NDC 59212-003

Dyrenium

Triamterene

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

• Product ID: 59212-003_0818de3a-75e9-4c96-8cee-afeea533ef7c
• NDC: 59212-003
• Product Type: Human Prescription Drug
• Proprietary Name: Dyrenium
• Generic Name: Triamterene
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 1999-01-01
• Marketing Category: NDA / NDA
• Application Number: NDA013174
• Labeler Name: Concordia Pharmaceuticals Inc.
• Substance Name: TRIAMTERENE
• Active Ingredient Strength: 100 mg/1
• Pharm Classes: Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 59212-003-01

100 CAPSULE in 1 BOTTLE (59212-003-01)

• Marketing Start Date: 1999-01-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 59212-003-01 [59212000301]

Dyrenium CAPSULE

• Marketing Category: NDA
• Application Number: NDA013174
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1999-01-01

Drug Details

Active Ingredients

Ingredient	Strength
TRIAMTERENE	100 mg/1

OpenFDA Data

• SPL SET ID: ebb177c0-d45d-4443-a85a-e76bd9931a42
• Manufacturer:
  • Concordia Pharmaceuticals Inc.
• UNII:
  • WS821Z52LQ
• RxNorm Concept Unique ID - RxCUI:
  • 198312
  • 198313
  • 208675
  • 208674
• UPC Code:
  • 0359212003010
  • 0359212002013

Pharmacological Class

• Decreased Renal K+ Excretion [PE]
• Increased Diuresis [PE]
• Potassium-sparing Diuretic [EPC]

NDC Crossover Matching brand name "Dyrenium" or generic name "Triamterene"

NDC	Brand Name	Generic Name
59212-002	Dyrenium	Triamterene
59212-003	Dyrenium	Triamterene
65197-002	Dyrenium	Triamterene
65197-003	Dyrenium	Triamterene
68151-1494	Dyrenium	Triamterene
66993-831	triamterene	Triamterene
66993-832	Triamterene	Triamterene