Metformin Hydrochloride NDC 42571-333

NDC codes

FDA NDC Directory

Product NDC (as listed)42571-333Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42571-0333Add 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
42571-333-01	42571033301	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42571-333-01)Marketed from Mar 1, 2023
42571-333-05	42571033305	500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42571-333-05)Marketed from Mar 1, 2023
42571-333-60	42571033360	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42571-333-60)Marketed from Mar 1, 2023
42571-333-90	42571033390	90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42571-333-90)Marketed from Mar 1, 2023

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: Micro Labs Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212448
Marketing start: Mar 1, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Biguanides (Chemical structure)
Identifiers: Product ID 42571-333_46836128-22ce-1c77-e063-6294a90a9768SPL ID 46836128-22ce-1c77-e063-6294a90a9768SPL set ID cc070735-5e8d-4bb3-9caa-e84d29bb8943RxCUI 1807888, 1807915UNII 786Z46389EUPC 0342571334901, 0342571333010
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

N442571033301 followed by a unit qualifier and the quantity

Package 42571-0333-01. 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 21, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Metformin hydrochloride extended-release tablet is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Metformin hydrochloride extended-release tablets is 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 212448

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

FDA NDC Directory listings under ANDA 212448
Product	Strength	Form · route	Labeler	Product NDC
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	Tablet, Film coated, Extended releaseOral	Micro Labs Limited	42571-334