Rosuvastatin Calcium

Product NDC
45865-893
11-digit product format
458650893
Labeler code
45865
Product ID
45865-893_7df002ca-e0ad-24fe-e053-2991aa0ab75f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
medsource pharmaceuticals
Application
ANDA079166
Marketing category
ANDA
Marketing start
2016-08-18
Marketing end
0000-00-00
Substance
ROSUVASTATIN CALCIUM
Active strength
10 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct45865-893IInactivated by FDA2026-08-17
excluded packagepackage45865-89345865-893-49IInactivated by FDA2026-08-17
excluded packagepackage45865-89345865-893-60IInactivated by FDA2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 2 · 63 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage45865-893-49d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage45865-893-60d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage45865-893-49f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage45865-893-60f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage45865-893-492ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage45865-893-602ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage45865-893-49a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage45865-893-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage45865-893-49cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage45865-893-60cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage45865-893-49cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage45865-893-60cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage45865-893-49302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage45865-893-60302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage45865-893-49ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage45865-893-60ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage45865-893-490efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage45865-893-600efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage45865-893-49ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage45865-893-60ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage45865-893-49367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage45865-893-60367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage45865-893-49557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage45865-893-60557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage45865-893-498af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage45865-893-608af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage45865-893-49834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage45865-893-60834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage45865-893-491332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage45865-893-601332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage45865-893-49fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage45865-893-60fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage45865-893-4986f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage45865-893-6086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage45865-893-49bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage45865-893-60bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage45865-893-498dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage45865-893-608dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage45865-893-49e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage45865-893-60e2bbac7714bc…27bdfed8d636…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A079166-001ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORAL2016-07-19
A079166-002ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2016-07-19
A079166-003ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2016-07-19
A079166-004ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2016-07-19

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A079166-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORAL2016-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A079166-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2016-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A079166-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2016-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A079166-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2016-07-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A079166-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORAL2016-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079166-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2016-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079166-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2016-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079166-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2016-07-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079166-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORAL2016-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079166-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2016-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079166-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2016-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079166-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2016-07-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A079166-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORAL2016-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079166-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2016-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079166-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2016-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079166-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2016-07-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079166-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORAL2016-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079166-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2016-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079166-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2016-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079166-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2016-07-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079166-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORAL2016-07-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079166-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2016-07-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079166-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2016-07-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079166-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2016-07-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079166-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORAL2016-07-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079166-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2016-07-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079166-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2016-07-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079166-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2016-07-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079166-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORAL2016-07-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079166-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2016-07-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079166-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2016-07-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079166-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2016-07-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079166-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORAL2016-07-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079166-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2016-07-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079166-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2016-07-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079166-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2016-07-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079166-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORAL2016-07-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079166-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2016-07-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079166-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2016-07-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079166-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2016-07-19d8e5a09893c0…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-07-19 19:46 UTC2019-07A079166-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A079166-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A079166-003AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A079166-004AB1ea99ee380514…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
c8f25656-847a-4de8-96a7-06bf98d83c2bProduct name120210916
b6a872b4-e31a-fff0-6f62-fd0253265e2fProduct name920190618
5a2818e5-ef92-49b1-bc6c-9fe2427d21d5Product name120190429
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-893-49Rosuvastatin Calcium100 in 1 BOTTLETABLET, FILM COATED1001
45865-893-60Rosuvastatin Calcium60 in 1 BOTTLETABLET, FILM COATED601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-893ROSUVASTATIN CALCIUM TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1Legacy NDC, 2 package rows20181227_7defeea4-b909-bd8b-e053-2a91aa0afedd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859747rosuvastatin calcium 10 MG Oral TabletPSN7defeea4-b909-bd8b-e053-2a91aa0afedd1
859747rosuvastatin calcium 10 MG Oral TabletSCD7defeea4-b909-bd8b-e053-2a91aa0afedd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
45865-893-4945865089349100 in 1 BOTTLEHistorical
45865-893-604586508936060 in 1 BOTTLEHistorical