55700-303 : Buprenorphine Hcl 8 mg Sublingual Tablet


NDC55700-303
Labeler: Lake Erie Medical Dba Quality Care Products LLC
Product Type: Human Prescription Drug
Drug Name:  Buprenorphine Hcl
Dosage Form: Sublingual Tablet
Application #: ANDA078633
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: 54;411
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.

54 411: (0054-0177) Buprenorphine Hcl 8 mg Sublingual Tablet by Lake Erie Medical Dba Quality Care Products LLC
The above image is provided by the U.S. National Library of Medicine (NLM) and is not part of the official label.

NDC Package Codes:

  • 55700-303-30: 30 TABLET IN 1 BOTTLE (55700‑303‑30)

Active Ingredients:

  • Buprenorphine Hydrochloride

Dosage Strength:

  • 8 mg

Inactive Ingredients:

  • Anhydrous Citric Acid
  • Starch, Corn
  • Crospovidone
  • Lactose Monohydrate
  • Magnesium Stearate
  • Mannitol
  • Povidones
  • Sodium Citrate

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 55700-302 Buprenorphine Hcl 2 mg Sublingual Tablet by Lake Erie Medical Dba Quality Care Products LLC
  • 0054-0176 Buprenorphine 2 mg (As Buprenorphine Hydrochloride 2.16 mg) Sublingual Tablet by Roxane Laboratories, Inc
  • 0054-0177 Buprenorphine 8 mg (As Buprenorphine Hydrochloride 8.64 mg) Sublingual Tablet by Roxane Laboratories, Inc
  • 43063-753 Buprenorphine Hcl 8 mg Sublingual Tablet by Pd-rx Pharmaceuticals, Inc.
  • 55154-4962 Buprenorphine 2 mg (As Buprenorphine Hydrochloride 2.16 mg) Sublingual Tablet by Cardinal Health
  • 58118-0176 Buprenorphine Hcl 2 mg Sublingual Tablet by Clinical Solutions Wholesale, LLC
  • 58118-0177 Buprenorphine Hcl 8 mg Sublingual Tablet by Clinical Solutions Wholesale, LLC
  • 67046-998 Buprenorphine Hcl 2 mg Sublingual Tablet by Contract Pharmacy Services-pa
  • 67046-999 Buprenorphine Hcl 8 mg Sublingual Tablet by Contract Pharmacy Services-pa
  • 70518-2014 Buprenorphine Hcl 8 mg Sublingual Tablet by Remedyrepack Inc.
  • 70518-2226 Buprenorphine Hcl 2 mg Sublingual Tablet by Remedyrepack Inc.
  • 71335-1163 Buprenorphine Hcl 8 mg Sublingual Tablet by Bryant Ranch Prepack

NDC QR Code

Scan the QR code below to easily reference this data in the future:

NDC 55700-303 QR Code

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