0378-0924 : Buprenorphine Hydrochloride Sublingual 8 mg Sublingual Tablet


NDC0378-0924
Labeler: Mylan Pharmaceuticals 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;924
Shapes:  Round
Colors:  White
Size (mm): 10
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:

  • 0378-0924-05: 500 TABLET IN 1 BOTTLE, PLASTIC (0378‑0924‑05)
  • 0378-0924-93: 30 TABLET IN 1 BOTTLE, PLASTIC (0378‑0924‑93)

Active Ingredients:

  • Buprenorphine Hydrochloride

Dosage Strength:

  • 8 mg

Inactive Ingredients:

  • Anhydrous Citric Acid
  • Anhydrous Lactose
  • Silicon Dioxide
  • Starch, Corn
  • Crospovidone
  • Lactose Monohydrate
  • Magnesium Stearate
  • Mannitol
  • Cellulose, Microcrystalline
  • Sodium Citrate

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 0378-0923 Buprenorphine Hydrochloride Sublingual 2 mg Sublingual Tablet by Mylan Pharmaceuticals Inc.
  • 61786-678 Buprenorphine Hydrochloride Sublingual Sublingual 2 mg Sublingual Tablet by Remedyrepack 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
  • 70518-0652 Buprenorphine Hydrochloride Sublingual Sublingual 2 mg Sublingual Tablet by Remedyrepack Inc.

NDC QR Code

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NDC 0378-0924 QR Code

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