NDC codes

FDA NDC Directory
Product NDC (as listed)42571-102Labeler and product segments. Claims need a package NDC.
Product NDC at billing width42571-0102Add 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 NDC11-digit (billing)PackageCopy
42571-102-014257101020142571010201100 TABLET in 1 BOTTLE (42571-102-01)Marketed from Jun 13, 2013
42571-102-054257101020542571010205500 TABLET in 1 BOTTLE (42571-102-05)Marketed from Jun 13, 2013

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 — 3 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Micro Labs LimitedNDC labeler code 42571
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 091220
Marketing start
Listing expires
Other FDA classes
Sulfonylurea Compounds (Chemical structure)
Identifiers
Product ID 42571-102_34e9a6b6-450b-7d20-e063-6294a90ac831SPL ID 34e9a6b6-450b-7d20-e063-6294a90ac831SPL set ID 60e9397e-83b9-489e-9683-6f87e458bbaaRxCUI 153842, 199245, 199246, 199247, 1361493, 1361495UNII 6KY687524KUPC 0342571100018, 0342571102012, 0342571101015, 0342571104016, 0342571105013, 0342571103019
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

N442571010201 followed by a unit qualifier and the quantity

Package 42571-0102-01. 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 .

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 42571-102

What is NDC 42571-102?
42571-102 is the product NDC for Glimepiride, Glimepiride 3 mg/1 tablet, listed with the FDA by Micro Labs Limited. 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?
Micro Labs Limited, NDC labeler code 42571. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
GlimepirideGlimepiride 4 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-419168788-4191-0368788-4191-0668788-4191-09
GlimepirideGlimepiride 2 mg/1TabletOralCoupler LLC67046-160867046-1608-03
GlimepirideGlimepiride 2 mg/1TabletOralREMEDYREPACK INC.70518-448670518-4486-00
GlimepirideGlimepiride 4 mg/1TabletOralREMEDYREPACK INC.70518-448570518-4485-0070518-4485-0170518-4485-02
GlimepirideGlimepiride 4 mg/1TabletOralDirect_rx72189-58572189-0585-90
GlimepirideGlimepiride 2 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-872868788-8728-0168788-8728-0368788-8728-06+1 more
GlimepirideGlimepiride 2 mg/1TabletOralNorthwind Health Company, LLC82868-04282868-0042-90
GlimepirideGlimepiride 1 mg/1TabletOralBluePoint Laboratories68001-58468001-0584-0068001-0584-03
GlimepirideGlimepiride 2 mg/1TabletOralBluePoint Laboratories68001-58568001-0585-0068001-0585-03
GlimepirideGlimepiride 4 mg/1TabletOralBluePoint Laboratories68001-58668001-0586-0068001-0586-03

All 102 Glimepiride NDCs

Other NDCs under ANDA 091220

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

FDA NDC Directory listings under ANDA 091220
ProductStrengthForm · routeLabelerProduct NDC
GlimepirideGlimepiride 1 mg/1TabletOralNCS HealthCare of KY, Inc dba Vangard Labs0615-8332
GlimepirideGlimepiride 2 mg/1TabletOralNCS HealthCare of KY, Inc dba Vangard Labs0615-8333
GlimepirideGlimepiride 4 mg/1TabletOralNCS HealthCare of KY, Inc dba Vangard Labs0615-8334
GlimepirideGlimepiride 1 mg/1TabletOralMicro Labs Limited42571-100
GlimepirideGlimepiride 2 mg/1TabletOralMicro Labs Limited42571-101
GlimepirideGlimepiride 4 mg/1TabletOralMicro Labs Limited42571-103
GlimepirideGlimepiride 6 mg/1TabletOralMicro Labs Limited42571-104
GlimepirideGlimepiride 8 mg/1TabletOralMicro Labs Limited42571-105
GlimepirideGlimepiride 1 mg/1TabletOralBluePoint Laboratories68001-584
GlimepirideGlimepiride 2 mg/1TabletOralBluePoint Laboratories68001-585
GlimepirideGlimepiride 4 mg/1TabletOralBluePoint Laboratories68001-586
GlimepirideGlimepiride 1 mg/1TabletOralBryant Ranch Prepack71335-1885
GlimepirideGlimepiride 2 mg/1TabletOralBryant Ranch Prepack71335-1886
Glimepiride 3 mgglimepirideGlimepiride 3 mg/1TabletOralLifsa Drugs LLC72336-641

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