Robotablets Tablet
NDC 71598-015
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
Robotablets (dextromethorphan) is a OTC MONOGRAPH DRUG-approved product labeled by Dxm Pharmaceutical, Inc. This medication is typically used as a sigma-1 agonist [epc]. It is supplied as a white tablet for oral administration. This product entry covers the primary NDC 71598-015 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
71598-015
Proprietary Name:
Robotablets
Non-Proprietary Name: [1]
Dextromethorphan
Substance Name: [2]
Dextromethorphan
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:
Clinical Specifications
Dosage Form:
Tablet
- A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
71598
Product Label ID:
FDA Application Number: [6]
M012
Marketing Category: [8]
OTC MONOGRAPH DRUG
Marketing Timeline
Start Marketing Date: [9]
10-15-2020
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N
Product Characteristics
Color(s):
WHITE (C48325)
Shape:
ROUND (C48348)
Size(s):
5 MM
Imprint(s):
R30
Score:
1
Code Structure Chart
Product Details
What is NDC 71598-015?
The NDC code 71598-015 is assigned by the FDA to the product Robotablets. It is commonly known by its generic name, dextromethorphan. This pharmaceutical product is labeled by Dxm Pharmaceutical, Inc and is currently categorized as listed product. The medication is a tablet administered via oral route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 71598-015-30. 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?
Only use this product according to these directions or as directed by a doctordo not exceed 4 tablets in any 24-hour periodthis adult product is not intended for use in children under 12 years of ageAgeDose adults and children 12 years and over take 1 tablet every 6 to 8 hours, as needed children under 12 years do not useOther Informationstore at 20-25°C (68-77°F).TAMPER EVIDENT: Do not use if safety seal under child-resistant cap is broken or missing.
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.
- DEXTROMETHORPHAN 30 mg/1 - Methyl analog of DEXTRORPHAN that shows high affinity binding to several regions of the brain, including the medullary cough center. This compound is an NMDA receptor antagonist (RECEPTORS, N-METHYL-D-ASPARTATE) and acts as a non-competitive channel blocker. It is one of the widely used ANTITUSSIVES, and is also used to study the involvement of glutamate receptors in neurotoxicity.
Which are the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- DEXTROMETHORPHAN (UNII: 7355X3ROTS)
- DEXTROMETHORPHAN (UNII: 7355X3ROTS) (Active Moiety)
Which are the Inactive Ingredients associated UNII Codes?
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:
- MAGNESIUM STEARATE (UNII: 70097M6I30)
- MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
- SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)
Which are the Pharmacologic Classes of this product?
A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.
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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".
