Metformin Hydrochloride NDC 66689-318

NDC codes

FDA NDC Directory

Product NDC (as listed)66689-318Labeler and product segments. Claims need a package NDC.

Product NDC at billing width66689-0318Add 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
66689-318-16	66689031816	1 BOTTLE in 1 CARTON (66689-318-16) / 473 mL in 1 BOTTLEMarketed from Dec 19, 2022

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 — 500 mg/5mL
Dosage form: Solution
Route: Oral
Labeler: VistaPharm, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212677
Marketing start: Dec 19, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Biguanides (Chemical structure)
Identifiers: Product ID 66689-318_88a5077b-b1b5-47bb-ab45-32de55907ea6SPL ID 88a5077b-b1b5-47bb-ab45-32de55907ea6SPL set ID e087ce3b-8d7f-43a3-8d20-54513da7617dRxCUI 861025UNII 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

N466689031816 followed by a unit qualifier and the quantity

Package 66689-0318-16. 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 Oct 10, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Metformin hydrochloride oral solution 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. Metformin hydrochloride 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)