SPIRONOLACTONE
- Product NDC
- 63629-1067
- 11-digit product format
- 636291067
- Labeler code
- 63629
- Product ID
- 63629-1067_aacb3b94-5748-48db-8bda-1bd28e6c0c79
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SPIRONOLACTONE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- SPIRONOLACTONE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SPIRONOLACTONE | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 27O7W4T232 |
| Rxcui | 198223 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63629-1067-1 | SPIRONOLACTONE | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 109 |
| 63629-1067-2 | SPIRONOLACTONE | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 60 | | 109 |
| 63629-1067-3 | SPIRONOLACTONE | 90 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 90 | | 109 |
| 63629-1067-4 | SPIRONOLACTONE | 500 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 500 | | 109 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63629-1067 | SPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK] | 109 | Current NDC, Legacy NDC, 4 package rows | 20241006_3b60de71-2afa-4922-ba3e-0664c2ae29a0.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63629-1067-1 | 63629106701 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63629-1067-1) | 2020-09-21 | 0000-00-00 | No | No | Current |
| 63629-1067-2 | 63629106702 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63629-1067-2) | 2020-12-01 | 0000-00-00 | No | No | Current |
| 63629-1067-3 | 63629106703 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63629-1067-3) | 2020-12-14 | 0000-00-00 | No | No | Current |
| 63629-1067-4 | 63629106704 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63629-1067-4) | 2022-10-26 | 0000-00-00 | No | No | Current |