NDC 68788-7297

Spironolactone

Spironolactone

Spironolactone is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Preferred Pharmaceuticals Inc... The primary component is Spironolactone.

• Product ID: 68788-7297_300ee450-7d84-428b-b606-5019ff273486
• NDC: 68788-7297
• Product Type: Human Prescription Drug
• Proprietary Name: Spironolactone
• Generic Name: Spironolactone
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2019-01-08
• Marketing Category: ANDA / ANDA
• Application Number: ANDA203512
• Labeler Name: Preferred Pharmaceuticals Inc..
• Substance Name: SPIRONOLACTONE
• Active Ingredient Strength: 25 mg/1
• Pharm Classes: Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 68788-7297-3

30 TABLET, FILM COATED in 1 BOTTLE (68788-7297-3)

• Marketing Start Date: 2019-01-08
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68788-7297-6 [68788729706]

Spironolactone TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA203512
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-01-08

NDC 68788-7297-9 [68788729709]

Spironolactone TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA203512
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-01-08

NDC 68788-7297-3 [68788729703]

Spironolactone TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA203512
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-01-08

Drug Details

Active Ingredients

Ingredient	Strength
SPIRONOLACTONE	25 mg/1

OpenFDA Data

• SPL SET ID: c26c2af4-f9fd-47d1-81d0-b995fd1cc17d
• Manufacturer:
  • Preferred Pharmaceuticals Inc..
• UNII:
  • 27O7W4T232
• RxNorm Concept Unique ID - RxCUI:
  • 313096

Pharmacological Class

• Aldosterone Antagonist [EPC]
• Aldosterone Antagonists [MoA]
• Aldosterone Antagonist [EPC]
• Aldosterone Antagonists [MoA]

NDC Crossover Matching brand name "Spironolactone" or generic name "Spironolactone"

NDC	Brand Name	Generic Name
0228-2672	Spironolactone	Spironolactone
0228-2673	Spironolactone	Spironolactone
0228-2803	Spironolactone	Spironolactone
0378-0243	Spironolactone	spironolactone
0378-0437	Spironolactone	spironolactone
0378-2146	Spironolactone	spironolactone
0603-5763	Spironolactone	spironolactone
0603-5764	Spironolactone	spironolactone
0603-5765	Spironolactone	spironolactone
0615-1535	Spironolactone	spironolactone
0615-5592	Spironolactone	spironolactone
0615-6591	Spironolactone	spironolactone
0615-8031	Spironolactone	spironolactone
0615-8178	Spironolactone	spironolactone
0615-8221	Spironolactone	spironolactone
0781-1599	Spironolactone	Spironolactone
68071-1992	Spironolactone	Spironolactone
68071-3112	Spironolactone	Spironolactone
68071-3375	Spironolactone	Spironolactone
68071-4073	Spironolactone	Spironolactone
68071-4374	Spironolactone	Spironolactone
68084-207	Spironolactone	Spironolactone
68084-208	Spironolactone	Spironolactone
68084-206	Spironolactone	Spironolactone
68151-2776	Spironolactone	Spironolactone
68382-661	spironolactone	spironolactone
68382-662	spironolactone	spironolactone
68382-660	spironolactone	spironolactone
68788-7051	Spironolactone	Spironolactone
68788-6332	Spironolactone	Spironolactone
68788-6895	Spironolactone	Spironolactone
68788-6900	Spironolactone	Spironolactone
68788-9227	Spironolactone	Spironolactone
68788-7019	Spironolactone	Spironolactone
68788-7258	Spironolactone	Spironolactone
68788-7297	Spironolactone	Spironolactone
68788-9124	Spironolactone	Spironolactone
68788-9729	Spironolactone	Spironolactone
70518-0455	Spironolactone	Spironolactone
70518-0563	Spironolactone	Spironolactone
70518-0603	Spironolactone	Spironolactone
70518-0630	Spironolactone	Spironolactone
70518-1334	Spironolactone	Spironolactone
70518-0665	Spironolactone	Spironolactone
70518-1314	Spironolactone	Spironolactone
70518-1746	Spironolactone	Spironolactone
70518-1742	Spironolactone	Spironolactone
70771-1029	spironolactone	spironolactone
70771-1028	spironolactone	spironolactone
70771-1027	spironolactone	spironolactone