NDC 15343-125

Epi-Mist

Racepinephrine Hydrochloride

Epi-Mist is a Respiratory (inhalation) Aerosol, Spray in the Human Otc Drug category. It is labeled and distributed by Drnaturalhealing Inc. The primary component is Racepinephrine Hydrochloride.

• Product ID: 15343-125_ada43ab1-6d9c-4707-b77b-905b81ef8705
• NDC: 15343-125
• Product Type: Human Otc Drug
• Proprietary Name: Epi-Mist
• Generic Name: Racepinephrine Hydrochloride
• Dosage Form: Aerosol, Spray
• Route of Administration: RESPIRATORY (INHALATION)
• Marketing Start Date: 2015-05-15
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: DRNATURALHEALING INC
• Substance Name: RACEPINEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 1 mg/.12mL
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 15343-125-22

1 INHALER in 1 KIT (15343-125-22) > 15 mL in 1 INHALER

• Marketing Start Date: 2018-03-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 15343-125-22 [15343012522]

Epi-Mist AEROSOL, SPRAY

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2018-03-15
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
RACEPINEPHRINE HYDROCHLORIDE	.594 mg/.12mL

OpenFDA Data

• SPL SET ID: cd4a46b6-e381-4b0b-b679-349f233f98e3
• Manufacturer:
  • DRNATURALHEALING INC
• UNII:
  • 336096P2WE
• RxNorm Concept Unique ID - RxCUI:
  • 1658178
• UPC Code:
  • 0852291006076

NDC Crossover Matching brand name "Epi-Mist" or generic name "Racepinephrine Hydrochloride"

NDC	Brand Name	Generic Name
15343-125	Epi-Mist	RACEPINEPHRINE HYDROCHLORIDE
0487-2784	Asthmanefrin	racepinephrine hydrochloride
68071-5149	Racepinephrine	racepinephrine hydrochloride
0487-5901	S2	racepinephrine hydrochloride
55154-4352	S2	racepinephrine hydrochloride