NDC 13985-611

Proparacaine Hydrochloride

Proparacaine Hydrochloride

Proparacaine Hydrochloride is a Ophthalmic Solution/ Drops in the Human Prescription Drug category. It is labeled and distributed by Mwi. The primary component is Proparacaine Hydrochloride.

Product ID13985-611_0b2e3681-4ed3-44b6-9087-1ec7ccfe160c
NDC13985-611
Product TypeHuman Prescription Drug
Proprietary NameProparacaine Hydrochloride
Generic NameProparacaine Hydrochloride
Dosage FormSolution/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date2015-03-27
Marketing CategoryANDA / ANDA
Application NumberANDA040277
Labeler NameMWI
Substance NamePROPARACAINE HYDROCHLORIDE
Active Ingredient Strength5 mg/mL
Pharm ClassesLocal Anesthesia [PE],Local Anesthetic [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 13985-611-15

1 BOTTLE, DROPPER in 1 CARTON (13985-611-15) > 15 mL in 1 BOTTLE, DROPPER
Marketing Start Date2015-03-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 13985-611-15 [13985061115]

Proparacaine Hydrochloride SOLUTION/ DROPS
Marketing CategoryANDA
Application NumberANDA040277
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-03-27

Drug Details

Active Ingredients

IngredientStrength
PROPARACAINE HYDROCHLORIDE5 mg/mL

OpenFDA Data

SPL SET ID:66e8723a-620c-42ed-a43e-cfa30014e1dc
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1191013
  • UPC Code
  • 0313985012600
  • Pharmacological Class

    • Local Anesthesia [PE]
    • Local Anesthetic [EPC]
    • Local Anesthesia [PE]
    • Local Anesthetic [EPC]

    NDC Crossover Matching brand name "Proparacaine Hydrochloride" or generic name "Proparacaine Hydrochloride"

    NDCBrand NameGeneric Name
    0404-7199Proparacaine HydrochlorideProparacaine Hydrochloride
    13985-611Proparacaine HydrochlorideProparacaine Hydrochloride
    17478-263Proparacaine HydrochlorideProparacaine Hydrochloride
    21695-530Proparacaine HydrochlorideProparacaine Hydrochloride
    24208-730Proparacaine HydrochlorideProparacaine Hydrochloride
    50090-0259Proparacaine HydrochlorideProparacaine Hydrochloride
    50090-1923Proparacaine HydrochlorideProparacaine Hydrochloride
    50090-1931Proparacaine HydrochlorideProparacaine Hydrochloride
    52959-705Proparacaine HydrochlorideProparacaine Hydrochloride
    61314-016Proparacaine HydrochlorideProparacaine Hydrochloride
    68071-1332Proparacaine HydrochlorideProparacaine Hydrochloride
    68071-4368Proparacaine HydrochlorideProparacaine Hydrochloride
    68071-4701Proparacaine HydrochlorideProparacaine Hydrochloride
    68071-5139proparacaine hydrochlorideproparacaine hydrochloride
    68788-0736Proparacaine HydrochlorideProparacaine Hydrochloride
    70518-2056Proparacaine HydrochlorideProparacaine Hydrochloride
    70518-3408Proparacaine HydrochlorideProparacaine Hydrochloride
    0998-0016Alcaineproparacaine hydrochloride

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.