67046-999 : Buprenorphine Hcl 8 mg Sublingual Tablet


NDC67046-999
Labeler: Contract Pharmacy Services-pa
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 Contract Pharmacy Services-pa
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:

  • 67046-999-30: 30 TABLET IN 1 BLISTER PACK (67046‑999‑30)

Active Ingredients:

  • Buprenorphine Hydrochloride

Dosage Strength:

  • 8 mg

Inactive Ingredients:

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

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 67046-998 Buprenorphine Hcl 2 mg Sublingual Tablet by Contract Pharmacy Services-pa
  • 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
  • 0904-7154 Buprenorphine Hcl 2 mg Sublingual Tablet by Major Pharmaceuticals
  • 0904-7155 Buprenorphine Hcl 8 mg Sublingual Tablet by Major Pharmaceuticals
  • 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
  • 55700-302 Buprenorphine Hcl 2 mg Sublingual Tablet by Lake Erie Medical Dba Quality Care Products LLC
  • 55700-303 Buprenorphine Hcl 8 mg Sublingual Tablet by Lake Erie Medical Dba Quality Care Products LLC
  • 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
  • 68071-2915 Buprenorphine Hcl 8 mg Sublingual Tablet by Nucare Pharmaceuticals, Inc.
  • 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

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