NDC 53489-328 – Spironolactone
Spironolactone 50 mg/1 · Tablet, Film Coated · Oral
Product NDC53489-328
Product details
- Brand name
- Spironolactone
- Generic name
- Spironolactone
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Dosage form
- Tablet, Film Coated
- Route
- Oral
- Marketing category
- ANDA · ANDA089424
- Marketed since
- July 23, 1986
- Listing expires
- December 31, 2027
- Pharmacologic class
- Aldosterone Antagonist
Active ingredients
- Spironolactone 50 mg/1
Uses, dosage, side effects and warnings for Spironolactone →
Package NDC codes (6)
| Package NDC | Description | Since |
|---|---|---|
| 53489-328-01 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-328-01) | Jul 23, 1986 |
| 53489-328-02 | 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-328-02) | Jul 23, 1986 |
| 53489-328-03 | 250 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-328-03) | Jul 23, 1986 |
| 53489-328-05 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-328-05) | Jul 23, 1986 |
| 53489-328-07 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-328-07) | Jul 23, 1986 |
| 53489-328-10 | 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-328-10) | Jul 23, 1986 |
Recalls mentioning this NDC
- D-0574-2025 Aug 13, 2025 · Class II
Presence of foreign substance: identified as aluminum.
Other Spironolactone products
- 50090-0136 Spironolactone 25 mg/1 · Tablet · A-S Medication Solutions
- 50090-6369 Spironolactone 25 mg/1 · Tablet, Coated · A-S Medication Solutions
- 50090-3747 Spironolactone 25 mg/1 · Tablet, Film Coated · A-S Medication Solutions
- 50090-6432 Spironolactone 100 mg/1 · Tablet, Film Coated · A-S Medication Solutions
- 50090-6539 Spironolactone 100 mg/1 · Tablet, Coated · A-S Medication Solutions
- 50090-6458 Spironolactone 50 mg/1 · Tablet, Coated · A-S Medication Solutions
- 50090-6408 Spironolactone 50 mg/1 · Tablet, Film Coated · A-S Medication Solutions
- 50090-7082 Spironolactone 50 mg/1 · Tablet · A-S Medication Solutions
- 50090-7083 Spironolactone 50 mg/1 · Tablet · A-S Medication Solutions
- 50090-6908 Spironolactone 25 mg/1 · Tablet · A-S Medication Solutions
- 50090-6909 Spironolactone 25 mg/1 · Tablet · A-S Medication Solutions
- 50090-6600 Spironolactone 50 mg/1 · Tablet, Coated · A-S Medication Solutions