Metformin Hydrochloride NDC 53746-219

NDC codes

FDA NDC Directory

Product NDC (as listed)53746-219Labeler and product segments. Claims need a package NDC.

Product NDC at billing width53746-0219Add 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
53746-219-01	53746021901	100 TABLET in 1 BOTTLE (53746-219-01)Marketed from Dec 17, 2012
53746-219-05	53746021905	500 TABLET in 1 BOTTLE (53746-219-05)Marketed from Dec 17, 2012
53746-219-10	53746021910	1000 TABLET in 1 BOTTLE (53746-219-10)Marketed from Dec 17, 2012

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 — 850 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Amneal Pharmaceuticals of New York LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077880
Marketing start: Dec 17, 2012
Listing expires: Dec 31, 2026
Other FDA classes: Biguanides (Chemical structure)
Identifiers: Product ID 53746-219_87735a77-fc44-4fb2-b8f4-1dc44d13ad0aSPL ID 87735a77-fc44-4fb2-b8f4-1dc44d13ad0aSPL set ID b090b18b-b53c-4c92-892f-d11551cfedc3RxCUI 861004, 861007, 861010UNII 786Z46389EUPC 0353746219015, 0353746220011, 0353746218018
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

N453746021901 followed by a unit qualifier and the quantity

Package 53746-0219-01. 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 14, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

Metformin hydrochloride 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 tablets is 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 077880

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

FDA NDC Directory listings under ANDA 077880
Product	Strength	Form · route	Labeler	Product NDC
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	43063-527
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	43063-544
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	TabletOral	Amneal Pharmaceuticals of New York LLC	53746-218
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	TabletOral	Amneal Pharmaceuticals of New York LLC	53746-220