NDC codes

FDA NDC Directory
Product NDC (as listed)67877-508Labeler and product segments. Claims need a package NDC.
Product NDC at billing width67877-0508Add 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
67877-508-0167877050801678770508011000 TABLET in 1 BOTTLE (67877-508-01)Marketed from Dec 24, 2017
67877-508-30678770508306787705083030 TABLET in 1 BOTTLE (67877-508-30)Marketed from Dec 24, 2017
67877-508-38678770508386787705083810 BLISTER PACK in 1 CARTON (67877-508-38) / 10 TABLET in 1 BLISTER PACK (67877-508-33)Marketed from Dec 24, 2017
67877-508-90678770508906787705089090 TABLET in 1 BOTTLE (67877-508-90)Marketed from Dec 24, 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)
Ezetimibe and Simvastatin
Generic name (nonproprietary)
ezetimibe and simvastatin
Active ingredients
Ezetimibe — 10 mg/1Simvastatin — 20 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Ascend Laboratories, LLCNDC labeler code 67877
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 209222
Marketing start
Listing expires
Other FDA classes
Decreased Cholesterol Absorption (Physiologic effect)Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
Identifiers
Product ID 67877-508_ca1a42e2-f129-462a-8e87-a034da71862bSPL ID ca1a42e2-f129-462a-8e87-a034da71862bSPL set ID c90e8c96-e130-42d7-bf0d-5833652e40d5RxCUI 476345, 476349, 476350, 476351UNII AGG2FN16EV, EOR26LQQ24UPC 0367877507309, 0367877510057, 0367877508016, 0367877509907
Pharmacologic class
Dietary Cholesterol Absorption Inhibitor; 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

N467877050801 followed by a unit qualifier and the quantity

Package 67877-0508-01. 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

Current FDA label (SPL), effective .

Indications (excerpt from the label)

Ezetimibe and Simvastatin Ezetimibe and simvastatin is a combination of simvastatin and ezetimibe indicated: • As an adjunct to diet to reduce elevated low density lipoprotein cholesterol (LDL-C): o In adults with primary hyperlipidemia. o In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). • As an adjunct to other LDL-C-lowering therapies to reduce elevated LDL-C in adults with homozygous familial hypercholesterolemia (HoFH). Simvastatin Simvastatin, when used as a component of ezetimibe and simvastatin, is indicated to reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarc…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 67877-508

What is NDC 67877-508?
67877-508 is the product NDC for Ezetimibe and Simvastatin, Ezetimibe 10 mg/1; Simvastatin 20 mg/1 tablet, listed with the FDA by Ascend Laboratories, LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Ezetimibe and Simvastatin.
What is the active ingredient?
Ezetimibe, Simvastatin.
Who is the labeler?
Ascend Laboratories, LLC, NDC labeler code 67877. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Ezetimibe and Simvastatin?
23 other product NDCs are listed under this name. See all Ezetimibe and 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 Ezetimibe and Simvastatin NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Ezetimibe and SimvastatinEzetimibe 10 mg/1; Simvastatin 10 mg/1TabletOralAurobindo Pharma Limited59651-83559651-0835-3059651-0835-90
Ezetimibe and SimvastatinEzetimibe 10 mg/1; Simvastatin 20 mg/1TabletOralAurobindo Pharma Limited59651-83659651-0836-3059651-0836-90
Ezetimibe and SimvastatinEzetimibe 10 mg/1; Simvastatin 40 mg/1TabletOralAurobindo Pharma Limited59651-83759651-0837-3059651-0837-90
Ezetimibe and SimvastatinEzetimibe 10 mg/1; Simvastatin 80 mg/1TabletOralAurobindo Pharma Limited59651-83859651-0838-3059651-0838-90
ezetimibe and simvastatinEzetimibe 10 mg/1; Simvastatin 40 mg/1TabletOralNORTHSTAR RX LLC16714-78016714-0780-0116714-0780-02
ezetimibe and simvastatinEzetimibe 10 mg/1; Simvastatin 80 mg/1TabletOralNORTHSTAR RX LLC16714-78116714-0781-0116714-0781-02
ezetimibe and simvastatinEzetimibe 10 mg/1; Simvastatin 40 mg/1TabletOralA-S Medication Solutions50090-704750090-7047-00
ezetimibe and simvastatinEzetimibe 10 mg/1; Simvastatin 10 mg/1TabletOralGlenmark Pharmaceuticals Inc., USA68462-32168462-0321-1068462-0321-3068462-0321-90
ezetimibe and simvastatinEzetimibe 10 mg/1; Simvastatin 20 mg/1TabletOralGlenmark Pharmaceuticals Inc., USA68462-32268462-0322-1068462-0322-3068462-0322-90
ezetimibe and simvastatinEzetimibe 10 mg/1; Simvastatin 40 mg/1TabletOralGlenmark Pharmaceuticals Inc., USA68462-32368462-0323-0568462-0323-3068462-0323-90

All 24 Ezetimibe and Simvastatin NDCs

Other NDCs under ANDA 209222

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

FDA NDC Directory listings under ANDA 209222
ProductStrengthForm · routeLabelerProduct NDC
Ezetimibe and SimvastatinEzetimibe 10 mg/1; Simvastatin 40 mg/1TabletOralA-S Medication Solutions50090-4772
Ezetimibe and SimvastatinEzetimibe 10 mg/1; Simvastatin 10 mg/1TabletOralAscend Laboratories, LLC67877-507
Ezetimibe and SimvastatinEzetimibe 10 mg/1; Simvastatin 40 mg/1TabletOralAscend Laboratories, LLC67877-509
Ezetimibe and SimvastatinEzetimibe 10 mg/1; Simvastatin 80 mg/1TabletOralAscend Laboratories, LLC67877-510

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in