Prescription drug · ANDA
Metformin NDC 67046-1584
Metformin hydrochloride 1000 mg/1 · Tablet, Extended release · Oral · Coupler LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67046-1584-3 | 6704615840367046158403 | 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (67046-1584-3)Marketed from Sep 15, 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 — 1000 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Coupler LLCNDC labeler code 67046
- 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 67046-1584_3edcaeec-b5bf-2682-e063-6394a90a2ddcSPL ID 3edcaeec-b5bf-2682-e063-6394a90a2ddcSPL set ID 3edc9b51-ddee-61f8-e063-6294a90ad3c5RxCUI 1807894UNII 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
N467046158403followed by a unit qualifier and the quantityPackage 67046-1584-03. 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.
About NDC 67046-1584
- What is NDC 67046-1584?
- 67046-1584 is the product NDC for Metformin, Metformin hydrochloride 1000 mg/1 tablet, extended release, listed with the FDA by Coupler LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Metformin.
- What is the active ingredient?
- Metformin hydrochloride.
- Who is the labeler?
- Coupler LLC, NDC labeler code 67046. 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?
- 18 other product NDCs are listed under this name. See all Metformin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Metformin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Metforminmetformin er 500 mg | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | Coupler LLC | 67046-0437 | 67046-0437-03 |
| Metformin | Metformin hydrochloride 1000 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4651 | 70518-4651-00 |
| Metforminmetformin er 500 mg | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4370 | 70518-4370-0070518-4370-0170518-4370-03+1 more |
| Metformin | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | Coupler LLC | 67046-1557 | 67046-1557-03 |
| Metforminmetformin er 500 mg | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | Legacy Pharmaceutical Packaging, LLC | 68645-595 | 68645-0595-59 |
| Metformin | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | Ingenus Pharmaceuticals, LLC | 50742-633 | 50742-0633-1050742-0633-6050742-0633-90 |
| Metformin | Metformin hydrochloride 1000 mg/1 | Tablet, Extended releaseOral | Ingenus Pharmaceuticals, LLC | 50742-634 | 50742-0634-1050742-0634-3050742-0634-60 |
| Metforminmetformin er 500 mg | Metformin hydrochloride 500 mg/1 | TabletOral | A-S Medication Solutions | 50090-6515 | 50090-6515-0050090-6515-0150090-6515-02+2 more |
| Metforminmetformin er 500 mg | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-6516 | 50090-6516-00 |
| Metforminmetformin er 750 mg | Metformin hydrochloride 750 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-7372 | 50090-7372-0050090-7372-0150090-7372-02+1 more |
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 500 mg/1 | Tablet, Extended releaseOral | Coupler LLC | 67046-1557 |
| Metformin | Metformin hydrochloride 1000 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4651 |