ROSUVASTATIN CALCIUM

Product NDC
76519-1162
11-digit product format
765191162
Labeler code
76519
Product ID
76519-1162_5f248416-c8f9-98b2-e053-2991aa0aa855
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ROSUVASTATIN CALCIUM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
H. J. Harkins Company Inc.
Application
ANDA079171
Marketing category
ANDA
Marketing start
2017-01-03
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct76519-1162IInactivated by FDA2026-08-17
excluded packagepackage76519-116276519-1162-9IInactivated 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 1 · 42 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 packagepackage76519-1162-9d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage76519-1162-9f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage76519-1162-92ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage76519-1162-9a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage76519-1162-9cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage76519-1162-9cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage76519-1162-9302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage76519-1162-9ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage76519-1162-90efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage76519-1162-9ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage76519-1162-9367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage76519-1162-9557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage76519-1162-98af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage76519-1162-9834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage76519-1162-91332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage76519-1162-9fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage76519-1162-986f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage76519-1162-9bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage76519-1162-98dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage76519-1162-9e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage76519-1162-99bebd1f3094a…5416666fcb17…

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
A079171-001ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORAL2016-07-19
A079171-002ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2016-07-19
A079171-003ROSUVASTATIN CALCIUMROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2016-07-19
A079171-004ROSUVASTATIN 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 06:07:402026-07A079171-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORAL2016-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A079171-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2016-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A079171-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2016-07-19caaa826d4ba7…
2026-08-18 06:07:402026-07A079171-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2016-07-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A079171-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORAL2016-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079171-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2016-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079171-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2016-07-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079171-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2016-07-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079171-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORAL2016-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079171-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2016-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079171-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2016-07-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079171-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2016-07-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A079171-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORAL2016-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079171-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2016-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079171-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2016-07-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079171-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2016-07-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079171-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORAL2016-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079171-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2016-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079171-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2016-07-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079171-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2016-07-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079171-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORAL2016-07-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079171-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2016-07-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079171-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2016-07-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079171-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2016-07-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079171-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORAL2016-07-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079171-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2016-07-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079171-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2016-07-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079171-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2016-07-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079171-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORAL2016-07-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079171-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2016-07-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079171-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2016-07-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079171-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2016-07-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079171-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORAL2016-07-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079171-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2016-07-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079171-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2016-07-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079171-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2016-07-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079171-001ROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORAL2016-07-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079171-002ROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORAL2016-07-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079171-003ROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORAL2016-07-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079171-004ROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORAL2016-07-19d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 96 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A079171-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A079171-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A079171-003AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A079171-004AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A079171-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A079171-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A079171-003AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A079171-004AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A079171-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A079171-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A079171-003AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A079171-004AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A079171-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A079171-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A079171-003AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A079171-004AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A079171-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A079171-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A079171-003AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A079171-004AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A079171-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A079171-002AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A079171-003AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A079171-004AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A079171-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A079171-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A079171-003AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A079171-004AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A079171-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A079171-002AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A079171-003AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A079171-004AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A079171-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A079171-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A079171-003AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A079171-004AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A079171-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A079171-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A079171-003AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A079171-004AB1c0c555d07b60…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c8f25656-847a-4de8-96a7-06bf98d83c2bProduct name120210916
b6a872b4-e31a-fff0-6f62-fd0253265e2fProduct name920190618
5a2818e5-ef92-49b1-bc6c-9fe2427d21d5Product name120190429

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76519-1162-92020-01-31C16284748780-19d75b9d0-c5fb-f424-e053-dadaa90a57ce5f248416-c8f8-98b2-e053-2991aa0aa855

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76519-1162-9ROSUVASTATIN CALCIUM90 in 1 CONTAINERTABLET, FILM COATED901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76519-1162ROSUVASTATIN CALCIUM TABLET, FILM COATED [H. J. HARKINS COMPANY INC.]1Legacy NDC, 1 package rows20171130_5f248416-c8f8-98b2-e053-2991aa0aa855.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859747rosuvastatin calcium 10 MG Oral TabletPSN5f248416-c8f8-98b2-e053-2991aa0aa8551
859747rosuvastatin calcium 10 MG Oral TabletSCD5f248416-c8f8-98b2-e053-2991aa0aa8551

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
76519-1162-97651911620990 in 1 CONTAINERHistorical