NDC codes

FDA NDC Directory
Product NDC (as listed)50228-106Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50228-0106Add 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
50228-106-0050228010600502280106004200 TABLET in 1 BOTTLE (50228-106-00)Marketed from Feb 1, 2015
50228-106-015022801060150228010601100 TABLET in 1 BOTTLE (50228-106-01)Marketed from Feb 1, 2015
50228-106-055022801060550228010605500 TABLET in 1 BOTTLE (50228-106-05)Marketed from Feb 1, 2015
50228-106-1050228010610502280106101000 TABLET in 1 BOTTLE (50228-106-10)Marketed from Feb 1, 2015
50228-106-30502280106305022801063030 TABLET in 1 BOTTLE (50228-106-30)Marketed from Feb 1, 2015

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
Route
Oral
Labeler
ScieGen Pharmaceuticals IncNDC labeler code 50228
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 203769
Marketing start
Listing expires
Other FDA classes
Biguanides (Chemical structure)
Identifiers
Product ID 50228-106_10bdcce2-08e7-4d4d-b655-33c57ccafadcSPL ID 10bdcce2-08e7-4d4d-b655-33c57ccafadcSPL set ID 4e4c4ba9-65c6-4273-8f6b-2423ab521dadRxCUI 861004, 861007, 861010, 861021, 2703582UNII 786Z46389EUPC 0350228589055, 0350228589307, 0350228107600, 0350228588058, 0350228588300, 0350228105019
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

N450228010600 followed by a unit qualifier and the quantity

Package 50228-0106-00. 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 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 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. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50228-106

What is NDC 50228-106?
50228-106 is the product NDC for Metformin Hydrochloride, Metformin hydrochloride 850 mg/1 tablet, listed with the FDA by ScieGen Pharmaceuticals Inc. 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?
ScieGen Pharmaceuticals Inc, NDC labeler code 50228. 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 203769

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

FDA NDC Directory listings under ANDA 203769
ProductStrengthForm · routeLabelerProduct NDC
Metformin HydrochlorideMetformin hydrochloride 500 mg/1TabletOralPreferred Pharmaceuticals Inc68788-4076
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Film coatedOralWestminster Pharmaceuticals, LLC69367-180
Metformin HydrochlorideMetformin hydrochloride 850 mg/1Tablet, Film coatedOralWestminster Pharmaceuticals, LLC69367-181
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1Tablet, Film coatedOralWestminster Pharmaceuticals, LLC69367-182
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1TabletOralA-S Medication Solutions50090-7588
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1TabletOralA-S Medication Solutions50090-7586
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1TabletOralA-S Medication Solutions50090-7587
Metformin HydrochlorideMetformin hydrochloride 500 mg/1TabletOralBryant Ranch Prepack72162-1522
Metformin HydrochlorideMetformin hydrochloride 500 mg/1TabletOraldirect rx72189-219
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1TabletOralBryant Ranch Prepack72162-1523
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1TabletOraldirect rx72189-220
Metformin HydrochlorideMetformin hydrochloride 850 mg/1TabletOraldirect rx72189-221
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-672
Metformin HydrochlorideMetformin hydrochloride 500 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-917
Metformin HydrochlorideMetformin hydrochloride 850 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-918
Metformin HydrochlorideMetformin hydrochloride 850 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-923
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1Tablet, Film coatedOralProficient Rx LP71205-783
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Film coatedOralProficient Rx LP71205-784
Metformin HydrochlorideMetformin hydrochloride 625 mg/1TabletOralScieGen Pharmaceuticals Inc50228-588
Metformin HydrochlorideMetformin hydrochloride 750 mg/1TabletOralScieGen Pharmaceuticals Inc50228-589

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