Prescription drug · ANDA
Metformin Hydrochloride NDC 71610-578
Metformin hydrochloride 500 mg/1 · Tablet, Extended release · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-578-60 | 71610057860 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-578-60)Marketed from Jul 1, 2021 | |
| 71610-578-70 | 71610057870 | 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-578-70)Marketed from Jul 1, 2021 | |
| 71610-578-80 | 71610057880 | 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-578-80)Marketed from Jul 1, 2021 | |
| 71610-578-94 | 71610057894 | 360 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-578-94)Marketed from Jul 1, 2021 |
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)
- Metformin Hydrochloride
- Generic name (nonproprietary)
- metformin hydrochloride
- Active ingredients
- Metformin hydrochloride — 500 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206145
- Marketing start
- Listing expires
- Other FDA classes
- Biguanides (Chemical structure)
- Identifiers
- Product ID 71610-578_ae39b6bc-4b1a-4db9-b5a1-7195832a1cecSPL ID ae39b6bc-4b1a-4db9-b5a1-7195832a1cecSPL set ID 1e298db3-439e-4e91-8f9e-01c3cdc4d552RxCUI 860975UNII 786Z46389E
- Pharmacologic class
- Biguanide
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
N471610057860followed by a unit qualifier and the quantityPackage 71610-0578-60. 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 206145
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 |
|---|---|---|---|---|
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-5396 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-5397 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | Ascend Laboratories, LLC | 67877-413 |
| Metformin Hydrochloride | Metformin hydrochloride 750 mg/1 | Tablet, Extended releaseOral | Ascend Laboratories, LLC | 67877-414 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | Proficient Rx LP | 71205-686 |
| Metformin Hydrochloride | Metformin hydrochloride 750 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-6839 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | Quallent Pharmaceuticals Health LLC | 82009-180 |
| Metformin Hydrochloride | Metformin hydrochloride 750 mg/1 | Tablet, Extended releaseOral | Quallent Pharmaceuticals Health LLC | 82009-181 |
| Metformin Hydrochloride | Metformin hydrochloride 750 mg/1 | Tablet, Extended releaseOral | Northwind Health Company, LLC | 51655-077 |
| Metformin Hydrochloride | Metformin hydrochloride 750 mg/1 | Tablet, Extended releaseOral | PD-Rx Pharmaceuticals, Inc. | 72789-472 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | Northwind Health Company, LLC | 51655-853 |
| Metformin Hydrochloride | Metformin hydrochloride 750 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-5246 |