Riomet (metformin hydrochloride) NDC 10631-238

NDC codes

FDA NDC Directory

Product NDC (as listed)10631-238Labeler and product segments. Claims need a package NDC.

Product NDC at billing width10631-0238Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
10631-238-01	10631023801	118 mL in 1 BOTTLE (10631-238-01)Marketed from Jan 4, 2004
10631-238-02	10631023802	473 mL in 1 BOTTLE (10631-238-02)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.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 021591
Marketing start: Jan 4, 2004
Listing expires: Dec 31, 2026
Other FDA classes: Biguanides (Chemical structure)
Identifiers: Product ID 10631-238_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

N410631023801 followed by a unit qualifier and the quantity

Package 10631-0238-01. 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 Dec 6, 2018. 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 021591

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 021591
Product	Strength	Form · route	Labeler	Product NDC
Riometmetformin hydrochloride	Metformin hydrochloride 500 mg/5mL	SolutionOral	Sun Pharmaceutical Industries, Inc.	10631-206