What is NDC 33342-264?

33342-264 is the product NDC for Rosuvastatin, Rosuvastatin calcium 40 mg/1 tablet, listed with the FDA by Macleods Pharmaceuticals Limited. It has 4 package NDCs, shown above in 10- and 11-digit form.

Macleods Pharmaceuticals Limited, NDC labeler code 33342. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Rosuvastatin?

64 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Rosuvastatin NDC 33342-264 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)33342-264Labeler and product segments. Claims need a package NDC.

Product NDC at billing width33342-0264Add 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 NDC	11-digit (billing)	Package
33342-264-07	33342026407	30 TABLET in 1 CONTAINER (33342-264-07)Marketed from Nov 6, 2024
33342-264-10	33342026410	90 TABLET in 1 CONTAINER (33342-264-10)Marketed from Nov 6, 2024
33342-264-12	33342026412	10 BLISTER PACK in 1 CARTON (33342-264-12) / 10 TABLET in 1 BLISTER PACKMarketed from Nov 6, 2024
33342-264-44	33342026444	1000 TABLET in 1 CONTAINER (33342-264-44)Marketed from Nov 6, 2024

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): Rosuvastatin
Generic name (nonproprietary): rosuvastatin
Active ingredients: Rosuvastatin calcium — 40 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Macleods Pharmaceuticals LimitedNDC labeler code 33342
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207296
Marketing start: Nov 6, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
Identifiers: Product ID 33342-264_093ea34a-0a0b-4642-8e8e-62d6fc5c37d4SPL ID 093ea34a-0a0b-4642-8e8e-62d6fc5c37d4SPL set ID d7b9f280-bda6-40d4-9778-e45efb87ab23RxCUI 859419, 859424, 859747, 859751UNII 83MVU38M7QUPC 0333342261441
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

N433342026407 followed by a unit qualifier and the quantity

Package 33342-0264-07. 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 Jun 2, 2026.

Indications (excerpt from the label)

Rosuvastatin tablets are indicated: • To reduce the risk of major adverse cardiovascular (CV) events (CV death, nonfatal myocardial infarction, nonfatal stroke, or an arterial revascularization procedure) in adults at increased risk for CV events. • As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C): o in adults with hypercholesterolemia. o and slow the progression of atherosclerosis in adults. o in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (He FH). o in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (Ho FH). • As an adjunct to diet for the trea…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 33342-264

What is NDC 33342-264?: 33342-264 is the product NDC for Rosuvastatin, Rosuvastatin calcium 40 mg/1 tablet, listed with the FDA by Macleods Pharmaceuticals Limited. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Rosuvastatin.
What is the active ingredient?: Rosuvastatin calcium.
Who is the labeler?: Macleods Pharmaceuticals Limited, NDC labeler code 33342. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Rosuvastatin?: 64 other product NDCs are listed under this name. See all Rosuvastatin 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 Rosuvastatin NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Rosuvastatin	Rosuvastatin 5 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-4161	68788-4161-0368788-4161-0668788-4161-09
Rosuvastatin	Rosuvastatin calcium 5 mg/1	Tablet, CoatedOral	AiPing Pharmaceutical, Inc.	11788-130	11788-0130-0511788-0130-1011788-0130-90
Rosuvastatin	Rosuvastatin calcium 10 mg/1	Tablet, CoatedOral	AiPing Pharmaceutical, Inc.	11788-131	11788-0131-0511788-0131-1011788-0131-90
Rosuvastatin	Rosuvastatin calcium 20 mg/1	Tablet, CoatedOral	AiPing Pharmaceutical, Inc.	11788-132	11788-0132-0511788-0132-1011788-0132-90
Rosuvastatin	Rosuvastatin calcium 40 mg/1	Tablet, CoatedOral	AiPing Pharmaceutical, Inc.	11788-133	11788-0133-0511788-0133-1011788-0133-90
Rosuvastatin	Rosuvastatin 10 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1627	67046-1627-03
Rosuvastatin	Rosuvastatin calcium 5 mg/1	Tablet, Film coatedOral	Quallent Pharmaceuticals Health LLC	82009-188	82009-0188-05
Rosuvastatin	Rosuvastatin calcium 10 mg/1	Tablet, Film coatedOral	Quallent Pharmaceuticals Health LLC	82009-189	82009-0189-05
Rosuvastatin	Rosuvastatin calcium 20 mg/1	Tablet, Film coatedOral	Quallent Pharmaceuticals Health LLC	82009-190	82009-0190-05
Rosuvastatin	Rosuvastatin calcium 40 mg/1	Tablet, Film coatedOral	Quallent Pharmaceuticals Health LLC	82009-191	82009-0191-05

All 65 Rosuvastatin NDCs

Other NDCs under ANDA 207296

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

FDA NDC Directory listings under ANDA 207296
Product	Strength	Form · route	Labeler	Product NDC
Rosuvastatin	Rosuvastatin calcium 5 mg/1	TabletOral	Macleods Pharmaceuticals Limited	33342-261
Rosuvastatin	Rosuvastatin calcium 10 mg/1	TabletOral	Macleods Pharmaceuticals Limited	33342-262
Rosuvastatin	Rosuvastatin calcium 20 mg/1	TabletOral	Macleods Pharmaceuticals Limited	33342-263