Diethylpropion Hydrochloride
NDC 52959-150
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
Diethylpropion Hydrochloride is a ANDA-approved product labeled by H.j. Harkins Company, Inc.. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a product. This product entry covers the primary NDC 52959-150 and 3 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
52959-150
Proprietary Name:
Diethylpropion Hydrochloride
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
52959
Product Label ID:
FDA Application Number: [6]
ANDA200177
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Marketing Timeline
Start Marketing Date: [9]
09-25-2000
Listing Expiration Date: [11]
12-31-2019
Exclude Flag: [12]
I
Code Structure Chart
Product Details
What is NDC 52959-150?
The NDC code 52959-150 is assigned by the FDA to the product Diethylpropion Hydrochloride. This pharmaceutical product is labeled by H.j. Harkins Company, Inc. and is currently categorized as listed product. In terms of distribution, this product is available in 3 different package configurations. The associated package NDC(s) include: 52959-150-00, 52959-150-30, 52959-150-90. 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?
Pulmonary hypertension, advanced arteriosclerosis, hyperthyroidism, known hypersensitivity or idiosyncrasy to the sympathomimetic amines, glaucoma, severe hypertension. (See PRECAUTIONS).Agitated states.Patients with a history of drug abuse.Use in combination with other anorectic agents is contraindicated.During or within 14 days following the administration of monoamine oxidase inhibitors, hypertensive crises may result.
What is the NDC to RxNorm Crosswalk for this product?
RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
- RxCUI: 978654 - diethylpropion HCl 25 MG Oral Tablet
- RxCUI: 978654 - diethylpropion hydrochloride 25 MG Oral Tablet
- RxCUI: 978668 - diethylpropion HCl 75 MG 24HR Extended Release Oral Tablet
- RxCUI: 978668 - 24 HR diethylpropion hydrochloride 75 MG Extended Release Oral Tablet
- RxCUI: 978668 - diethylpropion hydrochloride 75 MG 24 HR Extended Release Oral Tablet
* Please review the full disclaimer at the bottom of this page.
Patient Education
Diethylpropion
Diethylpropion decreases appetite. It is used on a short-term basis (a few weeks), in combination with diet, to help you lose weight. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
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* Please review the full disclaimer at the bottom of this page.
Product & Regulatory Definitions
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".
