0121-2036 : Buprenorphine and Naloxone Sublingual Tablet

NDC:	0121-2036
Labeler:	Pai Holdings, LLC Dba Pharmaceutical Associates, Inc. and Dba Pai Pharma
Product Type:	Human Prescription Drug
Drug Name:	Buprenorphine and Naloxone
Dosage Form:	Sublingual Tablet
Application #:	ANDA204431
Rev. Date:	Sep 5, 2023
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:

0121-2036-30: 30 TABLET IN 1 BOTTLE, PLASTIC (0121‑2036‑30)

Active Ingredients:

Buprenorphine Hydrochloride
Naloxone Hydrochloride

Dosage Strength:

8 mg
2 mg

Pharmaceutical Classes:

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

NDC QR Code

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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.