Spironolactone
- Product NDC
- 53002-4720
- 11-digit product format
- 530024720
- Labeler code
- 53002
- Product ID
- 53002-4720_6bfe9b99-9c3e-4acc-88d0-1dbaf9ebe5bb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- spironolactone
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA203512
- Marketing category
- ANDA
- Marketing start
- 2017-06-02
- Marketing end
- 0000-00-00
- Substance
- SPIRONOLACTONE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53002-4720-0 | Spironolactone | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-4720 | SPIRONOLACTONE TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.] | 5 | Legacy NDC, 1 package rows | 20230609_ef98c4cc-ff5d-48ce-b25e-1e80cf8052d4.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 |
|---|
| 53002-4720-0 | 53002472000 | 100 TABLET, FILM COATED in 1 BOTTLE (53002-4720-0) | 2018-10-01 | 0000-00-00 | No | No | Current |