Prescription drug · ANDA
Metformin Hydrochloride NDC 82804-309
Metformin hydrochloride 500 mg/1 · Tablet, Film coated · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82804-309-60 | 82804030960 | 60 TABLET, FILM COATED in 1 BOTTLE (82804-309-60)Marketed from Sep 14, 2026 | |
| 82804-309-78 | 82804030978 | 180 TABLET, FILM COATED in 1 BOTTLE (82804-309-78)Marketed from Aug 12, 2026 |
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
- Generic name (nonproprietary)
- metformin hydrochloride
- Active ingredients
- Metformin hydrochloride — 500 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213320
- Marketing start
- Listing expires
- Other FDA classes
- Biguanides (Chemical structure)
- Identifiers
- Product ID 82804-309_d8613b40-2671-4a44-87a8-d2d3aea556cbSPL ID d8613b40-2671-4a44-87a8-d2d3aea556cb
- 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
N482804030960followed by a unit qualifier and the quantityPackage 82804-0309-60. 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.
Other NDCs under ANDA 213320
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, Film coatedOral | QPharma,Inc. | 42708-203 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-551 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | QPharma Inc | 42708-202 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-932 |
| Metformin Hydrochloride | Metformin hydrochloride 850 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-931 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | TabletOral | Coupler LLC | 67046-1516 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8560 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8564 |
| Metformin Hydrochloride | Metformin hydrochloride 850 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8603 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-843 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-841 |
| Metformin Hydrochloride | Metformin hydrochloride 850 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-842 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2466 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticcals,Inc. | 68071-5306 |
| Metformin Hydrochloride | Metformin hydrochloride 850 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-409 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-8041 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-8043 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3739 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-930 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-561 |
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