What is NDC 43547-395?

43547-395 is the product NDC for Glimepiride, Glimepiride 2 mg/1 tablet, listed with the FDA by Solco Healthcare U.S., LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

Solco Healthcare U.S., LLC, NDC labeler code 43547. 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 43547-395 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)43547-395Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43547-0395Add 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
43547-395-10	43547039510	100 TABLET in 1 BOTTLE, PLASTIC (43547-395-10)Marketed from Jan 30, 2017
43547-395-50	43547039550	500 TABLET in 1 BOTTLE, PLASTIC (43547-395-50)Marketed from Jan 30, 2017

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 — 2 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Solco Healthcare U.S., LLCNDC labeler code 43547
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077370
Marketing start: Jan 30, 2017
Listing expires: Dec 31, 2026
Other FDA classes: Sulfonylurea Compounds (Chemical structure)
Identifiers: Product ID 43547-395_95a5568d-751c-4497-b70c-5cc358bbb2afSPL ID 95a5568d-751c-4497-b70c-5cc358bbb2afSPL set ID 86acdd9e-8637-43e4-8bf7-b3a123b871b8RxCUI 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

N443547039510 followed by a unit qualifier and the quantity

Package 43547-0395-10. 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 Aug 13, 2021.

Indications (excerpt from the label)

Glimepiride tablets USP 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 USP 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 43547-395

What is NDC 43547-395?: 43547-395 is the product NDC for Glimepiride, Glimepiride 2 mg/1 tablet, listed with the FDA by Solco Healthcare U.S., LLC. It has 2 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?: Solco Healthcare U.S., LLC, NDC labeler code 43547. 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 077370

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

FDA NDC Directory listings under ANDA 077370
Product	Strength	Form · route	Labeler	Product NDC
Glimepiride	Glimepiride 1 mg/1	TabletOral	Solco Healthcare U.S., LLC	43547-394
Glimepiride	Glimepiride 4 mg/1	TabletOral	Solco Healthcare U.S., LLC	43547-396