SPIRONOLACTONE
- Product NDC
- 53489-329
- 11-digit product format
- 534890329
- Labeler code
- 53489
- Product ID
- 53489-329_d58f76e0-60c3-42ec-8375-128cd42485f1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SPIRONOLACTONE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA089424
- Marketing category
- ANDA
- Marketing start
- 1986-07-23
- Substance
- SPIRONOLACTONE
- Active strength
- 100 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 | 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 |
|---|
| 53489-329-01 | SPIRONOLACTONE | 100 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 100 | | 14 |
| 53489-329-02 | SPIRONOLACTONE | 50 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 50 | | 14 |
| 53489-329-03 | SPIRONOLACTONE | 250 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 250 | | 14 |
| 53489-329-05 | SPIRONOLACTONE | 500 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 500 | | 14 |
| 53489-329-06 | SPIRONOLACTONE | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 60 | | 14 |
| 53489-329-07 | SPIRONOLACTONE | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 14 |
| 53489-329-10 | SPIRONOLACTONE | 1000 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 1000 | | 14 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53489-329 | SPIRONOLACTONE TABLET SPIRONOLACTONE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 13 | Current NDC, Legacy NDC, 7 package rows | 20230126_c23b6b9b-aec3-48a8-a518-76e4097f6479.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 |
|---|
| 53489-329-01 | 53489032901 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-329-01) | 1986-07-23 | 0000-00-00 | No | No | Current |
| 53489-329-02 | 53489032902 | 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-329-02) | 1986-07-23 | 0000-00-00 | No | No | Current |
| 53489-329-03 | 53489032903 | 250 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-329-03) | 1986-07-23 | 0000-00-00 | No | No | Current |
| 53489-329-05 | 53489032905 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-329-05) | 1986-07-23 | 0000-00-00 | No | No | Current |
| 53489-329-06 | 53489032906 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-329-06) | 1986-07-23 | 0000-00-00 | No | No | Current |
| 53489-329-07 | 53489032907 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-329-07) | 1986-07-23 | 0000-00-00 | No | No | Current |
| 53489-329-10 | 53489032910 | 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53489-329-10) | 1986-07-23 | 0000-00-00 | No | No | Current |