NDC 45865-402

Triamterene and Hydrochlorothiazide

Triamterene And Hydrochlorothiazide

Triamterene and Hydrochlorothiazide is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Medsource Pharmaceuticals. The primary component is Triamterene; Hydrochlorothiazide.

• Product ID: 45865-402_1d631948-6492-7270-e054-00144ff88e88
• NDC: 45865-402
• Product Type: Human Prescription Drug
• Proprietary Name: Triamterene and Hydrochlorothiazide
• Generic Name: Triamterene And Hydrochlorothiazide
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 1997-06-05
• Marketing Category: ANDA / ANDA
• Application Number: ANDA074821
• Labeler Name: Medsource Pharmaceuticals
• Substance Name: TRIAMTERENE; HYDROCHLOROTHIAZIDE
• Active Ingredient Strength: 38 mg/1; mg/1
• Pharm Classes: Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 45865-402-60

60 CAPSULE in 1 BOTTLE (45865-402-60)

• Marketing Start Date: 2015-08-26
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 45865-402-60 [45865040260]

Triamterene and Hydrochlorothiazide CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA074821
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2015-08-26

Drug Details

Active Ingredients

Ingredient	Strength
TRIAMTERENE	37.5 mg/1

OpenFDA Data

• SPL SET ID: 1d631948-6491-7270-e054-00144ff88e88
• Manufacturer:
  • Medsource Pharmaceuticals
• UNII:
  • WS821Z52LQ
  • 0J48LPH2TH
• RxNorm Concept Unique ID - RxCUI:
  • 198316

Pharmacological Class

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