0121-2038 : Buprenorphine Hydrochloride 8 mg Sublingual Tablet


NDC: 0121-2038
Labeler: Pai Holdings, LLC Dba Pharmaceutical Associates, Inc. and Dba Pai Pharma
Product Type: Human Prescription Drug
Drug Name:  Buprenorphine Hydrochloride
Dosage Form: Sublingual Tablet
Application #: ANDA090622
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.

NDC Package Codes:

  • 0121-2038-30: 30 TABLET IN 1 BOTTLE (0121‑2038‑30)

Active Ingredients:

  • Buprenorphine Hydrochloride

Dosage Strength:

  • 8 mg

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 0121-1019 Buprenorphine Hydrochloride 2 mg Sublingual Tablet by Pai Holdings, LLC Dba Pharmaceutical Associates, Inc. and Dba Pai Pharma
  • 0093-5378 Buprenorphine 2 mg (As Buprenorphine Hydrochloride 2.16 mg) Sublingual Tablet by Teva Pharmaceuticals USA Inc
  • 0093-5379 Buprenorphine 8 mg (As Buprenorphine Hydrochloride 8.64 mg) Sublingual Tablet by Teva Pharmaceuticals USA Inc
  • 0143-9246 Buprenorphine Hydrochloride .324 mg/ml Intramuscular; Intravenous Injection by Hikma Pharmaceuticals USA Inc.
  • 0409-2012 Buprenorphine Hydrochloride .3 mg/ml Intramuscular; Intravenous Injection, Solution by Hospira, Inc.
  • 0517-0725 Buprenorphine Hydrochloride .324 mg/ml Intramuscular; Intravenous Injection, Solution by American Regent, Inc.
  • 21695-515 Buprenorphine Hydrochloride .3 mg/ml Intramuscular; Intravenous Injection, Solution by Rebel Distributors Corp
  • 35356-556 Buprenorphine Hydrochloride 8 mg Sublingual Tablet by Lake Erie Medical Dba Quality Care Products LLC
  • 42023-179 Buprenorphine Hydrochloride .324 mg/ml Intramuscular; Intravenous Injection by Par Pharmaceutical Inc.
  • 43063-667 Buprenorphine Hydrochloride 8 mg Sublingual Tablet by Pd-rx Pharmaceuticals, Inc.
  • 49349-421 Buprenorphine 2 mg (As Buprenorphine Hydrochloride 2.16 mg) Sublingual Tablet by Remedyrepack Inc.
  • 49349-554 Buprenorphine 2 mg (As Buprenorphine Hydrochloride 2.16 mg) Sublingual Tablet by Remedyrepack Inc.
  • 50090-1571 Buprenorphine Hydrochloride 8 mg Sublingual Tablet by A-s Medication Solutions
  • 50383-924 Buprenorphine 2 mg (As Buprenorphine Hydrochloride 2.16 mg) Sublingual Tablet by Hi-tech Pharmacal Co., Inc.
  • 50383-930 Buprenorphine 8 mg (As Buprenorphine Hydrochloride 8.64 mg) Sublingual Tablet by Hi-tech Pharmacal Co., Inc.
  • 52125-649 Buprenorphine 8 mg (As Buprenorphine Hydrochloride 8.64 mg) Sublingual Tablet by Remedyrepack Inc.
  • 52125-678 Buprenorphine 2 mg (As Buprenorphine Hydrochloride 2.16 mg) Sublingual Tablet by Remedyrepack Inc.
  • 53217-246 Buprenorphine Hydrochloride 8 mg Sublingual Tablet by Aidarex Pharmaceuticals LLC
  • 54569-6578 Buprenorphine Hydrochloride 8 mg Sublingual Tablet by A-s Medication Solutions LLC
  • 63629-4092 Buprenorphine 8 mg (As Buprenorphine Hydrochloride 8.64 mg) Sublingual Tablet by Bryant Ranch Prepack
  • More related products ...

NDC QR Code

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NDC 0121-2038 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.