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  5. NDC Package Code: 55111-284-48 Fluoxetine Hydrochloride

NDC Package 55111-284-48 Fluoxetine Hydrochloride

Capsule, Delayed Release Pellets Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

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:
55111-284-48
Package Description:
1 BLISTER PACK in 1 CARTON / 4 CAPSULE, DELAYED RELEASE PELLETS in 1 BLISTER PACK
Product Code:
55111-284
Proprietary Name:
Fluoxetine Hydrochloride
Non-Proprietary Name:
Fluoxetine Hydrochloride
Substance Name:
Fluoxetine Hydrochloride
Usage Information:
Fluoxetine delayed-release capsules are indicated for the treatment of:• Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies (14.1)].
11-Digit NDC Billing Format:
55111028448
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 313995 - FLUoxetine 90 MG Delayed Release Oral Capsule
  • RxCUI: 313995 - fluoxetine 90 MG Delayed Release Oral Capsule
  • RxCUI: 313995 - fluoxetine 90 MG (fluoxetine hydrochloride 101 MG) Delayed Release Oral Capsule
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Dr.reddy's Laboratories Limited
    Dosage Form:
    Capsule, Delayed Release Pellets - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container or "shell" made from a suitable form of gelatin; the drug itself is in the form of granules to which enteric coating has been applied, thus delaying release of the drug until its passage into the intestines.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • FLUOXETINE HYDROCHLORIDE 90 mg/1
    • Pharmacologic Class(es):
  • Serotonin Reuptake Inhibitor - [EPC] (Established Pharmacologic Class)
  • Serotonin Uptake Inhibitors - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    ANDA078572
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    03-24-2010
    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.

    Frequently Asked Questions

    What is NDC 55111-284-48?

    The NDC Packaged Code 55111-284-48 is assigned to a package of 1 blister pack in 1 carton / 4 capsule, delayed release pellets in 1 blister pack of Fluoxetine Hydrochloride, a human prescription drug labeled by Dr.reddy's Laboratories Limited. The product's dosage form is capsule, delayed release pellets and is administered via oral form.

    Is NDC 55111-284 included in the NDC Directory?

    Yes, Fluoxetine Hydrochloride with product code 55111-284 is active and included in the NDC Directory. The product was first marketed by Dr.reddy's Laboratories Limited on March 24, 2010 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 NDC billing unit for package 55111-284-48?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 1.

    What is the 11-digit format for NDC 55111-284-48?

    The 11-digit format is 55111028448. 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
    5-3-255111-284-485-4-255111-0284-48