NDC codes

FDA NDC Directory
Product NDC (as listed)71205-780Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71205-0780Add 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
71205-780-307120507803030 TABLET, FILM COATED in 1 BOTTLE (71205-780-30)Marketed from Mar 23, 2023
71205-780-607120507806060 TABLET, FILM COATED in 1 BOTTLE (71205-780-60)Marketed from Mar 23, 2023
71205-780-907120507809090 TABLET, FILM COATED in 1 BOTTLE (71205-780-90)Marketed from Mar 23, 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
Proficient Rx LPNDC labeler code 71205
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 077691
Marketing start
Listing expires
Other FDA classes
Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
Identifiers
Product ID 71205-780_b5b47d5b-f953-4e82-99ef-e4e10164095eSPL ID b5b47d5b-f953-4e82-99ef-e4e10164095eSPL set ID b5b47d5b-f953-4e82-99ef-e4e10164095eRxCUI 312961UNII AGG2FN16EVUPC 0371205780302
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

N471205078030 followed by a unit qualifier and the quantity

Package 71205-0780-30. 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)

Simvastatin tablets are indicated: • To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events. • As an adjunct to diet to reduce 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 therapi…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71205-780

What is NDC 71205-780?
71205-780 is the product NDC for Simvastatin, Simvastatin 20 mg/1 tablet, film coated, listed with the FDA by Proficient Rx LP. It has 3 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?
Proficient Rx LP, NDC labeler code 71205. 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 077691

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

FDA NDC Directory listings under ANDA 077691
ProductStrengthForm · routeLabelerProduct NDC
SimvastatinSimvastatin 5 mg/1Tablet, Film coatedOralNorthStar Rx LLC16714-681
SimvastatinSimvastatin 10 mg/1Tablet, Film coatedOralNorthStar Rx LLC16714-682
SimvastatinSimvastatin 20 mg/1Tablet, Film coatedOralNorthStar Rx LLC16714-683
SimvastatinSimvastatin 40 mg/1Tablet, Film coatedOralNorthStar Rx LLC16714-684
SimvastatinSimvastatin 80 mg/1Tablet, Film coatedOralNorthStar Rx LLC16714-685
SimvastatinSimvastatin 20 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-4801
SimvastatinSimvastatin 20 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-5019
SimvastatinSimvastatin 20 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6389
SimvastatinSimvastatin 20 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6390
SimvastatinSimvastatin 40 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6421
SimvastatinSimvastatin 40 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6424
SimvastatinSimvastatin 40 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6425
SimvastatinSimvastatin 10 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6922
SimvastatinSimvastatin 80 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7088
SimvastatinSimvastatin 5 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7776
SimvastatinSimvastatin 5 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7777
SimvastatinSimvastatin 10 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7780
SimvastatinSimvastatin 20 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7781
SimvastatinSimvastatin 40 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7782
SimvastatinSimvastatin 80 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7783

Showing 20 of 30.

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