SPIRONOLACTONE
- Product NDC
- 76420-557
- 11-digit product format
- 764200557
- Labeler code
- 76420
- Product ID
- 76420-557_f8b9eb31-4486-7638-e053-6394a90aee92
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SPIRONOLACTONE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA089424
- Marketing category
- ANDA
- Marketing start
- 1986-07-23
- Substance
- SPIRONOLACTONE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 27O7W4T232 | SPIRONOLACTONE | 52-01-7 | SPIRONOLACTONE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 76420-557-01 | 76420055701 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-557-01) | 2023-04-07 | No | No | Historical |
| 76420-557-30 | 76420055730 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-557-30) | 2023-04-07 | No | No | Historical |
| 76420-557-60 | 76420055760 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-557-60) | 2023-04-07 | No | No | Historical |
| 76420-557-90 | 76420055790 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-557-90) | 2023-04-07 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| SPIRONOLACTONE | Asclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM | 2023-04-07 | HUMAN PRESCRIPTION DRUG LABEL | 1 |