Home NDC 47335-586 ESZOPICLONE
Product NDC 47335-586
11-digit product format 473350586
Labeler code 47335
Product ID 47335-586_95e952a3-5a7d-4b4c-9ac8-b5256a4371c3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ESZOPICLONE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA091103
Marketing category ANDA
Marketing start 2014-04-15
Substance ESZOPICLONE
Active strength 1 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 A091103-001 ESZOPICLONE ESZOPICLONE 1MG TABLET / ORAL AB 2013-04-03 A091103-002 ESZOPICLONE ESZOPICLONE 2MG TABLET / ORAL AB 2013-04-03 A091103-003 ESZOPICLONE ESZOPICLONE 3MG TABLET / ORAL AB 2013-04-03
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 A091103-001 ESZOPICLONE 1MG TABLET / ORAL AB 2013-04-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091103-002 ESZOPICLONE 2MG TABLET / ORAL AB 2013-04-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A091103-003 ESZOPICLONE 3MG TABLET / ORAL AB 2013-04-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091103-001 ESZOPICLONE 1MG TABLET / ORAL AB 2013-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091103-002 ESZOPICLONE 2MG TABLET / ORAL AB 2013-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A091103-003 ESZOPICLONE 3MG TABLET / ORAL AB 2013-04-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091103-001 ESZOPICLONE 1MG TABLET / ORAL AB 2013-04-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091103-002 ESZOPICLONE 2MG TABLET / ORAL AB 2013-04-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091103-003 ESZOPICLONE 3MG TABLET / ORAL AB 2013-04-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091103-001 ESZOPICLONE 1MG TABLET / ORAL AB 2013-04-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091103-002 ESZOPICLONE 2MG TABLET / ORAL AB 2013-04-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A091103-003 ESZOPICLONE 3MG TABLET / ORAL AB 2013-04-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091103-001 ESZOPICLONE 1MG TABLET / ORAL AB 2013-04-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091103-002 ESZOPICLONE 2MG TABLET / ORAL AB 2013-04-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091103-003 ESZOPICLONE 3MG TABLET / ORAL AB 2013-04-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091103-001 ESZOPICLONE 1MG TABLET / ORAL AB 2013-04-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091103-002 ESZOPICLONE 2MG TABLET / ORAL AB 2013-04-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091103-003 ESZOPICLONE 3MG TABLET / ORAL AB 2013-04-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091103-001 ESZOPICLONE 1MG TABLET / ORAL AB 2013-04-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091103-002 ESZOPICLONE 2MG TABLET / ORAL AB 2013-04-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091103-003 ESZOPICLONE 3MG TABLET / ORAL AB 2013-04-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091103-001 ESZOPICLONE 1MG TABLET / ORAL AB 2013-04-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091103-002 ESZOPICLONE 2MG TABLET / ORAL AB 2013-04-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091103-003 ESZOPICLONE 3MG TABLET / ORAL AB 2013-04-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091103-001 ESZOPICLONE 1MG TABLET / ORAL AB 2013-04-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091103-002 ESZOPICLONE 2MG TABLET / ORAL AB 2013-04-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091103-003 ESZOPICLONE 3MG TABLET / ORAL AB 2013-04-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091103-001 ESZOPICLONE 1MG TABLET / ORAL AB 2013-04-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091103-002 ESZOPICLONE 2MG TABLET / ORAL AB 2013-04-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091103-003 ESZOPICLONE 3MG TABLET / ORAL AB 2013-04-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091103-001 ESZOPICLONE 1MG TABLET / ORAL AB 2013-04-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091103-002 ESZOPICLONE 2MG TABLET / ORAL AB 2013-04-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A091103-003 ESZOPICLONE 3MG TABLET / ORAL AB 2013-04-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091103-001 ESZOPICLONE 1MG TABLET / ORAL AB 2013-04-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091103-002 ESZOPICLONE 2MG TABLET / ORAL AB 2013-04-03 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091103-003 ESZOPICLONE 3MG TABLET / ORAL AB 2013-04-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091103-001 ESZOPICLONE 1MG TABLET / ORAL AB 2013-04-03 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091103-002 ESZOPICLONE 2MG TABLET / ORAL AB 2013-04-03 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091103-003 ESZOPICLONE 3MG TABLET / ORAL AB 2013-04-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091103-001 ESZOPICLONE 1MG TABLET / ORAL AB 2013-04-03 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 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 47335-586-08 ESZOPICLONE 100 in 1 BOTTLE TABLET, FILM COATED 100 8 47335-586-18 ESZOPICLONE 1000 in 1 BOTTLE TABLET, FILM COATED 1000 8 47335-586-83 ESZOPICLONE 30 in 1 BOTTLE TABLET, FILM COATED 30 8 47335-586-88 ESZOPICLONE 100 in 1 BOTTLE TABLET, FILM COATED 100 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ESZOPICLONE ACTIVE INGREDIENT UZX80K71OE ESZOPICLONE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 ESZOPICLONE ACTIVE MOIETY UZX80K71OE ESZOPICLONE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK ESZOPICLONE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ESZOPICLONE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 ESZOPICLONE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK ESZOPICLONE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ESZOPICLONE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ESZOPICLONE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ ESZOPICLONE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H ESZOPICLONE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ESZOPICLONE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ ESZOPICLONE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ESZOPICLONE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1001 ESZOPICLONE ACTIVE INGREDIENT UZX80K71OE ESZOPICLONE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] 5 ESZOPICLONE ACTIVE MOIETY UZX80K71OE ESZOPICLONE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] 5 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK ESZOPICLONE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] 5 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ESZOPICLONE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] 5 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 ESZOPICLONE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] 5 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK ESZOPICLONE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] 5 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA ESZOPICLONE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] 5 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 ESZOPICLONE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] 5 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ESZOPICLONE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] 5 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ESZOPICLONE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] 5 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ ESZOPICLONE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] 5 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H ESZOPICLONE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] 5 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ESZOPICLONE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] 5 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ ESZOPICLONE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] 5 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ESZOPICLONE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] 5 ESZOPICLONE ACTIVE INGREDIENT UZX80K71OE ESZOPICLONE TABLET, FILM COATED [UNIT DOSE SERVICES] 2 ESZOPICLONE ACTIVE INGREDIENT UZX80K71OE ESZOPICLONE TABLET, FILM COATED [DIRECT RX] 2 ESZOPICLONE ACTIVE INGREDIENT UZX80K71OE ESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] 2 ESZOPICLONE ACTIVE MOIETY UZX80K71OE ESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] 2 ESZOPICLONE ACTIVE MOIETY UZX80K71OE ESZOPICLONE TABLET, FILM COATED [UNIT DOSE SERVICES] 2 ESZOPICLONE ACTIVE MOIETY UZX80K71OE ESZOPICLONE TABLET, FILM COATED [DIRECT RX] 2 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK ESZOPICLONE TABLET, FILM COATED [UNIT DOSE SERVICES] 2 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK ESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] 2 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK ESZOPICLONE TABLET, FILM COATED [DIRECT RX] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ESZOPICLONE TABLET, FILM COATED [DIRECT RX] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ESZOPICLONE TABLET, FILM COATED [UNIT DOSE SERVICES] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 ESZOPICLONE TABLET, FILM COATED [DIRECT RX] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 ESZOPICLONE TABLET, FILM COATED [UNIT DOSE SERVICES] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 ESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] 2 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK ESZOPICLONE TABLET, FILM COATED [UNIT DOSE SERVICES] 2 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK ESZOPICLONE TABLET, FILM COATED [DIRECT RX] 2 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK ESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA ESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 ESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ESZOPICLONE TABLET, FILM COATED [UNIT DOSE SERVICES] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ESZOPICLONE TABLET, FILM COATED [DIRECT RX] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ESZOPICLONE TABLET, FILM COATED [DIRECT RX] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ESZOPICLONE TABLET, FILM COATED [UNIT DOSE SERVICES] 2 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ ESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] 2 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ ESZOPICLONE TABLET, FILM COATED [DIRECT RX] 2 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ ESZOPICLONE TABLET, FILM COATED [UNIT DOSE SERVICES] 2 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H ESZOPICLONE TABLET, FILM COATED [DIRECT RX] 2 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H ESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] 2 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H ESZOPICLONE TABLET, FILM COATED [UNIT DOSE SERVICES] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ESZOPICLONE TABLET, FILM COATED [UNIT DOSE SERVICES] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ESZOPICLONE TABLET, FILM COATED [DIRECT RX] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ ESZOPICLONE TABLET, FILM COATED [DIRECT RX] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ ESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ ESZOPICLONE TABLET, FILM COATED [UNIT DOSE SERVICES] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ESZOPICLONE TABLET, FILM COATED [DIRECT RX] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ESZOPICLONE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ESZOPICLONE TABLET, FILM COATED [UNIT DOSE SERVICES] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 47335-586 ESZOPICLONE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.] 8 Current NDC, Legacy NDC, 4 package rows 20181025_8bb1965e-7845-4c5b-b021-38e251303d68.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 · 1 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 47335-586-08 47335058608 100 TABLET, FILM COATED in 1 BOTTLE (47335-586-08) 2014-04-15 0000-00-00 No No Current 47335-586-18 47335058618 1000 TABLET, FILM COATED in 1 BOTTLE (47335-586-18) 2014-04-15 0000-00-00 No No Current 47335-586-83 47335058683 30 TABLET, FILM COATED in 1 BOTTLE (47335-586-83) 2014-04-15 0000-00-00 No No Current 47335-586-88 47335058688 100 TABLET, FILM COATED in 1 BOTTLE (47335-586-88) 2014-04-15 0000-00-00 No No Current