buprenorphine hydrochloride 2 mg/1

buprenorphine hydrochloride · TABLET · REMEDYREPACK INC.

No Recall History

Plain English

buprenorphine hydrochloride is a tablet containing buprenorphine hydrochloride at 2 mg/1, taken sublingual. Manufactured by REMEDYREPACK INC..

Key Facts

Brand Name: buprenorphine hydrochloride
Generic Name: buprenorphine hydrochloride
NDC Code (Product): 70518-4570
Manufacturer: REMEDYREPACK INC.
Strength: 2 mg/1
Dosage Form: TABLET
Route: SUBLINGUAL
Marketing Status
DEA Schedule: Schedule III (Controlled)
Application #: ANDA090279
Marketing Start: 02/10/2026

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Buprenorphine sublingual tablets is indicated for the treatment of opioid dependence and is preferred for induction. Buprenorphine sublingual tablets should be used as part of a complete treatment plan to include counseling and psychosocial support. Buprenorphine sublingual tablets contains buprenorphine, a partial opioid agonist, and is indicated for the treatment of opioid dependence and is preferred for induction. ( 1 ) Buprenorphine sublingual tablets should be used as part of a complete treatment plan that includes counseling and psychosocial support ( 1 ).

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Administer buprenorphine sublingual tablets sublingually as a single daily dose. ( 2.1 ) Strongly consider prescribing naloxone at the time buprenorphine sublingual tablets is initiated or renewed because patients being treated for opioid use disorder have the potential for relapse, putting them at risk for opioid overdose ( 2.2 ) To avoid precipitating withdrawal, induction with buprenorphine sublingual tablets should be undertaken when objective and clear signs of withdrawal are evident. ( 2.3 ). Buprenorphine and naloxone sublingual film or buprenorphine and naloxone sublingual tablet is generally initiated after two days of buprenorphine sublingual tablets titration. ( 2.4 ) Administer buprenorphine sublingual tablets as directed in the Full Prescribing Information. ( 2.3 , 2.4 , 2.5 ) Buprenorphine sublingual tablets must be administered whole. Do not cut, chew, or swallow buprenorphine sublingual tablets. ( 2.5 ) When discontinuing treatment, gradually taper to avoid signs and symptoms of withdrawal. ( 2.9 ) 2.1 Important Dosage and Administration Instructions Buprenorphine sublingual tablets is administered sublingually as a single daily dose. Bup…

Contraindications

4 CONTRAINDICATIONS Buprenorphine sublingual tablets is contraindicated in patients with a history of hypersensitivity to buprenorphine, as serious adverse reactions, including anaphylactic shock, have been reported [see Warnings and Precautions ( 5.9 )] . Hypersensitivity to buprenorphine. ( 4 )

Drug Interactions

7 DRUG INTERACTIONS Table 3 includes clinically significant drug interactions with buprenorphine sublingual tablets Table 3. Clinically Significant Drug Interactions Benzodiazepines or other Central Nervous System (CNS) Depressants Clinical Impact: Due to additive pharmacologic effects, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, increases the risk of respiratory depression, profound sedation, coma, and death. Intervention: Cessation of benzodiazepines or other CNS depressants is preferred in most cases of concomitant use. In some cases, monitoring in a higher level of care for taper may be appropriate. In others, gradually tapering a patient off of a prescribed benzodiazepine or CNS depressant or decreasing to the lowest effective dose may be appropriate. Before co-prescribing benzodiazepines for anxiety or insomnia, ensure that patients are appropriately diagnosed and consider alternative medications and non-pharmacologic treatments [see Warnings and Precautions ( 5.2 , 5.3 )] . If concomitant use is warranted, strongly consider prescribing naloxone for the emergency treatment of opioid overdose, as is recommended for all patients in treatm…

Adverse Reactions

6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Addiction, Abuse, and Misuse [see Warnings and Precautions ( 5.1 )] Respiratory and CNS Depression [see Warnings and Precautions ( 5.2 , 5.3 )] Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions ( 5.5 )] Adrenal Insufficiency [see Warnings and Precautions ( 5.6 )] Opioid Withdrawal [see Warnings and Precautions ( 5.7 , 5.10 )] Hepatitis, Hepatic Events [see Warnings and Precautions ( 5.8 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.9 )] Orthostatic Hypotension [see Warnings and Precautions ( 5.16 )] Elevation of Cerebrospinal Fluid Pressure [see Warnings and Precautions ( 5.17 )] Elevation of Intracholedochal Pressure [see Warnings and Precautions ( 5.18 )] Adverse events commonly observed with administration of buprenorphine are oral hypoesthesia, glossodynia, oral mucosal erythema, headache, nausea, vomiting, hyperhidrosis, constipation, signs and symptoms of withdrawal, insomnia,pain and peripheral edema. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact PAI Pharma at 1-800-845-8210 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinic…

Frequently Asked Questions

What is buprenorphine hydrochloride used for?

buprenorphine hydrochloride contains buprenorphine hydrochloride. It is a tablet taken sublingual. Consult your doctor for specific uses.

Is buprenorphine hydrochloride a controlled substance?

Yes, buprenorphine hydrochloride is classified as CIII under the DEA Controlled Substances Act.

What is the generic name for buprenorphine hydrochloride?

The generic name for buprenorphine hydrochloride is buprenorphine hydrochloride. There are 12 other brand versions of buprenorphine hydrochloride.

What is the NDC code for buprenorphine hydrochloride 2 mg/1?

The NDC (National Drug Code) for buprenorphine hydrochloride 2 mg/1 is 70518-4570, listed by REMEDYREPACK INC..

Product NDC

70518-4570

Package NDC

70518-4570-0

Other Buprenorphine Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)