NDC codes

FDA NDC Directory
Product NDC (as listed)68084-327Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68084-0327Add 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
68084-327-016808403270168084032701100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-327-01) / 1 TABLET in 1 BLISTER PACK (68084-327-11)Marketed from Apr 22, 2009

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 — 4 mg/1
Dosage form
Tablet
Route
Oral
Labeler
American Health PackagingNDC labeler code 68084
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 077091
Marketing start
Listing expires
Other FDA classes
Sulfonylurea Compounds (Chemical structure)
Identifiers
Product ID 68084-327_26cca05b-82f8-e191-e063-6394a90a56bdSPL ID 26cca05b-82f8-e191-e063-6394a90a56bdSPL set ID 0003458f-352a-46fa-9d99-230daa76ae29RxCUI 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

N468084032701 followed by a unit qualifier and the quantity

Package 68084-0327-01. 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 are 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 68084-327

What is NDC 68084-327?
68084-327 is the product NDC for Glimepiride, Glimepiride 4 mg/1 tablet, listed with the FDA by American Health Packaging. It has 1 package NDC, 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?
American Health Packaging, NDC labeler code 68084. 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 077091

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

FDA NDC Directory listings under ANDA 077091
ProductStrengthForm · routeLabelerProduct NDC
GlimepirideGlimepiride 1 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.43063-121
GlimepirideGlimepiride 4 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.43063-122
GlimepirideGlimepiride 4 mg/1TabletOralA-S Medication Solutions50090-1006
GlimepirideGlimepiride 2 mg/1TabletOralA-S Medication Solutions50090-6415
GlimepirideGlimepiride 4 mg/1TabletOralA-S Medication Solutions50090-6852
GlimepirideGlimepiride 2 mg/1TabletOralA-S Medication Solutions50090-6910
GlimepirideGlimepiride 1 mg/1TabletOralAvPAK50268-358
GlimepirideGlimepiride 2 mg/1TabletOralAvPAK50268-359
GlimepirideGlimepiride 4 mg/1TabletOralAvPAK50268-360
GlimepirideGlimepiride 4 mg/1TabletOralNorthwind Health Company, LLC51655-489
GlimepirideGlimepiride 2 mg/1TabletOralNorthwind Health Company, LLC51655-565
GlimepirideGlimepiride 1 mg/1TabletOralDr. Reddy's Laboratories Limited55111-320
GlimepirideGlimepiride 2 mg/1TabletOralDr. Reddy's Laboratories Limited55111-321
GlimepirideGlimepiride 4 mg/1TabletOralDr. Reddy's Laboratories Limited55111-322
GlimepirideGlimepiride 2 mg/1TabletOralCardinal Health 107, LLC55154-8175
GlimepirideGlimepiride 2 mg/1TabletOralBryant Ranch Prepack63629-3043
GlimepirideGlimepiride 4 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-2228
GlimepirideGlimepiride 2 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-2385
GlimepirideGlimepiride 2 mg/1TabletOralAmerican Health Packaging68084-326
GlimepirideGlimepiride 1 mg/1TabletOralAmerican Health Packaging68084-788

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