Prescription drug · ANDA
Atorvastatin Calcium NDC 77771-453
Atorvastatin calcium trihydrate 40 mg/1 · Tablet, Film coated · Oral · Radha Pharmaceuticals, Inc.
NDC codes
FDA NDC DirectoryProduct NDC (as listed)77771-453Labeler and product segments. Claims need a package NDC.
Product NDC at billing width77771-0453Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 77771-453-10 | 7777104531077771045310 | 1000 TABLET, FILM COATED in 1 BOTTLE (77771-453-10)Marketed from Aug 10, 2023 | |
| 77771-453-90 | 7777104539077771045390 | 90 TABLET, FILM COATED in 1 BOTTLE (77771-453-90)Marketed from Aug 10, 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
- Active ingredients
- Atorvastatin calcium trihydrate — 40 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Radha Pharmaceuticals, Inc.NDC labeler code 77771
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205519
- Marketing start
- Listing expires
- Other FDA classes
- Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 77771-453_44cdf1a7-8b12-4820-a2ff-45dfcc4dbab2SPL ID 44cdf1a7-8b12-4820-a2ff-45dfcc4dbab2
- 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
N477771045310followed by a unit qualifier and the quantityPackage 77771-0453-10. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 77771-453
- What is NDC 77771-453?
- 77771-453 is the product NDC for Atorvastatin Calcium, Atorvastatin calcium trihydrate 40 mg/1 tablet, film coated, listed with the FDA by Radha Pharmaceuticals, Inc.. 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 trihydrate.
- Who is the labeler?
- Radha Pharmaceuticals, Inc., NDC labeler code 77771. 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 205519
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 10 mg/1 | Tablet, Film coatedOral | ScieGen Pharmaceuticals, Inc. | 50228-451 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 20 mg/1 | Tablet, Film coatedOral | ScieGen Pharmaceuticals, Inc. | 50228-452 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 40 mg/1 | Tablet, Film coatedOral | ScieGen Pharmaceuticals, Inc. | 50228-453 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 80 mg/1 | Tablet, Film coatedOral | ScieGen Pharmaceuticals, Inc. | 50228-454 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 80 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-907 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-8469 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 20 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-8470 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 20 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-8471 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 80 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-8472 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 20 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1643 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 40 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-3267 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 10 mg/1 | Tablet, Film coatedOral | Cipla USA Inc., | 69097-897 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 20 mg/1 | Tablet, Film coatedOral | Cipla USA Inc., | 69097-898 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 40 mg/1 | Tablet, Film coatedOral | Cipla USA Inc., | 69097-899 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 80 mg/1 | Tablet, Film coatedOral | Cipla USA Inc., | 69097-911 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 10 mg/1 | Tablet, Film coatedOral | Cipla USA Inc., | 69097-944 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 20 mg/1 | Tablet, Film coatedOral | Cipla USA Inc., | 69097-945 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 40 mg/1 | Tablet, Film coatedOral | Cipla USA Inc., | 69097-946 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 80 mg/1 | Tablet, Film coatedOral | Cipla USA Inc., | 69097-947 |
| Atorvastatin Calcium | Atorvastatin calcium trihydrate 80 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-036 |
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