Prescription drug · ANDA
Metformin hydrochloride ER (Metformin hydrochloride) NDC 71610-867
Metformin hydrochloride 750 mg/1 · Tablet, Extended release · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-867-53 | 7161008675371610086753 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-867-53)Marketed from Nov 25, 2024 | |
| 71610-867-60 | 7161008676071610086760 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-867-60)Marketed from Nov 25, 2024 | |
| 71610-867-70 | 7161008677071610086770 | 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-867-70)Marketed from Nov 25, 2024 | |
| 71610-867-80 | 7161008678071610086780 | 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-867-80)Marketed from Jan 13, 2025 |
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 ERSuffix: ER
- Generic name (nonproprietary)
- metformin hydrochloride
- Active ingredients
- Metformin hydrochloride — 750 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610
- 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 71610-867_2bc26279-774d-c799-e063-6394a90aae86SPL ID 2bc26279-774d-c799-e063-6394a90aae86SPL set ID 27d6fdbc-27a8-c599-e063-6394a90a2233RxCUI 860981UNII 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
N471610086753followed by a unit qualifier and the quantityPackage 71610-0867-53. 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 patients 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.
About NDC 71610-867
- What is NDC 71610-867?
- 71610-867 is the product NDC for Metformin hydrochloride ER (metformin hydrochloride), Metformin hydrochloride 750 mg/1 tablet, extended release, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Metformin hydrochloride ER (Metformin hydrochloride).
- What is the active ingredient?
- Metformin hydrochloride.
- Who is the labeler?
- Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Metformin hydrochloride ER?
- 5 other product NDCs are listed under this name. See all Metformin hydrochloride ER NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Metformin hydrochloride ER products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Metformin Hydrochloride ERmetformin hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | Leading Pharma, LLC | 69315-410 | 69315-0410-0169315-0410-05 |
| Metformin hydrochloride ERmetformin hydrochloride | Metformin hydrochloride 750 mg/1 | Tablet, Extended releaseOral | AvKARE | 42291-824 | 42291-0824-1042291-0824-5042291-0824-90 |
| Metformin hydrochloride ERmetformin hydrochloride | Metformin hydrochloride 750 mg/1 | Tablet, Extended releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-666 | 71610-0666-5371610-0666-6071610-0666-80 |
| Metformin hydrochloride ERmetformin hydrochloride | Metformin hydrochloride 750 mg/1 | Tablet, Extended releaseOral | PD-Rx Pharmaceuticals, Inc. | 72789-106 | 72789-0106-0172789-0106-8272789-0106-90+1 more |
| Metformin hydrochloride ERmetformin hydrochloride | Metformin hydrochloride 750 mg/1 | Tablet, Extended releaseOral | UNICHEM PHARMACEUTICALS (USA), INC. | 76385-129 | 76385-0129-0176385-0129-50 |
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 | Aphena Pharma Solutions - Tennessee, LLC | 71610-587 |
| Metformin hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-858 |
| 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 |
| 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 | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | UNICHEM PHARMACEUTICALS (USA), INC. | 76385-128 |
| 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 | Aphena Pharma Solutions - Tennessee, LLC | 71610-554 |