glyburide NDC 68382-658

NDC codes

FDA NDC Directory

Product NDC (as listed)68382-658Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68382-0658Add 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 NDC	11-digit (billing)	Package
68382-658-01	68382065801	100 TABLET in 1 BOTTLE (68382-658-01)Marketed from Jun 2, 2016
68382-658-05	68382065805	500 TABLET in 1 BOTTLE (68382-658-05)Marketed from Jun 2, 2016
68382-658-06	68382065806	30 TABLET in 1 BOTTLE (68382-658-06)Marketed from Jun 2, 2016
68382-658-10	68382065810	1000 TABLET in 1 BOTTLE (68382-658-10)Marketed from Jun 2, 2016
68382-658-16	68382065816	90 TABLET in 1 BOTTLE (68382-658-16)Marketed from Jun 2, 2016
68382-658-77	68382065877	10 BLISTER PACK in 1 CARTON (68382-658-77) / 10 TABLET in 1 BLISTER PACK (68382-658-30)Marketed from Jun 2, 2016

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): glyburide
Generic name (nonproprietary): glyburide
Active ingredients: Glyburide — 5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Zydus Pharmaceuticals (USA) Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206749
Marketing start: Jun 2, 2016
Listing expires: Dec 31, 2026
Other FDA classes: Sulfonylurea Compounds (Chemical structure)
Identifiers: Product ID 68382-658_1ff75368-1bfd-4173-b0aa-18eca2c97a4fSPL ID 1ff75368-1bfd-4173-b0aa-18eca2c97a4fSPL set ID 87781ea8-62ec-483c-a4dd-8c965ce59485RxCUI 197737, 310534, 310537UNII SX6K58TVWC
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

N468382065801 followed by a unit qualifier and the quantity

Package 68382-0658-01. 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 Nov 16, 2022.

Indications (excerpt from the label)

INDICATIONS AND USAGE Glyburide tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 206749

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

FDA NDC Directory listings under ANDA 206749
Product	Strength	Form · route	Labeler	Product NDC
glyburide	Glyburide 1.25 mg/1	TabletOral	Zydus Pharmaceuticals (USA) Inc.	68382-656
glyburide	Glyburide 2.5 mg/1	TabletOral	Zydus Pharmaceuticals (USA) Inc.	68382-657
glyburide	Glyburide 1.25 mg/1	TabletOral	Zydus Lifesciences Limited	65841-832
glyburide	Glyburide 2.5 mg/1	TabletOral	Zydus Lifesciences Limited	65841-833
glyburide	Glyburide 5 mg/1	TabletOral	Zydus Lifesciences Limited	65841-834