FDA.reportPublic FDA data

NDC 68788-7667-00 - ESZOPICLONE

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
68788-7667
Requested NDC
68788-7667-00
Package NDCs from labels
68788-7667-7, 68788-7667-1, 68788-7667-5, 68788-7667-2, 68788-7667-3, 68788-7667-6, 68788-7667-9, 68788-7667-0, 68788-7667-00
Manufacturer
Preferred Pharmaceuticals, Inc.
Effective date
2026-04-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ESZOPICLONE - Preferred Pharmaceuticals, Inc.Preferred Pharmaceuticals, Inc.2026-04-13HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-7667-0ESZOPICLONE100 in 1 BOTTLETABLET, FILM COATED1007
68788-7667-1ESZOPICLONE10 in 1 BOTTLETABLET, FILM COATED107
68788-7667-2ESZOPICLONE20 in 1 BOTTLETABLET, FILM COATED207
68788-7667-3ESZOPICLONE30 in 1 BOTTLETABLET, FILM COATED307
68788-7667-5ESZOPICLONE15 in 1 BOTTLETABLET, FILM COATED157
68788-7667-6ESZOPICLONE60 in 1 BOTTLETABLET, FILM COATED607
68788-7667-7ESZOPICLONE7 in 1 BOTTLETABLET, FILM COATED77
68788-7667-9ESZOPICLONE90 in 1 BOTTLETABLET, FILM COATED907

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7667ESZOPICLONE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 8 package rows20250504_45558f0a-83f1-49b9-ab18-f436c0be9677.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7667-0EA - Each68788-76677636ec67-9db7-4051-ad2d-908e0320dfb612020-05-08
68788-7667-1EA - Each68788-7667d3955f4d-dc78-4d1f-b74f-21e0a73ff56e12020-05-08
68788-7667-2EA - Each68788-7667404924a1-6ea9-48cb-a94e-52b1f33d0e6e12020-05-08
68788-7667-3EA - Each68788-76671f4a6642-4042-417b-a820-a01f7df741f312020-05-08
68788-7667-5EA - Each68788-7667675d597f-82fc-47b0-ba62-2ff559d6b99612020-05-08
68788-7667-6EA - Each68788-7667c42f48cd-7c7f-4352-933c-e9214917925112020-05-08
68788-7667-7EA - Each68788-76671560ef9b-4447-437d-902d-06e87a96a4c612020-05-08
68788-7667-9EA - Each68788-7667545de869-6f5b-4df0-a9af-bf4128511fb012020-05-08

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 110 · 2,195 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
leader clearlaxPOLYETHYLENE GLYCOL 3350Cardinal Health 110, LLC. dba Leader812c59b0-e7ce-4c7a-91ed-e74b7b1b84be2026-09-22WarningsExact identifier
unii: G2M7P15E5P
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350L.N.K. International, Inc.bbc11078-73f7-4d27-b0d3-4d4ae5dae2402026-09-10WarningsExact identifier
unii: G2M7P15E5P
EszopicloneESZOPICLONEREMEDYREPACK INC.9dfe774a-2c7a-4e10-bedd-cde64ad286762026-09-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485442
unii: UZX80K71OE
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
CLEARLAXPOLYETHYLENE GLYCOL 3350Amazon.com Services LLC7ed915ec-7e99-4e0e-aca0-20718987a88c2026-09-08WarningsExact identifier
unii: G2M7P15E5P
EszopicloneESZOPICLONEREMEDYREPACK INC.52ab8ee9-a04d-4e27-b0f4-eb050f1447152026-09-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485442
unii: UZX80K71OE
purelaxPOLYETHYLENE GLYCOL 3350CVS Pharmacyfc3b6006-a75a-41b3-9f0b-a3152df1363f2026-09-04WarningsExact identifier
unii: G2M7P15E5P
basic care clearlaxPOLYETHYLENE GLYCOL 3350Amazon.com Services LLC1ccb8604-34f6-4e1e-beed-eb81d6aa7aef2026-09-03WarningsExact identifier
unii: G2M7P15E5P
purelaxPOLYETHYLENE GLYCOL 3350CVS Pharmacy006a9eca-400f-47f5-bee5-facf7034043e2026-09-02WarningsExact identifier
unii: G2M7P15E5P
KrogerPOLYETHYLENE GLYCOL 3350KROGER COMPANYc56271ff-703a-40c4-840f-1962798c9e422026-09-02WarningsExact identifier
unii: G2M7P15E5P
gentle laxPOLYETHYLENE GLYCOL 3350Kroger Company0d820dcc-440a-4036-86e9-fdb30cac95732026-09-01WarningsExact identifier
unii: G2M7P15E5P
EszopicloneESZOPICLONESt Mary's Medical Park Pharmacyc4ff1d6a-918e-c046-e053-2a95a90a9c9b2026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 485442
unii: UZX80K71OE
CLEARLAXPOLYETHYLENE GLYCOL 3350Amazon.com Services LLCbd33463b-eb1a-41ed-92d1-f50d0923eb3b2026-08-31WarningsExact identifier
unii: G2M7P15E5P
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350Cardinal Health 107, LLC4d524ace-9de5-4f62-9263-7cd88a36b67c2026-08-28WarningsExact identifier
unii: G2M7P15E5P
PEG3350POLYETHYLENE GLYCOL 3350Major Pharmaceuticals161629f6-6193-4712-bba7-7d5b174a93382026-08-28WarningsExact identifier
unii: G2M7P15E5P
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
Mix-In Laxative PacketsPOLYETHYLENE GLYCOL 3350Wal-Mart Stores Inc0347c934-1e85-4f8d-8d35-bb07f16810ad2026-08-27WarningsExact identifier
unii: G2M7P15E5P
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
unii: 15FIX9V2JP
MELAO zinc stick(GREEN)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c70c82-f7ff-9a04-e063-6294a90a7b3d2026-08-24WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.