What is NDC 42677-302?

42677-302 is the product NDC for Rosuvastatin Calcium, Rosuvastatin calcium 10 mg/1 tablet, film coated, listed with the FDA by Shandong New Time Pharmaceutical Co., Ltd.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Shandong New Time Pharmaceutical Co., Ltd., NDC labeler code 42677. 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 Calcium?

202 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Rosuvastatin Calcium NDC 42677-302

NDC codes

FDA NDC Directory

Product NDC (as listed)42677-302Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42677-0302Add 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	Copy
42677-302-01	4267703020142677030201	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42677-302-01)Marketed from Jan 22, 2022
42677-302-02	4267703020242677030202	500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42677-302-02)Marketed from Jan 22, 2022

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 Calcium
Generic name (nonproprietary): rosuvastatin calcium
Active ingredients: Rosuvastatin calcium — 10 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Shandong New Time Pharmaceutical Co., Ltd.NDC labeler code 42677
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207375
Marketing start: Jan 22, 2022
Listing expires: Dec 31, 2027
Other FDA classes: Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
Identifiers: Product ID 42677-302_52c7b3fe-56c6-3cd9-e063-6294a90acfbbSPL ID 52c7b3fe-56c6-3cd9-e063-6294a90acfbbSPL set ID ae865404-ecf4-41a8-b40b-62f887c220f2RxCUI 859419, 859424, 859747, 859751UNII 83MVU38M7QUPC 0342677303023, 0342677304013
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

N442677030201 followed by a unit qualifier and the quantity

Package 42677-0302-01. 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 May 27, 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 without established coronary heart disease who are at increased risk of CV disease based on age, high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L, and at least one additional CV risk factor. As an adjunct to diet to: Reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. Reduce low-density lipoprotein cholesterol (LDL-C) and slow the progression of atherosclerosis in adults. Reduce LDL-C in adults and pediatric patients aged 8 years and older wi…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 42677-302

What is NDC 42677-302?: 42677-302 is the product NDC for Rosuvastatin Calcium, Rosuvastatin calcium 10 mg/1 tablet, film coated, listed with the FDA by Shandong New Time Pharmaceutical Co., Ltd.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Rosuvastatin Calcium.
What is the active ingredient?: Rosuvastatin calcium.
Who is the labeler?: Shandong New Time Pharmaceutical Co., Ltd., NDC labeler code 42677. 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 Calcium?: 202 other product NDCs are listed under this name. See all Rosuvastatin Calcium 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 Calcium NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Rosuvastatin Calcium	Rosuvastatin calcium 5 mg/1	Tablet, Film coatedOral	Zhejiang Yongtai Pharmaceutical Co., Ltd.	69434-005	69434-0005-0269434-0005-03
Rosuvastatin Calcium	Rosuvastatin calcium 10 mg/1	Tablet, Film coatedOral	Zhejiang Yongtai Pharmaceutical Co., Ltd.	69434-006	69434-0006-0269434-0006-03
Rosuvastatin Calcium	Rosuvastatin calcium 20 mg/1	Tablet, Film coatedOral	Zhejiang Yongtai Pharmaceutical Co., Ltd.	69434-007	69434-0007-0269434-0007-03
Rosuvastatin Calcium	Rosuvastatin calcium 40 mg/1	Tablet, Film coatedOral	Zhejiang Yongtai Pharmaceutical Co., Ltd.	69434-008	69434-0008-0169434-0008-03
Rosuvastatin Calcium	Rosuvastatin calcium 5 mg/1	TabletOral	REMEDYREPACK INC.	70518-4697	70518-4697-00
Rosuvastatin calcium	Rosuvastatin calcium 5 mg/1	Tablet, Film coatedOral	HEC Pharm USA Inc.	72303-0827	72303-0827-01
Rosuvastatin calcium	Rosuvastatin calcium 10 mg/1	Tablet, Film coatedOral	HEC Pharm USA Inc.	72303-0828	72303-0828-01
Rosuvastatin calcium	Rosuvastatin calcium 20 mg/1	Tablet, Film coatedOral	HEC Pharm USA Inc.	72303-0829	72303-0829-01
Rosuvastatin calcium	Rosuvastatin calcium 40 mg/1	Tablet, Film coatedOral	HEC Pharm USA Inc.	72303-0830	72303-0830-01
Rosuvastatin Calcium	Rosuvastatin calcium 20 mg/1	Tablet, Film coatedOral	Shandong New Time Pharmaceutical Co., Ltd.	42677-303	42677-0303-0142677-0303-02

All 203 Rosuvastatin Calcium NDCs

Other NDCs under ANDA 207375

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

FDA NDC Directory listings under ANDA 207375
Product	Strength	Form · route	Labeler	Product NDC
Rosuvastatin Calcium	Rosuvastatin calcium 5 mg/1	Tablet, Film coatedOral	Shandong New Time Pharmaceutical Co., Ltd.	42677-301
Rosuvastatin Calcium	Rosuvastatin calcium 20 mg/1	Tablet, Film coatedOral	Shandong New Time Pharmaceutical Co., Ltd.	42677-303
Rosuvastatin Calcium	Rosuvastatin calcium 40 mg/1	Tablet, Film coatedOral	Shandong New Time Pharmaceutical Co., Ltd.	42677-304