What is NDC 65862-581?

65862-581 is the product NDC for Glimepiride, Glimepiride 4 mg/1 tablet, listed with the FDA by Aurobindo Pharma Limited. It has 4 package NDCs, shown above in 10- and 11-digit form.

Aurobindo Pharma Limited, NDC labeler code 65862. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Glimepiride?

102 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Glimepiride NDC 65862-581 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)65862-581Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65862-0581Add 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
65862-581-01	65862058101	100 TABLET in 1 BOTTLE (65862-581-01)Marketed from Jun 29, 2012
65862-581-05	65862058105	500 TABLET in 1 BOTTLE (65862-581-05)Marketed from Jun 29, 2012
65862-581-25	65862058125	250 TABLET in 1 BOTTLE (65862-581-25)Marketed from Jun 29, 2012
65862-581-99	65862058199	1000 TABLET in 1 BOTTLE (65862-581-99)Marketed from Jun 29, 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): Glimepiride
Generic name (nonproprietary): glimepiride
Active ingredients: Glimepiride — 4 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Aurobindo Pharma LimitedNDC labeler code 65862
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202759
Marketing start: Jun 29, 2012
Listing expires: Dec 31, 2027
Other FDA classes: Sulfonylurea Compounds (Chemical structure)
Identifiers: Product ID 65862-581_cb22d2cd-964e-4ce6-8647-2abe0426b570SPL ID cb22d2cd-964e-4ce6-8647-2abe0426b570SPL set ID 28eefc95-d92e-4555-b6c5-2933860b0610RxCUI 199245, 199246, 199247UNII 6KY687524K
Pharmacologic class: Sulfonylurea

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

N465862058101 followed by a unit qualifier and the quantity

Package 65862-0581-01. 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 Mar 18, 2026.

Indications (excerpt from the label)

Glimepiride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see Clinical Studies (14.1)] . Limitations of Use Glimepiride tablets should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings. Glimepiride is a sulfonylurea indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1) . Limitations of Use: Not for treating type 1 diabetes mellitus or diabetic ketoacidosis ( 1 ).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 65862-581

What is NDC 65862-581?: 65862-581 is the product NDC for Glimepiride, Glimepiride 4 mg/1 tablet, listed with the FDA by Aurobindo Pharma Limited. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Glimepiride.
What is the active ingredient?: Glimepiride.
Who is the labeler?: Aurobindo Pharma Limited, NDC labeler code 65862. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Glimepiride?: 102 other product NDCs are listed under this name. See all Glimepiride 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 Glimepiride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Glimepiride	Glimepiride 4 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-4191	68788-4191-0368788-4191-0668788-4191-09
Glimepiride	Glimepiride 2 mg/1	TabletOral	Coupler LLC	67046-1608	67046-1608-03
Glimepiride	Glimepiride 2 mg/1	TabletOral	REMEDYREPACK INC.	70518-4486	70518-4486-00
Glimepiride	Glimepiride 4 mg/1	TabletOral	REMEDYREPACK INC.	70518-4485	70518-4485-0070518-4485-0170518-4485-02
Glimepiride	Glimepiride 4 mg/1	TabletOral	Direct_rx	72189-585	72189-0585-90
Glimepiride	Glimepiride 2 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-8728	68788-8728-0168788-8728-0368788-8728-06+1 more
Glimepiride	Glimepiride 2 mg/1	TabletOral	Northwind Health Company, LLC	82868-042	82868-0042-90
Glimepiride	Glimepiride 1 mg/1	TabletOral	BluePoint Laboratories	68001-584	68001-0584-0068001-0584-03
Glimepiride	Glimepiride 2 mg/1	TabletOral	BluePoint Laboratories	68001-585	68001-0585-0068001-0585-03
Glimepiride	Glimepiride 4 mg/1	TabletOral	BluePoint Laboratories	68001-586	68001-0586-0068001-0586-03

All 103 Glimepiride NDCs

Other NDCs under ANDA 202759

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

FDA NDC Directory listings under ANDA 202759
Product	Strength	Form · route	Labeler	Product NDC
Glimepiride	Glimepiride 2 mg/1	TabletOral	Direct_Rx	72189-485
Glimepiride	Glimepiride 2 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	72789-370
Glimepiride	Glimepiride 4 mg/1	TabletOral	St. Mary's Medical Park Pharmacy	60760-800
Glimepiride	Glimepiride 4 mg/1	TabletOral	Bryant Ranch Prepack	71335-9654
Glimepiride	Glimepiride 1 mg/1	TabletOral	Bryant Ranch Prepack	71335-9655
Glimepiride	Glimepiride 4 mg/1	TabletOral	Proficient Rx LP	71205-773
Glimepiride	Glimepiride 2 mg/1	TabletOral	Proficient Rx LP	82804-065
Glimepiride	Glimepiride 1 mg/1	TabletOral	Proficient Rx LP	71205-779
Glimepiride	Glimepiride 1 mg/1	TabletOral	Aurobindo Pharma Limited	65862-579
Glimepiride	Glimepiride 1 mg/1	TabletOral	Rising Pharma Holdings, Inc.	16571-773
Glimepiride	Glimepiride 2 mg/1	TabletOral	Aurobindo Pharma Limited	65862-580
Glimepiride	Glimepiride 2 mg/1	TabletOral	Rising Pharma Holdings, Inc.	16571-774
Glimepiride	Glimepiride 4 mg/1	TabletOral	Rising Pharma Holdings, Inc.	16571-775
Glimepiride	Glimepiride 4 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-8432
Glimepiride	Glimepiride 4 mg/1	TabletOral	A-S Medication Solutions	50090-7823
Glimepiride	Glimepiride 4 mg/1	TabletOral	A-S Medication Solutions	50090-6322
Glimepiride	Glimepiride 2 mg/1	TabletOral	A-S Medication Solutions	50090-7628
Glimepiride	Glimepiride 1 mg/1	TabletOral	A-S Medication Solutions	50090-6394
Glimepiride	Glimepiride 2 mg/1	TabletOral	Northwind Health Company, LLC	82868-042
Glimepiride	Glimepiride 2 mg/1	TabletOral	A-S Medication Solutions	50090-6426