Crestor

Product NDC
21695-659
11-digit product format
216950659
Labeler code
21695
Product ID
21695-659_3bf80420-7482-44c0-a117-30793ba89544
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rebel Distributors Corp
Application
NDA021366
Marketing category
NDA
Marketing start
2004-11-01
Marketing end
0000-00-00
Substance
ROSUVASTATIN CALCIUM
Active strength
40 mg/1
NDC exclude flag
E
Listing certified through
2017-12-31
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 productproduct21695-659IInactivated by FDA2026-08-17
excluded packagepackage21695-65921695-659-30IInactivated 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 · 44 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 packagepackage21695-659-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-659-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-659-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-659-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-659-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-659-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-659-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-659-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-659-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage21695-659-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage21695-659-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage21695-659-30557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage21695-659-308af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage21695-659-30834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage21695-659-301332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage21695-659-30fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage21695-659-3086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage21695-659-30bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage21695-659-308dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage21695-659-30e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage21695-659-309bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage21695-659-30110d247fa046…a55b01930146…

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
N021366-002CRESTORROSUVASTATIN CALCIUMEQ 5MG BASETABLET / ORALABRLD2003-08-12
N021366-003CRESTORROSUVASTATIN CALCIUMEQ 10MG BASETABLET / ORALABRLD2003-08-12
N021366-004CRESTORROSUVASTATIN CALCIUMEQ 20MG BASETABLET / ORALABRLD2003-08-12
N021366-005CRESTORROSUVASTATIN CALCIUMEQ 40MG BASETABLET / ORALABRLD, RS2003-08-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
N021366-002AB
N021366-003AB
N021366-004AB
N021366-005AB

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 06:07:402026-07N021366-002CRESTOREQ 5MG BASETABLET / ORALABRLD2003-08-12caaa826d4ba7…
2026-08-18 06:07:402026-07N021366-003CRESTOREQ 10MG BASETABLET / ORALABRLD2003-08-12caaa826d4ba7…
2026-08-18 06:07:402026-07N021366-004CRESTOREQ 20MG BASETABLET / ORALABRLD2003-08-12caaa826d4ba7…
2026-08-18 06:07:402026-07N021366-005CRESTOREQ 40MG BASETABLET / ORALABRLD, RS2003-08-12caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021366-002CRESTOREQ 5MG BASETABLET / ORALABRLD2003-08-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021366-003CRESTOREQ 10MG BASETABLET / ORALABRLD2003-08-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021366-004CRESTOREQ 20MG BASETABLET / ORALABRLD2003-08-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021366-005CRESTOREQ 40MG BASETABLET / ORALABRLD, RS2003-08-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021366-002CRESTOREQ 5MG BASETABLET / ORALABRLD2003-08-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021366-003CRESTOREQ 10MG BASETABLET / ORALABRLD2003-08-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021366-004CRESTOREQ 20MG BASETABLET / ORALABRLD2003-08-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021366-005CRESTOREQ 40MG BASETABLET / ORALABRLD, RS2003-08-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08N021366-002CRESTOREQ 5MG BASETABLET / ORALABRLD2003-08-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021366-003CRESTOREQ 10MG BASETABLET / ORALABRLD2003-08-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021366-004CRESTOREQ 20MG BASETABLET / ORALABRLD2003-08-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021366-005CRESTOREQ 40MG BASETABLET / ORALABRLD, RS2003-08-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021366-002CRESTOREQ 5MG BASETABLET / ORALABRLD2003-08-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021366-003CRESTOREQ 10MG BASETABLET / ORALABRLD2003-08-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021366-004CRESTOREQ 20MG BASETABLET / ORALABRLD2003-08-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021366-005CRESTOREQ 40MG BASETABLET / ORALABRLD, RS2003-08-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021366-002CRESTOREQ 5MG BASETABLET / ORALABRLD2003-08-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021366-003CRESTOREQ 10MG BASETABLET / ORALABRLD2003-08-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021366-004CRESTOREQ 20MG BASETABLET / ORALABRLD2003-08-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021366-005CRESTOREQ 40MG BASETABLET / ORALABRLD, RS2003-08-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021366-002CRESTOREQ 5MG BASETABLET / ORALABRLD2003-08-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021366-003CRESTOREQ 10MG BASETABLET / ORALABRLD2003-08-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021366-004CRESTOREQ 20MG BASETABLET / ORALABRLD2003-08-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021366-005CRESTOREQ 40MG BASETABLET / ORALABRLD, RS2003-08-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021366-002CRESTOREQ 5MG BASETABLET / ORALABRLD2003-08-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021366-003CRESTOREQ 10MG BASETABLET / ORALABRLD2003-08-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021366-004CRESTOREQ 20MG BASETABLET / ORALABRLD2003-08-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021366-005CRESTOREQ 40MG BASETABLET / ORALABRLD, RS2003-08-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021366-002CRESTOREQ 5MG BASETABLET / ORALABRLD2003-08-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021366-003CRESTOREQ 10MG BASETABLET / ORALABRLD2003-08-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021366-004CRESTOREQ 20MG BASETABLET / ORALABRLD2003-08-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021366-005CRESTOREQ 40MG BASETABLET / ORALABRLD, RS2003-08-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021366-002CRESTOREQ 5MG BASETABLET / ORALABRLD2003-08-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021366-003CRESTOREQ 10MG BASETABLET / ORALABRLD2003-08-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021366-004CRESTOREQ 20MG BASETABLET / ORALABRLD2003-08-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021366-005CRESTOREQ 40MG BASETABLET / ORALABRLD, RS2003-08-12d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N021366-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N021366-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N021366-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N021366-005AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021366-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021366-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021366-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021366-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021366-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021366-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021366-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021366-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021366-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021366-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021366-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021366-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021366-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021366-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021366-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021366-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021366-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021366-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021366-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021366-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021366-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021366-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021366-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021366-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021366-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021366-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021366-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021366-005AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021366-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021366-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021366-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021366-005AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021366-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021366-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021366-004AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021366-005AB1d8e5a09893c0…

Observed Orange Book patent history#

Patent history page 1 of 6 · 222 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021366-0026858618*PED2022-06-17Pediatric extension5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021366-0036858618*PED2022-06-17Pediatric extension5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021366-0046858618*PED2022-06-17Pediatric extension5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021366-0056858618*PED2022-06-17Pediatric extension5c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021366-0026858618*PED2022-06-17Pediatric extension5d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021366-0036858618*PED2022-06-17Pediatric extension5d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021366-0046858618*PED2022-06-17Pediatric extension5d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021366-0056858618*PED2022-06-17Pediatric extension5d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021366-0026858618*PED2022-06-17Pediatric extension4b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021366-0036858618*PED2022-06-17Pediatric extension4b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021366-0046858618*PED2022-06-17Pediatric extension4b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021366-0056858618*PED2022-06-17Pediatric extension4b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021366-00263164602020-08-04Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021366-0026316460*PED2021-02-04Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021366-00268586182021-12-17U-61874a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021366-00268586182021-12-17U-180774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021366-00268586182021-12-17U-103274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021366-0026858618*PED2022-06-17Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021366-00363164602020-08-04Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021366-0036316460*PED2021-02-04Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021366-00368586182021-12-17U-103274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021366-00368586182021-12-17U-61874a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021366-00368586182021-12-17U-180774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021366-0036858618*PED2022-06-17Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021366-00463164602020-08-04Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021366-0046316460*PED2021-02-04Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021366-00468586182021-12-17U-103274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021366-00468586182021-12-17U-61874a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021366-00468586182021-12-17U-180774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021366-0046858618*PED2022-06-17Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021366-00563164602020-08-04Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021366-0056316460*PED2021-02-04Pediatric extension74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021366-00568586182021-12-17U-61874a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021366-0056858618*PED2022-06-17Pediatric extension74a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021366-0026858618*PED2022-06-17Pediatric extensionbb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021366-0036858618*PED2022-06-17Pediatric extensionbb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021366-0046858618*PED2022-06-17Pediatric extensionbb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021366-0056858618*PED2022-06-17Pediatric extensionbb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021366-0026316460*PED2021-02-04Pediatric extension782e0a99824c…
2021-12-28 21:50 UTC2021-12N021366-00268586182021-12-17U-618782e0a99824c…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 100 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021366-002ODE-1182023-05-275c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021366-003ODE-1182023-05-275c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021366-004ODE-1182023-05-275c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021366-005ODE-1182023-05-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021366-002ODE-1182023-05-275d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021366-003ODE-1182023-05-275d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021366-004ODE-1182023-05-275d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021366-005ODE-1182023-05-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021366-002ODE-1182023-05-274b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021366-003ODE-1182023-05-274b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021366-004ODE-1182023-05-274b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021366-005ODE-1182023-05-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021366-002ODE-1182023-05-2774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021366-003ODE-1182023-05-2774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021366-004I-7322019-05-2774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021366-004ODE-1182023-05-2774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021366-005ODE-1182023-05-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021366-002ODE-1182023-05-27bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021366-003ODE-1182023-05-27bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021366-004ODE-1182023-05-27bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021366-005ODE-1182023-05-27bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021366-002ODE-1182023-05-27782e0a99824c…
2021-12-28 21:50 UTC2021-12N021366-003ODE-1182023-05-27782e0a99824c…
2021-12-28 21:50 UTC2021-12N021366-004ODE-1182023-05-27782e0a99824c…
2021-12-28 21:50 UTC2021-12N021366-005ODE-1182023-05-27782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021366-002ODE-1182023-05-2787673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021366-003ODE-1182023-05-2787673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021366-004ODE-1182023-05-2787673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021366-005ODE-1182023-05-2787673890dc5c…
2021-03-12 10:30 UTC2021-03N021366-002ODE-1182023-05-275aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021366-003ODE-1182023-05-275aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021366-004ODE-1182023-05-275aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021366-005ODE-1182023-05-275aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021366-002ODE-1182023-05-278869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021366-003ODE-1182023-05-278869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021366-004ODE-1182023-05-278869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021366-005ODE-1182023-05-278869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021366-002ODE-1182023-05-27c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021366-003ODE-1182023-05-27c0c555d07b60…
2020-11-12 02:37 UTC2020-11N021366-004ODE-1182023-05-27c0c555d07b60…

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
21695-659-302019-09-24C16284748780-1934fe258-4848-48b1-e053-8cdaa90a720a3bf80420-7482-44c0-a117-30793ba89544

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-659-30Crestor30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-659-30EA - Each21695-65933126a33-424b-4b5d-8b8e-4c5086f9225112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ROSUVASTATIN CALCIUMACTIVE INGREDIENT83MVU38M7QCRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
ROSUVASTATIN CALCIUMACTIVE MOIETY83MVU38M7QCRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
TRIACETININACTIVE INGREDIENTXHX3C3X673CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
TRIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENT91D9GV0Z28CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-659CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20110622_3bf80420-7482-44c0-a117-30793ba89544.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CrestorROSUVASTATINAstraZeneca Pharmaceuticals LP325a5d0e-9a72-4015-9fcd-1655fb504cee2026-04-29Warnings, Adverse reactionsExact identifier
application applno (NDA): 021366
application number: NDA021366

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859749CRESTOR 10 MG Oral TabletPSN3bf80420-7482-44c0-a117-30793ba895441
859753CRESTOR 20 MG Oral TabletPSN3bf80420-7482-44c0-a117-30793ba895441
859421CRESTOR 40 MG Oral TabletPSN3bf80420-7482-44c0-a117-30793ba895441
859426CRESTOR 5 MG Oral TabletPSN3bf80420-7482-44c0-a117-30793ba895441
859747rosuvastatin calcium 10 MG Oral TabletPSN3bf80420-7482-44c0-a117-30793ba895441
859751rosuvastatin calcium 20 MG Oral TabletPSN3bf80420-7482-44c0-a117-30793ba895441
859419rosuvastatin calcium 40 MG Oral TabletPSN3bf80420-7482-44c0-a117-30793ba895441
859424rosuvastatin calcium 5 MG Oral TabletPSN3bf80420-7482-44c0-a117-30793ba895441
859749rosuvastatin calcium 10 MG Oral Tablet [Crestor]SBD3bf80420-7482-44c0-a117-30793ba895441
859753rosuvastatin calcium 20 MG Oral Tablet [Crestor]SBD3bf80420-7482-44c0-a117-30793ba895441
859421rosuvastatin calcium 40 MG Oral Tablet [Crestor]SBD3bf80420-7482-44c0-a117-30793ba895441
859426rosuvastatin calcium 5 MG Oral Tablet [Crestor]SBD3bf80420-7482-44c0-a117-30793ba895441
859747rosuvastatin calcium 10 MG Oral TabletSCD3bf80420-7482-44c0-a117-30793ba895441
859751rosuvastatin calcium 20 MG Oral TabletSCD3bf80420-7482-44c0-a117-30793ba895441
859419rosuvastatin calcium 40 MG Oral TabletSCD3bf80420-7482-44c0-a117-30793ba895441
859424rosuvastatin calcium 5 MG Oral TabletSCD3bf80420-7482-44c0-a117-30793ba895441
859749Crestor 10 MG Oral TabletSY3bf80420-7482-44c0-a117-30793ba895441
859753Crestor 20 MG Oral TabletSY3bf80420-7482-44c0-a117-30793ba895441
859421Crestor 40 MG Oral TabletSY3bf80420-7482-44c0-a117-30793ba895441
859426Crestor 5 MG Oral TabletSY3bf80420-7482-44c0-a117-30793ba895441

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-659-302169506593030 in 1 BOTTLEHistorical