Home NDC 82804-159-60 Eszopiclone
Product NDC 82804-159
Requested package NDC 82804-159-60
11-digit product format 828040159
Labeler code 82804
Product ID 82804-159_b36c020d-b30c-45b8-b5af-1c07a29ac3d0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Eszopiclone
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Proficient Rx LP
Application ANDA205504
Marketing category ANDA
Marketing start 2024-01-04
Substance ESZOPICLONE
Active strength 1 mg/1
DEA schedule CIV
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A205504-001 ESZOPICLONE ESZOPICLONE 1MG TABLET / ORAL AB 2024-01-04 A205504-002 ESZOPICLONE ESZOPICLONE 2MG TABLET / ORAL AB 2024-01-04 A205504-003 ESZOPICLONE ESZOPICLONE 3MG TABLET / ORAL AB 2024-01-04
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 2 · 57 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 2026-09-14 22:38:34 2026-08 A205504-001 ESZOPICLONE 1MG TABLET / ORAL AB 2024-01-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 A205504-002 ESZOPICLONE 2MG TABLET / ORAL AB 2024-01-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 A205504-003 ESZOPICLONE 3MG TABLET / ORAL AB 2024-01-04 84e616aacf4f…2026-08-18 06:07:40 2026-07 A205504-001 ESZOPICLONE 1MG TABLET / ORAL AB 2024-01-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205504-002 ESZOPICLONE 2MG TABLET / ORAL AB 2024-01-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A205504-003 ESZOPICLONE 3MG TABLET / ORAL AB 2024-01-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A205504-001 ESZOPICLONE 1MG TABLET / ORAL AB 2024-01-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205504-002 ESZOPICLONE 2MG TABLET / ORAL AB 2024-01-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A205504-003 ESZOPICLONE 3MG TABLET / ORAL AB 2024-01-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205504-001 ESZOPICLONE 1MG TABLET / ORAL AB 2024-01-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205504-002 ESZOPICLONE 2MG TABLET / ORAL AB 2024-01-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205504-003 ESZOPICLONE 3MG TABLET / ORAL AB 2024-01-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205504-001 ESZOPICLONE 1MG TABLET / ORAL AB 2024-01-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205504-002 ESZOPICLONE 2MG TABLET / ORAL AB 2024-01-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A205504-003 ESZOPICLONE 3MG TABLET / ORAL AB 2024-01-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205504-001 ESZOPICLONE 1MG TABLET / ORAL AB 2024-01-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205504-002 ESZOPICLONE 2MG TABLET / ORAL AB 2024-01-04 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205504-003 ESZOPICLONE 3MG TABLET / ORAL AB 2024-01-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205504-001 ESZOPICLONE 1MG TABLET / ORAL AB 2024-01-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205504-002 ESZOPICLONE 2MG TABLET / ORAL AB 2024-01-04 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205504-003 ESZOPICLONE 3MG TABLET / ORAL AB 2024-01-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205504-001 ESZOPICLONE 1MG TABLET / ORAL AB 2024-01-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205504-002 ESZOPICLONE 2MG TABLET / ORAL AB 2024-01-04 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205504-003 ESZOPICLONE 3MG TABLET / ORAL AB 2024-01-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205504-001 ESZOPICLONE 1MG TABLET / ORAL AB 2024-01-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205504-002 ESZOPICLONE 2MG TABLET / ORAL AB 2024-01-04 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205504-003 ESZOPICLONE 3MG TABLET / ORAL AB 2024-01-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205504-001 ESZOPICLONE 1MG TABLET / ORAL AB 2024-01-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205504-002 ESZOPICLONE 2MG TABLET / ORAL AB 2024-01-04 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205504-003 ESZOPICLONE 3MG TABLET / ORAL AB 2024-01-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205504-001 ESZOPICLONE 1MG TABLET / ORAL AB 2024-01-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205504-002 ESZOPICLONE 2MG TABLET / ORAL AB 2024-01-04 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205504-003 ESZOPICLONE 3MG TABLET / ORAL AB 2024-01-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205504-001 ESZOPICLONE 1MG TABLET / ORAL AB 2024-01-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A205504-002 ESZOPICLONE 2MG TABLET / ORAL AB 2024-01-04 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A205504-003 ESZOPICLONE 3MG TABLET / ORAL AB 2024-01-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205504-001 ESZOPICLONE 1MG TABLET / ORAL AB 2024-01-04 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205504-002 ESZOPICLONE 2MG TABLET / ORAL AB 2024-01-04 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205504-003 ESZOPICLONE 3MG TABLET / ORAL AB 2024-01-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205504-001 ESZOPICLONE 1MG TABLET / ORAL AB 2024-01-04 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 57 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Eszopiclone
Listing expiration 2027-12-31 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 485440 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 82804-159-30 Eszopiclone 30 in 1 BOTTLE TABLET, FILM COATED 30 3 82804-159-60 Eszopiclone 60 in 1 BOTTLE TABLET, FILM COATED 60 3 82804-159-90 Eszopiclone 90 in 1 BOTTLE TABLET, FILM COATED 90 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82804-159 ESZOPICLONE TABLET, FILM COATED [PROFICIENT RX LP] 2 Current NDC, 3 package rows 20250321_dd7e4bab-8e25-4788-89e4-6b391f9596fe.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 82804-159-60 82804015960 60 TABLET, FILM COATED in 1 BOTTLE (82804-159-60) 2025-03-12 No No Current