Amlodipine Besylate
NDC Package 67046-005-30

11-digit billing NDC: 67046000530
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Amlodipine Besylate is haloperidol tablets, USP are indicated for use in the management of manifestations of psychotic disorders.Haloperidol tablets, USP are indicated for the control of tics and vocal utterances of Tourette’s Disorder in children and adults. Marketed by Contract Pharmacy Services-pa, this product is identified by NDC 67046-005 and is authorized under FDA application ANDA077955.

Identification & Billing

NDC Package Code
67046-005-30
Package Description
30 TABLET in 1 BLISTER PACK
Product Code
67046-005
11-Digit Billing Format
67046000530
RxNorm Crosswalk
RxCUI: 310672 - haloperidol 5 MG Oral Tablet

Clinical Specifications

Proprietary Name
Amlodipine Besylate
Dosage Form
-
Usage Information
Haloperidol tablets, USP are indicated for use in the management of manifestations of psychotic disorders.Haloperidol tablets, USP are indicated for the control of tics and vocal utterances of Tourette’s Disorder in children and adults. Haloperidol tablets, USP are effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation). Haloperidol tablets, USP are also effective in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability, and poor frustration tolerance. Haloperidol tablets, USP should be reserved for these two groups of children only after failure to respond to psychotherapy or medications other than antipsychotics.

Regulatory & Marketing

Labeler Name
Contract Pharmacy Services-pa
FDA Application #
ANDA077955
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
07-01-2016
Listing Expiration
12-31-2019
Exclude Flag
I
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 67046-005-30 identifies a specific commercial package of 30 tablet in 1 blister pack of Amlodipine Besylate, labeled by Contract Pharmacy Services-pa. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Contract Pharmacy Services-pa on July 01, 2016. The current certification is valid through December 31, 2019.

How is this Contract Pharmacy Services-pa product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67046000530. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
67046-005-30
11-Digit CMS (5-4-2)
67046-0005-30

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.