What is NDC 25000-101?

25000-101 is the product NDC for Metformin Hydrochloride, Metformin hydrochloride 500 mg/1 tablet, extended release, listed with the FDA by MARKSANS PHARMA LIMITED. It has 5 package NDCs, shown above in 10- and 11-digit form.

MARKSANS PHARMA LIMITED, NDC labeler code 25000. 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 25000-101

NDC codes

FDA NDC Directory

Product NDC (as listed)25000-101Labeler and product segments. Claims need a package NDC.

Product NDC at billing width25000-0101Add 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
25000-101-03	2500001010325000010103	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (25000-101-03)Marketed from May 12, 2016
25000-101-12	2500001011225000010112	500 TABLET, EXTENDED RELEASE in 1 BOTTLE (25000-101-12)Marketed from May 12, 2016
25000-101-14	2500001011425000010114	1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (25000-101-14)Marketed from Jun 24, 2022
25000-101-97	2500001019725000010197	4 BAG in 1 BOX (25000-101-97) / 2000 TABLET, EXTENDED RELEASE in 1 BAGMarketed from May 12, 2016
25000-101-98	2500001019825000010198	1 BAG in 1 BOX (25000-101-98) / 11695 TABLET, EXTENDED RELEASE in 1 BAGMarketed from May 12, 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): Metformin Hydrochloride
Generic name (nonproprietary): metformin hydrochloride
Active ingredients: Metformin hydrochloride — 500 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: MARKSANS PHARMA LIMITEDNDC labeler code 25000
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090295
Marketing start: May 12, 2016
Listing expires: Dec 31, 2027
Other FDA classes: Biguanides (Chemical structure)
Identifiers: Product ID 25000-101_2e4551d7-a4e0-4b7a-b7d6-b05021007658SPL ID 2e4551d7-a4e0-4b7a-b7d6-b05021007658SPL set ID d09a2eda-fdd8-44ed-8e2f-ea91ddfd3c68RxCUI 860975, 860981UNII 786Z46389EUPC 0325000101039, 0325000102036, 0325000101145, 0325000101121, 0325000102128
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

N425000010103 followed by a unit qualifier and the quantity

Package 25000-0101-03. 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 Jun 29, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Metformin hydrochloride extended-release tablets, USP is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Metformin Hydrochloride Extended-Release Tablet is 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 25000-101

What is NDC 25000-101?: 25000-101 is the product NDC for Metformin Hydrochloride, Metformin hydrochloride 500 mg/1 tablet, extended release, listed with the FDA by MARKSANS PHARMA LIMITED. It has 5 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?: MARKSANS PHARMA LIMITED, NDC labeler code 25000. 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	Tablet, Film coatedOral	Advanced Rx of Tennessee, LLC	80425-0591	80425-0591-0180425-0591-0280425-0591-03+1 more
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-054	87441-0054-01

All 367 Metformin Hydrochloride NDCs

Other NDCs under ANDA 090295

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

FDA NDC Directory listings under ANDA 090295
Product	Strength	Form · route	Labeler	Product NDC
Metformin Hydrochloride	Metformin hydrochloride 750 mg/1	Tablet, Extended releaseOral	MARKSANS PHARMA LIMITED	25000-102
Metformin Hydrochloride Extended Releasemetformin hydrochloride	Metformin hydrochloride 750 mg/1	Tablet, Extended releaseOral	PD-Rx Pharmaceuticals, Inc.	43063-902
Metformin Hydrochloride Extended Releasemetformin hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Extended releaseOral	TIME CAP LABORATORIES, INC	49483-623
Metformin Hydrochloride Extended Releasemetformin hydrochloride	Metformin hydrochloride 750 mg/1	Tablet, Extended releaseOral	TIME CAP LABORATORIES, INC	49483-624
Metformin Hydrochloride Extended Releasemetformin hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Extended releaseOral	Northwind Health Company, LLC	51655-555
Metformin Hydrochloride Extended Releasemetformin hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Extended releaseOral	NuCare Pharmaceuticals, Inc.	68071-3111
Metformin Hydrochloride Extended Releasemetformin hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Extended releaseOral	Bryant Ranch Prepack	71335-0293
Metformin Hydrochloride Extended Releasemetformin hydrochloride	Metformin hydrochloride 750 mg/1	Tablet, Extended releaseOral	Bryant Ranch Prepack	71335-0889
Metformin Hydrochloride Extended Releasemetformin hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Extended releaseOral	Aphena Pharma Solutions - Tennessee, LLC	71610-454
Metformin Hydrochloride Extended Releasemetformin hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Extended releaseOral	direct rx	72189-064
Metformin Hydrochloride Extended Releasemetformin hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Extended releaseOral	PD-Rx Pharmaceuticals, Inc.	72789-009
Metformin Hydrochloride Extended Releasemetformin hydrochloride	Metformin hydrochloride 750 mg/1	Tablet, Extended releaseOral	Proficient Rx LP	82804-148