Home NDC 43547-592-09 Rosuvastatin Calcium
Product NDC 43547-592
Requested package NDC 43547-592-09
11-digit product format 435470592
Labeler code 43547
Product ID 43547-592_ab55fc1d-c567-40bc-acbf-089c5a0cc091
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name rosuvastatin calcium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Solco Healthcare LLC
Application ANDA212059
Marketing category ANDA
Marketing start 2021-03-10
Marketing end 0000-00-00
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 2022-12-31
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 1 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…
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.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 43547-592-09 43547059209 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-592-09) 2021-03-10 0000-00-00 No No Current