FDA.reportPublic FDA data

NDC 68071-3805-07 - Cyclobenzaprine Hydrochloride

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
68071-3805
Requested NDC
68071-3805-07
Package NDCs from labels
68071-3805-7, 68071-3805-1, 68071-3805-2, 68071-3805-07
Manufacturer
NuCare Pharmaceuticals, Inc.
Effective date
2026-04-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Cyclobenzaprine Hydrochloride Tablets, USP Film coated Rx onlyNuCare Pharmaceuticals, Inc.2026-04-06HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3805-1Cyclobenzaprine Hydrochloride15 in 1 BOTTLETABLET, FILM COATED153
68071-3805-2Cyclobenzaprine Hydrochloride20 in 1 BOTTLETABLET, FILM COATED203
68071-3805-7Cyclobenzaprine Hydrochloride21 in 1 BOTTLETABLET, FILM COATED213

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3805CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [NUCARE PHARMACEUTICALS, INC.]2Current NDC, 3 package rows20250331_2f89c8f6-7f3c-8396-e063-6294a90a643e.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 120 · 2,382 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEREMEDYREPACK INC.f2eb32c3-3da0-4938-9ed9-ea8420450fde2026-07-27Warnings, Adverse reactionsExact identifier
application number: ANDA208170
rxcui: 828320
unii: 0VE05JYS2P
True Coast SPF 50 Mineral SunscreenZINC OXIDE 18%, TITANIUM DIOXIDE 6%Foshan Sugar Max Cosmetics CO.,Ltd5379466d-8d14-5fc2-e063-6394a90abd7e2026-07-22WarningsExact identifier
unii: 15FIX9V2JP
Droptics Dry Eye ReliefCARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80Droptics LLC29d7614b-f4b7-48e2-97c5-d1bff27731d22026-07-22WarningsExact identifier
unii: 6OZP39ZG8H
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE571f23e9-1126-e32d-e063-6294a90a99512026-07-21WarningsExact identifier
unii: 15FIX9V2JP
MENS SPF50 ALL IN ONE SUNSCREENMENS SPF50 ALL IN ONE SUNSCREENLance (Guangzhou) Biological Technology Co., Ltd.57074480-77fd-cc06-e063-6294a90a28d42026-07-20WarningsExact identifier
unii: 15FIX9V2JP
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc5711364c-f9b4-bfa6-e063-6294a90ace4a2026-07-20WarningsExact identifier
unii: 15FIX9V2JP
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDETruPharma LLC08adc97f-feef-46fb-ac75-f015b4f3a43a2026-07-17Warnings, Adverse reactionsExact identifier
application number: ANDA208170
rxcui: 828299
rxcui: 828320
rxcui: 828348
unii: 0VE05JYS2P
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.4ee4feec-4590-fa7f-e063-6394a90a55502026-07-17Warnings, Adverse reactionsExact identifier
application number: ANDA208170
rxcui: 828348
unii: 0VE05JYS2P
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.84be93c5-1526-465e-ab0b-c6d10ba1521d2026-07-15Warnings, Adverse reactionsExact identifier
rxcui: 828348
unii: 0VE05JYS2P
Cyclobenzaprine hydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEREMEDYREPACK INC.51d85ea8-8317-4a76-a108-20383f118ad42026-07-10Warnings, Adverse reactionsExact identifier
rxcui: 828348
unii: 0VE05JYS2P
Bombee Honey Daily Glow Shield SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDEABT ASIA Inc.56112dff-b091-7a56-e063-6294a90a77d32026-07-08WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25- shade BB3 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.4a233350-729a-1e0c-e063-6394a90ad48c2026-07-08WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25- shade BB9 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.4a23f72b-4c33-a100-e063-6294a90ac6322026-07-08WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25- shade BB10 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.4a241d80-b9d2-ea93-e063-6294a90ab3662026-07-08WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25- shade BB8 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.4a23f728-a824-48a6-e063-6394a90acae72026-07-08WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25- shade BB4 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.4a23653a-2481-bd15-e063-6394a90a71332026-07-08WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25- shade BB5 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.4a238f2d-efa9-01d1-e063-6294a90aae6f2026-07-08WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25- shade BB1 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.4a2105a7-6ae8-ed6e-e063-6394a90a3d072026-07-08WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25- shade BB2 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.4a22c1c6-912a-7222-e063-6294a90a54062026-07-08WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25- shade BB7 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.4a23b531-ac53-f0df-e063-6294a90afcf92026-07-08WarningsExact identifier
unii: 15FIX9V2JP