NDC 63323-286

Naropin

Ropivacaine Hydrochloride

Naropin is a Epidural; Infiltration; Perineural Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Ropivacaine Hydrochloride.

Product ID63323-286_0a867cf6-2e82-42c5-9cfc-a481cec305c9
NDC63323-286
Product TypeHuman Prescription Drug
Proprietary NameNaropin
Generic NameRopivacaine Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationEPIDURAL; INFILTRATION; PERINEURAL
Marketing Start Date2009-08-04
Marketing CategoryNDA / NDA
Application NumberNDA020533
Labeler NameFresenius Kabi USA, LLC
Substance NameROPIVACAINE HYDROCHLORIDE
Active Ingredient Strength5 mg/mL
Pharm ClassesAmide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 63323-286-27

25 VIAL, SINGLE-DOSE in 1 CARTON (63323-286-27) > 20 mL in 1 VIAL, SINGLE-DOSE (63323-286-41)
Marketing Start Date2009-08-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63323-286-03 [63323028603]

Naropin INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA020533
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-12-08

NDC 63323-286-00 [63323028600]

Naropin INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA020533
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2010-06-10

NDC 63323-286-27 [63323028627]

Naropin INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA020533
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2009-08-04

NDC 63323-286-37 [63323028637]

Naropin INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA020533
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2009-08-04
Marketing End Date2018-04-27

NDC 63323-286-63 [63323028663]

Naropin INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA020533
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2010-06-10

NDC 63323-286-30 [63323028630]

Naropin INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA020533
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2010-06-16

NDC 63323-286-35 [63323028635]

Naropin INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA020533
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2011-05-31

NDC 63323-286-95 [63323028695]

Naropin INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA020533
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2009-08-04

NDC 63323-286-11 [63323028611]

Naropin INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA020533
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-12-08

NDC 63323-286-09 [63323028609]

Naropin INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA020533
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-12-08

NDC 63323-286-97 [63323028697]

Naropin INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA020533
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-05-31
Marketing End Date2019-12-08

NDC 63323-286-05 [63323028605]

Naropin INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA020533
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-12-08

NDC 63323-286-01 [63323028601]

Naropin INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA020533
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-12-08

NDC 63323-286-38 [63323028638]

Naropin INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA020533
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2009-08-04

NDC 63323-286-23 [63323028623]

Naropin INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA020533
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2011-05-31

NDC 63323-286-33 [63323028633]

Naropin INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA020533
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-12-08

NDC 63323-286-20 [63323028620]

Naropin INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA020533
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2011-05-31

NDC 63323-286-31 [63323028631]

Naropin INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA020533
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2010-06-16

NDC 63323-286-64 [63323028664]

Naropin INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA020533
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-05-31
Marketing End Date2019-12-08

Drug Details

Active Ingredients

IngredientStrength
ROPIVACAINE HYDROCHLORIDE5 mg/mL

OpenFDA Data

SPL SET ID:c6613708-c1f7-4f5c-91a3-ebbc1d7905c6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1996298
  • 1734480
  • 1734481
  • 1734482
  • 1734483
  • 1734484
  • 1996291
  • 1734090
  • 1734479
  • 1734207
  • 1734204
  • 1734347
  • 1734203
  • 1734348
  • 1734475
  • 1734208
  • 1734476
  • 1996297
  • 1996293
  • 1734355
  • 1734356
  • 1734084
  • 1734086
  • 1734091

    • Pharmacological Class

    • Amide Local Anesthetic [EPC]
    • Amides [CS]
    • Local Anesthesia [PE]
    • Amide Local Anesthetic [EPC]
    • Amides [CS]
    • Local Anesthesia [PE]

    NDC Crossover Matching brand name "Naropin" or generic name "Ropivacaine Hydrochloride"

    NDCBrand NameGeneric Name
    0404-9924NAROPINropivacaine hydrochloride
    52584-286NAROPINNAROPIN
    63323-285NaropinNaropin
    63323-286NaropinNaropin
    63323-287NaropinNaropin
    63323-288NaropinNaropin
    0143-9263Ropivacaine HydrochlorideRopivacaine Hydrochloride
    0143-9264Ropivacaine HydrochlorideRopivacaine Hydrochloride
    0143-9265Ropivacaine HydrochlorideRopivacaine Hydrochloride
    0143-9266Ropivacaine HydrochlorideRopivacaine Hydrochloride
    0409-9300Ropivacaine HydrochlorideROPIVACAINE HYDROCHLORIDE
    0409-9301Ropivacaine HydrochlorideROPIVACAINE HYDROCHLORIDE
    0409-9302Ropivacaine HydrochlorideROPIVACAINE HYDROCHLORIDE
    0409-9303Ropivacaine HydrochlorideROPIVACAINE HYDROCHLORIDE
    0781-3140Ropivacaine HydrochlorideRopivacaine Hydrochloride
    0781-3142Ropivacaine HydrochlorideRopivacaine Hydrochloride
    17478-081Ropivacaine HydrochlorideRopivacaine Hydrochloride
    17478-082Ropivacaine HydrochlorideRopivacaine Hydrochloride
    25021-652ropivacaine hydrochlorideropivacaine hydrochloride
    25021-653Ropivacaine Hydrochlorideropivacaine hydrochloride
    25021-671ropivacaine hydrochlorideropivacaine hydrochloride

    Trademark Results [Naropin]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    NAROPIN
    NAROPIN
    78276844 not registered Dead/Abandoned
    AstraZeneca AB
    2003-07-21
    NAROPIN
    NAROPIN
    75229359 2130448 Live/Registered
    FRESENIUS KABI USA, LLC
    1997-01-22
    NAROPIN
    NAROPIN
    75085662 2148189 Live/Registered
    FRESENIUS KABI USA, LLC
    1996-04-09
    NAROPIN
    NAROPIN
    74716292 not registered Dead/Abandoned
    ASTRA AKTIEBOLAG
    1995-08-16
    NAROPIN
    NAROPIN
    74581013 2061834 Dead/Cancelled
    ABRAXIS BIOSCIENCES, INC.
    1994-10-03
    NAROPIN
    NAROPIN
    74157414 not registered Dead/Abandoned
    AKTIEBOLAGET ASTRA
    1991-04-12
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.