{
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"IndicationAndUsage": "Fexmid is 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. Fexmid 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. Fexmid has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
"Description": "Fexmid® (cyclobenzaprine hydrochloride) is a white, crystalline tricyclic amine salt. 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 HCl is designated chemically as 3-(5H-dibenzo[a,d]cyclohepten-5-ylidene)-N,N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Fexmid is available for oral administration as 7.5 mg tablets. Fexmid contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, hydroxypropyl cellulose, hypromellose, polyethylene glycol, magnesium stearate, microcrystalline cellulose, and titanium dioxide."
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{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"IndicationAndUsage": "Fexmid is 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. Fexmid 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. Fexmid has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
"Description": "Fexmid® (cyclobenzaprine hydrochloride) is a white, crystalline tricyclic amine salt. 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 HCl is designated chemically as 3-(5H-dibenzo[a,d]cyclohepten-5-ylidene)-N,N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Fexmid is available for oral administration as 7.5 mg tablets. Fexmid contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, hydroxypropyl cellulose, hypromellose, polyethylene glycol, magnesium stearate, microcrystalline cellulose, and titanium dioxide."
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{
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"IndicationAndUsage": "Fexmid is 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. Fexmid 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. Fexmid has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
"Description": "Fexmid® (cyclobenzaprine hydrochloride) is a white, crystalline tricyclic amine salt. 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 HCl is designated chemically as 3-(5H-dibenzo[a,d]cyclohepten-5-ylidene)-N,N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Fexmid is available for oral administration as 7.5 mg tablets. Fexmid contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, hydroxypropyl cellulose, hypromellose, polyethylene glycol, magnesium stearate, microcrystalline cellulose, and titanium dioxide."
},
{
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"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (53149-4850-6) ",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"ApplicationNumber": "ANDA071611",
"LabelerName": "All Pharma, LLC",
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"IndicationAndUsage": "Fexmid is 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. Fexmid 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. Fexmid has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
"Description": "Fexmid® (cyclobenzaprine hydrochloride) is a white, crystalline tricyclic amine salt. 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 HCl is designated chemically as 3-(5H-dibenzo[a,d]cyclohepten-5-ylidene)-N,N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Fexmid is available for oral administration as 7.5 mg tablets. Fexmid contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, hydroxypropyl cellulose, hypromellose, polyethylene glycol, magnesium stearate, microcrystalline cellulose, and titanium dioxide."
},
{
"NDCCode": "53149-4841-9",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (53149-4841-9)",
"NDC11Code": "53149-4841-09",
"ProductNDC": "53149-4841",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclobenzaprine Hydrochloride",
"NonProprietaryName": "Cyclobenzaprine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20150325",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078722",
"LabelerName": "All Pharma, LLC",
"SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]",
"Status": "Deprecated",
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"ProductNdcExcludeFlag": "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 have 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 crystalline powder with the molecular formula C H NHCl and a molecular weight of 311.9. It has a melting point of 217° C, and a pK of 8.47 at 25° C. It is freely soluble in water, in alcohol and in methanol, sparingly soluble in isopropanol, slightly soluble in chloroform and in methylene chloride and insoluble in hydrocarbons. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl is designated chemically as 3-(5H-dibenzo[a,d] cyclohepten-5-ylidene)-N,N-dimethyl-1-propanamine hydrochloride, and has the following structural formula: 2021a. Cyclobenzaprine hydrochloride tablets, USP are supplied as 7.5 mg tablets for oral administration. Cyclobenzaprine hydrochloride 7.5 mg tablets contain the following inactive ingredients: corn starch, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, pregelatinized starch, talc and titanium dioxide."
},
{
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"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (53149-4842-9) ",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclobenzaprine",
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"StartMarketingDatePackage": "20181107",
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"IndicationAndUsage": "Cyclobenzaprine HCl is 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 HCl 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 HCl 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 is a white, crystalline tricyclic amine salt. 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 HCl 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 tablets, USP are available for oral administration as 7.5 mg tablets. Cyclobenzaprine hydrochloride 7.5 mg tablets contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, hydroxypropyl cellulose, hypromellose, polyethylene glycol, magnesium stearate, microcrystalline cellulose, and titanium dioxide."
},
{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fexmid",
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"IndicationAndUsage": "Fexmid is 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. Fexmid 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. Fexmid has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
"Description": "Fexmid® (cyclobenzaprine hydrochloride) is a white, crystalline tricyclic amine salt. 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 HCl is designated chemically as 3-(5H-dibenzo[a,d]cyclohepten-5-ylidene)-N,N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Fexmid is available for oral administration as 7.5 mg tablets. Fexmid contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, hydroxypropyl cellulose, hypromellose, polyethylene glycol, magnesium stearate, microcrystalline cellulose, and titanium dioxide."
},
{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclobenzaprine Hydrochloride",
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"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 crystalline powder with the molecular 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, in alcohol and in methanol, sparingly soluble in isopropanol, slightly soluble in chloroform and in methylene chloride and insoluble in hydrocarbons. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl 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 tablets, USP are supplied as a 7.5 mg tablets for oral administration. Cyclobenzaprine hydrochloride 7.5 mg tablets contain the following inactive ingredients: corn starch, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, pregelatinized starch, talc and titanium dioxide."
},
{
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"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 crystalline powder with the molecular 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, in alcohol and in methanol, sparingly soluble in isopropanol, slightly soluble in chloroform and in methylene chloride and insoluble in hydrocarbons. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl 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 tablets, USP are supplied as a 7.5 mg tablets for oral administration. Cyclobenzaprine hydrochloride 7.5 mg tablets contain the following inactive ingredients: corn starch, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, pregelatinized starch, talc and titanium dioxide."
},
{
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"LabelerName": "All Pharma, LLC",
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"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 crystalline powder with the molecular 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, in alcohol and in methanol, sparingly soluble in isopropanol, slightly soluble in chloroform and in methylene chloride and insoluble in hydrocarbons. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl 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 tablets, USP are supplied as a 7.5 mg tablets for oral administration. Cyclobenzaprine hydrochloride 7.5 mg tablets contain the following inactive ingredients: corn starch, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, pregelatinized starch, talc and titanium dioxide."
},
{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclobenzaprine Hydrochloride",
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"LabelerName": "All Pharma, LLC",
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"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20180813",
"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 crystalline powder with the molecular 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, in alcohol and in methanol, sparingly soluble in isopropanol, slightly soluble in chloroform and in methylene chloride and insoluble in hydrocarbons. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl 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 tablets, USP are supplied as a 7.5 mg tablets for oral administration. Cyclobenzaprine hydrochloride 7.5 mg tablets contain the following inactive ingredients: corn starch, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, pregelatinized starch, talc and titanium dioxide."
},
{
"NDCCode": "0067-4850-14",
"PackageDescription": "14 POUCH in 1 BOX, UNIT-DOSE (0067-4850-14) > 1 PATCH in 1 POUCH > 24 h in 1 PATCH",
"NDC11Code": "00067-4850-14",
"ProductNDC": "0067-4850",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Habitrol Patch",
"ProprietaryNameSuffix": "Nicotine Transdermal System, Step 3",
"NonProprietaryName": "Nicotine",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20030226",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020076",
"LabelerName": "Novartis Consumer Health, Inc.",
"SubstanceName": "NICOTINE",
"StrengthNumber": "7",
"StrengthUnit": "mg/24h",
"Status": "Deprecated",
"LastUpdate": "2016-12-09"
},
{
"NDCCode": "0220-4850-41",
"PackageDescription": "200 [kp_C] in 1 TUBE (0220-4850-41) ",
"NDC11Code": "00220-4850-41",
"ProductNDC": "0220-4850",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Symphoricarpus Racemosus",
"NonProprietaryName": "Symphoricarpos Albus Fruit",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Boiron",
"SubstanceName": "SYMPHORICARPOS ALBUS FRUIT",
"StrengthNumber": "200",
"StrengthUnit": "[kp_C]/200[kp_C]",
"Status": "Active",
"LastUpdate": "2025-08-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250101",
"SamplePackage": "N",
"IndicationAndUsage": "Relieves nausea aggravated by the slightest motion *. Uses: See symptoms on front panel."
},
{
"NDCCode": "0264-4850-01",
"PackageDescription": "10 VIAL in 1 CARTON (0264-4850-01) > 100 mL in 1 VIAL",
"NDC11Code": "00264-4850-01",
"ProductNDC": "0264-4850",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propofol Lipuro",
"NonProprietaryName": "Propofol Lipuro",
"DosageFormName": "INJECTION, EMULSION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20210312",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "B. Braun Medical Inc.",
"SubstanceName": "PROPOFOL",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "General Anesthesia [PE], General Anesthetic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20210312",
"SamplePackage": "N"
},
{
"NDCCode": "0363-4850-08",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (0363-4850-08) > 12 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "00363-4850-08",
"ProductNDC": "0363-4850",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Wal-dryl Pe Allergy And Sinus",
"NonProprietaryName": "Diphenhydramine Hcl, Phenylephrine Hcl",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20050810",
"EndMarketingDate": "20211206",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Walgreen Company",
"SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "25; 10",
"StrengthUnit": "mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2021-12-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20050810",
"EndMarketingDatePackage": "20211206",
"SamplePackage": "N"
},
{
"NDCCode": "49452-4850-1",
"PackageDescription": "100 g in 1 CONTAINER (49452-4850-1)",
"NDC11Code": "49452-4850-01",
"ProductNDC": "49452-4850",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Niacinamide",
"DosageFormName": "POWDER",
"StartMarketingDate": "19900301",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Spectrum Laboratory Products, Inc.",
"SubstanceName": "NIACINAMIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "49452-4850-2",
"PackageDescription": "1000 g in 1 CONTAINER (49452-4850-2)",
"NDC11Code": "49452-4850-02",
"ProductNDC": "49452-4850",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Niacinamide",
"DosageFormName": "POWDER",
"StartMarketingDate": "19900301",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Spectrum Laboratory Products, Inc.",
"SubstanceName": "NIACINAMIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "49452-4850-3",
"PackageDescription": "500 g in 1 CONTAINER (49452-4850-3)",
"NDC11Code": "49452-4850-03",
"ProductNDC": "49452-4850",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Niacinamide",
"DosageFormName": "POWDER",
"StartMarketingDate": "19900301",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Spectrum Laboratory Products, Inc.",
"SubstanceName": "NIACINAMIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "49452-4850-4",
"PackageDescription": "5000 g in 1 PAIL (49452-4850-4)",
"NDC11Code": "49452-4850-04",
"ProductNDC": "49452-4850",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Niacinamide",
"DosageFormName": "POWDER",
"StartMarketingDate": "19900301",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Spectrum Laboratory Products, Inc.",
"SubstanceName": "NIACINAMIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "49452-4850-5",
"PackageDescription": "25000 g in 1 DRUM (49452-4850-5)",
"NDC11Code": "49452-4850-05",
"ProductNDC": "49452-4850",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Niacinamide",
"DosageFormName": "POWDER",
"StartMarketingDate": "19900301",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Spectrum Laboratory Products, Inc.",
"SubstanceName": "NIACINAMIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "50090-4850-0",
"PackageDescription": "40 TABLET in 1 BOTTLE (50090-4850-0) ",
"NDC11Code": "50090-4850-00",
"ProductNDC": "50090-4850",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulfamethoxazole And Trimethoprim",
"NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100913",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076899",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
"StrengthNumber": "800; 160",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]",
"Status": "Active",
"LastUpdate": "2024-01-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200120",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy. Urinary Tract Infections. For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination. Acute Otitis Media. For the treatment of acute otitis media in pediatric patients due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of sulfamethoxazole and trimethoprim tablets in pediatric patients under two years of age. Sulfamethoxazole and trimethoprim tablets are not indicated for prophylactic or prolonged administration in otitis media at any age. Acute Exacerbations of Chronic Bronchitis in Adults. For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when a physician deems that sulfamethoxazole and trimethoprim could offer some advantage over the use of a single antimicrobial agent. Shigellosis. For the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei when antibacterial therapy is indicated. Pneumocystis jirovecii Pneumonia. For the treatment of documented Pneumocystis jirovecii pneumonia and for prophylaxis against P. jirovecii pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing P. jirovecii pneumonia. Traveler’s Diarrhea in Adults. For the treatment of traveler’s diarrhea due to susceptible strains of enterotoxigenic E. coli.",
"Description": "Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product available in DS (double strength) tablets, each containing 800 mg sulfamethoxazole, USP and 160 mg trimethoprim, USP; in tablets, each containing 400 mg sulfamethoxazole, USP and 80 mg trimethoprim, USP for oral administration. Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl) sulfanilamide; the molecular formula is C10H11N3O3S. It is an almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula:. Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine; the molecular formula is C14H18N4O3. It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.3 and the following structural formula:. Inactive ingredients: Magnesium stearate, povidone, pregelatinized starch and sodium starch glycolate."
},
{
"NDCCode": "50090-4850-1",
"PackageDescription": "30 TABLET in 1 BOTTLE (50090-4850-1) ",
"NDC11Code": "50090-4850-01",
"ProductNDC": "50090-4850",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulfamethoxazole And Trimethoprim",
"NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100913",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076899",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
"StrengthNumber": "800; 160",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]",
"Status": "Active",
"LastUpdate": "2024-01-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200120",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy. Urinary Tract Infections. For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination. Acute Otitis Media. For the treatment of acute otitis media in pediatric patients due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of sulfamethoxazole and trimethoprim tablets in pediatric patients under two years of age. Sulfamethoxazole and trimethoprim tablets are not indicated for prophylactic or prolonged administration in otitis media at any age. Acute Exacerbations of Chronic Bronchitis in Adults. For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when a physician deems that sulfamethoxazole and trimethoprim could offer some advantage over the use of a single antimicrobial agent. Shigellosis. For the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei when antibacterial therapy is indicated. Pneumocystis jirovecii Pneumonia. For the treatment of documented Pneumocystis jirovecii pneumonia and for prophylaxis against P. jirovecii pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing P. jirovecii pneumonia. Traveler’s Diarrhea in Adults. For the treatment of traveler’s diarrhea due to susceptible strains of enterotoxigenic E. coli.",
"Description": "Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product available in DS (double strength) tablets, each containing 800 mg sulfamethoxazole, USP and 160 mg trimethoprim, USP; in tablets, each containing 400 mg sulfamethoxazole, USP and 80 mg trimethoprim, USP for oral administration. Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl) sulfanilamide; the molecular formula is C10H11N3O3S. It is an almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula:. Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine; the molecular formula is C14H18N4O3. It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.3 and the following structural formula:. Inactive ingredients: Magnesium stearate, povidone, pregelatinized starch and sodium starch glycolate."
},
{
"NDCCode": "53002-4850-2",
"PackageDescription": "20 TABLET, FILM COATED in 1 BOTTLE (53002-4850-2) ",
"NDC11Code": "53002-4850-02",
"ProductNDC": "53002-4850",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydroxychloroquine Sulfate",
"NonProprietaryName": "Hydroxychloroquine Sulfate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160330",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040133",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"SubstanceName": "HYDROXYCHLOROQUINE SULFATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antimalarial [EPC], Antirheumatic Agent [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20181001",
"SamplePackage": "N",
"IndicationAndUsage": "Hydroxychloroquine sulfate is indicated for the treatment of uncomplicated malaria due to P. falciparum, P. malariae, P. ovale, and P. vivax. Hydroxychloroquine sulfate is indicated for the prophylaxis of malaria in geographic areas where chloroquine resistance is not reported. Limitations of Use in Malaria: 1 Hydroxychloroquine sulfate is not recommended for the treatment of complicated malaria., 2 Hydroxychloroquine sulfate is not effective against chloroquine or hydroxychloroquine-resistant strains of Plasmodium species (see CLINICAL PHARMACOLOGY - Microbiology). Hydroxychloroquine sulfate is not recommended for the treatment of malaria acquired in geographic areas where chloroquine resistance occurs or when the Plasmodium species has not been identified., 3 Hydroxychloroquine sulfate is not recommended for malaria prophylaxis in geographic areas where chloroquine resistance occurs., 4 Hydroxychloroquine sulfate does not prevent relapses of P. vivax or P. ovale because it is not active against the hypnozoite forms of these parasites. For radical cure of P. vivax and P. ovale infections, concomitant therapy with an 8-aminoquinoline compound is necessary (see CLINICAL PHARMACOLOGY - Microbiology).",
"Description": "Hydroxychloroquine Sulfate, USP is a colorless crystalline solid, soluble in water to at least 20 percent; chemically the drug is (±)-2-[[4-[(7-Chloro-4-quinolyl)amino]pentyl]ethylamino] ethanol sulfate (1:1) (salt). It has the following structural formula. C18H26ClN3OH2SO4           Molecular Weight: 433.95. Hydroxychloroquine Sulfate Tablets, USP contain 200 mg hydroxychloroquine sulfate, equivalent to 155 mg base, and are for oral administration. Inactive Ingredients: colloidal silicon dioxide, dextrates, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium starch glycolate, starch (corn), titanium dioxide, and triacetin."
},
{
"NDCCode": "53002-4850-6",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (53002-4850-6) ",
"NDC11Code": "53002-4850-06",
"ProductNDC": "53002-4850",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydroxychloroquine Sulfate",
"NonProprietaryName": "Hydroxychloroquine Sulfate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160330",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040133",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"SubstanceName": "HYDROXYCHLOROQUINE SULFATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antimalarial [EPC], Antirheumatic Agent [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20181001",
"SamplePackage": "N",
"IndicationAndUsage": "Hydroxychloroquine sulfate is indicated for the treatment of uncomplicated malaria due to P. falciparum, P. malariae, P. ovale, and P. vivax. Hydroxychloroquine sulfate is indicated for the prophylaxis of malaria in geographic areas where chloroquine resistance is not reported. Limitations of Use in Malaria: 1 Hydroxychloroquine sulfate is not recommended for the treatment of complicated malaria., 2 Hydroxychloroquine sulfate is not effective against chloroquine or hydroxychloroquine-resistant strains of Plasmodium species (see CLINICAL PHARMACOLOGY - Microbiology). Hydroxychloroquine sulfate is not recommended for the treatment of malaria acquired in geographic areas where chloroquine resistance occurs or when the Plasmodium species has not been identified., 3 Hydroxychloroquine sulfate is not recommended for malaria prophylaxis in geographic areas where chloroquine resistance occurs., 4 Hydroxychloroquine sulfate does not prevent relapses of P. vivax or P. ovale because it is not active against the hypnozoite forms of these parasites. For radical cure of P. vivax and P. ovale infections, concomitant therapy with an 8-aminoquinoline compound is necessary (see CLINICAL PHARMACOLOGY - Microbiology).",
"Description": "Hydroxychloroquine Sulfate, USP is a colorless crystalline solid, soluble in water to at least 20 percent; chemically the drug is (±)-2-[[4-[(7-Chloro-4-quinolyl)amino]pentyl]ethylamino] ethanol sulfate (1:1) (salt). It has the following structural formula. C18H26ClN3OH2SO4           Molecular Weight: 433.95. Hydroxychloroquine Sulfate Tablets, USP contain 200 mg hydroxychloroquine sulfate, equivalent to 155 mg base, and are for oral administration. Inactive Ingredients: colloidal silicon dioxide, dextrates, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium starch glycolate, starch (corn), titanium dioxide, and triacetin."
},
{
"NDCCode": "54868-4850-0",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (54868-4850-0) > 1 KIT in 1 BLISTER PACK",
"NDC11Code": "54868-4850-00",
"ProductNDC": "54868-4850",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Low-ogestrel",
"NonProprietaryName": "Norgestrel And Ethinyl Estradiol",
"DosageFormName": "KIT",
"RouteName": "ORAL",
"StartMarketingDate": "20090924",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075288",
"LabelerName": "Physicians Total Care, Inc.",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Low-Ogestrel®(norgestrel and ethinyl estradiol tablets USP, 0.3 mg/0.03 mg) is indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception.1 The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.",
"Description": "Low-Ogestrel ® Tablets (norgestrel and ethinyl estradiol tablets USP, 0.3 mg/0.03 mg) provide an oral contraceptive regimen consisting of 21 white tablets followed by 7 peach tablets. Each white tablet, for oral administration contains 0.3 mg of norgestrel and 0.03 mg ethinyl estradiol and the following inactive ingredients: croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, and povidone. Each inactive peach tablet, for oral administration, in the 28 day regimen contains the following inactive ingredients: anhydrous lactose, FD&C Yellow No. 6 Lake, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Norgestrel is a totally synthetic progestogen, insoluble in water, freely soluble in chloroform, sparingly soluble in alcohol with the chemical name (±)-13-Ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one. Ethinyl estradiol is an estrogen, insoluble in water, soluble in alcohol, in chloroform, in ether, in vegetable oils, and in solutions of fixed alkali hydroxides with the chemical name 19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol. Their structural formulae follow. Therapeutic class: Oral contraceptive."
},
{
"NDCCode": "55714-4850-1",
"PackageDescription": "28 g in 1 BOTTLE, GLASS (55714-4850-1) ",
"NDC11Code": "55714-4850-01",
"ProductNDC": "55714-4850",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Warts",
"NonProprietaryName": "Antimon. Crud., Bryonia, Calc.carb., Causticum, Dulcamara, Graphites, Lycopodium, Merc. Sulph. Rub., Nat. Carb., Nitricum Ac., Nux Vom., Rhus Toxicodendron, Sabina, Sepia, Silicea, Staphysag., Sulphur, Thuja Occ., Taraxacum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20221219",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
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<Description>Fexmid® (cyclobenzaprine hydrochloride) is a white, crystalline tricyclic amine salt. 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 HCl is designated chemically as 3-(5H-dibenzo[a,d]cyclohepten-5-ylidene)-N,N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Fexmid is available for oral administration as 7.5 mg tablets. Fexmid contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, hydroxypropyl cellulose, hypromellose, polyethylene glycol, magnesium stearate, microcrystalline cellulose, and titanium dioxide.</Description>
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<Description>Cyclobenzaprine hydrochloride is a white, crystalline tricyclic amine salt. 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 HCl 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 tablets, USP are available for oral administration as 7.5 mg tablets. Cyclobenzaprine hydrochloride 7.5 mg tablets contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, hydroxypropyl cellulose, hypromellose, polyethylene glycol, magnesium stearate, microcrystalline cellulose, and titanium dioxide.</Description>
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<Description>Fexmid® (cyclobenzaprine hydrochloride) is a white, crystalline tricyclic amine salt. 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 HCl is designated chemically as 3-(5H-dibenzo[a,d]cyclohepten-5-ylidene)-N,N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Fexmid is available for oral administration as 7.5 mg tablets. Fexmid contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, hydroxypropyl cellulose, hypromellose, polyethylene glycol, magnesium stearate, microcrystalline cellulose, and titanium dioxide.</Description>
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<LastUpdate>2020-01-01</LastUpdate>
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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 crystalline powder with the molecular 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, in alcohol and in methanol, sparingly soluble in isopropanol, slightly soluble in chloroform and in methylene chloride and insoluble in hydrocarbons. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl 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 tablets, USP are supplied as a 7.5 mg tablets for oral administration. Cyclobenzaprine hydrochloride 7.5 mg tablets contain the following inactive ingredients: corn starch, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, pregelatinized starch, talc and titanium dioxide.</Description>
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<SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
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<LastUpdate>2020-01-01</LastUpdate>
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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 crystalline powder with the molecular 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, in alcohol and in methanol, sparingly soluble in isopropanol, slightly soluble in chloroform and in methylene chloride and insoluble in hydrocarbons. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl 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 tablets, USP are supplied as a 7.5 mg tablets for oral administration. Cyclobenzaprine hydrochloride 7.5 mg tablets contain the following inactive ingredients: corn starch, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, pregelatinized starch, talc and titanium dioxide.</Description>
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<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]</Pharm_Classes>
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<LastUpdate>2020-01-01</LastUpdate>
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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 crystalline powder with the molecular 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, in alcohol and in methanol, sparingly soluble in isopropanol, slightly soluble in chloroform and in methylene chloride and insoluble in hydrocarbons. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl 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 tablets, USP are supplied as a 7.5 mg tablets for oral administration. Cyclobenzaprine hydrochloride 7.5 mg tablets contain the following inactive ingredients: corn starch, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, pregelatinized starch, talc and titanium dioxide.</Description>
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<NDC11Code>53149-4852-06</NDC11Code>
<ProductNDC>53149-4852</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
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<StartMarketingDate>20170801</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078722</ApplicationNumber>
<LabelerName>All Pharma, LLC</LabelerName>
<SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>7.5</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>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180813</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 crystalline powder with the molecular 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, in alcohol and in methanol, sparingly soluble in isopropanol, slightly soluble in chloroform and in methylene chloride and insoluble in hydrocarbons. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl 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 tablets, USP are supplied as a 7.5 mg tablets for oral administration. Cyclobenzaprine hydrochloride 7.5 mg tablets contain the following inactive ingredients: corn starch, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, pregelatinized starch, talc and titanium dioxide.</Description>
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<PackageDescription>14 POUCH in 1 BOX, UNIT-DOSE (0067-4850-14) > 1 PATCH in 1 POUCH > 24 h in 1 PATCH</PackageDescription>
<NDC11Code>00067-4850-14</NDC11Code>
<ProductNDC>0067-4850</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Habitrol Patch</ProprietaryName>
<ProprietaryNameSuffix>Nicotine Transdermal System, Step 3</ProprietaryNameSuffix>
<NonProprietaryName>Nicotine</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20030226</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020076</ApplicationNumber>
<LabelerName>Novartis Consumer Health, Inc.</LabelerName>
<SubstanceName>NICOTINE</SubstanceName>
<StrengthNumber>7</StrengthNumber>
<StrengthUnit>mg/24h</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2016-12-09</LastUpdate>
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<NDC>
<NDCCode>0220-4850-41</NDCCode>
<PackageDescription>200 [kp_C] in 1 TUBE (0220-4850-41) </PackageDescription>
<NDC11Code>00220-4850-41</NDC11Code>
<ProductNDC>0220-4850</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Symphoricarpus Racemosus</ProprietaryName>
<NonProprietaryName>Symphoricarpos Albus Fruit</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Boiron</LabelerName>
<SubstanceName>SYMPHORICARPOS ALBUS FRUIT</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>[kp_C]/200[kp_C]</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-08-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Relieves nausea aggravated by the slightest motion *. Uses: See symptoms on front panel.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0264-4850-01</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (0264-4850-01) > 100 mL in 1 VIAL</PackageDescription>
<NDC11Code>00264-4850-01</NDC11Code>
<ProductNDC>0264-4850</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propofol Lipuro</ProprietaryName>
<NonProprietaryName>Propofol Lipuro</NonProprietaryName>
<DosageFormName>INJECTION, EMULSION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20210312</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>B. Braun Medical Inc.</LabelerName>
<SubstanceName>PROPOFOL</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>General Anesthesia [PE], General Anesthetic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210312</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>0363-4850-08</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (0363-4850-08) > 12 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00363-4850-08</NDC11Code>
<ProductNDC>0363-4850</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Wal-dryl Pe Allergy And Sinus</ProprietaryName>
<NonProprietaryName>Diphenhydramine Hcl, Phenylephrine Hcl</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050810</StartMarketingDate>
<EndMarketingDate>20211206</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Walgreen Company</LabelerName>
<SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-12-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20050810</StartMarketingDatePackage>
<EndMarketingDatePackage>20211206</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49452-4850-1</NDCCode>
<PackageDescription>100 g in 1 CONTAINER (49452-4850-1)</PackageDescription>
<NDC11Code>49452-4850-01</NDC11Code>
<ProductNDC>49452-4850</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Niacinamide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>19900301</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Spectrum Laboratory Products, Inc.</LabelerName>
<SubstanceName>NIACINAMIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>49452-4850-2</NDCCode>
<PackageDescription>1000 g in 1 CONTAINER (49452-4850-2)</PackageDescription>
<NDC11Code>49452-4850-02</NDC11Code>
<ProductNDC>49452-4850</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Niacinamide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>19900301</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Spectrum Laboratory Products, Inc.</LabelerName>
<SubstanceName>NIACINAMIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>49452-4850-3</NDCCode>
<PackageDescription>500 g in 1 CONTAINER (49452-4850-3)</PackageDescription>
<NDC11Code>49452-4850-03</NDC11Code>
<ProductNDC>49452-4850</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Niacinamide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>19900301</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Spectrum Laboratory Products, Inc.</LabelerName>
<SubstanceName>NIACINAMIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>49452-4850-4</NDCCode>
<PackageDescription>5000 g in 1 PAIL (49452-4850-4)</PackageDescription>
<NDC11Code>49452-4850-04</NDC11Code>
<ProductNDC>49452-4850</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Niacinamide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>19900301</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Spectrum Laboratory Products, Inc.</LabelerName>
<SubstanceName>NIACINAMIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>49452-4850-5</NDCCode>
<PackageDescription>25000 g in 1 DRUM (49452-4850-5)</PackageDescription>
<NDC11Code>49452-4850-05</NDC11Code>
<ProductNDC>49452-4850</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Niacinamide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>19900301</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Spectrum Laboratory Products, Inc.</LabelerName>
<SubstanceName>NIACINAMIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>50090-4850-0</NDCCode>
<PackageDescription>40 TABLET in 1 BOTTLE (50090-4850-0) </PackageDescription>
<NDC11Code>50090-4850-00</NDC11Code>
<ProductNDC>50090-4850</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName>
<NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100913</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076899</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>SULFAMETHOXAZOLE; TRIMETHOPRIM</SubstanceName>
<StrengthNumber>800; 160</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy. Urinary Tract Infections. For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination. Acute Otitis Media. For the treatment of acute otitis media in pediatric patients due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of sulfamethoxazole and trimethoprim tablets in pediatric patients under two years of age. Sulfamethoxazole and trimethoprim tablets are not indicated for prophylactic or prolonged administration in otitis media at any age. Acute Exacerbations of Chronic Bronchitis in Adults. For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when a physician deems that sulfamethoxazole and trimethoprim could offer some advantage over the use of a single antimicrobial agent. Shigellosis. For the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei when antibacterial therapy is indicated. Pneumocystis jirovecii Pneumonia. For the treatment of documented Pneumocystis jirovecii pneumonia and for prophylaxis against P. jirovecii pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing P. jirovecii pneumonia. Traveler’s Diarrhea in Adults. For the treatment of traveler’s diarrhea due to susceptible strains of enterotoxigenic E. coli.</IndicationAndUsage>
<Description>Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product available in DS (double strength) tablets, each containing 800 mg sulfamethoxazole, USP and 160 mg trimethoprim, USP; in tablets, each containing 400 mg sulfamethoxazole, USP and 80 mg trimethoprim, USP for oral administration. Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl) sulfanilamide; the molecular formula is C10H11N3O3S. It is an almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula:. Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine; the molecular formula is C14H18N4O3. It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.3 and the following structural formula:. Inactive ingredients: Magnesium stearate, povidone, pregelatinized starch and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>50090-4850-1</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (50090-4850-1) </PackageDescription>
<NDC11Code>50090-4850-01</NDC11Code>
<ProductNDC>50090-4850</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName>
<NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100913</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076899</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>SULFAMETHOXAZOLE; TRIMETHOPRIM</SubstanceName>
<StrengthNumber>800; 160</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy. Urinary Tract Infections. For the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris. It is recommended that initial episodes of uncomplicated urinary tract infections be treated with a single effective antibacterial agent rather than the combination. Acute Otitis Media. For the treatment of acute otitis media in pediatric patients due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when in the judgment of the physician sulfamethoxazole and trimethoprim offers some advantage over the use of other antimicrobial agents. To date, there are limited data on the safety of repeated use of sulfamethoxazole and trimethoprim tablets in pediatric patients under two years of age. Sulfamethoxazole and trimethoprim tablets are not indicated for prophylactic or prolonged administration in otitis media at any age. Acute Exacerbations of Chronic Bronchitis in Adults. For the treatment of acute exacerbations of chronic bronchitis due to susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae when a physician deems that sulfamethoxazole and trimethoprim could offer some advantage over the use of a single antimicrobial agent. Shigellosis. For the treatment of enteritis caused by susceptible strains of Shigella flexneri and Shigella sonnei when antibacterial therapy is indicated. Pneumocystis jirovecii Pneumonia. For the treatment of documented Pneumocystis jirovecii pneumonia and for prophylaxis against P. jirovecii pneumonia in individuals who are immunosuppressed and considered to be at an increased risk of developing P. jirovecii pneumonia. Traveler’s Diarrhea in Adults. For the treatment of traveler’s diarrhea due to susceptible strains of enterotoxigenic E. coli.</IndicationAndUsage>
<Description>Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product available in DS (double strength) tablets, each containing 800 mg sulfamethoxazole, USP and 160 mg trimethoprim, USP; in tablets, each containing 400 mg sulfamethoxazole, USP and 80 mg trimethoprim, USP for oral administration. Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl) sulfanilamide; the molecular formula is C10H11N3O3S. It is an almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula:. Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine; the molecular formula is C14H18N4O3. It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.3 and the following structural formula:. Inactive ingredients: Magnesium stearate, povidone, pregelatinized starch and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>53002-4850-2</NDCCode>
<PackageDescription>20 TABLET, FILM COATED in 1 BOTTLE (53002-4850-2) </PackageDescription>
<NDC11Code>53002-4850-02</NDC11Code>
<ProductNDC>53002-4850</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydroxychloroquine Sulfate</ProprietaryName>
<NonProprietaryName>Hydroxychloroquine Sulfate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160330</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040133</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>HYDROXYCHLOROQUINE SULFATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antimalarial [EPC], Antirheumatic Agent [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydroxychloroquine sulfate is indicated for the treatment of uncomplicated malaria due to P. falciparum, P. malariae, P. ovale, and P. vivax. Hydroxychloroquine sulfate is indicated for the prophylaxis of malaria in geographic areas where chloroquine resistance is not reported. Limitations of Use in Malaria: 1 Hydroxychloroquine sulfate is not recommended for the treatment of complicated malaria., 2 Hydroxychloroquine sulfate is not effective against chloroquine or hydroxychloroquine-resistant strains of Plasmodium species (see CLINICAL PHARMACOLOGY - Microbiology). Hydroxychloroquine sulfate is not recommended for the treatment of malaria acquired in geographic areas where chloroquine resistance occurs or when the Plasmodium species has not been identified., 3 Hydroxychloroquine sulfate is not recommended for malaria prophylaxis in geographic areas where chloroquine resistance occurs., 4 Hydroxychloroquine sulfate does not prevent relapses of P. vivax or P. ovale because it is not active against the hypnozoite forms of these parasites. For radical cure of P. vivax and P. ovale infections, concomitant therapy with an 8-aminoquinoline compound is necessary (see CLINICAL PHARMACOLOGY - Microbiology).</IndicationAndUsage>
<Description>Hydroxychloroquine Sulfate, USP is a colorless crystalline solid, soluble in water to at least 20 percent; chemically the drug is (±)-2-[[4-[(7-Chloro-4-quinolyl)amino]pentyl]ethylamino] ethanol sulfate (1:1) (salt). It has the following structural formula. C18H26ClN3OH2SO4           Molecular Weight: 433.95. Hydroxychloroquine Sulfate Tablets, USP contain 200 mg hydroxychloroquine sulfate, equivalent to 155 mg base, and are for oral administration. Inactive Ingredients: colloidal silicon dioxide, dextrates, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium starch glycolate, starch (corn), titanium dioxide, and triacetin.</Description>
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<NDCCode>53002-4850-6</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (53002-4850-6) </PackageDescription>
<NDC11Code>53002-4850-06</NDC11Code>
<ProductNDC>53002-4850</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydroxychloroquine Sulfate</ProprietaryName>
<NonProprietaryName>Hydroxychloroquine Sulfate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160330</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040133</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>HYDROXYCHLOROQUINE SULFATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antimalarial [EPC], Antirheumatic Agent [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydroxychloroquine sulfate is indicated for the treatment of uncomplicated malaria due to P. falciparum, P. malariae, P. ovale, and P. vivax. Hydroxychloroquine sulfate is indicated for the prophylaxis of malaria in geographic areas where chloroquine resistance is not reported. Limitations of Use in Malaria: 1 Hydroxychloroquine sulfate is not recommended for the treatment of complicated malaria., 2 Hydroxychloroquine sulfate is not effective against chloroquine or hydroxychloroquine-resistant strains of Plasmodium species (see CLINICAL PHARMACOLOGY - Microbiology). Hydroxychloroquine sulfate is not recommended for the treatment of malaria acquired in geographic areas where chloroquine resistance occurs or when the Plasmodium species has not been identified., 3 Hydroxychloroquine sulfate is not recommended for malaria prophylaxis in geographic areas where chloroquine resistance occurs., 4 Hydroxychloroquine sulfate does not prevent relapses of P. vivax or P. ovale because it is not active against the hypnozoite forms of these parasites. For radical cure of P. vivax and P. ovale infections, concomitant therapy with an 8-aminoquinoline compound is necessary (see CLINICAL PHARMACOLOGY - Microbiology).</IndicationAndUsage>
<Description>Hydroxychloroquine Sulfate, USP is a colorless crystalline solid, soluble in water to at least 20 percent; chemically the drug is (±)-2-[[4-[(7-Chloro-4-quinolyl)amino]pentyl]ethylamino] ethanol sulfate (1:1) (salt). It has the following structural formula. C18H26ClN3OH2SO4           Molecular Weight: 433.95. Hydroxychloroquine Sulfate Tablets, USP contain 200 mg hydroxychloroquine sulfate, equivalent to 155 mg base, and are for oral administration. Inactive Ingredients: colloidal silicon dioxide, dextrates, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium starch glycolate, starch (corn), titanium dioxide, and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>54868-4850-0</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (54868-4850-0) > 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>54868-4850-00</NDC11Code>
<ProductNDC>54868-4850</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Low-ogestrel</ProprietaryName>
<NonProprietaryName>Norgestrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090924</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075288</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Low-Ogestrel®(norgestrel and ethinyl estradiol tablets USP, 0.3 mg/0.03 mg) is indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception.1 The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.</IndicationAndUsage>
<Description>Low-Ogestrel ® Tablets (norgestrel and ethinyl estradiol tablets USP, 0.3 mg/0.03 mg) provide an oral contraceptive regimen consisting of 21 white tablets followed by 7 peach tablets. Each white tablet, for oral administration contains 0.3 mg of norgestrel and 0.03 mg ethinyl estradiol and the following inactive ingredients: croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, and povidone. Each inactive peach tablet, for oral administration, in the 28 day regimen contains the following inactive ingredients: anhydrous lactose, FD&C Yellow No. 6 Lake, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Norgestrel is a totally synthetic progestogen, insoluble in water, freely soluble in chloroform, sparingly soluble in alcohol with the chemical name (±)-13-Ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one. Ethinyl estradiol is an estrogen, insoluble in water, soluble in alcohol, in chloroform, in ether, in vegetable oils, and in solutions of fixed alkali hydroxides with the chemical name 19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol. Their structural formulae follow. Therapeutic class: Oral contraceptive.</Description>
</NDC>
<NDC>
<NDCCode>55714-4850-1</NDCCode>
<PackageDescription>28 g in 1 BOTTLE, GLASS (55714-4850-1) </PackageDescription>
<NDC11Code>55714-4850-01</NDC11Code>
<ProductNDC>55714-4850</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Warts</ProprietaryName>
<NonProprietaryName>Antimon. Crud., Bryonia, Calc.carb., Causticum, Dulcamara, Graphites, Lycopodium, Merc. Sulph. Rub., Nat. Carb., Nitricum Ac., Nux Vom., Rhus Toxicodendron, Sabina, Sepia, Silicea, Staphysag., Sulphur, Thuja Occ., Taraxacum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221219</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>LYCOPODIUM CLAVATUM SPORE; MERCURIC SULFIDE; SODIUM CARBONATE; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; JUNIPERUS SABINA LEAFY TWIG; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; DELPHINIUM STAPHISAGRIA SEED; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; TARAXACUM OFFICINALE; ANTIMONY TRISULFIDE; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CAUSTICUM; SOLANUM DULCAMARA TOP; GRAPHITE</SubstanceName>
<StrengthNumber>15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 6; 15; 15; 15; 15; 15; 15</StrengthNumber>
<StrengthUnit>[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-12-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Formulated for moist, cauliflower-like skin growths, warty growths, skin eruptions, fig warts and smooth warts.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58198-4850-1</NDCCode>
<PackageDescription>1 BAG in 1 DRUM (58198-4850-1) / 13500 TABLET in 1 BAG</PackageDescription>
<NDC11Code>58198-4850-01</NDC11Code>
<ProductNDC>58198-4850</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Milbemycin Oxime</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<StartMarketingDate>19940721</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Elanco US Inc.</LabelerName>
<SubstanceName>MILBEMYCIN OXIME</SubstanceName>
<StrengthNumber>23</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-09-10</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>21-JUL-94</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>60505-4850-3</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (60505-4850-3) </PackageDescription>
<NDC11Code>60505-4850-03</NDC11Code>
<ProductNDC>60505-4850</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nuvigil</ProprietaryName>
<NonProprietaryName>Armodafinil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250831</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021875</ApplicationNumber>
<LabelerName>Apotex Corp.</LabelerName>
<SubstanceName>ARMODAFINIL</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-09-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250831</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62670-4850-0</NDCCode>
<PackageDescription>29 mL in 1 BOTTLE (62670-4850-0)</PackageDescription>
<NDC11Code>62670-4850-00</NDC11Code>
<ProductNDC>62670-4850</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti-bacterial Hand</ProprietaryName>
<ProprietaryNameSuffix>Vanilla Cookie</ProprietaryNameSuffix>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20141114</StartMarketingDate>
<EndMarketingDate>20150630</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Bath & Body Works, Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>68</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2015-07-03</LastUpdate>
</NDC>
<NDC>
<NDCCode>63629-4850-1</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (63629-4850-1) </PackageDescription>
<NDC11Code>63629-4850-01</NDC11Code>
<ProductNDC>63629-4850</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atorvastatin Calcium</ProprietaryName>
<NonProprietaryName>Atorvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076477</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-03-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140324</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
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