61786-678 : Buprenorphine Hydrochloride Sublingual Sublingual 2 mg Sublingual Tablet


NDC61786-678
Labeler: Remedyrepack Inc.
Product Type: Human Prescription Drug
Drug Name:  Buprenorphine Hydrochloride Sublingual
Dosage Form: Sublingual Tablet
Application #: ANDA201066
Rev. Date: 
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: M;923
Shapes:  Round
Colors:  White
Size (mm): 6
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:

  • 61786-678-02: 30 TABLET IN 1 BOTTLE (61786‑678‑02)

Active Ingredients:

  • Buprenorphine Hydrochloride

Dosage Strength:

  • 2 mg

Inactive Ingredients:

  • Anhydrous Citric Acid
  • Anhydrous Lactose
  • Silicon Dioxide
  • Starch, Corn
  • Crospovidone (15 Mpa.s At 5%)
  • Lactose Monohydrate
  • Magnesium Stearate
  • Mannitol
  • Cellulose, Microcrystalline
  • Sodium Citrate, Unspecified Form

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 70518-0652 Buprenorphine Hydrochloride Sublingual Sublingual 2 mg Sublingual Tablet by Remedyrepack Inc.
  • 0378-0923 Buprenorphine Hydrochloride Sublingual 2 mg Sublingual Tablet by Mylan Pharmaceuticals Inc.
  • 0378-0924 Buprenorphine Hydrochloride Sublingual 8 mg Sublingual Tablet by Mylan Pharmaceuticals Inc.
  • 67046-996 Buprenorphine Hydrochloride Sublingual Sublingual 2 mg Sublingual Tablet by Contract Pharmacy Services-pa
  • 67046-997 Buprenorphine Hydrochloride Sublingual Sublingual 8 mg Sublingual Tablet by Contract Pharmacy Services-pa

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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.