FDA.reportPublic FDA data

NDC 67046-637-03 - Quetiapine fumarate

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
67046-637
Requested NDC
67046-637-03
Package NDCs from labels
67046-637-07, 67046-637-14, 67046-637-15, 67046-637-20, 67046-637-21, 67046-637-60, 67046-637-28, 67046-637-30, 67046-637-03
Manufacturer
Contract Pharmacy Services-PA | Coupler Enterprises Inc.
Effective date
2017-09-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Quetiapine fumarate - Contract Pharmacy Services-PA | Coupler Enterprises Inc.Contract Pharmacy Services-PA | Coupler Enterprises Inc.2017-09-26HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
67046-637-07636 Quetiapine 100 mg 637 Quetiapine 200 mg 638 Quetiapine 300 mg These highlights do not include all the information needed to use Quetiapine Tablets USP safely and effectively. See full prescribing information for Quetiapine Tablets USP. QUETIAPINE Tablets USP, for oral use Initial U.S. Approval: 1997
67046-637-14636 Quetiapine 100 mg 637 Quetiapine 200 mg 638 Quetiapine 300 mg These highlights do not include all the information needed to use Quetiapine Tablets USP safely and effectively. See full prescribing information for Quetiapine Tablets USP. QUETIAPINE Tablets USP, for oral use Initial U.S. Approval: 1997
67046-637-15636 Quetiapine 100 mg 637 Quetiapine 200 mg 638 Quetiapine 300 mg These highlights do not include all the information needed to use Quetiapine Tablets USP safely and effectively. See full prescribing information for Quetiapine Tablets USP. QUETIAPINE Tablets USP, for oral use Initial U.S. Approval: 1997
67046-637-20636 Quetiapine 100 mg 637 Quetiapine 200 mg 638 Quetiapine 300 mg These highlights do not include all the information needed to use Quetiapine Tablets USP safely and effectively. See full prescribing information for Quetiapine Tablets USP. QUETIAPINE Tablets USP, for oral use Initial U.S. Approval: 1997
67046-637-21636 Quetiapine 100 mg 637 Quetiapine 200 mg 638 Quetiapine 300 mg These highlights do not include all the information needed to use Quetiapine Tablets USP safely and effectively. See full prescribing information for Quetiapine Tablets USP. QUETIAPINE Tablets USP, for oral use Initial U.S. Approval: 1997
67046-637-28636 Quetiapine 100 mg 637 Quetiapine 200 mg 638 Quetiapine 300 mg These highlights do not include all the information needed to use Quetiapine Tablets USP safely and effectively. See full prescribing information for Quetiapine Tablets USP. QUETIAPINE Tablets USP, for oral use Initial U.S. Approval: 1997
67046-637-30636 Quetiapine 100 mg 637 Quetiapine 200 mg 638 Quetiapine 300 mg These highlights do not include all the information needed to use Quetiapine Tablets USP safely and effectively. See full prescribing information for Quetiapine Tablets USP. QUETIAPINE Tablets USP, for oral use Initial U.S. Approval: 1997
67046-637-60636 Quetiapine 100 mg 637 Quetiapine 200 mg 638 Quetiapine 300 mg These highlights do not include all the information needed to use Quetiapine Tablets USP safely and effectively. See full prescribing information for Quetiapine Tablets USP. QUETIAPINE Tablets USP, for oral use Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-637-07Quetiapine fumarate7 in 1 BLISTER PACKTABLET71
67046-637-14Quetiapine fumarate14 in 1 BLISTER PACKTABLET141
67046-637-15Quetiapine fumarate15 in 1 BLISTER PACKTABLET151
67046-637-20Quetiapine fumarate20 in 1 BLISTER PACKTABLET201
67046-637-21Quetiapine fumarate21 in 1 BLISTER PACKTABLET211
67046-637-28Quetiapine fumarate28 in 1 BLISTER PACKTABLET281
67046-637-30Quetiapine fumarate30 in 1 BLISTER PACKTABLET301
67046-637-60Quetiapine fumarate60 in 1 BLISTER PACKTABLET601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-637QUETIAPINE FUMARATE (QUETIAPINE) TABLET [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 8 package rows20170926_5a19e429-21d0-efd1-e053-2a91aa0acb63.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 115 · 2,290 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
Dr.Harry EYES PROTECTIONPOLYETHYLENE GLYCOL 400 1% EYES PROTECTIONWenzhou Yuyuan Pharmaceutical Co., Ltd.5a9fe033-89d3-da62-e063-6294a90a45032026-09-03WarningsExact identifier
unii: B697894SGQ
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
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
Quetiapine fumarateQUETIAPINE FUMARATEPreferred Pharmaceuticals Inc.711f42c5-0719-46de-81fb-3d03801b9ed92026-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA201109
rxcui: 317174
rxcui: 312743
unii: 2S3PL1B6UJ
Quetiapine FumarateQUETIAPINE FUMARATEPreferred Pharmaceuticals Inc.717b55c4-a23f-4d74-8023-0f4e14d89ec82026-08-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 616487
unii: 2S3PL1B6UJ
MELAO zinc stick(GREEN)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c70c82-f7ff-9a04-e063-6294a90a7b3d2026-08-24WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.59d74e3f-e3fa-a7a9-e063-6294a90a76e52026-08-24WarningsExact identifier
unii: 15FIX9V2JP
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: 15FIX9V2JP
HEADHUNTER SURF SCREEN SPF 50 SUNSCREENZINC OXIDE,TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.4339df13-77d3-31a1-e063-6394a90a52082026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Quetiapine fumarateQUETIAPINE FUMARATENuCare Pharmaceuticals,Inc.227b8b2b-a238-efb4-e063-6394a90acc7e2026-08-17Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA201109
rxcui: 312744
unii: 2S3PL1B6UJ
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30HAMBLIN DERMATOLOGY5942e64c-416e-7525-e063-6394a90a28392026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Protect Tinted Mineral SunscreenBROAD SPECTRUM SPF30Opal Day Spa5943413a-48e1-0bdf-e063-6294a90a2fff2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30MedSpa By Beauty Bar LLC5943ba3d-688e-9e9c-e063-6294a90afa9a2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30CORBY, JR., TERRY L.594443fd-8e27-4ec6-e063-6294a90a3ff02026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: B697894SGQ
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DR. SAMRAO'S OFFICE58b2ca35-11ed-d848-e063-6294a90a5b372026-08-11WarningsExact identifier
unii: 15FIX9V2JP
SYSTANE HYDRATION PF PRESERVATIVE FREEPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.8936f66f-10fe-44ab-a26e-dd8b05dfa9972026-08-10WarningsExact identifier
unii: B697894SGQ
Journee Firm Riche Broad Spectrum Sunscreen SPF 30TITANIUM DIOXIDE AND ZINC OXIDEMerz North America, Inc.d4d4bfcf-3674-4847-8ad8-1716a8e821ae2026-08-10WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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