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  5. NDC Package Code: 70069-027-05 Buprenorphine Hydrochloride

NDC Package 70069-027-05 Buprenorphine Hydrochloride

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

Table of Contents

    1. Package Information
    2. 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:
70069-027-05
Package Description:
5 VIAL in 1 CARTON / 1 mL in 1 VIAL
Product Code:
70069-027
Proprietary Name:
Buprenorphine Hydrochloride
Non-Proprietary Name:
Buprenorphine Hydrochloride
Substance Name:
Buprenorphine Hydrochloride
Usage Information:
Buprenorphine hydrochloride injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate.Limitations of Use:Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see WARNINGS: Addiction, Abuse, and Misuse], reserve buprenorphine hydrochloride injection for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products):Have not been tolerated or are not expected to be tolerated,Have not provided adequate analgesia or are not expected to provide adequate analgesia.Buprenorphine 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:
70069002705
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.
Active Ingredient(s):
BUPRENORPHINE HYDROCHLORIDE .324 mg/mL
Pharmacologic Class(es):
DEA Schedule:
Schedule III (CIII) Substances
Sample Package:
No
FDA Application Number:
ANDA219302
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
02-11-2025
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.

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 70069-027-05?

The NDC Packaged Code 70069-027-05 is assigned to a package of 5 vial in 1 carton / 1 ml in 1 vial of Buprenorphine Hydrochloride, a human prescription drug labeled by Somerset Therapeutics, Llc. The product's dosage form is injection and is administered via intramuscular; intravenous form.

Is NDC 70069-027 included in the NDC Directory?

Yes, Buprenorphine Hydrochloride with product code 70069-027 is active and included in the NDC Directory. The product was first marketed by Somerset Therapeutics, Llc on February 11, 2025 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 70069-027-05?

The 11-digit format is 70069002705. 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
5-3-270069-027-055-4-270069-0027-05