Home NDC 71335-1017 Rosuvastatin Calcium
Product NDC 71335-1017
11-digit product format 713351017
Labeler code 71335
Product ID 71335-1017_02d779d4-e291-4676-8cca-b1eb7ec20945
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Rosuvastatin Calcium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA208898
Marketing category ANDA
Marketing start 2017-11-22
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 2026-12-31
Current FDA listing Yes 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 · 10 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A208898-001 ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2017-11-22 A208898-002 ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2017-11-22 A208898-003 ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2017-11-22 A208898-004 ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2017-11-22
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 A208898-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2017-11-22 c2088c7a36db…2026-10-15 13:18:30 2026-09 A208898-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2017-11-22 c2088c7a36db…2026-10-15 13:18:30 2026-09 A208898-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2017-11-22 c2088c7a36db…2026-10-15 13:18:30 2026-09 A208898-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2017-11-22 c2088c7a36db…2026-09-14 22:38:34 2026-08 A208898-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2017-11-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A208898-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2017-11-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A208898-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2017-11-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A208898-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2017-11-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 A208898-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2017-11-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208898-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2017-11-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208898-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2017-11-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208898-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2017-11-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208898-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2017-11-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208898-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2017-11-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208898-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2017-11-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208898-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2017-11-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208898-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2017-11-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208898-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2017-11-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208898-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2017-11-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208898-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2017-11-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208898-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2017-11-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208898-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2017-11-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208898-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2017-11-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208898-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2017-11-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208898-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2017-11-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208898-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2017-11-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208898-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2017-11-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208898-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2017-11-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208898-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2017-11-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208898-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2017-11-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208898-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2017-11-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208898-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2017-11-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208898-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2017-11-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208898-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2017-11-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208898-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2017-11-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208898-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2017-11-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208898-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2017-11-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208898-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2017-11-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208898-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2017-11-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208898-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2017-11-22 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 176 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 Rosuvastatin Calcium
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ROSUVASTATIN CALCIUM 5 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 859424 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# NDC, Effective, Related label table NDC Effective Related label 71335-1017-1 2024-05-17 These highlights do not include all the information needed to use ROSUVASTATIN TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN TABLETS. ROSUVASTATIN tablets, for oral use Initial U.S. Approval: 2003 71335-1017-2 2024-05-17 These highlights do not include all the information needed to use ROSUVASTATIN TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN TABLETS. ROSUVASTATIN tablets, for oral use Initial U.S. Approval: 2003 71335-1017-3 2024-05-17 These highlights do not include all the information needed to use ROSUVASTATIN TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN TABLETS. ROSUVASTATIN tablets, for oral use Initial U.S. Approval: 2003 71335-1017-4 2024-05-17 These highlights do not include all the information needed to use ROSUVASTATIN TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN TABLETS. ROSUVASTATIN tablets, for oral use Initial U.S. Approval: 2003 71335-1017-1 2024-01-30 These highlights do not include all the information needed to use ROSUVASTATIN TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN TABLETS. ROSUVASTATIN tablets, for oral use Initial U.S. Approval: 2003 71335-1017-2 2024-01-30 These highlights do not include all the information needed to use ROSUVASTATIN TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN TABLETS. ROSUVASTATIN tablets, for oral use Initial U.S. Approval: 2003 71335-1017-3 2024-01-30 These highlights do not include all the information needed to use ROSUVASTATIN TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN TABLETS. ROSUVASTATIN tablets, for oral use Initial U.S. Approval: 2003 71335-1017-4 2024-01-30 These highlights do not include all the information needed to use ROSUVASTATIN TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN TABLETS. ROSUVASTATIN tablets, for oral use Initial U.S. Approval: 2003
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71335-1017-1 Rosuvastatin Calcium 30 in 1 BOTTLE TABLET, FILM COATED 30 9 71335-1017-2 Rosuvastatin Calcium 90 in 1 BOTTLE TABLET, FILM COATED 90 9 71335-1017-3 Rosuvastatin Calcium 28 in 1 BOTTLE TABLET, FILM COATED 28 9 71335-1017-4 Rosuvastatin Calcium 60 in 1 BOTTLE TABLET, FILM COATED 60 9 71335-1017-5 Rosuvastatin Calcium 100 in 1 BOTTLE TABLET, FILM COATED 100 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-1017 ROSUVASTATIN CALCIUM TABLET, FILM COATED [BRYANT RANCH PREPACK] 9 Current NDC, Legacy NDC, 5 package rows 20240518_d6645266-9626-430e-bf04-b6426525ae0a.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 2 of 2 · 25 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 71335-1017-1 71335101701 30 TABLET, FILM COATED in 1 BOTTLE (71335-1017-1) 2018-12-03 0000-00-00 No No Current 71335-1017-2 71335101702 90 TABLET, FILM COATED in 1 BOTTLE (71335-1017-2) 2018-12-04 0000-00-00 No No Current 71335-1017-3 71335101703 28 TABLET, FILM COATED in 1 BOTTLE (71335-1017-3) 2024-05-17 0000-00-00 No No Current 71335-1017-4 71335101704 60 TABLET, FILM COATED in 1 BOTTLE (71335-1017-4) 2024-05-17 0000-00-00 No No Current 71335-1017-5 71335101705 100 TABLET, FILM COATED in 1 BOTTLE (71335-1017-5) 2024-05-17 No No Current