NDC codes

FDA NDC Directory
Product NDC (as listed)68788-4191Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68788-4191Add 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
68788-4191-36878841910330 TABLET in 1 BOTTLE (68788-4191-3)Marketed from Sep 24, 2026
68788-4191-66878841910660 TABLET in 1 BOTTLE (68788-4191-6)Marketed from Sep 24, 2026
68788-4191-96878841910990 TABLET in 1 BOTTLE (68788-4191-9)Marketed from Sep 24, 2026

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 — 4 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Preferred Pharmaceuticals Inc.NDC labeler code 68788
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 68788-4191_aa533cde-4b32-450e-b080-127351524678SPL ID aa533cde-4b32-450e-b080-127351524678
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

N468788419103 followed by a unit qualifier and the quantity

Package 68788-4191-03. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 68788-4191

What is NDC 68788-4191?
68788-4191 is the product NDC for Glimepiride, Glimepiride 4 mg/1 tablet, listed with the FDA by Preferred Pharmaceuticals 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?
Preferred Pharmaceuticals Inc., NDC labeler code 68788. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
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
GlimepirideGlimepiride 1 mg/1TabletOralBryant Ranch Prepack71335-256171335-2561-0171335-2561-0271335-2561-03+2 more

All 103 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/1TabletOralBryant Ranch Prepack71335-2561
GlimepirideGlimepiride 2 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-8728
GlimepirideGlimepiride 2 mg/1TabletOralBryant Ranch Prepack71335-2367
GlimepirideGlimepiride 4 mg/1TabletOralREMEDYREPACK INC.70518-4485
GlimepirideGlimepiride 2 mg/1TabletOralREMEDYREPACK INC.70518-4486
GlimepirideGlimepiride 2 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-3639
GlimepirideGlimepiride 4 mg/1TabletOralA-S Medication Solutions50090-7406
GlimepirideGlimepiride 4 mg/1TabletOralA-S Medication Solutions50090-7407
GlimepirideGlimepiride 4 mg/1TabletOralBryant Ranch Prepack71335-2409
GlimepirideGlimepiride 1 mg/1TabletOralA-S Medication Solutions50090-7187
GlimepirideGlimepiride 4 mg/1TabletOralST. MARY'S MEDICAL PARK PHARMACY60760-845
GlimepirideGlimepiride 2 mg/1TabletOralCoupler LLC67046-1608
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 2 mg/1TabletOralA-S Medication Solutions50090-7246
GlimepirideGlimepiride 2 mg/1TabletOralA-S Medication Solutions50090-7247
GlimepirideGlimepiride 4 mg/1TabletOralDirect_rx72189-585

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