NDC 55700-303

Buprenorphine HCl

Buprenorphine Hcl

Buprenorphine HCl is a Sublingual Tablet in the Human Prescription Drug category. It is labeled and distributed by Lake Erie Medical Dba Quality Care Products Llc. The primary component is Buprenorphine Hydrochloride.

• Product ID: 55700-303_08baddc7-e814-4a5e-a886-fc98860ab478
• NDC: 55700-303
• Product Type: Human Prescription Drug
• Proprietary Name: Buprenorphine HCl
• Generic Name: Buprenorphine Hcl
• Dosage Form: Tablet
• Route of Administration: SUBLINGUAL
• Marketing Start Date: 2009-10-08
• Marketing Category: ANDA / ANDA
• Application Number: ANDA078633
• Labeler Name: Lake Erie Medical DBA Quality Care Products LLC
• Substance Name: BUPRENORPHINE HYDROCHLORIDE
• Active Ingredient Strength: 8 mg/1
• Pharm Classes: Partial Opioid Agonists [MoA],Partial Opioid Agonist [EPC]
• DEA Schedule: CIII
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 55700-303-30

30 TABLET in 1 BOTTLE (55700-303-30)

• Marketing Start Date: 2015-09-23
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55700-303-30 [55700030330]

Buprenorphine HCl TABLET

• Marketing Category: ANDA
• Application Number: ANDA078633
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-09-23
• Marketing End Date: 2019-10-11

Drug Details

Active Ingredients

Ingredient	Strength
BUPRENORPHINE HYDROCHLORIDE	8 mg/1

OpenFDA Data

• SPL SET ID: 8ca10664-b194-4e28-b40c-91b84fd727fc
• Manufacturer:
  • Lake Erie Medical DBA Quality Care Products LLC
• UNII:
  • 56W8MW3EN1
• RxNorm Concept Unique ID - RxCUI:
  • 351265
  • 351264

Pharmacological Class

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

NDC Crossover Matching brand name "Buprenorphine HCl" or generic name "Buprenorphine Hcl"

NDC	Brand Name	Generic Name
0054-0176	Buprenorphine HCl	Buprenorphine HCl
0054-0177	Buprenorphine HCl	Buprenorphine HCl
0904-7154	Buprenorphine HCl	Buprenorphine HCl
0904-7155	Buprenorphine HCl	Buprenorphine HCl
55700-302	Buprenorphine HCl	Buprenorphine HCl
55700-303	Buprenorphine HCl	Buprenorphine HCl
58118-0176	Buprenorphine HCl	Buprenorphine HCl
58118-0177	Buprenorphine HCl	Buprenorphine HCl
67046-998	Buprenorphine HCl	Buprenorphine HCl
67046-999	Buprenorphine HCl	Buprenorphine HCl
70518-2014	Buprenorphine HCl	Buprenorphine HCl
70518-2226	Buprenorphine HCl	Buprenorphine HCl
71335-1163	Buprenorphine HCl	Buprenorphine HCl
76519-1170	BUPRENORPHINE HCL	BUPRENORPHINE HCL