SPIRONOLACTONE
- Product NDC
- 72603-135
- 11-digit product format
- 726030135
- Labeler code
- 72603
- Product ID
- 72603-135_04da3e98-02e5-4d5a-94b2-9a6f74c44f15
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SPIRONOLACTONE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NorthStar Rx LLC
- Application
- ANDA202187
- Marketing category
- ANDA
- Marketing start
- 2019-12-13
- Substance
- SPIRONOLACTONE
- Active strength
- 50 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 | 50 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 |
|---|
| 72603-135-01 | SPIRONOLACTONE | 100 in 1 BOTTLE | TABLET | 100 | | 4 |
| 72603-135-02 | SPIRONOLACTONE | 500 in 1 BOTTLE | TABLET | 500 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72603-135 | SPIRONOLACTONE TABLET [NORTHSTAR RX LLC] | 3 | Current NDC, 2 package rows | 20231007_ae0dcb4e-63df-459c-8e60-0caa817b8135.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 72603-135-01 | 72603013501 | 100 TABLET in 1 BOTTLE (72603-135-01) | 100 tablet | 2019-12-13 | No | No | Historical |
| 72603-135-02 | 72603013502 | 500 TABLET in 1 BOTTLE (72603-135-02) | 500 tablet | 2019-12-13 | No | No | Historical |