Home NDC 0378-5272 Eszopiclone
Product NDC 0378-5272
11-digit product format 003785272
Labeler code 0378
Product ID 0378-5272_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 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 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# 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 · 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 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 0378-5272-01 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 0378-5272 ESZOPICLONE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 11 Current NDC, Legacy NDC, 1 package rows 20221102_5469cc59-78f9-447a-9c33-12553bb4073d.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 0378-5272-01 00378527201 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-5272-01) 2013-03-26 0000-00-00 No No Current