Prescription drug · ANDA
Metformin ER 500 mg NDC 82009-117
Metformin hydrochloride 500 mg/1 · Tablet · Oral · Quallent Pharmaceuticals Health LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82009-117-10 | 82009011710 | 1000 TABLET in 1 BOTTLE (82009-117-10)Marketed from Jul 25, 2023 |
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 ER 500 mg
- Generic name (nonproprietary)
- metformin er 500 mg
- Active ingredients
- Metformin hydrochloride — 500 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209313
- Marketing start
- Listing expires
- Other FDA classes
- Biguanides (Chemical structure)
- Identifiers
- Product ID 82009-117_451e9a75-128c-6b1d-e063-6394a90aa5d8SPL ID 451e9a75-128c-6b1d-e063-6394a90aa5d8SPL set ID ff196435-14f4-8b9d-e053-6294a90a4ee8RxCUI 860975, 860981UNII 786Z46389EUPC 0382009117102, 0382009118017
- 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
N482009011710followed by a unit qualifier and the quantityPackage 82009-0117-10. 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 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.
Other NDCs under ANDA 209313
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 |
|---|---|---|---|---|
| Metforminmetformin er 500 mg | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-2354 |
| Metforminmetformin er 750 mg | Metformin hydrochloride 750 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-7372 |
| Metforminmetformin er 750 mg | Metformin hydrochloride 750 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-7373 |
| Metformin ER 500 mg | Metformin hydrochloride 500 mg/1 | TabletOral | Granules India Ltd | 62207-491 |
| Metformin ER 750 mg | Metformin hydrochloride 750 mg/1 | TabletOral | Granules India Ltd | 62207-492 |
| Metforminmetformin er 500 mg | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | Proficient Rx LP | 82804-147 |
| Metforminmetformin er 500 mg | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | Coupler LLC | 67046-0437 |
| Metformin ER 750 mg | Metformin hydrochloride 750 mg/1 | TabletOral | Quallent Pharmaceuticals Health LLC | 82009-118 |
| Metforminmetformin er 500 mg | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | Legacy Pharmaceutical Packaging, LLC | 68645-595 |
| Metforminmetformin er 750 mg | Metformin hydrochloride 750 mg/1 | Tablet, Extended releaseOral | Granules Pharmaceuticals Inc. | 70010-492 |
| Metforminmetformin er 500 mg | Metformin hydrochloride 500 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-613 |
| Metforminmetformin er 500 mg | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | Granules Pharmaceuticals Inc. | 70010-491 |
| Metforminmetformin er 500 mg | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-6516 |
| Metforminmetformin er 500 mg | Metformin hydrochloride 500 mg/1 | TabletOral | A-S Medication Solutions | 50090-6515 |
| Metforminmetformin er 750 mg | Metformin hydrochloride 750 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-2524 |
| Metforminmetformin er 500 mg | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4370 |
| Metforminmetformin er 500 mg | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 72162-2424 |