Home NDC 63629-5319-5 ESZOPICLONE
Product NDC 63629-5319
Requested package NDC 63629-5319-5
11-digit product format 636295319
Labeler code 63629
Product ID 63629-5319_29295c36-c640-48a5-8b6b-bae3b559f2c9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ESZOPICLONE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Bryant Ranch Prepack
Application ANDA091103
Marketing category ANDA
Marketing start 2014-04-15
Marketing end 0000-00-00
Substance ESZOPICLONE
Active strength 2 mg/1
DEA schedule CIV
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 17 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2020-06-10 20:45 UTC · source 2020-06-10 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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 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 · 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 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…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091103-002 ESZOPICLONE 2MG TABLET / ORAL AB 2013-04-03 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091103-003 ESZOPICLONE 3MG TABLET / ORAL AB 2013-04-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091103-001 ESZOPICLONE 1MG TABLET / ORAL AB 2013-04-03 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 63629-5319-1 2024-01-30 These highlights do not include all the information needed to use ESZOPICLONE safely and effectively. See full prescribing information for ESZOPICLONE tablets. ESZOPICLONE tablets, for oral use, CIV Initial U.S. Approval: 2004 63629-5319-2 2024-01-30 These highlights do not include all the information needed to use ESZOPICLONE safely and effectively. See full prescribing information for ESZOPICLONE tablets. ESZOPICLONE tablets, for oral use, CIV Initial U.S. Approval: 2004 63629-5319-3 2024-01-30 These highlights do not include all the information needed to use ESZOPICLONE safely and effectively. See full prescribing information for ESZOPICLONE tablets. ESZOPICLONE tablets, for oral use, CIV Initial U.S. Approval: 2004 63629-5319-4 2024-01-30 These highlights do not include all the information needed to use ESZOPICLONE safely and effectively. See full prescribing information for ESZOPICLONE tablets. ESZOPICLONE tablets, for oral use, CIV Initial U.S. Approval: 2004 63629-5319-5 2024-01-30 These highlights do not include all the information needed to use ESZOPICLONE safely and effectively. See full prescribing information for ESZOPICLONE tablets. ESZOPICLONE tablets, for oral use, CIV Initial U.S. Approval: 2004 63629-5319-6 2024-01-30 These highlights do not include all the information needed to use ESZOPICLONE safely and effectively. See full prescribing information for ESZOPICLONE tablets. ESZOPICLONE tablets, for oral use, CIV Initial U.S. Approval: 2004 63629-5319-7 2024-01-30 These highlights do not include all the information needed to use ESZOPICLONE safely and effectively. See full prescribing information for ESZOPICLONE tablets. ESZOPICLONE tablets, for oral use, CIV Initial U.S. Approval: 2004 63629-5319-8 2024-01-30 These highlights do not include all the information needed to use ESZOPICLONE safely and effectively. See full prescribing information for ESZOPICLONE tablets. ESZOPICLONE tablets, for oral use, CIV Initial U.S. Approval: 2004 63629-5319-1 2020-07-07 These highlights do not include all the information needed to use ESZOPICLONE safely and effectively. See full prescribing information for ESZOPICLONE tablets. ESZOPICLONE tablets, for oral use, CIV Initial U.S. Approval: 2004 63629-5319-2 2020-07-07 These highlights do not include all the information needed to use ESZOPICLONE safely and effectively. See full prescribing information for ESZOPICLONE tablets. ESZOPICLONE tablets, for oral use, CIV Initial U.S. Approval: 2004 63629-5319-3 2020-07-07 These highlights do not include all the information needed to use ESZOPICLONE safely and effectively. See full prescribing information for ESZOPICLONE tablets. ESZOPICLONE tablets, for oral use, CIV Initial U.S. Approval: 2004 63629-5319-4 2020-07-07 These highlights do not include all the information needed to use ESZOPICLONE safely and effectively. See full prescribing information for ESZOPICLONE tablets. ESZOPICLONE tablets, for oral use, CIV Initial U.S. Approval: 2004 63629-5319-5 2020-07-07 These highlights do not include all the information needed to use ESZOPICLONE safely and effectively. See full prescribing information for ESZOPICLONE tablets. ESZOPICLONE tablets, for oral use, CIV Initial U.S. Approval: 2004 63629-5319-6 2020-07-07 These highlights do not include all the information needed to use ESZOPICLONE safely and effectively. See full prescribing information for ESZOPICLONE tablets. ESZOPICLONE tablets, for oral use, CIV Initial U.S. Approval: 2004 63629-5319-7 2020-07-07 These highlights do not include all the information needed to use ESZOPICLONE safely and effectively. See full prescribing information for ESZOPICLONE tablets. ESZOPICLONE tablets, for oral use, CIV Initial U.S. Approval: 2004 63629-5319-1 2020-01-31 These highlights do not include all the information needed to use ESZOPICLONE safely and effectively. See full prescribing information for ESZOPICLONE tablets. ESZOPICLONE tablets, for oral use, CIV Initial U.S. Approval: 2004 63629-5319-2 2020-01-31 These highlights do not include all the information needed to use ESZOPICLONE safely and effectively. See full prescribing information for ESZOPICLONE tablets. ESZOPICLONE tablets, for oral use, CIV Initial U.S. Approval: 2004 63629-5319-3 2020-01-31 These highlights do not include all the information needed to use ESZOPICLONE safely and effectively. See full prescribing information for ESZOPICLONE tablets. ESZOPICLONE tablets, for oral use, CIV Initial U.S. Approval: 2004 63629-5319-4 2020-01-31 These highlights do not include all the information needed to use ESZOPICLONE safely and effectively. See full prescribing information for ESZOPICLONE tablets. ESZOPICLONE tablets, for oral use, CIV Initial U.S. Approval: 2004 63629-5319-5 2020-01-31 These highlights do not include all the information needed to use ESZOPICLONE safely and effectively. See full prescribing information for ESZOPICLONE tablets. ESZOPICLONE tablets, for oral use, CIV Initial U.S. Approval: 2004 63629-5319-6 2020-01-31 These highlights do not include all the information needed to use ESZOPICLONE safely and effectively. See full prescribing information for ESZOPICLONE tablets. ESZOPICLONE tablets, for oral use, CIV Initial U.S. Approval: 2004 63629-5319-7 2020-01-31 These highlights do not include all the information needed to use ESZOPICLONE safely and effectively. See full prescribing information for ESZOPICLONE tablets. ESZOPICLONE tablets, for oral use, CIV Initial U.S. Approval: 2004
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63629-5319-1 ESZOPICLONE 30 in 1 BOTTLE TABLET, FILM COATED 30 1007 63629-5319-2 ESZOPICLONE 60 in 1 BOTTLE TABLET, FILM COATED 60 1007 63629-5319-3 ESZOPICLONE 90 in 1 BOTTLE TABLET, FILM COATED 90 1007 63629-5319-4 ESZOPICLONE 120 in 1 BOTTLE TABLET, FILM COATED 120 1007 63629-5319-5 ESZOPICLONE 20 in 1 BOTTLE TABLET, FILM COATED 20 1007 63629-5319-6 ESZOPICLONE 100 in 1 BOTTLE TABLET, FILM COATED 100 1007 63629-5319-7 ESZOPICLONE 28 in 1 BOTTLE TABLET, FILM COATED 28 1007 63629-5319-8 ESZOPICLONE 10 in 1 BOTTLE TABLET, FILM COATED 10 1007
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] 1000 ESZOPICLONE ACTIVE MOIETY UZX80K71OE ESZOPICLONE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK ESZOPICLONE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ESZOPICLONE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 ESZOPICLONE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ESZOPICLONE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ESZOPICLONE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ ESZOPICLONE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H ESZOPICLONE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ESZOPICLONE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ ESZOPICLONE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ESZOPICLONE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1000
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63629-5319 ESZOPICLONE TABLET, FILM COATED [BRYANT RANCH PREPACK] 1007 Legacy NDC, 8 package rows 20220401_29295c36-c640-48a5-8b6b-bae3b559f2c9.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ESZOPICLONE ESZOPICLONE Sun Pharmaceutical Industries, Inc. 8bb1965e-7845-4c5b-b021-38e251303d68 2018-10-25 Warnings, Adverse reactions Exact identifier application applno (ANDA): 091103 application number: ANDA091103
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 63629-5319-5 63629531905 20 TABLET, FILM COATED in 1 BOTTLE (63629-5319-5) 2022-03-31 0000-00-00 No No Current