NDC 0378-0577

Amiloride Hydrochloride and Hydrochlorothiazide

Amiloride Hydrochloride And Hydrochlorothiazide

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

• Product ID: 0378-0577_0688e19e-b4be-491f-a836-9ffb80f2eccf
• NDC: 0378-0577
• Product Type: Human Prescription Drug
• Proprietary Name: Amiloride Hydrochloride and Hydrochlorothiazide
• Generic Name: Amiloride Hydrochloride And Hydrochlorothiazide
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 1991-10-31
• Marketing End Date: 2023-02-28
• Marketing Category: ANDA / ANDA
• Application Number: ANDA073209
• Labeler Name: Mylan Pharmaceuticals Inc.
• Substance Name: AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
• Active Ingredient Strength: 5 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

Packaging

NDC 0378-0577-01

100 TABLET in 1 BOTTLE, PLASTIC (0378-0577-01)

• Marketing Start Date: 1991-10-31
• Marketing End Date: 2023-02-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0378-0577-05 [00378057705]

Amiloride Hydrochloride and Hydrochlorothiazide TABLET

• Marketing Category: ANDA
• Application Number: ANDA073209
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1991-10-31

NDC 0378-0577-01 [00378057701]

Amiloride Hydrochloride and Hydrochlorothiazide TABLET

• Marketing Category: ANDA
• Application Number: ANDA073209
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1991-10-31

Drug Details

Active Ingredients

Ingredient	Strength
AMILORIDE HYDROCHLORIDE	5 mg/1

OpenFDA Data

• SPL SET ID: dc7aef5e-9585-45b9-b317-4af570202ef5
• Manufacturer:
  • Mylan Pharmaceuticals Inc.
• UNII:
  • FZJ37245UC
  • 0J48LPH2TH
• RxNorm Concept Unique ID - RxCUI:
  • 977883

Pharmacological Class

• 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 "Amiloride Hydrochloride and Hydrochlorothiazide" or generic name "Amiloride Hydrochloride And Hydrochlorothiazide"

NDC	Brand Name	Generic Name
0378-0577	Amiloride Hydrochloride and Hydrochlorothiazide	amiloride hydrochloride and hydrochlorothiazide
0555-0483	Amiloride Hydrochloride and Hydrochlorothiazide	Amiloride Hydrochloride and Hydrochlorothiazide
50090-0513	Amiloride Hydrochloride and Hydrochlorothiazide	Amiloride Hydrochloride and Hydrochlorothiazide