Home NDC 72303-0828 Rosuvastatin calcium
Product NDC 72303-0828
11-digit product format 723030828
Labeler code 72303
Product ID 72303-0828_57a6409f-9fd1-54ae-e063-6294a90ae490
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Rosuvastatin calcium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler HEC Pharm USA Inc.
Application ANDA210667
Marketing category ANDA
Marketing start 2026-07-01
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 2027-12-31
Current FDA listing Yes 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 A210667-001 ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2020-04-01 A210667-002 ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2020-04-01 A210667-003 ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2020-04-01 A210667-004 ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2020-04-01
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 4 · 156 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 A210667-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2020-04-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 A210667-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2020-04-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 A210667-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2020-04-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 A210667-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2020-04-01 84e616aacf4f…2026-08-18 06:07:40 2026-07 A210667-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2020-04-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210667-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2020-04-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210667-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2020-04-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210667-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2020-04-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210667-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL 2020-04-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210667-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2020-04-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210667-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2020-04-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210667-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2020-04-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210667-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL 2020-04-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210667-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2020-04-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210667-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2020-04-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210667-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2020-04-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210667-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL 2020-04-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210667-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2020-04-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210667-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2020-04-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210667-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2020-04-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210667-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL 2020-04-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210667-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2020-04-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210667-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2020-04-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210667-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2020-04-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210667-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL 2020-04-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210667-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2020-04-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210667-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2020-04-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210667-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2020-04-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210667-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL 2020-04-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210667-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2020-04-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210667-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2020-04-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210667-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2020-04-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210667-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL 2020-04-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210667-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2020-04-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210667-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2020-04-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210667-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2020-04-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210667-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL 2020-04-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210667-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2020-04-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210667-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2020-04-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210667-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2020-04-01 5bbf6a4d5a75…
Observed Orange Book normalized TE history# 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 10 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.
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 Sample Exclude flag Status 72303-0828-1 72303082801 90 TABLET, FILM COATED in 1 BOTTLE (72303-0828-1) 2026-07-01 No No Current