Rosuvastatin calcium
- Product NDC
- 42708-191
- 11-digit product format
- 427080191
- Labeler code
- 42708
- Product ID
- 42708-191_519efcd6-a50c-1343-e063-6394a90afc78
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Rosuvastatin calcium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- QPharma, Inc.
- Application
- ANDA079172
- Marketing category
- ANDA
- Marketing start
- 2016-07-19
- Substance
- ROSUVASTATIN CALCIUM
- Active strength
- 20 mg/1
- Pharmacologic classes
- HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| fb7ab793-2c12-4079-b100-a64f73bef25a | Product name | 4 | 20240712 |
| b0cbf770-6cc3-4aa4-9158-755110c2b9f7 | Product name | 2 | 20230717 |
| dc7c5daa-021f-40dd-b00d-63982cb2067a | Product name | 1 | 20230426 |
| c8f25656-847a-4de8-96a7-06bf98d83c2b | Product name | 1 | 20210916 |
| 08ffbcbf-26df-b99c-1dab-64fc4cfae89f | Product name | 5 | 20200925 |
| b6a872b4-e31a-fff0-6f62-fd0253265e2f | Product name | 9 | 20190618 |
| 5a2818e5-ef92-49b1-bc6c-9fe2427d21d5 | Product name | 1 | 20190429 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| 08ffbcbf-26df-b99c-1dab-64fc4cfae89f | Product name | 2 | 20160823 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 42708-191-30 | Rosuvastatin calcium | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | 2 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 859747 | rosuvastatin calcium 10 MG Oral Tablet | PSN | 4148e0b3-0340-9f3a-e063-6394a90afc96 | 2 |
| 859751 | rosuvastatin calcium 20 MG Oral Tablet | PSN | 4148e0b3-0340-9f3a-e063-6394a90afc96 | 2 |
| 859747 | rosuvastatin calcium 10 MG Oral Tablet | SCD | 4148e0b3-0340-9f3a-e063-6394a90afc96 | 2 |
| 859751 | rosuvastatin calcium 20 MG Oral Tablet | SCD | 4148e0b3-0340-9f3a-e063-6394a90afc96 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 42708-191-30 | 42708019130 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42708-191-30) | 2025-10-17 | Yes | No | Historical |