NDC Package 35356-816-01 Hydromorphone Hydrochloride

View Billable Units, 11-Digit Format, RxNorm

Package Information
Other Packages
Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

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:

35356-816-01

Package Description:

120 TABLET in 1 BOTTLE, PLASTIC

Product Code:

35356-816

Proprietary Name:

Hydromorphone Hydrochloride

Usage Information:

Hydromorphone hydrochloride tablets are indicated for the management of pain in patients where an opioid analgesic is appropriate.

11-Digit NDC Billing Format:

35356081601

Labeler Name:

Lake Erie Medical Dba Quality Care Products Llc

Sample Package:

FDA Application Number:

ANDA078439

Marketing Category:

ANDA - A product marketed under an approved Abbreviated New Drug Application.

Start Marketing Date:

12-09-2009

End Marketing Date:

12-31-2020

Listing Expiration Date:

12-31-2020

Exclude Flag:

Code Structure:

35356 - Lake Erie Medical Dba Quality Care Products Llc
- 35356-816 - Hydromorphone Hydrochloride
  - 35356-816-01 - 120 TABLET in 1 BOTTLE, PLASTIC

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 Code	Package Description
35356-816-30	30 TABLET in 1 BOTTLE, PLASTIC
35356-816-60	60 TABLET in 1 BOTTLE, PLASTIC
35356-816-90	90 TABLET in 1 BOTTLE, PLASTIC

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 35356-816-01?

The NDC Packaged Code 35356-816-01 is assigned to a package of 120 tablet in 1 bottle, plastic of Hydromorphone Hydrochloride, labeled by Lake Erie Medical Dba Quality Care Products Llc. The product's dosage form is and is administered via form.

Is NDC 35356-816 included in the NDC Directory?

No, Hydromorphone Hydrochloride with product code 35356-816 is excluded from the NDC Directory because it was discontinued by the manufacturer. The product was first marketed by Lake Erie Medical Dba Quality Care Products Llc on December 09, 2009 and its listing in the NDC Directory is set to expire on December 31, 2020 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 35356-816-01?

The 11-digit format is 35356081601. 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 Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	35356-816-01	5-4-2	35356-0816-01

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