Metformin Hydrochloride NDC 42385-948

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

Laurus Labs Limited

Product type

Prescription drug

Marketing category

ANDA — Abbreviated New Drug Application (generic)Application ANDA 209882

Marketing start

May 17, 2021

Listing expires

Dec 31, 2027

Other FDA classes

Biguanides (Chemical structure)

Identifiers

Product ID 42385-948_4afe5891-539c-4299-a96a-4a6bfcc22407SPL ID 4afe5891-539c-4299-a96a-4a6bfcc22407SPL set ID c3dfa8a1-d10a-4a1a-8eba-5f4e2a5a2949RxCUI 861004, 861007, 861010UNII 786Z46389EUPC 0342385949605, 0342385948905, 0342385949100, 0342385948103

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

N442385094801 followed by a unit qualifier and the quantity Copy

Package 42385-0948-01. 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

Other NDCs under ANDA 209882

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