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#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 47 · 926 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hypertonic SalineSODIUM CHLORIDENAVEH PHARMA (1996) LTD167c7a9c-1228-4fb2-a89c-d3e1483863232026-07-30WarningsExact identifier
unii: 451W47IQ8X
Hypertonic Saline Solution Sodium ChlorideSODIUM CHLORIDENAVEH PHARMA (1996) LTD750ea4b1-de2b-4299-aaa2-331daf383d0d2026-07-30WarningsExact identifier
unii: 451W47IQ8X
DELFLEXDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLCbbc5b820-4973-11e2-a192-0002a5d5c51b2026-07-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
DELFLEXDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLCc29bdfa0-4976-11e2-939b-0002a5d5c51b2026-07-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
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
DELFLEXDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLC515dcee0-3e34-11e2-a25f-0800200c9a662026-07-27Warnings, 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
NAROPINROPIVACAINE HYDROCHLORIDEHenry Schein, Inc.6a2f1f6d-026f-4f39-aee0-5b75b8eb5c022026-07-22Warnings, Adverse reactionsExact identifier
application number: NDA020533
rxcui: 1734475
rxcui: 1734476
unii: V910P86109
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
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
OHTrust Artifical EyedropSODIUM CHLORIDENanoplus Technology Co., Limited2ea26d96-704b-17bb-e063-6394a90a7e272026-07-01WarningsExact 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