Prescription drug · ANDA
Spironolactone NDC 63629-2438
Spironolactone 50 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-2438-1 | 63629243801 | 100 TABLET, FILM COATED in 1 BOTTLE (63629-2438-1)Marketed from Apr 4, 2017 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Bryant Ranch Prepack
- 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 63629-2438_dca8fb3f-0258-4cc5-b4c6-4ac3bc31f1deSPL ID dca8fb3f-0258-4cc5-b4c6-4ac3bc31f1deSPL set ID 9d747bf5-31aa-48a5-9c6d-3cf8ce99a8f1RxCUI 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
N463629243801followed by a unit qualifier and the quantityPackage 63629-2438-01. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
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 50 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-861 |
| Spironolactone | Spironolactone 25 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-2437 |