What is NDC 82009-117?

82009-117 is the product NDC for Metformin ER 500 mg, Metformin hydrochloride 500 mg/1 tablet, listed with the FDA by Quallent Pharmaceuticals Health LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Quallent Pharmaceuticals Health LLC, NDC labeler code 82009. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Metformin ER 500 mg?

1 other product NDC are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Metformin ER 500 mg NDC 82009-117 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)82009-117Labeler and product segments. Claims need a package NDC.

Product NDC at billing width82009-0117Add 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
82009-117-10	8200901171082009011710	1000 TABLET in 1 BOTTLE (82009-117-10)Marketed from Jul 25, 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 ER 500 mg
Generic name (nonproprietary): metformin er 500 mg
Active ingredients: Metformin hydrochloride — 500 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Quallent Pharmaceuticals Health LLCNDC labeler code 82009
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209313
Marketing start: Jul 25, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Biguanides (Chemical structure)
Identifiers: Product ID 82009-117_451e9a75-128c-6b1d-e063-6394a90aa5d8SPL ID 451e9a75-128c-6b1d-e063-6394a90aa5d8SPL set ID ff196435-14f4-8b9d-e053-6294a90a4ee8RxCUI 860975, 860981UNII 786Z46389EUPC 0382009117102, 0382009118017
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

N482009011710 followed by a unit qualifier and the quantity

Package 82009-0117-10. 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 4, 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 patients with type 2 diabetes mellitus. Metformin hydrochloride extended-release tablets are 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)

About NDC 82009-117

What is NDC 82009-117?: 82009-117 is the product NDC for Metformin ER 500 mg, Metformin hydrochloride 500 mg/1 tablet, listed with the FDA by Quallent Pharmaceuticals Health LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Metformin ER 500 mg.
What is the active ingredient?: Metformin hydrochloride.
Who is the labeler?: Quallent Pharmaceuticals Health LLC, NDC labeler code 82009. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Metformin ER 500 mg?: 1 other product NDC are listed under this name. See all Metformin ER 500 mg NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Metformin ER 500 mg NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Metformin ER 500 mg	Metformin hydrochloride 500 mg/1	TabletOral	Granules India Ltd	62207-491	62207-0491-3162207-0491-3562207-0491-43+3 more

Other NDCs under ANDA 209313

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

FDA NDC Directory listings under ANDA 209313
Product	Strength	Form · route	Labeler	Product NDC
Metforminmetformin er 500 mg	Metformin hydrochloride 500 mg/1	TabletOral	A-S Medication Solutions	50090-6515
Metforminmetformin er 500 mg	Metformin hydrochloride 500 mg/1	Tablet, Extended releaseOral	A-S Medication Solutions	50090-6516
Metforminmetformin er 750 mg	Metformin hydrochloride 750 mg/1	Tablet, Extended releaseOral	A-S Medication Solutions	50090-7372
Metforminmetformin er 750 mg	Metformin hydrochloride 750 mg/1	Tablet, Extended releaseOral	A-S Medication Solutions	50090-7373
Metforminmetformin er 500 mg	Metformin hydrochloride 500 mg/1	Tablet, Extended releaseOral	Coupler LLC	67046-0437
Metforminmetformin er 500 mg	Metformin hydrochloride 500 mg/1	Tablet, Extended releaseOral	Legacy Pharmaceutical Packaging, LLC	68645-595
Metforminmetformin er 500 mg	Metformin hydrochloride 500 mg/1	Tablet, Extended releaseOral	Granules Pharmaceuticals Inc.	70010-491
Metforminmetformin er 750 mg	Metformin hydrochloride 750 mg/1	Tablet, Extended releaseOral	Granules Pharmaceuticals Inc.	70010-492
Metforminmetformin er 500 mg	Metformin hydrochloride 500 mg/1	Tablet, Extended releaseOral	REMEDYREPACK INC.	70518-4370
Metforminmetformin er 500 mg	Metformin hydrochloride 500 mg/1	Tablet, Extended releaseOral	Bryant Ranch Prepack	71335-2354
Metforminmetformin er 750 mg	Metformin hydrochloride 750 mg/1	Tablet, Extended releaseOral	Bryant Ranch Prepack	71335-2524
Metforminmetformin er 500 mg	Metformin hydrochloride 500 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-613
Metforminmetformin er 500 mg	Metformin hydrochloride 500 mg/1	Tablet, Extended releaseOral	Bryant Ranch Prepack	72162-2424
Metforminmetformin er 500 mg	Metformin hydrochloride 500 mg/1	Tablet, Extended releaseOral	Proficient Rx LP	82804-147
Metformin ER 500 mg	Metformin hydrochloride 500 mg/1	TabletOral	Granules India Ltd	62207-491
Metformin ER 750 mg	Metformin hydrochloride 750 mg/1	TabletOral	Granules India Ltd	62207-492
Metformin ER 750 mg	Metformin hydrochloride 750 mg/1	TabletOral	Quallent Pharmaceuticals Health LLC	82009-118