NDC codes

FDA NDC Directory
Product NDC (as listed)0093-8344Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00093-8344Add 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
0093-8344-010009383440100093834401100 TABLET in 1 BOTTLE (0093-8344-01)Marketed from Aug 30, 1995
0093-8344-050009383440500093834405500 TABLET in 1 BOTTLE (0093-8344-05)Marketed from Aug 30, 1995
0093-8344-1000093834410000938344101000 TABLET in 1 BOTTLE (0093-8344-10)Marketed from Aug 30, 1995
0093-8344-98000938344980009383449890 TABLET in 1 BOTTLE (0093-8344-98)Marketed from Mar 30, 2010

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
Glyburide
Generic name (nonproprietary)
glyburide
Active ingredients
Glyburide — 5 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Teva Pharmaceuticals USA, Inc.NDC labeler code 0093
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 074388
Marketing start
Listing expires
Other FDA classes
Sulfonylurea Compounds (Chemical structure)
Identifiers
Product ID 0093-8344_2ef0bcc2-d9f5-406a-863e-b070f0052232SPL ID 2ef0bcc2-d9f5-406a-863e-b070f0052232
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

N400093834401 followed by a unit qualifier and the quantity

Package 00093-8344-01. 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

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

About NDC 0093-8344

What is NDC 0093-8344?
0093-8344 is the product NDC for Glyburide, Glyburide 5 mg/1 tablet, listed with the FDA by Teva Pharmaceuticals USA, Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Glyburide.
What is the active ingredient?
Glyburide.
Who is the labeler?
Teva Pharmaceuticals USA, Inc., NDC labeler code 0093. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Glyburide?
51 other product NDCs are listed under this name. See all Glyburide 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 Glyburide NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
GlyburideGlyburide 5 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-407368788-4073-0168788-4073-0368788-4073-06+1 more
GlyburideGlyburide 2.5 mg/1TabletOralCoupler LLC67046-162067046-1620-03
GlyburideGlyburide 5 mg/1TabletOralREMEDYREPACK INC.70518-403570518-4035-0070518-4035-01
GlyburideGlyburide 5 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-850868788-8508-0168788-8508-0368788-8508-06+1 more
GlyburideGlyburide 2.5 mg/1TabletOralREMEDYREPACK INC.70518-350470518-3504-0070518-3504-01
GlyburideGlyburide 5 mg/1TabletOralA-S Medication Solutions50090-619650090-6196-0050090-6196-0150090-6196-02+2 more
GlyburideGlyburide 2.5 mg/1TabletOralA-S Medication Solutions50090-740850090-7408-0050090-7408-02
GlyburideGlyburide 5 mg/1TabletOralA-S Medication Solutions50090-785950090-7859-00
GlyburideGlyburide 5 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-345268071-3452-0368071-3452-06
GlyburideGlyburide 5 mg/1TabletOralBryant Ranch Prepack71335-277171335-2771-0171335-2771-0271335-2771-03+3 more

All 52 Glyburide NDCs

Other NDCs under ANDA 074388

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

FDA NDC Directory listings under ANDA 074388
ProductStrengthForm · routeLabelerProduct NDC
GlyburideGlyburide 1.25 mg/1TabletOralTeva Pharmaceuticals USA, Inc.0093-8342
GlyburideGlyburide 2.5 mg/1TabletOralTeva Pharmaceuticals USA, Inc.0093-8343
GlyburideGlyburide 5 mg/1TabletOralA-S Medication Solutions50090-6607
GlyburideGlyburide 2.5 mg/1TabletOralProficient Rx LP63187-848
GlyburideGlyburide 2.5 mg/1TabletOralCoupler LLC67046-1620
GlyburideGlyburide 5 mg/1TabletOralNuCare Pharmaceuticals, Inc.68071-3677
GlyburideGlyburide 5 mg/1TabletOralNuCare Pharmaceuticals, Inc.68071-3702
GlyburideGlyburide 5 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-4073
GlyburideGlyburide 5 mg/1TabletOralProficient Rx LP82804-150

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