What is NDC 80425-0435?

80425-0435 is the product NDC for Metformin HCl, Metformin hydrochloride 1000 mg/1 tablet, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.

Advanced Rx of Tennessee, LLC, NDC labeler code 80425. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Metformin HCl?

32 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Metformin HCl NDC 80425-0435 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)80425-0435Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80425-0435Add 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
80425-0435-1	8042504350180425043501	30 TABLET in 1 BOTTLE (80425-0435-1)Marketed from Sep 3, 2024
80425-0435-2	8042504350280425043502	60 TABLET in 1 BOTTLE (80425-0435-2)Marketed from Sep 3, 2024
80425-0435-3	8042504350380425043503	90 TABLET in 1 BOTTLE (80425-0435-3)Marketed from Sep 3, 2024
80425-0435-4	8042504350480425043504	108 TABLET in 1 BOTTLE (80425-0435-4)Marketed from Sep 3, 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): Metformin HCl
Generic name (nonproprietary): metformin hcl
Active ingredients: Metformin hydrochloride — 1000 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Advanced Rx of Tennessee, LLCNDC labeler code 80425
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090564
Marketing start: Sep 3, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Biguanides (Chemical structure)
Identifiers: Product ID 80425-0435_22cef642-e37b-a74f-e063-6394a90aef9dSPL ID 22cef642-e37b-a74f-e063-6394a90aef9dSPL set ID 21b76183-af30-e06f-e063-6394a90a9653RxCUI 861004UNII 786Z46389E
Pharmacologic class: Biguanide

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

N480425043501 followed by a unit qualifier and the quantity

Package 80425-0435-01. 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 Sep 23, 2024.

Indications (excerpt from the label)

INDICATIONS & USAGE Metformin Hydrochloride Tablets USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults and children 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 80425-0435

What is NDC 80425-0435?: 80425-0435 is the product NDC for Metformin HCl, Metformin hydrochloride 1000 mg/1 tablet, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Metformin HCl.
What is the active ingredient?: Metformin hydrochloride.
Who is the labeler?: Advanced Rx of Tennessee, LLC, NDC labeler code 80425. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Metformin HCl?: 32 other product NDCs are listed under this name. See all Metformin HCl 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 Metformin HCl NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Metformin HCl	Metformin hydrochloride 500 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-056	87441-0056-01
Metformin HCl	Metformin hydrochloride 1000 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-055	87441-0055-01
Metformin HCL	Metformin hydrochloride 500 mg/1	Tablet, Film coatedOral	Direct_Rx	72189-658	72189-0658-3072189-0658-8272189-0658-90
Metformin HCl	Metformin hydrochloride 850 mg/1	TabletOral	REMEDYREPACK INC.	70518-4479	70518-4479-0070518-4479-01
Metformin HCL	Metformin hydrochloride 1000 mg/1	TabletOral	Direct_Rx	72189-635	72189-0635-82
Metformin HCL	Metformin hydrochloride 500 mg/1	TabletOral	Direct_Rx	72189-617	72189-0617-3072189-0617-82
Metformin HCl	Metformin hydrochloride 500 mg/1	TabletOral	Northwind Health Company, LLC	82868-049	82868-0049-6082868-0049-9082868-0049-98
Metformin HCl	Metformin hydrochloride 500 mg/1	TabletOral	QPharma, Inc.	42708-009	42708-0009-60
Metformin HCl	Metformin hydrochloride 1000 mg/1	TabletOral	QPharma, Inc.	42708-018	42708-0018-30
Metformin HCl	Metformin hydrochloride 850 mg/1	TabletOral	A-S Medication Solutions	50090-3050	50090-3050-0050090-3050-0250090-3050-04+1 more

All 33 Metformin HCl NDCs

Other NDCs under ANDA 090564

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

FDA NDC Directory listings under ANDA 090564
Product	Strength	Form · route	Labeler	Product NDC
Metformin Hydrochloride	Metformin hydrochloride 850 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-3495
Metformin Hydrochloride	Metformin hydrochloride 850 mg/1	TabletOral	Major Pharmaceuticals	0904-7163
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Film coatedOral	Epic Pharma, LLC	42806-313
Metformin Hydrochloride	Metformin hydrochloride 850 mg/1	Tablet, Film coatedOral	Epic Pharma, LLC	42806-314
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	Tablet, Film coatedOral	Epic Pharma, LLC	42806-315
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-8652
Metformin HCl	Metformin hydrochloride 500 mg/1	TabletOral	Bryant Ranch Prepack	71335-1072
Metformin Hydrochloride	Metformin hydrochloride 850 mg/1	TabletOral	Coupler LLC	67046-0804
Metformin HCl	Metformin hydrochloride 500 mg/1	TabletOral	Ascend Laboratories, LLC	67877-561
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	TabletOral	Major Pharmaceuticals	0904-7162
Metformin HCl	Metformin hydrochloride 850 mg/1	TabletOral	Ascend Laboratories, LLC	67877-562
Metformin HCl	Metformin hydrochloride 1000 mg/1	TabletOral	Ascend Laboratories, LLC	67877-563
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	Tablet, Film coatedOral	Metcure Pharmaceuticals, Inc.	71709-112
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Film coatedOral	Metcure Pharmaceuticals, Inc.	71709-110
Metformin Hydrochloride	Metformin hydrochloride 850 mg/1	Tablet, Film coatedOral	Metcure Pharmaceuticals, Inc.	71709-111
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	TabletOral	Major Pharmaceuticals	0904-7164
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	TabletOral	A-S Medication Solutions	50090-7595
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	TabletOral	A-S Medication Solutions	50090-7597
Metformin HCl	Metformin hydrochloride 500 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-3541
Metformin HCl	Metformin hydrochloride 500 mg/1	TabletOral	Northwind Health Company, LLC	82868-049

Showing 20 of 40.