Spironolactone
- Product NDC
- 54348-340
- 11-digit product format
- 543480340
- Labeler code
- 54348
- Product ID
- 54348-340_eb00ddbc-db02-8bba-e053-2a95a90af70c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SPIRONOLACTONE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- PharmPak, Inc.
- Application
- ANDA091426
- Marketing category
- ANDA
- Marketing start
- 2019-07-09
- 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 |
|---|
| 54348-340-90 | Spironolactone | 90 in 1 BOTTLE | TABLET | 90 | | 2 |
| 54348-340-90 | Spironolactone | 1 in 1 BOX | TABLET | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 54348-340 | SPIRONOLACTONE TABLET [PHARMPAK, INC.] | 2 | Current NDC, Legacy NDC, 2 package rows | 20221015_c450e66a-0f05-445e-b1df-df2b17a2f064.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 54348-340-90 | 54348034090 | 1 BOTTLE in 1 BOX (54348-340-90) / 90 TABLET in 1 BOTTLE | 1 bottle | 2019-07-09 | 0000-00-00 | No | No | Current |