CRESTOR

Product NDC
63629-4372
11-digit product format
636294372
Labeler code
63629
Product ID
63629-4372_9a087c00-02c9-48a4-84a5-d215ca9f5101
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
NDA021366
Marketing category
NDA
Marketing start
2003-08-18
Marketing end
0000-00-00
Substance
ROSUVASTATIN CALCIUM
Active strength
5 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63629-4372DDiscontinued by firm2026-10-16
excluded packagepackage63629-437263629-4372-1DDiscontinued by firm2026-10-16
excluded packagepackage63629-437263629-4372-2DDiscontinued by firm2026-10-16
excluded packagepackage63629-437263629-4372-3DDiscontinued by firm2026-10-16

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 · 50 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 productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-4372-3DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-4372-1DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-4372-2DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-4372-3DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-4372-1DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-4372-2DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-4372-3DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-4372-1DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-4372-2DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-4372-3DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-4372-1DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-4372-2DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-4372-3DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-4372-1DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-4372-2DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-4372-3DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-4372-1DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-4372-2DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-4372-3DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-4372-1DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-4372-2DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-4372-3DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-4372-1DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-4372-2DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63629-4372-3DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63629-4372-1DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63629-4372-2DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63629-4372-3DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63629-4372-1DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63629-4372-2DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63629-4372-3DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63629-4372-1DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63629-4372-2DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63629-4372-3DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63629-4372-1DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63629-4372-2DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage63629-4372-1IInactivated by FDA9bebd1f3094a…5416666fcb17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 176 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N021366-002CRESTOREQ 5MG BASETABLET / ORALABRLD2003-08-12c2088c7a36db…
2026-10-15 13:18:302026-09N021366-003CRESTOREQ 10MG BASETABLET / ORALABRLD2003-08-12c2088c7a36db…
2026-10-15 13:18:302026-09N021366-004CRESTOREQ 20MG BASETABLET / ORALABRLD2003-08-12c2088c7a36db…
2026-10-15 13:18:302026-09N021366-005CRESTOREQ 40MG BASETABLET / ORALABRLD, RS2003-08-12c2088c7a36db…
2026-09-14 22:38:342026-08N021366-002CRESTOREQ 5MG BASETABLET / ORALABRLD2003-08-1284e616aacf4f…
2026-09-14 22:38:342026-08N021366-003CRESTOREQ 10MG BASETABLET / ORALABRLD2003-08-1284e616aacf4f…
2026-09-14 22:38:342026-08N021366-004CRESTOREQ 20MG BASETABLET / ORALABRLD2003-08-1284e616aacf4f…
2026-09-14 22:38:342026-08N021366-005CRESTOREQ 40MG BASETABLET / ORALABRLD, RS2003-08-1284e616aacf4f…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 4 of 5 · 176 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021366-002AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021366-003AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021366-004AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021366-005AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021366-002AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02N021366-003AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02N021366-004AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02N021366-005AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021366-002AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12N021366-003AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12N021366-004AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12N021366-005AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021366-002AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021366-003AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021366-004AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021366-005AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021366-002AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021366-003AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021366-004AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021366-005AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021366-002AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021366-003AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021366-004AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021366-005AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021366-002AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021366-003AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021366-004AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021366-005AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N021366-002AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05N021366-003AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05N021366-004AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05N021366-005AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N021366-002AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01N021366-003AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01N021366-004AB13bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01N021366-005AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021366-002AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021366-003AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021366-004AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021366-005AB13a93d1ddd44b…

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…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-4372-16362943720130 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63629-4372-1) 2010-12-010000-00-00NoNoCurrent
63629-4372-26362943720260 TABLET, FILM COATED in 1 BOTTLE (63629-4372-2) 2010-11-090000-00-00NoNoCurrent
63629-4372-36362943720390 TABLET, FILM COATED in 1 BOTTLE (63629-4372-3) 2010-11-090000-00-00NoNoCurrent