16729-549 : Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate Sublingual Tablet

NDC:	16729-549
Labeler:	Accord Healthcare, Inc
Product Type:	Human Prescription Drug
Drug Name:	Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate
Dosage Form:	Sublingual Tablet
Application #:	ANDA209069
Rev. Date:	Jan 22, 2021
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:

16729-549-10: 30 TABLET IN 1 BOTTLE, PLASTIC (16729‑549‑10)

Active Ingredients:

Buprenorphine Hydrochloride
Naloxone Hydrochloride Dihydrate

Dosage Strength:

2 mg
.5 mg

Pharmaceutical Classes:

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