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 3 of 142 · 2,836 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Drainage-ToneCALCAREA IODATA, CAPSICUM ANNUUM, COENZYME A, ECHINACEA ANGUSTIFOLIA, EQUISETUM ARVENSE, HYDRASTIS CANADENSIS, NADIDUM, NITRICUM ACIDUM, OLEUM MORRHUAE, PETROSELINUM SATIVUM, PHYTOLACCA DECANDRA, SCROPHULARIA NODOSA, SILICEA, SINAPIS ALBA, THUJA OCCIDENTALIS.Energetix Corporation296b455e-27c5-4f6e-929d-c4ee75b7fb0e2026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
HypothalmapathGELSEMIUM, GINKGO, GLYCYRRHIZA, HYDROCOTYLE, HYPOTHALAMUS, PETROSELINUM, PITUITARUM POSTERIUM, PYRIDOXINUM HYDROCHLORICUM, SENNA, SILICEAEnergetix Corporation3c4e2867-4d75-416b-9f3d-e6e500e46f6f2026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
Lipo-ChordACETICUM AC, ACETYLSAL AC, ADRENOCORTICOTROPHIN, ALUMINA, ARSENICUM ALB, BORAGO, CEANOTHUS, CHELIDONIUM MAJ, CHIONANTHUS, CHLORAMPHENICOLUM, CHLORPROMAZINUM, CHOLESTERINUM, CORTISONE ACETICUM, DAMIANA, FOLLICULINUM, FUMARICUM AC, KALI IOD, LYCOPODIUM, NAT SULPHURICUM, NUX VOM, OLEUM MORRHUAE, PETROLEUM, PHENACETINUM, PHOSPHORICUM AC, PHOSPHORUS, PLUMB MET, SACCHARUM OFF, SILICEA, TARAXACUM, THYROIDINUM.Energetix Corporation5c83cbd5-46fb-48a0-a739-ff9c81e7129c2026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
Lymph-Tone IIAESCULUS HIPP, AZADIRACHTA, BARYTA CARB, BERBER VULG, BOLDO, BUFO, CALC CARB, CALC PHOS, COENZYME A, COLLINSONIA, ECHINACEA, FERRUM PHOS, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS, KREOSOTUM, NADIDUM, NAT MUR, PHOS, PHYTOLACCA, PINUS SYL, PITUITARUM POSTERIUM, PIX LIQUIDA, PULSATILLA, SILICEA, STILLINGIA, THUJA OCC.Energetix Corporationc46aa8d3-4aa5-4e07-be3d-d71abc5e24072026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DR. SAMRAO'S OFFICE58b2ca35-11ed-d848-e063-6294a90a5b372026-08-11WarningsExact identifier
unii: 15FIX9V2JP
Lymph-Tone IIIADENOSINUM CYCLOPHOSPHORICUM, ARNICA, BOLDO, CALC IOD, CALENDULA, CARTILAGO SUIS, CEANOTHUS, COENZYME A, ECHINACEA, HAMAMELIS, HEPAR SULPH CALC, HYPOTHALAMUS, NADIDUM, NAJA, NAT SULPHURICUM, PHASEOLUS, PHOS, PHYTOLACCA, PINUS SYL, PITUITARUM POSTERIUM, PYROGENIUM, SILICEA, SULPHUR, THUJA OCC, THYROIDINUM, VISCUMEnergetix Corporation4c9ae54c-ce7d-4276-add7-2922a8f0e3102026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
MetabopathADENOSINUM CYCLOPHOSPHORICUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, BERBERIS VULGARIS, CITRICUM ACIDUM, COENZYME A, DNA, FUMARICUM ACIDUM, GLYCYRRHIZA GLABRA, HEPAR SULPHURIS CALCAREUM, LAPPA MAJOR, MAGNESIA PHOSPHORICA, MANGANUM ACETICUM, NADIDUM, NATRUM MURIATICUM, NATRUM OXALACETICUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PULSATILLA, PYRIDOXINUM HYDROCHLORICUM, RHAMNUS PURSHIANA, RIBOFLAVINUM, RNA, SILICEA, SUCCINICUM ACIDUM, SULPHUR, THIAMINUM HYDROCHLORICUM,Energetix Corporation58bfe670-d308-45a2-8046-7897b62214522026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
Vac-ChordALUMINA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BELLADONNA, BOLDO, CALCAREA CARBONICA, CARDUUS MARIANUS, CHAMOMILLA, CHELIDONIUM MAJUS, ECHINACEA, HYDRASTIS CANADENSIS, LECITHIN, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, MORBILLINUM, PERTUSSINUM, PHYTOLACCA DECANDRA, PYROGENIUM, RHUS TOX, SILICEA, SULPHUR, TARAXACUM OFFICINALE, THUJA OCCIDENTALIS, THYROIDINUM.Energetix Corporation880ea1e6-8d4d-486e-9a8f-9d3158a996672026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
Tox-ChordALFALFA, ALUMINA, BENZOICUM AC, CARBONEUM, CETRARIA, FOLLICULINUM, FUCUS, FUMARICUM AC, HEPAR SUIS, KALI CARB, KREOSOTUM, NAT MUR, PARAFFINUM, PETROLEUM, PHOSPHORICUM AC, PHOS, PIX LIQUIDA, PLANTAGO, PLUMB MET, PULSATILLA, RADIUM BROM, RESORCINUM, SALOL, SILICEA, SYMPHYTUM, TABACUM, TEREBINTHINA, THYROIDINUM, TRITICUM, ZINC OXYD.Energetix Corporationb06b4794-e5bb-4ccd-87fd-37afca7b0f982026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
Thyro-ChordHOMEOPATHIC LIQUIDEnergetix Corporation6655b504-dfa8-46df-9d3a-b7fa4078207e2026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
Para-ChordHOMEOPATHIC LIQUIDEnergetix Corporation9f8f646e-634a-47ff-b208-b2249d685e552026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
MycoCan-ChordALUMINA, AVENA SATIVA, BORAX, CANDIDA ALBICANS, CARBOLICUM ACIDUM, CEANOTHUS AMERICANUS, ECHINACEA, GAULTHERIA PROCUMBENS, GLANDULA SUPRARENALIS SUIS, HYDRASTIS CANADENSIS, LINUM USITATISSIMUM, LITHIUM CARBONICUM, MEDULLA OSSIS SUIS, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHYTOLACCA DECANDRA, SARCOLACTICUM ACIDUM, SEPIA, SILICEA, SOLIDAGO VIRGAUREA, TELLURIUM METALLICUM, TEUCRIUM MARUM, ZINCUM METALLICUMEnergetix Corporation227199f8-a45e-44ff-892d-ade4fefea3542026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
Cyclobenzaprine HydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEREMEDYREPACK INC.b09ca979-ab6b-441b-a66f-41ca32eae6cb2026-08-10Warnings, Adverse reactionsExact identifier
rxcui: 828348
unii: 0VE05JYS2P
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
CYCLOBENZAPRINE HYDROCHLORIDECYCLOBENZAPRINE HYDROCHLORIDEREMEDYREPACK INC.8bef97d4-1b92-4316-8733-7751d627230f2026-08-07Warnings, Adverse reactionsExact identifier
rxcui: 828348
unii: 0VE05JYS2P
VEIRFOO Brightening Hydrating Antiwrinkle SunscreenTITANIUM DIOXIDE, OCTINOXATELCM TECHNOLOGY Co., Ltd4cbbf8aa-8910-b7e7-e063-6294a90a4f072026-08-07WarningsExact identifier
unii: 15FIX9V2JP
EltaMD UV RestoreTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc37fee381-ce6b-4949-9a4a-778aa839fb842026-08-06WarningsExact identifier
unii: 15FIX9V2JP
Cyclobenzaprine hydrochlorideCYCLOBENZAPRINE HYDROCHLORIDEREMEDYREPACK INC.eb2b24b1-2851-440f-9075-b6a123a1fd5c2026-08-05Warnings, Adverse reactionsExact identifier
rxcui: 828320
unii: 0VE05JYS2P
ROROBELL WAWA Whitening ToothSILICA, HYDROGEN PEROXIDE, TOCOPHERYL ACETATEROROBELL58336a0d-49dd-ef13-e063-6394a90a38c12026-08-04WarningsExact identifier
unii: ETJ7Z6XBU4
Silicea 6XSILICON DIOXIDEHyland's Inc.db4be3c1-aa7e-24a2-e053-2a95a90a0c662026-08-04WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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