Rosuvastatin Calcium

Product NDC
63187-869
Requested package NDC
63187-869-60
11-digit product format
631870869
Labeler code
63187
Product ID
63187-869_a54f604f-fa5f-4403-ab1a-b58a05a9da45
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA079166
Marketing category
ANDA
Marketing start
2016-08-18
Marketing end
0000-00-00
Substance
ROSUVASTATIN CALCIUM
Active strength
40 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

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63187-86963187-869-60DDiscontinued by firm2026-08-17

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63187-86963187-869-60DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63187-86963187-869-60DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-869-30EA - Each63187-869ab8c965f-cf7b-437c-9b67-0aba0c6996ec12017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-869ROSUVASTATIN CALCIUM TABLET, FILM COATED [PROFICIENT RX LP]3Legacy NDC20191113_9e8e4b93-31ef-41eb-a1ed-3d351ae6ca72.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-869-606318708696060 TABLET, FILM COATED in 1 BOTTLE (63187-869-60) 2017-07-030000-00-00NoNoCurrent