Prescription drug · ANDA
spironolactone NDC 70771-1029
Spironolactone 100 mg/1 · Tablet, Film coated · Oral · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70771-1029-0 | 70771102900 | 1000 TABLET, FILM COATED in 1 BOTTLE (70771-1029-0)Marketed from Aug 15, 2018 | |
| 70771-1029-1 | 70771102901 | 100 TABLET, FILM COATED in 1 BOTTLE (70771-1029-1)Marketed from Aug 15, 2018 | |
| 70771-1029-3 | 70771102903 | 30 TABLET, FILM COATED in 1 BOTTLE (70771-1029-3)Marketed from Aug 15, 2018 | |
| 70771-1029-4 | 70771102904 | 10 BLISTER PACK in 1 CARTON (70771-1029-4) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Aug 15, 2018 | |
| 70771-1029-5 | 70771102905 | 500 TABLET, FILM COATED in 1 BOTTLE (70771-1029-5)Marketed from Aug 15, 2018 | |
| 70771-1029-9 | 70771102909 | 90 TABLET, FILM COATED in 1 BOTTLE (70771-1029-9)Marketed from Aug 15, 2018 |
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 — 100 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Zydus Lifesciences Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205936
- Marketing start
- Listing expires
- Other FDA classes
- Aldosterone Antagonists (Mechanism)
- Identifiers
- Product ID 70771-1029_038310cc-d190-4868-9442-00f7222d0597SPL ID 038310cc-d190-4868-9442-00f7222d0597SPL set ID 963af399-feb7-49d2-a59c-c19edad9c682RxCUI 198222, 198223, 313096UNII 27O7W4T232UPC 0370771102716
- 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
N470771102900followed by a unit qualifier and the quantityPackage 70771-1029-00. 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)
Spironolactone is an aldosterone antagonist indicated for: The treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure ( 1.1 ). Use as an add-on therapy for 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 ). The management of edema in adult patients who are cirrhotic when edema is not responsive to fluid and sodium restrictions and in the setting of nephrotic syndrome when treatment of the underlying disease, restriction of fluid and s…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 205936
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 50 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-861 |
| spironolactone | Spironolactone 25 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1027 |
| spironolactone | Spironolactone 50 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1028 |
| Spironolactone | Spironolactone 50 mg/1 | TabletOral | American Health Packaging | 60687-476 |
| Spironolactone | Spironolactone 100 mg/1 | TabletOral | American Health Packaging | 60687-487 |
| spironolactone | Spironolactone 50 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4468 |
| spironolactone | Spironolactone 25 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-3556 |
| spironolactone | Spironolactone 25 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4470 |
| spironolactone | Spironolactone 100 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4512 |
| spironolactone | Spironolactone 25 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals (USA) Inc. | 68382-660 |
| spironolactone | Spironolactone 50 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals (USA) Inc. | 68382-661 |
| spironolactone | Spironolactone 100 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals (USA) Inc. | 68382-662 |
| spironolactone | Spironolactone 100 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-153 |
| spironolactone | Spironolactone 25 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-636 |
| spironolactone | Spironolactone 25 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6927 |
| Spironolactone | Spironolactone 25 mg/1 | TabletOral | American Health Packaging | 60687-465 |