SPIRONOLACTONE
- Product NDC
- 0615-8451
- 11-digit product format
- 006158451
- Labeler code
- 0615
- Product ID
- 0615-8451_876a2024-3f0f-4afd-8229-4e05a6270315
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SPIRONOLACTONE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA202187
- Marketing category
- ANDA
- Marketing start
- 2019-12-13
- Substance
- SPIRONOLACTONE
- Active strength
- 25 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 | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 27O7W4T232 |
| Rxcui | 198223, 313096 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0615-8451-05 | SPIRONOLACTONE | 15 in 1 BLISTER PACK | TABLET | 15 | | 8 |
| 0615-8451-30 | SPIRONOLACTONE | 6 in 1 BOX, UNIT-DOSE | TABLET | 6 | | 8 |
| 0615-8451-30 | SPIRONOLACTONE | 5 in 1 BLISTER PACK | TABLET | 5 | | 8 |
| 0615-8451-39 | SPIRONOLACTONE | 30 in 1 BLISTER PACK | TABLET | 30 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0615-8451 | SPIRONOLACTONE TABLET [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS] | 8 | Current NDC, 4 package rows | 20240806_e34fc3ca-1272-446b-8dc2-25b62add01c3.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 |
|---|
| 0615-8451-05 | 00615845105 | 15 TABLET in 1 BLISTER PACK (0615-8451-05) | 15 tablet | 2023-04-13 | No | No | Historical |
| 0615-8451-30 | 00615845130 | 6 in 1 BOX, UNIT-DOSE | | | | | Historical |
| 0615-8451-39 | 00615845139 | 30 TABLET in 1 BLISTER PACK (0615-8451-39) | 30 tablet | 2023-04-13 | No | No | Historical |