Prescription drug · ANDA
Metformin (Metformin er 500 mg) NDC 82804-147
Metformin hydrochloride 500 mg/1 · Tablet, Extended release · Oral · Proficient Rx LP
NDC codes
FDA NDC DirectoryProduct NDC (as listed)82804-147Labeler and product segments. Claims need a package NDC.
Product NDC at billing width82804-0147Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82804-147-30 | 8280401473082804014730 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (82804-147-30)Marketed from Apr 8, 2025 | |
| 82804-147-60 | 8280401476082804014760 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (82804-147-60)Marketed from Sep 20, 2024 | |
| 82804-147-78 | 8280401477882804014778 | 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (82804-147-78)Marketed from Oct 1, 2024 | |
| 82804-147-90 | 8280401479082804014790 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (82804-147-90)Marketed from Nov 4, 2024 |
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
- Generic name (nonproprietary)
- metformin er 500 mg
- Active ingredients
- Metformin hydrochloride — 500 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Proficient Rx LPNDC labeler code 82804
- 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 82804-147_f71c1195-68bc-435d-abba-f28a10150004SPL ID f71c1195-68bc-435d-abba-f28a10150004SPL set ID 92855c8d-59be-458b-97f1-2ff11b9bf6b0RxCUI 860975UNII 786Z46389EUPC 0382804147601
- 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
N482804014730followed by a unit qualifier and the quantityPackage 82804-0147-30. 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 .
Indications (excerpt from the label)
INDICATIONS & USAGE Metformin hydrochloride extended-release tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.
Excerpt only. Read the full label for complete information.
About NDC 82804-147
- What is NDC 82804-147?
- 82804-147 is the product NDC for Metformin (metformin er 500 mg), Metformin hydrochloride 500 mg/1 tablet, extended release, listed with the FDA by Proficient Rx LP. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Metformin (Metformin ER 500 mg).
- What is the active ingredient?
- Metformin hydrochloride.
- Who is the labeler?
- Proficient Rx LP, NDC labeler code 82804. 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 |
| Metformin | Metformin hydrochloride 1000 mg/1 | Tablet, Extended releaseOral | Coupler LLC | 67046-1584 | 67046-1584-03 |
| 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 |
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 | TabletOral | A-S Medication Solutions | 50090-6515 |
| Metforminmetformin er 500 mg | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-6516 |
| 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 |
| Metforminmetformin er 500 mg | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | Coupler LLC | 67046-0437 |
| Metforminmetformin er 500 mg | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | Legacy Pharmaceutical Packaging, LLC | 68645-595 |
| Metforminmetformin er 500 mg | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | Granules Pharmaceuticals Inc. | 70010-491 |
| 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 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4370 |
| 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 | Bryant Ranch Prepack | 71335-2524 |
| 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 | Bryant Ranch Prepack | 72162-2424 |
| Metformin ER 500 mg | Metformin hydrochloride 500 mg/1 | TabletOral | Granules India Ltd | 62207-491 |
| Metformin ER 500 mg | Metformin hydrochloride 500 mg/1 | TabletOral | Quallent Pharmaceuticals Health LLC | 82009-117 |
| Metformin ER 750 mg | Metformin hydrochloride 750 mg/1 | TabletOral | Granules India Ltd | 62207-492 |
| Metformin ER 750 mg | Metformin hydrochloride 750 mg/1 | TabletOral | Quallent Pharmaceuticals Health LLC | 82009-118 |