58118-8005 : Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate Sublingual Tablet

NDC:	58118-8005
Labeler:	Clinical Solutions Wholesale, LLC
Product Type:	Human Prescription Drug
Drug Name:	Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate
Dosage Form:	Sublingual Tablet
Application #:	ANDA207000
Rev. Date:	Dec 13, 2017
CSA Schedule:	CIII (US) ^[1]

^[1] Schedule III / IIIN Controlled Substance: Has a potential for abuse less than substances in Schedules I or II and abuse may lead to moderate or low physical dependence or high psychological dependence. (i.e. Products containing not more than 90 milligrams of Codeine per dosage unit [such as Tylenol with Codeine], other narcotics such as Buprenorphine (Suboxone), and Schedule IIIN non-narcotics such as Didrex, Ketamine, Phendimetrazine, and Anabolic Steroids). More Details: US Dept of Justice Controlled Substance Schedules.

NDC Package Codes:

58118-8005-8: 30 TABLET IN 1 BLISTER PACK (58118‑8005‑8)

Active Ingredients:

Buprenorphine Hydrochloride
Naloxone Hydrochloride Dihydrate

Dosage Strength:

2 mg
.5 mg

Pharmaceutical Classes:

Opioid Antagonist [EPC]
Opioid Antagonists [MoA]
Partial Opioid Agonist [EPC]
Partial Opioid Agonists [MoA]

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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.