NDC 68382-418

OXYMETAZOLINE HYDROCHLORIDE

Oxymetazoline Hydrochloride

OXYMETAZOLINE HYDROCHLORIDE is a Nasal Spray, Metered in the Human Otc Drug category. It is labeled and distributed by Zydus Pharmaceuticals (usa) Inc.. The primary component is Oxymetazoline Hydrochloride.

Product ID68382-418_f98fc905-f9bc-4237-b193-e5be2977df46
NDC68382-418
Product TypeHuman Otc Drug
Proprietary NameOXYMETAZOLINE HYDROCHLORIDE
Generic NameOxymetazoline Hydrochloride
Dosage FormSpray, Metered
Route of AdministrationNASAL
Marketing Start Date2009-09-24
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart341
Labeler NameZydus Pharmaceuticals (USA) Inc.
Substance NameOXYMETAZOLINE HYDROCHLORIDE
Active Ingredient Strength1 mg/mL
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 68382-418-07

1 INHALER in 1 CARTON (68382-418-07) > 22 mL in 1 INHALER
Marketing Start Date2009-09-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68382-418-07 [68382041807]

OXYMETAZOLINE HYDROCHLORIDE SPRAY, METERED
Marketing CategoryOTC monograph not final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2009-09-24
Inactivation Date2019-10-29

Drug Details

Active Ingredients

IngredientStrength
OXYMETAZOLINE HYDROCHLORIDE.5 mg/mL

OpenFDA Data

SPL SET ID:d3ecb8ca-1e02-4dbe-8858-e801b76809e4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1000990
    • UPC Code
  • 0368382418074

    • NDC Crossover Matching brand name "OXYMETAZOLINE HYDROCHLORIDE" or generic name "Oxymetazoline Hydrochloride"

    NDCBrand NameGeneric Name
    68382-418OXYMETAZOLINE HYDROCHLORIDEOXYMETAZOLINE HYDROCHLORIDE
    21695-875OXYMETAZOLINE HYDROCHLORIDEOXYMETAZOLINE HYDROCHLORIDE
    64762-865Oxymetazoline HydrochlorideOxymetazoline Hydrochloride
    64762-864Oxymetazoline HydrochlorideOxymetazoline Hydrochloride
    65841-711OXYMETAZOLINE HYDROCHLORIDEOXYMETAZOLINE HYDROCHLORIDE
    10202-3047 Select Nasaloxymetazoline hydrochloride
    10202-8497 Select Original NasalOxymetazoline Hydrochloride
    11523-1159AfrinOxymetazoline hydrochloride
    11523-0073Afrin Allergy Sinus Nasaloxymetazoline hydrochloride
    11523-1160Afrin No Drip Nightoxymetazoline hydrochloride
    11523-0034Afrin NoDrip Allergy Sinus Nightoxymetazoline hydrochloride
    0363-0304Anefrin Nasaloxymetazoline hydrochloride
    0113-7388basic care nasalOxymetazoline Hydrochloride
    0113-7494basic care no drip nasalOxymetazoline hydrochloride
    11523-0091Children Afrin Extra Moisturizing Stuffy Nose Pump MistOxymetazoline hydrochloride
    11523-0090Children Afrin No Drip Extra Moisturizing Stuffy Nose Pump MistOxymetazoline hydrochloride
    0573-1191DRISTAN 12 HRoxymetazoline hydrochloride
    0113-0304Good Sense Nasaloxymetazoline hydrochloride
    0113-0817Good Sense Nasaloxymetazoline hydrochloride
    0113-2304Nasaloxymetazoline hydrochloride
    0904-5711NasalOxymetazoline Hydrochloride
    0536-5005Nasal ReliefOxymetazoline Hydrochloride
    0363-7007No Drip Anefrin NasalOXYMETAZOLINE HYDROCHLORIDE
    0023-5300RHOFADEOxymetazoline Hydrochloride
    0363-2021Severe AnefrinOXYMETAZOLINE HYDROCHLORIDE
    0363-7009Severe Sinus Relief Mistoxymetazoline hydrochloride
    10237-464Zicam Extreme Congestion Reliefoxymetazoline hydrochloride
    10237-471Zicam Intense Sinus Reliefoxymetazoline hydrochloride
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