Home NDC 31722-856 Eszopiclone
Product NDC 31722-856
11-digit product format 317220856
Labeler code 31722
Product ID 31722-856_2e8f0952-b678-2e0a-e063-6294a90aaf4e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Eszopiclone
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Camber Pharmaceuticals, Inc.
Application ANDA205504
Marketing category ANDA
Marketing start 2024-01-04
Substance ESZOPICLONE
Active strength 2 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 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 · 51 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 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…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205504-002 ESZOPICLONE 2MG TABLET / ORAL AB 2024-01-04 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205504-003 ESZOPICLONE 3MG TABLET / ORAL AB 2024-01-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205504-001 ESZOPICLONE 1MG TABLET / ORAL AB 2024-01-04 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205504-002 ESZOPICLONE 2MG TABLET / ORAL AB 2024-01-04 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205504-003 ESZOPICLONE 3MG TABLET / ORAL AB 2024-01-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205504-001 ESZOPICLONE 1MG TABLET / ORAL AB 2024-01-04 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 51 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 · 3 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 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 31722-856-01 Eszopiclone 100 in 1 BOTTLE TABLET, FILM COATED 100 2 31722-856-30 Eszopiclone 30 in 1 BOTTLE TABLET, FILM COATED 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 31722-856 ESZOPICLONE (ESZOPICLONE) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] 2 Current NDC, 2 package rows 20250223_00fc3250-3e29-4a4b-ac0c-74910659337c.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 31722-856-01 31722085601 100 TABLET, FILM COATED in 1 BOTTLE (31722-856-01) 2024-01-04 No No Current 31722-856-30 31722085630 30 TABLET, FILM COATED in 1 BOTTLE (31722-856-30) 2024-01-04 No No Current