Home NDC 0093-5538 Eszopiclone
Product NDC 0093-5538
11-digit product format 000935538
Labeler code 0093
Product ID 0093-5538_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 2026-10-31
Substance ESZOPICLONE
Active strength 2 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.
Additional Listing Data#
Finished product Yes
Brand name base Eszopiclone 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 0093-5538-01 Eszopiclone 100 in 1 BOTTLE TABLET, FILM COATED 100 17
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ESZOPICLONE ACTIVE INGREDIENT UZX80K71OE ESZOPICLONE TABLET, FILM COATED [UNIT DOSE SERVICES] 7 ESZOPICLONE ACTIVE MOIETY UZX80K71OE ESZOPICLONE TABLET, FILM COATED [UNIT DOSE SERVICES] 7 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 ESZOPICLONE TABLET, FILM COATED [UNIT DOSE SERVICES] 7 CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS INACTIVE INGREDIENT L11K75P92J ESZOPICLONE TABLET, FILM COATED [UNIT DOSE SERVICES] 7 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ESZOPICLONE TABLET, FILM COATED [UNIT DOSE SERVICES] 7 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 ESZOPICLONE TABLET, FILM COATED [UNIT DOSE SERVICES] 7 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK ESZOPICLONE TABLET, FILM COATED [UNIT DOSE SERVICES] 7 HYPROMELLOSE 2910 (3 MPA.S) INACTIVE INGREDIENT 0VUT3PMY82 ESZOPICLONE TABLET, FILM COATED [UNIT DOSE SERVICES] 7 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 ESZOPICLONE TABLET, FILM COATED [UNIT DOSE SERVICES] 7 INDIGOTINDISULFONATE SODIUM INACTIVE INGREDIENT D3741U8K7L ESZOPICLONE TABLET, FILM COATED [UNIT DOSE SERVICES] 7 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ESZOPICLONE TABLET, FILM COATED [UNIT DOSE SERVICES] 7 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ ESZOPICLONE TABLET, FILM COATED [UNIT DOSE SERVICES] 7 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H ESZOPICLONE TABLET, FILM COATED [UNIT DOSE SERVICES] 7 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ESZOPICLONE TABLET, FILM COATED [UNIT DOSE SERVICES] 7 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ESZOPICLONE TABLET, FILM COATED [UNIT DOSE SERVICES] 7 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 0093-5538 ESZOPICLONE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.] 15 Current NDC, Legacy NDC, 1 package rows 20211102_2435e2f1-bc52-488f-80e9-f1758e354aae.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 · 2 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 0093-5538-01 00093553801 100 TABLET, FILM COATED in 1 BOTTLE (0093-5538-01) 2014-04-14 2026-10-31 No No Current