NDC 25021-652

ropivacaine hydrochloride

Ropivacaine Hydrochloride

ropivacaine hydrochloride is a Epidural; Infiltration Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Sagent Pharmaceuticals. The primary component is Ropivacaine Hydrochloride.

Product ID25021-652_086afe58-e11d-4ac3-b71d-04ce227e0c60
NDC25021-652
Product TypeHuman Prescription Drug
Proprietary Nameropivacaine hydrochloride
Generic NameRopivacaine Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationEPIDURAL; INFILTRATION
Marketing Start Date2019-07-15
Marketing CategoryANDA / ANDA
Application NumberANDA206166
Labeler NameSagent Pharmaceuticals
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 25021-652-82

10 BAG in 1 CARTON (25021-652-82) > 100 mL in 1 BAG
Marketing Start Date2019-07-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 25021-652-87 [25021065287]

ropivacaine hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA206166
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-07-15

NDC 25021-652-31 [25021065231]

ropivacaine hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA090318
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2014-09-23
Marketing End Date2018-04-30

NDC 25021-652-82 [25021065282]

ropivacaine hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA206166
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-07-15

NDC 25021-652-30 [25021065230]

ropivacaine hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA090318
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2014-09-23
Marketing End Date2019-05-31

Drug Details

Active Ingredients

IngredientStrength
ROPIVACAINE HYDROCHLORIDE5 mg/mL

OpenFDA Data

SPL SET ID:8c5c762f-d266-4b1a-809e-f11bfc89bc2d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1734479
  • 1734347
  • 1734355
    • UPC Code
  • 0325021671825

    • Pharmacological Class

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

    NDC Crossover Matching brand name "ropivacaine hydrochloride" or generic name "Ropivacaine Hydrochloride"

    NDCBrand NameGeneric Name
    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
    70069-062Ropivacaine HydrochlorideRopivacaine Hydrochloride
    70069-064Ropivacaine HydrochlorideRopivacaine Hydrochloride
    70069-066Ropivacaine HydrochlorideRopivacaine Hydrochloride
    70069-065Ropivacaine HydrochlorideRopivacaine Hydrochloride
    70069-061Ropivacaine HydrochlorideRopivacaine Hydrochloride
    70069-067Ropivacaine HydrochlorideRopivacaine Hydrochloride
    70069-063Ropivacaine HydrochlorideRopivacaine Hydrochloride
    55150-196Ropivacaine HydrochlorideRopivacaine Hydrochloride
    55150-199Ropivacaine HydrochlorideRopivacaine Hydrochloride
    55150-195Ropivacaine HydrochlorideRopivacaine Hydrochloride
    55150-197Ropivacaine HydrochlorideRopivacaine Hydrochloride
    55150-201Ropivacaine HydrochlorideRopivacaine Hydrochloride
    55150-200Ropivacaine HydrochlorideRopivacaine Hydrochloride
    55150-198Ropivacaine HydrochlorideRopivacaine Hydrochloride
    67457-878Ropivacaine HydrochlorideRopivacaine Hydrochloride
    67457-876Ropivacaine HydrochlorideRopivacaine Hydrochloride
    67457-877Ropivacaine HydrochlorideRopivacaine Hydrochloride
    67457-875Ropivacaine HydrochlorideRopivacaine Hydrochloride
    0404-9924NAROPINropivacaine hydrochloride
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