Prescription drug · ANDA
Spironolactone NDC 70518-4447
Spironolactone 100 mg/1 · Tablet · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-4447-0 | 7051844470070518444700 | 100 POUCH in 1 BOX (70518-4447-0) / 1 TABLET in 1 POUCH (70518-4447-1)Marketed from Aug 19, 2025 |
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
- Route
- Oral
- Labeler
- REMEDYREPACK INC.NDC labeler code 70518
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202187
- Marketing start
- Listing expires
- Other FDA classes
- Aldosterone Antagonists (Mechanism)
- Identifiers
- Product ID 70518-4447_5b358288-929a-abb5-e063-6394a90aadd2SPL ID 5b358288-929a-abb5-e063-6394a90aadd2
- 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
N470518444700followed by a unit qualifier and the quantityPackage 70518-4447-00. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 70518-4447
- What is NDC 70518-4447?
- 70518-4447 is the product NDC for Spironolactone, Spironolactone 100 mg/1 tablet, listed with the FDA by REMEDYREPACK INC.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Spironolactone.
- What is the active ingredient?
- Spironolactone.
- Who is the labeler?
- REMEDYREPACK INC., NDC labeler code 70518. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Spironolactone?
- 177 other product NDCs are listed under this name. See all Spironolactone NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Spironolactone products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Spironolactone | Spironolactone 100 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-4188 | 68788-4188-0368788-4188-0668788-4188-09 |
| Spironolactone | Spironolactone 50 mg/1 | Tablet, CoatedOral | Coupler LLC | 67046-0613 | 67046-0613-03 |
| Spironolactone | Spironolactone 25 mg/1 | Tablet, CoatedOral | Coupler LLC | 67046-0744 | 67046-0744-03 |
| Spironolactone | Spironolactone 25 mg/1 | Tablet, Film coatedOral | Safecor Health LLC | 48433-087 | 48433-0087-20 |
| Spironolactone | Spironolactone 50 mg/1 | Tablet, Film coatedOral | Safecor Health LLC | 48433-088 | 48433-0088-20 |
| Spironolactone | Spironolactone 100 mg/1 | Tablet, Film coatedOral | Safecor Health LLC | 48433-089 | 48433-0089-08 |
| Spironolactone | Spironolactone 100 mg/1 | Tablet, CoatedOral | Coupler LLC | 67046-1636 | 67046-1636-03 |
| spironolactone | Spironolactone 100 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4512 | 70518-4512-0070518-4512-02 |
| Spironolactone | Spironolactone 25 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 64980-706 | 64980-0706-0164980-0706-50 |
| Spironolactone | Spironolactone 50 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 64980-707 | 64980-0707-0164980-0707-50 |
Other NDCs under ANDA 202187
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 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8451 |
| Spironolactone | Spironolactone 50 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8452 |
| Spironolactone | Spironolactone 25 mg/1 | TabletOral | A-S Medication Solutions | 50090-6908 |
| Spironolactone | Spironolactone 25 mg/1 | TabletOral | A-S Medication Solutions | 50090-6909 |
| Spironolactone | Spironolactone 50 mg/1 | TabletOral | A-S Medication Solutions | 50090-7082 |
| Spironolactone | Spironolactone 50 mg/1 | TabletOral | A-S Medication Solutions | 50090-7083 |
| Spironolactone | Spironolactone 25 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-426 |
| Spironolactone | Spironolactone 50 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-427 |
| Spironolactone | Spironolactone 100 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-428 |
| Spironolactone | Spironolactone 50 mg/1 | TabletOral | Redpharm Drug | 67296-2285 |
| Spironolactone | Spironolactone 25 mg/1 | TabletOral | Redpharm Drug | 67296-2319 |
| Spironolactone | Spironolactone 100 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2988 |
| Spironolactone | Spironolactone 25 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2989 |
| Spironolactone | Spironolactone 50 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3795 |
| Spironolactone | Spironolactone 100 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3903 |
| Spironolactone | Spironolactone 100 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2681 |
| Spironolactone | Spironolactone 25 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2682 |
| Spironolactone | Spironolactone 50 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2683 |
| Spironolactone | Spironolactone 25 mg/1 | TabletOral | NorthStar Rx LLC | 72603-134 |
| Spironolactone | Spironolactone 50 mg/1 | TabletOral | NorthStar Rx LLC | 72603-135 |
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