Buprenorphine Hydrochloride Injection
NDC 70069-027
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
Buprenorphine Hydrochloride is a ANDA-approved product labeled by Somerset Therapeutics, Llc. This medication is typically used as a partial opioid agonist [epc]. It is supplied as a injection for intramuscular; intravenous administration. This product entry covers the primary NDC 70069-027 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
70069-027
Proprietary Name:
Buprenorphine Hydrochloride
Non-Proprietary Name: [1]
Buprenorphine Hydrochloride
Substance Name: [2]
Buprenorphine Hydrochloride
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:
Clinical Specifications
Dosage Form:
Injection
- A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route(s): [4]
- Intramuscular - Administration within a muscle.
- Intravenous - Administration within or into a vein or veins.
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
70069
Product Label ID:
HCPCS Code:
J0592
- INJECTION, BUPRENORPHINE HYDROCHLORIDE, 0.1 MG
FDA Application Number: [6]
ANDA219302
DEA Schedule: [7]
Schedule III (CIII) Substances
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Marketing Timeline
Start Marketing Date: [9]
02-11-2025
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N
Code Structure Chart
Product Details
What is NDC 70069-027?
The NDC code 70069-027 is assigned by the FDA to the product Buprenorphine Hydrochloride. This pharmaceutical product is labeled by Somerset Therapeutics, Llc and is currently categorized as listed product. The medication is a injection administered via intramuscular; intravenous route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 70069-027-05. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
What are the uses of this product?
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.
What are Active Ingredients of this product?
An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
- BUPRENORPHINE HYDROCHLORIDE .324 mg/mL - A derivative of the opioid alkaloid THEBAINE that is a more potent and longer lasting analgesic than MORPHINE. It appears to act as a partial agonist at mu and kappa opioid receptors and as an antagonist at delta receptors. The lack of delta-agonist activity has been suggested to account for the observation that buprenorphine tolerance may not develop with chronic use.
Which are the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- BUPRENORPHINE HYDROCHLORIDE (UNII: 56W8MW3EN1)
- BUPRENORPHINE (UNII: 40D3SCR4GZ) (Active Moiety)
Which are the Inactive Ingredients associated UNII Codes?
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:
- ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)
- HYDROCHLORIC ACID (UNII: QTT17582CB)
- WATER (UNII: 059QF0KO0R)
What is the NDC to RxNorm Crosswalk for this product?
RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
- RxCUI: 238129 - buprenorphine HCl 0.3 MG in 1 ML Injection
- RxCUI: 238129 - 1 ML buprenorphine 0.3 MG/ML Injection
- RxCUI: 238129 - buprenorphine 0.3 MG/ML (as buprenorphine HCl 0.324 MG/ML) Injection
- RxCUI: 238129 - buprenorphine HCl 0.3 MG per 1 ML Injection
Which are the Pharmacologic Classes of this product?
A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.
* Please review the full disclaimer at the bottom of this page.
Patient Education
Buprenorphine Injection (opioid dependence)
Buprenorphine extended-release injection (Sublocade) is used to treat opioid dependence (addiction to opioid drugs, including heroin and narcotic painkillers) in people who have received buccal or sublingual buprenorphine for at least 7 days. Buprenorphine extended-release injection (Brixadi) is used to treat opioid dependence in people who have received at least one dose of buccal or sublingual buprenorphine. Buprenorphine extended-release injection is in a class of medications called opiate partial agonists. It works to prevent withdrawal symptoms when someone stops taking opioid drugs by producing similar effects to these drugs.
[Learn More]
Buprenorphine Injection (Pain Relief)
Buprenorphine injection is used as a short-term treatment to relieve severe pain in people who are expected to need an opioid pain medication and who cannot be treated with other pain medications. Buprenorphine injection is in a class of medications called opiate partial agonists. It works by changing the way the body senses pain.
[Learn More]
Pain Relievers
Pain relievers are medicines that reduce or relieve headaches, sore muscles, arthritis, or other aches and pains. There are many different pain medicines, and each one has advantages and risks. Some types of pain respond better to certain medicines than others. Each person may also have a slightly different response to a pain reliever.
Over-the-counter (OTC) medicines are good for many types of pain. There are two main types of OTC pain medicines: acetaminophen (Tylenol) and nonsteroidal anti-inflammatory drugs (NSAIDs). Aspirin, naproxen (Aleve), and ibuprofen (Advil, Motrin) are examples of OTC NSAIDs.
If OTC medicines don't relieve your pain, your doctor may prescribe something stronger. Many NSAIDs are also available at higher prescription doses. The most powerful pain relievers are opioids. They are very effective, but they can sometimes have serious side effects. There is also a risk of addiction. Because of the risks, you must use them only under a doctor's supervision.
There are many things you can do to help ease pain. Pain relievers are just one part of a pain treatment plan.
[Learn More]
* Please review the full disclaimer at the bottom of this page.
Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the DEA Schedule? This is the assigned DEA Schedule number as reported by the labeler. Values are CI, CII, CIII, CIV, and CV.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".
