Home NDC 55111-619 Eszopiclone
Product NDC 55111-619
11-digit product format 551110619
Labeler code 55111
Product ID 55111-619_bf1433f5-bde8-8c67-9ff7-ec5d3ed26581
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Eszopiclone
Dosage form TABLET, COATED
Route ORAL
Labeler Dr. Reddy's Laboratories Limited
Application ANDA091024
Marketing category ANDA
Marketing start 2014-04-15
Substance ESZOPICLONE
Active strength 2 mg/1
DEA schedule CIV
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 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A091024-001 ESZOPICLONE ESZOPICLONE 1MG TABLET / ORAL AB 2014-04-15 A091024-002 ESZOPICLONE ESZOPICLONE 2MG TABLET / ORAL AB 2014-04-15 A091024-003 ESZOPICLONE ESZOPICLONE 3MG TABLET / ORAL AB 2014-04-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 · 123 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 2026-02-19 14:30 UTC 2026-02 A091024-001 ESZOPICLONE 1MG TABLET / ORAL AB 2014-04-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091024-002 ESZOPICLONE 2MG TABLET / ORAL AB 2014-04-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091024-003 ESZOPICLONE 3MG TABLET / ORAL AB 2014-04-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091024-001 ESZOPICLONE 1MG TABLET / ORAL AB 2014-04-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091024-002 ESZOPICLONE 2MG TABLET / ORAL AB 2014-04-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091024-003 ESZOPICLONE 3MG TABLET / ORAL AB 2014-04-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091024-001 ESZOPICLONE 1MG TABLET / ORAL AB 2014-04-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091024-002 ESZOPICLONE 2MG TABLET / ORAL AB 2014-04-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091024-003 ESZOPICLONE 3MG TABLET / ORAL AB 2014-04-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091024-001 ESZOPICLONE 1MG TABLET / ORAL AB 2014-04-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091024-002 ESZOPICLONE 2MG TABLET / ORAL AB 2014-04-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091024-003 ESZOPICLONE 3MG TABLET / ORAL AB 2014-04-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091024-001 ESZOPICLONE 1MG TABLET / ORAL AB 2014-04-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091024-002 ESZOPICLONE 2MG TABLET / ORAL AB 2014-04-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091024-003 ESZOPICLONE 3MG TABLET / ORAL AB 2014-04-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091024-001 ESZOPICLONE 1MG TABLET / ORAL AB 2014-04-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091024-002 ESZOPICLONE 2MG TABLET / ORAL AB 2014-04-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091024-003 ESZOPICLONE 3MG TABLET / ORAL AB 2014-04-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091024-001 ESZOPICLONE 1MG TABLET / ORAL AB 2014-04-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091024-002 ESZOPICLONE 2MG TABLET / ORAL AB 2014-04-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091024-003 ESZOPICLONE 3MG TABLET / ORAL AB 2014-04-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091024-001 ESZOPICLONE 1MG TABLET / ORAL AB 2014-04-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091024-002 ESZOPICLONE 2MG TABLET / ORAL AB 2014-04-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091024-003 ESZOPICLONE 3MG TABLET / ORAL AB 2014-04-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091024-001 ESZOPICLONE 1MG TABLET / ORAL AB 2014-04-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091024-002 ESZOPICLONE 2MG TABLET / ORAL AB 2014-04-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091024-003 ESZOPICLONE 3MG TABLET / ORAL AB 2014-04-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091024-001 ESZOPICLONE 1MG TABLET / ORAL AB 2014-04-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091024-002 ESZOPICLONE 2MG TABLET / ORAL AB 2014-04-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091024-003 ESZOPICLONE 3MG TABLET / ORAL AB 2014-04-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091024-001 ESZOPICLONE 1MG TABLET / ORAL AB 2014-04-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091024-002 ESZOPICLONE 2MG TABLET / ORAL AB 2014-04-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091024-003 ESZOPICLONE 3MG TABLET / ORAL AB 2014-04-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091024-001 ESZOPICLONE 1MG TABLET / ORAL AB 2014-04-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091024-002 ESZOPICLONE 2MG TABLET / ORAL AB 2014-04-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091024-003 ESZOPICLONE 3MG TABLET / ORAL AB 2014-04-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091024-001 ESZOPICLONE 1MG TABLET / ORAL AB 2014-04-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091024-002 ESZOPICLONE 2MG TABLET / ORAL AB 2014-04-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091024-003 ESZOPICLONE 3MG TABLET / ORAL AB 2014-04-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091024-001 ESZOPICLONE 1MG TABLET / ORAL AB 2014-04-15 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Eszopiclone
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ESZOPICLONE 2 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination UZX80K71OE Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 485440 Internal RxNorm lookup 485442 Internal RxNorm lookup 485465 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 55111-619-01 Eszopiclone 100 in 1 BOTTLE TABLET, COATED 100 16 55111-619-05 Eszopiclone 500 in 1 BOTTLE TABLET, COATED 500 16 55111-619-09 Eszopiclone 9 in 1 CARTON TABLET, COATED 9 16 55111-619-30 Eszopiclone 30 in 1 BOTTLE TABLET, COATED 30 16 55111-619-79 Eszopiclone 10 in 1 BLISTER PACK TABLET, COATED 10 16 55111-619-90 Eszopiclone 90 in 1 BOTTLE TABLET, COATED 90 16
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ESZOPICLONE ACTIVE INGREDIENT UZX80K71OE ESZOPICLONE TABLET, COATED [DR. REDDY'S LABORATORIES LIMITED] 8 ESZOPICLONE ACTIVE MOIETY UZX80K71OE ESZOPICLONE TABLET, COATED [DR. REDDY'S LABORATORIES LIMITED] 8 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ESZOPICLONE TABLET, COATED [DR. REDDY'S LABORATORIES LIMITED] 8 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 ESZOPICLONE TABLET, COATED [DR. REDDY'S LABORATORIES LIMITED] 8 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK ESZOPICLONE TABLET, COATED [DR. REDDY'S LABORATORIES LIMITED] 8 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ESZOPICLONE TABLET, COATED [DR. REDDY'S LABORATORIES LIMITED] 8 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X ESZOPICLONE TABLET, COATED [DR. REDDY'S LABORATORIES LIMITED] 8 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ESZOPICLONE TABLET, COATED [DR. REDDY'S LABORATORIES LIMITED] 8 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ ESZOPICLONE TABLET, COATED [DR. REDDY'S LABORATORIES LIMITED] 8 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ESZOPICLONE TABLET, COATED [DR. REDDY'S LABORATORIES LIMITED] 8 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 ESZOPICLONE TABLET, COATED [DR. REDDY'S LABORATORIES LIMITED] 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55111-619 ESZOPICLONE TABLET, COATED [DR. REDDY'S LABORATORIES LIMITED] 16 Current NDC, Legacy NDC, 6 package rows 20241222_0b363b90-93dc-1fc1-0501-d140dfc762c7.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 · 3 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Eszopiclone ESZOPICLONE Advanced Rx of Tennessee, LLC af86ebdb-e47b-706a-e053-2995a90ad51c 2024-12-31 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091024 application number: ANDA091024 Eszopiclone ESZOPICLONE Advanced Rx of Tennessee, LLC af86b753-d2ee-9b5f-e053-2a95a90ad23d 2024-12-31 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091024 application number: ANDA091024 Eszopiclone ESZOPICLONE Dr. Reddy's Laboratories Limited 0b363b90-93dc-1fc1-0501-d140dfc762c7 2024-12-19 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091024 application number: ANDA091024 ndc (product): 55111-619
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55111-619-01 55111061901 100 TABLET, COATED in 1 BOTTLE (55111-619-01) 2014-04-15 0000-00-00 No No Current 55111-619-05 55111061905 500 TABLET, COATED in 1 BOTTLE (55111-619-05) 2014-04-15 0000-00-00 No No Current 55111-619-09 55111061909 9 BLISTER PACK in 1 CARTON (55111-619-09) / 10 TABLET, COATED in 1 BLISTER PACK (55111-619-79) 9 blister pack 2014-04-15 0000-00-00 No No Current 55111-619-30 55111061930 30 TABLET, COATED in 1 BOTTLE (55111-619-30) 2014-04-15 0000-00-00 No No Current 55111-619-79 55111061979 10 in 1 BLISTER PACK Historical 55111-619-90 55111061990 90 TABLET, COATED in 1 BOTTLE (55111-619-90) 2014-04-15 0000-00-00 No No Current