NDC 12496-1208

Suboxone

Buprenorphine Hydrochloride, Naloxone Hydrochloride

Suboxone is a Buccal; Sublingual Film, Soluble in the Human Prescription Drug category. It is labeled and distributed by Indivior Inc.. The primary component is Buprenorphine Hydrochloride; Naloxone Hydrochloride.

• Product ID: 12496-1208_1e2afa2f-2bc7-481c-a1f6-97632642199f
• NDC: 12496-1208
• Product Type: Human Prescription Drug
• Proprietary Name: Suboxone
• Generic Name: Buprenorphine Hydrochloride, Naloxone Hydrochloride
• Dosage Form: Film, Soluble
• Route of Administration: BUCCAL; SUBLINGUAL
• Marketing Start Date: 2010-09-13
• Marketing Category: NDA / NDA
• Application Number: NDA022410
• Labeler Name: Indivior Inc.
• Substance Name: BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
• Active Ingredient Strength: 8 mg/1; mg/1
• Pharm Classes: Opioid Antagonist [EPC], Opioid Antagonists [MoA], Partial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]
• DEA Schedule: CIII
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 12496-1208-3

30 POUCH in 1 CARTON (12496-1208-3) > 1 FILM, SOLUBLE in 1 POUCH (12496-1208-1)

• Marketing Start Date: 2010-09-13
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 12496-1208-1 [12496120801]

Suboxone FILM, SOLUBLE

• Marketing Category: NDA
• Application Number: NDA022410
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2010-09-13

NDC 12496-1208-3 [12496120803]

Suboxone FILM, SOLUBLE

• Marketing Category: NDA
• Application Number: NDA022410
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2010-09-13

Drug Details

Active Ingredients

Ingredient	Strength
BUPRENORPHINE HYDROCHLORIDE	8 mg/1

OpenFDA Data

• SPL SET ID: 8a5edcf9-828c-4f97-b671-268ab13a8ecd
• Manufacturer:
  • Indivior Inc.
• UNII:
  • 56W8MW3EN1
  • F850569PQR
• RxNorm Concept Unique ID - RxCUI:
  • 1010600
  • 1010603
  • 1010604
  • 1010606
  • 1307058
  • 1307063
  • 1307061
  • 1307056
• UPC Code:
  • 0312496120835
  • 0312496120439
  • 0312496120231
  • 0312496121238

Pharmacological Class

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

Medicade Reported Pricing

12496120803 SUBOXONE 8 MG-2 MG SL FILM

Pricing Unit: EA | Drug Type:

NDC Crossover Matching brand name "Suboxone" or generic name "Buprenorphine Hydrochloride, Naloxone Hydrochloride"

NDC	Brand Name	Generic Name
12496-1202	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride
12496-1204	Suboxone	buprenorphine hydrochloride, naloxone hydrochloride
12496-1212	Suboxone	Suboxone
12496-1208	Suboxone	Suboxone
53217-328	Suboxone	Suboxone
55700-147	Suboxone	Suboxone
63629-4028	Suboxone	Suboxone
0781-7216	BUPRENORPHINE AND NALOXONE	buprenorphine hydrochloride, naloxone hydrochloride
0781-7227	BUPRENORPHINE AND NALOXONE	buprenorphine hydrochloride, naloxone hydrochloride
0781-7238	BUPRENORPHINE AND NALOXONE	buprenorphine hydrochloride, naloxone hydrochloride
0781-7249	BUPRENORPHINE AND NALOXONE	buprenorphine hydrochloride, naloxone hydrochloride