Glimepiride NDC 43547-394

NDC codes

FDA NDC Directory

Product NDC (as listed)43547-394Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43547-0394Add 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
43547-394-10	43547039410	100 TABLET in 1 BOTTLE, PLASTIC (43547-394-10)Marketed from Jan 30, 2017
43547-394-50	43547039450	500 TABLET in 1 BOTTLE, PLASTIC (43547-394-50)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 — 1 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Solco Healthcare U.S., LLC
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 43547-394_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

N443547039410 followed by a unit qualifier and the quantity

Package 43547-0394-10. 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)

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 2 mg/1	TabletOral	Solco Healthcare U.S., LLC	43547-395
Glimepiride	Glimepiride 4 mg/1	TabletOral	Solco Healthcare U.S., LLC	43547-396