Prescription drug · ANDA
Metformin Hydrochloride NDC 82804-309
Metformin hydrochloride 500 mg/1 · Tablet, Film coated · Oral · Proficient Rx LP
NDC codes
FDA NDC DirectoryProduct NDC (as listed)82804-309Labeler and product segments. Claims need a package NDC.
Product NDC at billing width82804-0309Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82804-309-30 | 8280403093082804030930 | 30 TABLET, FILM COATED in 1 BOTTLE (82804-309-30)Marketed from Sep 29, 2026 | |
| 82804-309-60 | 8280403096082804030960 | 60 TABLET, FILM COATED in 1 BOTTLE (82804-309-60)Marketed from Sep 14, 2026 | |
| 82804-309-78 | 8280403097882804030978 | 180 TABLET, FILM COATED in 1 BOTTLE (82804-309-78)Marketed from Aug 12, 2026 | |
| 82804-309-90 | 8280403099082804030990 | 90 TABLET, FILM COATED in 1 BOTTLE (82804-309-90)Marketed from Sep 21, 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 LPNDC labeler code 82804
- 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_b0f6bff2-0981-4dde-84e4-5dfa6f6346e2SPL ID b0f6bff2-0981-4dde-84e4-5dfa6f6346e2
- 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
N482804030930followed by a unit qualifier and the quantityPackage 82804-0309-30. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 82804-309
- What is NDC 82804-309?
- 82804-309 is the product NDC for Metformin Hydrochloride, Metformin hydrochloride 500 mg/1 tablet, film coated, 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 Hydrochloride.
- 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 Hydrochloride?
- 366 other product NDCs are listed under this name. See all Metformin Hydrochloride 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 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 | Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4781 | 70518-4781-00 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | Marlex Pharmaceuticals, Inc. | 10135-823 | 10135-0823-0510135-0823-1010135-0823-30+5 more |
| Metformin Hydrochloride | Metformin hydrochloride 750 mg/1 | Tablet, Extended releaseOral | Marlex Pharmaceuticals, Inc. | 10135-824 | 10135-0824-0510135-0824-1010135-0824-90 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-4185 | 68788-4185-0168788-4185-0368788-4185-06+3 more |
| Metformin Hydrochloride | Metformin hydrochloride 625 mg/1 | TabletOral | ScieGen Pharmaceuticals Inc | 50228-588 | 50228-0588-0550228-0588-30 |
| Metformin Hydrochloride | Metformin hydrochloride 750 mg/1 | TabletOral | ScieGen Pharmaceuticals Inc | 50228-589 | 50228-0589-0550228-0589-30 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4710 | 70518-4710-0070518-4710-02 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4698 | 70518-4698-00 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | Advanced Rx of Tennessee, LLC | 80425-0591 | 80425-0591-0180425-0591-0280425-0591-03+1 more |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-054 | 87441-0054-01 |
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 HCL | Metformin hydrochloride 500 mg/1 | TabletOral | Direct_Rx | 72189-617 |
| Metformin HCL | Metformin hydrochloride 1000 mg/1 | TabletOral | Direct_Rx | 72189-635 |
| 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 1000 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-843 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | QPharma Inc | 42708-202 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | QPharma,Inc. | 42708-203 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7877 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7878 |
| 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 1000 mg/1 | TabletOral | Coupler LLC | 67046-1516 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-930 |
| Metformin Hydrochloride | Metformin hydrochloride 850 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-931 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-932 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3518 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3526 |
| Metformin Hydrochloride | Metformin hydrochloride 850 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3531 |
| Metformin Hydrochloride | Metformin hydrochloride 850 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3575 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3739 |
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