What is NDC 61442-115?

61442-115 is the product NDC for Glimepiride, Glimepiride 1 mg/1 tablet, listed with the FDA by Carlsbad Technology, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.

Carlsbad Technology, Inc., NDC labeler code 61442. 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 61442-115 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)61442-115Labeler and product segments. Claims need a package NDC.

Product NDC at billing width61442-0115Add 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
61442-115-01	61442011501	100 TABLET in 1 BOTTLE (61442-115-01)Marketed from Jan 1, 2012
61442-115-05	61442011505	500 TABLET in 1 BOTTLE (61442-115-05)Marketed from Jan 1, 2012
61442-115-10	61442011510	1000 TABLET in 1 BOTTLE (61442-115-10)Marketed from Jan 1, 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 — 1 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Carlsbad Technology, Inc.NDC labeler code 61442
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077911
Marketing start: Jan 1, 2012
Listing expires: Dec 31, 2026
Other FDA classes: Sulfonylurea Compounds (Chemical structure)
Identifiers: Product ID 61442-115_2386d706-9dab-4ae0-e063-6394a90a8a06SPL ID 2386d706-9dab-4ae0-e063-6394a90a8a06SPL set ID 72d88c6d-2f0a-4bf8-aa7f-1e1811794187RxCUI 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

N461442011501 followed by a unit qualifier and the quantity

Package 61442-0115-01. 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 Oct 2, 2024.

Indications (excerpt from the label)

Glimepiride Tablet 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 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 ). Important 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 61442-115

What is NDC 61442-115?: 61442-115 is the product NDC for Glimepiride, Glimepiride 1 mg/1 tablet, listed with the FDA by Carlsbad Technology, Inc.. It has 3 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?: Carlsbad Technology, Inc., NDC labeler code 61442. 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 077911

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

FDA NDC Directory listings under ANDA 077911
Product	Strength	Form · route	Labeler	Product NDC
Glimepiride	Glimepiride 2 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	43063-698
Glimepiride	Glimepiride 4 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	43063-699
Glimepiride	Glimepiride 4 mg/1	TabletOral	Carlsbad Technology, Inc.	61442-117
Glimepiride	Glimepiride 2 mg/1	TabletOral	Carlsbad Technology, Inc.	61442-116
Glimepiride	Glimepiride 2 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	43063-946
Glimepiride	Glimepiride 4 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	72789-048
Glimepiride	Glimepiride 1 mg/1	TabletOral	Golden State Medical Supply, Inc.	60429-918
Glimepiride	Glimepiride 2 mg/1	TabletOral	Golden State Medical Supply, Inc.	60429-919
Glimepiride	Glimepiride 4 mg/1	TabletOral	Golden State Medical Supply, Inc.	60429-920
Glimepiride	Glimepiride 4 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-236
Glimepiride	Glimepiride 1 mg/1	TabletOral	PD-Rx Pharmaceuticals, Inc.	43063-697