What is NDC 68788-8791?

68788-8791 is the product NDC for glyburide-metformin hydrochloride, Glyburide 5 mg/1; Metformin hydrochloride 500 mg/1 tablet, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 5 package NDCs, shown above in 10- and 11-digit form.

Preferred Pharmaceuticals Inc., NDC labeler code 68788. 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-metformin hydrochloride?

8 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

glyburide-metformin hydrochloride NDC 68788-8791

NDC codes

FDA NDC Directory

Product NDC (as listed)68788-8791Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68788-8791Add 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
68788-8791-1	6878887910168788879101	100 TABLET in 1 BOTTLE (68788-8791-1)Marketed from Dec 17, 2024
68788-8791-3	6878887910368788879103	30 TABLET in 1 BOTTLE (68788-8791-3)Marketed from Dec 17, 2024
68788-8791-6	6878887910668788879106	60 TABLET in 1 BOTTLE (68788-8791-6)Marketed from Dec 17, 2024
68788-8791-8	6878887910868788879108	120 TABLET in 1 BOTTLE (68788-8791-8)Marketed from Dec 17, 2024
68788-8791-9	6878887910968788879109	90 TABLET in 1 BOTTLE (68788-8791-9)Marketed from Dec 17, 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-metformin hydrochloride
Generic name (nonproprietary): glyburide-metformin hydrochloride
Active ingredients: Glyburide — 5 mg/1Metformin hydrochloride — 500 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Preferred Pharmaceuticals Inc.NDC labeler code 68788
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 079009
Marketing start: Dec 17, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Biguanides (Chemical structure)Sulfonylurea Compounds (Chemical structure)
Identifiers: Product ID 68788-8791_d7d4d255-6028-4047-8907-75469f545f87SPL ID d7d4d255-6028-4047-8907-75469f545f87SPL set ID a0ff8ee6-0da8-40f8-b5b0-a7b334e1a15fRxCUI 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

N468788879101 followed by a unit qualifier and the quantity

Package 68788-8791-01. 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 Jan 23, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Glyburide and metformin hydrochloride tablets is 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. ()

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68788-8791

What is NDC 68788-8791?: 68788-8791 is the product NDC for glyburide-metformin hydrochloride, Glyburide 5 mg/1; Metformin hydrochloride 500 mg/1 tablet, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 5 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: glyburide-metformin hydrochloride.
What is the active ingredient?: Glyburide, Metformin hydrochloride.
Who is the labeler?: Preferred Pharmaceuticals Inc., NDC labeler code 68788. 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-metformin hydrochloride?: 8 other product NDCs are listed under this name. See all glyburide-metformin hydrochloride 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-metformin hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
glyburide-metformin hydrochloride	Glyburide 1.25 mg/1; Metformin hydrochloride 250 mg/1	TabletOral	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-233	23155-0233-0123155-0233-0523155-0233-10
glyburide-metformin hydrochloride	Glyburide 2.5 mg/1; Metformin hydrochloride 500 mg/1	TabletOral	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-234	23155-0234-0123155-0234-0523155-0234-10
glyburide-metformin hydrochloride	Glyburide 5 mg/1; Metformin hydrochloride 500 mg/1	TabletOral	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-235	23155-0235-0123155-0235-0523155-0235-10
glyburide-metformin hydrochloride	Glyburide 5 mg/1; Metformin hydrochloride 500 mg/1	TabletOral	A-S Medication Solutions	50090-7514	50090-7514-0050090-7514-0250090-7514-03+1 more
glyburide-metformin hydrochloride	Glyburide 2.5 mg/1; Metformin hydrochloride 500 mg/1	TabletOral	A-S Medication Solutions	50090-7814	50090-7814-0050090-7814-02
glyburide-metformin hydrochloride	Glyburide 5 mg/1; Metformin hydrochloride 500 mg/1	TabletOral	NuCare Pharmaceuticals, Inc.	68071-3950	68071-3950-03
glyburide-metformin hydrochloride	Glyburide 5 mg/1; Metformin hydrochloride 500 mg/1	TabletOral	Bryant Ranch Prepack	71335-2508	71335-2508-0171335-2508-0371335-2508-04+4 more
glyburide-metformin hydrochloride	Glyburide 2.5 mg/1; Metformin hydrochloride 500 mg/1	TabletOral	Bryant Ranch Prepack	71335-2694	71335-2694-0171335-2694-0271335-2694-03+2 more

Other NDCs under ANDA 079009

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

FDA NDC Directory listings under ANDA 079009
Product	Strength	Form · route	Labeler	Product NDC
glyburide-metformin hydrochloride	Glyburide 2.5 mg/1; Metformin hydrochloride 500 mg/1	TabletOral	Bryant Ranch Prepack	71335-2694
glyburide-metformin hydrochloride	Glyburide 2.5 mg/1; Metformin hydrochloride 500 mg/1	TabletOral	A-S Medication Solutions	50090-7814
glyburide-metformin hydrochloride	Glyburide 5 mg/1; Metformin hydrochloride 500 mg/1	TabletOral	Bryant Ranch Prepack	71335-2508
glyburide-metformin hydrochloride	Glyburide 2.5 mg/1; Metformin hydrochloride 500 mg/1	TabletOral	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-234
glyburide-metformin hydrochloride	Glyburide 5 mg/1; Metformin hydrochloride 500 mg/1	TabletOral	NuCare Pharmaceuticals, Inc.	68071-3950
glyburide-metformin hydrochloride	Glyburide 1.25 mg/1; Metformin hydrochloride 250 mg/1	TabletOral	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-233
glyburide-metformin hydrochloride	Glyburide 5 mg/1; Metformin hydrochloride 500 mg/1	TabletOral	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-235
glyburide-metformin hydrochloride	Glyburide 5 mg/1; Metformin hydrochloride 500 mg/1	TabletOral	A-S Medication Solutions	50090-7514