53217-246 : Buprenorphine Hydrochloride 8 mg Sublingual Tablet

NDC:	53217-246
Labeler:	Aidarex Pharmaceuticals LLC
Product Type:	Human Prescription Drug
Drug Name:	Buprenorphine Hydrochloride
Dosage Form:	Sublingual Tablet
Application #:	ANDA090622
Rev. Date:	Sep 24, 2010
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.

Appearance:

Markings:	8
Shapes:	Round
Colors:	White
Size (mm):	7
Segments: ^*	1
^* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

NDC Package Codes:

53217-246-30: 30 TABLET IN 1 BOTTLE (53217‑246‑30)

Active Ingredients:

Buprenorphine Hydrochloride

Dosage Strength:

8 mg

Inactive Ingredients:

Sodium Stearyl Fumarate
Lactose Monohydrate
Mannitol
Anhydrous Citric Acid
Trisodium Citrate Dihydrate
Povidone K30

Pharmaceutical Classes:

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

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.