63323-285 NDC - NAROPIN (ROPIVACAINE HYDROCHLORIDE)

Drug Information

Product NDC: 63323-285

Proprietary Name: Naropin

Non Proprietary Name: ROPIVACAINE HYDROCHLORIDE

Active Ingredient(s):
  • 2 mg/mL ROPIVACAINE HYDROCHLORIDE


Administration Route(s): EPIDURAL; INFILTRATION

Dosage Form(s): INJECTION, SOLUTION

Pharmacy Class(es):
  • Amide Local Anesthetic [EPC];
  • Amides [CS];
  • Local Anesthesia [PE]

Labeler Information

Labeler Name: Fresenius Kabi USA, LLC
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA020533
Marketing Category: NDA
Start Marketing Date:9/24/1996

Package Information

No. Package Code Package Description Billing Unit
163323-285-105 AMPULE in 1 BOX (63323-285-10) > 10 mL in 1 AMPULE (63323-285-01)ML
263323-285-1325 VIAL, SINGLE-DOSE in 1 CARTON (63323-285-13) > 10 mL in 1 VIAL, SINGLE-DOSE (63323-285-03)ML
363323-285-205 AMPULE in 1 BOX (63323-285-20) > 20 mL in 1 AMPULE (63323-285-06)ML
463323-285-2325 VIAL, SINGLE-DOSE in 1 CARTON (63323-285-23) > 20 mL in 1 VIAL, SINGLE-DOSE (63323-285-07)ML
563323-285-2825 VIAL, SINGLE-USE in 1 CARTON (63323-285-28) > 20 mL in 1 VIAL, SINGLE-USE (63323-285-41)ML
663323-285-6124 BAG in 1 CASE (63323-285-61) > 100 mL in 1 BAG (63323-285-02)ML
763323-285-6324 BAG in 1 CASE (63323-285-63) > 200 mL in 1 BAG (63323-285-04)ML
863323-285-6412 BOTTLE in 1 CASE (63323-285-64) > 200 mL in 1 BOTTLE (63323-285-57)ML
963323-285-6512 BOTTLE in 1 CASE (63323-285-65) > 100 mL in 1 BOTTLE (63323-285-51)ML
1063323-285-6712 BOTTLE in 1 CASE (63323-285-67) > 100 mL in 1 BOTTLE (63323-285-55)ML
1163323-285-6812 BOTTLE in 1 CASE (63323-285-68) > 100 mL in 1 BOTTLE (63323-285-53)ML
1263323-285-7312 BOTTLE in 1 CASE (63323-285-73) > 200 mL in 1 BOTTLE (63323-285-59)ML

NDC Record

Field Name Field Value Definition
PRODUCT NDC63323-285The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMENaropinThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEROPIVACAINE HYDROCHLORIDEThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEINJECTION, SOLUTIONThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEEPIDURAL; INFILTRATIONThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE8/4/2009This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMENDAProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERNDA020533This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMEFresenius Kabi USA, LLCName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEROPIVACAINE HYDROCHLORIDEThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH2 
ACTIVE INGRED UNITmg/mL 
PHARM CLASSESAmide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE] 
PRODUCT NDC63323-285The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMENaropinThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEROPIVACAINE HYDROCHLORIDEThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEINJECTION, SOLUTIONThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEEPIDURAL; INFILTRATIONThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE8/4/2009This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMENDAProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERNDA020533This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMEFresenius Kabi USA, LLCName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEROPIVACAINE HYDROCHLORIDEThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH2 
ACTIVE INGRED UNITmg/mL 
PHARM CLASSESAmide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE] 
PRODUCT NDC63323-285The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMENaropinThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEROPIVACAINE HYDROCHLORIDEThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEINJECTION, SOLUTIONThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEEPIDURAL; INFILTRATIONThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE9/24/1996This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMENDAProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERNDA020533This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMEFresenius Kabi USA, LLCName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEROPIVACAINE HYDROCHLORIDEThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH2 
ACTIVE INGRED UNITmg/mL 
PHARM CLASSESAmide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE] 

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This page was last updated on: 7/26/2021