Prescription drug · ANDA
Metformin Hydrochloride NDC 71610-652
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 |
|---|---|---|---|
| 71610-652-30 | 71610065230 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-652-30)Marketed from Jul 14, 2022 | |
| 71610-652-53 | 71610065253 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-652-53)Marketed from Jul 14, 2022 | |
| 71610-652-60 | 71610065260 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-652-60)Marketed from Jul 14, 2022 | |
| 71610-652-70 | 71610065270 | 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-652-70)Marketed from Jul 14, 2022 | |
| 71610-652-80 | 71610065280 | 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-652-80)Marketed from Jul 14, 2022 | |
| 71610-652-94 | 71610065294 | 360 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-652-94)Marketed from Jul 14, 2022 |
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 078596
- Marketing start
- Listing expires
- Other FDA classes
- Biguanides (Chemical structure)
- Identifiers
- Product ID 71610-652_2f692050-7ea1-49b8-a19d-3b0134b7aa2aSPL ID 2f692050-7ea1-49b8-a19d-3b0134b7aa2aSPL set ID 6b8824c0-ece0-4b15-ba71-e893d6d2bfdfRxCUI 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
N471610065230followed by a unit qualifier and the quantityPackage 71610-0652-30. 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)
Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Metformin hydrochloride extended-release tablets are a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078596
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 | Amneal Pharmaceuticals LLC | 69238-2125 |
| Metformin Hydrochloride | Metformin hydrochloride 750 mg/1 | Tablet, Extended releaseOral | Amneal Pharmaceuticals LLC | 69238-2126 |
| Metformin Hydrochloride | Metformin hydrochloride 750 mg/1 | Tablet, Extended releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-740 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | Amneal Pharmaceuticals LLC | 65162-178 |
| Metformin Hydrochloride | Metformin hydrochloride 750 mg/1 | Tablet, Extended releaseOral | Amneal Pharmaceuticals LLC | 65162-179 |