NDC 53217-328

Suboxone

Buprenorphine Hydrochloride, Naloxone Hydrochloride

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

• Product ID: 53217-328_4f1210ae-a8ec-4253-b825-35e66ac93a1c
• NDC: 53217-328
• Product Type: Human Prescription Drug
• Proprietary Name: Suboxone
• Generic Name: Buprenorphine Hydrochloride, Naloxone Hydrochloride
• Dosage Form: Film, Soluble
• Route of Administration: SUBLINGUAL
• Marketing Start Date: 2010-09-13
• Marketing Category: NDA / NDA
• Application Number: NDA022410
• Labeler Name: Aidarex Pharmaceuticals LLC
• Substance Name: BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
• Active Ingredient Strength: 8 mg/1; mg/1
• Pharm Classes: Partial Opioid Agonists [MoA],Partial Opioid Agonist [EPC],Opioid Antagonist [EPC],Opioid Antagonists [MoA]
• DEA Schedule: CIII
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 53217-328-01

30 POUCH in 1 CARTON (53217-328-01) > 1 FILM, SOLUBLE in 1 POUCH

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

NDC SPL Data Element Entries

NDC 53217-328-01 [53217032801]

Suboxone FILM, SOLUBLE

• Marketing Category: NDA
• Application Number: NDA022410
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2010-09-13
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
BUPRENORPHINE HYDROCHLORIDE	8 mg/1

OpenFDA Data

• SPL SET ID: 54c487ac-750b-462e-a4cb-dcab1dd43ba8
• Manufacturer:
  • Aidarex Pharmaceuticals LLC
• UNII:
  • 56W8MW3EN1
  • F850569PQR
• RxNorm Concept Unique ID - RxCUI:
  • 1010604
  • 1010606

Pharmacological Class

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

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