Metformin Hydrochloride NDC 69367-412

NDC codes

FDA NDC Directory

Product NDC (as listed)69367-412Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69367-0412Add 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
69367-412-60	69367041260	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69367-412-60)Marketed from Oct 23, 2025

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/1
Dosage form: Tablet, Film coated, Extended release
Route: Oral
Labeler: Westminster Pharmaceuticals, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203832
Marketing start: Oct 23, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Biguanides (Chemical structure)
Identifiers: Product ID 69367-412_0bcfb466-d20c-472a-8e3e-aee3df526272SPL ID 0bcfb466-d20c-472a-8e3e-aee3df526272SPL set ID 07b4ee2a-8435-4d38-a6b0-b919e3424153RxCUI 1807894, 1807917UNII 786Z46389EUPC 0369367412605, 0369367413602
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

N469367041260 followed by a unit qualifier and the quantity

Package 69367-0412-60. 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 Jun 30, 2025. 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 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 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 203832

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

FDA NDC Directory listings under ANDA 203832
Product	Strength	Form · route	Labeler	Product NDC
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	Tablet, Film coated, Extended releaseOral	Golden State Medical Supply, Inc.	51407-059
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	Tablet, Film coated, Extended releaseOral	Westminster Pharmaceuticals, LLC	69367-413