NDC 63323-288

Naropin

Ropivacaine Hydrochloride

Naropin is a Epidural 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 ID63323-288_1f70dfce-5103-465e-b276-1cb838c70637
NDC63323-288
Product TypeHuman Prescription Drug
Proprietary NameNaropin
Generic NameRopivacaine Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationEPIDURAL
Marketing Start Date1996-09-24
Marketing CategoryNDA / NDA
Application NumberNDA020533
Labeler NameFresenius Kabi USA, LLC
Substance NameROPIVACAINE HYDROCHLORIDE
Active Ingredient Strength10 mg/mL
Pharm ClassesAmide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 63323-288-27

5 AMPULE in 1 BOX (63323-288-27) > 20 mL in 1 AMPULE (63323-288-25)
Marketing Start Date2009-08-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63323-288-06 [63323028806]

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

NDC 63323-288-11 [63323028811]

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

NDC 63323-288-01 [63323028801]

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

NDC 63323-288-27 [63323028827]

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

NDC 63323-288-20 [63323028820]

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

NDC 63323-288-03 [63323028803]

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

NDC 63323-288-25 [63323028825]

Naropin INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA020533
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-03-03

NDC 63323-288-21 [63323028821]

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

NDC 63323-288-10 [63323028810]

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

NDC 63323-288-07 [63323028807]

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

NDC 63323-288-29 [63323028829]

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

Drug Details

Active Ingredients

IngredientStrength
ROPIVACAINE HYDROCHLORIDE10 mg/mL

OpenFDA Data

SPL SET ID:23d2d448-a744-4877-9f2d-7e57c198da89
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1996298
  • 1734480
  • 1734481
  • 1734482
  • 1734483
  • 1734484
  • 1996291
  • 1734090
  • 1734479
  • 1734207
  • 1734204
  • 1734347
  • 1734203
  • 1734348
  • 1734475
  • 905191
  • 1734208
  • 1734476
  • 1996297
  • 1996293
  • 905189
  • 1734355
  • 1734356
  • 1734084
  • 1734086
  • 1734091

    • Pharmacological Class

    • 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
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