NDC codes

FDA NDC Directory
Product NDC (as listed)49483-622Labeler and product segments. Claims need a package NDC.
Product NDC at billing width49483-0622Add 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
49483-622-0149483062201100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49483-622-01)Marketed from Nov 16, 2016
49483-622-10494830622101000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49483-622-10)Marketed from Jun 5, 2017
49483-622-5049483062250500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49483-622-50)Marketed from Nov 16, 2016
49483-622-8149483062281180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49483-622-81)Marketed from Jun 5, 2017

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 HCl
Generic name (nonproprietary)
metformin hcl
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 090888
Marketing start
Listing expires
Other FDA classes
Biguanides (Chemical structure)
Identifiers
Product ID 49483-622_2dc48b61-581f-fe5c-e063-6394a90aa557SPL ID 2dc48b61-581f-fe5c-e063-6394a90aa557SPL set ID 542cec22-eeae-4704-9bb6-4176640e5ea8RxCUI 861004, 861007, 861010UNII 786Z46389EUPC 0349483622102, 0349483621013, 0349483621105, 0349483621815, 0349483622812, 0349483620818, 0349483622010, 0349483620016
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

N449483062201 followed by a unit qualifier and the quantity

Package 49483-0622-01. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

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 HydrochlorideMetformin hydrochloride 850 mg/1Tablet, Film coatedOralMARKSANS PHARMA LIMITED25000-131
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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