Prescription drug · NDA
Riomet (Metformin hydrochloride) NDC 10631-206
Metformin hydrochloride 500 mg/5mL · Solution · Oral · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 10631-206-01 | 1063102060110631020601 | 118 mL in 1 BOTTLE (10631-206-01)Marketed from Jan 4, 2004 | |
| 10631-206-02 | 1063102060210631020602 | 473 mL in 1 BOTTLE (10631-206-02)Marketed from Jan 4, 2004 |
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)
- Riomet
- Generic name (nonproprietary)
- metformin hydrochloride
- Active ingredients
- Metformin hydrochloride — 500 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Sun Pharmaceutical Industries, Inc.NDC labeler code 10631
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021591
- Marketing start
- Listing expires
- Other FDA classes
- Biguanides (Chemical structure)
- Identifiers
- Product ID 10631-206_8ed86d67-8a49-4334-82c4-1dbf6a489d3bSPL ID 8ed86d67-8a49-4334-82c4-1dbf6a489d3bSPL set ID 05d4df4b-dfe8-4828-b423-a3d4f2c4114aRxCUI 861025, 861027UNII 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
N410631020601followed by a unit qualifier and the quantityPackage 10631-0206-01. 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)
RIOMET 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. RIOMET 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)
Excerpt only. Read the full label for complete information.
About NDC 10631-206
- What is NDC 10631-206?
- 10631-206 is the product NDC for Riomet (metformin hydrochloride), Metformin hydrochloride 500 mg/5mL solution, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Riomet (Metformin Hydrochloride).
- What is the active ingredient?
- Metformin hydrochloride.
- Who is the labeler?
- Sun Pharmaceutical Industries, Inc., NDC labeler code 10631. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Riomet?
- 1 other product NDC are listed under this name. See all Riomet NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Riomet products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Riometmetformin hydrochloride | Metformin hydrochloride 500 mg/5mL | SolutionOral | Sun Pharmaceutical Industries, Inc. | 10631-238 | 10631-0238-0110631-0238-02 |
Other NDCs under NDA 021591
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 |
|---|---|---|---|---|
| Riometmetformin hydrochloride | Metformin hydrochloride 500 mg/5mL | SolutionOral | Sun Pharmaceutical Industries, Inc. | 10631-238 |