Home NDC 0378-5271 Eszopiclone
Product NDC 0378-5271
11-digit product format 003785271
Labeler code 0378
Product ID 0378-5271_850bc29d-2353-4e1f-bfe4-0811eb79000f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name eszopiclone
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application ANDA091151
Marketing category ANDA
Marketing start 2013-03-26
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 42 .
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 · 126 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 2026-08-18 06:07:40 2026-07 A091151-001 ESZOPICLONE 1MG TABLET / ORAL AB 2013-03-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091151-002 ESZOPICLONE 2MG TABLET / ORAL AB 2013-03-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091151-003 ESZOPICLONE 3MG TABLET / ORAL AB 2013-03-26 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 observed states.
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 0378-5271-01 Eszopiclone 100 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 100 11
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ESZOPICLONE ACTIVE INGREDIENT UZX80K71OE ESZOPICLONE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 4 ESZOPICLONE ACTIVE MOIETY UZX80K71OE ESZOPICLONE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ESZOPICLONE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 4 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 ESZOPICLONE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 4 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 ESZOPICLONE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 4 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT ESZOPICLONE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 4 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 ESZOPICLONE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 4 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ESZOPICLONE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 4 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X ESZOPICLONE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ESZOPICLONE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 4 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A ESZOPICLONE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 4 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ESZOPICLONE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 4 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ESZOPICLONE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 4 ESZOPICLONE ACTIVE INGREDIENT UZX80K71OE ESZOPICLONE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 1 ESZOPICLONE ACTIVE MOIETY UZX80K71OE ESZOPICLONE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ESZOPICLONE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 ESZOPICLONE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 ESZOPICLONE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT ESZOPICLONE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 1 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 ESZOPICLONE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ESZOPICLONE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X ESZOPICLONE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ESZOPICLONE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A ESZOPICLONE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ESZOPICLONE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ESZOPICLONE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0378-5271 ESZOPICLONE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 11 Current NDC, Legacy NDC, 1 package rows 20221102_5469cc59-78f9-447a-9c33-12553bb4073d.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 0378-5271-01 00378527101 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5271-01) 2013-03-26 0000-00-00 No No Current