Prescription drug · ANDA
Metformin Hydrochloride (Metformin hydrochloride tablet) NDC 82009-046
Metformin hydrochloride 500 mg/1 · Tablet · Oral · Quallent Pharmaceuticals Health LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82009-046-10 | 8200900461082009004610 | 1000 TABLET in 1 BOTTLE (82009-046-10)Marketed from Feb 1, 2023 |
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 tablet
- Active ingredients
- Metformin hydrochloride — 500 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Quallent Pharmaceuticals Health LLCNDC labeler code 82009
- 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 82009-046_451e8dd3-039f-4756-e063-6394a90a0483SPL ID 451e8dd3-039f-4756-e063-6394a90a0483SPL set ID f39ee08d-73db-71b9-e053-2995a90a877cRxCUI 861004, 861007UNII 786Z46389EUPC 0382009046105, 0382009047102
- 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
N482009004610followed by a unit qualifier and the quantityPackage 82009-0046-10. 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.
About NDC 82009-046
- What is NDC 82009-046?
- 82009-046 is the product NDC for Metformin Hydrochloride (metformin hydrochloride tablet), Metformin hydrochloride 500 mg/1 tablet, listed with the FDA by Quallent Pharmaceuticals Health LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Metformin Hydrochloride (Metformin Hydrochloride Tablet).
- What is the active ingredient?
- Metformin hydrochloride.
- Who is the labeler?
- Quallent Pharmaceuticals Health LLC, NDC labeler code 82009. 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 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 | NuCare Pharmaceuticals,Inc. | 68071-3495 |
| Metformin Hydrochloride | Metformin hydrochloride 850 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7163 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Epic Pharma, LLC | 42806-313 |
| Metformin Hydrochloride | Metformin hydrochloride 850 mg/1 | Tablet, Film coatedOral | Epic Pharma, LLC | 42806-314 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | Epic Pharma, LLC | 42806-315 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8652 |
| Metformin HCl | Metformin hydrochloride 500 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1072 |
| Metformin Hydrochloride | Metformin hydrochloride 850 mg/1 | TabletOral | Coupler LLC | 67046-0804 |
| Metformin HCl | Metformin hydrochloride 500 mg/1 | TabletOral | Ascend Laboratories, LLC | 67877-561 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7162 |
| Metformin HCl | Metformin hydrochloride 850 mg/1 | TabletOral | Ascend Laboratories, LLC | 67877-562 |
| Metformin HCl | Metformin hydrochloride 1000 mg/1 | TabletOral | Ascend Laboratories, LLC | 67877-563 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | Metcure Pharmaceuticals, Inc. | 71709-112 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Metcure Pharmaceuticals, Inc. | 71709-110 |
| Metformin Hydrochloride | Metformin hydrochloride 850 mg/1 | Tablet, Film coatedOral | Metcure Pharmaceuticals, Inc. | 71709-111 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7164 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | TabletOral | A-S Medication Solutions | 50090-7595 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | TabletOral | A-S Medication Solutions | 50090-7597 |
| Metformin HCl | Metformin hydrochloride 500 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3541 |
| Metformin HCl | Metformin hydrochloride 500 mg/1 | TabletOral | Northwind Health Company, LLC | 82868-049 |
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