Home NDC 0310-7580 Crestor
Product NDC 0310-7580
11-digit product format 003107580
Labeler code 0310
Product ID 0310-7580_ea84b28f-156f-48df-89e4-b94dbe44fa55
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Rosuvastatin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler AstraZeneca Pharmaceuticals LP
Application NDA021366
Marketing category NDA
Marketing start 2022-01-24
Substance ROSUVASTATIN CALCIUM
Active strength 20 mg/1
Pharmacologic classes HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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-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 · 176 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 2026-10-15 13:18:30 2026-09 N021366-002 CRESTOR EQ 5MG BASE TABLET / ORAL AB RLD 2003-08-12 c2088c7a36db…2026-10-15 13:18:30 2026-09 N021366-003 CRESTOR EQ 10MG BASE TABLET / ORAL AB RLD 2003-08-12 c2088c7a36db…2026-10-15 13:18:30 2026-09 N021366-004 CRESTOR EQ 20MG BASE TABLET / ORAL AB RLD 2003-08-12 c2088c7a36db…2026-10-15 13:18:30 2026-09 N021366-005 CRESTOR EQ 40MG BASE TABLET / ORAL AB RLD, RS 2003-08-12 c2088c7a36db…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…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 5 · 176 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.
Additional Listing Data#
Finished product Yes
Brand name base Crestor
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ROSUVASTATIN CALCIUM 20 mg/1
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0310-7580-90 Crestor 90 in 1 BOTTLE TABLET, FILM COATED 90 14
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0310-7580 CRESTOR (ROSUVASTATIN) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP] 12 Current NDC, Legacy NDC, 1 package rows 20240807_325a5d0e-9a72-4015-9fcd-1655fb504cee.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0310-7580-90 00310758090 90 TABLET, FILM COATED in 1 BOTTLE (0310-7580-90) 2022-01-24 0000-00-00 No No Current