NDC 16590-922 Aplenzin ER

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:
16590-922
Proprietary Name:
Aplenzin ER
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Labeler Code:
16590
Start Marketing Date: [9]
03-30-2009
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325 - WHITE TO OFF-WHITE)
Shape:
ROUND (C48348)
Size(s):
8 MM
Imprint(s):
BR;348
Score:
1

Code Structure Chart

Product Details

What is NDC 16590-922?

The NDC code 16590-922 is assigned by the FDA to the product Aplenzin ER 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 16590-922-30 30 tablet, extended release in 1 bottle , 16590-922-60 60 tablet, extended release in 1 bottle , 16590-922-90 90 tablet, 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 Aplenzin ER?

This medication is used to treat depression. It may also be used to prevent seasonal affective disorder (SAD), a type of depression that occurs each year at the same time (for example, during winter). This medication can improve your mood and feelings of well-being. It may work by restoring the balance of certain natural substances (dopamine, norepinephrine) in the brain.

Which are Aplenzin ER UNII Codes?

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

Which are Aplenzin 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 Aplenzin 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: 993567 - buPROPion HBr 348 MG 24HR Extended Release Oral Tablet
  • RxCUI: 993567 - 24 HR bupropion hydrobromide 348 MG Extended Release Oral Tablet
  • RxCUI: 993567 - bupropion hydrobromide 348 MG 24 HR Extended Release Oral Tablet
  • RxCUI: 993569 - Aplenzin 348 MG 24HR Extended Release Oral Tablet
  • RxCUI: 993569 - 24 HR bupropion hydrobromide 348 MG Extended Release Oral Tablet [Aplenzin]

* 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".