NDC 68071-5149

Racepinephrine

Racepinephrine Hydrochloride

Racepinephrine is a Respiratory (inhalation) Solution in the Human Otc Drug category. It is labeled and distributed by Nucare Pharmaceuticals,inc.. The primary component is Racepinephrine Hydrochloride.

Product ID68071-5149_9c496655-8a6b-47e2-e053-2a95a90a7f01
NDC68071-5149
Product TypeHuman Otc Drug
Proprietary NameRacepinephrine
Generic NameRacepinephrine Hydrochloride
Dosage FormSolution
Route of AdministrationRESPIRATORY (INHALATION)
Marketing Start Date2000-01-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameNuCare Pharmaceuticals,Inc.
Substance NameRACEPINEPHRINE HYDROCHLORIDE
Active Ingredient Strength11 mg/.5mL
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 68071-5149-3

.5 mL in 1 VIAL, SINGLE-USE (68071-5149-3)
Marketing Start Date2020-01-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68071-5149-3 [68071514903]

Racepinephrine SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2020-01-16

Drug Details

Active Ingredients

IngredientStrength
RACEPINEPHRINE HYDROCHLORIDE11.25 mg/.5mL

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

NDCBrand NameGeneric Name
68071-5149Racepinephrineracepinephrine hydrochloride
0487-2784Asthmanefrinracepinephrine hydrochloride
15343-125Epi-MistRACEPINEPHRINE HYDROCHLORIDE
0487-5901S2racepinephrine hydrochloride
55154-4352S2racepinephrine hydrochloride
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.