Prescription drug · ANDA
Metformin hydrochloride NDC 76385-128
Metformin hydrochloride 500 mg/1 · Tablet, Extended release · Oral · UNICHEM PHARMACEUTICALS (USA), INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76385-128-01 | 76385012801 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (76385-128-01)Marketed from Jul 17, 2018 | |
| 76385-128-10 | 76385012810 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (76385-128-10)Marketed from Jul 17, 2018 | |
| 76385-128-50 | 76385012850 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (76385-128-50)Marketed from Jul 25, 2019 |
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 76385-128_ffb50294-b2b1-46ed-a344-de6f6fef7406SPL ID ffb50294-b2b1-46ed-a344-de6f6fef7406SPL set ID 93c8deae-3103-4cbf-a5d1-fe0d37e76df8RxCUI 860975, 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
N476385012801followed by a unit qualifier and the quantityPackage 76385-0128-01. 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 and pediatric patients 10 years of age and older 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 and pediatric patients 10 years of age and older 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 | Aphena Pharma Solutions - Tennessee, LLC | 71610-554 |
| 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 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 |