Prescription drug · ANDA
Metformin Hydrochloride NDC 70010-063
Metformin hydrochloride 500 mg/1 · Tablet · Oral · Granules Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70010-063-01 | 70010006301 | 100 TABLET in 1 BOTTLE (70010-063-01)Marketed from Jun 26, 2019 | |
| 70010-063-05 | 70010006305 | 500 TABLET in 1 BOTTLE (70010-063-05)Marketed from Jun 26, 2019 | |
| 70010-063-06 | 70010006306 | 60 TABLET in 1 BOTTLE (70010-063-06)Marketed from Jun 26, 2019 | |
| 70010-063-09 | 70010006309 | 90 TABLET in 1 BOTTLE (70010-063-09)Marketed from Jun 26, 2019 | |
| 70010-063-10 | 70010006310 | 1000 TABLET in 1 BOTTLE (70010-063-10)Marketed from Jun 26, 2019 |
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
- 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 70010-063_4f91aad8-765b-eeb5-e063-6394a90ae95dSPL ID 4f91aad8-765b-eeb5-e063-6394a90ae95dSPL set ID 2387a618-24d8-4813-aa83-9114edb35374RxCUI 861004, 861007, 861010UNII 786Z46389EUPC 0370010065062, 0370010063068, 0370010064065
- 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
N470010006301followed by a unit qualifier and the quantityPackage 70010-0063-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. Metformin hydrochloride tablets are biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. ( 1 )
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 | 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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