Prescription drug · ANDA
Metformin HCl NDC 67877-563
Metformin hydrochloride 1000 mg/1 · Tablet · Oral · Ascend Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67877-563-01 | 67877056301 | 100 TABLET in 1 BOTTLE (67877-563-01)Marketed from Feb 6, 2017 | |
| 67877-563-05 | 67877056305 | 500 TABLET in 1 BOTTLE (67877-563-05)Marketed from Feb 6, 2017 | |
| 67877-563-10 | 67877056310 | 1000 TABLET in 1 BOTTLE (67877-563-10)Marketed from Feb 6, 2017 |
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 HCl
- Generic name (nonproprietary)
- metformin hcl
- Active ingredients
- Metformin hydrochloride — 1000 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Ascend Laboratories, LLC
- 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 67877-563_2d98aea3-35ba-447a-b88f-a5a20b612b2fSPL ID 2d98aea3-35ba-447a-b88f-a5a20b612b2fSPL set ID 2d98aea3-35ba-447a-b88f-a5a20b612b2fRxCUI 861004, 861007, 861010UNII 786Z46389EUPC 0367877561011, 0367877563015
- 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
N467877056301followed by a unit qualifier and the quantityPackage 67877-0563-01. 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
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS & USAGE Metformin Hydrochloride Tablets USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus.
Excerpt only. Read the full label for complete information.
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 HCl | Metformin hydrochloride 1000 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0435 |
| 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 |
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