Home NDC 33342-261 Rosuvastatin
Product NDC 33342-261
11-digit product format 333420261
Labeler code 33342
Product ID 33342-261_d7b9f280-bda6-40d4-9778-e45efb87ab23
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Rosuvastatin
Dosage form TABLET
Route ORAL
Labeler Macleods Pharmaceuticals Limited
Application ANDA207296
Marketing category ANDA
Marketing start 2024-11-06
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 2026-12-31
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 A207296-001 ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL 2024-11-06 A207296-002 ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2024-11-06 A207296-003 ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2024-11-06 A207296-004 ROSUVASTATIN CALCIUM ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2024-11-06
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.
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 A207296-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL 2024-11-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207296-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2024-11-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207296-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2024-11-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207296-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2024-11-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207296-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL 2024-11-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207296-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2024-11-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207296-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2024-11-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207296-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2024-11-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207296-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL 2024-11-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207296-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2024-11-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207296-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2024-11-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207296-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2024-11-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207296-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL 2024-11-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207296-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2024-11-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207296-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2024-11-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207296-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2024-11-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207296-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2024-11-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207296-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2024-11-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207296-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2024-11-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207296-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2024-11-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207296-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2024-11-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207296-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2024-11-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207296-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2024-11-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207296-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2024-11-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207296-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2024-11-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207296-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2024-11-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207296-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2024-11-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207296-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2024-11-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207296-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2024-11-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207296-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2024-11-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207296-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2024-11-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207296-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2024-11-06 2680178bc6a6…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207296-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL AB 2024-11-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207296-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL AB 2024-11-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207296-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL AB 2024-11-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207296-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL AB 2024-11-06 d8e5a09893c0…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A207296-001 ROSUVASTATIN CALCIUM EQ 5MG BASE TABLET / ORAL 2024-11-06 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A207296-002 ROSUVASTATIN CALCIUM EQ 10MG BASE TABLET / ORAL 2024-11-06 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A207296-003 ROSUVASTATIN CALCIUM EQ 20MG BASE TABLET / ORAL 2024-11-06 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A207296-004 ROSUVASTATIN CALCIUM EQ 40MG BASE TABLET / ORAL 2024-11-06 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Rosuvastatin
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 33342-261-07 Rosuvastatin 30 in 1 CONTAINER TABLET 30 1 33342-261-10 Rosuvastatin 90 in 1 CONTAINER TABLET 90 1 33342-261-12 Rosuvastatin 10 in 1 BLISTER PACK TABLET 10 1 33342-261-12 Rosuvastatin 10 in 1 CARTON TABLET 10 1 33342-261-44 Rosuvastatin 1000 in 1 CONTAINER TABLET 1000 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 33342-261 ROSUVASTATIN TABLET [MACLEODS PHARMACEUTICALS LIMITED] 1 Current NDC, 5 package rows 20241128_d7b9f280-bda6-40d4-9778-e45efb87ab23.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 Units Marketing start Sample Exclude flag Status 33342-261-07 33342026107 30 TABLET in 1 CONTAINER (33342-261-07) 30 tablet 2024-11-06 No No Current 33342-261-10 33342026110 90 TABLET in 1 CONTAINER (33342-261-10) 90 tablet 2024-11-06 No No Current 33342-261-12 33342026112 10 BLISTER PACK in 1 CARTON (33342-261-12) / 10 TABLET in 1 BLISTER PACK 10 blister pack 2024-11-06 No No Current 33342-261-44 33342026144 1000 TABLET in 1 CONTAINER (33342-261-44) 1000 tablet 2024-11-06 No No Current