12496-0100 : Sublocade 100 mg Subcutaneous Solution

Labeler: Indivior Inc.
Product Type: Human Prescription Drug
Drug Name:  Sublocade
Dosage Form: Subcutaneous Solution
Application #: NDA209819
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:

  • 12496-0100-1: 1 POUCH IN 1 CARTON (12496‑0100‑1) > 1 SYRINGE IN 1 POUCH (12496‑0100‑2) > 1 SOLUTION IN 1 SYRINGE (12496‑0100‑5)

Active Ingredients:

  • Buprenorphine

Dosage Strength:

  • 100 mg

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 12496-0300 Sublocade 300 mg Subcutaneous Solution by Indivior Inc.


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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.