71335-1163 : Buprenorphine Hcl 8 mg Sublingual Tablet


NDC: 71335-1163
Labeler: Bryant Ranch Prepack
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 Bryant Ranch Prepack
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:

  • 71335-1163-0: 120 TABLET IN 1 BOTTLE (71335‑1163‑0)
  • 71335-1163-1: 90 TABLET IN 1 BOTTLE (71335‑1163‑1)
  • 71335-1163-2: 60 TABLET IN 1 BOTTLE (71335‑1163‑2)
  • 71335-1163-3: 30 TABLET IN 1 BOTTLE (71335‑1163‑3)
  • 71335-1163-4: 20 TABLET IN 1 BOTTLE (71335‑1163‑4)
  • 71335-1163-5: 7 TABLET IN 1 BOTTLE (71335‑1163‑5)
  • 71335-1163-6: 28 TABLET IN 1 BOTTLE (71335‑1163‑6)
  • 71335-1163-7: 1 TABLET IN 1 BOTTLE (71335‑1163‑7)
  • 71335-1163-8: 12 TABLET IN 1 BOTTLE (71335‑1163‑8)
  • 71335-1163-9: 14 TABLET IN 1 BOTTLE (71335‑1163‑9)

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
  • Povidone, Unspecified
  • Sodium Citrate, Unspecified Form
  • Water /

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 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
  • 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
  • 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.

NDC QR Code

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NDC 71335-1163 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.