Nebuclear Md Solution
NDC 73117-523
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
Nebuclear Md (racepinephrine hydrochloride) is a OTC MONOGRAPH DRUG-approved product labeled by Blue Echo Care Llc. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a solution for respiratory (inhalation) administration. This product entry covers the primary NDC 73117-523 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
73117-523
Proprietary Name:
Nebuclear Md
Non-Proprietary Name: [1]
Racepinephrine Hydrochloride
Substance Name: [2]
Racepinephrine Hydrochloride
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:
Clinical Specifications
Dosage Form:
Solution
- A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route(s): [4]
- Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.
- Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
73117
Product Label ID:
FDA Application Number: [6]
M012
Marketing Category: [8]
OTC MONOGRAPH DRUG
Marketing Timeline
Start Marketing Date: [9]
11-18-2025
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N
Code Structure Chart
Product Details
What is NDC 73117-523?
The NDC code 73117-523 is assigned by the FDA to the product Nebuclear Md. It is commonly known by its generic name, racepinephrine hydrochloride. This pharmaceutical product is labeled by Blue Echo Care Llc and is currently categorized as listed product. The medication is a solution administered via respiratory (inhalation) route. In terms of distribution, this product is available in 2 different package configurations. The associated package NDC(s) include: 73117-523-18, 73117-523-19. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
What are the uses of this product?
The ingredient is used in an aqueous solution at a concentration equivalent to 1 percent epinephrine.Do not use more than directedFor use with a Jet or Ultrasonic Nebulizer.Add 0.5 mL (contents of one vial) of solution to Nebulizer.Adults and children 4 years of age and over:1 to 3 inhalations not more often than every 3 hours.Do not use more than 12 inhalations in 24 hours.The use of this product by children should be supervised by an adult.Children under 4 years of age: ask a doctor.
What are Active Ingredients of this product?
An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
- RACEPINEPHRINE HYDROCHLORIDE 11.25 mg/.5mL - A racemic mixture of d-epinephrine and l-epinephrine.
- RACEPINEPHRINE HYDROCHLORIDE 11.25 mg/.5mL - A racemic mixture of d-epinephrine and l-epinephrine.
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Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".
