Metformin Hydrochloride NDC 50228-446

NDC codes

FDA NDC Directory

Product NDC (as listed)50228-446Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50228-0446Add 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
50228-446-05	50228044605	500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-446-05)Marketed from Apr 16, 2021
50228-446-30	50228044630	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-446-30)Marketed from Apr 16, 2021
50228-446-90	50228044690	90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50228-446-90)Marketed from Apr 16, 2021

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 — 1000 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 213334
Marketing start: Apr 16, 2021
Listing expires: Dec 31, 2026
Other FDA classes: Biguanides (Chemical structure)
Identifiers: Product ID 50228-446_2cd1dc49-0219-4df8-8865-96ac77e77334SPL ID 2cd1dc49-0219-4df8-8865-96ac77e77334SPL set ID 1452fbb1-e591-4a51-9f83-8a8a6a780b52RxCUI 1807888, 1807915UNII 786Z46389EUPC 0350228446907, 0350228445016
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

N450228044605 followed by a unit qualifier and the quantity

Package 50228-0446-05. 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 Jun 28, 2021. 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 213334

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

FDA NDC Directory listings under ANDA 213334
Product	Strength	Form · route	Labeler	Product NDC
Metformin Hydrochloridemetformin hydrochloride extended-release tablets	Metformin hydrochloride 500 mg/1	Tablet, Film coated, Extended releaseOral	ScieGen Pharmaceuticals, Inc.	50228-445