1. Home
  2. Labeler Index
  3. Specgx Llc
  4. NDC Product Code: 0406-1182 Quetiapine Fumarate Extended-release

NDC 0406-1182 Quetiapine Fumarate Extended-release

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 0406-1182?
  5. Quetiapine Fumarate Extended-release 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 inactivated by the FDA.
NDC Product Code:
0406-1182
Proprietary Name:
Quetiapine Fumarate Extended-release
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Specgx Llc
Labeler Code:
0406
Product Label ID:
b56d057a-f5d9-4919-a0f2-b96a76ff83b7
Start Marketing Date: [9]
05-15-2017
Listing Expiration Date: [11]
12-31-2020
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
RED (C48326 - MAROON)
WHITE (C48325)
YELLOW (C48330 - PALE YELLOW)
Shape:
OVAL (C48345)
CAPSULE (C48336)
Size(s):
8 MM
15 MM
Imprint(s):
Q50
Q150
Q200
Score:
1

Code Structure Chart

Product Details

What is NDC 0406-1182?

The NDC code 0406-1182 is assigned by the FDA to the product Quetiapine Fumarate Extended-release which is product labeled by Specgx Llc. The product's dosage form is . The product is distributed in a single package with assigned NDC code 0406-1182-60 60 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 Quetiapine Fumarate Extended-release?

This medication is used to treat certain mental/mood conditions (such as schizophrenia, bipolar disorder, sudden episodes of mania or depression associated with bipolar disorder). Quetiapine is known as an anti-psychotic drug (atypical type). It works by helping to restore the balance of certain natural substances (neurotransmitters) in the brain. This medication can decrease hallucinations and improve your concentration. It helps you to think more clearly and positively about yourself, feel less nervous, and take a more active part in everyday life. It may also improve your mood, sleep, appetite, and energy level. Quetiapine can help prevent severe mood swings or decrease how often mood swings occur.

Which are Quetiapine Fumarate Extended-release UNII Codes?

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

Which are Quetiapine Fumarate Extended-release 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 Quetiapine Fumarate Extended-release?

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: 721791 - QUEtiapine fumarate 200 MG 24HR Extended Release Oral Tablet
  • RxCUI: 721791 - 24 HR quetiapine 200 MG Extended Release Oral Tablet
  • RxCUI: 721791 - quetiapine 200 MG (as quetiapine fumarate 230 MG) 24 HR Extended Release Oral Tablet
  • RxCUI: 721791 - quetiapine 200 MG 24 HR Extended Release Oral Tablet
  • RxCUI: 721794 - QUEtiapine fumarate 300 MG 24HR 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".