Prescription drug · ANDA
Metformin Hydrochloride NDC 68382-759
Metformin hydrochloride 850 mg/1 · Tablet, Film coated · Oral · Zydus Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68382-759-01 | 68382075901 | 100 TABLET, FILM COATED in 1 BOTTLE (68382-759-01)Marketed from Dec 9, 2014 | |
| 68382-759-05 | 68382075905 | 500 TABLET, FILM COATED in 1 BOTTLE (68382-759-05)Marketed from Dec 9, 2014 | |
| 68382-759-10 | 68382075910 | 1000 TABLET, FILM COATED in 1 BOTTLE (68382-759-10)Marketed from Dec 9, 2014 | |
| 68382-759-16 | 68382075916 | 90 TABLET, FILM COATED in 1 BOTTLE (68382-759-16)Marketed from Dec 9, 2014 | |
| 68382-759-77 | 68382075977 | 100 BLISTER PACK in 1 CARTON (68382-759-77) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68382-759-30)Marketed from Dec 9, 2014 |
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 — 850 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203686
- Marketing start
- Listing expires
- Other FDA classes
- Biguanides (Chemical structure)
- Identifiers
- Product ID 68382-759_278de28c-b40d-4fb7-802e-24b98e9de3b2SPL ID 278de28c-b40d-4fb7-802e-24b98e9de3b2SPL set ID c82a10fa-1e8e-46b6-890a-737de3f34ee1RxCUI 861004, 861007, 861010UNII 786Z46389EUPC 0368382759016
- 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
N468382075901followed by a unit qualifier and the quantityPackage 68382-0759-01. 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 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 203686
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 1000 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 65841-811 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 65841-809 |
| Metformin Hydrochloride | Metformin hydrochloride 850 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 65841-810 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Quallent Pharmaceuticals Health LLC | 82009-174 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | Quallent Pharmaceuticals Health LLC | 82009-175 |
| Metformin Hydrochloride | Metformin hydrochloride 850 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-143 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-155 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-162 |
| Metformin Hydrochloride | Metformin hydrochloride 500 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals USA Inc. | 68382-758 |
| Metformin Hydrochloride | Metformin hydrochloride 1000 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals USA Inc. | 68382-760 |