NDC 43353-786 Quetiapine Fumarate

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:
43353-786
Proprietary Name:
Quetiapine Fumarate
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Aphena Pharma Solutions - Tennessee, Llc
Labeler Code:
43353
Start Marketing Date: [9]
03-27-2012
Listing Expiration Date: [11]
12-31-2019
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
PINK (C48328 - PEACH)
YELLOW (C48330)
WHITE (C48325)
Shape:
ROUND (C48348)
Size(s):
5 MM
8 MM
10 MM
Imprint(s):
APO;QUE;25
APO;QUE;100
APO;QUE;200
Score:
1

Product Packages

NDC Code 43353-786-16

Package Description: 6000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

NDC Code 43353-786-30

Package Description: 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

NDC Code 43353-786-53

Package Description: 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

NDC Code 43353-786-60

Package Description: 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

Product Details

What is NDC 43353-786?

The NDC code 43353-786 is assigned by the FDA to the product Quetiapine Fumarate which is product labeled by Aphena Pharma Solutions - Tennessee, Llc. The product's dosage form is . The product is distributed in 4 packages with assigned NDC codes 43353-786-16 6000 tablet, film coated in 1 bottle, plastic , 43353-786-30 30 tablet, film coated in 1 bottle, plastic , 43353-786-53 60 tablet, film coated in 1 bottle, plastic , 43353-786-60 90 tablet, film coated in 1 bottle, plastic . 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?

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 UNII Codes?

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

Which are Quetiapine Fumarate 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?

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:

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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.

[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".