ROSUVASTATIN CALCIUM
- Product NDC
- 61919-701
- 11-digit product format
- 619190701
- Labeler code
- 61919
- Product ID
- 61919-701_907901e7-9595-7423-e053-2a95a90a3636
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ROSUVASTATIN CALCIUM
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Direct_Rx
- Application
- ANDA207616
- Marketing category
- ANDA
- Marketing start
- 2019-08-19
- Marketing end
- 0000-00-00
- 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
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
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 |
| e2db08c6-133f-4f4f-afb4-e90a2418d6f6 | Product name | 1 | 20230320 |
| 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 |
| 11ed6f83-cdd2-4637-8379-b1a1d3ae3cde | Product name | 1 | 20181101 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| 86c45a79-b9f0-4476-a27c-6e10db098497 | Product name | 1 | 20180125 |
| 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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 61919-701-20 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-1c9d-a910-e053-dadaa90a0b85 | ROSUVASTATIN CALCIUM |
| 61919-701-30 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-1ead-a910-e053-dadaa90a0b85 | ROSUVASTATIN CALCIUM |
| 61919-701-90 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-5189-a910-e053-dadaa90a0b85 | ROSUVASTATIN CALCIUM |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61919-701-20 | ROSUVASTATIN CALCIUM | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | 3 | |
| 61919-701-30 | ROSUVASTATIN CALCIUM | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 1 | |
| 61919-701-90 | ROSUVASTATIN CALCIUM | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 61919-701 | ROSUVASTATIN CALCIUM TABLET, FILM COATED ROSUVASTATIN CALCIUM (ROSUVASTATIN CALCIUN) TABLET, FILM COATED [DIRECT RX] | 3 | Legacy NDC, 1 package rows | 20190425_7a8db339-b98c-6fab-e053-2a91aa0a1247.zip |
| 61919-701 | ROSUVASTATIN CALCIUM TABLET, FILM COATED [DIRECT_RX] | 1 | Legacy NDC, 1 package rows | 20190820_907901e7-9594-7423-e053-2a95a90a3636.zip |
| 61919-701 | ROSUVASTATIN CALCIUM TABLET, FILM COATED [DIRECT_RX] | 1 | Legacy NDC, 1 package rows | 20190820_907951ac-e1e1-86f0-e053-2a95a90a3551.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 859751 | rosuvastatin calcium 20 MG Oral Tablet | PSN | 7a8db339-b98c-6fab-e053-2a91aa0a1247 | 3 |
| 859419 | rosuvastatin calcium 40 MG Oral Tablet | PSN | 7a8db339-b98c-6fab-e053-2a91aa0a1247 | 3 |
| 859424 | rosuvastatin calcium 5 MG Oral Tablet | PSN | 7a8db339-b98c-6fab-e053-2a91aa0a1247 | 3 |
| 859751 | rosuvastatin calcium 20 MG Oral Tablet | SCD | 7a8db339-b98c-6fab-e053-2a91aa0a1247 | 3 |
| 859419 | rosuvastatin calcium 40 MG Oral Tablet | SCD | 7a8db339-b98c-6fab-e053-2a91aa0a1247 | 3 |
| 859424 | rosuvastatin calcium 5 MG Oral Tablet | SCD | 7a8db339-b98c-6fab-e053-2a91aa0a1247 | 3 |
| 859751 | rosuvastatin calcium 20 MG Oral Tablet | PSN | 907901e7-9594-7423-e053-2a95a90a3636 | 1 |
| 859751 | rosuvastatin calcium 20 MG Oral Tablet | PSN | 907951ac-e1e1-86f0-e053-2a95a90a3551 | 1 |
| 859751 | rosuvastatin calcium 20 MG Oral Tablet | SCD | 907901e7-9594-7423-e053-2a95a90a3636 | 1 |
| 859751 | rosuvastatin calcium 20 MG Oral Tablet | SCD | 907951ac-e1e1-86f0-e053-2a95a90a3551 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 61919-701-20 | 61919070120 | 20 in 1 BOTTLE | Historical |
| 61919-701-30 | 61919070130 | 30 in 1 BOTTLE | Historical |
| 61919-701-90 | 61919070190 | 90 in 1 BOTTLE | Historical |