NDC codes

FDA NDC Directory
Product NDC (as listed)70377-048Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70377-0048Add 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
70377-048-11703770048117037700481130 TABLET in 1 BOTTLE (70377-048-11)Marketed from Feb 1, 2021
70377-048-12703770048127037700481290 TABLET in 1 BOTTLE (70377-048-12)Marketed from Feb 1, 2021
70377-048-137037700481370377004813500 TABLET in 1 BOTTLE (70377-048-13)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 — 80 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Biocon Pharma Inc.NDC labeler code 70377
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 70377-048_dc0074c0-e58a-3655-2a66-084168c39615SPL ID dc0074c0-e58a-3655-2a66-084168c39615SPL set ID 9bd4a493-1f75-e33a-53fb-4e2fbc64a1ebRxCUI 904458, 904467, 904475, 904481UNII 3M8608UQ61UPC 0370377048128
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

N470377004811 followed by a unit qualifier and the quantity

Package 70377-0048-11. 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)

Pravastatin sodium tablets are indicated: To reduce the risk of myocardial infarction, myocardial revascularization procedures, and cardiovascular mortality in adults with elevated low-density lipoprotein cholesterol (LDL-C) without clinically evident coronary heart disease (CHD). To reduce the risk of coronary death, myocardial infarction, myocardial revascularization procedures, stroke or transient ischemic attack, and slow the progression of coronary atherosclerosis in adults with clinically evident CHD. As an adjunct to diet to reduce LDL-C in adults with primary hyperlipidemia. As an adjunct to diet to reduce LDL-C in pediatric patients ages 8 years and older with heterozygous familial …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70377-048

What is NDC 70377-048?
70377-048 is the product NDC for Pravastatin sodium, Pravastatin sodium 80 mg/1 tablet, listed with the FDA by Biocon Pharma Inc.. It has 3 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?
Biocon Pharma Inc., NDC labeler code 70377. 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?
183 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 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
Pravastatin sodiumPravastatin sodium 40 mg/1TabletOralNorthwind Health Company, LLC82868-09682868-0096-30
Pravastatin sodiumPravastatin sodium 10 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-405968788-4059-0368788-4059-0668788-4059-09

All 184 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 80 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-877
Pravastatin sodiumPravastatin sodium 40 mg/1TabletOralBryant Ranch Prepack71335-2687
Pravastatin SodiumPravastatin sodium 20 mg/1TabletOralBryant Ranch Prepack63629-9163
Pravastatin SodiumPravastatin sodium 10 mg/1TabletOralBryant Ranch Prepack63629-9162
Pravastatin SodiumPravastatin sodium 40 mg/1TabletOralBryant Ranch Prepack63629-9164
Pravastatin SodiumPravastatin sodium 80 mg/1TabletOralBryant Ranch Prepack63629-9165
Pravastatin SodiumPravastatin sodium 40 mg/1TabletOralBryant Ranch Prepack72162-1953
Pravastatin SodiumPravastatin sodium 40 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-884
Pravastatin sodiumPravastatin sodium 40 mg/1TabletOralBryant Ranch Prepack71335-2746
Pravastatin sodiumPravastatin sodium 10 mg/1TabletOralGolden State Medical Supply, Inc.51407-887
Pravastatin sodiumPravastatin sodium 20 mg/1TabletOralGolden State Medical Supply, Inc.51407-888
Pravastatin sodiumPravastatin sodium 40 mg/1TabletOralA-S Medication Solutions50090-7612
Pravastatin sodiumPravastatin sodium 40 mg/1TabletOralGolden State Medical Supply, Inc.51407-889
Pravastatin sodiumPravastatin sodium 80 mg/1TabletOralGolden State Medical Supply, Inc.51407-890
Pravastatin sodiumPravastatin sodium 40 mg/1TabletOralA-S Medication Solutions50090-7613
Pravastatin sodiumPravastatin sodium 20 mg/1TabletOralA-S Medication Solutions50090-7892
Pravastatin sodiumPravastatin sodium 20 mg/1TabletOralA-S Medication Solutions50090-7893
Pravastatin sodiumPravastatin sodium 40 mg/1TabletOralNorthwind Health Company, LLC82868-081
Pravastatin SodiumPravastatin sodium 20 mg/1TabletOralBryant Ranch Prepack71335-9692
Pravastatin sodiumPravastatin sodium 20 mg/1TabletOralNorthwind Health Company, LLC82868-091

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