Home NDC 0310-7570 Crestor
Product NDC 0310-7570
11-digit product format 003107570
Labeler code 0310
Product ID 0310-7570_afc9b415-ee6f-4905-a281-13e74dcf6ce6
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 2022-05-09
Substance ROSUVASTATIN CALCIUM
Active strength 10 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 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.
Additional Listing Data#
Finished product Yes
Brand name base Crestor
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ROSUVASTATIN CALCIUM 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 83MVU38M7Q Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 8 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 859419 Internal RxNorm lookup 859421 Internal RxNorm lookup 859424 Internal RxNorm lookup 859426 Internal RxNorm lookup 859747 Internal RxNorm lookup 859749 Internal RxNorm lookup 859751 Internal RxNorm lookup 859753 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 0310-7570-90 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 0310-7570 CRESTOR (ROSUVASTATIN) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP] 12 Current NDC, Legacy NDC, 1 package rows 20240807_325a5d0e-9a72-4015-9fcd-1655fb504cee.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.
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 0310-7570-90 00310757090 90 TABLET, FILM COATED in 1 BOTTLE (0310-7570-90) 2022-05-09 0000-00-00 No No Current