NDC 68084-753-95 - 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
68084-753
Requested NDC
68084-753-95
Package NDCs from labels
68084-753-95, 68084-753-25, 68084-753-11, 68084-753-65
Manufacturer
American Health Packaging
Effective date
2024-12-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Cyclobenzaprine Hydrochloride - American Health PackagingAmerican Health Packaging2024-12-13HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68084-753-11Cyclobenzaprine Hydrochloride1 in 1 BLISTER PACKTABLET, FILM COATED19
68084-753-25Cyclobenzaprine Hydrochloride30 in 1 BOX, UNIT-DOSETABLET, FILM COATED309
68084-753-65Cyclobenzaprine Hydrochloride50 in 1 CARTONTABLET, FILM COATED509
68084-753-95Cyclobenzaprine Hydrochloride1 in 1 BLISTER PACKTABLET, FILM COATED19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-753CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]9Current NDC, Legacy NDC, 4 package rows20241215_5f321a03-ccfb-4c11-ac60-a461a5580c69.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-753-11EA - Each68084-753a5b90c64-a22b-4ced-be79-7040b4536ea612014-07-02
68084-753-21EA - Each68084-75388cbeef1-4a81-475e-a204-ffd0cf01450712014-07-02
68084-753-25EA - Each68084-753822ee498-a47e-4690-98f6-9f568ca1ab4812016-02-04
68084-753-65EA - Each68084-75312a83990-9240-45b0-bc91-34ebb3e4cc7512024-02-14
68084-753-95EA - Each68084-753eb18035b-a36c-4787-bd64-6184f5abbc1c12016-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CYCLOBENZAPRINE HYDROCHLORIDEACTIVE INGREDIENT0VE05JYS2PCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1
CYCLOBENZAPRINEACTIVE MOIETY69O5WQQ5TICYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1
TALCINACTIVE INGREDIENT7SEV7J4R1UCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCYCLOBENZAPRINE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1

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 5 of 142 · 2,836 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Jacksons Cell Salts SILICA 12X 12SILICEAZettl Health Inc.5647dafc-1fff-6a25-e063-6294a90a8b4f2026-07-10Exact identifier
unii: ETJ7Z6XBU4
Bombee Honey Daily Glow Shield SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDEABT ASIA Inc.56112dff-b091-7a56-e063-6294a90a77d32026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DERMIO DERMATOLOGY LLC562f5b0d-6a10-305d-e063-6394a90a59802026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30Suzanne's Skin2soul LLC562fbaa6-f93a-5ec4-e063-6294a90a96342026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINECipla USA Inc.575a31fb-04c5-4001-88a7-c33adbacc6a82026-07-08Warnings, Adverse reactionsExact identifier
rxcui: 828320
rxcui: 828348
unii: 0VE05JYS2P
Aussie Betta Tallow Sunscreen SPF50 SPF50TITANIUM DIOXIDE AND ZINC OXIDE SUNSCREENAUSSIE BETTA HEALTHY CARE PTY LTD56007d82-ff5b-6c26-e063-6294a90a09b62026-07-07WarningsExact identifier
unii: 15FIX9V2JP
Polyvinyl AlcoholPOLYVINYL ALCOHOLAvPAKf18b61da-4033-341a-e053-2a95a90a8ebf2026-07-07WarningsExact identifier
unii: 532B59J990
EELHOE Body Coverage PerfectorTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.5610c3b7-456b-3bc1-e063-6394a90a3fa82026-07-07WarningsExact identifier
unii: 15FIX9V2JP
Premier Tinted Mineral SunscreenBROAD SPECTRUM SPF30Emerald Aesthetics LLC55f88dd1-346c-22a5-e063-6294a90a711f2026-07-06WarningsExact identifier
unii: 15FIX9V2JP
OHUI Ultimate Cover CC Cushion Compact 02 Natural BeigeTITANIUM DIOXIDELG H&H Co., Ltd.d307471c-6cc6-ce48-e053-2995a90a3e022026-07-02WarningsExact identifier
unii: 15FIX9V2JP
Evereden Fluid Silk Mineral Sunscreen PRO SPF50TITANIUM DIOXIDE, ZINC OXIDEEden Brands Inc.2cb7773f-9a05-ad02-e063-6294a90af0242026-07-01WarningsExact identifier
unii: 15FIX9V2JP
The Cell Salt Co. Daily Blend 12 in 1CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEAThe Cell Salt Company LLC55826f59-acf4-7370-e063-6394a90afed72026-07-01WarningsExact identifier
unii: ETJ7Z6XBU4
Cyclobenzaprine HCLCYCLOBENZAPRINE HCLDirect_Rx55683c5c-0f86-9a26-e063-6294a90a8e8c2026-07-01Warnings, Adverse reactionsExact identifier
rxcui: 828348
unii: 0VE05JYS2P
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEProficient Rx LPdfe7288c-a477-4f32-a9ab-00cc981a1a572026-07-01Warnings, Adverse reactionsExact identifier
rxcui: 828348
unii: 0VE05JYS2P
OHUI Ultimate Cover CC Cushion Compact 01 Light BeigeTITANIUM DIOXIDELG H&H Co., Ltd.d2f9c54b-ac4e-5141-e053-2a95a90aa2b82026-06-30WarningsExact identifier
unii: 15FIX9V2JP
Bambusa StannumBAMBUSA STANNUMUriel Pharmacy Inc.a0d4d0ac-e2d2-4381-8f93-e417195218592026-06-30WarningsExact identifier
unii: ETJ7Z6XBU4
TOCOBO Blur Finish Sun Cushion Cotton BlueHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEPICTON Co., Ltd.4d6ddee3-9a76-6c9c-e063-6394a90a15292026-06-29WarningsExact identifier
unii: 15FIX9V2JP
Earth Baby Broad Spectrum SPF 30SUNSCREENEarth Baby, Inc.42556876-74ea-38e6-e054-00144ff8d46c2026-06-28WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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