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"Description": "Cyclobenzaprine hydrochloride, USP is a tricyclic amine salt which is white to off white, odourless, crystalline powder with the molecular formula C 20H 21N HCl 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, insoluble in n-hexane. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine hydrochloride 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 as 10 mg tablets for oral administration. Each 10 mg tablet contains cyclobenzaprine hydrochloride and the following inactive ingredients: crospovidone, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Sunset Yellow FCF Aluminum Lake, hypromellose, lactose anhydrous, macrogol, magnesium stearate, polysorbate 80, pregelatinized starch, silicified microcrystalline cellulose, titanium dioxide."
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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 should be used only for short periods (up to 2 or 3 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 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 tricyclic amine salt which is white to off white, odourless, crystalline powder with the molecular formula C 20H 21N HCl 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, insoluble in n-hexane. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine hydrochloride 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 as 10 mg tablets for oral administration. Each 10 mg tablet contains cyclobenzaprine hydrochloride and the following inactive ingredients: crospovidone, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Sunset Yellow FCF Aluminum Lake, hypromellose, lactose anhydrous, macrogol, magnesium stearate, polysorbate 80, pregelatinized starch, silicified microcrystalline cellulose, titanium dioxide."
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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 should be used only for short periods (up to 2 or 3 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 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 tricyclic amine salt which is white to off white, odourless, crystalline powder with the molecular formula C 20H 21N HCl 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, insoluble in n-hexane. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine hydrochloride 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 as 10 mg tablets for oral administration. Each 10 mg tablet contains cyclobenzaprine hydrochloride and the following inactive ingredients: crospovidone, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Sunset Yellow FCF Aluminum Lake, hypromellose, lactose anhydrous, macrogol, magnesium stearate, polysorbate 80, pregelatinized starch, silicified microcrystalline cellulose, titanium dioxide."
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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 should be used only for short periods (up to 2 or 3 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 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 tricyclic amine salt which is white to off white, odourless, crystalline powder with the molecular formula C 20H 21N HCl 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, insoluble in n-hexane. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine hydrochloride 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 as 10 mg tablets for oral administration. Each 10 mg tablet contains cyclobenzaprine hydrochloride and the following inactive ingredients: crospovidone, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Sunset Yellow FCF Aluminum Lake, hypromellose, lactose anhydrous, macrogol, magnesium stearate, polysorbate 80, pregelatinized starch, silicified microcrystalline cellulose, titanium dioxide."
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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 should be used only for short periods (up to 2 or 3 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 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 tricyclic amine salt which is white to off white, odourless, crystalline powder with the molecular formula C 20H 21N HCl 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, insoluble in n-hexane. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine hydrochloride 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 as 10 mg tablets for oral administration. Each 10 mg tablet contains cyclobenzaprine hydrochloride and the following inactive ingredients: crospovidone, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Sunset Yellow FCF Aluminum Lake, hypromellose, lactose anhydrous, macrogol, magnesium stearate, polysorbate 80, pregelatinized starch, silicified microcrystalline cellulose, titanium dioxide."
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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 should be used only for short periods (up to 2 or 3 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 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 tricyclic amine salt which is white to off white, odourless, crystalline powder with the molecular formula C 20H 21N HCl 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, insoluble in n-hexane. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine hydrochloride 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 as 10 mg tablets for oral administration. Each 10 mg tablet contains cyclobenzaprine hydrochloride and the following inactive ingredients: crospovidone, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Sunset Yellow FCF Aluminum Lake, hypromellose, lactose anhydrous, macrogol, magnesium stearate, polysorbate 80, pregelatinized starch, silicified microcrystalline cellulose, titanium dioxide."
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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 should be used only for short periods (up to 2 or 3 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 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 tricyclic amine salt which is white to off white, odourless, crystalline powder with the molecular formula C 20H 21N HCl 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, insoluble in n-hexane. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine hydrochloride 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 as 10 mg tablets for oral administration. Each 10 mg tablet contains cyclobenzaprine hydrochloride and the following inactive ingredients: crospovidone, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Sunset Yellow FCF Aluminum Lake, hypromellose, lactose anhydrous, macrogol, magnesium stearate, polysorbate 80, pregelatinized starch, silicified microcrystalline cellulose, titanium dioxide."
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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 should be used only for short periods (up to 2 or 3 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 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 tricyclic amine salt which is white to off white, odourless, crystalline powder with the molecular formula C 20H 21N HCl 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, insoluble in n-hexane. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine hydrochloride 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 as 10 mg tablets for oral administration. Each 10 mg tablet contains cyclobenzaprine hydrochloride and the following inactive ingredients: crospovidone, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Sunset Yellow FCF Aluminum Lake, hypromellose, lactose anhydrous, macrogol, magnesium stearate, polysorbate 80, pregelatinized starch, silicified microcrystalline cellulose, titanium dioxide."
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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 should be used only for short periods (up to 2 or 3 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 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 tricyclic amine salt which is white to off white, odourless, crystalline powder with the molecular formula C 20H 21N HCl 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, insoluble in n-hexane. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine hydrochloride 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 as 10 mg tablets for oral administration. Each 10 mg tablet contains cyclobenzaprine hydrochloride and the following inactive ingredients: crospovidone, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Sunset Yellow FCF Aluminum Lake, hypromellose, lactose anhydrous, macrogol, magnesium stearate, polysorbate 80, pregelatinized starch, silicified microcrystalline cellulose, titanium dioxide."
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"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 should be used only for short periods (up to 2 or 3 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 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 tricyclic amine salt which is white to off white, odourless, crystalline powder with the molecular formula C 20H 21N HCl 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, insoluble in n-hexane. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine hydrochloride 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 as 10 mg tablets for oral administration. Each 10 mg tablet contains cyclobenzaprine hydrochloride and the following inactive ingredients: crospovidone, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Sunset Yellow FCF Aluminum Lake, hypromellose, lactose anhydrous, macrogol, magnesium stearate, polysorbate 80, pregelatinized starch, silicified microcrystalline cellulose, titanium dioxide."
},
{
"NDCCode": "11410-218-30",
"PackageDescription": "1 KIT in 1 BOX (11410-218-30) * 1 TUBE in 1 CARTON (11410-046-20) / 30 mL in 1 TUBE * 1 TUBE in 1 BOX (11410-023-00) / 30 mL in 1 TUBE * 1 TUBE in 1 BOX (11410-011-82) / 60 mL in 1 TUBE",
"NDC11Code": "11410-0218-30",
"ProductNDC": "11410-218",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Proactiv Plus Kit",
"NonProprietaryName": "Solutions Kit",
"DosageFormName": "KIT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240508",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M006",
"LabelerName": "Alchemee, LLC",
"Status": "Active",
"LastUpdate": "2026-02-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240508",
"SamplePackage": "N"
},
{
"NDCCode": "30805-011-20",
"PackageDescription": "567 g in 1 CAN (30805-011-20) ",
"NDC11Code": "30805-0011-20",
"ProductNDC": "30805-011",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Symmetry Foaming Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "AEROSOL, FOAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20171214",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Buckeye International, Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "62",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "41701-011-20",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (41701-011-20) / 1.2 g in 1 BOTTLE, PLASTIC (41701-011-19) ",
"NDC11Code": "41701-0011-20",
"ProductNDC": "41701-011",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Cetrorelix Powder (synthetic)",
"DosageFormName": "POWDER",
"StartMarketingDate": "20110318",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Piramal Pharma Limited",
"SubstanceName": "CETRORELIX",
"StrengthNumber": "1.2",
"StrengthUnit": "g/1.2g",
"Status": "Unfinished",
"LastUpdate": "2023-02-21",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "18-MAR-11"
},
{
"NDCCode": "42659-011-20",
"PackageDescription": "200 mL in 1 BOTTLE (42659-011-20)",
"NDC11Code": "42659-0011-20",
"ProductNDC": "42659-011",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Plum Emergency Eyewash/eyewash Duo/eyewash Shower Iss Usa",
"NonProprietaryName": "Water",
"DosageFormName": "LIQUID",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20160617",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part349",
"LabelerName": "Plum A/S",
"SubstanceName": "WATER",
"StrengthNumber": "99.1",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "For rinsing the eyes and skin to reduce risk of severe injury caused by chemicals or particulate contamination."
},
{
"NDCCode": "42708-011-20",
"PackageDescription": "20 TABLET, COATED in 1 BOTTLE (42708-011-20) ",
"NDC11Code": "42708-0011-20",
"ProductNDC": "42708-011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin",
"NonProprietaryName": "Amoxicillin",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20060329",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065255",
"LabelerName": "QPharma Inc",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "875",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC],Penicillins [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20180314",
"SamplePackage": "Y"
},
{
"NDCCode": "42851-011-20",
"PackageDescription": "1 TUBE in 1 CARTON (42851-011-20) > 20 g in 1 TUBE",
"NDC11Code": "42851-0011-20",
"ProductNDC": "42851-011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tretinoin (emollient)",
"NonProprietaryName": "Tretinoin",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076498",
"LabelerName": "ZO Skin Health, Inc.",
"SubstanceName": "TRETINOIN",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Retinoid [EPC],Retinoids [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-02-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20170501",
"SamplePackage": "N"
},
{
"NDCCode": "44119-011-01",
"PackageDescription": "20 PATCH in 1 POUCH (44119-011-01) > 3.15 mL in 1 PATCH",
"NDC11Code": "44119-0011-01",
"ProductNDC": "44119-011",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Disney Frozen Ii Antibacterial Hand Wipes",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210401",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Peachtree Playthings, Inc.",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "1.3",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2023-10-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20210401",
"SamplePackage": "N"
},
{
"NDCCode": "44397-011-20",
"PackageDescription": "7760 L in 1 CYLINDER (44397-011-20)",
"NDC11Code": "44397-0011-20",
"ProductNDC": "44397-011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitrogen",
"NonProprietaryName": "Nitrogen",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19740101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205891",
"LabelerName": "Argyle Welding Supply Company, Inc.",
"SubstanceName": "NITROGEN",
"StrengthNumber": "99",
"StrengthUnit": "L/100L",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "48433-011-20",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (48433-011-20) / 1 TABLET in 1 BLISTER PACK (48433-011-01) ",
"NDC11Code": "48433-0011-20",
"ProductNDC": "48433-011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Buspirone Hydrochloride",
"NonProprietaryName": "Buspirone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260204",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076008",
"LabelerName": "Safecor Health, LLC",
"SubstanceName": "BUSPIRONE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-02-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260204",
"SamplePackage": "N",
"IndicationAndUsage": "Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets have been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association’s Diagnostic and Statistical Manual, III 1as follows:. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate., 3 Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling “on edge,” irritability, impatience.",
"Description": "Buspirone hydrochloride tablets, USP are an antianxiety agent that are not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride, USP is a white crystalline, water soluble compound with a molecular weight of 422.0. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The molecular formula C 21H 31N 5O 2HCl is represented by the following structural formula:. Buspirone hydrochloride tablets are supplied as tablets for oral administration containing 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.9 mg, 9.1 mg, 13.7 mg, and 27.4 mg of buspirone free base, respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg and 30 mg tablets are provided in a multi-scored tablet design. These tablets are scored so they can be either bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two thirds of a tablet), 7.5 mg (one half of a tablet), or 5 mg (one third of a tablet). A single 30 mg tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two thirds of a tablet), 15 mg (one half of a tablet), or 10 mg (one third of a tablet). Buspirone hydrochloride tablets contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, and sodium starch glycolate (potato)."
},
{
"NDCCode": "49999-011-20",
"PackageDescription": "20 CAPSULE in 1 BOTTLE, PLASTIC (49999-011-20)",
"NDC11Code": "49999-0011-20",
"ProductNDC": "49999-011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clindamycin Hydrochloride",
"NonProprietaryName": "Clindamycin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20110201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA063083",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "CLINDAMYCIN HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-07-11",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "50814-021-01",
"PackageDescription": "1 KIT in 1 KIT (50814-021-01) * 1 BOX in 1 BOX (50814-012-01) / 20 PATCH in 1 BOX / .9 g in 1 PATCH * 1 BOX in 1 BOX (50814-014-01) / 10 PACKAGE in 1 BOX / .9 g in 1 PACKAGE * 1 BOX in 1 BOX (50814-013-01) / 10 PACKAGE in 1 BOX / .9 g in 1 PACKAGE * 1 BOX in 1 BOX (50814-015-01) / 6 PACKAGE in 1 BOX / .9 g in 1 PACKAGE * 2 BOX in 1 BOX (50814-011-01) / 10 PATCH in 1 BOX / .9 g in 1 PATCH * 1 TUBE in 1 BOX (50814-010-01) / 30 mL in 1 TUBE",
"NDC11Code": "50814-0021-01",
"ProductNDC": "50814-021",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Large Ansi First Aid Kit",
"NonProprietaryName": "Water, Benzalkonium Chloride, Isopropyl Alcohol, Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, Lidocaine Hydrochloride",
"DosageFormName": "KIT",
"StartMarketingDate": "20160809",
"EndMarketingDate": "20251231",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M004",
"LabelerName": "GFA Production (Xiamen) Co., Ltd.",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160809",
"EndMarketingDatePackage": "20251231",
"SamplePackage": "N"
},
{
"NDCCode": "50814-031-01",
"PackageDescription": "1 KIT in 1 KIT (50814-031-01) * 20 PATCH in 1 BOX (50814-012-01) / .9 g in 1 PATCH * 6 PACKAGE in 1 BOX (50814-015-01) / .9 g in 1 PACKAGE * 10 PACKAGE in 1 BOX (50814-013-01) / .9 g in 1 PACKAGE * 1 TUBE in 1 BOX (50814-010-01) / 30 mL in 1 TUBE * 10 PACKAGE in 1 BOX (50814-014-01) / .9 g in 1 PACKAGE * 1 BAG in 1 BOX (50814-002-01) / 4.5 g in 1 BAG * 10 PATCH in 1 BOX (50814-011-01) / 1.8 g in 1 PATCH",
"NDC11Code": "50814-0031-01",
"ProductNDC": "50814-031",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fak Large Office First Aid Kit",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "KIT",
"StartMarketingDate": "20180208",
"EndMarketingDate": "20251231",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M018",
"LabelerName": "GFA Production (Xiamen) Co., Ltd.",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180208",
"EndMarketingDatePackage": "20251231",
"SamplePackage": "N"
},
{
"NDCCode": "50814-032-01",
"PackageDescription": "1 KIT in 1 KIT (50814-032-01) * 1 BOX in 1 BOX (50814-014-01) / 10 PACKAGE in 1 BOX / .9 g in 1 PACKAGE * 1 BOX in 1 BOX (50814-015-01) / 6 PACKAGE in 1 BOX / .9 g in 1 PACKAGE * 1 BOX in 1 BOX (50814-013-01) / 10 PACKAGE in 1 BOX / .9 g in 1 PACKAGE * 1 TUBE in 1 BOX (50814-010-01) / 30 mL in 1 TUBE * 1 BOX in 1 BOX (50814-012-01) / 20 PATCH in 1 BOX / .9 g in 1 PATCH * 1 POUCH in 1 BOX (50814-002-01) / .45 g in 1 POUCH * 2 BOX in 1 BOX (50814-011-01) / 10 PATCH in 1 BOX / .9 g in 1 PATCH",
"NDC11Code": "50814-0032-01",
"ProductNDC": "50814-032",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fak Standard Office First Aid",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "KIT",
"StartMarketingDate": "20180208",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "GFA Production (Xiamen) Co., Ltd.",
"Status": "Active",
"LastUpdate": "2025-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180208",
"SamplePackage": "N"
},
{
"NDCCode": "51224-011-20",
"PackageDescription": "60 POUCH in 1 CARTON (51224-011-20) / 8.3 g in 1 POUCH",
"NDC11Code": "51224-0011-20",
"ProductNDC": "51224-011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cholestyramine",
"NonProprietaryName": "Cholestyramine",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20210310",
"EndMarketingDate": "20261130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209597",
"LabelerName": "TAGI Pharma, Inc.",
"SubstanceName": "CHOLESTYRAMINE",
"StrengthNumber": "4",
"StrengthUnit": "g/8.3g",
"Pharm_Classes": "Bile Acid Sequestrant [EPC], Bile-acid Binding Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-04-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20210310",
"EndMarketingDatePackage": "20261130",
"SamplePackage": "N",
"IndicationAndUsage": "1) Cholestyramine for Oral Suspension, USP is indicated as adjunctive therapy to diet for the reduction of elevated serum cholesterol in patients with primary hypercholesterolemia (elevated low density lipoprotein [LDL] cholesterol) who do not respond adequately to diet. Cholestyramine for Oral Suspension, USP may be useful to lower LDL cholesterol in patients who also have hypertriglyceridemia, but it is not indicated where hypertriglyceridemia is the abnormality of most concern. Therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Treatment should begin and continue with dietary therapy specific for the type of hyperlipoproteinemia determined prior to initiation of drug therapy. Excess body weight may be an important factor and caloric restriction for weight normalization should be addressed prior to drug therapy in the overweight. Prior to initiating therapy with cholestyramine resin, secondary causes of hypercholesterolemia (e.g., poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism), should be excluded and a lipid profile performed to assess Total cholesterol, HDL-C and triglycerides (TG). For individuals with TG less than 400 mg/dL (<4.5 mmol/L), LDL-C can be estimated using the following equation: LDL-C = Total cholesterol - [(TG/5) + HDL-C]. For TG levels > 400 mg/dL, this equation is less accurate and LDL-C concentrations should be determined by ultracentrifugation. In hypertriglyceridemic patients, LDL-C may be low or normal despite elevated Total-C. In such cases cholestyramine resin, may not be indicated. Serum cholesterol and triglyceride levels should be determined periodically based on NCEP guidelines to confirm initial and adequate long-term response. A favorable trend in cholesterol reduction should occur during the first month of cholestyramine resin therapy. The therapy should be continued to sustain cholesterol reduction. If adequate cholesterol reduction is not attained, increasing the dosage of cholestyramine resin or adding other lipid-lowering agents in combination with cholestyramine resin should be considered. Since the goal of treatment is to lower LDL-C, the NCEP4 recommends that LDL-C levels be used to initiate and assess treatment response. If LDL-C levels are not available, then Total-C alone may be used to monitor long-term therapy. A lipoprotein analysis (including LDL-C determination) should be carried out once a year. The NCEP treatment guidelines are summarized below. Cholestyramine resin monotherapy has been demonstrated to retard the rate of progression2,3 and increase the rate of regression3 of coronary atherosclerosis. 2) Cholestyramine for Oral Suspension, USP is indicated for the relief of pruritus associated with partial biliary obstruction. Cholestyramine resin has been shown to have a variable effect on serum cholesterol in these patients. Patients with primary biliary cirrhosis may exhibit an elevated cholesterol as part of their disease.",
"Description": "Cholestyramine for Oral Suspension, USP, the chloride salt of a basic anion exchange resin, a cholesterol lowering agent, is intended for oral administration. Cholestyramine resin is quite hydrophilic, but insoluble in water. Cholestyramine resin is not absorbed from the digestive tract. 8.3 grams of Cholestyramine for Oral Suspension, USP contain 4 grams of cholestyramine resin. It is represented by the following structural formula. Inactive ingredients: sucrose (429.5 mg/g), propylene glycol alginate, natural orange flavor, anhydrous citric acid, D&C Yellow No. 10 aluminum lake and FD&C Yellow No. 6 aluminum lake."
},
{
"NDCCode": "51655-011-20",
"PackageDescription": "20 TABLET in 1 BOTTLE, DISPENSING (51655-011-20)",
"NDC11Code": "51655-0011-20",
"ProductNDC": "51655-011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Penicillin V Potassium",
"NonProprietaryName": "Penicillin V Potassium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062935",
"LabelerName": "Northwind Pharmaceuticals",
"SubstanceName": "PENICILLIN V POTASSIUM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillins [CS],Penicillin-class Antibacterial [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "52003-011-20",
"PackageDescription": "18144 L in 1 TANK (52003-011-20) ",
"NDC11Code": "52003-0011-20",
"ProductNDC": "52003-011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxygen",
"NonProprietaryName": "Oxygen",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19600101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205817",
"LabelerName": "Messer Canada Inc.",
"SubstanceName": "OXYGEN",
"StrengthNumber": "995",
"StrengthUnit": "mL/L",
"Status": "Active",
"LastUpdate": "2025-11-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19600101",
"SamplePackage": "N"
},
{
"NDCCode": "52086-011-20",
"PackageDescription": "1132 L in 1 CYLINDER (52086-011-20) ",
"NDC11Code": "52086-0011-20",
"ProductNDC": "52086-011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxygen",
"NonProprietaryName": "Oxygen",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19830908",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205889",
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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 should be used only for short periods (up to 2 or 3 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 have 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 tricyclic amine salt which is white to off white, odourless, crystalline powder with the molecular formula C 20H 21N HCl 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, insoluble in n-hexane. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine hydrochloride 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 as 10 mg tablets for oral administration. Each 10 mg tablet contains cyclobenzaprine hydrochloride and the following inactive ingredients: crospovidone, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Sunset Yellow FCF Aluminum Lake, hypromellose, lactose anhydrous, macrogol, magnesium stearate, polysorbate 80, pregelatinized starch, silicified microcrystalline cellulose, titanium dioxide.</Description>
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<IndicationAndUsage>Cyclobenzaprine hydrochloride tablets, USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine hydrochloride tablets should be used only for short periods (up to 2 or 3 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 have 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 tricyclic amine salt which is white to off white, odourless, crystalline powder with the molecular formula C 20H 21N HCl 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, insoluble in n-hexane. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine hydrochloride 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 as 10 mg tablets for oral administration. Each 10 mg tablet contains cyclobenzaprine hydrochloride and the following inactive ingredients: crospovidone, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Sunset Yellow FCF Aluminum Lake, hypromellose, lactose anhydrous, macrogol, magnesium stearate, polysorbate 80, pregelatinized starch, silicified microcrystalline cellulose, titanium dioxide.</Description>
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<SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
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<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
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<LastUpdate>2026-02-16</LastUpdate>
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<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 should be used only for short periods (up to 2 or 3 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 have 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 tricyclic amine salt which is white to off white, odourless, crystalline powder with the molecular formula C 20H 21N HCl 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, insoluble in n-hexane. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine hydrochloride 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 as 10 mg tablets for oral administration. Each 10 mg tablet contains cyclobenzaprine hydrochloride and the following inactive ingredients: crospovidone, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Sunset Yellow FCF Aluminum Lake, hypromellose, lactose anhydrous, macrogol, magnesium stearate, polysorbate 80, pregelatinized starch, silicified microcrystalline cellulose, titanium dioxide.</Description>
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<NDC11Code>11410-0218-30</NDC11Code>
<ProductNDC>11410-218</ProductNDC>
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<ProprietaryName>Proactiv Plus Kit</ProprietaryName>
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<LabelerName>Alchemee, LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-02-19</LastUpdate>
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<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>30805-011-20</NDCCode>
<PackageDescription>567 g in 1 CAN (30805-011-20) </PackageDescription>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Symmetry Foaming Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>AEROSOL, FOAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
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<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Buckeye International, Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>62</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
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<NDC>
<NDCCode>41701-011-20</NDCCode>
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<NDC11Code>41701-0011-20</NDC11Code>
<ProductNDC>41701-011</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Cetrorelix Powder (synthetic)</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20110318</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Piramal Pharma Limited</LabelerName>
<SubstanceName>CETRORELIX</SubstanceName>
<StrengthNumber>1.2</StrengthNumber>
<StrengthUnit>g/1.2g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2023-02-21</LastUpdate>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>18-MAR-11</StartMarketingDatePackage>
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<NDC>
<NDCCode>42659-011-20</NDCCode>
<PackageDescription>200 mL in 1 BOTTLE (42659-011-20)</PackageDescription>
<NDC11Code>42659-0011-20</NDC11Code>
<ProductNDC>42659-011</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Plum Emergency Eyewash/eyewash Duo/eyewash Shower Iss Usa</ProprietaryName>
<NonProprietaryName>Water</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20160617</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part349</ApplicationNumber>
<LabelerName>Plum A/S</LabelerName>
<SubstanceName>WATER</SubstanceName>
<StrengthNumber>99.1</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For rinsing the eyes and skin to reduce risk of severe injury caused by chemicals or particulate contamination.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>42708-011-20</NDCCode>
<PackageDescription>20 TABLET, COATED in 1 BOTTLE (42708-011-20) </PackageDescription>
<NDC11Code>42708-0011-20</NDC11Code>
<ProductNDC>42708-011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin</ProprietaryName>
<NonProprietaryName>Amoxicillin</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060329</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065255</ApplicationNumber>
<LabelerName>QPharma Inc</LabelerName>
<SubstanceName>AMOXICILLIN</SubstanceName>
<StrengthNumber>875</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC],Penicillins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180314</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
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<NDC>
<NDCCode>42851-011-20</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (42851-011-20) > 20 g in 1 TUBE</PackageDescription>
<NDC11Code>42851-0011-20</NDC11Code>
<ProductNDC>42851-011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tretinoin (emollient)</ProprietaryName>
<NonProprietaryName>Tretinoin</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076498</ApplicationNumber>
<LabelerName>ZO Skin Health, Inc.</LabelerName>
<SubstanceName>TRETINOIN</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Retinoid [EPC],Retinoids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-02-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>44119-011-01</NDCCode>
<PackageDescription>20 PATCH in 1 POUCH (44119-011-01) > 3.15 mL in 1 PATCH</PackageDescription>
<NDC11Code>44119-0011-01</NDC11Code>
<ProductNDC>44119-011</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Disney Frozen Ii Antibacterial Hand Wipes</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210401</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Peachtree Playthings, Inc.</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>1.3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-10-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>44397-011-20</NDCCode>
<PackageDescription>7760 L in 1 CYLINDER (44397-011-20)</PackageDescription>
<NDC11Code>44397-0011-20</NDC11Code>
<ProductNDC>44397-011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitrogen</ProprietaryName>
<NonProprietaryName>Nitrogen</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19740101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205891</ApplicationNumber>
<LabelerName>Argyle Welding Supply Company, Inc.</LabelerName>
<SubstanceName>NITROGEN</SubstanceName>
<StrengthNumber>99</StrengthNumber>
<StrengthUnit>L/100L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>48433-011-20</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (48433-011-20) / 1 TABLET in 1 BLISTER PACK (48433-011-01) </PackageDescription>
<NDC11Code>48433-0011-20</NDC11Code>
<ProductNDC>48433-011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Buspirone Hydrochloride</ProprietaryName>
<NonProprietaryName>Buspirone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260204</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076008</ApplicationNumber>
<LabelerName>Safecor Health, LLC</LabelerName>
<SubstanceName>BUSPIRONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-02-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260204</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets have been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association’s Diagnostic and Statistical Manual, III 1as follows:. Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1 Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle., 2 Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate., 3 Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others., 4 Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling “on edge,” irritability, impatience.</IndicationAndUsage>
<Description>Buspirone hydrochloride tablets, USP are an antianxiety agent that are not chemically or pharmacologically related to the benzodiazepines, barbiturates, or other sedative/anxiolytic drugs. Buspirone hydrochloride, USP is a white crystalline, water soluble compound with a molecular weight of 422.0. Chemically, buspirone hydrochloride is 8-[4-[4-(2-pyrimidinyl)-1-piperazinyl]butyl]-8-azaspiro[4.5]decane-7,9-dione monohydrochloride. The molecular formula C 21H 31N 5O 2HCl is represented by the following structural formula:. Buspirone hydrochloride tablets are supplied as tablets for oral administration containing 5 mg, 7.5 mg, 10 mg, 15 mg or 30 mg of buspirone hydrochloride, USP (equivalent to 4.6 mg, 6.9 mg, 9.1 mg, 13.7 mg, and 27.4 mg of buspirone free base, respectively). The 5 mg and 10 mg tablets are scored so they can be bisected. Thus, the 5 mg tablet can also provide a 2.5 mg dose, and the 10 mg tablet can provide a 5 mg dose. The 15 mg and 30 mg tablets are provided in a multi-scored tablet design. These tablets are scored so they can be either bisected or trisected. Thus, a single 15 mg tablet can provide the following doses: 15 mg (entire tablet), 10 mg (two thirds of a tablet), 7.5 mg (one half of a tablet), or 5 mg (one third of a tablet). A single 30 mg tablet can provide the following doses: 30 mg (entire tablet), 20 mg (two thirds of a tablet), 15 mg (one half of a tablet), or 10 mg (one third of a tablet). Buspirone hydrochloride tablets contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, and sodium starch glycolate (potato).</Description>
</NDC>
<NDC>
<NDCCode>49999-011-20</NDCCode>
<PackageDescription>20 CAPSULE in 1 BOTTLE, PLASTIC (49999-011-20)</PackageDescription>
<NDC11Code>49999-0011-20</NDC11Code>
<ProductNDC>49999-011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clindamycin Hydrochloride</ProprietaryName>
<NonProprietaryName>Clindamycin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA063083</ApplicationNumber>
<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>CLINDAMYCIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-07-11</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>50814-021-01</NDCCode>
<PackageDescription>1 KIT in 1 KIT (50814-021-01) * 1 BOX in 1 BOX (50814-012-01) / 20 PATCH in 1 BOX / .9 g in 1 PATCH * 1 BOX in 1 BOX (50814-014-01) / 10 PACKAGE in 1 BOX / .9 g in 1 PACKAGE * 1 BOX in 1 BOX (50814-013-01) / 10 PACKAGE in 1 BOX / .9 g in 1 PACKAGE * 1 BOX in 1 BOX (50814-015-01) / 6 PACKAGE in 1 BOX / .9 g in 1 PACKAGE * 2 BOX in 1 BOX (50814-011-01) / 10 PATCH in 1 BOX / .9 g in 1 PATCH * 1 TUBE in 1 BOX (50814-010-01) / 30 mL in 1 TUBE</PackageDescription>
<NDC11Code>50814-0021-01</NDC11Code>
<ProductNDC>50814-021</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Large Ansi First Aid Kit</ProprietaryName>
<NonProprietaryName>Water, Benzalkonium Chloride, Isopropyl Alcohol, Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, Lidocaine Hydrochloride</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20160809</StartMarketingDate>
<EndMarketingDate>20251231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M004</ApplicationNumber>
<LabelerName>GFA Production (Xiamen) Co., Ltd.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160809</StartMarketingDatePackage>
<EndMarketingDatePackage>20251231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50814-031-01</NDCCode>
<PackageDescription>1 KIT in 1 KIT (50814-031-01) * 20 PATCH in 1 BOX (50814-012-01) / .9 g in 1 PATCH * 6 PACKAGE in 1 BOX (50814-015-01) / .9 g in 1 PACKAGE * 10 PACKAGE in 1 BOX (50814-013-01) / .9 g in 1 PACKAGE * 1 TUBE in 1 BOX (50814-010-01) / 30 mL in 1 TUBE * 10 PACKAGE in 1 BOX (50814-014-01) / .9 g in 1 PACKAGE * 1 BAG in 1 BOX (50814-002-01) / 4.5 g in 1 BAG * 10 PATCH in 1 BOX (50814-011-01) / 1.8 g in 1 PATCH</PackageDescription>
<NDC11Code>50814-0031-01</NDC11Code>
<ProductNDC>50814-031</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fak Large Office First Aid Kit</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20180208</StartMarketingDate>
<EndMarketingDate>20251231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M018</ApplicationNumber>
<LabelerName>GFA Production (Xiamen) Co., Ltd.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180208</StartMarketingDatePackage>
<EndMarketingDatePackage>20251231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50814-032-01</NDCCode>
<PackageDescription>1 KIT in 1 KIT (50814-032-01) * 1 BOX in 1 BOX (50814-014-01) / 10 PACKAGE in 1 BOX / .9 g in 1 PACKAGE * 1 BOX in 1 BOX (50814-015-01) / 6 PACKAGE in 1 BOX / .9 g in 1 PACKAGE * 1 BOX in 1 BOX (50814-013-01) / 10 PACKAGE in 1 BOX / .9 g in 1 PACKAGE * 1 TUBE in 1 BOX (50814-010-01) / 30 mL in 1 TUBE * 1 BOX in 1 BOX (50814-012-01) / 20 PATCH in 1 BOX / .9 g in 1 PATCH * 1 POUCH in 1 BOX (50814-002-01) / .45 g in 1 POUCH * 2 BOX in 1 BOX (50814-011-01) / 10 PATCH in 1 BOX / .9 g in 1 PATCH</PackageDescription>
<NDC11Code>50814-0032-01</NDC11Code>
<ProductNDC>50814-032</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fak Standard Office First Aid</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20180208</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>GFA Production (Xiamen) Co., Ltd.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180208</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>51224-011-20</NDCCode>
<PackageDescription>60 POUCH in 1 CARTON (51224-011-20) / 8.3 g in 1 POUCH</PackageDescription>
<NDC11Code>51224-0011-20</NDC11Code>
<ProductNDC>51224-011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cholestyramine</ProprietaryName>
<NonProprietaryName>Cholestyramine</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210310</StartMarketingDate>
<EndMarketingDate>20261130</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209597</ApplicationNumber>
<LabelerName>TAGI Pharma, Inc.</LabelerName>
<SubstanceName>CHOLESTYRAMINE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>g/8.3g</StrengthUnit>
<Pharm_Classes>Bile Acid Sequestrant [EPC], Bile-acid Binding Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20210310</StartMarketingDatePackage>
<EndMarketingDatePackage>20261130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>1) Cholestyramine for Oral Suspension, USP is indicated as adjunctive therapy to diet for the reduction of elevated serum cholesterol in patients with primary hypercholesterolemia (elevated low density lipoprotein [LDL] cholesterol) who do not respond adequately to diet. Cholestyramine for Oral Suspension, USP may be useful to lower LDL cholesterol in patients who also have hypertriglyceridemia, but it is not indicated where hypertriglyceridemia is the abnormality of most concern. Therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Treatment should begin and continue with dietary therapy specific for the type of hyperlipoproteinemia determined prior to initiation of drug therapy. Excess body weight may be an important factor and caloric restriction for weight normalization should be addressed prior to drug therapy in the overweight. Prior to initiating therapy with cholestyramine resin, secondary causes of hypercholesterolemia (e.g., poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism), should be excluded and a lipid profile performed to assess Total cholesterol, HDL-C and triglycerides (TG). For individuals with TG less than 400 mg/dL (<4.5 mmol/L), LDL-C can be estimated using the following equation: LDL-C = Total cholesterol - [(TG/5) + HDL-C]. For TG levels > 400 mg/dL, this equation is less accurate and LDL-C concentrations should be determined by ultracentrifugation. In hypertriglyceridemic patients, LDL-C may be low or normal despite elevated Total-C. In such cases cholestyramine resin, may not be indicated. Serum cholesterol and triglyceride levels should be determined periodically based on NCEP guidelines to confirm initial and adequate long-term response. A favorable trend in cholesterol reduction should occur during the first month of cholestyramine resin therapy. The therapy should be continued to sustain cholesterol reduction. If adequate cholesterol reduction is not attained, increasing the dosage of cholestyramine resin or adding other lipid-lowering agents in combination with cholestyramine resin should be considered. Since the goal of treatment is to lower LDL-C, the NCEP4 recommends that LDL-C levels be used to initiate and assess treatment response. If LDL-C levels are not available, then Total-C alone may be used to monitor long-term therapy. A lipoprotein analysis (including LDL-C determination) should be carried out once a year. The NCEP treatment guidelines are summarized below. Cholestyramine resin monotherapy has been demonstrated to retard the rate of progression2,3 and increase the rate of regression3 of coronary atherosclerosis. 2) Cholestyramine for Oral Suspension, USP is indicated for the relief of pruritus associated with partial biliary obstruction. Cholestyramine resin has been shown to have a variable effect on serum cholesterol in these patients. Patients with primary biliary cirrhosis may exhibit an elevated cholesterol as part of their disease.</IndicationAndUsage>
<Description>Cholestyramine for Oral Suspension, USP, the chloride salt of a basic anion exchange resin, a cholesterol lowering agent, is intended for oral administration. Cholestyramine resin is quite hydrophilic, but insoluble in water. Cholestyramine resin is not absorbed from the digestive tract. 8.3 grams of Cholestyramine for Oral Suspension, USP contain 4 grams of cholestyramine resin. It is represented by the following structural formula. Inactive ingredients: sucrose (429.5 mg/g), propylene glycol alginate, natural orange flavor, anhydrous citric acid, D&C Yellow No. 10 aluminum lake and FD&C Yellow No. 6 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>51655-011-20</NDCCode>
<PackageDescription>20 TABLET in 1 BOTTLE, DISPENSING (51655-011-20)</PackageDescription>
<NDC11Code>51655-0011-20</NDC11Code>
<ProductNDC>51655-011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Penicillin V Potassium</ProprietaryName>
<NonProprietaryName>Penicillin V Potassium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062935</ApplicationNumber>
<LabelerName>Northwind Pharmaceuticals</LabelerName>
<SubstanceName>PENICILLIN V POTASSIUM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillins [CS],Penicillin-class Antibacterial [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>52003-011-20</NDCCode>
<PackageDescription>18144 L in 1 TANK (52003-011-20) </PackageDescription>
<NDC11Code>52003-0011-20</NDC11Code>
<ProductNDC>52003-011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxygen</ProprietaryName>
<NonProprietaryName>Oxygen</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19600101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205817</ApplicationNumber>
<LabelerName>Messer Canada Inc.</LabelerName>
<SubstanceName>OXYGEN</SubstanceName>
<StrengthNumber>995</StrengthNumber>
<StrengthUnit>mL/L</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-11-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19600101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>52086-011-20</NDCCode>
<PackageDescription>1132 L in 1 CYLINDER (52086-011-20) </PackageDescription>
<NDC11Code>52086-0011-20</NDC11Code>
<ProductNDC>52086-011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxygen</ProprietaryName>
<NonProprietaryName>Oxygen</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19830908</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205889</ApplicationNumber>
<LabelerName>Helget Gas Products</LabelerName>
<SubstanceName>OXYGEN</SubstanceName>
<StrengthNumber>999</StrengthNumber>
<StrengthUnit>mL/L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19830908</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>52266-011-20</NDCCode>
<PackageDescription>78 VIAL in 1 TRAY (52266-011-20) > 20 mL in 1 VIAL</PackageDescription>
<NDC11Code>52266-0011-20</NDC11Code>
<ProductNDC>52266-011</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Bendamustine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<StartMarketingDate>20160411</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>NerPharMa S.r.l</LabelerName>
<SubstanceName>BENDAMUSTINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/20mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>52346-011-04</NDCCode>
<PackageDescription>20 L in 1 DEWAR (52346-011-04) </PackageDescription>
<NDC11Code>52346-0011-04</NDC11Code>
<ProductNDC>52346-011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitrogen</ProprietaryName>
<NonProprietaryName>Nitrogen</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19851201</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205866</ApplicationNumber>
<LabelerName>AMERICAN WELDING & GAS, INC.</LabelerName>
<SubstanceName>NITROGEN</SubstanceName>
<StrengthNumber>990</StrengthNumber>
<StrengthUnit>mL/L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-10-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19851201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>52374-011-20</NDCCode>
<PackageDescription>18144 L in 1 TANK (52374-011-20) </PackageDescription>
<NDC11Code>52374-0011-20</NDC11Code>
<ProductNDC>52374-011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxygen</ProprietaryName>
<NonProprietaryName>Oxygen</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19600101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205818</ApplicationNumber>
<LabelerName>Messer Gas Puerto Rico, Inc</LabelerName>
<SubstanceName>OXYGEN</SubstanceName>
<StrengthNumber>995</StrengthNumber>
<StrengthUnit>mL/L</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-11-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19600101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>