NDC Package 55111-188-01 Quetiapine Fumarate

Tablet, Film Coated Oral - View Billable Units, 11-Digit Format, RxNorm

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
55111-188-01
Package Description:
100 TABLET, FILM COATED in 1 BOTTLE
Product Code:
Proprietary Name:
Quetiapine Fumarate
Non-Proprietary Name:
Quetiapine Fumarate
Substance Name:
Quetiapine Fumarate
Usage Information:
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.
11-Digit NDC Billing Format:
55111018801
NDC to RxNorm Crosswalk:
  • RxCUI: 312743 - QUEtiapine fumarate 100 MG Oral Tablet
  • RxCUI: 312743 - quetiapine 100 MG Oral Tablet
  • RxCUI: 312743 - quetiapine (as quetiapine fumarate) 100 MG Oral Tablet
  • RxCUI: 312744 - QUEtiapine fumarate 25 MG Oral Tablet
  • RxCUI: 312744 - quetiapine 25 MG Oral Tablet
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Dr.reddy's Laboratories Limited
    Dosage Form:
    Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
  • Active Ingredient(s):
    Sample Package:
    No
    FDA Application Number:
    ANDA077380
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    03-27-2012
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

    * Please review the disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    55111-188-05500 TABLET, FILM COATED in 1 BOTTLE
    55111-188-3030 TABLET, FILM COATED in 1 BOTTLE
    55111-188-6060 TABLET, FILM COATED in 1 BOTTLE
    55111-188-7810 BLISTER PACK in 1 CARTON / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-188-79)

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 55111-188-01?

    The NDC Packaged Code 55111-188-01 is assigned to a package of 100 tablet, film coated in 1 bottle of Quetiapine Fumarate, a human prescription drug labeled by Dr.reddy's Laboratories Limited. The product's dosage form is tablet, film coated and is administered via oral form.

    Is NDC 55111-188 included in the NDC Directory?

    Yes, Quetiapine Fumarate with product code 55111-188 is active and included in the NDC Directory. The product was first marketed by Dr.reddy's Laboratories Limited on March 27, 2012 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 55111-188-01?

    The 11-digit format is 55111018801. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-255111-188-015-4-255111-0188-01