Spironolactone
- Product NDC
- 70518-0665
- 11-digit product format
- 705180665
- Labeler code
- 70518
- Product ID
- 70518-0665_8a9df3a5-e760-5da2-e053-2995a90a696b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- spironolactone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA203253
- Marketing category
- ANDA
- Marketing start
- 2017-08-09
- Marketing end
- 0000-00-00
- Substance
- SPIRONOLACTONE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Spironolactone
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SPIRONOLACTONE | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 27O7W4T232 |
| Rxcui | 198222 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Status |
|---|
| 70518-0665-1 | 70518066501 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0665-1) | 2026-05-29 | 0 | Current |