NDC codes

FDA NDC Directory
Product NDC (as listed)63629-9162Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63629-9162Add 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
63629-9162-1636299162016362991620130 TABLET in 1 BOTTLE (63629-9162-1)Marketed from Feb 4, 2022
63629-9162-2636299162026362991620260 TABLET in 1 BOTTLE (63629-9162-2)Marketed from Feb 4, 2022

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)
Pravastatin Sodium
Generic name (nonproprietary)
pravastatin sodium
Active ingredients
Pravastatin sodium — 10 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Bryant Ranch PrepackNDC labeler code 63629
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 209869
Marketing start
Listing expires
Other FDA classes
Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
Identifiers
Product ID 63629-9162_1d58e035-58ec-4729-80f8-fb47f544da8cSPL ID 1d58e035-58ec-4729-80f8-fb47f544da8cSPL set ID 6bb60d07-0787-4d5f-8a8c-1224d5b02b2bRxCUI 904458UNII 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

N463629916201 followed by a unit qualifier and the quantity

Package 63629-9162-01. 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)

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 coron…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63629-9162

What is NDC 63629-9162?
63629-9162 is the product NDC for Pravastatin Sodium, Pravastatin sodium 10 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 2 package NDCs, 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?
Bryant Ranch Prepack, NDC labeler code 63629. 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 209869

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

FDA NDC Directory listings under ANDA 209869
ProductStrengthForm · routeLabelerProduct NDC
Pravastatin SodiumPravastatin sodium 20 mg/1TabletOralBryant Ranch Prepack71335-9692
Pravastatin SodiumPravastatin sodium 10 mg/1TabletOralBryant Ranch Prepack71335-2298
Pravastatin sodiumPravastatin sodium 20 mg/1TabletOralBiocon Pharma Inc.70377-046
Pravastatin sodiumPravastatin sodium 40 mg/1TabletOralBryant Ranch Prepack71335-2833
Pravastatin sodiumPravastatin sodium 10 mg/1TabletOralBiocon Pharma Inc.70377-045
Pravastatin sodiumPravastatin sodium 40 mg/1TabletOralBiocon Pharma Inc.70377-047
Pravastatin sodiumPravastatin sodium 80 mg/1TabletOralBiocon Pharma Inc.70377-048
Pravastatin SodiumPravastatin sodium 20 mg/1TabletOralBryant Ranch Prepack63629-8909
Pravastatin SodiumPravastatin sodium 10 mg/1TabletOralBryant Ranch Prepack63629-8904
Pravastatin SodiumPravastatin sodium 20 mg/1TabletOralBryant Ranch Prepack63629-8906
Pravastatin SodiumPravastatin sodium 80 mg/1TabletOralBryant Ranch Prepack63629-8913
Pravastatin SodiumPravastatin sodium 40 mg/1TabletOralBryant Ranch Prepack63629-8910
Pravastatin SodiumPravastatin sodium 40 mg/1TabletOralBryant Ranch Prepack63629-8911
Pravastatin SodiumPravastatin sodium 80 mg/1TabletOralBryant Ranch Prepack63629-8912
Pravastatin sodiumPravastatin sodium 10 mg/1TabletOralBryant Ranch Prepack71335-2848
Pravastatin SodiumPravastatin sodium 80 mg/1TabletOralBryant Ranch Prepack63629-9165
Pravastatin SodiumPravastatin sodium 20 mg/1TabletOralBryant Ranch Prepack63629-9163
Pravastatin SodiumPravastatin sodium 40 mg/1TabletOralBryant Ranch Prepack63629-9164
Pravastatin sodiumPravastatin sodium 40 mg/1TabletOralBryant Ranch Prepack71335-2687
Pravastatin sodiumPravastatin sodium 40 mg/1TabletOralA-S Medication Solutions50090-7613

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