Prescription drug · NDA
Inspra (Eplerenone) NDC 58151-143
Eplerenone 50 mg/1 · Tablet, Film coated · Oral · Viatris Specialty LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58151-143-93 | 5815101439358151014393 | 30 TABLET, FILM COATED in 1 BOTTLE (58151-143-93)Marketed from Sep 17, 2024 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Inspra
- Generic name (nonproprietary)
- eplerenone
- Active ingredients
- Eplerenone — 50 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Viatris Specialty LLCNDC labeler code 58151
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021437
- Marketing start
- Marketing end
- Other FDA classes
- Aldosterone Antagonists (Mechanism)
- Identifiers
- Product ID 58151-143_77698b88-befe-44ae-b67d-03c56dcbbdf6SPL ID 77698b88-befe-44ae-b67d-03c56dcbbdf6SPL set ID 1a52bedc-8e2c-4116-a296-a87770676b4aRxCUI 351256, 351257, 402105, 402106UNII 6995V82D0BUPC 0358151142934, 0358151143931
- Pharmacologic class
- Aldosterone Antagonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N458151014393followed by a unit qualifier and the quantityPackage 58151-0143-93. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INSPRA is an aldosterone antagonist indicated for: • Improving survival of stable adult patients with symptomatic heart failure with reduced ejection fraction (HFrEF) after an acute myocardial infarction. ( 1.1 ) • The treatment of hypertension in adults, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.2 ) 1.1 Heart Failure Post-Myocardial Infarction INSPRA is indicated to improve survival of stable adult patients with symptomatic heart failure with reduced ejection fraction (≤40%) (HFrEF) after an acute myocardial infarction (MI). 1.2 Hypertension INSPRA is indicated for the trea…
Excerpt only. Read the full label for complete information.
About NDC 58151-143
- What is NDC 58151-143?
- 58151-143 is the product NDC for Inspra (eplerenone), Eplerenone 50 mg/1 tablet, film coated, listed with the FDA by Viatris Specialty LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Inspra (Eplerenone).
- What is the active ingredient?
- Eplerenone.
- Who is the labeler?
- Viatris Specialty LLC, NDC labeler code 58151. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Inspra?
- 1 other product NDC are listed under this name. See all Inspra NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Inspra products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Inspraeplerenone | Eplerenone 25 mg/1 | Tablet, Film coatedOral | Viatris Specialty LLC | 58151-142 | 58151-0142-93 |
Other NDCs under NDA 021437
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Eplerenone | Eplerenone 25 mg/1 | Tablet, Film coatedOral | Mylan Pharmaceuticals Inc. | 59762-1107 |
| Eplerenone | Eplerenone 50 mg/1 | Tablet, Film coatedOral | Mylan Pharmaceuticals Inc. | 59762-1108 |
| Inspraeplerenone | Eplerenone 25 mg/1 | Tablet, Film coatedOral | Viatris Specialty LLC | 58151-142 |