NDC 0378-0141

Spironolactone and Hydrochlorothiazide

Spironolactone And Hydrochlorothiazide

Spironolactone 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 Spironolactone; Hydrochlorothiazide.

• Product ID: 0378-0141_44957b79-6f3a-48b0-b985-060aaa923bfd
• NDC: 0378-0141
• Product Type: Human Prescription Drug
• Proprietary Name: Spironolactone and Hydrochlorothiazide
• Generic Name: Spironolactone And Hydrochlorothiazide
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2012-07-26
• Marketing End Date: 2020-02-29
• Marketing Category: ANDA / ANDA
• Application Number: ANDA086513
• Labeler Name: Mylan Pharmaceuticals Inc.
• Substance Name: SPIRONOLACTONE; HYDROCHLOROTHIAZIDE
• Active Ingredient Strength: 25 mg/1; mg/1
• Pharm Classes: Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]
• NDC Exclude Flag: N

Packaging

NDC 0378-0141-01

100 TABLET in 1 BOTTLE, PLASTIC (0378-0141-01)

• Marketing Start Date: 2012-07-26
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0378-0141-05 [00378014105]

Spironolactone and Hydrochlorothiazide TABLET

• Marketing Category: ANDA
• Application Number: ANDA086513
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2012-07-26
• Marketing End Date: 2020-02-29

NDC 0378-0141-01 [00378014101]

Spironolactone and Hydrochlorothiazide TABLET

• Marketing Category: ANDA
• Application Number: ANDA086513
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2012-07-26
• Marketing End Date: 2020-02-29

Drug Details

Active Ingredients

Ingredient	Strength
SPIRONOLACTONE	25 mg/1

OpenFDA Data

• SPL SET ID: 66134130-5718-483b-a076-36ecdb0add34
• Manufacturer:
  • Mylan Pharmaceuticals Inc.
• UNII:
  • 27O7W4T232
  • 0J48LPH2TH
• RxNorm Concept Unique ID - RxCUI:
  • 198224

Pharmacological Class

• Aldosterone Antagonist [EPC]
• Aldosterone Antagonists [MoA]
• Increased Diuresis [PE]
• Thiazide Diuretic [EPC]
• Thiazides [CS]

NDC Crossover Matching brand name "Spironolactone and Hydrochlorothiazide" or generic name "Spironolactone And Hydrochlorothiazide"

NDC	Brand Name	Generic Name
0378-0141	Spironolactone and Hydrochlorothiazide	spironolactone and hydrochlorothiazide
0378-0403	Spironolactone and Hydrochlorothiazide	spironolactone and hydrochlorothiazide
42292-017	Spironolactone and Hydrochlorothiazide	spironolactone and hydrochlorothiazide
53489-144	Spironolactone and Hydrochlorothiazide	Spironolactone and Hydrochlorothiazide
59762-5014	Spironolactone and Hydrochlorothiazide	spironolactone and hydrochlorothiazide
63629-1068	Spironolactone and Hydrochlorothiazide	Spironolactone and Hydrochlorothiazide
63629-1069	Spironolactone and Hydrochlorothiazide	Spironolactone and Hydrochlorothiazide
63629-1071	Spironolactone and Hydrochlorothiazide	Spironolactone and Hydrochlorothiazide
66993-188	Spironolactone and Hydrochlorothiazide	spironolactone and hydrochlorothiazide
0025-1011	ALDACTAZIDE	spironolactone and hydrochlorothiazide
0025-1021	ALDACTAZIDE	spironolactone and hydrochlorothiazide