Home NDC 60429-632 Eszopiclone
Product NDC 60429-632
11-digit product format 604290632
Labeler code 60429
Product ID 60429-632_02e9fcb6-a4fc-ed47-e063-6394a90a7976
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name eszopiclone
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Golden State Medical Supply, Inc.
Application ANDA091151
Marketing category ANDA
Marketing start 2013-03-26
Substance ESZOPICLONE
Active strength 1 mg/1
DEA schedule CIV
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 60429-632 60429-632-01 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 60429-632 60429-632-01 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 60429-632 60429-632-01 D Discontinued by firm excluded / ndc_excluded.zip 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 60429-632 60429-632-01 D Discontinued by firm excluded / ndc_excluded.zip a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 60429-632 60429-632-01 D Discontinued by firm excluded / ndc_excluded.zip cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 60429-632 60429-632-01 D Discontinued by firm excluded / ndc_excluded.zip cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 60429-632 60429-632-01 D Discontinued by firm excluded / ndc_excluded.zip 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 60429-632 60429-632-01 D Discontinued by firm excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 60429-632 60429-632-01 D Discontinued by firm excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 60429-632 60429-632-01 D Discontinued by firm excluded / ndc_excluded.zip ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 60429-632 60429-632-01 D Discontinued by firm excluded / ndc_excluded.zip 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 60429-632 60429-632-01 D Discontinued by firm excluded / ndc_excluded.zip 557ba5c1ecfa…9c80585c8c6e…
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 A091151-001 ESZOPICLONE ESZOPICLONE 1MG TABLET / ORAL AB 2013-03-26 A091151-002 ESZOPICLONE ESZOPICLONE 2MG TABLET / ORAL AB 2013-03-26 A091151-003 ESZOPICLONE ESZOPICLONE 3MG TABLET / ORAL AB 2013-03-26
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 A091151-001 ESZOPICLONE 1MG TABLET / ORAL AB 2013-03-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091151-002 ESZOPICLONE 2MG TABLET / ORAL AB 2013-03-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091151-003 ESZOPICLONE 3MG TABLET / ORAL AB 2013-03-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091151-001 ESZOPICLONE 1MG TABLET / ORAL AB 2013-03-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091151-002 ESZOPICLONE 2MG TABLET / ORAL AB 2013-03-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091151-003 ESZOPICLONE 3MG TABLET / ORAL AB 2013-03-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091151-001 ESZOPICLONE 1MG TABLET / ORAL AB 2013-03-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091151-002 ESZOPICLONE 2MG TABLET / ORAL AB 2013-03-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091151-003 ESZOPICLONE 3MG TABLET / ORAL AB 2013-03-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091151-001 ESZOPICLONE 1MG TABLET / ORAL AB 2013-03-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091151-002 ESZOPICLONE 2MG TABLET / ORAL AB 2013-03-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091151-003 ESZOPICLONE 3MG TABLET / ORAL AB 2013-03-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091151-001 ESZOPICLONE 1MG TABLET / ORAL AB 2013-03-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091151-002 ESZOPICLONE 2MG TABLET / ORAL AB 2013-03-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091151-003 ESZOPICLONE 3MG TABLET / ORAL AB 2013-03-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091151-001 ESZOPICLONE 1MG TABLET / ORAL AB 2013-03-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091151-002 ESZOPICLONE 2MG TABLET / ORAL AB 2013-03-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091151-003 ESZOPICLONE 3MG TABLET / ORAL AB 2013-03-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091151-001 ESZOPICLONE 1MG TABLET / ORAL AB 2013-03-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091151-002 ESZOPICLONE 2MG TABLET / ORAL AB 2013-03-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091151-003 ESZOPICLONE 3MG TABLET / ORAL AB 2013-03-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091151-001 ESZOPICLONE 1MG TABLET / ORAL AB 2013-03-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091151-002 ESZOPICLONE 2MG TABLET / ORAL AB 2013-03-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091151-003 ESZOPICLONE 3MG TABLET / ORAL AB 2013-03-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091151-001 ESZOPICLONE 1MG TABLET / ORAL AB 2013-03-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091151-002 ESZOPICLONE 2MG TABLET / ORAL AB 2013-03-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091151-003 ESZOPICLONE 3MG TABLET / ORAL AB 2013-03-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091151-001 ESZOPICLONE 1MG TABLET / ORAL AB 2013-03-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091151-002 ESZOPICLONE 2MG TABLET / ORAL AB 2013-03-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091151-003 ESZOPICLONE 3MG TABLET / ORAL AB 2013-03-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091151-001 ESZOPICLONE 1MG TABLET / ORAL AB 2013-03-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091151-002 ESZOPICLONE 2MG TABLET / ORAL AB 2013-03-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091151-003 ESZOPICLONE 3MG TABLET / ORAL AB 2013-03-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091151-001 ESZOPICLONE 1MG TABLET / ORAL AB 2013-03-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091151-002 ESZOPICLONE 2MG TABLET / ORAL AB 2013-03-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091151-003 ESZOPICLONE 3MG TABLET / ORAL AB 2013-03-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091151-001 ESZOPICLONE 1MG TABLET / ORAL AB 2013-03-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091151-002 ESZOPICLONE 2MG TABLET / ORAL AB 2013-03-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091151-003 ESZOPICLONE 3MG TABLET / ORAL AB 2013-03-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091151-001 ESZOPICLONE 1MG TABLET / ORAL AB 2013-03-26 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
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.
Additional Listing Data#
Finished product Yes
Brand name base Eszopiclone
Listing expiration 2026-12-31 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 · 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 60429-632-01 Eszopiclone 100 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 100 8 60429-632-30 Eszopiclone 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60429-632 ESZOPICLONE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.] 8 Current NDC, Legacy NDC, 2 package rows 20230819_fef87d8d-f375-4b00-8765-957ef076bf1a.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 60429-632-01 60429063201 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60429-632-01) 2016-04-04 0000-00-00 No No Current 60429-632-30 60429063230 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60429-632-30) 2021-02-22 0000-00-00 No No Current