Prescription drug · ANDA
Atorvastatin Calcium NDC 0904-6293
Atorvastatin calcium propylene glycol solvate 80 mg/1 · Tablet, Film coated · Oral · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-6293-04 | 00904629304 | 30 BLISTER PACK in 1 CARTON (0904-6293-04) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Oct 31, 2014 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Atorvastatin Calcium
- Generic name (nonproprietary)
- atorvastatin calcium
- Active ingredients
- Atorvastatin calcium propylene glycol solvate — 80 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Major Pharmaceuticals
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090548
- Marketing start
- Listing expires
- Other FDA classes
- Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 0904-6293_0f81ecdd-087c-4084-9c3b-3b74230e8650SPL ID 0f81ecdd-087c-4084-9c3b-3b74230e8650SPL set ID e74278b6-31fc-48d4-97b7-ba500e9e15fbRxCUI 259255, 617311UNII YRZ789OWMI
- 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
N400904629304followed by a unit qualifier and the quantityPackage 00904-6293-04. 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)
Atorvastatin Calcium Tablets are indicated: • To reduce the risk of: o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD o 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: o Adults with primary hyperlipidemia. o Adults and pediatric patients …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 090548
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 propylene glycol solvate 40 mg/1 | Tablet, Film coatedOral | Apotex Corp. | 60505-2580 |
| Atorvastatin Calcium | Atorvastatin calcium propylene glycol solvate 80 mg/1 | Tablet, Film coatedOral | Apotex Corp. | 60505-2671 |
| Atorvastatin Calcium | Atorvastatin calcium propylene glycol solvate 80 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-656 |
| Atorvastatin Calcium | Atorvastatin calcium propylene glycol solvate 80 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-2018 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 20 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-022 |
| Atorvastatin Calcium | Atorvastatin calcium propylene glycol solvate 40 mg/1 | Tablet, Film coatedOral | Unit Dose Solutions, Inc. | 87441-013 |
| Atorvastatin Calcium | Atorvastatin calcium propylene glycol solvate 40 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-4166 |
| Atorvastatin Calcium | Atorvastatin calcium propylene glycol solvate 40 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6440 |
| Atorvastatin Calcium | Atorvastatin calcium propylene glycol solvate 40 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6441 |
| Atorvastatin Calcium | Atorvastatin calcium propylene glycol solvate 80 mg/1 | Tablet, Film coatedOral | NORTHSTAR RX LLC | 16714-176 |
| Atorvastatin Calcium | Atorvastatin calcium propylene glycol solvate 20 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1051 |
| Atorvastatin Calcium | Atorvastatin calcium propylene glycol solvate 10 mg/1 | Tablet, Film coatedOral | NORTHSTAR RX LLC | 16714-173 |
| Atorvastatin Calcium | Atorvastatin calcium propylene glycol solvate 40 mg/1 | Tablet, Film coatedOral | NORTHSTAR RX LLC | 16714-175 |
| Atorvastatin Calcium | Atorvastatin calcium propylene glycol solvate 80 mg/1 | Tablet, Film coatedOral | American Health Packaging | 68084-590 |
| Atorvastatin Calcium | Atorvastatin calcium propylene glycol solvate 40 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 82868-029 |
| Atorvastatin Calcium | Atorvastatin calcium propylene glycol solvate 10 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-613 |
| Atorvastatin Calcium | Atorvastatin calcium propylene glycol solvate 10 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6479 |
| Atorvastatin Calcium | Atorvastatin calcium propylene glycol solvate 10 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6480 |
| Atorvastatin Calcium | Atorvastatin calcium propylene glycol solvate 20 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6481 |
| Atorvastatin Calcium | Atorvastatin calcium propylene glycol solvate 20 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6482 |
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