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 4 of 46 · 915 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium ChlorideSODIUM CHLORIDECardinal Health 107, LLC107af8bc-b6af-4b85-8c8a-ea757dcef1da2026-06-12Adverse reactionsExact identifier
unii: 451W47IQ8X
Jacksons Cell Salts DIGESTIVE BALANCENAT MUR, NAT PHOS, NAT SULPHZettl Health Inc.54018d0e-372f-8afc-e063-6394a90aeb152026-06-11WarningsExact identifier
unii: 451W47IQ8X
GUNA-ALLERGY TAMMONIUM CARBONATE - APIS MELLIFERA - ARSENIC TRIOXIDE - BLATTA ORIENTALIS - CUPRIC ACETATE - DRIMIA MARITIMA BULB - EPINEPHRINE - GALPHIMIA GLAUCA FLOWERING TOP - HISTAMINE DIHYDROCHLORIDE - LUFFA OPERCULATA - MANGANESE GLUCONATE - ONION - SCHOENOCAULON OFFICINALE SEED - SODIUM CHLORIDE - SUS SCROFA ADRENAL GLAND - SUS SCROFA BRONCHUS - SUS SCROFA NASAL MUCOSA -Guna spafddba85e-2bec-468f-a01a-b71a3aeed9d32026-06-10WarningsExact 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, SILICEABM Private Limited53d1c51a-77eb-bb3c-e063-6394a90aab3f2026-06-09WarningsExact identifier
unii: 451W47IQ8X
BM BIO16CALC PHOS, FERR PHOS, KALI PHOS, MAG PHOS, NAT MUR.Total Operations Management LLC DBA:Bestmade Natural Products Micro53d2c34e-fa4d-9240-e063-6294a90a28da2026-06-09WarningsExact identifier
unii: 451W47IQ8X
BM BIO20CALC FLUOR, CALC SULF, KALI SULF, NAT MUR, NAT SULFTotal Operations Management LLC DBA:Bestmade Natural Products Micro53d48847-c0bf-1334-e063-6294a90acf7e2026-06-09WarningsExact identifier
unii: 451W47IQ8X
BM BM68ARGENTUM NIT, BARYTA CARB, DULCAMARA, GELSEMIUM, KALI BROM, NAT MUR, CAUSTICUMBM Private Limited53d52b7e-1e84-d4d3-e063-6294a90a9efc2026-06-09WarningsExact identifier
unii: 451W47IQ8X
ApizelenGERMANIUM METALLICUM, ALFALFA, ARALIA QUINQUEFOLIA, AVENA SATIVA, BETA VULGARIS, CALENDULA OFFICINALIS, CHELIDONIUM MAJUS, ECHINACEA (ANGUSTIFOLIA), NATRUM MURIATICUM, PALOONDO, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, URTICA DIOICA, VISCUM ALBUM, COBALT ACETATE, COBALT GLUCONATE, COPPER GLUCONATE, CUPRUM ACETICUM, GLUTATHIONE, MAGNESIUM GLUCONICUM DIHYDRICUM, GANODERMA LUCIDUM, UBIDECARENONUM, ARGENTUM METALLICUMBioActive Nutritional, Inc.471a7fab-1ef1-4d13-a28e-75f9762a711a2026-06-08WarningsExact identifier
unii: 451W47IQ8X
BM Nat MurNATRIUM MURIATICUMTotal Operations Management LLC DBA:Bestmade Natural Products Micro53baa9ce-5ce6-7bba-e063-6294a90a517a2026-06-08WarningsExact identifier
unii: 451W47IQ8X
BM Nat Mur Icing SugarNATRUM MURIATICUM ICING SUGARTotal Operations Management LLC DBA:Bestmade Natural Products Micro5356d350-1325-7299-e063-6294a90a96a02026-06-03WarningsExact identifier
unii: 451W47IQ8X
PlegisolPOTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, AND MAGNESIUM CHLORIDEHospira, Inc.35a174f0-f0d7-4ec7-3f81-d3d572c059cf2026-05-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
TPN ElectrolytesSODIUM CHLORIDE, CALCIUM CHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, AND SODIUM ACETATE ANHYDROUSHospira, Inc.c00817bc-7b62-4abe-0280-e7930eda3f942026-05-25Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
SALINE CLEANINGSODIUM CHLORIDEGuangzhou Huanmei Cosmetics Co., Ltd.524f07cc-ddb9-dda5-e063-6394a90ac0a52026-05-21WarningsExact identifier
unii: 451W47IQ8X
Ropivacaine HydrochlorideROPIVACAINE HYDROCHLORIDEArmas Pharmaceuticals Inc.3849f5ce-d077-4318-935d-294be69481422026-05-20Warnings, Adverse reactionsExact identifier
rxcui: 1734475
unii: V910P86109
Sodium ChlorideSODIUM CHLORIDEHospira, Inc.a2a964f7-c3ec-4dfb-e3a0-6d8136a803972026-05-19Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Muriaticum acidumHYDROCHLORIC ACIDBoiron8643bc58-bb0e-5c79-e053-2991aa0a02ae2026-05-19WarningsExact identifier
unii: QTT17582CB
HerplexANATHERUM MURICATUM, CLEMATIS ERECTA, MEZEREUM, PHYTOLACCA DECANDRA, RANUNCULUS BULBOSUS, RHUS TOX, THUJA OCCIDENTALIS, NATRUM MURIATICUM, SEPIANashco Products LLCe5e7aa2f-3697-4747-9045-670ea2b135572026-05-14WarningsExact identifier
unii: 451W47IQ8X
NebuClear MDSALINEBlue Echo Care LLC3f85fe62-230f-b0f1-e063-6394a90a5cb82026-05-11WarningsExact identifier
unii: 451W47IQ8X
Acne ReliefBELLADONNA, SILICEA, GRAPHITES, HEPAR SULPHURIS CALCAREUM, KALI BROMATUM, LEDUM PALUSTRE, NATRUM MURIATICUM, SELENIUM, SULPHURNaturalCare487b1373-b78c-4510-964a-6ab0fe781ff42026-05-08WarningsExact identifier
unii: 451W47IQ8X
Migraine ReliefBELLADONNA, BRYONIA (ALBA), CHAMOMILLA, CIMICIFUGA RACEMOSA, COFFEA CRUDA, GLONOINUM, IRIS VERSICOLOR, NATRUM MURIATICUM, PASSIFLORA INCARNATA, VALERIANA OFFICINALISThe Magni Company79b25c52-e145-4ee5-af2e-1ccf6ad5ac2d2026-05-07WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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