SPIRONOLACTONE
- Product NDC
- 71205-772
- 11-digit product format
- 712050772
- Labeler code
- 71205
- Product ID
- 71205-772_67aa6f82-72d2-437f-8c23-4f913640c8f1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SPIRONOLACTONE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA089424
- Marketing category
- ANDA
- Marketing start
- 1986-07-23
- Substance
- SPIRONOLACTONE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data
- Finished product
- Yes
- Brand name base
- SPIRONOLACTONE
- Listing expiration
- 2026-12-31
Active Ingredients
| Ingredient | Strength |
|---|
| SPIRONOLACTONE | 25 mg/1 |
Harmonized Identifiers
| Field | Values |
|---|
| Unii | 27O7W4T232 |
| Rxcui | 313096 |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 27O7W4T232 | SPIRONOLACTONE | 52-01-7 | SPIRONOLACTONE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71205-772-30 | 71205077230 | 30 TABLET in 1 BOTTLE, PLASTIC (71205-772-30) | 30 tablet | 2023-03-09 | No | No | Current |
| 71205-772-60 | 71205077260 | 60 TABLET in 1 BOTTLE, PLASTIC (71205-772-60) | 60 tablet | 2023-03-09 | No | No | Current |
| 71205-772-90 | 71205077290 | 90 TABLET in 1 BOTTLE, PLASTIC (71205-772-90) | 90 tablet | 2023-03-09 | No | No | Current |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| SPIRONOLACTONE | Proficient Rx LP | 2023-04-01 | HUMAN PRESCRIPTION DRUG LABEL | 2 |