What is NDC 80425-0591?

80425-0591 is the product NDC for Metformin Hydrochloride, Metformin hydrochloride 1000 mg/1 tablet, film coated, 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 Hydrochloride?

366 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Metformin Hydrochloride NDC 80425-0591

NDC codes

FDA NDC Directory

Product NDC (as listed)80425-0591Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80425-0591Add 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
80425-0591-1	8042505910180425059101	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0591-1)Marketed from Jul 10, 2026
80425-0591-2	8042505910280425059102	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0591-2)Marketed from Jul 10, 2026
80425-0591-3	8042505910380425059103	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0591-3)Marketed from Jul 10, 2026
80425-0591-4	8042505910480425059104	108 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0591-4)Marketed from Jul 10, 2026

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 Hydrochloride
Generic name (nonproprietary): metformin hydrochloride
Active ingredients: Metformin hydrochloride — 1000 mg/1
Dosage form: Tablet, Film coated
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 075973
Marketing start: Jul 10, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Biguanides (Chemical structure)
Identifiers: Product ID 80425-0591_5647163f-4654-233e-e063-6394a90a8fadSPL ID 5647163f-4654-233e-e063-6394a90a8fadSPL set ID 5647230e-5bc6-1802-e063-6394a90a2724RxCUI 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

N480425059101 followed by a unit qualifier and the quantity

Package 80425-0591-01. 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 Jul 10, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. Metformin hydrochloride tablets are a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 80425-0591

What is NDC 80425-0591?: 80425-0591 is the product NDC for Metformin Hydrochloride, Metformin hydrochloride 1000 mg/1 tablet, film coated, 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 Hydrochloride.
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 Hydrochloride?: 366 other product NDCs are listed under this name. See all 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 Metformin Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4781	70518-4781-00
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Extended releaseOral	Marlex Pharmaceuticals, Inc.	10135-823	10135-0823-0510135-0823-1010135-0823-30+5 more
Metformin Hydrochloride	Metformin hydrochloride 750 mg/1	Tablet, Extended releaseOral	Marlex Pharmaceuticals, Inc.	10135-824	10135-0824-0510135-0824-1010135-0824-90
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-4185	68788-4185-0168788-4185-0368788-4185-06+3 more
Metformin Hydrochloride	Metformin hydrochloride 625 mg/1	TabletOral	ScieGen Pharmaceuticals Inc	50228-588	50228-0588-0550228-0588-30
Metformin Hydrochloride	Metformin hydrochloride 750 mg/1	TabletOral	ScieGen Pharmaceuticals Inc	50228-589	50228-0589-0550228-0589-30
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	Tablet, Extended releaseOral	REMEDYREPACK INC.	70518-4710	70518-4710-0070518-4710-02
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	TabletOral	REMEDYREPACK INC.	70518-4698	70518-4698-00
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-054	87441-0054-01
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	Tablet, Extended releaseOral	REMEDYREPACK INC.	70518-4677	70518-4677-0070518-4677-0170518-4677-03

All 367 Metformin Hydrochloride NDCs

Other NDCs under ANDA 075973

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

FDA NDC Directory listings under ANDA 075973
Product	Strength	Form · route	Labeler	Product NDC
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Film coatedOral	Mylan Pharmaceuticals Inc.	0378-7185
Metformin Hydrochloride	Metformin hydrochloride 850 mg/1	Tablet, Film coatedOral	Mylan Pharmaceuticals Inc.	0378-7186
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	Tablet, Film coatedOral	Mylan Pharmaceuticals Inc.	0378-7187