NDC codes

FDA NDC Directory
Product NDC (as listed)0310-7590Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00310-7590Add 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
0310-7590-30003107590300031075903030 TABLET, FILM COATED in 1 BOTTLE (0310-7590-30)Marketed from Jan 24, 2022

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
Crestor
Generic name (nonproprietary)
rosuvastatin
Active ingredients
Rosuvastatin calcium — 40 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
AstraZeneca Pharmaceuticals LPNDC labeler code 0310
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 021366
Marketing start
Listing expires
Other FDA classes
Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
Identifiers
Product ID 0310-7590_ea84b28f-156f-48df-89e4-b94dbe44fa55SPL ID ea84b28f-156f-48df-89e4-b94dbe44fa55
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

N400310759030 followed by a unit qualifier and the quantity

Package 00310-7590-30. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 0310-7590

What is NDC 0310-7590?
0310-7590 is the product NDC for Crestor (rosuvastatin), Rosuvastatin calcium 40 mg/1 tablet, film coated, listed with the FDA by AstraZeneca Pharmaceuticals LP. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Crestor (Rosuvastatin).
What is the active ingredient?
Rosuvastatin calcium.
Who is the labeler?
AstraZeneca Pharmaceuticals LP, NDC labeler code 0310. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Crestor?
3 other product NDCs are listed under this name. See all Crestor 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 Crestor NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
CrestorrosuvastatinRosuvastatin calcium 5 mg/1Tablet, Film coatedOralAstraZeneca Pharmaceuticals LP0310-756000310-7560-90
CrestorrosuvastatinRosuvastatin calcium 10 mg/1Tablet, Film coatedOralAstraZeneca Pharmaceuticals LP0310-757000310-7570-90
CrestorrosuvastatinRosuvastatin calcium 20 mg/1Tablet, Film coatedOralAstraZeneca Pharmaceuticals LP0310-758000310-7580-90

Other NDCs under NDA 021366

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

FDA NDC Directory listings under NDA 021366
ProductStrengthForm · routeLabelerProduct NDC
CrestorrosuvastatinRosuvastatin calcium 5 mg/1Tablet, Film coatedOralAstraZeneca Pharmaceuticals LP0310-7560
CrestorrosuvastatinRosuvastatin calcium 10 mg/1Tablet, Film coatedOralAstraZeneca Pharmaceuticals LP0310-7570
CrestorrosuvastatinRosuvastatin calcium 20 mg/1Tablet, Film coatedOralAstraZeneca Pharmaceuticals LP0310-7580

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