Prescription drug · ANDA
Metformin Hydrochloride NDC 68788-8866
Metformin hydrochloride 500 mg/1 · Tablet, Extended release · Oral · Preferred Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-8866-1 | 68788886601 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8866-1)Marketed from Apr 23, 2025 | |
| 68788-8866-3 | 68788886603 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8866-3)Marketed from Apr 23, 2025 | |
| 68788-8866-6 | 68788886606 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8866-6)Marketed from Apr 23, 2025 | |
| 68788-8866-8 | 68788886608 | 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8866-8)Marketed from Apr 23, 2025 | |
| 68788-8866-9 | 68788886609 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8866-9)Marketed from Apr 23, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217631
- Marketing start
- Listing expires
- Other FDA classes
- Biguanides (Chemical structure)
- Identifiers
- Product ID 68788-8866_103080cb-6381-44f6-8a31-1fc81e7c890fSPL ID 103080cb-6381-44f6-8a31-1fc81e7c890fSPL set ID 103080cb-6381-44f6-8a31-1fc81e7c890fRxCUI 860975UNII 786Z46389E
- 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
N468788886601followed by a unit qualifier and the quantityPackage 68788-8866-01. 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 extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Metformin hydrochloride extended-release tablets are 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 217631
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 | 50090-7918 |
| Metformin Hydrochloride | Metformin hydrochloride 750 mg/1 | Tablet, Extended releaseOral | Coupler LLC | 67046-1556 |
| Metformin Hydrochloride | Metformin hydrochloride 750 mg/1 | Tablet, Extended releaseOral | Laurus Labs Limited | 42385-978 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | Laurus Labs Limited | 42385-977 |
| Metformin Hydrochloride | Metformin hydrochloride 750 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-7535 |
| Metformin Hydrochloride | Metformin hydrochloride 750 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-7534 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | Redpharm Drug | 67296-2305 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-2568 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-7576 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-7577 |