Prescription drug · ANDA
Eplerenone NDC 31722-049
Eplerenone 25 mg/1 · Tablet, Film coated · Oral · Camber Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 31722-049-30 | 31722004930 | 30 TABLET, FILM COATED in 1 BOTTLE (31722-049-30)Marketed from Jun 2, 2023 | |
| 31722-049-90 | 31722004990 | 90 TABLET, FILM COATED in 1 BOTTLE (31722-049-90)Marketed from Jun 2, 2023 |
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)
- Eplerenone
- Generic name (nonproprietary)
- eplerenone
- Active ingredients
- Eplerenone — 25 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Camber Pharmaceuticals, Inc.NDC labeler code 31722
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213812
- Marketing start
- Listing expires
- Other FDA classes
- Aldosterone Antagonists (Mechanism)
- Identifiers
- Product ID 31722-049_fe285cf1-1e78-943b-e053-6394a90a760dSPL ID fe285cf1-1e78-943b-e053-6394a90a760dSPL set ID 25a1c77c-7008-4b07-af14-5522a282783aRxCUI 351256, 351257UNII 6995V82D0BUPC 0331722049306
- 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
N431722004930followed by a unit qualifier and the quantityPackage 31722-0049-30. 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)
Eplerenone tablets are an aldosterone antagonist indicated for: • Improving survival of stable patients with symptomatic heart failure with reduced ejection fraction (HFrEF) after an acute myocardial infarction. ( 1.1 ) • The treatment of hypertension, 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 Eplerenone tablets are indicated to improve survival of stable patients with symptomatic heart failure with reduced ejection fraction (≤40%) (HFrEF) after an acute myocardial infarction (MI). 1.2 Hypertension Eplerenone tablets are indic…
Excerpt only. Read the full label for complete information.
About NDC 31722-049
- What is NDC 31722-049?
- 31722-049 is the product NDC for Eplerenone, Eplerenone 25 mg/1 tablet, film coated, listed with the FDA by Camber Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Eplerenone.
- What is the active ingredient?
- Eplerenone.
- Who is the labeler?
- Camber Pharmaceuticals, Inc., NDC labeler code 31722. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Eplerenone?
- 18 other product NDCs are listed under this name. See all Eplerenone NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Eplerenone products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Eplerenone | Eplerenone 25 mg/1 | Tablet, Film coatedOral | Mylan Pharmaceuticals Inc. | 59762-1107 | 59762-1107-0259762-1107-03 |
| Eplerenone | Eplerenone 50 mg/1 | Tablet, Film coatedOral | Mylan Pharmaceuticals Inc. | 59762-1108 | 59762-1108-0159762-1108-02 |
| Eplerenone | Eplerenone 25 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 16571-173 | 16571-0173-0316571-0173-09 |
| Eplerenone | Eplerenone 50 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 16571-174 | 16571-0174-0316571-0174-09 |
| Eplerenone | Eplerenone 50 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-050 | 31722-0050-3031722-0050-90 |
| Eplerenone | Eplerenone 25 mg/1 | Tablet, CoatedOral | AvKARE | 42291-454 | 42291-0454-90 |
| Eplerenone | Eplerenone 50 mg/1 | Tablet, CoatedOral | AvKARE | 42291-455 | 42291-0455-90 |
| Eplerenone | Eplerenone 25 mg/1 | Tablet, CoatedOral | Westminster Pharmaceuticals, LLC | 69367-307 | 69367-0307-0969367-0307-30 |
| Eplerenone | Eplerenone 50 mg/1 | Tablet, CoatedOral | Westminster Pharmaceuticals, LLC | 69367-308 | 69367-0308-0969367-0308-30 |
| Eplerenone | Eplerenone 25 mg/1 | Tablet, CoatedOral | Proficient Rx LP | 71205-863 | 71205-0863-0071205-0863-1171205-0863-30+5 more |
Other NDCs under ANDA 213812
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 50 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-050 |