NDC 16590-036 Bupropion Hydrochloride

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
16590-036
Proprietary Name:
Bupropion Hydrochloride
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Stat Rx Usa Llc
Labeler Code:
16590
Start Marketing Date: [9]
07-02-2009
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325 - OFF-WHITE)
Shape:
ROUND (C48348)
Size(s):
10 MM
Imprint(s):
WPI;858
Score:
1

Product Packages

NDC Code 16590-036-30

Package Description: 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

NDC Code 16590-036-60

Package Description: 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

NDC Code 16590-036-90

Package Description: 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

Product Details

What is NDC 16590-036?

The NDC code 16590-036 is assigned by the FDA to the product Bupropion Hydrochloride which is product labeled by Stat Rx Usa Llc. The product's dosage form is . The product is distributed in 3 packages with assigned NDC codes 16590-036-30 30 tablet, film coated, extended release in 1 bottle , 16590-036-60 60 tablet, film coated, extended release in 1 bottle , 16590-036-90 90 tablet, film coated, extended release 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 Bupropion Hydrochloride?

Bupropion hydrochloride extended-release tablets (SR) are indicated for the treatment of major depressive disorder.The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled trials of depressed inpatients and in one 6-week controlled trial of depressed outpatients whose diagnoses corresponded most closely to the Major Depression category of the APA Diagnostic and Statistical Manual (DSM) (see CLINICAL PHARMACOLOGY).A major depressive episode (DSM-IV) implies the presence of 1) depressed mood or 2) loss of interest or pleasure; in addition, at least 5 of the following symptoms have been present during the same 2-week period and represent a change from previous functioning: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation.The efficacy of bupropion in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial (see CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use bupropion hydrochloride extended-release tablets (SR) for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.

Which are Bupropion Hydrochloride UNII Codes?

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

Which are Bupropion Hydrochloride 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 Bupropion Hydrochloride?

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: 993503 - buPROPion HCl 100 MG 12HR Extended Release Oral Tablet
  • RxCUI: 993503 - 12 HR bupropion hydrochloride 100 MG Extended Release Oral Tablet
  • RxCUI: 993503 - bupropion HCl 100 MG 12 HR Extended Release Oral Tablet
  • RxCUI: 993518 - buPROPion HCl 150 MG 12HR Extended Release Oral Tablet
  • RxCUI: 993518 - 12 HR bupropion hydrochloride 150 MG Extended Release Oral Tablet

* Please review the disclaimer below.

Product Footnotes

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

[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.

[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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".