Prescription drug · ANDA
Rosuvastatin Calcium NDC 68788-8775
Rosuvastatin calcium 10 mg/1 · Tablet · Oral · Preferred Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-8775-2 | 6878887750268788877502 | 20 TABLET in 1 BOTTLE (68788-8775-2)Marketed from Nov 22, 2024 | |
| 68788-8775-3 | 6878887750368788877503 | 30 TABLET in 1 BOTTLE (68788-8775-3)Marketed from Nov 22, 2024 | |
| 68788-8775-4 | 6878887750468788877504 | 60 TABLET in 1 BOTTLE (68788-8775-4)Marketed from Nov 22, 2024 | |
| 68788-8775-5 | 6878887750568788877505 | 90 TABLET in 1 BOTTLE (68788-8775-5)Marketed from Nov 22, 2024 | |
| 68788-8775-9 | 6878887750968788877509 | 36 TABLET in 1 BOTTLE (68788-8775-9)Marketed from Nov 22, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Rosuvastatin Calcium
- Generic name (nonproprietary)
- rosuvastatin calcium
- Active ingredients
- Rosuvastatin calcium — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Preferred Pharmaceuticals Inc.NDC labeler code 68788
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207626
- Marketing start
- Listing expires
- Other FDA classes
- Hydroxymethylglutaryl-CoA Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 68788-8775_91d62e28-86cf-4121-9f08-77ecbff376c4SPL ID 91d62e28-86cf-4121-9f08-77ecbff376c4
- 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
N468788877502followed by a unit qualifier and the quantityPackage 68788-8775-02. 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 68788-8775
- What is NDC 68788-8775?
- 68788-8775 is the product NDC for Rosuvastatin Calcium, Rosuvastatin calcium 10 mg/1 tablet, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 5 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Rosuvastatin Calcium.
- What is the active ingredient?
- Rosuvastatin calcium.
- Who is the labeler?
- Preferred Pharmaceuticals Inc., NDC labeler code 68788. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Rosuvastatin Calcium?
- 202 other product NDCs are listed under this name. See all Rosuvastatin Calcium NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Rosuvastatin 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) |
|---|---|---|---|---|---|
| Rosuvastatin Calcium | Rosuvastatin calcium 5 mg/1 | Tablet, Film coatedOral | Zhejiang Yongtai Pharmaceutical Co., Ltd. | 69434-005 | 69434-0005-0269434-0005-03 |
| Rosuvastatin Calcium | Rosuvastatin calcium 10 mg/1 | Tablet, Film coatedOral | Zhejiang Yongtai Pharmaceutical Co., Ltd. | 69434-006 | 69434-0006-0269434-0006-03 |
| Rosuvastatin Calcium | Rosuvastatin calcium 20 mg/1 | Tablet, Film coatedOral | Zhejiang Yongtai Pharmaceutical Co., Ltd. | 69434-007 | 69434-0007-0269434-0007-03 |
| Rosuvastatin Calcium | Rosuvastatin calcium 40 mg/1 | Tablet, Film coatedOral | Zhejiang Yongtai Pharmaceutical Co., Ltd. | 69434-008 | 69434-0008-0169434-0008-03 |
| Rosuvastatin Calcium | Rosuvastatin calcium 5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4697 | 70518-4697-00 |
| Rosuvastatin calcium | Rosuvastatin calcium 5 mg/1 | Tablet, Film coatedOral | HEC Pharm USA Inc. | 72303-0827 | 72303-0827-01 |
| Rosuvastatin calcium | Rosuvastatin calcium 10 mg/1 | Tablet, Film coatedOral | HEC Pharm USA Inc. | 72303-0828 | 72303-0828-01 |
| Rosuvastatin calcium | Rosuvastatin calcium 20 mg/1 | Tablet, Film coatedOral | HEC Pharm USA Inc. | 72303-0829 | 72303-0829-01 |
| Rosuvastatin calcium | Rosuvastatin calcium 40 mg/1 | Tablet, Film coatedOral | HEC Pharm USA Inc. | 72303-0830 | 72303-0830-01 |
| Rosuvastatin Calcium | Rosuvastatin calcium 20 mg/1 | Tablet, Film coatedOral | Shandong New Time Pharmaceutical Co., Ltd. | 42677-303 | 42677-0303-0142677-0303-02 |
Other NDCs under ANDA 207626
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 |
|---|---|---|---|---|
| Rosuvastatin Calcium | Rosuvastatin calcium 5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-3172 |
| Rosuvastatin Calcium | Rosuvastatin calcium 10 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-5333 |
| Rosuvastatin Calcium | Rosuvastatin calcium 5 mg/1 | TabletOral | NorthStar Rx, LLC | 72603-364 |
| Rosuvastatin Calcium | Rosuvastatin calcium 10 mg/1 | TabletOral | NorthStar Rx, LLC | 72603-365 |
| Rosuvastatin Calcium | Rosuvastatin calcium 20 mg/1 | TabletOral | NorthStar Rx, LLC | 72603-366 |
| Rosuvastatin Calcium | Rosuvastatin calcium 40 mg/1 | TabletOral | NorthStar Rx, LLC | 72603-367 |
| Rosuvastatin Calcium | Rosuvastatin calcium 5 mg/1 | TabletOral | Umedica Laboratories USA Inc. | 60290-043 |
| Rosuvastatin Calcium | Rosuvastatin calcium 10 mg/1 | TabletOral | Umedica Laboratories USA Inc. | 60290-044 |
| Rosuvastatin Calcium | Rosuvastatin calcium 20 mg/1 | TabletOral | Umedica Laboratories USA Inc. | 60290-045 |
| Rosuvastatin Calcium | Rosuvastatin calcium 40 mg/1 | TabletOral | Umedica Laboratories USA Inc. | 60290-046 |
| Rosuvastatin Calcium | Rosuvastatin calcium 10 mg/1 | TabletOral | Redpharm Drug | 67296-2360 |
| Rosuvastatin Calcium | Rosuvastatin calcium 5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4697 |
| Rosuvastatin Calcium | Rosuvastatin calcium 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-7967 |
| Rosuvastatin Calcium | Rosuvastatin calcium 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-7968 |
| Rosuvastatin Calcium | Rosuvastatin calcium 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-7975 |
| Rosuvastatin Calcium | Rosuvastatin calcium 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-7976 |
| Rosuvastatin Calcium | Rosuvastatin calcium 5 mg/1 | TabletOral | TORRENT PHARMACEUTICALS LIMITED | 13668-720 |
| Rosuvastatin Calcium | Rosuvastatin calcium 10 mg/1 | TabletOral | TORRENT PHARMACEUTICALS LIMITED | 13668-721 |
| Rosuvastatin Calcium | Rosuvastatin calcium 20 mg/1 | TabletOral | TORRENT PHARMACEUTICALS LIMITED | 13668-722 |
| Rosuvastatin Calcium | Rosuvastatin calcium 40 mg/1 | TabletOral | TORRENT PHARMACEUTICALS LIMITED | 13668-723 |
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