Home NDC 68180-733 ROSUVASTATIN CALCIUM
Product NDC 68180-733
11-digit product format 681800733
Labeler code 68180
Product ID 68180-733_abb25f86-915e-4e61-8221-cfebb4f71068
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ROSUVASTATIN CALCIUM
Dosage form TABLET
Route ORAL
Labeler Lupin Pharmaceuticals, Inc.
Application ANDA205587
Marketing category ANDA
Marketing start 2017-07-31
Marketing end 0000-00-00
Substance ROSUVASTATIN CALCIUM
Active strength 40 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 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 A205587-001 ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL 2017-07-31 A205587-002 ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2017-07-31 A205587-003 ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2017-07-31 A205587-004 ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2017-07-31
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 A205587-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL 2017-07-31 c2088c7a36db…2026-10-15 13:18:30 2026-09 A205587-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2017-07-31 c2088c7a36db…2026-10-15 13:18:30 2026-09 A205587-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2017-07-31 c2088c7a36db…2026-10-15 13:18:30 2026-09 A205587-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2017-07-31 c2088c7a36db…2026-09-14 22:38:34 2026-08 A205587-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL 2017-07-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 A205587-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2017-07-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 A205587-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2017-07-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 A205587-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2017-07-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 A205587-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL 2017-07-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205587-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2017-07-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205587-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2017-07-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205587-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2017-07-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A205587-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL 2017-07-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205587-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2017-07-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205587-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2017-07-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205587-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2017-07-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205587-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2017-07-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205587-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2017-07-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205587-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2017-07-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205587-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2017-07-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205587-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2017-07-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205587-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2017-07-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205587-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2017-07-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205587-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2017-07-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205587-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2017-07-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205587-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2017-07-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205587-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2017-07-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205587-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2017-07-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205587-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2017-07-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205587-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2017-07-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205587-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2017-07-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205587-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2017-07-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205587-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2017-07-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205587-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2017-07-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205587-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2017-07-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205587-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2017-07-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205587-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2017-07-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205587-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2017-07-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205587-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2017-07-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205587-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2017-07-31 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 156 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68180-733-02 ROSUVASTATIN CALCIUM 500 in 1 BOTTLE TABLET 500 7 68180-733-06 ROSUVASTATIN CALCIUM 30 in 1 BOTTLE TABLET 30 7 68180-733-09 ROSUVASTATIN CALCIUM 90 in 1 BOTTLE TABLET 90 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68180-733 ROSUVASTATIN CALCIUM TABLET [LUPIN PHARMACEUTICALS, INC.] 7 Legacy NDC, 3 package rows 20181026_f68aa10b-d6bd-4fb4-a652-fad85efdaabd.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 68180-733-02 68180073302 500 in 1 BOTTLE Historical 68180-733-06 68180073306 30 in 1 BOTTLE Historical 68180-733-09 68180073309 90 in 1 BOTTLE Historical