Home NDC 69434-005 Rosuvastatin Calcium
Product NDC 69434-005
11-digit product format 694340005
Labeler code 69434
Product ID 69434-005_f378d351-0576-4496-baca-a2858712bc5c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name rosuvastatin calcium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Zhejiang Yongtai Pharmaceutical Co., Ltd.
Application ANDA212059
Marketing category ANDA
Marketing start 2026-08-01
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 2027-12-31
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 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A212059-001 ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2019-11-04 A212059-002 ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2019-11-04 A212059-003 ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2019-11-04 A212059-004 ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2019-11-04
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 · 164 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 A212059-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2019-11-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 A212059-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2019-11-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 A212059-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2019-11-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 A212059-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2019-11-04 84e616aacf4f…2026-08-18 06:07:40 2026-07 A212059-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2019-11-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A212059-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2019-11-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A212059-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2019-11-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A212059-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2019-11-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212059-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2019-11-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212059-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2019-11-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212059-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2019-11-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212059-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2019-11-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212059-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2019-11-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212059-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2019-11-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212059-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2019-11-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212059-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2019-11-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212059-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2019-11-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212059-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2019-11-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212059-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2019-11-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212059-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2019-11-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212059-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2019-11-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212059-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2019-11-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212059-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2019-11-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212059-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2019-11-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212059-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2019-11-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212059-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2019-11-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212059-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2019-11-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212059-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2019-11-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212059-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2019-11-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212059-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2019-11-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212059-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2019-11-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212059-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2019-11-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212059-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2019-11-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212059-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2019-11-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212059-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2019-11-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212059-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2019-11-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212059-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2019-11-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212059-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2019-11-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212059-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2019-11-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212059-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2019-11-04 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 152 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 2027-12-31 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 859419 Internal RxNorm lookup 859424 Internal RxNorm lookup 859747 Internal RxNorm lookup 859751 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 69434-005-02 2025-02-28 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 69434-005-02 2025-02-28 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 69434-005-03 2025-02-28 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 69434-005-03 2025-02-28 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 69434-005-02 2022-01-28 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 69434-005-02 2022-01-28 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 69434-005-03 2022-01-28 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 69434-005-03 2022-01-28 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 69434-005-02 Rosuvastatin Calcium 90 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 90 10 69434-005-03 Rosuvastatin Calcium 500 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 500 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69434-005 ROSUVASTATIN CALCIUM TABLET, FILM COATED [ZHEJIANG YONGTAI PHARMACEUTICAL CO., LTD.] 9 Current NDC, Legacy NDC, 2 package rows 20250303_40c2900e-4659-49ce-ba4b-5df529b3c53b.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 69434-005-02 69434000502 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69434-005-02) 2026-08-01 0000-00-00 No No Current 69434-005-03 69434000503 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69434-005-03) 2026-08-01 0000-00-00 No No Current