{
"NDC": [
{
"NDCCode": "70481-311-24",
"PackageDescription": "236 mL in 1 BOTTLE, SPRAY (70481-311-24) ",
"NDC11Code": "70481-0311-24",
"ProductNDC": "70481-311",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hyr Hand Sanitizer",
"NonProprietaryName": "Ethanol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200405",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "General Resources LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "73",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200405",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. Hand sanitizing to help reduce bacteria on the skin."
},
{
"NDCCode": "70481-311-06",
"PackageDescription": "60 mL in 1 BOTTLE, SPRAY (70481-311-06) ",
"NDC11Code": "70481-0311-06",
"ProductNDC": "70481-311",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hyr Hand Sanitizer",
"NonProprietaryName": "Ethanol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200405",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "General Resources LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "73",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200405",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. Hand sanitizing to help reduce bacteria on the skin."
},
{
"NDCCode": "70481-311-26",
"PackageDescription": "3800 mL in 1 JUG (70481-311-26) ",
"NDC11Code": "70481-0311-26",
"ProductNDC": "70481-311",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hyr Hand Sanitizer",
"NonProprietaryName": "Ethanol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200405",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "General Resources LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "73",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200405",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. Hand sanitizing to help reduce bacteria on the skin."
},
{
"NDCCode": "27854-311-01",
"PackageDescription": "1 PATCH in 1 POUCH (27854-311-01) / .24 g in 1 PATCH",
"NDC11Code": "27854-0311-01",
"ProductNDC": "27854-311",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Flanax Back Pain Relief",
"NonProprietaryName": "Lidocaine",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200201",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Belmora Llc",
"SubstanceName": "LIDOCAINE",
"StrengthNumber": "4",
"StrengthUnit": "g/100g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2024-10-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200201",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieves minor pain."
},
{
"NDCCode": "50066-311-24",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (50066-311-24) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
"NDC11Code": "50066-0311-24",
"ProductNDC": "50066-311",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tukol Night Time Cold And Flu Relief Softgels",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, And Doxylamine Succinate",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20230110",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Genomma Lab USA",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE",
"StrengthNumber": "325; 15; 6.25",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20230110",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves common cold and flu symptoms: 1 cough due to minor throat and bronchial irritation, 2 sore throat, 3 headache, 4 minor aches and pains, 5 fever, 6 runny nose and sneezing."
},
{
"NDCCode": "52328-311-02",
"PackageDescription": "24 POUCH in 1 CARTON (52328-311-02) / 1 mL in 1 POUCH",
"NDC11Code": "52328-0311-02",
"ProductNDC": "52328-311",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Neutrogena Collagen Bank Spf Moisturizer Sunscreen Broad Spectrum Spf 30",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250301",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Acupac Packaging, Inc.",
"SubstanceName": "OCTOCRYLENE; AVOBENZONE; OCTISALATE; HOMOSALATE",
"StrengthNumber": "80; 25; 45; 60",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Active",
"LastUpdate": "2026-04-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250609",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun ."
},
{
"NDCCode": "54473-311-24",
"PackageDescription": "71 mL in 1 BOTTLE (54473-311-24) ",
"NDC11Code": "54473-0311-24",
"ProductNDC": "54473-311",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Clear Defense",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200331",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "Melaleuca, Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "150.97",
"StrengthUnit": "g/266mL",
"Status": "Active",
"LastUpdate": "2025-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200331",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: 1 to reduce bacteria on the skin, 2 recommended for repeated use ."
},
{
"NDCCode": "54622-311-01",
"PackageDescription": "24 BOTTLE, PUMP in 1 BOX (54622-311-01) / 45 mL in 1 BOTTLE, PUMP",
"NDC11Code": "54622-0311-01",
"ProductNDC": "54622-311",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pacific Blue Select Foam Hand Sanitizer, Fragrance Free, Dye Free",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180607",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Georgia-Pacific Consumer Products",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2024-05-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180607",
"SamplePackage": "N",
"IndicationAndUsage": "To decrease bacteria on skin that could cause disease. Recommended for repeated use."
},
{
"NDCCode": "67091-311-24",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (67091-311-24) / 6 TABLET, CHEWABLE in 1 BLISTER PACK",
"NDC11Code": "67091-0311-24",
"ProductNDC": "67091-311",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Childrens Acetaminophen",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20050128",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "WinCo Foods, LLC",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "160",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-08-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20050128",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to: headachesore throatflutoothachethe common cold. temporarily reduces fever."
},
{
"NDCCode": "70481-001-24",
"PackageDescription": "240 mL in 1 BOTTLE, SPRAY (70481-001-24) ",
"NDC11Code": "70481-0001-24",
"ProductNDC": "70481-001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "All Day Hand Sanitizer",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160801",
"EndMarketingDate": "20201031",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "General Resources LLC",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".13",
"StrengthUnit": "g/mL",
"Status": "Deprecated",
"LastUpdate": "2020-11-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160801",
"EndMarketingDatePackage": "20201031",
"SamplePackage": "N"
},
{
"NDCCode": "70481-021-24",
"PackageDescription": "120 mL in 1 BOTTLE, SPRAY (70481-021-24) ",
"NDC11Code": "70481-0021-24",
"ProductNDC": "70481-021",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "All Day Antimicrobial Foot Cleanser",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160801",
"EndMarketingDate": "20201031",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "General Resources LLC",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".13",
"StrengthUnit": "g/mL",
"Status": "Deprecated",
"LastUpdate": "2020-11-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160801",
"EndMarketingDatePackage": "20201031",
"SamplePackage": "N"
},
{
"NDCCode": "70481-111-24",
"PackageDescription": ".237 L in 1 BOTTLE, SPRAY (70481-111-24) ",
"NDC11Code": "70481-0111-24",
"ProductNDC": "70481-111",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "All Day Hand Sanitizer Ultra",
"NonProprietaryName": "Ethanol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160825",
"EndMarketingDate": "20201031",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "General Resources LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "720",
"StrengthUnit": "g/L",
"Status": "Deprecated",
"LastUpdate": "2020-11-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160825",
"EndMarketingDatePackage": "20201031",
"SamplePackage": "N"
},
{
"NDCCode": "70481-300-24",
"PackageDescription": "237 mL in 1 BOTTLE, SPRAY (70481-300-24) ",
"NDC11Code": "70481-0300-24",
"ProductNDC": "70481-300",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hyr Hand Sanitizer",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200404",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "General Resources LLC",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".13",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200404",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. Hand sanitizing to help reduce bacteria on the skin."
},
{
"NDCCode": "70481-301-24",
"PackageDescription": "250 mL in 1 BOTTLE, PLASTIC (70481-301-24) ",
"NDC11Code": "70481-0301-24",
"ProductNDC": "70481-301",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hyr Hand Sanitizer With Aloe Vera",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201024",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "General Resources LLC",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".13",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20201024",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. Hand sanitizing to help reduce bacteria on the skin."
},
{
"NDCCode": "70481-302-24",
"PackageDescription": "250 mL in 1 BOTTLE, PLASTIC (70481-302-24) ",
"NDC11Code": "70481-0302-24",
"ProductNDC": "70481-302",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hyr Hand Sanitizer With Aloe Vera",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201024",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "General Resources LLC",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".13",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20201024",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. Hand sanitizing to help reduce bacteria on the skin."
},
{
"NDCCode": "70481-303-24",
"PackageDescription": "250 mL in 1 BOTTLE, PLASTIC (70481-303-24) ",
"NDC11Code": "70481-0303-24",
"ProductNDC": "70481-303",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hyr Hand Sanitizer With Aloe Vera",
"ProprietaryNameSuffix": "Lavender",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201024",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "General Resources LLC",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".13",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20201024",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. Hand sanitizing to help reduce bacteria on the skin."
},
{
"NDCCode": "70481-304-24",
"PackageDescription": "250 mL in 1 BOTTLE, PLASTIC (70481-304-24) ",
"NDC11Code": "70481-0304-24",
"ProductNDC": "70481-304",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hyr Hand Sanitizer With Aloe Vera",
"ProprietaryNameSuffix": "Lavender",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201024",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "General Resources LLC",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".13",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20201024",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. Hand sanitizing to help reduce bacteria on the skin."
},
{
"NDCCode": "70481-320-24",
"PackageDescription": "237 mL in 1 BOTTLE, SPRAY (70481-320-24) ",
"NDC11Code": "70481-0320-24",
"ProductNDC": "70481-320",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hyr Hydrogen Peroxide",
"ProprietaryNameSuffix": "First Aid Antiseptic",
"NonProprietaryName": "Hydrogen Peroxide",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200826",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "General Resources LLC",
"SubstanceName": "HYDROGEN PEROXIDE",
"StrengthNumber": "3",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200826",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. First aid to help prevent infection in minor cuts, scrapes, and burns."
},
{
"NDCCode": "12634-528-74",
"PackageDescription": "24 TABLET in 1 BOTTLE (12634-528-74)",
"NDC11Code": "12634-0528-74",
"ProductNDC": "12634-528",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclobenzaprine Hydrochloride",
"NonProprietaryName": "Cyclobenzaprine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120402",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090478",
"LabelerName": "Apotheca Inc.",
"SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Cyclobenzaprine hydrochloride tablets USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. cyclobenzaprine hydrochloride has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
"Description": "Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the empirical formula C 20H 21NHCl and a molecular weight of 311.9. It has a melting point of 217°C, and a pK a of 8.47 at 25°C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine hydrochloride, USP is designated chemically as 3-( 5H –dibenzo[ a,d]cyclohepten-5-ylidene)- N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula:. Cyclobenzaprine hydrochloride USP, 5 mg is supplied as a 5 mg tablet for oral administration. Cyclobenzaprine hydrochloride USP, 10 mg is supplied as a 10 mg tablet for oral administration. Cyclobenzaprine hydrochloride tablets USP, 5 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry beige (hypromellose 6cP, titanium dioxide, PEG 400, iron oxide yellow and iron oxide red). Cyclobenzaprine hydrochloride tablets USP, 10 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry yellow (hypromellose 3cp, hypromellose 6cp, titanium dioxide, PEG 400, iron oxide yellow and polysorbate 80)."
},
{
"NDCCode": "31722-282-01",
"PackageDescription": "24 BOTTLE in 1 CASE (31722-282-01) > 100 TABLET in 1 BOTTLE",
"NDC11Code": "31722-0282-01",
"ProductNDC": "31722-282",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclobenzaprine Hydrochloride",
"NonProprietaryName": "Cyclobenzaprine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120402",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090478",
"LabelerName": "Camber Pharmaceuticals",
"SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Cyclobenzaprine hydrochloride tablets USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. cyclobenzaprine hydrochloride has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
"Description": "Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the empirical formula C20H21NHCl and a molecular weight of 311.9. It has a melting point of 217°C, and a pKa of 8.47 at 25°C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine hydrochloride, USP is designated chemically as 3-(5H –dibenzo[a,d]cyclohepten-5-ylidene)-N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine hydrochloride USP, 5 mg is supplied as a 5 mg tablet for oral administration. Cyclobenzaprine hydrochloride USP, 10 mg is supplied as a 10 mg tablet for oral administration. Cyclobenzaprine hydrochloride tablets USP, 5 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry beige (hypromellose 6cP, titanium dioxide, PEG 400, iron oxide yellow and iron oxide red). Cyclobenzaprine hydrochloride tablets USP, 10 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry yellow (hypromellose 3cp, hypromellose 6cp, titanium dioxide, PEG 400, iron oxide yellow and polysorbate 80)."
},
{
"NDCCode": "31722-282-05",
"PackageDescription": "24 BOTTLE in 1 CASE (31722-282-05) > 500 TABLET in 1 BOTTLE",
"NDC11Code": "31722-0282-05",
"ProductNDC": "31722-282",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclobenzaprine Hydrochloride",
"NonProprietaryName": "Cyclobenzaprine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120402",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090478",
"LabelerName": "Camber Pharmaceuticals",
"SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Cyclobenzaprine hydrochloride tablets USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. cyclobenzaprine hydrochloride has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
"Description": "Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the empirical formula C20H21NHCl and a molecular weight of 311.9. It has a melting point of 217°C, and a pKa of 8.47 at 25°C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine hydrochloride, USP is designated chemically as 3-(5H –dibenzo[a,d]cyclohepten-5-ylidene)-N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine hydrochloride USP, 5 mg is supplied as a 5 mg tablet for oral administration. Cyclobenzaprine hydrochloride USP, 10 mg is supplied as a 10 mg tablet for oral administration. Cyclobenzaprine hydrochloride tablets USP, 5 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry beige (hypromellose 6cP, titanium dioxide, PEG 400, iron oxide yellow and iron oxide red). Cyclobenzaprine hydrochloride tablets USP, 10 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry yellow (hypromellose 3cp, hypromellose 6cp, titanium dioxide, PEG 400, iron oxide yellow and polysorbate 80)."
},
{
"NDCCode": "31722-283-01",
"PackageDescription": "24 BOTTLE in 1 CASE (31722-283-01) > 100 TABLET in 1 BOTTLE",
"NDC11Code": "31722-0283-01",
"ProductNDC": "31722-283",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclobenzaprine Hydrochloride",
"NonProprietaryName": "Cyclobenzaprine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120402",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090478",
"LabelerName": "Camber Pharmaceuticals",
"SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Cyclobenzaprine hydrochloride tablets USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. cyclobenzaprine hydrochloride has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
"Description": "Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the empirical formula C20H21NHCl and a molecular weight of 311.9. It has a melting point of 217°C, and a pKa of 8.47 at 25°C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine hydrochloride, USP is designated chemically as 3-(5H –dibenzo[a,d]cyclohepten-5-ylidene)-N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine hydrochloride USP, 5 mg is supplied as a 5 mg tablet for oral administration. Cyclobenzaprine hydrochloride USP, 10 mg is supplied as a 10 mg tablet for oral administration. Cyclobenzaprine hydrochloride tablets USP, 5 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry beige (hypromellose 6cP, titanium dioxide, PEG 400, iron oxide yellow and iron oxide red). Cyclobenzaprine hydrochloride tablets USP, 10 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry yellow (hypromellose 3cp, hypromellose 6cp, titanium dioxide, PEG 400, iron oxide yellow and polysorbate 80)."
},
{
"NDCCode": "31722-283-10",
"PackageDescription": "24 BOTTLE in 1 CASE (31722-283-10) > 1000 TABLET in 1 BOTTLE",
"NDC11Code": "31722-0283-10",
"ProductNDC": "31722-283",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclobenzaprine Hydrochloride",
"NonProprietaryName": "Cyclobenzaprine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120402",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090478",
"LabelerName": "Camber Pharmaceuticals",
"SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Cyclobenzaprine hydrochloride tablets USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. cyclobenzaprine hydrochloride has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
"Description": "Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the empirical formula C20H21NHCl and a molecular weight of 311.9. It has a melting point of 217°C, and a pKa of 8.47 at 25°C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine hydrochloride, USP is designated chemically as 3-(5H –dibenzo[a,d]cyclohepten-5-ylidene)-N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine hydrochloride USP, 5 mg is supplied as a 5 mg tablet for oral administration. Cyclobenzaprine hydrochloride USP, 10 mg is supplied as a 10 mg tablet for oral administration. Cyclobenzaprine hydrochloride tablets USP, 5 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry beige (hypromellose 6cP, titanium dioxide, PEG 400, iron oxide yellow and iron oxide red). Cyclobenzaprine hydrochloride tablets USP, 10 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry yellow (hypromellose 3cp, hypromellose 6cp, titanium dioxide, PEG 400, iron oxide yellow and polysorbate 80)."
},
{
"NDCCode": "50024-311-00",
"PackageDescription": "1 SYRINGE in 1 CARTON (50024-311-00) / .5 mL in 1 SYRINGE (50024-311-01) ",
"NDC11Code": "50024-0311-00",
"ProductNDC": "50024-311",
"ProductTypeName": "VACCINE",
"NonProprietaryName": "Respiratory Syncytial Virus Vaccine",
"DosageFormName": "SUSPENSION",
"StartMarketingDate": "20240531",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "ROVI Pharma Industrial Services S.A.",
"SubstanceName": "RNA-100-AR02",
"StrengthNumber": "50",
"StrengthUnit": "ug/.5mL",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "31-MAY-24"
},
{
"NDCCode": "50024-311-10",
"PackageDescription": "10 SYRINGE in 1 CARTON (50024-311-10) / .5 mL in 1 SYRINGE (50024-311-11) ",
"NDC11Code": "50024-0311-10",
"ProductNDC": "50024-311",
"ProductTypeName": "VACCINE",
"NonProprietaryName": "Respiratory Syncytial Virus Vaccine",
"DosageFormName": "SUSPENSION",
"StartMarketingDate": "20240531",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "ROVI Pharma Industrial Services S.A.",
"SubstanceName": "RNA-100-AR02",
"StrengthNumber": "50",
"StrengthUnit": "ug/.5mL",
"Status": "Unfinished",
"LastUpdate": "2025-04-11",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "31-MAY-24"
},
{
"NDCCode": "50024-311-20",
"PackageDescription": "2 SYRINGE in 1 CARTON (50024-311-20) / .5 mL in 1 SYRINGE (50024-311-21) ",
"NDC11Code": "50024-0311-20",
"ProductNDC": "50024-311",
"ProductTypeName": "VACCINE",
"NonProprietaryName": "Respiratory Syncytial Virus Vaccine",
"DosageFormName": "SUSPENSION",
"StartMarketingDate": "20240531",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "ROVI Pharma Industrial Services S.A.",
"SubstanceName": "RNA-100-AR02",
"StrengthNumber": "50",
"StrengthUnit": "ug/.5mL",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "31-MAY-24"
},
{
"NDCCode": "50090-5756-0",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (50090-5756-0) ",
"NDC11Code": "50090-5756-00",
"ProductNDC": "50090-5756",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclobenzaprine Hydrochloride",
"NonProprietaryName": "Cyclobenzaprine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200706",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213324",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20211001",
"SamplePackage": "N",
"IndicationAndUsage": "Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets, USP should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets, USP has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
"Description": "Cyclobenzaprine hydrochloride, USP is a white to off-white, odorless, crystalline powder with the molecular formula C20H21NHCl and a molecular weight of 311.85. It has a melting point between 215°C to 219°C and a pKa of 8.47. It is freely soluble in water, in alcohol, and in methanol, sparingly soluble in isopropanol, slightly soluble in chloroform and in methylene chloride, insoluble in n-Hexane. Cyclobenzaprine HCl, USP is designated chemically as 3-(5H-Dibenzo[a,d] cyclohepten-5 ylidene)-N,N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine hydrochloride USP, 5 mg is supplied as a 5 mg tablet for oral administration. Cyclobenzaprine hydrochloride USP, 7.5 mg is supplied as a 7.5 mg tablet for oral administration. Cyclobenzaprine hydrochloride USP, 10 mg is supplied as a 10 mg tablet for oral administration. Cyclobenzaprine hydrochloride tablets, USP 5 mg contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide and triacetin. Cyclobenzaprine hydrochloride tablets, USP 7.5 mg contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide, triacetin and yellow iron oxide. Cyclobenzaprine hydrochloride tablets, USP 10 mg contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, FD&C Blue No. 2 Aluminium Lake, hypromellose, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide, triacetin and yellow iron oxide. FDA approved organic impurities test acceptance criterion differs from the USP organic impurities test acceptance criterion in Cyclobenzaprine Hydrochloride Tablets."
},
{
"NDCCode": "50090-5756-1",
"PackageDescription": "20 TABLET, FILM COATED in 1 BOTTLE (50090-5756-1) ",
"NDC11Code": "50090-5756-01",
"ProductNDC": "50090-5756",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclobenzaprine Hydrochloride",
"NonProprietaryName": "Cyclobenzaprine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200706",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213324",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20211001",
"SamplePackage": "N",
"IndicationAndUsage": "Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets, USP should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets, USP has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
"Description": "Cyclobenzaprine hydrochloride, USP is a white to off-white, odorless, crystalline powder with the molecular formula C20H21NHCl and a molecular weight of 311.85. It has a melting point between 215°C to 219°C and a pKa of 8.47. It is freely soluble in water, in alcohol, and in methanol, sparingly soluble in isopropanol, slightly soluble in chloroform and in methylene chloride, insoluble in n-Hexane. Cyclobenzaprine HCl, USP is designated chemically as 3-(5H-Dibenzo[a,d] cyclohepten-5 ylidene)-N,N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine hydrochloride USP, 5 mg is supplied as a 5 mg tablet for oral administration. Cyclobenzaprine hydrochloride USP, 7.5 mg is supplied as a 7.5 mg tablet for oral administration. Cyclobenzaprine hydrochloride USP, 10 mg is supplied as a 10 mg tablet for oral administration. Cyclobenzaprine hydrochloride tablets, USP 5 mg contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide and triacetin. Cyclobenzaprine hydrochloride tablets, USP 7.5 mg contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide, triacetin and yellow iron oxide. Cyclobenzaprine hydrochloride tablets, USP 10 mg contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, FD&C Blue No. 2 Aluminium Lake, hypromellose, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide, triacetin and yellow iron oxide. FDA approved organic impurities test acceptance criterion differs from the USP organic impurities test acceptance criterion in Cyclobenzaprine Hydrochloride Tablets."
},
{
"NDCCode": "50090-5756-2",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (50090-5756-2) ",
"NDC11Code": "50090-5756-02",
"ProductNDC": "50090-5756",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclobenzaprine Hydrochloride",
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"RouteName": "ORAL",
"StartMarketingDate": "20200706",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213324",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
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"LastUpdate": "2026-09-24",
"PackageNdcExcludeFlag": "N",
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"IndicationAndUsage": "Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets, USP should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets, USP has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
"Description": "Cyclobenzaprine hydrochloride, USP is a white to off-white, odorless, crystalline powder with the molecular formula C20H21NHCl and a molecular weight of 311.85. It has a melting point between 215°C to 219°C and a pKa of 8.47. It is freely soluble in water, in alcohol, and in methanol, sparingly soluble in isopropanol, slightly soluble in chloroform and in methylene chloride, insoluble in n-Hexane. Cyclobenzaprine HCl, USP is designated chemically as 3-(5H-Dibenzo[a,d] cyclohepten-5 ylidene)-N,N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine hydrochloride USP, 5 mg is supplied as a 5 mg tablet for oral administration. Cyclobenzaprine hydrochloride USP, 7.5 mg is supplied as a 7.5 mg tablet for oral administration. Cyclobenzaprine hydrochloride USP, 10 mg is supplied as a 10 mg tablet for oral administration. Cyclobenzaprine hydrochloride tablets, USP 5 mg contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide and triacetin. Cyclobenzaprine hydrochloride tablets, USP 7.5 mg contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide, triacetin and yellow iron oxide. Cyclobenzaprine hydrochloride tablets, USP 10 mg contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, FD&C Blue No. 2 Aluminium Lake, hypromellose, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide, triacetin and yellow iron oxide. FDA approved organic impurities test acceptance criterion differs from the USP organic impurities test acceptance criterion in Cyclobenzaprine Hydrochloride Tablets."
},
{
"NDCCode": "50090-5756-3",
"PackageDescription": "24 TABLET, FILM COATED in 1 BOTTLE (50090-5756-3) ",
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"ProductNDC": "50090-5756",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclobenzaprine Hydrochloride",
"NonProprietaryName": "Cyclobenzaprine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200706",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213324",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
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"LastUpdate": "2026-09-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20211101",
"SamplePackage": "N",
"IndicationAndUsage": "Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets, USP should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets, USP has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
"Description": "Cyclobenzaprine hydrochloride, USP is a white to off-white, odorless, crystalline powder with the molecular formula C20H21NHCl and a molecular weight of 311.85. It has a melting point between 215°C to 219°C and a pKa of 8.47. It is freely soluble in water, in alcohol, and in methanol, sparingly soluble in isopropanol, slightly soluble in chloroform and in methylene chloride, insoluble in n-Hexane. Cyclobenzaprine HCl, USP is designated chemically as 3-(5H-Dibenzo[a,d] cyclohepten-5 ylidene)-N,N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine hydrochloride USP, 5 mg is supplied as a 5 mg tablet for oral administration. Cyclobenzaprine hydrochloride USP, 7.5 mg is supplied as a 7.5 mg tablet for oral administration. Cyclobenzaprine hydrochloride USP, 10 mg is supplied as a 10 mg tablet for oral administration. Cyclobenzaprine hydrochloride tablets, USP 5 mg contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide and triacetin. Cyclobenzaprine hydrochloride tablets, USP 7.5 mg contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide, triacetin and yellow iron oxide. Cyclobenzaprine hydrochloride tablets, USP 10 mg contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, FD&C Blue No. 2 Aluminium Lake, hypromellose, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide, triacetin and yellow iron oxide. FDA approved organic impurities test acceptance criterion differs from the USP organic impurities test acceptance criterion in Cyclobenzaprine Hydrochloride Tablets."
}
]
}
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<NDC>
<NDCCode>70481-311-24</NDCCode>
<PackageDescription>236 mL in 1 BOTTLE, SPRAY (70481-311-24) </PackageDescription>
<NDC11Code>70481-0311-24</NDC11Code>
<ProductNDC>70481-311</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hyr Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Ethanol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200405</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>General Resources LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>73</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200405</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. Hand sanitizing to help reduce bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70481-311-06</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE, SPRAY (70481-311-06) </PackageDescription>
<NDC11Code>70481-0311-06</NDC11Code>
<ProductNDC>70481-311</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hyr Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Ethanol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200405</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>General Resources LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>73</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200405</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. Hand sanitizing to help reduce bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70481-311-26</NDCCode>
<PackageDescription>3800 mL in 1 JUG (70481-311-26) </PackageDescription>
<NDC11Code>70481-0311-26</NDC11Code>
<ProductNDC>70481-311</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hyr Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Ethanol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200405</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>General Resources LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>73</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200405</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. Hand sanitizing to help reduce bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>27854-311-01</NDCCode>
<PackageDescription>1 PATCH in 1 POUCH (27854-311-01) / .24 g in 1 PATCH</PackageDescription>
<NDC11Code>27854-0311-01</NDC11Code>
<ProductNDC>27854-311</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Flanax Back Pain Relief</ProprietaryName>
<NonProprietaryName>Lidocaine</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>Belmora Llc</LabelerName>
<SubstanceName>LIDOCAINE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves minor pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50066-311-24</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (50066-311-24) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>50066-0311-24</NDC11Code>
<ProductNDC>50066-311</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tukol Night Time Cold And Flu Relief Softgels</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, And Doxylamine Succinate</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230110</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Genomma Lab USA</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE</SubstanceName>
<StrengthNumber>325; 15; 6.25</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230110</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves common cold and flu symptoms: 1 cough due to minor throat and bronchial irritation, 2 sore throat, 3 headache, 4 minor aches and pains, 5 fever, 6 runny nose and sneezing.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>52328-311-02</NDCCode>
<PackageDescription>24 POUCH in 1 CARTON (52328-311-02) / 1 mL in 1 POUCH</PackageDescription>
<NDC11Code>52328-0311-02</NDC11Code>
<ProductNDC>52328-311</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Neutrogena Collagen Bank Spf Moisturizer Sunscreen Broad Spectrum Spf 30</ProprietaryName>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250301</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Acupac Packaging, Inc.</LabelerName>
<SubstanceName>OCTOCRYLENE; AVOBENZONE; OCTISALATE; HOMOSALATE</SubstanceName>
<StrengthNumber>80; 25; 45; 60</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-04-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250609</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>54473-311-24</NDCCode>
<PackageDescription>71 mL in 1 BOTTLE (54473-311-24) </PackageDescription>
<NDC11Code>54473-0311-24</NDC11Code>
<ProductNDC>54473-311</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Clear Defense</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200331</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>Melaleuca, Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>150.97</StrengthNumber>
<StrengthUnit>g/266mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200331</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: 1 to reduce bacteria on the skin, 2 recommended for repeated use .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>54622-311-01</NDCCode>
<PackageDescription>24 BOTTLE, PUMP in 1 BOX (54622-311-01) / 45 mL in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>54622-0311-01</NDC11Code>
<ProductNDC>54622-311</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pacific Blue Select Foam Hand Sanitizer, Fragrance Free, Dye Free</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180607</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Georgia-Pacific Consumer Products</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-05-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180607</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To decrease bacteria on skin that could cause disease. Recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>67091-311-24</NDCCode>
<PackageDescription>4 BLISTER PACK in 1 CARTON (67091-311-24) / 6 TABLET, CHEWABLE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>67091-0311-24</NDC11Code>
<ProductNDC>67091-311</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Childrens Acetaminophen</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050128</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>WinCo Foods, LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-08-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20050128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pains due to: headachesore throatflutoothachethe common cold. temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70481-001-24</NDCCode>
<PackageDescription>240 mL in 1 BOTTLE, SPRAY (70481-001-24) </PackageDescription>
<NDC11Code>70481-0001-24</NDC11Code>
<ProductNDC>70481-001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>All Day Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160801</StartMarketingDate>
<EndMarketingDate>20201031</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>General Resources LLC</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.13</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-11-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160801</StartMarketingDatePackage>
<EndMarketingDatePackage>20201031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70481-021-24</NDCCode>
<PackageDescription>120 mL in 1 BOTTLE, SPRAY (70481-021-24) </PackageDescription>
<NDC11Code>70481-0021-24</NDC11Code>
<ProductNDC>70481-021</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>All Day Antimicrobial Foot Cleanser</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160801</StartMarketingDate>
<EndMarketingDate>20201031</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>General Resources LLC</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.13</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-11-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160801</StartMarketingDatePackage>
<EndMarketingDatePackage>20201031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70481-111-24</NDCCode>
<PackageDescription>.237 L in 1 BOTTLE, SPRAY (70481-111-24) </PackageDescription>
<NDC11Code>70481-0111-24</NDC11Code>
<ProductNDC>70481-111</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>All Day Hand Sanitizer Ultra</ProprietaryName>
<NonProprietaryName>Ethanol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160825</StartMarketingDate>
<EndMarketingDate>20201031</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>General Resources LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>720</StrengthNumber>
<StrengthUnit>g/L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-11-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160825</StartMarketingDatePackage>
<EndMarketingDatePackage>20201031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70481-300-24</NDCCode>
<PackageDescription>237 mL in 1 BOTTLE, SPRAY (70481-300-24) </PackageDescription>
<NDC11Code>70481-0300-24</NDC11Code>
<ProductNDC>70481-300</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hyr Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200404</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>General Resources LLC</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.13</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200404</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. Hand sanitizing to help reduce bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70481-301-24</NDCCode>
<PackageDescription>250 mL in 1 BOTTLE, PLASTIC (70481-301-24) </PackageDescription>
<NDC11Code>70481-0301-24</NDC11Code>
<ProductNDC>70481-301</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hyr Hand Sanitizer With Aloe Vera</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20201024</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>General Resources LLC</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.13</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201024</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. Hand sanitizing to help reduce bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70481-302-24</NDCCode>
<PackageDescription>250 mL in 1 BOTTLE, PLASTIC (70481-302-24) </PackageDescription>
<NDC11Code>70481-0302-24</NDC11Code>
<ProductNDC>70481-302</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hyr Hand Sanitizer With Aloe Vera</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20201024</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>General Resources LLC</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.13</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201024</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. Hand sanitizing to help reduce bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70481-303-24</NDCCode>
<PackageDescription>250 mL in 1 BOTTLE, PLASTIC (70481-303-24) </PackageDescription>
<NDC11Code>70481-0303-24</NDC11Code>
<ProductNDC>70481-303</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hyr Hand Sanitizer With Aloe Vera</ProprietaryName>
<ProprietaryNameSuffix>Lavender</ProprietaryNameSuffix>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20201024</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>General Resources LLC</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.13</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201024</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. Hand sanitizing to help reduce bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70481-304-24</NDCCode>
<PackageDescription>250 mL in 1 BOTTLE, PLASTIC (70481-304-24) </PackageDescription>
<NDC11Code>70481-0304-24</NDC11Code>
<ProductNDC>70481-304</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hyr Hand Sanitizer With Aloe Vera</ProprietaryName>
<ProprietaryNameSuffix>Lavender</ProprietaryNameSuffix>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20201024</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>General Resources LLC</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.13</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201024</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. Hand sanitizing to help reduce bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70481-320-24</NDCCode>
<PackageDescription>237 mL in 1 BOTTLE, SPRAY (70481-320-24) </PackageDescription>
<NDC11Code>70481-0320-24</NDC11Code>
<ProductNDC>70481-320</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hyr Hydrogen Peroxide</ProprietaryName>
<ProprietaryNameSuffix>First Aid Antiseptic</ProprietaryNameSuffix>
<NonProprietaryName>Hydrogen Peroxide</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200826</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>General Resources LLC</LabelerName>
<SubstanceName>HYDROGEN PEROXIDE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200826</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. First aid to help prevent infection in minor cuts, scrapes, and burns.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>12634-528-74</NDCCode>
<PackageDescription>24 TABLET in 1 BOTTLE (12634-528-74)</PackageDescription>
<NDC11Code>12634-0528-74</NDC11Code>
<ProductNDC>12634-528</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120402</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090478</ApplicationNumber>
<LabelerName>Apotheca Inc.</LabelerName>
<SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Cyclobenzaprine hydrochloride tablets USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. cyclobenzaprine hydrochloride has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.</IndicationAndUsage>
<Description>Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the empirical formula C 20H 21NHCl and a molecular weight of 311.9. It has a melting point of 217°C, and a pK a of 8.47 at 25°C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine hydrochloride, USP is designated chemically as 3-( 5H –dibenzo[ a,d]cyclohepten-5-ylidene)- N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula:. Cyclobenzaprine hydrochloride USP, 5 mg is supplied as a 5 mg tablet for oral administration. Cyclobenzaprine hydrochloride USP, 10 mg is supplied as a 10 mg tablet for oral administration. Cyclobenzaprine hydrochloride tablets USP, 5 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry beige (hypromellose 6cP, titanium dioxide, PEG 400, iron oxide yellow and iron oxide red). Cyclobenzaprine hydrochloride tablets USP, 10 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry yellow (hypromellose 3cp, hypromellose 6cp, titanium dioxide, PEG 400, iron oxide yellow and polysorbate 80).</Description>
</NDC>
<NDC>
<NDCCode>31722-282-01</NDCCode>
<PackageDescription>24 BOTTLE in 1 CASE (31722-282-01) > 100 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>31722-0282-01</NDC11Code>
<ProductNDC>31722-282</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120402</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090478</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals</LabelerName>
<SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Cyclobenzaprine hydrochloride tablets USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. cyclobenzaprine hydrochloride has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.</IndicationAndUsage>
<Description>Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the empirical formula C20H21NHCl and a molecular weight of 311.9. It has a melting point of 217°C, and a pKa of 8.47 at 25°C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine hydrochloride, USP is designated chemically as 3-(5H –dibenzo[a,d]cyclohepten-5-ylidene)-N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine hydrochloride USP, 5 mg is supplied as a 5 mg tablet for oral administration. Cyclobenzaprine hydrochloride USP, 10 mg is supplied as a 10 mg tablet for oral administration. Cyclobenzaprine hydrochloride tablets USP, 5 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry beige (hypromellose 6cP, titanium dioxide, PEG 400, iron oxide yellow and iron oxide red). Cyclobenzaprine hydrochloride tablets USP, 10 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry yellow (hypromellose 3cp, hypromellose 6cp, titanium dioxide, PEG 400, iron oxide yellow and polysorbate 80).</Description>
</NDC>
<NDC>
<NDCCode>31722-282-05</NDCCode>
<PackageDescription>24 BOTTLE in 1 CASE (31722-282-05) > 500 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>31722-0282-05</NDC11Code>
<ProductNDC>31722-282</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120402</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090478</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals</LabelerName>
<SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Cyclobenzaprine hydrochloride tablets USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. cyclobenzaprine hydrochloride has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.</IndicationAndUsage>
<Description>Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the empirical formula C20H21NHCl and a molecular weight of 311.9. It has a melting point of 217°C, and a pKa of 8.47 at 25°C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine hydrochloride, USP is designated chemically as 3-(5H –dibenzo[a,d]cyclohepten-5-ylidene)-N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine hydrochloride USP, 5 mg is supplied as a 5 mg tablet for oral administration. Cyclobenzaprine hydrochloride USP, 10 mg is supplied as a 10 mg tablet for oral administration. Cyclobenzaprine hydrochloride tablets USP, 5 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry beige (hypromellose 6cP, titanium dioxide, PEG 400, iron oxide yellow and iron oxide red). Cyclobenzaprine hydrochloride tablets USP, 10 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry yellow (hypromellose 3cp, hypromellose 6cp, titanium dioxide, PEG 400, iron oxide yellow and polysorbate 80).</Description>
</NDC>
<NDC>
<NDCCode>31722-283-01</NDCCode>
<PackageDescription>24 BOTTLE in 1 CASE (31722-283-01) > 100 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>31722-0283-01</NDC11Code>
<ProductNDC>31722-283</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120402</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090478</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals</LabelerName>
<SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Cyclobenzaprine hydrochloride tablets USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. cyclobenzaprine hydrochloride has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.</IndicationAndUsage>
<Description>Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the empirical formula C20H21NHCl and a molecular weight of 311.9. It has a melting point of 217°C, and a pKa of 8.47 at 25°C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine hydrochloride, USP is designated chemically as 3-(5H –dibenzo[a,d]cyclohepten-5-ylidene)-N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine hydrochloride USP, 5 mg is supplied as a 5 mg tablet for oral administration. Cyclobenzaprine hydrochloride USP, 10 mg is supplied as a 10 mg tablet for oral administration. Cyclobenzaprine hydrochloride tablets USP, 5 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry beige (hypromellose 6cP, titanium dioxide, PEG 400, iron oxide yellow and iron oxide red). Cyclobenzaprine hydrochloride tablets USP, 10 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry yellow (hypromellose 3cp, hypromellose 6cp, titanium dioxide, PEG 400, iron oxide yellow and polysorbate 80).</Description>
</NDC>
<NDC>
<NDCCode>31722-283-10</NDCCode>
<PackageDescription>24 BOTTLE in 1 CASE (31722-283-10) > 1000 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>31722-0283-10</NDC11Code>
<ProductNDC>31722-283</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120402</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090478</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals</LabelerName>
<SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Cyclobenzaprine hydrochloride tablets USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. cyclobenzaprine hydrochloride has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.</IndicationAndUsage>
<Description>Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the empirical formula C20H21NHCl and a molecular weight of 311.9. It has a melting point of 217°C, and a pKa of 8.47 at 25°C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine hydrochloride, USP is designated chemically as 3-(5H –dibenzo[a,d]cyclohepten-5-ylidene)-N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine hydrochloride USP, 5 mg is supplied as a 5 mg tablet for oral administration. Cyclobenzaprine hydrochloride USP, 10 mg is supplied as a 10 mg tablet for oral administration. Cyclobenzaprine hydrochloride tablets USP, 5 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry beige (hypromellose 6cP, titanium dioxide, PEG 400, iron oxide yellow and iron oxide red). Cyclobenzaprine hydrochloride tablets USP, 10 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry yellow (hypromellose 3cp, hypromellose 6cp, titanium dioxide, PEG 400, iron oxide yellow and polysorbate 80).</Description>
</NDC>
<NDC>
<NDCCode>50024-311-00</NDCCode>
<PackageDescription>1 SYRINGE in 1 CARTON (50024-311-00) / .5 mL in 1 SYRINGE (50024-311-01) </PackageDescription>
<NDC11Code>50024-0311-00</NDC11Code>
<ProductNDC>50024-311</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<NonProprietaryName>Respiratory Syncytial Virus Vaccine</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<StartMarketingDate>20240531</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>ROVI Pharma Industrial Services S.A.</LabelerName>
<SubstanceName>RNA-100-AR02</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>ug/.5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>31-MAY-24</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>50024-311-10</NDCCode>
<PackageDescription>10 SYRINGE in 1 CARTON (50024-311-10) / .5 mL in 1 SYRINGE (50024-311-11) </PackageDescription>
<NDC11Code>50024-0311-10</NDC11Code>
<ProductNDC>50024-311</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<NonProprietaryName>Respiratory Syncytial Virus Vaccine</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<StartMarketingDate>20240531</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>ROVI Pharma Industrial Services S.A.</LabelerName>
<SubstanceName>RNA-100-AR02</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>ug/.5mL</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-04-11</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>31-MAY-24</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>50024-311-20</NDCCode>
<PackageDescription>2 SYRINGE in 1 CARTON (50024-311-20) / .5 mL in 1 SYRINGE (50024-311-21) </PackageDescription>
<NDC11Code>50024-0311-20</NDC11Code>
<ProductNDC>50024-311</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<NonProprietaryName>Respiratory Syncytial Virus Vaccine</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<StartMarketingDate>20240531</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>ROVI Pharma Industrial Services S.A.</LabelerName>
<SubstanceName>RNA-100-AR02</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>ug/.5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>31-MAY-24</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>50090-5756-0</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (50090-5756-0) </PackageDescription>
<NDC11Code>50090-5756-00</NDC11Code>
<ProductNDC>50090-5756</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200706</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213324</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets, USP should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets, USP has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.</IndicationAndUsage>
<Description>Cyclobenzaprine hydrochloride, USP is a white to off-white, odorless, crystalline powder with the molecular formula C20H21NHCl and a molecular weight of 311.85. It has a melting point between 215°C to 219°C and a pKa of 8.47. It is freely soluble in water, in alcohol, and in methanol, sparingly soluble in isopropanol, slightly soluble in chloroform and in methylene chloride, insoluble in n-Hexane. Cyclobenzaprine HCl, USP is designated chemically as 3-(5H-Dibenzo[a,d] cyclohepten-5 ylidene)-N,N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine hydrochloride USP, 5 mg is supplied as a 5 mg tablet for oral administration. Cyclobenzaprine hydrochloride USP, 7.5 mg is supplied as a 7.5 mg tablet for oral administration. Cyclobenzaprine hydrochloride USP, 10 mg is supplied as a 10 mg tablet for oral administration. Cyclobenzaprine hydrochloride tablets, USP 5 mg contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide and triacetin. Cyclobenzaprine hydrochloride tablets, USP 7.5 mg contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide, triacetin and yellow iron oxide. Cyclobenzaprine hydrochloride tablets, USP 10 mg contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, FD&C Blue No. 2 Aluminium Lake, hypromellose, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide, triacetin and yellow iron oxide. FDA approved organic impurities test acceptance criterion differs from the USP organic impurities test acceptance criterion in Cyclobenzaprine Hydrochloride Tablets.</Description>
</NDC>
<NDC>
<NDCCode>50090-5756-1</NDCCode>
<PackageDescription>20 TABLET, FILM COATED in 1 BOTTLE (50090-5756-1) </PackageDescription>
<NDC11Code>50090-5756-01</NDC11Code>
<ProductNDC>50090-5756</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cyclobenzaprine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200706</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213324</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets, USP should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets, USP has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.</IndicationAndUsage>
<Description>Cyclobenzaprine hydrochloride, USP is a white to off-white, odorless, crystalline powder with the molecular formula C20H21NHCl and a molecular weight of 311.85. It has a melting point between 215°C to 219°C and a pKa of 8.47. It is freely soluble in water, in alcohol, and in methanol, sparingly soluble in isopropanol, slightly soluble in chloroform and in methylene chloride, insoluble in n-Hexane. Cyclobenzaprine HCl, USP is designated chemically as 3-(5H-Dibenzo[a,d] cyclohepten-5 ylidene)-N,N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine hydrochloride USP, 5 mg is supplied as a 5 mg tablet for oral administration. Cyclobenzaprine hydrochloride USP, 7.5 mg is supplied as a 7.5 mg tablet for oral administration. Cyclobenzaprine hydrochloride USP, 10 mg is supplied as a 10 mg tablet for oral administration. Cyclobenzaprine hydrochloride tablets, USP 5 mg contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide and triacetin. Cyclobenzaprine hydrochloride tablets, USP 7.5 mg contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide, triacetin and yellow iron oxide. Cyclobenzaprine hydrochloride tablets, USP 10 mg contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, FD&C Blue No. 2 Aluminium Lake, hypromellose, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide, triacetin and yellow iron oxide. FDA approved organic impurities test acceptance criterion differs from the USP organic impurities test acceptance criterion in Cyclobenzaprine Hydrochloride Tablets.</Description>
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<IndicationAndUsage>Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets, USP should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets, USP has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.</IndicationAndUsage>
<Description>Cyclobenzaprine hydrochloride, USP is a white to off-white, odorless, crystalline powder with the molecular formula C20H21NHCl and a molecular weight of 311.85. It has a melting point between 215°C to 219°C and a pKa of 8.47. It is freely soluble in water, in alcohol, and in methanol, sparingly soluble in isopropanol, slightly soluble in chloroform and in methylene chloride, insoluble in n-Hexane. Cyclobenzaprine HCl, USP is designated chemically as 3-(5H-Dibenzo[a,d] cyclohepten-5 ylidene)-N,N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine hydrochloride USP, 5 mg is supplied as a 5 mg tablet for oral administration. Cyclobenzaprine hydrochloride USP, 7.5 mg is supplied as a 7.5 mg tablet for oral administration. Cyclobenzaprine hydrochloride USP, 10 mg is supplied as a 10 mg tablet for oral administration. Cyclobenzaprine hydrochloride tablets, USP 5 mg contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide and triacetin. Cyclobenzaprine hydrochloride tablets, USP 7.5 mg contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide, triacetin and yellow iron oxide. Cyclobenzaprine hydrochloride tablets, USP 10 mg contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, FD&C Blue No. 2 Aluminium Lake, hypromellose, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide, triacetin and yellow iron oxide. FDA approved organic impurities test acceptance criterion differs from the USP organic impurities test acceptance criterion in Cyclobenzaprine Hydrochloride Tablets.</Description>
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<IndicationAndUsage>Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets, USP should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine hydrochloride tablets, USP has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.</IndicationAndUsage>
<Description>Cyclobenzaprine hydrochloride, USP is a white to off-white, odorless, crystalline powder with the molecular formula C20H21NHCl and a molecular weight of 311.85. It has a melting point between 215°C to 219°C and a pKa of 8.47. It is freely soluble in water, in alcohol, and in methanol, sparingly soluble in isopropanol, slightly soluble in chloroform and in methylene chloride, insoluble in n-Hexane. Cyclobenzaprine HCl, USP is designated chemically as 3-(5H-Dibenzo[a,d] cyclohepten-5 ylidene)-N,N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine hydrochloride USP, 5 mg is supplied as a 5 mg tablet for oral administration. Cyclobenzaprine hydrochloride USP, 7.5 mg is supplied as a 7.5 mg tablet for oral administration. Cyclobenzaprine hydrochloride USP, 10 mg is supplied as a 10 mg tablet for oral administration. Cyclobenzaprine hydrochloride tablets, USP 5 mg contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide and triacetin. Cyclobenzaprine hydrochloride tablets, USP 7.5 mg contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide, triacetin and yellow iron oxide. Cyclobenzaprine hydrochloride tablets, USP 10 mg contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, FD&C Blue No. 2 Aluminium Lake, hypromellose, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide, triacetin and yellow iron oxide. FDA approved organic impurities test acceptance criterion differs from the USP organic impurities test acceptance criterion in Cyclobenzaprine Hydrochloride Tablets.</Description>
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