12496-0100 : Sublocade 100 mg Subcutaneous Solution


NDC12496-0100
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.

NDC QR Code

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