Prescription drug · ANDA

Pravastatin Sodium NDC 50090-1594

Pravastatin sodium 10 mg/1 · Tablet · Oral · A-S Medication Solutions

NDC codes

FDA NDC Directory
Product NDC (as listed)50090-1594Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50090-1594Add 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
50090-1594-05009015940090 TABLET in 1 BOTTLE (50090-1594-0)Marketed from Jan 5, 2015
50090-1594-15009015940130 TABLET in 1 BOTTLE (50090-1594-1)Marketed from Jan 5, 2015

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
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 077987
Marketing start
Listing expires
Other FDA classes
Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
Identifiers
Product ID 50090-1594_8b71204c-39a3-472e-a755-b00e6baf26f9SPL ID 8b71204c-39a3-472e-a755-b00e6baf26f9SPL set ID bdf02140-3647-498e-ba0a-f4ca920b4e90RxCUI 904458, 904475UNII 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

N450090159400 followed by a unit qualifier and the quantity

Package 50090-1594-00. 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: 1. 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). 2. 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. 3. As an adjunct to diet to reduce LDL-C in adults with primary hyperlipidemia. 4. As an adjunct to diet to reduce LDL-C in pediatric patients ages 8 years and older with heterozygo…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 077987

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

FDA NDC Directory listings under ANDA 077987
ProductStrengthForm · routeLabelerProduct NDC
Pravastatin SodiumPravastatin sodium 10 mg/1TabletOralCoupler LLC67046-1518
Pravastatin SodiumPravastatin sodium 10 mg/1TabletOralAmerican Health Packaging60687-886
Pravastatin SodiumPravastatin sodium 20 mg/1TabletOralCoupler LLC67046-1519
Pravastatin SodiumPravastatin sodium 10 mg/1TabletOralCIPLA USA INC.69097-788
Pravastatin SodiumPravastatin sodium 20 mg/1TabletOralCIPLA USA INC.69097-789
Pravastatin SodiumPravastatin sodium 20 mg/1TabletOralAmerican Health Packaging60687-897
Pravastatin SodiumPravastatin sodium 40 mg/1TabletOralCIPLA USA INC.69097-791
Pravastatin SodiumPravastatin sodium 80 mg/1TabletOralCIPLA USA INC.69097-792
Pravastatin SodiumPravastatin sodium 10 mg/1TabletOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8539
Pravastatin SodiumPravastatin sodium 40 mg/1TabletOralNorthwind Health Company, LLC51655-594
Pravastatin SodiumPravastatin sodium 40 mg/1TabletOralAmerican Health Packaging60687-908
Pravastatin SodiumPravastatin sodium 20 mg/1TabletOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8540
Pravastatin SodiumPravastatin sodium 20 mg/1TabletOralA-S Medication Solutions50090-7710
Pravastatin SodiumPravastatin sodium 20 mg/1TabletOralA-S Medication Solutions50090-7709
Pravastatin SodiumPravastatin sodium 20 mg/1TabletOralGlenmark Pharmaceuticals Inc., USA68462-196
Pravastatin SodiumPravastatin sodium 10 mg/1TabletOralGlenmark Pharmaceuticals Inc., USA68462-195
Pravastatin SodiumPravastatin sodium 40 mg/1TabletOralGlenmark Pharmaceuticals Inc., USA68462-197
Pravastatin SodiumPravastatin sodium 20 mg/1TabletOralA-S Medication Solutions50090-0975
Pravastatin SodiumPravastatin sodium 40 mg/1TabletOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8541
Pravastatin SodiumPravastatin sodium 80 mg/1TabletOralGlenmark Pharmaceuticals Inc., USA68462-198

Showing 20 of 33.

Med-Code uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

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
Pravastatin Sodium NDC 50090-1594 | Med-Code