Home NDC 45865-893 Rosuvastatin Calcium
Product NDC 45865-893
11-digit product format 458650893
Labeler code 45865
Product ID 45865-893_7df002ca-e0ad-24fe-e053-2991aa0ab75f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Rosuvastatin Calcium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler medsource pharmaceuticals
Application ANDA079166
Marketing category ANDA
Marketing start 2016-08-18
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 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 · 63 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 A079166-001 ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL 2016-07-19 A079166-002 ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2016-07-19 A079166-003 ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2016-07-19 A079166-004 ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2016-07-19
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 A079166-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL 2016-07-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A079166-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2016-07-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A079166-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2016-07-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A079166-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2016-07-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A079166-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL 2016-07-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079166-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2016-07-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079166-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2016-07-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079166-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2016-07-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079166-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL 2016-07-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079166-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2016-07-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079166-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2016-07-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079166-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2016-07-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A079166-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL 2016-07-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079166-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2016-07-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079166-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2016-07-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079166-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2016-07-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079166-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL 2016-07-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079166-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2016-07-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079166-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2016-07-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079166-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2016-07-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079166-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL 2016-07-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079166-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2016-07-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079166-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2016-07-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079166-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2016-07-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079166-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL 2016-07-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079166-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2016-07-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079166-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2016-07-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079166-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2016-07-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079166-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL 2016-07-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079166-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2016-07-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079166-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2016-07-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079166-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2016-07-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079166-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL 2016-07-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079166-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2016-07-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079166-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2016-07-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079166-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2016-07-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079166-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL 2016-07-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079166-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2016-07-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079166-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2016-07-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079166-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2016-07-19 d8e5a09893c0…
Observed Orange Book normalized TE history# 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 45865-893-49 Rosuvastatin Calcium 100 in 1 BOTTLE TABLET, FILM COATED 100 1 45865-893-60 Rosuvastatin Calcium 60 in 1 BOTTLE TABLET, FILM COATED 60 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 45865-893 ROSUVASTATIN CALCIUM TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] 1 Legacy NDC, 2 package rows 20181227_7defeea4-b909-bd8b-e053-2a91aa0afedd.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 45865-893-49 45865089349 100 in 1 BOTTLE Historical 45865-893-60 45865089360 60 in 1 BOTTLE Historical