NDC 63323-288-01 - 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
63323-288
Requested NDC
63323-288-01
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 3 of 46 · 915 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Whisidom Saline SolutionSODIUM CHLORIDE 0.9% SALINE SOLUTIONJiangxi Yudexi Pharmaceutical Co., LTD4e4e4169-2a14-3466-e063-6394a90a081b2026-07-20WarningsExact identifier
unii: 451W47IQ8X
SalineNASALBEST CHOICE (VALU MERCHANDISERS COMPANY)71485e82-bf54-4b8b-8dd2-2a07615345202026-07-17WarningsExact identifier
unii: 451W47IQ8X
NaropinROPIVACAINE HYDROCHLORIDEFresenius Kabi USA, LLCcb6583ff-cde4-4280-aa5b-0bea2b8447922026-07-17Warnings, Adverse reactionsExact identifier
application number: NDA020533
ndc (product): 63323-286
rxcui: 1734484
rxcui: 1734480
rxcui: 1734479
rxcui: 1734481
rxcui: 1734483
rxcui: 1734482
rxcui: 1734475
rxcui: 1734476
spl id: cb6583ff-cde4-4280-aa5b-0bea2b844792
spl set id: cb6583ff-cde4-4280-aa5b-0bea2b844792
unii: V910P86109
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
The Cell Salt Co. Daily Blend 12 in 1CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEAThe Cell Salt Company LLC55826f59-acf4-7370-e063-6394a90afed72026-07-01WarningsExact identifier
unii: 451W47IQ8X
NebuClear MD SalineNEBUCLEAR MD SALINEBlue Echo Care LLC55820ff9-7b4b-2bce-e063-6394a90a8b432026-06-30WarningsExact identifier
unii: 451W47IQ8X
NebuClear MD SalineNEBUCLEAR MD SALINEBlue Echo Care LLC55806cb8-cf92-c4e5-e063-6394a90aaa2d2026-06-30WarningsExact identifier
unii: 451W47IQ8X
NebuClear MD SalineNEBUCLEAR MD SALINEBlue Echo Care LLC5581d8e5-4105-e9da-e063-6394a90a316e2026-06-30WarningsExact identifier
unii: 451W47IQ8X
MCAS SupportAPIS MELLIFICA, ANTIMONIUM CRUDUM, ASCORBICUM ACIDUM, BOVISTA, CARBOLICUM ACIDUM, CHAMOMILLA, CORTISONE ACETICUM, GINKGO BILOBA, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, NATRUM MURIATICUM, QUERCETIN, RHUS TOX, SCUTELLARIA LATERIFLORA, STOMACH (SUIS), URTICA URENSDeseret Biologicals, Inc.af3d5f8f-6f24-4045-8730-c776ff54bcc42026-06-24WarningsExact identifier
unii: 451W47IQ8X
0.9% Sodium Chloride Saline SolutionSODIUM CHLORIDEYunqi Cosmetics (Shenzhen) Co., Ltd546af257-dbd1-11fc-e063-6394a90a8e0a2026-06-16WarningsExact identifier
unii: 451W47IQ8X
BM BM68 DROPSARGENTUM NIT, BARYTA CARB., DULCAMARA, GELSEMIUM, KALI BROM, NAT MUR, CAUSTICUMBM Private Limited53f9c99a-0f20-0358-e063-6394a90af4e02026-06-15WarningsExact identifier
unii: 451W47IQ8X
BM BM68ARGENTUM NIT, BARYTA CARB, DULCAMARA, GELSEMIUM, KALI BROM, NAT MUR, CAUSTICUMTotal Operations Management LLC DBA:Bestmade Natural Products Micro5448c76a-2ecb-9402-e063-6294a90a6ad72026-06-15WarningsExact identifier
unii: 451W47IQ8X
BM BIO28 ALCOHOLCALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro544b66c4-49df-556f-e063-6394a90af3ed2026-06-15WarningsExact identifier
unii: 451W47IQ8X
Male SupportAGNUS CASTUS, AURUM METALLICUM, BENZOICUM ACIDUM, BRYONIA (ALBA), BUFO RANA, CALADIUM SEGUINUM, CHIMAPHILA UMBELLATA, CLEMATIS ERECTA, CONIUM MACULATUM, CORTISONE ACETICUM, HYPOTHALAMUS SUIS, KALI ARSENICOSUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PROSTATE (SUIS), RHODODENDRON CHRYSANTHUM, SABAL SERRULATA, SELENIUM METALLICUM, SEPIA, TESTOSTERONE, THUJA OCCIDENTALISDeseret Biologicals, Inc.29cefc89-3bb6-484e-84ab-116b5827a4c32026-06-15WarningsExact identifier
unii: 451W47IQ8X
BM BM182 DROPSHEPAR SULF, GRAPHITES, MERC SOL, MURIATIC ACIDTotal Operations Management LLC DBA:Bestmade Natural Products Micro5423bde6-3e31-38b0-e063-6294a90afb2d2026-06-13WarningsExact identifier
unii: QTT17582CB
BM BM182 DROPSHEPAR SULF, GRAPHITES, MERC SOL, MURIATIC ACIDBM Private Limited540d11e3-e4a1-0ca2-e063-6394a90a3c262026-06-12WarningsExact identifier
unii: QTT17582CB
BM BM68 DROPSARGENTUM NIT, BARYTA CARB., DULCAMARA, GELSEMIUM, KALI BROM, NAT MUR, CAUSTICUMTotal Operations Management LLC DBA:Bestmade Natural Products Micro5410ec88-8c65-3b26-e063-6294a90adf072026-06-12WarningsExact identifier
unii: 451W47IQ8X
V HPANAS BARBARIAE, HEPATIS ET CORDIS EXTRACTUM, ARSENICUM ALBUM, BELLADONNA, BRYONIA (ALBA), CARCINOSIN, ECHINACEA (ANGUSTIFOLIA), EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PYROGENIUM, RHUS TOX, SULPHUREnergique, Inc.ea12ca3b-19e0-4d4a-9514-4d28d214e1e72026-06-12WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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