Prescription drug · ANDA
Atorvastatin Calcium (Atorvastatin calcium, film coated) NDC 16571-137
Atorvastatin calcium trihydrate 20 mg/1 · Tablet · Oral · Rising Pharma Holdings, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16571-137-09 | 1657101370916571013709 | 90 TABLET in 1 BOTTLE (16571-137-09)Marketed from Oct 20, 2023 | |
| 16571-137-10 | 1657101371016571013710 | 1000 TABLET in 1 BOTTLE (16571-137-10)Marketed from Oct 20, 2023 | |
| 16571-137-50 | 1657101375016571013750 | 500 TABLET in 1 BOTTLE (16571-137-50)Marketed from Oct 20, 2023 |
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)
- Atorvastatin Calcium
- Generic name (nonproprietary)
- atorvastatin calcium, film coated
- Active ingredients
- Atorvastatin calcium trihydrate — 20 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Rising Pharma Holdings, Inc.NDC labeler code 16571
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209912
- Marketing start
- Listing expires
- Other FDA classes
- Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 16571-137_b94c6347-161c-44f2-8937-34c5098bf755SPL ID b94c6347-161c-44f2-8937-34c5098bf755SPL set ID 73cefb0b-1747-4fe0-b252-377f4ed94c6fRxCUI 259255, 617310, 617311, 617312UNII 48A5M73Z4QUPC 0316571136094, 0316571138098, 0316571137091
- 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
N416571013709followed by a unit qualifier and the quantityPackage 16571-0137-09. 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: ○ 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 …
Excerpt only. Read the full label for complete information.
About NDC 16571-137
- What is NDC 16571-137?
- 16571-137 is the product NDC for Atorvastatin Calcium, Atorvastatin calcium trihydrate 20 mg/1 tablet, listed with the FDA by Rising Pharma Holdings, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Atorvastatin Calcium (Atorvastatin calcium, film coated).
- What is the active ingredient?
- Atorvastatin calcium trihydrate.
- Who is the labeler?
- Rising Pharma Holdings, Inc., NDC labeler code 16571. 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 209912
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 calciumatorvastatin calcium, film coated | Atorvastatin calcium trihydrate 40 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2994 |
| Atorvastatin Calciumatorvastatin calcium, film coated | Atorvastatin calcium trihydrate 40 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3882 |
| Atorvastatin Calciumatorvastatin calcium, film coated | Atorvastatin calcium trihydrate 80 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2582 |
| Atorvastatin Calciumatorvastatin calcium, film coated | Atorvastatin calcium trihydrate 40 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2591 |
| Atorvastatin Calciumatorvastatin calcium, film coated | Atorvastatin calcium trihydrate 20 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3891 |
| Atorvastatin Calciumatorvastatin calcium, film coated | Atorvastatin calcium trihydrate 10 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8842 |
| Atorvastatin Calciumatorvastatin calcium, film coated | Atorvastatin calcium trihydrate 10 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3912 |
| Atorvastatin Calciumatorvastatin calcium, film coated | Atorvastatin calcium trihydrate 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2388 |
| Atorvastatin Calciumatorvastatin calcium, film coated | Atorvastatin calcium trihydrate 40 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8887 |
| Atorvastatin Calciumatorvastatin calcium, film coated | Atorvastatin calcium trihydrate 20 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2404 |
| Atorvastatin Calciumatorvastatin calcium, film coated | Atorvastatin calcium trihydrate 10 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3868 |
| Atorvastatin Calciumatorvastatin calcium, film coated | Atorvastatin calcium trihydrate 20 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8693 |
| Atorvastatin Calciumatorvastatin calcium, film coated | Atorvastatin calcium trihydrate 10 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 16571-136 |
| Atorvastatin Calciumatorvastatin calcium, film coated | Atorvastatin calcium trihydrate 40 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 16571-138 |
| Atorvastatin Calciumatorvastatin calcium, film coated | Atorvastatin calcium trihydrate 80 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 16571-139 |
| atorvastatin calciumatorvastatin calcium, film coated | Atorvastatin calcium trihydrate 10 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3546 |