Prescription drug · ANDA
Metformin NDC 67046-1557
Metformin hydrochloride 500 mg/1 · Tablet, Extended release · Oral · Coupler LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67046-1557-3 | 67046155703 | 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (67046-1557-3)Marketed from Apr 29, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Generic name (nonproprietary)
- metformin
- Active ingredients
- Metformin hydrochloride — 500 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Coupler LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209674
- Marketing start
- Listing expires
- Other FDA classes
- Biguanides (Chemical structure)
- Identifiers
- Product ID 67046-1557_33ece343-467c-aadf-e063-6394a90a767cSPL ID 33ece343-467c-aadf-e063-6394a90a767cSPL set ID 33ecddbe-860a-6ca8-e063-6294a90aac64RxCUI 1807917UNII 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
N467046155703followed by a unit qualifier and the quantityPackage 67046-1557-03. 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 a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 ) 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.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 209674
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 | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | Ingenus Pharmaceuticals, LLC | 50742-633 |
| Metformin | Metformin hydrochloride 1000 mg/1 | Tablet, Extended releaseOral | Ingenus Pharmaceuticals, LLC | 50742-634 |
| Metformin | Metformin hydrochloride 1000 mg/1 | Tablet, Extended releaseOral | Coupler LLC | 67046-1584 |
| Metformin | Metformin hydrochloride 1000 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4651 |