NDC 0406-8005

Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate

Buprenorphine Hydrochloride And Naloxone Hydrochloride Dihydrate

Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate is a Sublingual Tablet in the Human Prescription Drug category. It is labeled and distributed by Specgx Llc. The primary component is Buprenorphine Hydrochloride; Naloxone Hydrochloride Dihydrate.

• Product ID: 0406-8005_55ab91e0-8108-45b4-b4ba-4d6d395a9e83
• NDC: 0406-8005
• Product Type: Human Prescription Drug
• Proprietary Name: Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate
• Generic Name: Buprenorphine Hydrochloride And Naloxone Hydrochloride Dihydrate
• Dosage Form: Tablet
• Route of Administration: SUBLINGUAL
• Marketing Start Date: 2013-12-02
• Marketing Category: ANDA / ANDA
• Application Number: ANDA207000
• Labeler Name: SpecGx LLC
• Substance Name: BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE
• Active Ingredient Strength: 2 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 0406-8005-03

30 TABLET in 1 BOTTLE, PLASTIC (0406-8005-03)

• Marketing Start Date: 2017-12-13
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0406-8005-03 [00406800503]

Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate TABLET

• Marketing Category: ANDA
• Application Number: ANDA207000
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-12-13

Drug Details

Active Ingredients

Ingredient	Strength
BUPRENORPHINE HYDROCHLORIDE	2 mg/1

OpenFDA Data

• SPL SET ID: 62abde41-46cb-4e90-a798-23d6531bf9aa
• Manufacturer:
  • SpecGx LLC
• UNII:
  • 5Q187997EE
  • 56W8MW3EN1
• RxNorm Concept Unique ID - RxCUI:
  • 351267
  • 351266
• UPC Code:
  • 0304068005039
  • 0304068020032

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
0054-0188	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	buprenorphine hydrochloride and naloxone hydrochloride dihydrate
0054-0189	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	buprenorphine hydrochloride and naloxone hydrochloride dihydrate
0406-8005	Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate	Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate
0406-8020	Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate	Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate
0904-7009	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	buprenorphine hydrochloride and naloxone hydrochloride dihydrate
0904-7010	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	buprenorphine hydrochloride and naloxone hydrochloride dihydrate
16729-549	BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE	BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE
16729-550	BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE	BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE
71335-1653	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	buprenorphine hydrochloride and naloxone hydrochloride dihydrate
71335-1725	Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate	Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate
71335-1720	buprenorphine hydrochloride and naloxone hydrochloride dihydrate	buprenorphine hydrochloride and naloxone hydrochloride dihydrate