What is NDC 55111-320?

55111-320 is the product NDC for Glimepiride, Glimepiride 1 mg/1 tablet, listed with the FDA by Dr. Reddy's Laboratories Limited. It has 4 package NDCs, shown above in 10- and 11-digit form.

Dr. Reddy's Laboratories Limited, NDC labeler code 55111. 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?

101 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 55111-320 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)55111-320Labeler and product segments. Claims need a package NDC.

Product NDC at billing width55111-0320Add 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
55111-320-01	5511103200155111032001	100 TABLET in 1 BOTTLE (55111-320-01)Marketed from Oct 6, 2005
55111-320-05	5511103200555111032005	500 TABLET in 1 BOTTLE (55111-320-05)Marketed from Oct 6, 2005
55111-320-30	5511103203055111032030	30 TABLET in 1 BOTTLE (55111-320-30)Marketed from Oct 6, 2005
55111-320-78	5511103207855111032078	100 BLISTER PACK in 1 CARTON (55111-320-78) / 1 TABLET in 1 BLISTER PACK (55111-320-79)Marketed from Oct 6, 2005

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 — 1 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Dr. Reddy's Laboratories LimitedNDC labeler code 55111
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077091
Marketing start: Oct 6, 2005
Listing expires: Dec 31, 2027
Other FDA classes: Sulfonylurea Compounds (Chemical structure)
Identifiers: Product ID 55111-320_e3d50334-9896-b2f9-a481-8383eb84b16aSPL ID e3d50334-9896-b2f9-a481-8383eb84b16aSPL set ID 07ad4366-4b21-f633-49f3-c2b35f88168dRxCUI 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

N455111032001 followed by a unit qualifier and the quantity

Package 55111-0320-01. 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 Jan 16, 2019.

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 tablets are 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 55111-320

What is NDC 55111-320?: 55111-320 is the product NDC for Glimepiride, Glimepiride 1 mg/1 tablet, listed with the FDA by Dr. Reddy's Laboratories 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?: Dr. Reddy's Laboratories Limited, NDC labeler code 55111. 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?: 101 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 102 Glimepiride NDCs

Other NDCs under ANDA 077091

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

FDA NDC Directory listings under ANDA 077091
Product	Strength	Form · route	Labeler	Product NDC
Glimepiride	Glimepiride 1 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	43063-121
Glimepiride	Glimepiride 4 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	43063-122
Glimepiride	Glimepiride 4 mg/1	TabletOral	A-S Medication Solutions	50090-1006
Glimepiride	Glimepiride 2 mg/1	TabletOral	A-S Medication Solutions	50090-6415
Glimepiride	Glimepiride 4 mg/1	TabletOral	A-S Medication Solutions	50090-6852
Glimepiride	Glimepiride 2 mg/1	TabletOral	A-S Medication Solutions	50090-6910
Glimepiride	Glimepiride 1 mg/1	TabletOral	AvPAK	50268-358
Glimepiride	Glimepiride 2 mg/1	TabletOral	AvPAK	50268-359
Glimepiride	Glimepiride 4 mg/1	TabletOral	AvPAK	50268-360
Glimepiride	Glimepiride 4 mg/1	TabletOral	Northwind Health Company, LLC	51655-489
Glimepiride	Glimepiride 2 mg/1	TabletOral	Northwind Health Company, LLC	51655-565
Glimepiride	Glimepiride 2 mg/1	TabletOral	Dr. Reddy's Laboratories Limited	55111-321
Glimepiride	Glimepiride 4 mg/1	TabletOral	Dr. Reddy's Laboratories Limited	55111-322
Glimepiride	Glimepiride 2 mg/1	TabletOral	Cardinal Health 107, LLC	55154-8175
Glimepiride	Glimepiride 2 mg/1	TabletOral	Bryant Ranch Prepack	63629-3043
Glimepiride	Glimepiride 4 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-2228
Glimepiride	Glimepiride 2 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-2385
Glimepiride	Glimepiride 2 mg/1	TabletOral	American Health Packaging	68084-326
Glimepiride	Glimepiride 4 mg/1	TabletOral	American Health Packaging	68084-327
Glimepiride	Glimepiride 1 mg/1	TabletOral	American Health Packaging	68084-788

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