Metformin Hydrochloride NDC 50228-503

NDC codes

FDA NDC Directory

Product NDC (as listed)50228-503Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50228-0503Add 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
50228-503-05	50228050305	500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-503-05)Marketed from Feb 22, 2022
50228-503-30	50228050330	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-503-30)Marketed from Feb 22, 2022
50228-503-60	50228050360	60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-503-60)Marketed from Feb 22, 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 extended-release tablets
Active ingredients: Metformin hydrochloride — 500 mg/1
Dosage form: Tablet, Film coated, Extended release
Route: Oral
Labeler: ScieGen Pharmaceuticals, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 214629
Marketing start: Feb 22, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Biguanides (Chemical structure)
Identifiers: Product ID 50228-503_dabc66fe-9cb1-3e39-e053-2995a90ab45fSPL ID dabc66fe-9cb1-3e39-e053-2995a90ab45fSPL set ID 16dc4008-7b5e-4c6d-9bc8-8db96be911a1RxCUI 1807894, 1807917UNII 786Z46389EUPC 0350228504058, 0350228504607, 0350228503600, 0350228503303, 0350228503051
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

N450228050305 followed by a unit qualifier and the quantity

Package 50228-0503-05. 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 Mar 21, 2022. 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 tablet 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 214629

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

FDA NDC Directory listings under ANDA 214629
Product	Strength	Form · route	Labeler	Product NDC
Metformin Hydrochloridemetformin hydrochloride extended-release tablets	Metformin hydrochloride 1000 mg/1	Tablet, Film coated, Extended releaseOral	ScieGen Pharmaceuticals, Inc.	50228-504