NDC codes

FDA NDC Directory
Product NDC (as listed)25000-131Labeler and product segments. Claims need a package NDC.
Product NDC at billing width25000-0131Add 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 NDC11-digit (billing)PackageCopy
25000-131-03250000131032500001310330 TABLET, FILM COATED in 1 BOTTLE (25000-131-03)Marketed from Jun 1, 2012
25000-131-122500001311225000013112500 TABLET, FILM COATED in 1 BOTTLE (25000-131-12)Marketed from Jun 1, 2012
25000-131-5225000013152250000131521800 TABLET, FILM COATED in 1 BAG (25000-131-52)Marketed from Jun 1, 2012
25000-131-9825000013198250000131981 BAG in 1 BOX (25000-131-98) / 9680 TABLET, FILM COATED in 1 BAGMarketed from Jun 1, 2012

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 — 850 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
MARKSANS PHARMA LIMITEDNDC labeler code 25000
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 090888
Marketing start
Listing expires
Other FDA classes
Biguanides (Chemical structure)
Identifiers
Product ID 25000-131_6e1fd481-e776-4e5c-a9d3-736b6e4e88feSPL ID 6e1fd481-e776-4e5c-a9d3-736b6e4e88feSPL set ID b8004451-7b26-425b-b5ea-cbb1b08e30e3RxCUI 861004, 861007, 861010UNII 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

N425000013103 followed by a unit qualifier and the quantity

Package 25000-0131-03. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

Metformin Hydrochloride Tablets, USP is 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 Tablet is 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.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 25000-131

What is NDC 25000-131?
25000-131 is the product NDC for Metformin Hydrochloride, Metformin hydrochloride 850 mg/1 tablet, film coated, listed with the FDA by MARKSANS PHARMA LIMITED. 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?
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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-478170518-4781-00
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralMarlex Pharmaceuticals, Inc.10135-82310135-0823-0510135-0823-1010135-0823-30+5 more
Metformin HydrochlorideMetformin hydrochloride 750 mg/1Tablet, Extended releaseOralMarlex Pharmaceuticals, Inc.10135-82410135-0824-0510135-0824-1010135-0824-90
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-418568788-4185-0168788-4185-0368788-4185-06+3 more
Metformin HydrochlorideMetformin hydrochloride 625 mg/1TabletOralScieGen Pharmaceuticals Inc50228-58850228-0588-0550228-0588-30
Metformin HydrochlorideMetformin hydrochloride 750 mg/1TabletOralScieGen Pharmaceuticals Inc50228-58950228-0589-0550228-0589-30
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1Tablet, Extended releaseOralREMEDYREPACK INC.70518-471070518-4710-0070518-4710-02
Metformin HydrochlorideMetformin hydrochloride 500 mg/1TabletOralREMEDYREPACK INC.70518-469870518-4698-00
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1Tablet, Film coatedOralAdvanced Rx of Tennessee, LLC80425-059180425-0591-0180425-0591-0280425-0591-03+1 more
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1TabletOralUnit Dose Solutions, Inc.87441-05487441-0054-01

All 367 Metformin Hydrochloride NDCs

Other NDCs under ANDA 090888

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

FDA NDC Directory listings under ANDA 090888
ProductStrengthForm · routeLabelerProduct NDC
Metformin HClMetformin hydrochloride 1000 mg/1Tablet, Film coatedOralTIME CAP LABORATORIES, INC49483-620
Metformin HClMetformin hydrochloride 850 mg/1Tablet, Film coatedOralTIME CAP LABORATORIES, INC49483-621
Metformin HClMetformin hydrochloride 500 mg/1Tablet, Film coatedOralTIME CAP LABORATORIES, INC49483-622
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1Tablet, Film coatedOralMARKSANS PHARMA LIMITED25000-132
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Film coatedOralMARKSANS PHARMA LIMITED25000-134

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