Prescription drug · ANDA
Metformin HCl NDC 80425-0435
Metformin hydrochloride 1000 mg/1 · Tablet · Oral · Advanced Rx of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0435-1 | 80425043501 | 30 TABLET in 1 BOTTLE (80425-0435-1)Marketed from Sep 3, 2024 | |
| 80425-0435-2 | 80425043502 | 60 TABLET in 1 BOTTLE (80425-0435-2)Marketed from Sep 3, 2024 | |
| 80425-0435-3 | 80425043503 | 90 TABLET in 1 BOTTLE (80425-0435-3)Marketed from Sep 3, 2024 | |
| 80425-0435-4 | 80425043504 | 108 TABLET in 1 BOTTLE (80425-0435-4)Marketed from Sep 3, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 HCl
- Generic name (nonproprietary)
- metformin hcl
- Active ingredients
- Metformin hydrochloride — 1000 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090564
- Marketing start
- Listing expires
- Other FDA classes
- Biguanides (Chemical structure)
- Identifiers
- Product ID 80425-0435_22cef642-e37b-a74f-e063-6394a90aef9dSPL ID 22cef642-e37b-a74f-e063-6394a90aef9dSPL set ID 21b76183-af30-e06f-e063-6394a90a9653RxCUI 861004UNII 786Z46389E
- 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
N480425043501followed by a unit qualifier and the quantityPackage 80425-0435-01. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 090564
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 850 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8528 |
| Metformin Hydrochloride | Metformin hydrochloride 850 mg/1 | TabletOral | A-S Medication Solutions | 50090-6753 |
| Metformin Hydrochloride | Metformin hydrochloride 850 mg/1 | TabletOral | A-S Medication Solutions | 50090-6754 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | TabletOral | A-S Medication Solutions | 50090-7011 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | TabletOral | A-S Medication Solutions | 50090-7010 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | TabletOral | A-S Medication Solutions | 50090-7013 |
| Metformin Hydrochloridemetformin hydrochloride tablet | Metformin hydrochloride 500 mg/1 | TabletOral | Quallent Pharmaceuticals Health LLC | 82009-046 |
| Metformin HCl | Metformin hydrochloride 850 mg/1 | TabletOral | A-S Medication Solutions | 50090-3050 |
| Metformin Hydrochloridemetformin hydrochloride tablet | Metformin hydrochloride 1000 mg/1 | TabletOral | Quallent Pharmaceuticals Health LLC | 82009-047 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4698 |
| Metformin HCl | Metformin hydrochloride 500 mg/1 | TabletOral | A-S Medication Solutions | 50090-3064 |
| Metformin HCl | Metformin hydrochloride 500 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-531 |
| Metformin Hydrochloride | Metformin hydrochloride 850 mg/1 | TabletOral | Granules Pharmaceuticals Inc. | 70010-064 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | TabletOral | Granules Pharmaceuticals Inc. | 70010-063 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | TabletOral | Coupler LLC | 67046-0298 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | TabletOral | Granules Pharmaceuticals Inc. | 70010-065 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | TabletOral | Proficient Rx LP | 71205-622 |
| Metformin Hydrochloridemetformin hydrochloride tablet | Metformin hydrochloride 1000 mg/1 | TabletOral | Granules India Ltd | 62207-442 |
| Metformin Hydrochloride | Metformin hydrochloride 850 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3084 |
| Metformin Hydrochloridemetformin hydrochloride tablet | Metformin hydrochloride 500 mg/1 | TabletOral | Granules India Ltd | 62207-440 |
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