NDC codes

FDA NDC Directory
Product NDC (as listed)50268-667Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50268-0667Add 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
50268-667-15502680667155026806671550 BLISTER PACK in 1 BOX (50268-667-15) / 1 TABLET in 1 BLISTER PACK (50268-667-11)Marketed from Feb 1, 2021

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)
Pravastatin Sodium
Generic name (nonproprietary)
pravastatin sodium
Active ingredients
Pravastatin sodium — 40 mg/1
Dosage form
Tablet
Route
Oral
Labeler
AvPAKNDC labeler code 50268
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 076341
Marketing start
Listing expires
Other FDA classes
Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
Identifiers
Product ID 50268-667_47fb4c90-456b-508c-e063-6394a90a5da5SPL ID 47fb4c90-456b-508c-e063-6394a90a5da5SPL set ID ba4ac602-46fa-8386-e053-2995a90a9764RxCUI 904458, 904467, 904475, 904481UNII 3M8608UQ61
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

N450268066715 followed by a unit qualifier and the quantity

Package 50268-0667-15. 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)

Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. Pravastatin sodium is an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to: Reduce the risk of MI, revascularization, and cardiovascular mortality in hypercholesterolemic patients without clinically evident CHD. ( 1.1 ) Reduce the risk of total mortality by reducing cor…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50268-667

What is NDC 50268-667?
50268-667 is the product NDC for Pravastatin Sodium, Pravastatin sodium 40 mg/1 tablet, listed with the FDA by AvPAK. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Pravastatin Sodium.
What is the active ingredient?
Pravastatin sodium.
Who is the labeler?
AvPAK, NDC labeler code 50268. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Pravastatin Sodium?
184 other product NDCs are listed under this name. See all Pravastatin Sodium 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 Pravastatin Sodium NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Pravastatin SodiumPravastatin sodium 30 mg/1TabletOralHavix Group Inc d-b-a Aavis Pharmaceuticals71337-28971337-0289-09
Pravastatin SodiumPravastatin sodium 60 mg/1TabletOralHavix Group Inc d-b-a Aavis Pharmaceuticals71337-29071337-0290-09
Pravastatin sodiumPravastatin sodium 80 mg/1TabletOralAurobindo Pharma Limited84386-16784386-0167-9084386-0167-99
Pravastatin SodiumPravastatin sodium 10 mg/1TabletOralAmici Pharma, Inc.69292-10169292-0101-1069292-0101-5069292-0101-90
Pravastatin SodiumPravastatin sodium 20 mg/1TabletOralAmici Pharma, Inc.69292-10269292-0102-1069292-0102-5069292-0102-90
Pravastatin SodiumPravastatin sodium 40 mg/1TabletOralAmici Pharma, Inc.69292-10369292-0103-1069292-0103-5069292-0103-90
Pravastatin SodiumPravastatin sodium 80 mg/1TabletOralAmici Pharma, Inc.69292-10469292-0104-1069292-0104-5069292-0104-90
Pravastatin SodiumPravastatin sodium 10 mg/1TabletOralNorthwind Health Company, LLC82868-10482868-0104-30
Pravastatin sodiumPravastatin sodium 20 mg/1TabletOralSafecor Health LLC48433-14848433-0148-20
Pravastatin sodiumPravastatin sodium 40 mg/1TabletOralSafecor Health LLC48433-14948433-0149-20

All 185 Pravastatin Sodium NDCs

Other NDCs under ANDA 076341

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

FDA NDC Directory listings under ANDA 076341
ProductStrengthForm · routeLabelerProduct NDC
Pravastatin SodiumPravastatin sodium 10 mg/1TabletOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8618
Pravastatin SodiumPravastatin sodium 20 mg/1TabletOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8619
Pravastatin SodiumPravastatin sodium 40 mg/1TabletOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8620
Pravastatin SodiumPravastatin sodium 80 mg/1TabletOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8621
Pravastatin SodiumPravastatin sodium 10 mg/1TabletOralMajor Pharmaceuticals0904-5891
Pravastatin SodiumPravastatin sodium 20 mg/1TabletOralMajor Pharmaceuticals0904-5892
Pravastatin SodiumPravastatin sodium 40 mg/1TabletOralMajor Pharmaceuticals0904-5893
Pravastatin SodiumPravastatin sodium 20 mg/1TabletOralLake Erie Medical DBA Quality Care Products LLC35356-919
Pravastatin SodiumPravastatin sodium 40 mg/1TabletOralA-S Medication Solutions50090-2024
Pravastatin SodiumPravastatin sodium 20 mg/1TabletOralA-S Medication Solutions50090-2025
Pravastatin SodiumPravastatin sodium 80 mg/1TabletOralA-S Medication Solutions50090-3204
Pravastatin SodiumPravastatin sodium 10 mg/1TabletOralA-S Medication Solutions50090-3853
Pravastatin SodiumPravastatin sodium 40 mg/1TabletOralA-S Medication Solutions50090-6826
Pravastatin SodiumPravastatin sodium 20 mg/1TabletOralA-S Medication Solutions50090-7813
Pravastatin SodiumPravastatin sodium 10 mg/1TabletOralAvPAK50268-665
Pravastatin SodiumPravastatin sodium 20 mg/1TabletOralAvPAK50268-666
Pravastatin SodiumPravastatin sodium 80 mg/1TabletOralAvPAK50268-668
Pravastatin SodiumPravastatin sodium 40 mg/1TabletOralNorthwind Health Company, LLC51655-708
Pravastatin SodiumPravastatin sodium 80 mg/1TabletOralNorthwind Health Company, LLC51655-976
Pravastatin SodiumPravastatin sodium 10 mg/1TabletOralCardinal Health 107, LLC55154-3350

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