Prescription drug · ANDA
Metformin hydrochloride NDC 71610-587
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 |
|---|---|---|---|
| 71610-587-30 | 71610058730 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-587-30)Marketed from Jan 18, 2022 | |
| 71610-587-60 | 71610058760 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-587-60)Marketed from Jul 28, 2021 | |
| 71610-587-70 | 71610058770 | 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-587-70)Marketed from Jul 28, 2021 | |
| 71610-587-80 | 71610058780 | 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-587-80)Marketed from Jul 28, 2021 | |
| 71610-587-92 | 71610058792 | 270 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-587-92)Marketed from Jan 18, 2022 | |
| 71610-587-94 | 71610058794 | 360 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-587-94)Marketed from Jul 28, 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 207427
- Marketing start
- Listing expires
- Other FDA classes
- Biguanides (Chemical structure)
- Identifiers
- Product ID 71610-587_0f023696-fd07-41a2-8f06-bf3472b28de2SPL ID 0f023696-fd07-41a2-8f06-bf3472b28de2SPL set ID c789254c-be70-4d25-8c6c-b284b01eb513RxCUI 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
N471610058730followed by a unit qualifier and the quantityPackage 71610-0587-30. 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 Metformin Hydrochloride Extended-release Tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 207427
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 | AvKARE | 42291-825 |
| Metformin hydrochloride ERmetformin hydrochloride | Metformin hydrochloride 750 mg/1 | Tablet, Extended releaseOral | AvKARE | 42291-824 |
| Metformin hydrochloride ERmetformin hydrochloride | Metformin hydrochloride 750 mg/1 | Tablet, Extended releaseOral | UNICHEM PHARMACEUTICALS (USA), INC. | 76385-129 |
| Metformin hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | UNICHEM PHARMACEUTICALS (USA), INC. | 76385-128 |
| Metformin hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-554 |
| Metformin hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-858 |
| Metformin hydrochloride ERmetformin hydrochloride | Metformin hydrochloride 750 mg/1 | Tablet, Extended releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-867 |
| Metformin hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | PD-Rx Pharmaceuticals, Inc. | 72789-105 |
| Metformin hydrochloride ERmetformin hydrochloride | Metformin hydrochloride 750 mg/1 | Tablet, Extended releaseOral | PD-Rx Pharmaceuticals, Inc. | 72789-106 |
| Metformin hydrochloride ERmetformin hydrochloride | Metformin hydrochloride 750 mg/1 | Tablet, Extended releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-666 |