Home NDC 69452-349 ESZOPICLONE
Product NDC 69452-349
11-digit product format 694520349
Labeler code 69452
Product ID 69452-349_903d952f-704a-4227-a829-5bddbd5793cb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ESZOPICLONE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Bionpharma Inc.
Application ANDA091113
Marketing category ANDA
Marketing start 2022-06-01
Substance ESZOPICLONE
Active strength 3 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 A091113-001 ESZOPICLONE ESZOPICLONE 1MG TABLET / ORAL AB 2014-06-10 A091113-002 ESZOPICLONE ESZOPICLONE 2MG TABLET / ORAL AB 2014-06-10 A091113-003 ESZOPICLONE ESZOPICLONE 3MG TABLET / ORAL AB 2014-06-10
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 A091113-001 ESZOPICLONE 1MG TABLET / ORAL AB 2014-06-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091113-002 ESZOPICLONE 2MG TABLET / ORAL AB 2014-06-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091113-003 ESZOPICLONE 3MG TABLET / ORAL AB 2014-06-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091113-001 ESZOPICLONE 1MG TABLET / ORAL AB 2014-06-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091113-002 ESZOPICLONE 2MG TABLET / ORAL AB 2014-06-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091113-003 ESZOPICLONE 3MG TABLET / ORAL AB 2014-06-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091113-001 ESZOPICLONE 1MG TABLET / ORAL AB 2014-06-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091113-002 ESZOPICLONE 2MG TABLET / ORAL AB 2014-06-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091113-003 ESZOPICLONE 3MG TABLET / ORAL AB 2014-06-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091113-001 ESZOPICLONE 1MG TABLET / ORAL AB 2014-06-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091113-002 ESZOPICLONE 2MG TABLET / ORAL AB 2014-06-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091113-003 ESZOPICLONE 3MG TABLET / ORAL AB 2014-06-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091113-001 ESZOPICLONE 1MG TABLET / ORAL AB 2014-06-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091113-002 ESZOPICLONE 2MG TABLET / ORAL AB 2014-06-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091113-003 ESZOPICLONE 3MG TABLET / ORAL AB 2014-06-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091113-001 ESZOPICLONE 1MG TABLET / ORAL AB 2014-06-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091113-002 ESZOPICLONE 2MG TABLET / ORAL AB 2014-06-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091113-003 ESZOPICLONE 3MG TABLET / ORAL AB 2014-06-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091113-001 ESZOPICLONE 1MG TABLET / ORAL AB 2014-06-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091113-002 ESZOPICLONE 2MG TABLET / ORAL AB 2014-06-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091113-003 ESZOPICLONE 3MG TABLET / ORAL AB 2014-06-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091113-001 ESZOPICLONE 1MG TABLET / ORAL AB 2014-06-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091113-002 ESZOPICLONE 2MG TABLET / ORAL AB 2014-06-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091113-003 ESZOPICLONE 3MG TABLET / ORAL AB 2014-06-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091113-001 ESZOPICLONE 1MG TABLET / ORAL AB 2014-06-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091113-002 ESZOPICLONE 2MG TABLET / ORAL AB 2014-06-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091113-003 ESZOPICLONE 3MG TABLET / ORAL AB 2014-06-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091113-001 ESZOPICLONE 1MG TABLET / ORAL AB 2014-06-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091113-002 ESZOPICLONE 2MG TABLET / ORAL AB 2014-06-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091113-003 ESZOPICLONE 3MG TABLET / ORAL AB 2014-06-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091113-001 ESZOPICLONE 1MG TABLET / ORAL AB 2014-06-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091113-002 ESZOPICLONE 2MG TABLET / ORAL AB 2014-06-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091113-003 ESZOPICLONE 3MG TABLET / ORAL AB 2014-06-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091113-001 ESZOPICLONE 1MG TABLET / ORAL AB 2014-06-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091113-002 ESZOPICLONE 2MG TABLET / ORAL AB 2014-06-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091113-003 ESZOPICLONE 3MG TABLET / ORAL AB 2014-06-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091113-001 ESZOPICLONE 1MG TABLET / ORAL AB 2014-06-10 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091113-002 ESZOPICLONE 2MG TABLET / ORAL AB 2014-06-10 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091113-003 ESZOPICLONE 3MG TABLET / ORAL AB 2014-06-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091113-001 ESZOPICLONE 1MG TABLET / ORAL AB 2014-06-10 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 · 1 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 3 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 69452-349-20 ESZOPICLONE 100 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 100 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69452-349 ESZOPICLONE TABLET, FILM COATED [BIONPHARMA INC.] 4 Current NDC, Legacy NDC, 1 package rows 20231202_ec6ac172-509e-403a-aa0d-4c60010a0035.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 69452-349-20 69452034920 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69452-349-20) 2022-06-01 0000-00-00 No No Current