NDC codes

FDA NDC Directory
Product NDC (as listed)51655-448Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51655-0448Add 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
51655-448-265165504482690 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-448-26)Marketed from Oct 13, 2020
51655-448-525165504485230 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-448-52)Marketed from Feb 22, 2023

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)
Simvastatin
Generic name (nonproprietary)
simvastatin
Active ingredients
Simvastatin — 20 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Northwind Health Company, LLCNDC labeler code 51655
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078034
Marketing start
Listing expires
Other FDA classes
Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
Identifiers
Product ID 51655-448_4b44a532-fceb-f2c4-e063-6394a90a9512SPL ID 4b44a532-fceb-f2c4-e063-6394a90a9512SPL set ID f2f5ee7a-4f4e-12e9-e053-2a95a90a7eaeRxCUI 312961UNII AGG2FN16EV
Pharmacologic class
HMG-CoA Reductase Inhibitor

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

N451655044826 followed by a unit qualifier and the quantity

Package 51655-0448-26. 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.

About NDC 51655-448

What is NDC 51655-448?
51655-448 is the product NDC for Simvastatin, Simvastatin 20 mg/1 tablet, film coated, listed with the FDA by Northwind Health Company, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Simvastatin.
What is the active ingredient?
Simvastatin.
Who is the labeler?
Northwind Health Company, LLC, NDC labeler code 51655. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Simvastatin?
155 other product NDCs are listed under this name. See all Simvastatin 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 Simvastatin NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
SimvastatinSimvastatin 20 mg/1Tablet, Film coatedOralCoupler LLC67046-062667046-0626-03
SimvastatinSimvastatin 40 mg/1Tablet, Film coatedOralCoupler LLC67046-062867046-0628-03
SimvastatinSimvastatin 10 mg/1Tablet, Film coatedOralCoupler LLC67046-054267046-0542-03
SimvastatinSimvastatin 5 mg/1Tablet, Film coatedOralXLCare Pharmaceuticals Inc.72865-30572865-0305-0172865-0305-1072865-0305-30+1 more
SimvastatinSimvastatin 10 mg/1Tablet, Film coatedOralXLCare Pharmaceuticals Inc.72865-30672865-0306-0172865-0306-1072865-0306-30+1 more
SimvastatinSimvastatin 20 mg/1Tablet, Film coatedOralXLCare Pharmaceuticals Inc.72865-30772865-0307-0172865-0307-1072865-0307-30+2 more
SimvastatinSimvastatin 40 mg/1Tablet, Film coatedOralXLCare Pharmaceuticals Inc.72865-30872865-0308-0172865-0308-1072865-0308-30+2 more
SimvastatinSimvastatin 80 mg/1Tablet, Film coatedOralXLCare Pharmaceuticals Inc.72865-30972865-0309-0172865-0309-0572865-0309-10+3 more
SimvastatinSimvastatin 10 mg/1Tablet, Film coatedOralWestminster Pharmaceuticals, LLC69367-37469367-0374-0969367-0374-10
SimvastatinSimvastatin 20 mg/1Tablet, Film coatedOralWestminster Pharmaceuticals, LLC69367-37569367-0375-0969367-0375-10

All 156 Simvastatin NDCs

Other NDCs under ANDA 078034

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

FDA NDC Directory listings under ANDA 078034
ProductStrengthForm · routeLabelerProduct NDC
SimvastatinSimvastatin 5 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6459
SimvastatinSimvastatin 40 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-113
SimvastatinSimvastatin 10 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC53401-013
SimvastatinSimvastatin 80 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC53401-018
SimvastatinSimvastatin 40 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC53401-026
SimvastatinSimvastatin 5 mg/1Tablet, Film coatedOralBiocon Pharma Inc,70377-001
SimvastatinSimvastatin 10 mg/1Tablet, Film coatedOralBiocon Pharma Inc,70377-002
SimvastatinSimvastatin 20 mg/1Tablet, Film coatedOralBiocon Pharma Inc,70377-003
SimvastatinSimvastatin 40 mg/1Tablet, Film coatedOralBiocon Pharma Inc,70377-004
SimvastatinSimvastatin 80 mg/1Tablet, Film coatedOralBiocon Pharma Inc,70377-005
SimvastatinSimvastatin 20 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-3630
SimvastatinSimvastatin 10 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-3648
SimvastatinSimvastatin 5 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-4102
SimvastatinSimvastatin 20 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1891
SimvastatinSimvastatin 10 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1905
SimvastatinSimvastatin 40 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1906
SimvastatinSimvastatin 20 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-609
SimvastatinSimvastatin 40 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-610
SimvastatinSimvastatin 80 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-611
SimvastatinSimvastatin 10 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-615

Showing 20 of 27.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in