZINCUM METALLICUMHealing Natural Oils LLC4ee42911-3064-7f55-e063-6294a90abcc72026-04-07WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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