Home NDC 71209-043 Rosuvastatin Calcium
Product NDC 71209-043
11-digit product format 712090043
Labeler code 71209
Product ID 71209-043_e931da38-899a-4efb-9d6c-42e3a6a1b56f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Rosuvastatin Calcium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Cadila Pharmaceuticals Limited
Application ANDA207453
Marketing category ANDA
Marketing start 2017-03-24
Substance ROSUVASTATIN CALCIUM
Active strength 5 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 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 A207453-001 ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2016-11-23 A207453-002 ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2016-11-23 A207453-003 ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2016-11-23 A207453-004 ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2016-11-23
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 A207453-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2016-11-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207453-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2016-11-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207453-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2016-11-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207453-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2016-11-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207453-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2016-11-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207453-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2016-11-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207453-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2016-11-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207453-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2016-11-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207453-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2016-11-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207453-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2016-11-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207453-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2016-11-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207453-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2016-11-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207453-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2016-11-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207453-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2016-11-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207453-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2016-11-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207453-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2016-11-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207453-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2016-11-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207453-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2016-11-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207453-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2016-11-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207453-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2016-11-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207453-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2016-11-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207453-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2016-11-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207453-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2016-11-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207453-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2016-11-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207453-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2016-11-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207453-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2016-11-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207453-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2016-11-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207453-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2016-11-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207453-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2016-11-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207453-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2016-11-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207453-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2016-11-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207453-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2016-11-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207453-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2016-11-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207453-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2016-11-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207453-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2016-11-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207453-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2016-11-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207453-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2016-11-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207453-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2016-11-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207453-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2016-11-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207453-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2016-11-23 d8e5a09893c0…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 168 observed states.
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 5 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71209-043-04 Rosuvastatin Calcium 90 in 1 BOTTLE TABLET, FILM COATED 90 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71209-043 ROSUVASTATIN CALCIUM TABLET, FILM COATED [CADILA PHARMACEUTICALS LIMITED] 10 Current NDC, Legacy NDC, 1 package rows 20240929_6802a946-a29c-4d41-997b-3c078ed8e74d.zip
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 71209-043-04 71209004304 90 TABLET, FILM COATED in 1 BOTTLE (71209-043-04) 2018-11-21 0000-00-00 No No Current