NDC codes

FDA NDC Directory
Product NDC (as listed)71335-2561Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-2561Add 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
71335-2561-1713352561017133525610130 TABLET in 1 BOTTLE (71335-2561-1)Marketed from Jan 28, 2025
71335-2561-2713352561027133525610260 TABLET in 1 BOTTLE (71335-2561-2)Marketed from Jan 28, 2025
71335-2561-3713352561037133525610390 TABLET in 1 BOTTLE (71335-2561-3)Marketed from Jan 28, 2025
71335-2561-47133525610471335256104100 TABLET in 1 BOTTLE (71335-2561-4)Marketed from Jan 28, 2025
71335-2561-5713352561057133525610520 TABLET in 1 BOTTLE (71335-2561-5)Marketed from Jan 28, 2025

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
Bryant Ranch PrepackNDC labeler code 71335
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 202112
Marketing start
Listing expires
Other FDA classes
Sulfonylurea Compounds (Chemical structure)
Identifiers
Product ID 71335-2561_070cd0bc-0502-4130-b189-2305b26f4f91SPL ID 070cd0bc-0502-4130-b189-2305b26f4f91SPL set ID 661b5b13-6334-4965-8dc5-709e19080584RxCUI 199245UNII 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

N471335256101 followed by a unit qualifier and the quantity

Package 71335-2561-01. 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 tablets 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 71335-2561

What is NDC 71335-2561?
71335-2561 is the product NDC for Glimepiride, Glimepiride 1 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 5 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?
Bryant Ranch Prepack, NDC labeler code 71335. 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 202112

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

FDA NDC Directory listings under ANDA 202112
ProductStrengthForm · routeLabelerProduct NDC
GlimepirideGlimepiride 1 mg/1TabletOralA-S Medication Solutions50090-7187
GlimepirideGlimepiride 2 mg/1TabletOralA-S Medication Solutions50090-7246
GlimepirideGlimepiride 2 mg/1TabletOralA-S Medication Solutions50090-7247
GlimepirideGlimepiride 4 mg/1TabletOralA-S Medication Solutions50090-7406
GlimepirideGlimepiride 4 mg/1TabletOralA-S Medication Solutions50090-7407
GlimepirideGlimepiride 4 mg/1TabletOralST. MARY'S MEDICAL PARK PHARMACY60760-845
GlimepirideGlimepiride 2 mg/1TabletOralCoupler LLC67046-1608
GlimepirideGlimepiride 2 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-3639
GlimepirideGlimepiride 4 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-4191
GlimepirideGlimepiride 2 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-8728
GlimepirideGlimepiride 4 mg/1TabletOralREMEDYREPACK INC.70518-4485
GlimepirideGlimepiride 2 mg/1TabletOralREMEDYREPACK INC.70518-4486
GlimepirideGlimepiride 2 mg/1TabletOralBryant Ranch Prepack71335-2367
GlimepirideGlimepiride 4 mg/1TabletOralBryant Ranch Prepack71335-2409
GlimepirideGlimepiride 1 mg/1TabletOralFlorida Pharmaceutical Products, LLC71921-214
GlimepirideGlimepiride 2 mg/1TabletOralFlorida Pharmaceutical Products, LLC71921-215
GlimepirideGlimepiride 4 mg/1TabletOralFlorida Pharmaceutical Products, LLC71921-216
GlimepirideGlimepiride 4 mg/1TabletOralDirect_rx72189-585

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