What is NDC 16729-284?

16729-284 is the product NDC for Rosuvastatin, Rosuvastatin calcium 5 mg/1 tablet, film coated, listed with the FDA by Accord Healthcare Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Accord Healthcare Inc., NDC labeler code 16729. 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 16729-284 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)16729-284Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16729-0284Add 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
16729-284-15	1672902841516729028415	90 TABLET, FILM COATED in 1 BOTTLE (16729-284-15)Marketed from Oct 31, 2016
16729-284-17	1672902841716729028417	1000 TABLET, FILM COATED in 1 BOTTLE (16729-284-17)Marketed from Oct 31, 2016

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 — 5 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Accord Healthcare Inc.NDC labeler code 16729
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206434
Marketing start: Oct 31, 2016
Listing expires: Dec 31, 2026
Other FDA classes: Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
Identifiers: Product ID 16729-284_4390ed19-e509-95ab-e063-6294a90a2b08SPL ID 4390ed19-e509-95ab-e063-6294a90a2b08SPL set ID 3ffe0294-3997-2755-e054-00144ff8d46cRxCUI 859419, 859424, 859747, 859751UNII 83MVU38M7Q
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

N416729028415 followed by a unit qualifier and the quantity

Package 16729-0284-15. 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 Nov 14, 2025.

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 LDL-C and slow the progression of atherosclerosis in adults. Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholeste…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 16729-284

What is NDC 16729-284?: 16729-284 is the product NDC for Rosuvastatin, Rosuvastatin calcium 5 mg/1 tablet, film coated, listed with the FDA by Accord Healthcare Inc.. It has 2 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?: Accord Healthcare Inc., NDC labeler code 16729. 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 10 mg/1	Tablet, Film coatedOral	Quallent Pharmaceuticals Health LLC	82009-189	82009-0189-05
Rosuvastatin	Rosuvastatin calcium 5 mg/1	Tablet, Film coatedOral	Quallent Pharmaceuticals Health LLC	82009-188	82009-0188-05
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 206434

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

FDA NDC Directory listings under ANDA 206434
Product	Strength	Form · route	Labeler	Product NDC
Rosuvastatin	Rosuvastatin calcium 10 mg/1	Tablet, Film coatedOral	Accord Healthcare Inc.	16729-285
Rosuvastatin	Rosuvastatin calcium 20 mg/1	Tablet, Film coatedOral	Accord Healthcare Inc.	16729-286
Rosuvastatin	Rosuvastatin calcium 40 mg/1	Tablet, Film coatedOral	Accord Healthcare Inc.	16729-287
Rosuvastatin	Rosuvastatin calcium 10 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-0606
Rosuvastatin	Rosuvastatin calcium 5 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-0749
Rosuvastatin calcium	Rosuvastatin calcium 10 mg/1	Tablet, Film coatedOral	Proficient Rx LP	71205-008
Rosuvastatin calcium	Rosuvastatin calcium 20 mg/1	Tablet, Film coatedOral	Proficient Rx LP	71205-099
Rosuvastatin calcium	Rosuvastatin calcium 40 mg/1	Tablet, Film coatedOral	Proficient Rx LP	71205-176
Rosuvastatin Calcium	Rosuvastatin calcium 5 mg/1	Tablet, Film coatedOral	Proficient Rx LP	71205-355
Rosuvastatin Calcium	Rosuvastatin calcium 20 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-0302
Rosuvastatin calcium	Rosuvastatin calcium 40 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	71610-078
Rosuvastatin calcium	Rosuvastatin calcium 20 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	71610-187
Rosuvastatin calcium	Rosuvastatin calcium 10 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	71610-215