Prescription drug · ANDA

Metformin Hydrochloride NDC 50090-6858

Metformin hydrochloride 500 mg/1 · Tablet, Film coated · Oral · A-S Medication Solutions

NDC codes

FDA NDC Directory
Product NDC (as listed)50090-6858Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50090-6858Add 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
50090-6858-05009068580060 TABLET, FILM COATED in 1 BOTTLE (50090-6858-0)Marketed from Dec 1, 2023
50090-6858-350090685803100 TABLET, FILM COATED in 1 BOTTLE (50090-6858-3)Marketed from Dec 1, 2023
50090-6858-45009068580430 TABLET, FILM COATED in 1 BOTTLE (50090-6858-4)Marketed from Dec 1, 2023
50090-6858-550090685805180 TABLET, FILM COATED in 1 BOTTLE (50090-6858-5)Marketed from Dec 1, 2023
50090-6858-65009068580690 TABLET, FILM COATED in 1 BOTTLE (50090-6858-6)Marketed from Dec 1, 2023

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 — 500 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 209882
Marketing start
Listing expires
Other FDA classes
Biguanides (Chemical structure)
Identifiers
Product ID 50090-6858_0ab8e7e7-c37e-4c64-80af-e61e5091ad1dSPL ID 0ab8e7e7-c37e-4c64-80af-e61e5091ad1dSPL set ID f59ceea4-a84a-4082-8e73-7c6f340c28d6RxCUI 861007UNII 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

N450090685800 followed by a unit qualifier and the quantity

Package 50090-6858-00. 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, USP 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, USP 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)

Other NDCs under ANDA 209882

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

FDA NDC Directory listings under ANDA 209882
ProductStrengthForm · routeLabelerProduct NDC
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-8498
Metformin HCLMetformin hydrochloride 500 mg/1Tablet, Film coatedOralDirect_Rx72189-658
Metformin HydrochlorideMetformin hydrochloride 850 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7106
Metformin HydrochlorideMetformin hydrochloride 850 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7107
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-8600
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-644
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6857
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6856
Metformin HydrochlorideMetformin hydrochloride 850 mg/1Tablet, Film coatedOralLaurus Labs Limited42385-948
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Film coatedOralLaurus Labs Limited42385-947
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6859
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1Tablet, Film coatedOralLaurus Labs Limited42385-949
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2224
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Film coatedOralCoupler LLC67046-1594
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-4262
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2533
Metformin HydrochlorideMetformin hydrochloride 850 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2593
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7866
Metformin HydrochlorideMetformin hydrochloride 850 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-8756
Metformin HydrochlorideMetformin hydrochloride 850 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-3833

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