NDC 59212-001

Dibenzyline

Phenoxybenzamine Hydrochloride

Dibenzyline is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Concordia Pharmaceuticals Inc.. The primary component is Phenoxybenzamine Hydrochloride.

• Product ID: 59212-001_43b501fd-471f-41eb-b302-21fd63bc3424
• NDC: 59212-001
• Product Type: Human Prescription Drug
• Proprietary Name: Dibenzyline
• Generic Name: Phenoxybenzamine Hydrochloride
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 1953-01-26
• Marketing Category: NDA / NDA
• Application Number: NDA008708
• Labeler Name: Concordia Pharmaceuticals Inc.
• Substance Name: PHENOXYBENZAMINE HYDROCHLORIDE
• Active Ingredient Strength: 10 mg/1
• Pharm Classes: Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 59212-001-01

100 CAPSULE in 1 BOTTLE (59212-001-01)

• Marketing Start Date: 1953-01-26
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 59212-001-01 [59212000101]

Dibenzyline CAPSULE

• Marketing Category: NDA
• Application Number: NDA008708
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1953-01-26

Drug Details

Active Ingredients

Ingredient	Strength
PHENOXYBENZAMINE HYDROCHLORIDE	10 mg/1

OpenFDA Data

• SPL SET ID: 8852dd44-098c-4d99-88e0-a092a8e08e11
• Manufacturer:
  • Concordia Pharmaceuticals Inc.
• UNII:
  • X1IEG24OHL
• RxNorm Concept Unique ID - RxCUI:
  • 861402
  • 861404
• UPC Code:
  • 0359212001016

Pharmacological Class

• Adrenergic alpha-Antagonists [MoA]
• alpha-Adrenergic Blocker [EPC]

NDC Crossover Matching brand name "Dibenzyline" or generic name "Phenoxybenzamine Hydrochloride"

NDC	Brand Name	Generic Name
59212-001	Dibenzyline	Phenoxybenzamine Hydrochloride
0054-0349	Phenoxybenzamine Hydrochloride	Phenoxybenzamine Hydrochloride
49884-038	Phenoxybenzamine Hydrochloride	Phenoxybenzamine Hydrochloride
60219-1502	Phenoxybenzamine hydrochloride	Phenoxybenzamine hydrochloride
66993-066	Phenoxybenzamine Hydrochloride	Phenoxybenzamine Hydrochloride
69238-1502	Phenoxybenzamine hydrochloride	Phenoxybenzamine hydrochloride
70954-365	Phenoxybenzamine Hydrochloride	Phenoxybenzamine Hydrochloride