NDC 12496-0100

SUBLOCADE

Buprenorphine

SUBLOCADE is a Subcutaneous Solution in the Human Prescription Drug category. It is labeled and distributed by Indivior Inc.. The primary component is Buprenorphine.

• Product ID: 12496-0100_07dfc3a0-d6b1-4ca4-939a-2fb001a52164
• NDC: 12496-0100
• Product Type: Human Prescription Drug
• Proprietary Name: SUBLOCADE
• Generic Name: Buprenorphine
• Dosage Form: Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2018-02-26
• Marketing Category: NDA / NDA
• Application Number: NDA209819
• Labeler Name: Indivior Inc.
• Substance Name: BUPRENORPHINE
• Active Ingredient Strength: 100 mg/1
• Pharm Classes: Partial Opioid Agonists [MoA],Partial Opioid Agonist [EPC]
• DEA Schedule: CIII
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 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)

• Marketing Start Date: 2018-02-26
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 12496-0100-2 [12496010002]

SUBLOCADE SOLUTION

• Marketing Category: NDA
• Application Number: NDA209819
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-02-26

NDC 12496-0100-5 [12496010005]

SUBLOCADE SOLUTION

• Marketing Category: NDA
• Application Number: NDA209819
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-02-26

NDC 12496-0100-1 [12496010001]

SUBLOCADE SOLUTION

• Marketing Category: NDA
• Application Number: NDA209819
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-02-26

Drug Details

Active Ingredients

Ingredient	Strength
BUPRENORPHINE	100 mg/1

OpenFDA Data

• SPL SET ID: 6189fb21-9432-45f8-8481-0bfaf3ccde95
• Manufacturer:
  • Indivior Inc.
• UNII:
  • 40D3SCR4GZ
• RxNorm Concept Unique ID - RxCUI:
  • 1996184
  • 1996192
  • 1996189
  • 1996193

Pharmacological Class

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

NDC Crossover Matching brand name "SUBLOCADE" or generic name "Buprenorphine"

NDC	Brand Name	Generic Name
12496-0300	SUBLOCADE	SUBLOCADE
12496-0100	SUBLOCADE	SUBLOCADE
0093-3239	Buprenorphine	Buprenorphine
0093-3600	Buprenorphine	Buprenorphine
0093-3601	Buprenorphine	Buprenorphine
0093-3602	Buprenorphine	Buprenorphine
0093-3603	Buprenorphine	Buprenorphine
0093-3656	Buprenorphine	Buprenorphine
0093-3657	Buprenorphine	Buprenorphine
0093-3658	Buprenorphine	Buprenorphine
0093-3659	Buprenorphine	Buprenorphine
0228-3153	Buprenorphine	Buprenorphine
0228-3156	Buprenorphine	Buprenorphine