What is NDC 0615-8289?

0615-8289 is the product NDC for Metformin Hydrochloride, Metformin hydrochloride 500 mg/1 tablet, extended release, listed with the FDA by NCS HealthCare of KY, LLC dba Vangard Labs. It has 2 package NDCs, shown above in 10- and 11-digit form.

NCS HealthCare of KY, LLC dba Vangard Labs, NDC labeler code 0615. 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 Hydrochloride?

366 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Metformin Hydrochloride NDC 0615-8289

NDC codes

FDA NDC Directory

Product NDC (as listed)0615-8289Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00615-8289Add 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
0615-8289-28	0061582892800615828928	28 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-8289-28)Marketed from Mar 28, 2024
0615-8289-39	0061582893900615828939	30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-8289-39)Marketed from Jun 10, 2019

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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, Extended release
Route: Oral
Labeler: NCS HealthCare of KY, LLC dba Vangard LabsNDC labeler code 0615
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 201991
Marketing start: Mar 1, 2013
Listing expires: Dec 31, 2027
Other FDA classes: Biguanides (Chemical structure)
Identifiers: Product ID 0615-8289_e3d84126-2927-4507-aaef-6fc37fc5b105SPL ID e3d84126-2927-4507-aaef-6fc37fc5b105SPL set ID 5bb945c1-954a-4d43-aa24-33767d19c57cRxCUI 860975UNII 786Z46389E
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

N400615828928 followed by a unit qualifier and the quantity

Package 00615-8289-28. 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 Aug 23, 2024. 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 adults with type 2 diabetes mellitus. Metformin hydrochloride extended-release tablets are 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)

About NDC 0615-8289

What is NDC 0615-8289?: 0615-8289 is the product NDC for Metformin Hydrochloride, Metformin hydrochloride 500 mg/1 tablet, extended release, listed with the FDA by NCS HealthCare of KY, LLC dba Vangard Labs. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Metformin Hydrochloride.
What is the active ingredient?: Metformin hydrochloride.
Who is the labeler?: NCS HealthCare of KY, LLC dba Vangard Labs, NDC labeler code 0615. 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 Hydrochloride?: 366 other product NDCs are listed under this name. See all Metformin Hydrochloride 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 Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4781	70518-4781-00
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Extended releaseOral	Marlex Pharmaceuticals, Inc.	10135-823	10135-0823-0510135-0823-1010135-0823-30+5 more
Metformin Hydrochloride	Metformin hydrochloride 750 mg/1	Tablet, Extended releaseOral	Marlex Pharmaceuticals, Inc.	10135-824	10135-0824-0510135-0824-1010135-0824-90
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-4185	68788-4185-0168788-4185-0368788-4185-06+3 more
Metformin Hydrochloride	Metformin hydrochloride 625 mg/1	TabletOral	ScieGen Pharmaceuticals Inc	50228-588	50228-0588-0550228-0588-30
Metformin Hydrochloride	Metformin hydrochloride 750 mg/1	TabletOral	ScieGen Pharmaceuticals Inc	50228-589	50228-0589-0550228-0589-30
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	Tablet, Extended releaseOral	REMEDYREPACK INC.	70518-4710	70518-4710-0070518-4710-02
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	TabletOral	REMEDYREPACK INC.	70518-4698	70518-4698-00
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	Tablet, Film coatedOral	Advanced Rx of Tennessee, LLC	80425-0591	80425-0591-0180425-0591-0280425-0591-03+1 more
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-054	87441-0054-01

All 367 Metformin Hydrochloride NDCs

Other NDCs under ANDA 201991

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

FDA NDC Directory listings under ANDA 201991
Product	Strength	Form · route	Labeler	Product NDC
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Extended releaseOral	QPharma Inc	42708-201
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Extended releaseOral	A-S Medication Solutions	50090-1494
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Extended releaseOral	A-S Medication Solutions	50090-7116
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Extended releaseOral	A-S Medication Solutions	50090-7579
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Extended releaseOral	Northwind Health Company, LLC	51655-559
Metformin hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Extended releaseOral	Proficient Rx LP	63187-779
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Extended releaseOral	Ascend Laboratories, LLC	67877-159
Metformin hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Extended releaseOral	NuCare Pharmaceuticals, Inc.	68071-1419
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Extended releaseOral	Preferred Pharmaceuticals Inc.	68788-8814
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Extended releaseOral	Bryant Ranch Prepack	71335-0886
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Extended releaseOral	Aphena Pharma Solutions - Tennessee, LLC	71610-837
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Extended releaseOral	PD-Rx Pharmaceuticals, Inc.	72789-400
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Extended releaseOral	PD-Rx Pharmaceuticals, Inc.	72789-455
Metformin Hydrochloride ERmetformin hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Extended releaseOral	Leading Pharma, LLC	69315-410