NDC 54123-114

Zubsolv

Buprenorphine Hydrochloride And Naloxone Hydrochloride

Zubsolv is a Sublingual Tablet, Orally Disintegrating in the Human Prescription Drug category. It is labeled and distributed by Orexo Us, Inc.. The primary component is Buprenorphine Hydrochloride; Naloxone Hydrochloride.

• Product ID: 54123-114_568c06d0-5a40-4a95-aff6-08c8af8bb6f9
• NDC: 54123-114
• Product Type: Human Prescription Drug
• Proprietary Name: Zubsolv
• Generic Name: Buprenorphine Hydrochloride And Naloxone Hydrochloride
• Dosage Form: Tablet, Orally Disintegrating
• Route of Administration: SUBLINGUAL
• Marketing Start Date: 2014-12-11
• Marketing Category: NDA / NDA
• Application Number: NDA204242
• Labeler Name: Orexo US, Inc.
• Substance Name: BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
• Active Ingredient Strength: 11 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: 2020-12-31

Packaging

NDC 54123-114-30

3 BLISTER PACK in 1 CARTON (54123-114-30) > 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

• Marketing Start Date: 2014-12-11
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 54123-114-30 [54123011430]

Zubsolv TABLET, ORALLY DISINTEGRATING

• Marketing Category: NDA
• Application Number: NDA204242
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-12-11

Drug Details

Active Ingredients

Ingredient	Strength
BUPRENORPHINE HYDROCHLORIDE	11.4 mg/1

OpenFDA Data

• SPL SET ID: 5f5cfcfe-d52b-49e6-8fe4-550477332dd2
• Manufacturer:
  • Orexo US, Inc.
• UNII:
  • 56W8MW3EN1
  • F850569PQR
• RxNorm Concept Unique ID - RxCUI:
  • 1666338
  • 1597570
  • 1597573
  • 1597575
  • 1431076
  • 1597568
  • 1431083
  • 1666385
  • 1864412
  • 1431104
  • 1431102
  • 1864414

Pharmacological Class

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

Medicade Reported Pricing

54123011430 ZUBSOLV 11.4-2.9 MG TABLET SL

Pricing Unit: EA | Drug Type:

NDC Crossover Matching brand name "Zubsolv" or generic name "Buprenorphine Hydrochloride And Naloxone Hydrochloride"

NDC	Brand Name	Generic Name
54123-114	Zubsolv	buprenorphine hydrochloride and naloxone hydrochloride
54123-907	Zubsolv	buprenorphine hydrochloride and naloxone hydrochloride
54123-914	Zubsolv	buprenorphine hydrochloride and naloxone hydrochloride
54123-929	Zubsolv	buprenorphine hydrochloride and naloxone hydrochloride
54123-957	Zubsolv	buprenorphine hydrochloride and naloxone hydrochloride
54123-986	Zubsolv	buprenorphine hydrochloride and naloxone hydrochloride
50383-287	Buprenorphine and Naloxone	buprenorphine hydrochloride and naloxone hydrochloride
50383-294	Buprenorphine and Naloxone	buprenorphine hydrochloride and naloxone hydrochloride
53217-138	Buprenorphine and Naloxone	buprenorphine hydrochloride and naloxone hydrochloride
60429-586	Buprenorphine and Naloxone	buprenorphine hydrochloride and naloxone hydrochloride