Prescription drug · ANDA
Rosuvastatin NDC 72189-065
Rosuvastatin calcium 5 mg/1 · Tablet, Film coated · Oral · DIRECT RX
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72189-065-30 | 7218900653072189006530 | 30 TABLET, FILM COATED in 1 BOTTLE (72189-065-30)Marketed from Dec 10, 2019 | |
| 72189-065-90 | 7218900659072189006590 | 90 TABLET, FILM COATED in 1 BOTTLE (72189-065-90)Marketed from Dec 10, 2019 |
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
- DIRECT RXNDC labeler code 72189
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208898
- Marketing start
- Listing expires
- Other FDA classes
- Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 72189-065_4c499576-6f7a-6e58-e063-6294a90ab6a0SPL ID 4c499576-6f7a-6e58-e063-6294a90ab6a0SPL set ID 99602058-4681-7cb5-e053-2995a90a099cRxCUI 859419, 859424UNII 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
N472189006530followed by a unit qualifier and the quantityPackage 72189-0065-30. 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
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Pediatric use information for patients 7 to 17 years of age is approved for AstraZeneca’s CRESTOR (rosuvastatin calcium) tablets. However, due to AstraZeneca’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. 1.3 Hypertriglyceridemia Rosuvastatin tablets are indicated as adjunctive therapy to diet for the treatment of adult patients with hypertriglyceridemia. 1.4 Primary Dysbetalipoproteinemia (Type III Hyperlipoproteinemia) Rosuvastatin tablets are indicated as an adjunct to diet for the treatment of adult patients with primary dysbetalipoproteinemia (Type III Hyperlipoproteinemia). 1.5 Adult Patients with Homozygous Familial Hypercholesterolem…
Excerpt only. Read the full label for complete information.
About NDC 72189-065
- What is NDC 72189-065?
- 72189-065 is the product NDC for Rosuvastatin, Rosuvastatin calcium 5 mg/1 tablet, film coated, listed with the FDA by DIRECT RX. 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?
- DIRECT RX, NDC labeler code 72189. 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.
Related NDCs: other Rosuvastatin products
Other finished products listed under the same name: strengths, forms and labelers.
| 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 |
Other NDCs under ANDA 208898
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Rosuvastatin Calcium | Rosuvastatin calcium 10 mg/1 | Tablet, Film coatedOral | Quallent Pharmaceuticals Health LLC | 82009-018 |
| Rosuvastatin Calcium | Rosuvastatin calcium 20 mg/1 | Tablet, Film coatedOral | Quallent Pharmaceuticals Health LLC | 82009-019 |
| Rosuvastatin Calcium | Rosuvastatin calcium 40 mg/1 | Tablet, Film coatedOral | Quallent Pharmaceuticals Health LLC | 82009-020 |
| Rosuvastatin Calcium | Rosuvastatin calcium 20 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-1819 |
| Rosuvastatin Calcium | Rosuvastatin calcium 5 mg/1 | Tablet, Film coatedOral | Quallent Pharmaceuticals Health LLC | 82009-017 |
| Rosuvastatin Calcium | Rosuvastatin calcium 20 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-996 |
| Rosuvastatin Calcium | Rosuvastatin calcium 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1733 |
| Rosuvastatin Calcium | Rosuvastatin calcium 20 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 82804-090 |
| Rosuvastatin Calcium | Rosuvastatin calcium 5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1330 |
| Rosuvastatin Calcium | Rosuvastatin calcium 10 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-062 |
| Rosuvastatin Calcium | Rosuvastatin calcium 10 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-5176 |
| Rosuvastatin Calcium | Rosuvastatin calcium 20 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6519 |
| Rosuvastatin Calcium | Rosuvastatin calcium 5 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-5225 |
| Rosuvastatin Calcium | Rosuvastatin calcium 40 mg/1 | Tablet, Film coatedOral | DIRECT RX | 72189-106 |
| Rosuvastatin Calcium | Rosuvastatin calcium 5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1017 |
| Rosuvastatin Calcium | Rosuvastatin calcium 40 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 82804-176 |
| Rosuvastatin Calcium | Rosuvastatin calcium 40 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6611 |
| Rosuvastatin Calcium | Rosuvastatin calcium 20 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals, Inc. | 68788-7612 |
| Rosuvastatin Calcium | Rosuvastatin calcium 5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-5110 |
| Rosuvastatin Calcium | Rosuvastatin calcium 40 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6612 |
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