63629-5074 : Buprenorphine Hcl and Naloxone Hcl Sublingual Tablet


NDC: 63629-5074
Labeler: Bryant Ranch Prepack
Product Type: Human Prescription Drug
Drug Name: Buprenorphine Hcl and Naloxone Hcl
Dosage Form: Sublingual Tablet
Application #: ANDA203136
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: AN;415
Shapes:  Round
Colors:  Orange
Size (mm): 11
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.

AN 415: (42291-175) Buprenorphine Hcl and Naloxone Hcl 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:

  • 63629-5074-0: 42 TABLET IN 1 BOTTLE (63629‑5074‑0)
  • 63629-5074-1: 30 TABLET IN 1 BOTTLE (63629‑5074‑1)
  • 63629-5074-2: 60 TABLET IN 1 BOTTLE (63629‑5074‑2)
  • 63629-5074-3: 90 TABLET IN 1 BOTTLE (63629‑5074‑3)
  • 63629-5074-4: 120 TABLET IN 1 BOTTLE (63629‑5074‑4)
  • 63629-5074-5: 14 TABLET IN 1 BOTTLE (63629‑5074‑5)
  • 63629-5074-6: 28 TABLET IN 1 BOTTLE (63629‑5074‑6)
  • 63629-5074-7: 6 TABLET IN 1 BOTTLE (63629‑5074‑7)
  • 63629-5074-8: 10 TABLET IN 1 BOTTLE (63629‑5074‑8)
  • 63629-5074-9: 21 TABLET IN 1 BOTTLE (63629‑5074‑9)

Active Ingredients:

  • Buprenorphine Hydrochloride
  • Naloxone Hydrochloride Dihydrate

Dosage Strength:

  • 8 mg
  • 2 mg

Inactive Ingredients:

  • Acesulfame Potassium
  • Anhydrous Citric Acid
  • Fd&c Yellow No. 6
  • Lactose Monohydrate
  • Magnesium Stearate
  • Mannitol
  • Povidones
  • Sodium Citrate
  • Starch, Corn

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 63629-7269 Buprenorphine Hcl and Naloxone Hcl Sublingual Tablet by Bryant Ranch Prepack
  • 71335-1514 Buprenorphine 2 mg / Naloxone 0.5 mg Sublingual Tablet by Bryant Ranch Prepack
  • 0406-1923 Buprenorphine 2 mg / Naloxone 0.5 mg Sublingual Tablet by Mallinckrodt, Inc.
  • 0406-1924 Buprenorphine 8 mg / Naloxone 2 mg Sublingual Tablet by Mallinckrodt, Inc.
  • 42291-174 Buprenorphine 2 mg / Naloxone 0.5 mg Sublingual Tablet by Avkare, Inc.
  • 42291-175 Buprenorphine 8 mg / Naloxone 2 mg Sublingual Tablet by Avkare, Inc.
  • 50268-144 Buprenorphine Hcl and Naloxone Hcl Sublingual Tablet by Avpak
  • 50268-145 Buprenorphine Hcl and Naloxone Hcl Sublingual Tablet by Avpak
  • 54569-6408 Buprenorphine Hcl and Naloxone Hcl Sublingual Tablet by A-s Medication Solutions LLC
  • 65162-415 Buprenorphine 8 mg / Naloxone 2 mg Sublingual Tablet by Amneal Pharmaceuticals, LLC
  • 65162-416 Buprenorphine 2 mg / Naloxone 0.5 mg Sublingual Tablet by Amneal Pharmaceuticals, LLC
  • 70518-1007 Buprenorphine Hcl and Naloxone Hcl Sublingual Tablet by Remedyrepack Inc.
  • 70518-1684 Buprenorphine Hcl and Naloxone Hcl Sublingual Tablet by Remedyrepack Inc.

NDC QR Code

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NDC 63629-5074 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.