CRESTOR

Product NDC
69189-0752
11-digit product format
691890752
Labeler code
69189
Product ID
69189-0752_2e93067b-bc8b-4b88-b256-59efab5167b5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Avera McKennan Hospital
Application
NDA021366
Marketing category
NDA
Marketing start
2016-04-13
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
E
Listing certified through
2018-12-31
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 productproduct69189-0752IInactivated by FDA2026-08-17
excluded packagepackage69189-075269189-0752-1IInactivated 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 NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69189-0752-1IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69189-0752-1IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage69189-0752-1IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage69189-0752-1IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage69189-0752-1IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage69189-0752-1IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69189-0752-1IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69189-0752-1IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69189-0752-1IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage69189-0752-1IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage69189-0752-1IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage69189-0752-1IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage69189-0752-1IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage69189-0752-1IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage69189-0752-1IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage69189-0752-1IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage69189-0752-1IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage69189-0752-1IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage69189-0752-1IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage69189-0752-1IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage69189-0752-1IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage69189-0752-1EExcluded after deficient or non-compliant submission was not corrected110d247fa046…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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69189-0752-1CRESTOR1 in 1 DOSE PACKTABLET, FILM COATED11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69189-0752CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [AVERA MCKENNAN HOSPITAL]1Legacy NDC, 1 package rows20170411_598ecc9c-bfd4-4247-a2c3-bd0ce5aa20d0.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
859753CRESTOR 20 MG Oral TabletPSN598ecc9c-bfd4-4247-a2c3-bd0ce5aa20d01
859751rosuvastatin calcium 20 MG Oral TabletPSN598ecc9c-bfd4-4247-a2c3-bd0ce5aa20d01
859753rosuvastatin calcium 20 MG Oral Tablet [Crestor]SBD598ecc9c-bfd4-4247-a2c3-bd0ce5aa20d01
859751rosuvastatin calcium 20 MG Oral TabletSCD598ecc9c-bfd4-4247-a2c3-bd0ce5aa20d01
859753Crestor 20 MG Oral TabletSY598ecc9c-bfd4-4247-a2c3-bd0ce5aa20d01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
69189-0752-1691890752011 in 1 DOSE PACKHistorical