Home NDC 0093-5537 Eszopiclone
Product NDC 0093-5537
11-digit product format 000935537
Labeler code 0093
Product ID 0093-5537_efcf4106-ac0a-4f8b-bcd0-743e45e66924
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Eszopiclone
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Teva Pharmaceuticals USA, Inc.
Application ANDA091169
Marketing category ANDA
Marketing start 2014-04-14
Marketing end 2027-01-31
Substance ESZOPICLONE
Active strength 1 mg/1
DEA schedule CIV
NDC exclude flag No
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 A091169-001 ESZOPICLONE ESZOPICLONE 1MG TABLET / ORAL AB 2011-05-23 A091169-002 ESZOPICLONE ESZOPICLONE 2MG TABLET / ORAL AB 2011-05-23 A091169-003 ESZOPICLONE ESZOPICLONE 3MG TABLET / ORAL AB 2011-05-23
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 A091169-001 ESZOPICLONE 1MG TABLET / ORAL AB 2011-05-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091169-002 ESZOPICLONE 2MG TABLET / ORAL AB 2011-05-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091169-003 ESZOPICLONE 3MG TABLET / ORAL AB 2011-05-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091169-001 ESZOPICLONE 1MG TABLET / ORAL AB 2011-05-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091169-002 ESZOPICLONE 2MG TABLET / ORAL AB 2011-05-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091169-003 ESZOPICLONE 3MG TABLET / ORAL AB 2011-05-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091169-001 ESZOPICLONE 1MG TABLET / ORAL AB 2011-05-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091169-002 ESZOPICLONE 2MG TABLET / ORAL AB 2011-05-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091169-003 ESZOPICLONE 3MG TABLET / ORAL AB 2011-05-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091169-001 ESZOPICLONE 1MG TABLET / ORAL AB 2011-05-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091169-002 ESZOPICLONE 2MG TABLET / ORAL AB 2011-05-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091169-003 ESZOPICLONE 3MG TABLET / ORAL AB 2011-05-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091169-001 ESZOPICLONE 1MG TABLET / ORAL AB 2011-05-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091169-002 ESZOPICLONE 2MG TABLET / ORAL AB 2011-05-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091169-003 ESZOPICLONE 3MG TABLET / ORAL AB 2011-05-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091169-001 ESZOPICLONE 1MG TABLET / ORAL AB 2011-05-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091169-002 ESZOPICLONE 2MG TABLET / ORAL AB 2011-05-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091169-003 ESZOPICLONE 3MG TABLET / ORAL AB 2011-05-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091169-001 ESZOPICLONE 1MG TABLET / ORAL AB 2011-05-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091169-002 ESZOPICLONE 2MG TABLET / ORAL AB 2011-05-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091169-003 ESZOPICLONE 3MG TABLET / ORAL AB 2011-05-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091169-001 ESZOPICLONE 1MG TABLET / ORAL AB 2011-05-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091169-002 ESZOPICLONE 2MG TABLET / ORAL AB 2011-05-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091169-003 ESZOPICLONE 3MG TABLET / ORAL AB 2011-05-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091169-001 ESZOPICLONE 1MG TABLET / ORAL AB 2011-05-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091169-002 ESZOPICLONE 2MG TABLET / ORAL AB 2011-05-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091169-003 ESZOPICLONE 3MG TABLET / ORAL AB 2011-05-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091169-001 ESZOPICLONE 1MG TABLET / ORAL AB 2011-05-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091169-002 ESZOPICLONE 2MG TABLET / ORAL AB 2011-05-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091169-003 ESZOPICLONE 3MG TABLET / ORAL AB 2011-05-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091169-001 ESZOPICLONE 1MG TABLET / ORAL AB 2011-05-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091169-002 ESZOPICLONE 2MG TABLET / ORAL AB 2011-05-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091169-003 ESZOPICLONE 3MG TABLET / ORAL AB 2011-05-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091169-001 ESZOPICLONE 1MG TABLET / ORAL AB 2011-05-23 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091169-002 ESZOPICLONE 2MG TABLET / ORAL AB 2011-05-23 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091169-003 ESZOPICLONE 3MG TABLET / ORAL AB 2011-05-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091169-001 ESZOPICLONE 1MG TABLET / ORAL AB 2011-05-23 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091169-002 ESZOPICLONE 2MG TABLET / ORAL AB 2011-05-23 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091169-003 ESZOPICLONE 3MG TABLET / ORAL AB 2011-05-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091169-001 ESZOPICLONE 1MG TABLET / ORAL AB 2011-05-23 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Eszopiclone Active Ingredients# Ingredient, Strength table Ingredient Strength ESZOPICLONE 1 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 0093-5537-56 Eszopiclone 30 in 1 BOTTLE TABLET, FILM COATED 30 17
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ESZOPICLONE ACTIVE INGREDIENT UZX80K71OE ESZOPICLONE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 4 ESZOPICLONE ACTIVE MOIETY UZX80K71OE ESZOPICLONE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 4 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 ESZOPICLONE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 4 CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS INACTIVE INGREDIENT L11K75P92J ESZOPICLONE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ESZOPICLONE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 4 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 ESZOPICLONE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 4 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD ESZOPICLONE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 4 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK ESZOPICLONE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 4 HYPROMELLOSE 2910 (3 MPA.S) INACTIVE INGREDIENT 0VUT3PMY82 ESZOPICLONE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 4 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 ESZOPICLONE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 4 INDIGOTINDISULFONATE SODIUM INACTIVE INGREDIENT D3741U8K7L ESZOPICLONE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ESZOPICLONE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 4 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ ESZOPICLONE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 4 POLYETHYLENE GLYCOL 6000 INACTIVE INGREDIENT 30IQX730WE ESZOPICLONE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 4 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H ESZOPICLONE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 4 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ESZOPICLONE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 4 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ESZOPICLONE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0093-5537 ESZOPICLONE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.] 15 Current NDC, Legacy NDC, 1 package rows 20211102_2435e2f1-bc52-488f-80e9-f1758e354aae.zip
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 0093-5537-56 00093553756 30 TABLET, FILM COATED in 1 BOTTLE (0093-5537-56) 2014-04-14 2027-01-31 No No Current