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  5. NDC Package Code: 70069-661-10 Nalbuphine Hydrochloride

NDC Package 70069-661-10 Nalbuphine Hydrochloride

Injection Intramuscular; Intravenous; Subcutaneous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Frequently Asked Questions

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:
70069-661-10
Package Description:
1 VIAL, MULTI-DOSE in 1 CARTON / 10 mL in 1 VIAL, MULTI-DOSE
Product Code:
70069-661
Proprietary Name:
Nalbuphine Hydrochloride
Non-Proprietary Name:
Nalbuphine Hydrochloride
Substance Name:
Nalbuphine Hydrochloride
Usage Information:
Nalbuphine hydrochloride injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Nalbuphine hydrochloride injection can also be used as a supplement to balanced anesthesia, for preoperative and postoperative analgesia, and for obstetrical analgesia during labor and delivery.Limitations of Use:Because of the risks of addiction, abuse, and misuse, with opioids, which can occur at any dosage or duration [see WARNINGS], reserve nalbuphine hydrochloride injection for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]:Have not been tolerated, or are not expected to be tolerated,Have not provided adequate analgesia or are not expected to provide adequate analgesia.Nalbuphine hydrochloride injection should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.
11-Digit NDC Billing Format:
70069066110
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
Product Type:
Human Prescription Drug
Labeler Name:
Somerset Therapeutics, Llc
Dosage Form:
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route(s):
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s):
NALBUPHINE HYDROCHLORIDE 10 mg/mL
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
ANDA216049
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
09-26-2024
Listing Expiration Date:
12-31-2025
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.

* Please review the disclaimer below.

NDC HCPCS Crosswalk

This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

NDC 70069-661-10 HCPCS crosswalk information with package details and bill units information.

NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
70069066110J2300INJECTION, NALBUPHINE HYDROCHLORIDE, PER 10 MG10 MG10ML

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 70069-661-10?

The NDC Packaged Code 70069-661-10 is assigned to a package of 1 vial, multi-dose in 1 carton / 10 ml in 1 vial, multi-dose of Nalbuphine Hydrochloride, a human prescription drug labeled by Somerset Therapeutics, Llc. The product's dosage form is injection and is administered via intramuscular; intravenous; subcutaneous form.

Is NDC 70069-661 included in the NDC Directory?

Yes, Nalbuphine Hydrochloride with product code 70069-661 is active and included in the NDC Directory. The product was first marketed by Somerset Therapeutics, Llc on September 26, 2024 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 70069-661-10?

The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

What is the 11-digit format for NDC 70069-661-10?

The 11-digit format is 70069066110. 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
5-3-270069-661-105-4-270069-0661-10