NDC codes

FDA NDC Directory
Product NDC (as listed)50090-4736Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50090-4736Add 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
50090-4736-0500904736001000 TABLET, FILM COATED in 1 BOTTLE (50090-4736-0)Marketed from Nov 19, 2019
50090-4736-15009047360130 TABLET, FILM COATED in 1 BOTTLE (50090-4736-1)Marketed from Nov 19, 2019
50090-4736-250090473602100 TABLET, FILM COATED in 1 BOTTLE (50090-4736-2)Marketed from Nov 19, 2019
50090-4736-35009047360390 TABLET, FILM COATED in 1 BOTTLE (50090-4736-3)Marketed from Nov 19, 2019

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)
Simvastatin
Generic name (nonproprietary)
simvastatin
Active ingredients
Simvastatin — 40 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078103
Marketing start
Listing expires
Other FDA classes
Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
Identifiers
Product ID 50090-4736_9f5cb785-eced-4a37-8e92-3fb5a2e2e60fSPL ID 9f5cb785-eced-4a37-8e92-3fb5a2e2e60fSPL set ID 3b0720d2-b240-48e4-af77-9ccda509fae7RxCUI 198211UNII 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

N450090473600 followed by a unit qualifier and the quantity

Package 50090-4736-00. 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

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

Other NDCs under ANDA 078103

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

FDA NDC Directory listings under ANDA 078103
ProductStrengthForm · routeLabelerProduct NDC
SimvastatinSimvastatin 40 mg/1Tablet, Film coatedOralQPharma, Inc.42708-168
SimvastatinSimvastatin 20 mg/1Tablet, Film coatedOralQPharma, Inc42708-169
SimvastatinSimvastatin 40 mg/1Tablet, Film coatedOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8056
SimvastatinSimvastatin 20 mg/1Tablet, Film coatedOralDirect_Rx72189-421
SimvastatinSimvastatin 40 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.72789-304
SimvastatinSimvastatin 40 mg/1Tablet, Film coatedOralDirect_Rx72189-427
SimvastatinSimvastatin 10 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.72789-320
SimvastatinSimvastatin 10 mg/1Tablet, Film coatedOralDirect_Rx72189-452
SimvastatinSimvastatin 20 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-0954
SimvastatinSimvastatin 10 mg/1Tablet, Film coatedOralAmerican Health Packaging68084-511
SimvastatinSimvastatin 20 mg/1Tablet, Film coatedOralAmerican Health Packaging68084-512
SimvastatinSimvastatin 10 mg/1Tablet, Film coatedOralCoupler LLC67046-0542
SimvastatinSimvastatin 20 mg/1Tablet, Film coatedOralCoupler LLC67046-0626
SimvastatinSimvastatin 40 mg/1Tablet, Film coatedOralCoupler LLC67046-0628
SimvastatinSimvastatin 40 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-9630
SimvastatinSimvastatin 40 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-3349
SimvastatinSimvastatin 10 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-9636
SimvastatinSimvastatin 10 mg/1Tablet, Film coatedOralNCS HealthCare of KY, LLC dba Vangard Labs0615-7992
SimvastatinSimvastatin 40 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-210
SimvastatinSimvastatin 20 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-9642

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