Home NDC 49884-261 Rosuvastatin Calcium
Product NDC 49884-261
11-digit product format 498840261
Labeler code 49884
Product ID 49884-261_b4a8bf61-cdfd-4775-aa23-8bca571bc6a2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name rosuvastatin calcium
Dosage form TABLET
Route ORAL
Labeler Par Pharmaceutical, Inc.
Application ANDA079168
Marketing category ANDA
Marketing start 2016-07-19
Marketing end 2020-08-31
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 0000-00-00
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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 49884-261-09 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 49884-261-09 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 49884-261-09 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 49884-261-09 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 49884-261-09 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 49884-261-09 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 49884-261-09 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 49884-261-09 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 49884-261-09 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 49884-261-09 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 49884-261-09 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 49884-261-09 557ba5c1ecfa…9c80585c8c6e…
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 A079168-001 ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2016-07-19 A079168-002 ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2016-07-19 A079168-003 ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2016-07-19 A079168-004 ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2016-07-19
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 A079168-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2016-07-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A079168-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2016-07-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A079168-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2016-07-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A079168-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2016-07-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A079168-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2016-07-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079168-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2016-07-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079168-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2016-07-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079168-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2016-07-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079168-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2016-07-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079168-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2016-07-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079168-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2016-07-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079168-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2016-07-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A079168-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2016-07-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079168-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2016-07-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079168-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2016-07-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079168-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2016-07-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079168-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2016-07-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079168-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2016-07-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079168-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2016-07-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079168-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2016-07-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079168-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2016-07-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079168-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2016-07-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079168-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2016-07-19 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079168-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2016-07-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079168-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2016-07-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079168-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2016-07-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079168-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2016-07-19 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079168-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2016-07-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079168-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2016-07-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079168-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2016-07-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079168-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2016-07-19 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079168-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2016-07-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079168-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2016-07-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079168-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2016-07-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079168-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2016-07-19 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079168-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2016-07-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079168-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2016-07-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079168-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2016-07-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079168-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2016-07-19 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079168-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2016-07-19 d8e5a09893c0…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 168 observed states.
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.