What is NDC 65841-659?

65841-659 is the product NDC for Glipizide and Metformin Hydrochloride, Glipizide 2.5 mg/1; Metformin hydrochloride 250 mg/1 tablet, film coated, listed with the FDA by Zydus Lifesciences Limited. It has 4 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Glipizide, Metformin hydrochloride.

Zydus Lifesciences Limited, NDC labeler code 65841. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Glipizide and Metformin Hydrochloride?

13 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Glipizide and Metformin Hydrochloride NDC 65841-659

NDC codes

FDA NDC Directory

Product NDC (as listed)65841-659Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65841-0659Add 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
65841-659-01	6584106590165841065901	100 TABLET, FILM COATED in 1 BOTTLE (65841-659-01)Marketed from May 5, 2016
65841-659-10	6584106591065841065910	1000 TABLET, FILM COATED in 1 BOTTLE (65841-659-10)Marketed from May 5, 2016
65841-659-16	6584106591665841065916	90 TABLET, FILM COATED in 1 BOTTLE (65841-659-16)Marketed from May 5, 2016
65841-659-77	6584106597765841065977	10 BLISTER PACK in 1 CARTON (65841-659-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65841-659-30)Marketed from May 5, 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): Glipizide and Metformin Hydrochloride
Generic name (nonproprietary): glipizide and metformin hydrochloride
Active ingredients: Glipizide — 2.5 mg/1Metformin hydrochloride — 250 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Zydus Lifesciences LimitedNDC labeler code 65841
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078905
Marketing start: May 5, 2016
Listing expires: Dec 31, 2027
Other FDA classes: Biguanides (Chemical structure)Sulfonylurea Compounds (Chemical structure)
Identifiers: Product ID 65841-659_62c55ebc-1883-4bfb-a772-2614c99a2fecSPL ID 62c55ebc-1883-4bfb-a772-2614c99a2fecSPL set ID bd2e1c06-424b-4222-b723-90ffdcc3983cRxCUI 861731, 861736, 861740UNII 786Z46389E, X7WDT95N5C
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

N465841065901 followed by a unit qualifier and the quantity

Package 65841-0659-01. 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 30, 2024.

Full label on DailyMed (opens in a new tab)

About NDC 65841-659

What is NDC 65841-659?: 65841-659 is the product NDC for Glipizide and Metformin Hydrochloride, Glipizide 2.5 mg/1; Metformin hydrochloride 250 mg/1 tablet, film coated, listed with the FDA by Zydus Lifesciences Limited. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Glipizide and Metformin Hydrochloride.
What is the active ingredient?: Glipizide, Metformin hydrochloride.
Who is the labeler?: Zydus Lifesciences Limited, NDC labeler code 65841. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Glipizide and Metformin Hydrochloride?: 13 other product NDCs are listed under this name. See all Glipizide 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 Glipizide and Metformin Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Glipizide and Metformin Hydrochloride	Glipizide 5 mg/1; Metformin hydrochloride 500 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-0373	70518-0373-0070518-0373-01
Glipizide and Metformin Hydrochloride	Glipizide 2.5 mg/1; Metformin hydrochloride 500 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-2492	50090-2492-00
Glipizide and Metformin Hydrochloride	Glipizide 5 mg/1; Metformin hydrochloride 500 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-2556	50090-2556-00
Glipizide and Metformin Hydrochloride	Glipizide 2.5 mg/1; Metformin hydrochloride 500 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	65841-660	65841-0660-0165841-0660-1065841-0660-16+1 more
Glipizide and Metformin Hydrochloride	Glipizide 5 mg/1; Metformin hydrochloride 500 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	65841-661	65841-0661-0165841-0661-1065841-0661-16+1 more
Glipizide and Metformin Hydrochloride	Glipizide 2.5 mg/1; Metformin hydrochloride 250 mg/1	Tablet, Film coatedOral	Zydus Pharmaceuticals USA Inc.	68382-184	68382-0184-0168382-0184-1068382-0184-16+1 more
Glipizide and Metformin Hydrochloride	Glipizide 2.5 mg/1; Metformin hydrochloride 500 mg/1	Tablet, Film coatedOral	Zydus Pharmaceuticals USA Inc.	68382-185	68382-0185-0168382-0185-1068382-0185-16+1 more
Glipizide and Metformin Hydrochloride	Glipizide 5 mg/1; Metformin hydrochloride 500 mg/1	Tablet, Film coatedOral	Zydus Pharmaceuticals USA Inc.	68382-186	68382-0186-0168382-0186-1068382-0186-16+1 more
Glipizide and Metformin Hydrochloride	Glipizide 2.5 mg/1; Metformin hydrochloride 500 mg/1	Tablet, Film coatedOral	AvKARE	42291-305	42291-0305-01
Glipizide and Metformin Hydrochloride	Glipizide 5 mg/1; Metformin hydrochloride 500 mg/1	Tablet, Film coatedOral	AvKARE	42291-306	42291-0306-01

All 14 Glipizide and Metformin Hydrochloride NDCs

Other NDCs under ANDA 078905

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

FDA NDC Directory listings under ANDA 078905
Product	Strength	Form · route	Labeler	Product NDC
Glipizide and Metformin Hydrochloride	Glipizide 2.5 mg/1; Metformin hydrochloride 500 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-2492
Glipizide and Metformin Hydrochloride	Glipizide 5 mg/1; Metformin hydrochloride 500 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-2556
Glipizide and Metformin Hydrochloride	Glipizide 2.5 mg/1; Metformin hydrochloride 500 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	65841-660
Glipizide and Metformin Hydrochloride	Glipizide 5 mg/1; Metformin hydrochloride 500 mg/1	Tablet, Film coatedOral	Zydus Lifesciences Limited	65841-661
Glipizide and Metformin Hydrochloride	Glipizide 2.5 mg/1; Metformin hydrochloride 250 mg/1	Tablet, Film coatedOral	Zydus Pharmaceuticals USA Inc.	68382-184
Glipizide and Metformin Hydrochloride	Glipizide 2.5 mg/1; Metformin hydrochloride 500 mg/1	Tablet, Film coatedOral	Zydus Pharmaceuticals USA Inc.	68382-185
Glipizide and Metformin Hydrochloride	Glipizide 5 mg/1; Metformin hydrochloride 500 mg/1	Tablet, Film coatedOral	Zydus Pharmaceuticals USA Inc.	68382-186