glyburide and metformin hydrochloride NDC 68382-654

NDC codes

FDA NDC Directory

Product NDC (as listed)68382-654Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68382-0654Add 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
68382-654-01	68382065401	100 TABLET in 1 BOTTLE (68382-654-01)Marketed from Apr 7, 2016
68382-654-05	68382065405	500 TABLET in 1 BOTTLE (68382-654-05)Marketed from Apr 7, 2016
68382-654-06	68382065406	30 TABLET in 1 BOTTLE (68382-654-06)Marketed from Apr 7, 2016
68382-654-10	68382065410	1000 TABLET in 1 BOTTLE (68382-654-10)Marketed from Apr 7, 2016
68382-654-16	68382065416	90 TABLET in 1 BOTTLE (68382-654-16)Marketed from Apr 7, 2016
68382-654-77	68382065477	10 BLISTER PACK in 1 CARTON (68382-654-77) / 10 TABLET in 1 BLISTER PACK (68382-654-30)Marketed from Apr 7, 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 and metformin hydrochloride
Generic name (nonproprietary): glyburide and metformin hydrochloride
Active ingredients: Glyburide — 2.5 mg/1Metformin hydrochloride — 500 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 206748
Marketing start: Apr 7, 2016
Listing expires: Dec 31, 2027
Other FDA classes: Biguanides (Chemical structure)Sulfonylurea Compounds (Chemical structure)
Identifiers: Product ID 68382-654_10f3fa5d-7b0b-445b-8a83-7071295687afSPL ID 10f3fa5d-7b0b-445b-8a83-7071295687afSPL set ID 2239742b-74e1-4bc2-b5a8-15c4758d6f7bRxCUI 861743, 861748, 861753UNII 786Z46389E, SX6K58TVWC
Pharmacologic class: Biguanide; 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

N468382065401 followed by a unit qualifier and the quantity

Package 68382-0654-01. 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 Jun 10, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Glyburide and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Glyburide and metformin hydrochloride tablets are a combination of glyburide, a sulfonylurea, and metformin hydrochloride (HCl), a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 206748

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

FDA NDC Directory listings under ANDA 206748
Product	Strength	Form · route	Labeler	Product NDC
glyburide and metformin hydrochloride	Glyburide 1.25 mg/1; Metformin hydrochloride 250 mg/1	TabletOral	Zydus Pharmaceuticals (USA) Inc.	68382-653
glyburide and metformin hydrochloride	Glyburide 5 mg/1; Metformin hydrochloride 500 mg/1	TabletOral	Zydus Pharmaceuticals (USA) Inc.	68382-655
glyburide and metformin hydrochloride	Glyburide 5 mg/1; Metformin hydrochloride 500 mg/1	TabletOral	Zydus Lifesciences Limited	65841-826
glyburide and metformin hydrochloride	Glyburide 1.25 mg/1; Metformin hydrochloride 250 mg/1	TabletOral	Zydus Lifesciences Limited	65841-824
glyburide and metformin hydrochloride	Glyburide 2.5 mg/1; Metformin hydrochloride 500 mg/1	TabletOral	Zydus Lifesciences Limited	65841-825