Phentermine Hydrochloride
NDC 10544-602
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.
Phentermine Hydrochloride is a ANDA-approved product labeled by Blenheim Pharmacal, Inc.. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a white product. This product entry covers the primary NDC 10544-602 and 3 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
10544-602
Proprietary Name:
Phentermine Hydrochloride
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
10544
Product Label ID:
FDA Application Number: [6]
ANDA040527
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Marketing Timeline
Start Marketing Date: [9]
12-30-2009
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Product Characteristics
Color(s):
WHITE (C48325 - WITH BLUE SPECKS)
Shape:
OVAL (C48345)
Size(s):
10 MM
Imprint(s):
MP;273
Score:
1
Code Structure Chart
Product Details
What is NDC 10544-602?
The NDC code 10544-602 is assigned by the FDA to the product Phentermine Hydrochloride. This pharmaceutical product is labeled by Blenheim Pharmacal, 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: 10544-602-30, 10544-602-45, 10544-602-60. 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?
Phentermine hydrochloride is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥30 kg/m2, or ≥27 kg/m2 in the presence of other risk factors (e. g., hypertension, diabetes, hyperlipidemia).Below is a chart of Body Mass Index (BMI) based on various heights and weights.BMI is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. Metric conversions are as follows; pounds ÷ 2.2 = kg; inches × 0.0254 = meters.BODY MASS INDEX (BMI), kg/m2Height (feet, inches)Weight(pounds)5'0"5'3"5'6"5'9"6'0"6'3"140272523211918150292724222019160312826242220170333028252321180353229272523190373431282624200393632302725210413734312926220433936333028230454137343129240474339363330250494440373431The limited usefulness of agents of this class (see CLINICAL PHARMACOLOGY) should be measured against possible risk factors inherent in their use such as those described below.
Which are the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- PHENTERMINE HYDROCHLORIDE (UNII: 0K2I505OTV)
- PHENTERMINE (UNII: C045TQL4WP) (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:
- POVIDONE (UNII: FZ989GH94E)
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: 803353 - phentermine HCl 37.5 MG Oral Tablet
- RxCUI: 803353 - phentermine hydrochloride 37.5 MG Oral Tablet
- RxCUI: 803353 - phentermine hydrochloride 37.5 MG (equivalent to phentermine 30 MG) Oral Tablet
* Please review the full disclaimer at the bottom of this page.
Patient Education
Phentermine
Phentermine is used for a limited period of time to speed weight loss in overweight people who are exercising and eating a low-calorie diet. Phentermine is in a class of medications called anorectics. It works by decreasing appetite.
[Learn More]
* 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".
