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NDC 70518-2216-00 buprenorphine hydrochloride 2 mg/1 Details

buprenorphine hydrochloride 2 mg/1

buprenorphine hydrochloride is a SUBLINGUAL TABLET in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by REMEDYREPACK INC.. The primary component is BUPRENORPHINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Buprenorphine and the combination of buprenorphine and naloxone are used to treat opioid dependence (addiction to opioid drugs, including heroin and narcotic painkillers). Buprenorphine is in a class of medications called opioid partial agonist-antagonists and naloxone is in a class of medications called opioid antagonists. Buprenorphine alone and the combination of buprenorphine and naloxone work to prevent withdrawal symptoms when someone stops taking opioid drugs by producing similar effects to these drugs.

Related Packages: 70518-2216-00
Last Updated: 02/19/2023
MedLinePlus Full Drug Details: Buprenorphine Sublingual and Buccal (opioid dependence)

Product Information

NDC	70518-2216
Product ID	70518-2216_0b279036-7887-023a-e063-6294a90a15e4
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	buprenorphine hydrochloride
Proprietary Name Suffix	n/a
Non-Proprietary Name	buprenorphine hydrochloride
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	TABLET
Route	SUBLINGUAL
Active Ingredient Strength	2
Active Ingredient Units	mg/1
Substance Name	BUPRENORPHINE HYDROCHLORIDE
Labeler Name	REMEDYREPACK INC.
Pharmaceutical Class	Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]
DEA Schedule	CIII
Marketing Category	ANDA
Application Number	ANDA090622
Listing Certified Through	n/a

Package

NDC 70518-2216-00 (70518221600)

Pricing Information	N/A
NDC Package Code	70518-2216-0
Billing NDC	70518221600
Package	30 TABLET in 1 BLISTER PACK (70518-2216-0)
Marketing Start Date	2019-07-15
NDC Exclude Flag	N