Home NDC 43353-289 CRESTOR
Product NDC 43353-289
11-digit product format 433530289
Labeler code 43353
Product ID 43353-289_0291bd29-faa4-4aa9-83f6-7cb28c229413
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Rosuvastatin calcium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application NDA021366
Marketing category NDA
Marketing start 2003-08-18
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 No
Listing certified through 2019-12-31
Current FDA listing Historical FDA.report record 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 2 · 105 matching rows.
View current auxiliary records. · View the auxiliary file history.
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-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 · 168 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 2026-08-18 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…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021366-002 CRESTOR EQ 5MG BASE TABLET / ORAL AB RLD 2003-08-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021366-003 CRESTOR EQ 10MG BASE TABLET / ORAL AB RLD 2003-08-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021366-004 CRESTOR EQ 20MG BASE TABLET / ORAL AB RLD 2003-08-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021366-005 CRESTOR EQ 40MG BASE TABLET / ORAL AB RLD, RS 2003-08-12 d8e5a09893c0…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 168 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.
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 43353-289-15 CRESTOR 15 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 15 2 43353-289-17 CRESTOR 6030 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 6030 2 43353-289-45 CRESTOR 45 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 45 2 43353-289-91 CRESTOR 1260 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 1260 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ROSUVASTATIN CALCIUM ACTIVE INGREDIENT 83MVU38M7Q CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 ROSUVASTATIN ACTIVE MOIETY 413KH5ZJ73 CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 TRIBASIC CALCIUM PHOSPHATE INACTIVE INGREDIENT 91D9GV0Z28 CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43353-289 CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 Legacy NDC, 4 package rows 20140410_3ec57aa3-4399-46c9-9292-567d2a09df4f.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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Crestor ROSUVASTATIN AstraZeneca Pharmaceuticals LP 325a5d0e-9a72-4015-9fcd-1655fb504cee 2026-04-29 Warnings, Adverse reactions Exact identifier application applno (NDA): 021366 application number: NDA021366
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 43353-289-15 43353028915 15 in 1 BOTTLE, PLASTIC Historical 43353-289-17 43353028917 6030 in 1 BOTTLE, PLASTIC Historical 43353-289-45 43353028945 45 in 1 BOTTLE, PLASTIC Historical 43353-289-91 43353028991 1260 in 1 BOTTLE, PLASTIC Historical