What is NDC 68788-8341?

68788-8341 is the product NDC for Glyburide and Metformin Hydrochloride, Glyburide 5 mg/1; Metformin hydrochloride 500 mg/1 tablet, film coated, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 5 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Glyburide, Metformin hydrochloride.

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 and Metformin Hydrochloride?

20 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Glyburide and Metformin Hydrochloride NDC 68788-8341

NDC codes

FDA NDC Directory

Product NDC (as listed)68788-8341Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68788-8341Add 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
68788-8341-1	6878883410168788834101	100 TABLET, FILM COATED in 1 BOTTLE (68788-8341-1)Marketed from Feb 10, 2023
68788-8341-3	6878883410368788834103	30 TABLET, FILM COATED in 1 BOTTLE (68788-8341-3)Marketed from Feb 10, 2023
68788-8341-6	6878883410668788834106	60 TABLET, FILM COATED in 1 BOTTLE (68788-8341-6)Marketed from Feb 10, 2023
68788-8341-8	6878883410868788834108	120 TABLET, FILM COATED in 1 BOTTLE (68788-8341-8)Marketed from Feb 10, 2023
68788-8341-9	6878883410968788834109	90 TABLET, FILM COATED in 1 BOTTLE (68788-8341-9)Marketed from Feb 10, 2023

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.NDC labeler code 68788
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077870
Marketing start: Feb 10, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Biguanides (Chemical structure)Sulfonylurea Compounds (Chemical structure)
Identifiers: Product ID 68788-8341_d4b1f97c-2926-4712-ad42-eaac3025e6acSPL ID d4b1f97c-2926-4712-ad42-eaac3025e6acSPL set ID c284c146-436b-4eea-9dca-d7d21c82778cRxCUI 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

N468788834101 followed by a unit qualifier and the quantity

Package 68788-8341-01. 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.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68788-8341

What is NDC 68788-8341?: 68788-8341 is the product NDC for Glyburide and Metformin Hydrochloride, Glyburide 5 mg/1; Metformin hydrochloride 500 mg/1 tablet, film coated, 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 and 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 and Metformin Hydrochloride?: 20 other product NDCs are listed under this name. See all Glyburide and 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 and Metformin Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Glyburide and Metformin Hydrochloride	Glyburide 5 mg/1; Metformin hydrochloride 500 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8634	68788-8634-0168788-8634-0368788-8634-06+2 more
Glyburide and Metformin Hydrochloride	Glyburide 5 mg/1; Metformin hydrochloride 500 mg/1	Tablet, Film coatedOral	Northwind Health Company, LLC	51655-942	51655-0942-26
Glyburide and Metformin Hydrochloride	Glyburide 2.5 mg/1; Metformin hydrochloride 500 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-7180	68788-7180-0168788-7180-0368788-7180-06+1 more
glyburide and metformin hydrochloride	Glyburide 1.25 mg/1; Metformin hydrochloride 250 mg/1	TabletOral	Zydus Lifesciences Limited	65841-824	65841-0824-0165841-0824-0565841-0824-06+3 more
glyburide and metformin hydrochloride	Glyburide 2.5 mg/1; Metformin hydrochloride 500 mg/1	TabletOral	Zydus Lifesciences Limited	65841-825	65841-0825-0165841-0825-0565841-0825-06+3 more
glyburide and metformin hydrochloride	Glyburide 5 mg/1; Metformin hydrochloride 500 mg/1	TabletOral	Zydus Lifesciences Limited	65841-826	65841-0826-0165841-0826-0565841-0826-06+3 more
glyburide and metformin hydrochloride	Glyburide 1.25 mg/1; Metformin hydrochloride 250 mg/1	TabletOral	Zydus Pharmaceuticals (USA) Inc.	68382-653	68382-0653-0168382-0653-0568382-0653-06+3 more
glyburide and metformin hydrochloride	Glyburide 2.5 mg/1; Metformin hydrochloride 500 mg/1	TabletOral	Zydus Pharmaceuticals (USA) Inc.	68382-654	68382-0654-0168382-0654-0568382-0654-06+3 more
glyburide and metformin hydrochloride	Glyburide 5 mg/1; Metformin hydrochloride 500 mg/1	TabletOral	Zydus Pharmaceuticals (USA) Inc.	68382-655	68382-0655-0168382-0655-0568382-0655-06+3 more
Glyburide and Metformin Hydrochloride	Glyburide 5 mg/1; Metformin hydrochloride 500 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-2030	50090-2030-0050090-2030-0250090-2030-03+1 more

All 21 Glyburide and Metformin Hydrochloride NDCs

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	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	Northwind Health Company, LLC	51655-942
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 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	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	NuCare Pharmaceuticals,Inc.	68071-4718
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.	68788-8634
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	Bryant Ranch Prepack	71335-0967