Metformin Hydrochloride NDC 69238-2126

NDC codes

FDA NDC Directory

Product NDC (as listed)69238-2126Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69238-2126Add 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
69238-2126-1	69238212601	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (69238-2126-1)Marketed from Feb 26, 2010
69238-2126-3	69238212603	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (69238-2126-3)Marketed from Feb 26, 2010
69238-2126-5	69238212605	500 TABLET, EXTENDED RELEASE in 1 BOTTLE (69238-2126-5)Marketed from Feb 26, 2010
69238-2126-9	69238212609	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (69238-2126-9)Marketed from Feb 26, 2010

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 — 750 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Amneal Pharmaceuticals LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078596
Marketing start: Feb 26, 2010
Listing expires: Dec 31, 2027
Other FDA classes: Biguanides (Chemical structure)
Identifiers: Product ID 69238-2126_5843b577-819b-42a8-956b-b858e0558691SPL ID 5843b577-819b-42a8-956b-b858e0558691SPL set ID dc65065b-cba0-46d7-8fb5-3368f3210b4dRxCUI 860975, 860981UNII 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

N469238212601 followed by a unit qualifier and the quantity

Package 69238-2126-01. 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 Jul 1, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Metformin hydrochloride extended-release 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 extended-release 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 078596

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

FDA NDC Directory listings under ANDA 078596
Product	Strength	Form · route	Labeler	Product NDC
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Extended releaseOral	Amneal Pharmaceuticals LLC	69238-2125
Metformin Hydrochloride	Metformin hydrochloride 750 mg/1	Tablet, Extended releaseOral	Aphena Pharma Solutions - Tennessee, LLC	71610-740
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Extended releaseOral	Aphena Pharma Solutions - Tennessee, LLC	71610-652
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Extended releaseOral	Amneal Pharmaceuticals LLC	65162-178
Metformin Hydrochloride	Metformin hydrochloride 750 mg/1	Tablet, Extended releaseOral	Amneal Pharmaceuticals LLC	65162-179