Prescription drug · ANDA
Spironolactone NDC 63187-861
Spironolactone 50 mg/1 · Tablet, Film coated · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-861-30 | 63187086130 | 30 TABLET, FILM COATED in 1 BOTTLE (63187-861-30)Marketed from Jun 1, 2017 | |
| 63187-861-60 | 63187086160 | 60 TABLET, FILM COATED in 1 BOTTLE (63187-861-60)Marketed from Jun 1, 2017 | |
| 63187-861-90 | 63187086190 | 90 TABLET, FILM COATED in 1 BOTTLE (63187-861-90)Marketed from Jun 1, 2017 |
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)
- Spironolactone
- Generic name (nonproprietary)
- spironolactone
- Active ingredients
- Spironolactone — 50 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203253
- Marketing start
- Listing expires
- Other FDA classes
- Aldosterone Antagonists (Mechanism)
- Identifiers
- Product ID 63187-861_d5bfc979-a820-4d06-ab41-9ccbaf28a914SPL ID d5bfc979-a820-4d06-ab41-9ccbaf28a914SPL set ID caf9c845-63eb-40bd-8261-0582abdf705aRxCUI 198223UNII 27O7W4T232
- 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
N463187086130followed by a unit qualifier and the quantityPackage 63187-0861-30. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Spironolactone tablets are indicated in the management of: Primary hyperaldosteronism for: Establishing the diagnosis of primary hyperaldosteronism by therapeutic trial. Short-term preoperative treatment of patients with primary hyperaldosteronism. Long-term maintenance therapy for patients with discrete aldosterone-producing adrenal adenomas who are judged to be poor operative risks or who decline surgery. Long-term maintenance therapy for patients with bilateral micro or macronodular adrenal hyperplasia (idiopathic hyperaldosteronism). Edematous conditions for patients with: Congestive heart failure : For the management of edema and sodium retention when the patient i…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 203253
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 |
|---|---|---|---|---|
| Spironolactone | Spironolactone 25 mg/1 | Tablet, Film coatedOral | QPharma, Inc. | 42708-101 |
| Spironolactone | Spironolactone 25 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-1693 |
| Spironolactone | Spironolactone 50 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-1694 |
| Spironolactone | Spironolactone 100 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-0665 |
| Spironolactone | Spironolactone 50 mg/1 | Tablet, Film coatedOral | Jubilant Cadista Pharmacuticals Inc. | 59746-217 |
| Spironolactone | Spironolactone 25 mg/1 | Tablet, Film coatedOral | Jubilant Cadista Pharmacuticals Inc. | 59746-216 |
| Spironolactone | Spironolactone 25 mg/1 | Tablet, Film coatedOral | Jubilant Cadista Pharmacuticals Inc. | 59746-216 |
| Spironolactone | Spironolactone 50 mg/1 | Tablet, Film coatedOral | Jubilant Cadista Pharmacuticals Inc. | 59746-217 |
| Spironolactone | Spironolactone 100 mg/1 | Tablet, Film coatedOral | Jubilant Cadista Pharmacuticals Inc. | 59746-218 |
| Spironolactone | Spironolactone 100 mg/1 | Tablet, Film coatedOral | Jubilant Cadista Pharmacuticals Inc. | 59746-218 |
| Spironolactone | Spironolactone 25 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-841 |
| Spironolactone | Spironolactone 25 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-2437 |
| Spironolactone | Spironolactone 50 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-2438 |