Spironolactone
- Product NDC
- 48433-089
- 11-digit product format
- 484330089
- Labeler code
- 48433
- Product ID
- 48433-089_5127ec80-fbaa-f235-e063-6394a90a78f7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- spironolactone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Safecor Health LLC
- Application
- ANDA040424
- Marketing category
- ANDA
- Marketing start
- 2026-05-05
- Substance
- SPIRONOLACTONE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
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, 198223, 313096 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 48433-089-01 | Spironolactone | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 2 |
| 48433-089-08 | Spironolactone | 80 in 1 CARTON | TABLET, FILM COATED | 80 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 48433-089-01 | 48433008901 | 1 in 1 BLISTER PACK | | | | | Historical |
| 48433-089-08 | 48433008908 | 80 BLISTER PACK in 1 CARTON (48433-089-08) / 1 TABLET, FILM COATED in 1 BLISTER PACK (48433-089-01) | 80 blister pack | 2026-05-05 | No | No | Historical |