Prescription drug · ANDA
Metformin Hydrochloride ER (Metformin hydrochloride) NDC 69315-410
Metformin hydrochloride 500 mg/1 · Tablet, Extended release · Oral · Leading Pharma, LLC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)69315-410Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69315-0410Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69315-410-01 | 6931504100169315041001 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (69315-410-01)Marketed from May 1, 2025 | |
| 69315-410-05 | 6931504100569315041005 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (69315-410-05)Marketed from May 1, 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 — 500 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Leading Pharma, LLCNDC labeler code 69315
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201991
- Marketing start
- Listing expires
- Other FDA classes
- Biguanides (Chemical structure)
- Identifiers
- Product ID 69315-410_5bfcb3f8-cc3e-4e7f-e063-6394a90aa6b4SPL ID 5bfcb3f8-cc3e-4e7f-e063-6394a90aa6b4
- 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
N469315041001followed by a unit qualifier and the quantityPackage 69315-0410-01. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 69315-410
- What is NDC 69315-410?
- 69315-410 is the product NDC for Metformin Hydrochloride ER (metformin hydrochloride), Metformin hydrochloride 500 mg/1 tablet, extended release, listed with the FDA by Leading Pharma, LLC. It has 2 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?
- Leading Pharma, LLC, NDC labeler code 69315. 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 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 | 71610-867 | 71610-0867-5371610-0867-6071610-0867-70+1 more |
| 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 201991
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 | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8289 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | QPharma Inc | 42708-201 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-1494 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-7116 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-7579 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | Northwind Health Company, LLC | 51655-559 |
| Metformin hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | Proficient Rx LP | 63187-779 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | Ascend Laboratories, LLC | 67877-159 |
| Metformin hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | NuCare Pharmaceuticals, Inc. | 68071-1419 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | Preferred Pharmaceuticals Inc. | 68788-8814 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-0886 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-837 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | PD-Rx Pharmaceuticals, Inc. | 72789-400 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | PD-Rx Pharmaceuticals, Inc. | 72789-455 |