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  4. NDC Product Code: 69948-002 Quetiapine Extended-release

NDC 69948-002 Quetiapine Extended-release

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 69948-002?
  5. Quetiapine 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.

Get all the details for National Drug Code (NDC) 69948-002 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:
69948-002
Proprietary Name:
Quetiapine Extended-release
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Alignscience Pharma Inc.
Labeler Code:
69948
Product Label ID:
db3ba268-21a2-4988-b5c1-353741bcaee5
FDA Application Number: [6]
ANDA209497
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date: [9]
03-31-2020
Listing Expiration Date: [11]
12-31-2020
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325)
Shape:
OVAL (C48345)
Size(s):
13 MM
Imprint(s):
XR150
Score:
1

Code Structure Chart

Product Details

What is NDC 69948-002?

The NDC code 69948-002 is assigned by the FDA to the product Quetiapine Extended-release which is product labeled by Alignscience Pharma Inc.. The product's dosage form is . The product is distributed in 2 packages with assigned NDC codes 69948-002-03 60 tablet, film coated, extended release in 1 bottle , 69948-002-11 500 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 Quetiapine Extended-release?

Hypersensitivity to quetiapine or to any excipients in the quetiapine extended-release tablets formulation. Anaphylactic reactions have been reported in patients treated with quetiapine extended-release tablets.

Which are Quetiapine Extended-release UNII Codes?

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

Which are Quetiapine 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 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: 895670 - QUEtiapine fumarate 150 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.

[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.

[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".