Home NDC 47335-986 EZALLOR SPRINKLE
Product NDC 47335-986
11-digit product format 473350986
Labeler code 47335
Product ID 47335-986_01ae3339-db79-4759-85f9-937689743dc1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ROSUVASTATIN
Dosage form CAPSULE
Route ORAL
Labeler Sun Pharmaceutical Industries, Inc.
Application NDA208647
Marketing category NDA
Marketing start 2019-05-04
Substance ROSUVASTATIN CALCIUM
Active strength 20 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 N208647-001 EZALLOR SPRINKLE ROSUVASTATIN CALCIUM EQ 5MG BASE CAPSULE / ORAL RLD 2018-12-18 N208647-002 EZALLOR SPRINKLE ROSUVASTATIN CALCIUM EQ 10MG BASE CAPSULE / ORAL RLD 2018-12-18 N208647-003 EZALLOR SPRINKLE ROSUVASTATIN CALCIUM EQ 20MG BASE CAPSULE / ORAL RLD 2018-12-18 N208647-004 EZALLOR SPRINKLE ROSUVASTATIN CALCIUM EQ 40MG BASE CAPSULE / ORAL RLD 2018-12-18
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N208647-001 10413543 2036-02-12 Drug product 2019-10-09 N208647-002 10413543 2036-02-12 Drug product 2019-10-09 N208647-003 10413543 2036-02-12 Drug product 2019-10-09 N208647-004 10413543 2036-02-12 Drug product 2019-10-09
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 N208647-001 EZALLOR SPRINKLE EQ 5MG BASE CAPSULE / ORAL RLD 2018-12-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208647-002 EZALLOR SPRINKLE EQ 10MG BASE CAPSULE / ORAL RLD 2018-12-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208647-003 EZALLOR SPRINKLE EQ 20MG BASE CAPSULE / ORAL RLD 2018-12-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208647-004 EZALLOR SPRINKLE EQ 40MG BASE CAPSULE / ORAL RLD 2018-12-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208647-001 EZALLOR SPRINKLE EQ 5MG BASE CAPSULE / ORAL RLD 2018-12-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208647-002 EZALLOR SPRINKLE EQ 10MG BASE CAPSULE / ORAL RLD 2018-12-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208647-003 EZALLOR SPRINKLE EQ 20MG BASE CAPSULE / ORAL RLD 2018-12-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208647-004 EZALLOR SPRINKLE EQ 40MG BASE CAPSULE / ORAL RLD 2018-12-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208647-001 EZALLOR SPRINKLE EQ 5MG BASE CAPSULE / ORAL RLD 2018-12-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208647-002 EZALLOR SPRINKLE EQ 10MG BASE CAPSULE / ORAL RLD 2018-12-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208647-003 EZALLOR SPRINKLE EQ 20MG BASE CAPSULE / ORAL RLD 2018-12-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208647-004 EZALLOR SPRINKLE EQ 40MG BASE CAPSULE / ORAL RLD 2018-12-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208647-001 EZALLOR SPRINKLE EQ 5MG BASE CAPSULE / ORAL RLD 2018-12-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208647-002 EZALLOR SPRINKLE EQ 10MG BASE CAPSULE / ORAL RLD 2018-12-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208647-003 EZALLOR SPRINKLE EQ 20MG BASE CAPSULE / ORAL RLD 2018-12-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208647-004 EZALLOR SPRINKLE EQ 40MG BASE CAPSULE / ORAL RLD 2018-12-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208647-001 EZALLOR SPRINKLE EQ 5MG BASE CAPSULE / ORAL RLD 2018-12-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208647-002 EZALLOR SPRINKLE EQ 10MG BASE CAPSULE / ORAL RLD 2018-12-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208647-003 EZALLOR SPRINKLE EQ 20MG BASE CAPSULE / ORAL RLD 2018-12-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208647-004 EZALLOR SPRINKLE EQ 40MG BASE CAPSULE / ORAL RLD 2018-12-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208647-001 EZALLOR SPRINKLE EQ 5MG BASE CAPSULE / ORAL RLD 2018-12-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208647-002 EZALLOR SPRINKLE EQ 10MG BASE CAPSULE / ORAL RLD 2018-12-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208647-003 EZALLOR SPRINKLE EQ 20MG BASE CAPSULE / ORAL RLD 2018-12-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208647-004 EZALLOR SPRINKLE EQ 40MG BASE CAPSULE / ORAL RLD 2018-12-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208647-001 EZALLOR SPRINKLE EQ 5MG BASE CAPSULE / ORAL RLD 2018-12-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208647-002 EZALLOR SPRINKLE EQ 10MG BASE CAPSULE / ORAL RLD 2018-12-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208647-003 EZALLOR SPRINKLE EQ 20MG BASE CAPSULE / ORAL RLD 2018-12-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208647-004 EZALLOR SPRINKLE EQ 40MG BASE CAPSULE / ORAL RLD 2018-12-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208647-001 EZALLOR SPRINKLE EQ 5MG BASE CAPSULE / ORAL RLD 2018-12-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208647-002 EZALLOR SPRINKLE EQ 10MG BASE CAPSULE / ORAL RLD 2018-12-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208647-003 EZALLOR SPRINKLE EQ 20MG BASE CAPSULE / ORAL RLD 2018-12-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208647-004 EZALLOR SPRINKLE EQ 40MG BASE CAPSULE / ORAL RLD 2018-12-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208647-001 EZALLOR SPRINKLE EQ 5MG BASE CAPSULE / ORAL RLD 2018-12-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208647-002 EZALLOR SPRINKLE EQ 10MG BASE CAPSULE / ORAL RLD 2018-12-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208647-003 EZALLOR SPRINKLE EQ 20MG BASE CAPSULE / ORAL RLD 2018-12-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208647-004 EZALLOR SPRINKLE EQ 40MG BASE CAPSULE / ORAL RLD 2018-12-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208647-001 EZALLOR SPRINKLE EQ 5MG BASE CAPSULE / ORAL RLD 2018-12-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208647-002 EZALLOR SPRINKLE EQ 10MG BASE CAPSULE / ORAL RLD 2018-12-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208647-003 EZALLOR SPRINKLE EQ 20MG BASE CAPSULE / ORAL RLD 2018-12-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208647-004 EZALLOR SPRINKLE EQ 40MG BASE CAPSULE / ORAL RLD 2018-12-18 d8e5a09893c0…
Observed Orange Book patent history# Patent history page 1 of 4 · 160 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N208647-001 10413543 2036-02-12 Drug product 2019-10-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208647-002 10413543 2036-02-12 Drug product 2019-10-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208647-003 10413543 2036-02-12 Drug product 2019-10-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208647-004 10413543 2036-02-12 Drug product 2019-10-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208647-001 10413543 2036-02-12 Drug product 2019-10-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208647-002 10413543 2036-02-12 Drug product 2019-10-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208647-003 10413543 2036-02-12 Drug product 2019-10-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208647-004 10413543 2036-02-12 Drug product 2019-10-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208647-001 10413543 2036-02-12 Drug product 2019-10-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208647-002 10413543 2036-02-12 Drug product 2019-10-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208647-003 10413543 2036-02-12 Drug product 2019-10-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208647-004 10413543 2036-02-12 Drug product 2019-10-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208647-001 10413543 2036-02-12 Drug product 2019-10-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208647-002 10413543 2036-02-12 Drug product 2019-10-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208647-003 10413543 2036-02-12 Drug product 2019-10-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208647-004 10413543 2036-02-12 Drug product 2019-10-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208647-001 10413543 2036-02-12 Drug product 2019-10-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208647-002 10413543 2036-02-12 Drug product 2019-10-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208647-003 10413543 2036-02-12 Drug product 2019-10-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208647-004 10413543 2036-02-12 Drug product 2019-10-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208647-001 10413543 2036-02-12 Drug product 2019-10-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208647-002 10413543 2036-02-12 Drug product 2019-10-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208647-003 10413543 2036-02-12 Drug product 2019-10-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208647-004 10413543 2036-02-12 Drug product 2019-10-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208647-001 10413543 2036-02-12 Drug product 2019-10-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208647-002 10413543 2036-02-12 Drug product 2019-10-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208647-003 10413543 2036-02-12 Drug product 2019-10-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208647-004 10413543 2036-02-12 Drug product 2019-10-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208647-001 10413543 2036-02-12 Drug product 2019-10-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208647-002 10413543 2036-02-12 Drug product 2019-10-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208647-003 10413543 2036-02-12 Drug product 2019-10-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208647-004 10413543 2036-02-12 Drug product 2019-10-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208647-001 10413543 2036-02-12 Drug product 2019-10-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208647-002 10413543 2036-02-12 Drug product 2019-10-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208647-003 10413543 2036-02-12 Drug product 2019-10-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208647-004 10413543 2036-02-12 Drug product 2019-10-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208647-001 10413543 2036-02-12 Drug product 2019-10-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208647-002 10413543 2036-02-12 Drug product 2019-10-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208647-003 10413543 2036-02-12 Drug product 2019-10-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208647-004 10413543 2036-02-12 Drug product 2019-10-09 d8e5a09893c0…
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 47335-986-60 EZALLOR SPRINKLE 10 in 1 BLISTER PACK CAPSULE 10 13 47335-986-64 EZALLOR SPRINKLE 3 in 1 CARTON CAPSULE 3 13 47335-986-81 EZALLOR SPRINKLE 90 in 1 BOTTLE CAPSULE 90 13 47335-986-83 EZALLOR SPRINKLE 30 in 1 BOTTLE CAPSULE 30 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 47335-986 EZALLOR SPRINKLE (ROSUVASTATIN) CAPSULE [SUN PHARMACEUTICAL INDUSTRIES, INC.] 13 Current NDC, Legacy NDC, 4 package rows 20250402_619add8c-3e39-4bb7-8828-450bd82c0404.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 47335-986-60 47335098660 10 in 1 BLISTER PACK Historical 47335-986-64 47335098664 3 BLISTER PACK in 1 CARTON (47335-986-64) / 10 CAPSULE in 1 BLISTER PACK (47335-986-60) 3 blister pack 2019-05-04 0000-00-00 No No Current 47335-986-81 47335098681 90 CAPSULE in 1 BOTTLE (47335-986-81) 90 capsule 2019-05-04 0000-00-00 No No Current 47335-986-83 47335098683 30 CAPSULE in 1 BOTTLE (47335-986-83) 30 capsule 2019-05-04 0000-00-00 No No Current