Glyburide and Metformin Hydrochloride NDC 68788-8634

NDC codes

FDA NDC Directory

Product NDC (as listed)68788-8634Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68788-8634Add 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
68788-8634-1	68788863401	100 TABLET, FILM COATED in 1 BOTTLE (68788-8634-1)Marketed from Apr 16, 2024
68788-8634-3	68788863403	30 TABLET, FILM COATED in 1 BOTTLE (68788-8634-3)Marketed from Apr 16, 2024
68788-8634-6	68788863406	60 TABLET, FILM COATED in 1 BOTTLE (68788-8634-6)Marketed from Apr 16, 2024
68788-8634-8	68788863408	120 TABLET, FILM COATED in 1 BOTTLE (68788-8634-8)Marketed from Apr 16, 2024
68788-8634-9	68788863409	90 TABLET, FILM COATED in 1 BOTTLE (68788-8634-9)Marketed from Apr 16, 2024

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): Glyburide and Metformin Hydrochloride
Generic name (nonproprietary): glyburide and metformin hydrochloride
Active ingredients: Glyburide — 5 mg/1Metformin hydrochloride — 500 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Preferred Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077870
Marketing start: Apr 16, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Biguanides (Chemical structure)Sulfonylurea Compounds (Chemical structure)
Identifiers: Product ID 68788-8634_a585cd8a-3d17-48aa-8d80-80d35fb430d8SPL ID a585cd8a-3d17-48aa-8d80-80d35fb430d8SPL set ID a58ff524-e975-4d51-a896-e869f8ea6624RxCUI 861753UNII SX6K58TVWC, 786Z46389E
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

N468788863401 followed by a unit qualifier and the quantity

Package 68788-8634-01. 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 May 7, 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 077870

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

FDA NDC Directory listings under ANDA 077870
Product	Strength	Form · route	Labeler	Product NDC
Glyburide and Metformin Hydrochloride	Glyburide 5 mg/1; Metformin hydrochloride 500 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-0967
Glyburide and Metformin Hydrochloride	Glyburide 5 mg/1; Metformin hydrochloride 500 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-0360
Glyburide and Metformin Hydrochloride	Glyburide 5 mg/1; Metformin hydrochloride 500 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-2030
Glyburide and Metformin Hydrochloride	Glyburide 2.5 mg/1; Metformin hydrochloride 500 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-2031
Glyburide and Metformin Hydrochloride	Glyburide 5 mg/1; Metformin hydrochloride 500 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-4718
Glyburide and Metformin Hydrochloride	Glyburide 5 mg/1; Metformin hydrochloride 500 mg/1	Tablet, Film coatedOral	Rising Pharma Holdings, Inc.	57237-025
Glyburide and Metformin Hydrochloride	Glyburide 1.25 mg/1; Metformin hydrochloride 250 mg/1	Tablet, Film coatedOral	Rising Pharma Holdings, Inc.	57237-023
Glyburide and Metformin Hydrochloride	Glyburide 2.5 mg/1; Metformin hydrochloride 500 mg/1	Tablet, Film coatedOral	Rising Pharma Holdings, Inc.	57237-024
Glyburide and Metformin Hydrochloride	Glyburide 2.5 mg/1; Metformin hydrochloride 500 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-7180
Glyburide and Metformin Hydrochloride	Glyburide 5 mg/1; Metformin hydrochloride 500 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8341
Glyburide and Metformin Hydrochloride	Glyburide 1.25 mg/1; Metformin hydrochloride 250 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	65862-080
Glyburide and Metformin Hydrochloride	Glyburide 2.5 mg/1; Metformin hydrochloride 500 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	65862-081
Glyburide and Metformin Hydrochloride	Glyburide 5 mg/1; Metformin hydrochloride 500 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	65862-082
Glyburide and Metformin Hydrochloride	Glyburide 5 mg/1; Metformin hydrochloride 500 mg/1	Tablet, Film coatedOral	Northwind Health Company, LLC	51655-942