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  4. NDC Product Code: 12634-691 Diethylpropion Hydrochloride Er

NDC 12634-691 Diethylpropion Hydrochloride Er

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 12634-691?
  5. Diethylpropion Hydrochloride Er Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Get all the details for National Drug Code (NDC) 12634-691 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
12634-691
Proprietary Name:
Diethylpropion Hydrochloride Er
Product Type: [3]
Labeler Name: [5]
Apotheca Inc
Labeler Code:
12634
Product Label ID:
46d9dd37-a8c4-4c01-e054-00144ff8d46c
FDA Application Number: [6]
ANDA011722
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date: [9]
10-23-2008
End Marketing Date: [10]
01-23-2017
Listing Expiration Date: [11]
01-23-2017
Exclude Flag: [12]
D
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325)
Shape:
OVAL (C48345)
Size(s):
19 MM
Imprint(s):
WATSON;782
Score:
1

Code Structure Chart

Product Details

What is NDC 12634-691?

The NDC code 12634-691 is assigned by the FDA to the product Diethylpropion Hydrochloride Er which is product labeled by Apotheca Inc. The product's dosage form is . The product is distributed in 45 packages with assigned NDC codes 12634-691-00 10 tablet in 1 bottle , 12634-691-01 100 tablet in 1 bottle , 12634-691-09 35 tablet in 1 bottle , 12634-691-12 120 tablet in 1 bottle , 12634-691-18 180 tablet in 1 bottle , 12634-691-40 40 tablet in 1 bottle , 12634-691-42 42 tablet in 1 bottle , 12634-691-45 45 tablet in 1 bottle , 12634-691-50 50 tablet in 1 bottle , 12634-691-52 12 tablet in 1 blister pack , 12634-691-54 14 tablet in 1 blister pack , 12634-691-57 20 tablet in 1 blister pack , 12634-691-59 30 tablet in 1 blister pack , 12634-691-60 60 tablet in 1 bottle , 12634-691-60 60 tablet in 1 bottle , 12634-691-61 10 tablet in 1 blister pack , 12634-691-63 3 tablet in 1 blister pack , 12634-691-66 6 tablet in 1 blister pack , 12634-691-67 7 tablet in 1 blister pack , 12634-691-69 9 tablet in 1 blister pack , 12634-691-71 30 tablet in 1 bottle , 12634-691-71 30 tablet in 1 bottle , 12634-691-74 24 tablet in 1 bottle , 12634-691-78 28 tablet in 1 bottle , 12634-691-78 28 tablet in 1 bottle , 12634-691-79 25 tablet in 1 bottle , 12634-691-80 20 tablet in 1 bottle , 12634-691-81 21 tablet in 1 bottle , 12634-691-82 12 tablet in 1 bottle , 12634-691-84 14 tablet in 1 bottle , 12634-691-84 14 tablet in 1 bottle , 12634-691-85 15 tablet in 1 bottle , 12634-691-90 90 tablet in 1 bottle , 12634-691-90 90 tablet in 1 bottle , 12634-691-91 1 tablet in 1 blister pack , 12634-691-91 1 tablet in 1 blister pack , 12634-691-92 2 tablet in 1 bottle , 12634-691-93 3 tablet in 1 bottle , 12634-691-94 4 tablet in 1 bottle , 12634-691-95 5 tablet in 1 bottle , 12634-691-96 6 tablet in 1 bottle , 12634-691-97 7 tablet in 1 bottle , 12634-691-97 7 tablet in 1 bottle , 12634-691-98 8 tablet in 1 bottle , 12634-691-99 9 tablet in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Diethylpropion Hydrochloride Er?

Diethylpropion hydrochloride is indicated in the management of exogenous obesity as a short-term adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (BMI) of 30 kg/m 2 or higher and who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. Below is a chart of 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 divided by 2.2 = kg; inches x 0.0254 = meters. Body Mass Index (BMI), kg/m 2 Weight (pounds) Height (feet, inches)  5’0” 5’3” 5’6” 5’9” 6’0” 6’3” 140 27 25 23 21 19 18 150 29 27 24 22 20 19 160 31 28 26 24 22 20 170 33 30 28 25 23 21 180 35 32 29 27 25 23 190 37 34 31 28 26 24 200 39 36 32 30 27 25 210 41 37 34 31 29 26 220 43 39 36 33 30 28 230 45 41 37 34 31 29 240 47 43 39 36 33 30 250 49 44 40 37 34 31The 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. Diethylpropion hydrochloride is indicated for use as monotherapy only.

Which are Diethylpropion Hydrochloride Er UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Diethylpropion Hydrochloride Er Inactive Ingredients 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:

What is the NDC to RxNorm Crosswalk for Diethylpropion Hydrochloride Er?

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: 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

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Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[6] 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.

[8] 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.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[10] What is the End Marketing Date? - This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

[11] 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.

[12] 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".