Prescription drug · ANDA
Metformin Hydrochloride NDC 67877-413
Metformin hydrochloride 500 mg/1 · Tablet, Extended release · Oral · Ascend Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67877-413-01 | 67877041301 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-413-01)Marketed from Oct 27, 2018 | |
| 67877-413-05 | 67877041305 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-413-05)Marketed from Oct 27, 2018 | |
| 67877-413-10 | 67877041310 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-413-10)Marketed from Oct 27, 2018 | |
| 67877-413-33 | 67877041333 | 10 BLISTER PACK in 1 CARTON (67877-413-33) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Oct 27, 2018 | |
| 67877-413-90 | 67877041390 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-413-90)Marketed from Dec 27, 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, Extended release
- Route
- Oral
- Labeler
- Ascend Laboratories, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206145
- Marketing start
- Listing expires
- Other FDA classes
- Biguanides (Chemical structure)
- Identifiers
- Product ID 67877-413_4fa6bd66-7f2c-4b63-9809-be460cbc2527SPL ID 4fa6bd66-7f2c-4b63-9809-be460cbc2527SPL set ID 0ff1ba75-3c86-4baf-a6b1-1bb883839866RxCUI 860975, 860981, 861004, 861007, 861010UNII 786Z46389EUPC 0367877221014, 0367877218014, 0367877414904, 0367877413907
- 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
N467877041301followed by a unit qualifier and the quantityPackage 67877-0413-01. 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 is 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 extended-release tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Metformin is a 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 ) Metformin is a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 206145
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 500 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-5396 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-5397 |
| Metformin Hydrochloride | Metformin hydrochloride 750 mg/1 | Tablet, Extended releaseOral | Ascend Laboratories, LLC | 67877-414 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-578 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | Proficient Rx LP | 71205-686 |
| Metformin Hydrochloride | Metformin hydrochloride 750 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-6839 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | Quallent Pharmaceuticals Health LLC | 82009-180 |
| Metformin Hydrochloride | Metformin hydrochloride 750 mg/1 | Tablet, Extended releaseOral | Quallent Pharmaceuticals Health LLC | 82009-181 |
| Metformin Hydrochloride | Metformin hydrochloride 750 mg/1 | Tablet, Extended releaseOral | Northwind Health Company, LLC | 51655-077 |
| Metformin Hydrochloride | Metformin hydrochloride 750 mg/1 | Tablet, Extended releaseOral | PD-Rx Pharmaceuticals, Inc. | 72789-472 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | Northwind Health Company, LLC | 51655-853 |
| Metformin Hydrochloride | Metformin hydrochloride 750 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-5246 |