Prescription drug · ANDA
Atorvastatin Calcium NDC 81033-511
Atorvastatin calcium trihydrate 10 mg/1 · Tablet, Film coated · Oral · Kesin Pharma Corporation
NDC codes
FDA NDC DirectoryProduct NDC (as listed)81033-511Labeler and product segments. Claims need a package NDC.
Product NDC at billing width81033-0511Add the package segment from the table below.
Product information
- Brand name (proprietary)
- Atorvastatin Calcium
- Generic name (nonproprietary)
- atorvastatin calcium
- Active ingredients
- Atorvastatin calcium trihydrate — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Kesin Pharma CorporationNDC labeler code 81033
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209288
- Marketing start
- Listing expires
- Other FDA classes
- Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 81033-511_5f790a21-9767-edd7-e063-6294a90a4b40SPL ID 5f790a21-9767-edd7-e063-6294a90a4b40SPL set ID 56826bb5-ae70-af65-e063-6294a90abf74RxCUI 617310, 617312UNII 48A5M73Z4Q
- 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.
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Atorvastatin calcium is indicated: To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia. Adults and pediatric patients aged 10 years and older…
Excerpt only. Read the full label for complete information.
About NDC 81033-511
- What is NDC 81033-511?
- 81033-511 is the product NDC for Atorvastatin Calcium, Atorvastatin calcium trihydrate 10 mg/1 tablet, film coated, listed with the FDA by Kesin Pharma Corporation.
- What drug is associated with this NDC?
- Atorvastatin Calcium.
- What is the active ingredient?
- Atorvastatin calcium trihydrate.
- Who is the labeler?
- Kesin Pharma Corporation, NDC labeler code 81033. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Atorvastatin Calcium?
- 389 other product NDCs are listed under this name. See all Atorvastatin Calcium NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Atorvastatin Calcium products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Atorvastatin calcium | Atorvastatin calcium trihydrate 40 mg/1 | Tablet, Film coatedOral | St. Mary's Medical Park Pharmacy | 60760-979 | 60760-0979-30 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 80 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-0284 | 55154-0284-06 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 10 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-681 | 72189-0681-30 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 10 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals, Inc. | 0480-3585 | 00480-3585-1000480-3585-98 |
| Atorvastatin Calcium | Atorvastatin calcium propylene glycol solvate 40 mg/1 | Tablet, Film coatedOral | Unit Dose Solutions, Inc. | 87441-013 | 87441-0013-01 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 20 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals, Inc. | 0480-3586 | 00480-3586-1000480-3586-98 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 40 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals, Inc. | 0480-3587 | 00480-3587-1000480-3587-98 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 10 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1677 | 67046-1677-03 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 80 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals, Inc. | 0480-3588 | 00480-3588-1000480-3588-98 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 80 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1666 | 67046-1666-03 |
Other NDCs under ANDA 209288
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 |
|---|---|---|---|---|
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 40 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-5091 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 80 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6061 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2241 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 80 mg/1 | Tablet, Film coatedOral | Kesin Pharma Corporation | 81033-514 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 20 mg/1 | Tablet, Film coatedOral | Kesin Pharma Corporation | 81033-513 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 20 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-945 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 10 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-943 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 40 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-946 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 80 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-948 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 20 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-464 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 40 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-465 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 20 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-3037 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 40 mg/1 | Tablet, Film coatedOral | QPharma, Inc. | 42708-144 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 20 mg/1 | Tablet, Film coatedOral | QPharma, Inc. | 42708-141 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 20 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-5181 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 40 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-513 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 10 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-511 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 20 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-5182 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 20 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-512 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 10 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-5184 |
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