NDC 0378-0464

MAXZIDE-25

Maxzide

MAXZIDE-25 is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Hydrochlorothiazide; Triamterene.

• Product ID: 0378-0464_0e54ebec-df86-4205-9434-315913b56a94
• NDC: 0378-0464
• Product Type: Human Prescription Drug
• Proprietary Name: MAXZIDE-25
• Generic Name: Maxzide
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 1988-05-13
• Marketing End Date: 2024-03-31
• Marketing Category: NDA / NDA
• Application Number: NDA019129
• Labeler Name: Mylan Pharmaceuticals Inc.
• Substance Name: HYDROCHLOROTHIAZIDE; TRIAMTERENE
• Active Ingredient Strength: 25 mg/1; mg/1
• Pharm Classes: Decreased Renal K+ Excretion [PE], Increased Diuresis [PE], Increased Diuresis [PE], Potassium-sparing Diuretic [EPC], Thiazide Diuretic [EPC], Thiazides [CS]
• NDC Exclude Flag: N

Packaging

NDC 0378-0464-01

100 TABLET in 1 BOTTLE, PLASTIC (0378-0464-01)

• Marketing Start Date: 1988-05-13
• Marketing End Date: 2024-03-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0378-0464-01 [00378046401]

MAXZIDE-25 TABLET

• Marketing Category: NDA
• Application Number: NDA019129
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1988-05-13

Drug Details

Active Ingredients

Ingredient	Strength
TRIAMTERENE	37.5 mg/1

OpenFDA Data

• SPL SET ID: e92eda49-861e-4c79-b446-ec1213151d92
• Manufacturer:
  • Mylan Pharmaceuticals Inc.
• UNII:
  • WS821Z52LQ
  • 0J48LPH2TH
• RxNorm Concept Unique ID - RxCUI:
  • 310812
  • 310818
  • 93252
  • 93253
• UPC Code:
  • 0303780376687

Pharmacological Class

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

NDC Crossover Matching brand name "MAXZIDE-25" or generic name "Maxzide"

NDC	Brand Name	Generic Name
0378-0464	MAXZIDE-25	maxzide
0378-0460	MAXZIDE	maxzide