NDC Package 85534-0001-2 Amitryptline Hydrochloride

Kit - View Billable Units, 11-Digit Format, RxNorm

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

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:
85534-0001-2
Package Description:
1 KIT in 1 KIT * 2.4 g in 1 BOTTLE, PLASTIC * 117.6 g in 1 BOTTLE, PLASTIC
Product Code:
Non-Proprietary Name:
Amitryptline Hydrochloride
11-Digit NDC Billing Format:
85534000102
Product Type:
Bulk Ingredient
Labeler Name:
Hawaii Repack, Inc.
Dosage Form:
Kit - A packaged collection of related material.
Sample Package:
N/A
Marketing Category:
BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING - A category specifying that a bulk product is intended for use on humans and requires a prescription.
Start Marketing Date:
02-05-2014
Listing Expiration Date:
12-31-2026
Exclude Flag:
N
Unfinished Product:
Yes
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 85534-0001-2?

The NDC Packaged Code 85534-0001-2 is assigned to an UNFINISHED drug package of 1 kit in 1 kit * 2.4 g in 1 bottle, plastic * 117.6 g in 1 bottle, plastic of Amitryptline Hydrochloride, a bulk ingredient labeled by Hawaii Repack, Inc.. The product's dosage form is kit and is administered via form.

Is NDC 85534-0001 included in the NDC Directory?

Yes, Amitryptline Hydrochloride is an UNFINISHED PRODUCT with code 85534-0001 that is active and included in the NDC Directory. The product was first marketed by Hawaii Repack, Inc. on February 05, 2014 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 85534-0001-2?

The 11-digit format is 85534000102. 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 5-4-1 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
5-4-185534-0001-25-4-285534-0001-02