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 | 6787705630167877056301 | 100 TABLET in 1 BOTTLE (67877-563-01)Marketed from Feb 6, 2017 | |
| 67877-563-05 | 6787705630567877056305 | 500 TABLET in 1 BOTTLE (67877-563-05)Marketed from Feb 6, 2017 | |
| 67877-563-10 | 6787705631067877056310 | 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, LLCNDC labeler code 67877
- 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.
About NDC 67877-563
- What is NDC 67877-563?
- 67877-563 is the product NDC for Metformin HCl, Metformin hydrochloride 1000 mg/1 tablet, listed with the FDA by Ascend Laboratories, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Metformin HCl.
- What is the active ingredient?
- Metformin hydrochloride.
- Who is the labeler?
- Ascend Laboratories, LLC, NDC labeler code 67877. 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 HCl?
- 32 other product NDCs are listed under this name. See all Metformin HCl NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Metformin HCl 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 HCl | Metformin hydrochloride 500 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-056 | 87441-0056-01 |
| Metformin HCl | Metformin hydrochloride 1000 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-055 | 87441-0055-01 |
| Metformin HCL | Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-658 | 72189-0658-3072189-0658-8272189-0658-90 |
| Metformin HCl | Metformin hydrochloride 850 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4479 | 70518-4479-0070518-4479-01 |
| Metformin HCL | Metformin hydrochloride 1000 mg/1 | TabletOral | Direct_Rx | 72189-635 | 72189-0635-82 |
| Metformin HCL | Metformin hydrochloride 500 mg/1 | TabletOral | Direct_Rx | 72189-617 | 72189-0617-3072189-0617-82 |
| Metformin HCl | Metformin hydrochloride 1000 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0435 | 80425-0435-0180425-0435-0280425-0435-03+1 more |
| Metformin HCl | Metformin hydrochloride 500 mg/1 | TabletOral | Northwind Health Company, LLC | 82868-049 | 82868-0049-6082868-0049-9082868-0049-98 |
| Metformin HCl | Metformin hydrochloride 500 mg/1 | TabletOral | QPharma, Inc. | 42708-009 | 42708-0009-60 |
| Metformin HCl | Metformin hydrochloride 1000 mg/1 | TabletOral | QPharma, Inc. | 42708-018 | 42708-0018-30 |
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 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 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | TabletOral | A-S Medication Solutions | 50090-7010 |
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