Prescription drug · ANDA
Metformin Hydrochloride NDC 68788-8560
Metformin hydrochloride 1000 mg/1 · Tablet · Oral · Preferred Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-8560-1 | 68788856001 | 100 TABLET in 1 BOTTLE (68788-8560-1)Marketed from Jan 8, 2024 | |
| 68788-8560-3 | 68788856003 | 30 TABLET in 1 BOTTLE (68788-8560-3)Marketed from Jan 8, 2024 | |
| 68788-8560-6 | 68788856006 | 60 TABLET in 1 BOTTLE (68788-8560-6)Marketed from Jan 8, 2024 | |
| 68788-8560-8 | 68788856008 | 120 TABLET in 1 BOTTLE (68788-8560-8)Marketed from Jan 8, 2024 | |
| 68788-8560-9 | 68788856009 | 90 TABLET in 1 BOTTLE (68788-8560-9)Marketed from Jan 8, 2024 |
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 — 1000 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213320
- Marketing start
- Marketing end
- Other FDA classes
- Biguanides (Chemical structure)
- Identifiers
- Product ID 68788-8560_f1743b2e-36f8-43e7-b409-62ed64e411a2SPL ID f1743b2e-36f8-43e7-b409-62ed64e411a2SPL set ID 4182bcf0-1f9a-4f3a-9428-86b5d757954fRxCUI 861004UNII 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
N468788856001followed by a unit qualifier and the quantityPackage 68788-8560-01. 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 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 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 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 213320
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, Film coatedOral | QPharma,Inc. | 42708-203 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-551 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | QPharma Inc | 42708-202 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-932 |
| Metformin Hydrochloride | Metformin hydrochloride 850 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-931 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | TabletOral | Coupler LLC | 67046-1516 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8564 |
| Metformin Hydrochloride | Metformin hydrochloride 850 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8603 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-843 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-841 |
| Metformin Hydrochloride | Metformin hydrochloride 850 mg/1 | TabletOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-842 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2466 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticcals,Inc. | 68071-5306 |
| Metformin Hydrochloride | Metformin hydrochloride 850 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-409 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-8041 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-8043 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3739 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-930 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-561 |
| Metformin Hydrochloride | Metformin hydrochloride 850 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2245 |
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