NDC Package 17856-0392-8 Methadone Hydrochloride

Concentrate Oral - View Billable Units, 11-Digit Format, RxNorm

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:
17856-0392-8
Package Description:
1 SYRINGE in 1 BAG / 1 mL in 1 SYRINGE
Product Code:
Proprietary Name:
Methadone Hydrochloride
Non-Proprietary Name:
Methadone Hydrochloride
Substance Name:
Methadone Hydrochloride
Usage Information:
1.For detoxification treatment of opioid addiction (heroin or other morphine-like drugs). 2.For maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services. Limitations of UseMethadone products used for the treatment of opioid addiction in detoxification or maintenance programs are subject to the conditions for distribution and use required under 21 CFR, Title 42, Sec 8 (see DOSAGE AND ADMINISTRATION).
11-Digit NDC Billing Format:
17856039208
NDC to RxNorm Crosswalk:
  • RxCUI: 991147 - methadone HCl 10 MG in 1 mL Concentrate for Oral Solution
  • RxCUI: 991147 - methadone hydrochloride 10 MG/ML Oral Solution
  • RxCUI: 991147 - methadone hydrochloride 10 MG per 1 ML Oral Solution
  • RxCUI: 991147 - methadone hydrochloride 5 MG per 0.5 ML Oral Solution
Product Type:
Human Prescription Drug
Labeler Name:
Atlantic Biologicals Corp.
Dosage Form:
Concentrate - A liquid preparation of increased strength and reduced volume which is usually diluted prior to administration.
Administration Route(s):
Oral - Administration to or by way of the mouth.
DEA Schedule:
Schedule II (CII) Substances
Sample Package:
No
FDA Application Number:
ANDA040180
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
05-14-2019
Listing Expiration Date:
12-31-2026
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.

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Other Product Packages

The following packages are also available for this product:

NDC Package CodePackage Description
17856-0392-160 SYRINGE in 1 BOX, UNIT-DOSE / .5 mL in 1 SYRINGE
17856-0392-372 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE / 2.5 mL in 1 CUP, UNIT-DOSE (17856-0392-4)
17856-0392-61 SYRINGE in 1 BAG / .5 mL in 1 SYRINGE
17856-0392-75 BOX, UNIT-DOSE in 1 SYRINGE / 60 SYRINGE in 1 BOX, UNIT-DOSE (17856-0392-2) / 1 mL in 1 SYRINGE (17856-0392-5)
17856-0392-91 SYRINGE in 1 BAG / 2.5 mL in 1 SYRINGE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 17856-0392-8?

The NDC Packaged Code 17856-0392-8 is assigned to a package of 1 syringe in 1 bag / 1 ml in 1 syringe of Methadone Hydrochloride, a human prescription drug labeled by Atlantic Biologicals Corp.. The product's dosage form is concentrate and is administered via oral form.

Is NDC 17856-0392 included in the NDC Directory?

Yes, Methadone Hydrochloride with product code 17856-0392 is active and included in the NDC Directory. The product was first marketed by Atlantic Biologicals Corp. on May 14, 2019 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 17856-0392-8?

The 11-digit format is 17856039208. 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
5-4-117856-0392-85-4-217856-0392-08