NDC Package 21695-594-16 Re-pb Hyos Elixir

View Billable Units, 11-Digit Format, RxNorm

Package Information

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

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:
21695-594-16
Package Description:
480 mL in 1 BOTTLE
Product Code:
Proprietary Name:
Re-pb Hyos Elixir
Usage Information:
RE-PB Hyos Elixir is contraindicated in patients with known hypersensitivity to any of the ingredients. Phenobarbital iscontraindicated in patients with acute intermittent porphyria and in those patients in which phenobarbital producesrestlessness and/or excitement.It is also contraindicated in patients with glaucoma, obstructive uropathy; paralytic ileus; myasthenia gravis;intestinal atony; unstable cardiovascular status in acute hemorrhage; hiatal hernia associated with reflux esophagitis;obstructive disease of the gastrointestinal tract; or severe ulcerative colitis
11-Digit NDC Billing Format:
21695059416
NDC to RxNorm Crosswalk:
  • RxCUI: 1046787 - PHENobarbital 16.2 MG / hyoscyamine sulfate 0.1037 MG / atropine sulfate 0.0194 MG / scopolamine HBr 0.0065 MG in 5 mL Oral Solution
  • RxCUI: 1046787 - atropine sulfate 0.00388 MG/ML / hyoscyamine sulfate 0.0207 MG/ML / phenobarbital 3.24 MG/ML / scopolamine hydrobromide 0.0013 MG/ML Oral Solution
  • RxCUI: 1046787 - atropine sulfate 0.0194 MG / hyoscyamine sulfate 0.1037 MG / phenobarbital 16.2 MG / scopolamine hydrobromide 0.0065 MG per 5 ML Oral Solution
Labeler Name:
Rebel Distributors Corp
Sample Package:
No
Marketing Category:
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date:
10-20-2009
Listing Expiration Date:
12-31-2017
Exclude Flag:
I
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.

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Frequently Asked Questions

What is NDC 21695-594-16?

The NDC Packaged Code 21695-594-16 is assigned to a package of 480 ml in 1 bottle of Re-pb Hyos Elixir, labeled by Rebel Distributors Corp. The product's dosage form is and is administered via form.

Is NDC 21695-594 included in the NDC Directory?

No, Re-pb Hyos Elixir with product code 21695-594 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Rebel Distributors Corp on October 20, 2009 and its listing in the NDC Directory is set to expire on December 31, 2017 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 21695-594-16?

The 11-digit format is 21695059416. 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
5-3-221695-594-165-4-221695-0594-16