Home DailyMed a3572ec4-4fea-4eac-a176-dffc5edfdaa7 National Council for Prescription Drug Programs indexing - billing unit Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer National Council for Prescription Drug Programs
Effective date 2012-07-24
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 02:22:53 Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021366-002 CRESTOR ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB RLD 2003-08-12 N021366-003 CRESTOR ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB RLD 2003-08-12 N021366-004 CRESTOR ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB RLD 2003-08-12 N021366-005 CRESTOR ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB RLD, RS 2003-08-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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 · 172 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N021366-002 CRESTOR EQ 5MG BASE TABLET / ORAL AB RLD 2003-08-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021366-003 CRESTOR EQ 10MG BASE TABLET / ORAL AB RLD 2003-08-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021366-004 CRESTOR EQ 20MG BASE TABLET / ORAL AB RLD 2003-08-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021366-005 CRESTOR EQ 40MG BASE TABLET / ORAL AB RLD, RS 2003-08-12 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021366-002 CRESTOR EQ 5MG BASE TABLET / ORAL AB RLD 2003-08-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021366-003 CRESTOR EQ 10MG BASE TABLET / ORAL AB RLD 2003-08-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021366-004 CRESTOR EQ 20MG BASE TABLET / ORAL AB RLD 2003-08-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021366-005 CRESTOR EQ 40MG BASE TABLET / ORAL AB RLD, RS 2003-08-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021366-002 CRESTOR EQ 5MG BASE TABLET / ORAL AB RLD 2003-08-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021366-003 CRESTOR EQ 10MG BASE TABLET / ORAL AB RLD 2003-08-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021366-004 CRESTOR EQ 20MG BASE TABLET / ORAL AB RLD 2003-08-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021366-005 CRESTOR EQ 40MG BASE TABLET / ORAL AB RLD, RS 2003-08-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021366-002 CRESTOR EQ 5MG BASE TABLET / ORAL AB RLD 2003-08-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021366-003 CRESTOR EQ 10MG BASE TABLET / ORAL AB RLD 2003-08-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021366-004 CRESTOR EQ 20MG BASE TABLET / ORAL AB RLD 2003-08-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021366-005 CRESTOR EQ 40MG BASE TABLET / ORAL AB RLD, RS 2003-08-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021366-002 CRESTOR EQ 5MG BASE TABLET / ORAL AB RLD 2003-08-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021366-003 CRESTOR EQ 10MG BASE TABLET / ORAL AB RLD 2003-08-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021366-004 CRESTOR EQ 20MG BASE TABLET / ORAL AB RLD 2003-08-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021366-005 CRESTOR EQ 40MG BASE TABLET / ORAL AB RLD, RS 2003-08-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021366-002 CRESTOR EQ 5MG BASE TABLET / ORAL AB RLD 2003-08-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021366-003 CRESTOR EQ 10MG BASE TABLET / ORAL AB RLD 2003-08-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021366-004 CRESTOR EQ 20MG BASE TABLET / ORAL AB RLD 2003-08-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021366-005 CRESTOR EQ 40MG BASE TABLET / ORAL AB RLD, RS 2003-08-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021366-002 CRESTOR EQ 5MG BASE TABLET / ORAL AB RLD 2003-08-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021366-003 CRESTOR EQ 10MG BASE TABLET / ORAL AB RLD 2003-08-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021366-004 CRESTOR EQ 20MG BASE TABLET / ORAL AB RLD 2003-08-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021366-005 CRESTOR EQ 40MG BASE TABLET / ORAL AB RLD, RS 2003-08-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021366-002 CRESTOR EQ 5MG BASE TABLET / ORAL AB RLD 2003-08-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021366-003 CRESTOR EQ 10MG BASE TABLET / ORAL AB RLD 2003-08-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021366-004 CRESTOR EQ 20MG BASE TABLET / ORAL AB RLD 2003-08-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021366-005 CRESTOR EQ 40MG BASE TABLET / ORAL AB RLD, RS 2003-08-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021366-002 CRESTOR EQ 5MG BASE TABLET / ORAL AB RLD 2003-08-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021366-003 CRESTOR EQ 10MG BASE TABLET / ORAL AB RLD 2003-08-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021366-004 CRESTOR EQ 20MG BASE TABLET / ORAL AB RLD 2003-08-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021366-005 CRESTOR EQ 40MG BASE TABLET / ORAL AB RLD, RS 2003-08-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021366-002 CRESTOR EQ 5MG BASE TABLET / ORAL AB RLD 2003-08-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021366-003 CRESTOR EQ 10MG BASE TABLET / ORAL AB RLD 2003-08-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021366-004 CRESTOR EQ 20MG BASE TABLET / ORAL AB RLD 2003-08-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021366-005 CRESTOR EQ 40MG BASE TABLET / ORAL AB RLD, RS 2003-08-12 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 172 observed states.
Observed Orange Book patent history# Patent history page 1 of 6 · 222 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021366-002 6858618*PED 2022-06-17 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021366-003 6858618*PED 2022-06-17 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021366-004 6858618*PED 2022-06-17 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021366-005 6858618*PED 2022-06-17 Pediatric extension 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021366-002 6858618*PED 2022-06-17 Pediatric extension 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021366-003 6858618*PED 2022-06-17 Pediatric extension 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021366-004 6858618*PED 2022-06-17 Pediatric extension 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021366-005 6858618*PED 2022-06-17 Pediatric extension 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021366-002 6858618*PED 2022-06-17 Pediatric extension 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021366-003 6858618*PED 2022-06-17 Pediatric extension 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021366-004 6858618*PED 2022-06-17 Pediatric extension 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021366-005 6858618*PED 2022-06-17 Pediatric extension 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021366-002 6316460 2020-08-04 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021366-002 6316460*PED 2021-02-04 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021366-002 6858618 2021-12-17 U-618 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021366-002 6858618 2021-12-17 U-1807 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021366-002 6858618 2021-12-17 U-1032 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021366-002 6858618*PED 2022-06-17 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021366-003 6316460 2020-08-04 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021366-003 6316460*PED 2021-02-04 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021366-003 6858618 2021-12-17 U-1032 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021366-003 6858618 2021-12-17 U-618 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021366-003 6858618 2021-12-17 U-1807 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021366-003 6858618*PED 2022-06-17 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021366-004 6316460 2020-08-04 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021366-004 6316460*PED 2021-02-04 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021366-004 6858618 2021-12-17 U-1032 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021366-004 6858618 2021-12-17 U-618 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021366-004 6858618 2021-12-17 U-1807 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021366-004 6858618*PED 2022-06-17 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021366-005 6316460 2020-08-04 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021366-005 6316460*PED 2021-02-04 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021366-005 6858618 2021-12-17 U-618 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021366-005 6858618*PED 2022-06-17 Pediatric extension 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021366-002 6858618*PED 2022-06-17 Pediatric extension bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021366-003 6858618*PED 2022-06-17 Pediatric extension bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021366-004 6858618*PED 2022-06-17 Pediatric extension bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021366-005 6858618*PED 2022-06-17 Pediatric extension bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021366-002 6316460*PED 2021-02-04 Pediatric extension 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021366-002 6858618 2021-12-17 U-618 782e0a99824c…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 100 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.