Prescription drug · ANDA
Atorvastatin Calcium NDC 16714-175
Atorvastatin calcium propylene glycol solvate 40 mg/1 · Tablet, Film coated · Oral · NORTHSTAR RX LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16714-175-01 | 1671401750116714017501 | 90 TABLET, FILM COATED in 1 BOTTLE (16714-175-01)Marketed from Aug 1, 2021 | |
| 16714-175-03 | 1671401750316714017503 | 1000 TABLET, FILM COATED in 1 BOTTLE (16714-175-03)Marketed from Aug 1, 2021 |
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
- Active ingredients
- Atorvastatin calcium propylene glycol solvate — 40 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- NORTHSTAR RX LLCNDC labeler code 16714
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090548
- Marketing start
- Marketing end
- Other FDA classes
- Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 16714-175_ae4de6a7-ccde-a6fd-daaf-4a69151d89b7SPL ID ae4de6a7-ccde-a6fd-daaf-4a69151d89b7SPL set ID 52d8508b-aa98-cd89-5991-e2b5f982b6c6RxCUI 259255, 617310, 617311, 617312UNII 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
N416714017501followed by a unit qualifier and the quantityPackage 16714-0175-01. 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 aged 10 years …
Excerpt only. Read the full label for complete information.
About NDC 16714-175
- What is NDC 16714-175?
- 16714-175 is the product NDC for Atorvastatin Calcium, Atorvastatin calcium propylene glycol solvate 40 mg/1 tablet, film coated, listed with the FDA by NORTHSTAR RX LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Atorvastatin Calcium.
- What is the active ingredient?
- Atorvastatin calcium propylene glycol solvate.
- Who is the labeler?
- NORTHSTAR RX LLC, NDC labeler code 16714. 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 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 10 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8006 |
| Atorvastatin Calcium | Atorvastatin calcium propylene glycol solvate 20 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8007 |
| Atorvastatin Calcium | Atorvastatin calcium propylene glycol solvate 40 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8008 |
| Atorvastatin Calcium | Atorvastatin calcium propylene glycol solvate 80 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8009 |
| Atorvastatin Calcium | Atorvastatin calcium propylene glycol solvate 10 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6290 |
| Atorvastatin Calcium | Atorvastatin calcium propylene glycol solvate 20 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6291 |
| Atorvastatin Calcium | Atorvastatin calcium propylene glycol solvate 40 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6292 |
| Atorvastatin Calcium | Atorvastatin calcium propylene glycol solvate 80 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6293 |
| 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 80 mg/1 | Tablet, Film coatedOral | NORTHSTAR RX LLC | 16714-176 |
| Atorvastatin Calcium | Atorvastatin calcium propylene glycol solvate 20 mg/1 | Tablet, Film coatedOral | QPharma, Inc. | 42708-013 |
| Atorvastatin Calcium | Atorvastatin calcium propylene glycol solvate 10 mg/1 | Tablet, Film coatedOral | QPharma, Inc. | 42708-014 |
| Atorvastatin Calcium | Atorvastatin calcium propylene glycol solvate 40 mg/1 | Tablet, Film coatedOral | QPharma, Inc. | 42708-108 |
| Atorvastatin Calcium | Atorvastatin calcium propylene glycol solvate 40 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 43063-453 |
| Atorvastatin Calcium | Atorvastatin calcium propylene glycol solvate 10 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 43063-474 |
| Atorvastatin Calcium | Atorvastatin calcium propylene glycol solvate 20 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 43063-496 |
| 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 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 |
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