Prescription drug · ANDA
Atorvastatin Calcium NDC 68180-635
Atorvastatin calcium trihydrate 10 mg/1 · Tablet · Oral · Lupin Pharmaceuticals, Inc.
NDC codes
FDA NDC DirectoryProduct information
- Brand name (proprietary)
- Atorvastatin Calcium
- Generic name (nonproprietary)
- atorvastatin calcium
- Active ingredients
- Atorvastatin calcium trihydrate — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Lupin Pharmaceuticals, Inc.NDC labeler code 68180
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204991
- Marketing start
- Listing expires
- Other FDA classes
- Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 68180-635_ab716c10-785b-4d43-a5f0-59f95b0b78c8SPL ID ab716c10-785b-4d43-a5f0-59f95b0b78c8SPL set ID a5767370-15a2-45e5-b980-7af9523aea7bRxCUI 259255, 617310, 617311, 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 ol…
Excerpt only. Read the full label for complete information.
About NDC 68180-635
- What is NDC 68180-635?
- 68180-635 is the product NDC for Atorvastatin Calcium, Atorvastatin calcium trihydrate 10 mg/1 tablet, listed with the FDA by Lupin Pharmaceuticals, Inc..
- What drug is associated with this NDC?
- Atorvastatin Calcium.
- What is the active ingredient?
- Atorvastatin calcium trihydrate.
- Who is the labeler?
- Lupin Pharmaceuticals, Inc., NDC labeler code 68180. 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?
- 383 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 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 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 40 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4592 | 70518-4592-00 |
Other NDCs under ANDA 204991
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 | TabletOral | A-S Medication Solutions | 50090-5632 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 20 mg/1 | TabletOral | A-S Medication Solutions | 50090-5634 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-5636 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 20 mg/1 | TabletOral | Lupin Pharmaceuticals, Inc. | 68180-636 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 40 mg/1 | TabletOral | Lupin Pharmaceuticals, Inc. | 68180-637 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 80 mg/1 | TabletOral | Lupin Pharmaceuticals, Inc. | 68180-638 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 20 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1929 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 40 mg/1 | TabletOral | DIRECT RX | 72189-239 |