Prescription drug · ANDA
Metformin Hydrochloride NDC 68788-8903
Metformin hydrochloride 500 mg/1 · Tablet, Extended release · Oral · Preferred Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-8903-1 | 68788890301 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8903-1)Marketed from Jul 31, 2025 | |
| 68788-8903-3 | 68788890303 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8903-3)Marketed from Jul 31, 2025 | |
| 68788-8903-6 | 68788890306 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8903-6)Marketed from Jul 31, 2025 | |
| 68788-8903-8 | 68788890308 | 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8903-8)Marketed from Jul 31, 2025 | |
| 68788-8903-9 | 68788890309 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8903-9)Marketed from Jul 31, 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 078321
- Marketing start
- Listing expires
- Other FDA classes
- Biguanides (Chemical structure)
- Identifiers
- Product ID 68788-8903_e55ee270-5eb9-4848-8529-9af2a79669c0SPL ID e55ee270-5eb9-4848-8529-9af2a79669c0SPL set ID e55ee270-5eb9-4848-8529-9af2a79669c0RxCUI 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
N468788890301followed by a unit qualifier and the quantityPackage 68788-8903-01. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 078321
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 Extended-Release 500mgmetformin hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | Calvin Scott & Co., Inc. | 17224-311 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-533 |
| Metformin Hydrochloride | Metformin hydrochloride 750 mg/1 | Tablet, Extended releaseOral | PD-Rx Pharmaceuticals, Inc. | 72789-548 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | AvPAK | 50268-550 |
| Metformin Hydrochloride | Metformin hydrochloride 750 mg/1 | Tablet, Extended releaseOral | AvPAK | 50268-551 |
| Metformin Hydrochloride | Metformin hydrochloride 750 mg/1 | Tablet, Extended releaseOral | Preferred Pharmaceuticals Inc. | 68788-7205 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | direct rx | 72189-150 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-3166 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | Proficient Rx LP | 82804-195 |
| Metformin Hydrochloride | Metformin hydrochloride 750 mg/1 | Tablet, Extended releaseOral | Proficient Rx LP | 71205-141 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | TAGI Pharma, Inc. | 51224-007 |
| Metformin Hydrochloride | Metformin hydrochloride 750 mg/1 | Tablet, Extended releaseOral | TAGI Pharma, Inc. | 51224-107 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | Proficient Rx LP | 71205-186 |
| Metformin Hydrochloride | Metformin hydrochloride 750 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-2504 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-0720 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | PD-Rx Pharmaceuticals, Inc. | 72789-454 |
| Metformin Hydrochloride | Metformin hydrochloride 750 mg/1 | Tablet, Extended releaseOral | PD-Rx Pharmaceuticals, Inc. | 72789-451 |
| Metformin Hydrochloride | Metformin hydrochloride 750 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-0776 |
| Metformin Hydrochloride | Metformin hydrochloride 750 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-2709 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Extended releaseOral | RedPharm Drug, Inc. | 67296-1701 |
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