{
"NDC": [
{
"NDCCode": "58809-225-32",
"PackageDescription": "946 mL in 1 BOTTLE (58809-225-32) ",
"NDC11Code": "58809-0225-32",
"ProductNDC": "58809-225",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dayclear Hand Sanitizer",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200401",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "GM Pharmaceuticals, INC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".62",
"StrengthUnit": "mL/mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200401",
"SamplePackage": "N"
},
{
"NDCCode": "52642-225-32",
"PackageDescription": "32 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (52642-225-32)",
"NDC11Code": "52642-0225-32",
"ProductNDC": "52642-225",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tropical Panned",
"NonProprietaryName": "Calcium Carbonate, Simethicone",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20140319",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part331",
"LabelerName": "BestCo Inc.",
"SubstanceName": "CALCIUM CARBONATE; DIMETHICONE",
"StrengthNumber": "750; 80",
"StrengthUnit": "mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Uses for the relief of: 1 Acid indigestion, 2 Heartburn, 3 Sour stomach, 4 Upset stomach associated with these symptoms, 5 Bloating, pressure, or stuffed feeling commonl referred to as gas."
},
{
"NDCCode": "58809-225-02",
"PackageDescription": "59 mL in 1 BOTTLE (58809-225-02) ",
"NDC11Code": "58809-0225-02",
"ProductNDC": "58809-225",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dayclear Hand Sanitizer",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200401",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "GM Pharmaceuticals, INC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".62",
"StrengthUnit": "mL/mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200401",
"SamplePackage": "N"
},
{
"NDCCode": "58809-225-08",
"PackageDescription": "237 mL in 1 BOTTLE (58809-225-08) ",
"NDC11Code": "58809-0225-08",
"ProductNDC": "58809-225",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dayclear Hand Sanitizer",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200401",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "GM Pharmaceuticals, INC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".62",
"StrengthUnit": "mL/mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200401",
"SamplePackage": "N"
},
{
"NDCCode": "58809-225-12",
"PackageDescription": "355 mL in 1 BOTTLE (58809-225-12) ",
"NDC11Code": "58809-0225-12",
"ProductNDC": "58809-225",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dayclear Hand Sanitizer",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200401",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "GM Pharmaceuticals, INC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".62",
"StrengthUnit": "mL/mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200401",
"SamplePackage": "N"
},
{
"NDCCode": "0131-3268-32",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0131-3268-32)",
"NDC11Code": "00131-3268-32",
"ProductNDC": "0131-3268",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine Hydrochloride",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20100429",
"EndMarketingDate": "20180331",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022104",
"LabelerName": "UCB, Inc.",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "225",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-04-03",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0527-2604-32",
"PackageDescription": "30 TABLET in 1 BOTTLE (0527-2604-32) ",
"NDC11Code": "00527-2604-32",
"ProductNDC": "0527-2604",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine Hydrochloride",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20191226",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209193",
"LabelerName": "Lannett Company, Inc.",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-11-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20191226",
"SamplePackage": "N",
"IndicationAndUsage": "Venlafaxine Hydrochloride Extended-Release Tablets are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for: 1 Major Depressive Disorder (MDD) (1.1), 2 Social Anxiety Disorder (SAD) (1.2).",
"Description": "Venlafaxine Hydrochloride Extended-Release Tablets are extended-release tablets for oral administration that contain venlafaxine hydrochloride, a structurally novel antidepressant. Venlafaxine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI). It is designated (R/S)-1-[2-(dimethylamino)-1-(4‑methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino) methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Venlafaxine Hydrochloride Extended-Release Tablets are formulated as extended-release tablet for once-a-day oral administration. Venlafaxine Hydrochloride Extended-Release Tablets use matrix core and extended-release coating to deliver venlafaxine hydrochloride at a controlled rate over approximately 24 hours. The unitary tablet core is composed of the drug and excipients (including the matrix forming components). In an aqueous environment, such as the gastrointestinal tract, water permeates slowly through the coating into the tablet core, causing the hydrophilic matrix polymer to expand and to form a gel layer on the surface of the tablet. This gel acts as a barrier to the drug release, the drug is dissolved and is released by slow diffusion and erosion of the gel. The extended-release coating layer controls the rate at which water permeates into the tablet core, which in turn controls also the rate of drug delivery. The controlled rate of drug delivery into the gastrointestinal lumen is thus independent of pH or gastrointestinal motility. Tablets contain venlafaxine hydrochloride equivalent to 150 mg or 225 mg venlafaxine. Inactive ingredients consist of dibasic calcium phosphate dihydrate, hypromellose, methacrylic acid copolymer, colloidal silicon dioxide, magnesium stearate, polyvinyl acetate dispersion, talc, polyethylene glycol, polyvinyl alcohol, povidone, triethyl citrate, macrogol stearyl ether, sodium lauryl sulfate, carnauba wax, titanium dioxide, propylene glycol and FD&C blue #1."
},
{
"NDCCode": "0527-2605-32",
"PackageDescription": "30 TABLET in 1 BOTTLE (0527-2605-32) ",
"NDC11Code": "00527-2605-32",
"ProductNDC": "0527-2605",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine Hydrochloride",
"NonProprietaryName": "Venlafaxine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20191226",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209193",
"LabelerName": "Lannett Company, Inc.",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "225",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-11-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20191226",
"SamplePackage": "N",
"IndicationAndUsage": "Venlafaxine Hydrochloride Extended-Release Tablets are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for: 1 Major Depressive Disorder (MDD) (1.1), 2 Social Anxiety Disorder (SAD) (1.2).",
"Description": "Venlafaxine Hydrochloride Extended-Release Tablets are extended-release tablets for oral administration that contain venlafaxine hydrochloride, a structurally novel antidepressant. Venlafaxine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI). It is designated (R/S)-1-[2-(dimethylamino)-1-(4‑methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino) methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Venlafaxine Hydrochloride Extended-Release Tablets are formulated as extended-release tablet for once-a-day oral administration. Venlafaxine Hydrochloride Extended-Release Tablets use matrix core and extended-release coating to deliver venlafaxine hydrochloride at a controlled rate over approximately 24 hours. The unitary tablet core is composed of the drug and excipients (including the matrix forming components). In an aqueous environment, such as the gastrointestinal tract, water permeates slowly through the coating into the tablet core, causing the hydrophilic matrix polymer to expand and to form a gel layer on the surface of the tablet. This gel acts as a barrier to the drug release, the drug is dissolved and is released by slow diffusion and erosion of the gel. The extended-release coating layer controls the rate at which water permeates into the tablet core, which in turn controls also the rate of drug delivery. The controlled rate of drug delivery into the gastrointestinal lumen is thus independent of pH or gastrointestinal motility. Tablets contain venlafaxine hydrochloride equivalent to 150 mg or 225 mg venlafaxine. Inactive ingredients consist of dibasic calcium phosphate dihydrate, hypromellose, methacrylic acid copolymer, colloidal silicon dioxide, magnesium stearate, polyvinyl acetate dispersion, talc, polyethylene glycol, polyvinyl alcohol, povidone, triethyl citrate, macrogol stearyl ether, sodium lauryl sulfate, carnauba wax, titanium dioxide, propylene glycol and FD&C blue #1."
},
{
"NDCCode": "0603-5449-32",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0603-5449-32)",
"NDC11Code": "00603-5449-32",
"ProductNDC": "0603-5449",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propafenone Hydrochloride",
"NonProprietaryName": "Propafenone Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20021017",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075938",
"LabelerName": "Qualitest Pharmaceuticals",
"SubstanceName": "PROPAFENONE HYDROCHLORIDE",
"StrengthNumber": "225",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "31722-610-32",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (31722-610-32) / 7 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "31722-0610-32",
"ProductNDC": "31722-610",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pregabalin",
"NonProprietaryName": "Pregabalin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20191008",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206912",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "PREGABALIN",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2025-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191008",
"SamplePackage": "N",
"IndicationAndUsage": "Pregabalin capsules are indicated for: Management of neuropathic pain associated with diabetic peripheral neuropathy Management of postherpetic neuralgia Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older Management of fibromyalgia Management of neuropathic pain associated with spinal cord injury.",
"Description": "Pregabalin is described chemically as (3S)-3-(Aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8H 17NO 2and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin is a white to off-white powder with a pKa of 11.30. It is freely soluble in 1N hydrochloric acid and sparingly soluble in water. The log of the partition coefficient is 1.3. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with corn starch, mannitol and talc as inactive ingredients. The capsule shells contain gelatin, sodium lauryl sulfate and titanium dioxide. In addition, 75 mg, 100 mg, 200 mg, 225 mg and 300 mg capsules contain iron oxide red. The imprinting ink contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution."
},
{
"NDCCode": "31722-611-32",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (31722-611-32) / 7 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "31722-0611-32",
"ProductNDC": "31722-611",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pregabalin",
"NonProprietaryName": "Pregabalin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20191008",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206912",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "PREGABALIN",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2025-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191008",
"SamplePackage": "N",
"IndicationAndUsage": "Pregabalin capsules are indicated for: Management of neuropathic pain associated with diabetic peripheral neuropathy Management of postherpetic neuralgia Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older Management of fibromyalgia Management of neuropathic pain associated with spinal cord injury.",
"Description": "Pregabalin is described chemically as (3S)-3-(Aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8H 17NO 2and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin is a white to off-white powder with a pKa of 11.30. It is freely soluble in 1N hydrochloric acid and sparingly soluble in water. The log of the partition coefficient is 1.3. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with corn starch, mannitol and talc as inactive ingredients. The capsule shells contain gelatin, sodium lauryl sulfate and titanium dioxide. In addition, 75 mg, 100 mg, 200 mg, 225 mg and 300 mg capsules contain iron oxide red. The imprinting ink contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution."
},
{
"NDCCode": "31722-617-32",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (31722-617-32) / 10 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "31722-0617-32",
"ProductNDC": "31722-617",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pregabalin",
"NonProprietaryName": "Pregabalin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20191008",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206912",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "PREGABALIN",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2025-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191008",
"SamplePackage": "N",
"IndicationAndUsage": "Pregabalin capsules are indicated for: Management of neuropathic pain associated with diabetic peripheral neuropathy Management of postherpetic neuralgia Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older Management of fibromyalgia Management of neuropathic pain associated with spinal cord injury.",
"Description": "Pregabalin is described chemically as (3S)-3-(Aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8H 17NO 2and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin is a white to off-white powder with a pKa of 11.30. It is freely soluble in 1N hydrochloric acid and sparingly soluble in water. The log of the partition coefficient is 1.3. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with corn starch, mannitol and talc as inactive ingredients. The capsule shells contain gelatin, sodium lauryl sulfate and titanium dioxide. In addition, 75 mg, 100 mg, 200 mg, 225 mg and 300 mg capsules contain iron oxide red. The imprinting ink contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution."
},
{
"NDCCode": "31722-968-32",
"PackageDescription": "1 TUBE in 1 CARTON (31722-968-32) > 30 g in 1 TUBE",
"NDC11Code": "31722-0968-32",
"ProductNDC": "31722-968",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acyclovir",
"NonProprietaryName": "Acyclovir",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200901",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212495",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "ACYCLOVIR",
"StrengthNumber": "50",
"StrengthUnit": "mg/g",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [EXT]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200901",
"SamplePackage": "N",
"IndicationAndUsage": "Acyclovir Ointment USP, 5% is indicated in the management of initial genital herpes and in limited nonlifethreatening mucocutaneous HSV infections in immunocompromised patients.",
"Description": "Acyclovir Ointment USP, 5% is a synthetic nucleoside analogue active against herpes viruses. Acyclovir Ointment USP, 5% is a formulation for topical administration. Each gram of Acyclovir Ointment USP, 5% contains 50 mg of acyclovir in a polyethylene glycol (PEG) base. Acyclovir is a white, crystalline powder with the molecular formula C8H11N5O3 and a molecular weight of 225. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka's of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula."
},
{
"NDCCode": "35000-777-32",
"PackageDescription": "92 g in 1 CONTAINER (35000-777-32) ",
"NDC11Code": "35000-0777-32",
"ProductNDC": "35000-777",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Toms Of Maine",
"ProprietaryNameSuffix": "Tropical Island",
"NonProprietaryName": "Aluminum Chlorohydrate",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20251203",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M021",
"LabelerName": "Colgate-Palmolive Company",
"SubstanceName": "ALUMINUM CHLOROHYDRATE",
"StrengthNumber": "225",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251203",
"SamplePackage": "N",
"IndicationAndUsage": "reduces underarm wetness."
},
{
"NDCCode": "42658-150-04",
"PackageDescription": "225 mg in 1 BOTTLE (42658-150-04) ",
"NDC11Code": "42658-0150-04",
"ProductNDC": "42658-150",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206924",
"LabelerName": "Hisun Pharmaceuticals USA, Inc.",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/2.5mg",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-05-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250101",
"SamplePackage": "N",
"Description": "Olanzapine, USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)- 10H-thieno[2,3- b] [1,5]benzodiazepine. The molecular formula is C 17H 20N 4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine, USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine Tablets, USP are intended for oral administration only. Each tablet contains olanzapine equivalent to 2.5 mg (8 mcmol), 5 mg (16 mcmol), 7.5 mg (24 mcmol), 10 mg (32 mcmol), 15 mg (48 mcmol), or 20 mg (64 mcmol). Inactive ingredients are lactose monohydrate, maize starch, colloidal silicon dioxide, magnesium stearate, crospovidone, microcrystalline cellulose and talc. Olanzapine orally disintegrating tablets are intended for oral administration only. Each orally disintegrating tablet contains olanzapine equivalent to 5 mg (16 mcmol), 10 mg (32 mcmol), 15 mg (48 mcmol) or 20 mg (64 mcmol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. Olanzapine orally disintegrating tablets also contain the following inactive ingredients: aspartame, lactose monohydrate, maize starch, colloidal silicon dioxide, magnesium stearate, crospovidone, microcrystalline cellulose and talc. Olanzapine orally disintegrating tablets meet USP Disintegration Test 2."
},
{
"NDCCode": "42658-152-01",
"PackageDescription": "225 mg in 1 BOTTLE (42658-152-01) ",
"NDC11Code": "42658-0152-01",
"ProductNDC": "42658-152",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206924",
"LabelerName": "Hisun Pharmaceuticals USA, Inc.",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/7.5mg",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-05-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250101",
"SamplePackage": "N",
"Description": "Olanzapine, USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)- 10H-thieno[2,3- b] [1,5]benzodiazepine. The molecular formula is C 17H 20N 4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine, USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine Tablets, USP are intended for oral administration only. Each tablet contains olanzapine equivalent to 2.5 mg (8 mcmol), 5 mg (16 mcmol), 7.5 mg (24 mcmol), 10 mg (32 mcmol), 15 mg (48 mcmol), or 20 mg (64 mcmol). Inactive ingredients are lactose monohydrate, maize starch, colloidal silicon dioxide, magnesium stearate, crospovidone, microcrystalline cellulose and talc. Olanzapine orally disintegrating tablets are intended for oral administration only. Each orally disintegrating tablet contains olanzapine equivalent to 5 mg (16 mcmol), 10 mg (32 mcmol), 15 mg (48 mcmol) or 20 mg (64 mcmol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. Olanzapine orally disintegrating tablets also contain the following inactive ingredients: aspartame, lactose monohydrate, maize starch, colloidal silicon dioxide, magnesium stearate, crospovidone, microcrystalline cellulose and talc. Olanzapine orally disintegrating tablets meet USP Disintegration Test 2."
},
{
"NDCCode": "50228-225-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (50228-225-01) ",
"NDC11Code": "50228-0225-01",
"ProductNDC": "50228-225",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benztropine Mesylate",
"NonProprietaryName": "Benztropine Mesylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20241105",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040103",
"LabelerName": "ScieGen Pharmaceuticals Inc",
"SubstanceName": "BENZTROPINE MESYLATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC], Antihistamine [EPC], Cholinergic Antagonists [MoA], Histamine Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241105",
"SamplePackage": "N",
"IndicationAndUsage": "Benztropine mesylate tablets are indicated for use as an adjunct in the therapy of all forms of parkinsonism. Useful also in the control of extrapyramidal disorders (except tardive dyskinesia – see PRECAUTIONS) due to neuroleptic drugs (e.g., phenothiazines).",
"Description": "Benztropine mesylate is a synthetic compound containing structural features found in atropine and diphenhydramine. It is designated chemically as 3α-(Diphenylmethoxy)-1αH, 5αH-tropane methanesulfonate. Its molecular formula is C 21H 25NOCH 4O 3S, and its structural formula is:. Benztropine mesylate is a crystalline white powder, very soluble in water, and has a molecular weight of 403.54. Each benztropine mesylate tablet USP for oral administration contains benztropine mesylate USP 0.5 mg, 1 mg or 2 mg. Inactive ingredients: anhydrous lactose, croscarmellose sodium, FD&C Red #40 Aluminum Lake (2mg), FD&C Yellow #5 Aluminum Lake (1mg), povidone k-29/32, and magnesium stearate."
},
{
"NDCCode": "50228-225-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (50228-225-10) ",
"NDC11Code": "50228-0225-10",
"ProductNDC": "50228-225",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benztropine Mesylate",
"NonProprietaryName": "Benztropine Mesylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20241105",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040103",
"LabelerName": "ScieGen Pharmaceuticals Inc",
"SubstanceName": "BENZTROPINE MESYLATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC], Antihistamine [EPC], Cholinergic Antagonists [MoA], Histamine Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241105",
"SamplePackage": "N",
"IndicationAndUsage": "Benztropine mesylate tablets are indicated for use as an adjunct in the therapy of all forms of parkinsonism. Useful also in the control of extrapyramidal disorders (except tardive dyskinesia – see PRECAUTIONS) due to neuroleptic drugs (e.g., phenothiazines).",
"Description": "Benztropine mesylate is a synthetic compound containing structural features found in atropine and diphenhydramine. It is designated chemically as 3α-(Diphenylmethoxy)-1αH, 5αH-tropane methanesulfonate. Its molecular formula is C 21H 25NOCH 4O 3S, and its structural formula is:. Benztropine mesylate is a crystalline white powder, very soluble in water, and has a molecular weight of 403.54. Each benztropine mesylate tablet USP for oral administration contains benztropine mesylate USP 0.5 mg, 1 mg or 2 mg. Inactive ingredients: anhydrous lactose, croscarmellose sodium, FD&C Red #40 Aluminum Lake (2mg), FD&C Yellow #5 Aluminum Lake (1mg), povidone k-29/32, and magnesium stearate."
},
{
"NDCCode": "51009-861-32",
"PackageDescription": "92 g in 1 CONTAINER (51009-861-32) ",
"NDC11Code": "51009-0861-32",
"ProductNDC": "51009-861",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Toms Of Maine",
"ProprietaryNameSuffix": "Tropical Island",
"NonProprietaryName": "Aluminum Chlorohydrate",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20251203",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M021",
"LabelerName": "Tom's of Maine",
"SubstanceName": "ALUMINUM CHLOROHYDRATE",
"StrengthNumber": "225",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2026-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251203",
"SamplePackage": "N",
"IndicationAndUsage": "reduces underarm wetness."
},
{
"NDCCode": "58151-237-88",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (58151-237-88) / 1 CAPSULE in 1 BLISTER PACK (58151-237-32) ",
"NDC11Code": "58151-0237-88",
"ProductNDC": "58151-237",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lyrica",
"NonProprietaryName": "Pregabalin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20241119",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021446",
"LabelerName": "Viatris Specialty LLC",
"SubstanceName": "PREGABALIN",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2025-09-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241119",
"SamplePackage": "N",
"IndicationAndUsage": "LYRICA is indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial‑onset seizures in patients 1 month of age and older , 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.",
"Description": "Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is -1.35. LYRICA (pregabalin) Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with cornstarch, lactose monohydrate, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and the white capsule shells contain colloidal silicon dioxide and sodium lauryl sulfate. Colloidal silicon dioxide is a manufacturing aid that may or may not be present in the capsule shells. The imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, and shellac. LYRICA (pregabalin) oral solution, 20 mg/mL, is administered orally and is supplied as a clear, colorless solution contained in a 16 fluid ounce white HDPE bottle with a polyethylene-lined closure. The oral solution contains 20 mg/mL of pregabalin, along with artificial strawberry #11545, dibasic sodium phosphate anhydrous, methylparaben, monobasic sodium phosphate anhydrous, propylparaben, purified water, and sucralose as inactive ingredients."
},
{
"NDCCode": "58151-238-88",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (58151-238-88) / 1 CAPSULE in 1 BLISTER PACK (58151-238-32) ",
"NDC11Code": "58151-0238-88",
"ProductNDC": "58151-238",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lyrica",
"NonProprietaryName": "Pregabalin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20250617",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021446",
"LabelerName": "Viatris Specialty LLC",
"SubstanceName": "PREGABALIN",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2025-09-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250924",
"SamplePackage": "N",
"IndicationAndUsage": "LYRICA is indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial‑onset seizures in patients 1 month of age and older , 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.",
"Description": "Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is -1.35. LYRICA (pregabalin) Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with cornstarch, lactose monohydrate, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and the white capsule shells contain colloidal silicon dioxide and sodium lauryl sulfate. Colloidal silicon dioxide is a manufacturing aid that may or may not be present in the capsule shells. The imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, and shellac. LYRICA (pregabalin) oral solution, 20 mg/mL, is administered orally and is supplied as a clear, colorless solution contained in a 16 fluid ounce white HDPE bottle with a polyethylene-lined closure. The oral solution contains 20 mg/mL of pregabalin, along with artificial strawberry #11545, dibasic sodium phosphate anhydrous, methylparaben, monobasic sodium phosphate anhydrous, propylparaben, purified water, and sucralose as inactive ingredients."
},
{
"NDCCode": "58151-239-88",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (58151-239-88) / 1 CAPSULE in 1 BLISTER PACK (58151-239-32) ",
"NDC11Code": "58151-0239-88",
"ProductNDC": "58151-239",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lyrica",
"NonProprietaryName": "Pregabalin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20241022",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021446",
"LabelerName": "Viatris Specialty LLC",
"SubstanceName": "PREGABALIN",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2025-09-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250326",
"SamplePackage": "N",
"IndicationAndUsage": "LYRICA is indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial‑onset seizures in patients 1 month of age and older , 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.",
"Description": "Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is -1.35. LYRICA (pregabalin) Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with cornstarch, lactose monohydrate, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and the white capsule shells contain colloidal silicon dioxide and sodium lauryl sulfate. Colloidal silicon dioxide is a manufacturing aid that may or may not be present in the capsule shells. The imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, and shellac. LYRICA (pregabalin) oral solution, 20 mg/mL, is administered orally and is supplied as a clear, colorless solution contained in a 16 fluid ounce white HDPE bottle with a polyethylene-lined closure. The oral solution contains 20 mg/mL of pregabalin, along with artificial strawberry #11545, dibasic sodium phosphate anhydrous, methylparaben, monobasic sodium phosphate anhydrous, propylparaben, purified water, and sucralose as inactive ingredients."
},
{
"NDCCode": "58151-240-88",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (58151-240-88) / 1 CAPSULE in 1 BLISTER PACK (58151-240-32) ",
"NDC11Code": "58151-0240-88",
"ProductNDC": "58151-240",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lyrica",
"NonProprietaryName": "Pregabalin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20241112",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021446",
"LabelerName": "Viatris Specialty LLC",
"SubstanceName": "PREGABALIN",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2025-09-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241112",
"SamplePackage": "N",
"IndicationAndUsage": "LYRICA is indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial‑onset seizures in patients 1 month of age and older , 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.",
"Description": "Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is -1.35. LYRICA (pregabalin) Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with cornstarch, lactose monohydrate, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and the white capsule shells contain colloidal silicon dioxide and sodium lauryl sulfate. Colloidal silicon dioxide is a manufacturing aid that may or may not be present in the capsule shells. The imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, and shellac. LYRICA (pregabalin) oral solution, 20 mg/mL, is administered orally and is supplied as a clear, colorless solution contained in a 16 fluid ounce white HDPE bottle with a polyethylene-lined closure. The oral solution contains 20 mg/mL of pregabalin, along with artificial strawberry #11545, dibasic sodium phosphate anhydrous, methylparaben, monobasic sodium phosphate anhydrous, propylparaben, purified water, and sucralose as inactive ingredients."
},
{
"NDCCode": "60687-185-32",
"PackageDescription": "20 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-185-32) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (60687-185-33) ",
"NDC11Code": "60687-0185-32",
"ProductNDC": "60687-185",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propafenone Hydrochloride",
"NonProprietaryName": "Propafenone Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20160129",
"EndMarketingDate": "20231031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078540",
"LabelerName": "American Health Packaging",
"SubstanceName": "PROPAFENONE HYDROCHLORIDE",
"StrengthNumber": "225",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160129",
"EndMarketingDatePackage": "20231031",
"SamplePackage": "N"
},
{
"NDCCode": "60687-674-32",
"PackageDescription": "20 BLISTER PACK in 1 CARTON (60687-674-32) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (60687-674-33) ",
"NDC11Code": "60687-0674-32",
"ProductNDC": "60687-674",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propafenone Hydrochloride",
"NonProprietaryName": "Propafenone Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20230119",
"EndMarketingDate": "20250131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078540",
"LabelerName": "American Health Packaging",
"SubstanceName": "PROPAFENONE HYDROCHLORIDE",
"StrengthNumber": "225",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20230119",
"EndMarketingDatePackage": "20250131",
"SamplePackage": "N",
"IndicationAndUsage": "Propafenone HCl Extended Release Capsules, USP are indicated to prolong the time to recurrence of symptomatic atrial fibrillation (AF) in patients with episodic (most likely paroxysmal or persistent) AF who do not have structural heart disease. Usage Considerations: 1 The use of propafenone ER capsules in patients with permanent AF or in patients exclusively with atrial flutter or paroxysmal supraventricular tachycardia (PSVT) has not been evaluated. Do not use propafenone ER capsules to control ventricular rate during AF. , 2 Some patients with atrial flutter treated with propafenone have developed 1:1 conduction, producing an increase in ventricular rate. Concomitant treatment with drugs that increase the functional atrioventricular (AV) nodal refractory period is recommended. , 3 The effect of propafenone on mortality has not been determined [see BOXED WARNING]. .",
"Description": "Propafenone Hydrochloride Extended Release Capsule, USP is an antiarrhythmic drug supplied in extended release capsules of 225mg, 325mg and 425 mg for oral administration. Chemically, propafenone hydrochloride is 2'-[2-hydroxy-3-(propylamino)-propoxy]-3‑phenylpropiophenone hydrochloride, with a molecular weight of 377.92. The molecular formula is C 21H 27NO 3HCl. Propafenone HCl has some structural similarities to beta-blocking agents. The structural formula of propafenone HCl is given below. Propafenone HCl occurs as colorless crystals or white crystalline powder with a very bitter taste. It is slightly soluble in water (20ºC), chloroform, and ethanol. Propafenone ER capsules are filled with granules containing the following inactive ingredients: ethylcellulose, lactose anhydrous, magnesium stearate and povidone. Each capsule contains Titanium dioxide and gelatin. In addition the 325 mg capsule also contains FD&C Blue No. 1, D&C Yellow No. 10 and FD&C Red No. 40 and the 425 mg capsule contains FD&C Blue No. 1, FD&C Red No. 40 and FD&C Yellow No. 6. The black ink consists of D&C Yellow No.10, iron oxide black, n-butyl alcohol, propylene glycol, FD&C Blue No. 2, FD&C Red No. 40, FD&C Blue No. 1 and shellac glaze~45% (20% esterfied) in ethanol."
},
{
"NDCCode": "68084-858-32",
"PackageDescription": "20 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-858-32) > 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (68084-858-33)",
"NDC11Code": "68084-0858-32",
"ProductNDC": "68084-858",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propafenone Hydrochloride",
"NonProprietaryName": "Propafenone Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20141020",
"EndMarketingDate": "20161231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078540",
"LabelerName": "American Health Packaging",
"SubstanceName": "PROPAFENONE HYDROCHLORIDE",
"StrengthNumber": "225",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-01-05"
},
{
"NDCCode": "75834-225-25",
"PackageDescription": "25 VIAL in 1 TRAY (75834-225-25) / 10 mL in 1 VIAL (75834-225-01) ",
"NDC11Code": "75834-0225-25",
"ProductNDC": "75834-225",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zinc Sulfate",
"NonProprietaryName": "Zinc Sulfate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20240730",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214597",
"LabelerName": "Nivagen Pharmaceuticals, Inc.",
"SubstanceName": "ZINC SULFATE",
"StrengthNumber": "3",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20240730",
"SamplePackage": "N",
"IndicationAndUsage": "Zinc Sulfate Injection is indicated in adult and pediatric patients as a source of zinc for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.",
"Description": "Zinc Sulfate Injection, USP is a sterile, clear colorless solution, free from visible particles intended for use as a trace element and an additive to intravenous solutions for parenteral nutrition. 10 mg/10 mL Pharmacy Bulk Package vial. Each mL contains 1 mg of zinc present as 2.46 mg of zinc sulfate and water for injection q.s. 30 mg/10 mL Pharmacy Bulk Package vial. Each mL contains 3 mg of zinc present as 7.41 mg of zinc sulfate and water for injection q.s. 25 mg/5 mL Pharmacy Bulk Package vial. Each mL contains 5 mg of zinc present as 12.32 mg of zinc sulfate and water for injection q.s. All presentations do not contain preservatives. The pH range is 2 to 4; pH may be adjusted with sulfuric acid. 1 mg/mL of Zinc Sulfate Injection contains no more than 1,500 mcg/L of aluminum and has a calculated osmolarity of 33 mOsmol/L. 3 mg/mL of Zinc Sulfate Injection contains no more than 2,500 mcg/L of aluminum and has a calculated osmolarity of 96.5 mOsmol/L. 5 mg/mL of Zinc Sulfate Injection contains no more than 2,500 mcg/L of aluminum and has a calculated osmolarity of 157.2 mOsmol/L. Zinc sulfate heptahydrate has a molecular weight of 287.56 g/mol and a formula of ZnSO4·7H2O."
},
{
"NDCCode": "58809-063-60",
"PackageDescription": "57 mL in 1 BOTTLE, PLASTIC (58809-063-60) ",
"NDC11Code": "58809-0063-60",
"ProductNDC": "58809-063",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Texaclear Fast Acting Allergy Relief",
"NonProprietaryName": "Chlophedianol Hydrochloride, Pyrilamine Maleate",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20141021",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "GM Pharmaceuticals, Inc.",
"SubstanceName": "CHLOPHEDIANOL HYDROCHLORIDE; PYRILAMINE MALEATE",
"StrengthNumber": "25; 50",
"StrengthUnit": "mg/57mL; mg/57mL",
"Status": "Deprecated",
"LastUpdate": "2024-07-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20141021",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: 1 cough due to minor throat and bronchial irritation, 2 runny nose, 3 sneezing, 4 itching of the nose or throat, 5 itchy, watery eyes."
},
{
"NDCCode": "58809-111-30",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (58809-111-30) ",
"NDC11Code": "58809-0111-30",
"ProductNDC": "58809-111",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dayclear Allergy Immune Therapy",
"NonProprietaryName": "Dayclear",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "ORAL",
"StartMarketingDate": "20180813",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "GM Pharmaceuticals, INC",
"SubstanceName": "ACACIA POLLEN; ACER NEGUNDO POLLEN; ACER SACCHARINUM POLLEN; ACER SACCHARUM POLLEN; AGROSTIS GIGANTEA POLLEN; AILANTHUS ALTISSIMA POLLEN; ALLENROLFEA OCCIDENTALIS POLLEN; ALNUS INCANA SUBSP. RUGOSA POLLEN; AMARANTHUS HYBRIDUS POLLEN; AMARANTHUS PALMERI POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMARANTHUS SPINOSUS POLLEN; AMARANTHUS TUBERCULATUS POLLEN; AMBROSIA ACANTHICARPA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA BIDENTATA POLLEN; AMBROSIA CONFERTIFLORA POLLEN; AMBROSIA DUMOSA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; ARTEMISIA ANNUA POLLEN; ARTEMISIA LUDOVICIANA WHOLE; ARTEMISIA TRIDENTATA POLLEN; ARTEMISIA VULGARIS WHOLE; ATRIPLEX CANESCENS POLLEN; AVENA SATIVA POLLEN; BACCHARIS HALIMIFOLIA WHOLE; BAPTISIA TINCTORIA ROOT; BASSIA SCOPARIA POLLEN; BETULA NIGRA POLLEN; BETULA OCCIDENTALIS WHOLE; BROMUS INERMIS POLLEN; BROUSSONETIA PAPYRIFERA POLLEN; CARPINUS CAROLINIANA WHOLE; CARYA ALBA POLLEN; CARYA CORDIFORMIS WHOLE; CARYA GLABRA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA LACINIOSA POLLEN; CARYA OVATA POLLEN; CELTIS OCCIDENTALIS POLLEN; CHENOPODIUM ALBUM POLLEN; CUPRESSUS ARIZONICA POLLEN; CYCLACHAENA XANTHIFOLIA POLLEN; CYNODON DACTYLON POLLEN; DACTYLIS GLOMERATA POLLEN; DISTICHLIS SPICATA POLLEN; ECHINACEA, UNSPECIFIED; ELYMUS REPENS POLLEN; FAGUS GRANDIFOLIA POLLEN; FESTUCA PRATENSIS POLLEN; FRAXINUS AMERICANA POLLEN; FRAXINUS PENNSYLVANICA POLLEN; FRAXINUS VELUTINA POLLEN; GUTIERREZIA SAROTHRAE WHOLE; HOLCUS LANATUS POLLEN; HYDRASTIS CANADENSIS WHOLE; IVA ANGUSTIFOLIA POLLEN; IVA ANNUA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS ASHEI POLLEN; JUNIPERUS DEPPEANA WHOLE; JUNIPERUS MONOSPERMA POLLEN; JUNIPERUS OSTEOSPERMA POLLEN; JUNIPERUS PINCHOTII POLLEN; JUNIPERUS SCOPULORUM POLLEN; JUNIPERUS VIRGINIANA POLLEN; LIGUSTRUM LUCIDUM WHOLE; LIQUIDAMBAR STYRACIFLUA POLLEN; LOLIUM MULTIFLORUM POLLEN; LOLIUM PERENNE POLLEN; MELALEUCA QUINQUENERVIA POLLEN; MORUS ALBA WHOLE; MORUS RUBRA POLLEN; MYRRH; OSTRYA VIRGINIANA WHOLE; PASPALUM NOTATUM POLLEN; PHALARIS ARUNDINACEA POLLEN; PHLEUM PRATENSE POLLEN; PHYTOLACCA AMERICANA ROOT; PINUS NIGRA POLLEN; PINUS PONDEROSA POLLEN; PINUS STROBUS POLLEN; PINUS SYLVESTRIS POLLEN; PINUS TAEDA POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POA ANNUA POLLEN; POA PRATENSIS POLLEN; POPULUS ALBA POLLEN; POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN; POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN; POPULUS FREMONTII POLLEN; POPULUS NIGRA POLLEN; PROSOPIS PALLIDA POLLEN; QUERCUS ALBA WHOLE; QUERCUS GAMBELII POLLEN; QUERCUS MACROCARPA POLLEN; QUERCUS NIGRA POLLEN; QUERCUS RUBRA BARK; QUERCUS STELLATA POLLEN; QUERCUS VELUTINA WHOLE; QUERCUS VIRGINIANA POLLEN; RORIPPA NASTURTIUM-AQUATICUM; RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS POLLEN; SALIX NIGRA WHOLE; SALSOLA KALI WHOLE; SECALE CEREALE POLLEN; SOLIDAGO CANADENSIS WHOLE; SORGHUM HALEPENSE POLLEN; SORGHUM X DRUMMONDII WHOLE; TAMARIX GALLICA POLLEN; TAXODIUM DISTICHUM POLLEN; TRIADICA SEBIFERA WHOLE; TRIGONELLA FOENUM-GRAECUM WHOLE; TRITICUM AESTIVUM POLLEN; ULMUS AMERICANA POLLEN; ULMUS CRASSIFOLIA POLLEN; ULMUS CRASSIFOLIA WHOLE; ULMUS PUMILA POLLEN; URTICA DIOICA POLLEN; XANTHIUM STRUMARIUM POLLEN; ZEA MAYS POLLEN",
"StrengthNumber": "12; 12; 12; 12; 6; 12; 30; 12; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 6; 30; 30; 6; 30; 30; 6; 12; 3; 30; 12; 12; 6; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30; 12; 30; 6; 6; 6; 3; 6; 12; 6; 12; 12; 12; 30; 6; 3; 30; 30; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 6; 6; 12; 12; 12; 3; 12; 6; 6; 6; 3; 12; 12; 12; 12; 12; 30; 12; 6; 6; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30; 12; 3; 30; 30; 12; 30; 6; 30; 6; 12; 12; 12; 12; 3; 6; 12; 12; 12; 12; 30; 30; 6",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-11-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20180813",
"SamplePackage": "N"
},
{
"NDCCode": "58809-116-08",
"PackageDescription": "237 mL in 1 BOTTLE (58809-116-08) ",
"NDC11Code": "58809-0116-08",
"ProductNDC": "58809-116",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Texaclear Nighttime Sleep-aid",
"NonProprietaryName": "Diphenhydramine Hcl",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20160615",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M010",
"LabelerName": "GM Pharmaceuticals, Inc.",
"SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/30mL",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20160615",
"SamplePackage": "N",
"IndicationAndUsage": "for the relief of occasional sleeplessnes."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>58809-225-32</NDCCode>
<PackageDescription>946 mL in 1 BOTTLE (58809-225-32) </PackageDescription>
<NDC11Code>58809-0225-32</NDC11Code>
<ProductNDC>58809-225</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dayclear Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200401</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>GM Pharmaceuticals, INC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>.62</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>52642-225-32</NDCCode>
<PackageDescription>32 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (52642-225-32)</PackageDescription>
<NDC11Code>52642-0225-32</NDC11Code>
<ProductNDC>52642-225</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tropical Panned</ProprietaryName>
<NonProprietaryName>Calcium Carbonate, Simethicone</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140319</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part331</ApplicationNumber>
<LabelerName>BestCo Inc.</LabelerName>
<SubstanceName>CALCIUM CARBONATE; DIMETHICONE</SubstanceName>
<StrengthNumber>750; 80</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for the relief of: 1 Acid indigestion, 2 Heartburn, 3 Sour stomach, 4 Upset stomach associated with these symptoms, 5 Bloating, pressure, or stuffed feeling commonl referred to as gas.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58809-225-02</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE (58809-225-02) </PackageDescription>
<NDC11Code>58809-0225-02</NDC11Code>
<ProductNDC>58809-225</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dayclear Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200401</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>GM Pharmaceuticals, INC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>.62</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>58809-225-08</NDCCode>
<PackageDescription>237 mL in 1 BOTTLE (58809-225-08) </PackageDescription>
<NDC11Code>58809-0225-08</NDC11Code>
<ProductNDC>58809-225</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dayclear Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200401</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>GM Pharmaceuticals, INC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>.62</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>58809-225-12</NDCCode>
<PackageDescription>355 mL in 1 BOTTLE (58809-225-12) </PackageDescription>
<NDC11Code>58809-0225-12</NDC11Code>
<ProductNDC>58809-225</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dayclear Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200401</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>GM Pharmaceuticals, INC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>.62</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0131-3268-32</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0131-3268-32)</PackageDescription>
<NDC11Code>00131-3268-32</NDC11Code>
<ProductNDC>0131-3268</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100429</StartMarketingDate>
<EndMarketingDate>20180331</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022104</ApplicationNumber>
<LabelerName>UCB, Inc.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>225</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-04-03</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0527-2604-32</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (0527-2604-32) </PackageDescription>
<NDC11Code>00527-2604-32</NDC11Code>
<ProductNDC>0527-2604</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191226</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209193</ApplicationNumber>
<LabelerName>Lannett Company, Inc.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191226</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Venlafaxine Hydrochloride Extended-Release Tablets are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for: 1 Major Depressive Disorder (MDD) (1.1), 2 Social Anxiety Disorder (SAD) (1.2).</IndicationAndUsage>
<Description>Venlafaxine Hydrochloride Extended-Release Tablets are extended-release tablets for oral administration that contain venlafaxine hydrochloride, a structurally novel antidepressant. Venlafaxine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI). It is designated (R/S)-1-[2-(dimethylamino)-1-(4‑methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino) methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Venlafaxine Hydrochloride Extended-Release Tablets are formulated as extended-release tablet for once-a-day oral administration. Venlafaxine Hydrochloride Extended-Release Tablets use matrix core and extended-release coating to deliver venlafaxine hydrochloride at a controlled rate over approximately 24 hours. The unitary tablet core is composed of the drug and excipients (including the matrix forming components). In an aqueous environment, such as the gastrointestinal tract, water permeates slowly through the coating into the tablet core, causing the hydrophilic matrix polymer to expand and to form a gel layer on the surface of the tablet. This gel acts as a barrier to the drug release, the drug is dissolved and is released by slow diffusion and erosion of the gel. The extended-release coating layer controls the rate at which water permeates into the tablet core, which in turn controls also the rate of drug delivery. The controlled rate of drug delivery into the gastrointestinal lumen is thus independent of pH or gastrointestinal motility. Tablets contain venlafaxine hydrochloride equivalent to 150 mg or 225 mg venlafaxine. Inactive ingredients consist of dibasic calcium phosphate dihydrate, hypromellose, methacrylic acid copolymer, colloidal silicon dioxide, magnesium stearate, polyvinyl acetate dispersion, talc, polyethylene glycol, polyvinyl alcohol, povidone, triethyl citrate, macrogol stearyl ether, sodium lauryl sulfate, carnauba wax, titanium dioxide, propylene glycol and FD&C blue #1.</Description>
</NDC>
<NDC>
<NDCCode>0527-2605-32</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (0527-2605-32) </PackageDescription>
<NDC11Code>00527-2605-32</NDC11Code>
<ProductNDC>0527-2605</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
<NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191226</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209193</ApplicationNumber>
<LabelerName>Lannett Company, Inc.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>225</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191226</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Venlafaxine Hydrochloride Extended-Release Tablets are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for: 1 Major Depressive Disorder (MDD) (1.1), 2 Social Anxiety Disorder (SAD) (1.2).</IndicationAndUsage>
<Description>Venlafaxine Hydrochloride Extended-Release Tablets are extended-release tablets for oral administration that contain venlafaxine hydrochloride, a structurally novel antidepressant. Venlafaxine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI). It is designated (R/S)-1-[2-(dimethylamino)-1-(4‑methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino) methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Venlafaxine Hydrochloride Extended-Release Tablets are formulated as extended-release tablet for once-a-day oral administration. Venlafaxine Hydrochloride Extended-Release Tablets use matrix core and extended-release coating to deliver venlafaxine hydrochloride at a controlled rate over approximately 24 hours. The unitary tablet core is composed of the drug and excipients (including the matrix forming components). In an aqueous environment, such as the gastrointestinal tract, water permeates slowly through the coating into the tablet core, causing the hydrophilic matrix polymer to expand and to form a gel layer on the surface of the tablet. This gel acts as a barrier to the drug release, the drug is dissolved and is released by slow diffusion and erosion of the gel. The extended-release coating layer controls the rate at which water permeates into the tablet core, which in turn controls also the rate of drug delivery. The controlled rate of drug delivery into the gastrointestinal lumen is thus independent of pH or gastrointestinal motility. Tablets contain venlafaxine hydrochloride equivalent to 150 mg or 225 mg venlafaxine. Inactive ingredients consist of dibasic calcium phosphate dihydrate, hypromellose, methacrylic acid copolymer, colloidal silicon dioxide, magnesium stearate, polyvinyl acetate dispersion, talc, polyethylene glycol, polyvinyl alcohol, povidone, triethyl citrate, macrogol stearyl ether, sodium lauryl sulfate, carnauba wax, titanium dioxide, propylene glycol and FD&C blue #1.</Description>
</NDC>
<NDC>
<NDCCode>0603-5449-32</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0603-5449-32)</PackageDescription>
<NDC11Code>00603-5449-32</NDC11Code>
<ProductNDC>0603-5449</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propafenone Hydrochloride</ProprietaryName>
<NonProprietaryName>Propafenone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20021017</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075938</ApplicationNumber>
<LabelerName>Qualitest Pharmaceuticals</LabelerName>
<SubstanceName>PROPAFENONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>225</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>31722-610-32</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (31722-610-32) / 7 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>31722-0610-32</NDC11Code>
<ProductNDC>31722-610</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pregabalin</ProprietaryName>
<NonProprietaryName>Pregabalin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191008</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206912</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191008</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pregabalin capsules are indicated for: Management of neuropathic pain associated with diabetic peripheral neuropathy Management of postherpetic neuralgia Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older Management of fibromyalgia Management of neuropathic pain associated with spinal cord injury.</IndicationAndUsage>
<Description>Pregabalin is described chemically as (3S)-3-(Aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8H 17NO 2and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin is a white to off-white powder with a pKa of 11.30. It is freely soluble in 1N hydrochloric acid and sparingly soluble in water. The log of the partition coefficient is 1.3. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with corn starch, mannitol and talc as inactive ingredients. The capsule shells contain gelatin, sodium lauryl sulfate and titanium dioxide. In addition, 75 mg, 100 mg, 200 mg, 225 mg and 300 mg capsules contain iron oxide red. The imprinting ink contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>31722-611-32</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (31722-611-32) / 7 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>31722-0611-32</NDC11Code>
<ProductNDC>31722-611</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pregabalin</ProprietaryName>
<NonProprietaryName>Pregabalin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191008</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206912</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191008</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pregabalin capsules are indicated for: Management of neuropathic pain associated with diabetic peripheral neuropathy Management of postherpetic neuralgia Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older Management of fibromyalgia Management of neuropathic pain associated with spinal cord injury.</IndicationAndUsage>
<Description>Pregabalin is described chemically as (3S)-3-(Aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8H 17NO 2and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin is a white to off-white powder with a pKa of 11.30. It is freely soluble in 1N hydrochloric acid and sparingly soluble in water. The log of the partition coefficient is 1.3. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with corn starch, mannitol and talc as inactive ingredients. The capsule shells contain gelatin, sodium lauryl sulfate and titanium dioxide. In addition, 75 mg, 100 mg, 200 mg, 225 mg and 300 mg capsules contain iron oxide red. The imprinting ink contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>31722-617-32</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (31722-617-32) / 10 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>31722-0617-32</NDC11Code>
<ProductNDC>31722-617</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pregabalin</ProprietaryName>
<NonProprietaryName>Pregabalin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191008</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206912</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191008</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pregabalin capsules are indicated for: Management of neuropathic pain associated with diabetic peripheral neuropathy Management of postherpetic neuralgia Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older Management of fibromyalgia Management of neuropathic pain associated with spinal cord injury.</IndicationAndUsage>
<Description>Pregabalin is described chemically as (3S)-3-(Aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8H 17NO 2and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin is a white to off-white powder with a pKa of 11.30. It is freely soluble in 1N hydrochloric acid and sparingly soluble in water. The log of the partition coefficient is 1.3. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with corn starch, mannitol and talc as inactive ingredients. The capsule shells contain gelatin, sodium lauryl sulfate and titanium dioxide. In addition, 75 mg, 100 mg, 200 mg, 225 mg and 300 mg capsules contain iron oxide red. The imprinting ink contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>31722-968-32</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (31722-968-32) > 30 g in 1 TUBE</PackageDescription>
<NDC11Code>31722-0968-32</NDC11Code>
<ProductNDC>31722-968</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acyclovir</ProprietaryName>
<NonProprietaryName>Acyclovir</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200901</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212495</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ACYCLOVIR</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Acyclovir Ointment USP, 5% is indicated in the management of initial genital herpes and in limited nonlifethreatening mucocutaneous HSV infections in immunocompromised patients.</IndicationAndUsage>
<Description>Acyclovir Ointment USP, 5% is a synthetic nucleoside analogue active against herpes viruses. Acyclovir Ointment USP, 5% is a formulation for topical administration. Each gram of Acyclovir Ointment USP, 5% contains 50 mg of acyclovir in a polyethylene glycol (PEG) base. Acyclovir is a white, crystalline powder with the molecular formula C8H11N5O3 and a molecular weight of 225. The maximum solubility in water at 37°C is 2.5 mg/mL. The pka's of acyclovir are 2.27 and 9.25. The chemical name of acyclovir is 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one; it has the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>35000-777-32</NDCCode>
<PackageDescription>92 g in 1 CONTAINER (35000-777-32) </PackageDescription>
<NDC11Code>35000-0777-32</NDC11Code>
<ProductNDC>35000-777</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Toms Of Maine</ProprietaryName>
<ProprietaryNameSuffix>Tropical Island</ProprietaryNameSuffix>
<NonProprietaryName>Aluminum Chlorohydrate</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20251203</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M021</ApplicationNumber>
<LabelerName>Colgate-Palmolive Company</LabelerName>
<SubstanceName>ALUMINUM CHLOROHYDRATE</SubstanceName>
<StrengthNumber>225</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>reduces underarm wetness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>42658-150-04</NDCCode>
<PackageDescription>225 mg in 1 BOTTLE (42658-150-04) </PackageDescription>
<NDC11Code>42658-0150-04</NDC11Code>
<ProductNDC>42658-150</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206924</ApplicationNumber>
<LabelerName>Hisun Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/2.5mg</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-05-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Olanzapine, USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)- 10H-thieno[2,3- b] [1,5]benzodiazepine. The molecular formula is C 17H 20N 4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine, USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine Tablets, USP are intended for oral administration only. Each tablet contains olanzapine equivalent to 2.5 mg (8 mcmol), 5 mg (16 mcmol), 7.5 mg (24 mcmol), 10 mg (32 mcmol), 15 mg (48 mcmol), or 20 mg (64 mcmol). Inactive ingredients are lactose monohydrate, maize starch, colloidal silicon dioxide, magnesium stearate, crospovidone, microcrystalline cellulose and talc. Olanzapine orally disintegrating tablets are intended for oral administration only. Each orally disintegrating tablet contains olanzapine equivalent to 5 mg (16 mcmol), 10 mg (32 mcmol), 15 mg (48 mcmol) or 20 mg (64 mcmol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. Olanzapine orally disintegrating tablets also contain the following inactive ingredients: aspartame, lactose monohydrate, maize starch, colloidal silicon dioxide, magnesium stearate, crospovidone, microcrystalline cellulose and talc. Olanzapine orally disintegrating tablets meet USP Disintegration Test 2.</Description>
</NDC>
<NDC>
<NDCCode>42658-152-01</NDCCode>
<PackageDescription>225 mg in 1 BOTTLE (42658-152-01) </PackageDescription>
<NDC11Code>42658-0152-01</NDC11Code>
<ProductNDC>42658-152</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206924</ApplicationNumber>
<LabelerName>Hisun Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/7.5mg</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-05-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Olanzapine, USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)- 10H-thieno[2,3- b] [1,5]benzodiazepine. The molecular formula is C 17H 20N 4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine, USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine Tablets, USP are intended for oral administration only. Each tablet contains olanzapine equivalent to 2.5 mg (8 mcmol), 5 mg (16 mcmol), 7.5 mg (24 mcmol), 10 mg (32 mcmol), 15 mg (48 mcmol), or 20 mg (64 mcmol). Inactive ingredients are lactose monohydrate, maize starch, colloidal silicon dioxide, magnesium stearate, crospovidone, microcrystalline cellulose and talc. Olanzapine orally disintegrating tablets are intended for oral administration only. Each orally disintegrating tablet contains olanzapine equivalent to 5 mg (16 mcmol), 10 mg (32 mcmol), 15 mg (48 mcmol) or 20 mg (64 mcmol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. Olanzapine orally disintegrating tablets also contain the following inactive ingredients: aspartame, lactose monohydrate, maize starch, colloidal silicon dioxide, magnesium stearate, crospovidone, microcrystalline cellulose and talc. Olanzapine orally disintegrating tablets meet USP Disintegration Test 2.</Description>
</NDC>
<NDC>
<NDCCode>50228-225-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (50228-225-01) </PackageDescription>
<NDC11Code>50228-0225-01</NDC11Code>
<ProductNDC>50228-225</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benztropine Mesylate</ProprietaryName>
<NonProprietaryName>Benztropine Mesylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241105</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040103</ApplicationNumber>
<LabelerName>ScieGen Pharmaceuticals Inc</LabelerName>
<SubstanceName>BENZTROPINE MESYLATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Antihistamine [EPC], Cholinergic Antagonists [MoA], Histamine Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241105</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Benztropine mesylate tablets are indicated for use as an adjunct in the therapy of all forms of parkinsonism. Useful also in the control of extrapyramidal disorders (except tardive dyskinesia – see PRECAUTIONS) due to neuroleptic drugs (e.g., phenothiazines).</IndicationAndUsage>
<Description>Benztropine mesylate is a synthetic compound containing structural features found in atropine and diphenhydramine. It is designated chemically as 3α-(Diphenylmethoxy)-1αH, 5αH-tropane methanesulfonate. Its molecular formula is C 21H 25NOCH 4O 3S, and its structural formula is:. Benztropine mesylate is a crystalline white powder, very soluble in water, and has a molecular weight of 403.54. Each benztropine mesylate tablet USP for oral administration contains benztropine mesylate USP 0.5 mg, 1 mg or 2 mg. Inactive ingredients: anhydrous lactose, croscarmellose sodium, FD&C Red #40 Aluminum Lake (2mg), FD&C Yellow #5 Aluminum Lake (1mg), povidone k-29/32, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>50228-225-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (50228-225-10) </PackageDescription>
<NDC11Code>50228-0225-10</NDC11Code>
<ProductNDC>50228-225</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benztropine Mesylate</ProprietaryName>
<NonProprietaryName>Benztropine Mesylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241105</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040103</ApplicationNumber>
<LabelerName>ScieGen Pharmaceuticals Inc</LabelerName>
<SubstanceName>BENZTROPINE MESYLATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Antihistamine [EPC], Cholinergic Antagonists [MoA], Histamine Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241105</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Benztropine mesylate tablets are indicated for use as an adjunct in the therapy of all forms of parkinsonism. Useful also in the control of extrapyramidal disorders (except tardive dyskinesia – see PRECAUTIONS) due to neuroleptic drugs (e.g., phenothiazines).</IndicationAndUsage>
<Description>Benztropine mesylate is a synthetic compound containing structural features found in atropine and diphenhydramine. It is designated chemically as 3α-(Diphenylmethoxy)-1αH, 5αH-tropane methanesulfonate. Its molecular formula is C 21H 25NOCH 4O 3S, and its structural formula is:. Benztropine mesylate is a crystalline white powder, very soluble in water, and has a molecular weight of 403.54. Each benztropine mesylate tablet USP for oral administration contains benztropine mesylate USP 0.5 mg, 1 mg or 2 mg. Inactive ingredients: anhydrous lactose, croscarmellose sodium, FD&C Red #40 Aluminum Lake (2mg), FD&C Yellow #5 Aluminum Lake (1mg), povidone k-29/32, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>51009-861-32</NDCCode>
<PackageDescription>92 g in 1 CONTAINER (51009-861-32) </PackageDescription>
<NDC11Code>51009-0861-32</NDC11Code>
<ProductNDC>51009-861</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Toms Of Maine</ProprietaryName>
<ProprietaryNameSuffix>Tropical Island</ProprietaryNameSuffix>
<NonProprietaryName>Aluminum Chlorohydrate</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20251203</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M021</ApplicationNumber>
<LabelerName>Tom's of Maine</LabelerName>
<SubstanceName>ALUMINUM CHLOROHYDRATE</SubstanceName>
<StrengthNumber>225</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>reduces underarm wetness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58151-237-88</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (58151-237-88) / 1 CAPSULE in 1 BLISTER PACK (58151-237-32) </PackageDescription>
<NDC11Code>58151-0237-88</NDC11Code>
<ProductNDC>58151-237</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lyrica</ProprietaryName>
<NonProprietaryName>Pregabalin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241119</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021446</ApplicationNumber>
<LabelerName>Viatris Specialty LLC</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-09-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241119</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LYRICA is indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial‑onset seizures in patients 1 month of age and older , 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.</IndicationAndUsage>
<Description>Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is -1.35. LYRICA (pregabalin) Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with cornstarch, lactose monohydrate, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and the white capsule shells contain colloidal silicon dioxide and sodium lauryl sulfate. Colloidal silicon dioxide is a manufacturing aid that may or may not be present in the capsule shells. The imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, and shellac. LYRICA (pregabalin) oral solution, 20 mg/mL, is administered orally and is supplied as a clear, colorless solution contained in a 16 fluid ounce white HDPE bottle with a polyethylene-lined closure. The oral solution contains 20 mg/mL of pregabalin, along with artificial strawberry #11545, dibasic sodium phosphate anhydrous, methylparaben, monobasic sodium phosphate anhydrous, propylparaben, purified water, and sucralose as inactive ingredients.</Description>
</NDC>
<NDC>
<NDCCode>58151-238-88</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (58151-238-88) / 1 CAPSULE in 1 BLISTER PACK (58151-238-32) </PackageDescription>
<NDC11Code>58151-0238-88</NDC11Code>
<ProductNDC>58151-238</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lyrica</ProprietaryName>
<NonProprietaryName>Pregabalin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250617</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021446</ApplicationNumber>
<LabelerName>Viatris Specialty LLC</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-09-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250924</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LYRICA is indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial‑onset seizures in patients 1 month of age and older , 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.</IndicationAndUsage>
<Description>Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is -1.35. LYRICA (pregabalin) Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with cornstarch, lactose monohydrate, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and the white capsule shells contain colloidal silicon dioxide and sodium lauryl sulfate. Colloidal silicon dioxide is a manufacturing aid that may or may not be present in the capsule shells. The imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, and shellac. LYRICA (pregabalin) oral solution, 20 mg/mL, is administered orally and is supplied as a clear, colorless solution contained in a 16 fluid ounce white HDPE bottle with a polyethylene-lined closure. The oral solution contains 20 mg/mL of pregabalin, along with artificial strawberry #11545, dibasic sodium phosphate anhydrous, methylparaben, monobasic sodium phosphate anhydrous, propylparaben, purified water, and sucralose as inactive ingredients.</Description>
</NDC>
<NDC>
<NDCCode>58151-239-88</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (58151-239-88) / 1 CAPSULE in 1 BLISTER PACK (58151-239-32) </PackageDescription>
<NDC11Code>58151-0239-88</NDC11Code>
<ProductNDC>58151-239</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lyrica</ProprietaryName>
<NonProprietaryName>Pregabalin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241022</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021446</ApplicationNumber>
<LabelerName>Viatris Specialty LLC</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-09-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250326</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LYRICA is indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial‑onset seizures in patients 1 month of age and older , 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.</IndicationAndUsage>
<Description>Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is -1.35. LYRICA (pregabalin) Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with cornstarch, lactose monohydrate, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and the white capsule shells contain colloidal silicon dioxide and sodium lauryl sulfate. Colloidal silicon dioxide is a manufacturing aid that may or may not be present in the capsule shells. The imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, and shellac. LYRICA (pregabalin) oral solution, 20 mg/mL, is administered orally and is supplied as a clear, colorless solution contained in a 16 fluid ounce white HDPE bottle with a polyethylene-lined closure. The oral solution contains 20 mg/mL of pregabalin, along with artificial strawberry #11545, dibasic sodium phosphate anhydrous, methylparaben, monobasic sodium phosphate anhydrous, propylparaben, purified water, and sucralose as inactive ingredients.</Description>
</NDC>
<NDC>
<NDCCode>58151-240-88</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (58151-240-88) / 1 CAPSULE in 1 BLISTER PACK (58151-240-32) </PackageDescription>
<NDC11Code>58151-0240-88</NDC11Code>
<ProductNDC>58151-240</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lyrica</ProprietaryName>
<NonProprietaryName>Pregabalin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241112</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021446</ApplicationNumber>
<LabelerName>Viatris Specialty LLC</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-09-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241112</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LYRICA is indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial‑onset seizures in patients 1 month of age and older , 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.</IndicationAndUsage>
<Description>Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is -1.35. LYRICA (pregabalin) Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with cornstarch, lactose monohydrate, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and the white capsule shells contain colloidal silicon dioxide and sodium lauryl sulfate. Colloidal silicon dioxide is a manufacturing aid that may or may not be present in the capsule shells. The imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, and shellac. LYRICA (pregabalin) oral solution, 20 mg/mL, is administered orally and is supplied as a clear, colorless solution contained in a 16 fluid ounce white HDPE bottle with a polyethylene-lined closure. The oral solution contains 20 mg/mL of pregabalin, along with artificial strawberry #11545, dibasic sodium phosphate anhydrous, methylparaben, monobasic sodium phosphate anhydrous, propylparaben, purified water, and sucralose as inactive ingredients.</Description>
</NDC>
<NDC>
<NDCCode>60687-185-32</NDCCode>
<PackageDescription>20 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-185-32) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (60687-185-33) </PackageDescription>
<NDC11Code>60687-0185-32</NDC11Code>
<ProductNDC>60687-185</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propafenone Hydrochloride</ProprietaryName>
<NonProprietaryName>Propafenone Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160129</StartMarketingDate>
<EndMarketingDate>20231031</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078540</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>PROPAFENONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>225</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-11-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160129</StartMarketingDatePackage>
<EndMarketingDatePackage>20231031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>60687-674-32</NDCCode>
<PackageDescription>20 BLISTER PACK in 1 CARTON (60687-674-32) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (60687-674-33) </PackageDescription>
<NDC11Code>60687-0674-32</NDC11Code>
<ProductNDC>60687-674</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propafenone Hydrochloride</ProprietaryName>
<NonProprietaryName>Propafenone Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230119</StartMarketingDate>
<EndMarketingDate>20250131</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078540</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>PROPAFENONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>225</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20230119</StartMarketingDatePackage>
<EndMarketingDatePackage>20250131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Propafenone HCl Extended Release Capsules, USP are indicated to prolong the time to recurrence of symptomatic atrial fibrillation (AF) in patients with episodic (most likely paroxysmal or persistent) AF who do not have structural heart disease. Usage Considerations: 1 The use of propafenone ER capsules in patients with permanent AF or in patients exclusively with atrial flutter or paroxysmal supraventricular tachycardia (PSVT) has not been evaluated. Do not use propafenone ER capsules to control ventricular rate during AF. , 2 Some patients with atrial flutter treated with propafenone have developed 1:1 conduction, producing an increase in ventricular rate. Concomitant treatment with drugs that increase the functional atrioventricular (AV) nodal refractory period is recommended. , 3 The effect of propafenone on mortality has not been determined [see BOXED WARNING]. .</IndicationAndUsage>
<Description>Propafenone Hydrochloride Extended Release Capsule, USP is an antiarrhythmic drug supplied in extended release capsules of 225mg, 325mg and 425 mg for oral administration. Chemically, propafenone hydrochloride is 2'-[2-hydroxy-3-(propylamino)-propoxy]-3‑phenylpropiophenone hydrochloride, with a molecular weight of 377.92. The molecular formula is C 21H 27NO 3HCl. Propafenone HCl has some structural similarities to beta-blocking agents. The structural formula of propafenone HCl is given below. Propafenone HCl occurs as colorless crystals or white crystalline powder with a very bitter taste. It is slightly soluble in water (20ºC), chloroform, and ethanol. Propafenone ER capsules are filled with granules containing the following inactive ingredients: ethylcellulose, lactose anhydrous, magnesium stearate and povidone. Each capsule contains Titanium dioxide and gelatin. In addition the 325 mg capsule also contains FD&C Blue No. 1, D&C Yellow No. 10 and FD&C Red No. 40 and the 425 mg capsule contains FD&C Blue No. 1, FD&C Red No. 40 and FD&C Yellow No. 6. The black ink consists of D&C Yellow No.10, iron oxide black, n-butyl alcohol, propylene glycol, FD&C Blue No. 2, FD&C Red No. 40, FD&C Blue No. 1 and shellac glaze~45% (20% esterfied) in ethanol.</Description>
</NDC>
<NDC>
<NDCCode>68084-858-32</NDCCode>
<PackageDescription>20 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-858-32) > 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (68084-858-33)</PackageDescription>
<NDC11Code>68084-0858-32</NDC11Code>
<ProductNDC>68084-858</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propafenone Hydrochloride</ProprietaryName>
<NonProprietaryName>Propafenone Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141020</StartMarketingDate>
<EndMarketingDate>20161231</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078540</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>PROPAFENONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>225</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-01-05</LastUpdate>
</NDC>
<NDC>
<NDCCode>75834-225-25</NDCCode>
<PackageDescription>25 VIAL in 1 TRAY (75834-225-25) / 10 mL in 1 VIAL (75834-225-01) </PackageDescription>
<NDC11Code>75834-0225-25</NDC11Code>
<ProductNDC>75834-225</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zinc Sulfate</ProprietaryName>
<NonProprietaryName>Zinc Sulfate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20240730</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214597</ApplicationNumber>
<LabelerName>Nivagen Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ZINC SULFATE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240730</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Zinc Sulfate Injection is indicated in adult and pediatric patients as a source of zinc for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.</IndicationAndUsage>
<Description>Zinc Sulfate Injection, USP is a sterile, clear colorless solution, free from visible particles intended for use as a trace element and an additive to intravenous solutions for parenteral nutrition. 10 mg/10 mL Pharmacy Bulk Package vial. Each mL contains 1 mg of zinc present as 2.46 mg of zinc sulfate and water for injection q.s. 30 mg/10 mL Pharmacy Bulk Package vial. Each mL contains 3 mg of zinc present as 7.41 mg of zinc sulfate and water for injection q.s. 25 mg/5 mL Pharmacy Bulk Package vial. Each mL contains 5 mg of zinc present as 12.32 mg of zinc sulfate and water for injection q.s. All presentations do not contain preservatives. The pH range is 2 to 4; pH may be adjusted with sulfuric acid. 1 mg/mL of Zinc Sulfate Injection contains no more than 1,500 mcg/L of aluminum and has a calculated osmolarity of 33 mOsmol/L. 3 mg/mL of Zinc Sulfate Injection contains no more than 2,500 mcg/L of aluminum and has a calculated osmolarity of 96.5 mOsmol/L. 5 mg/mL of Zinc Sulfate Injection contains no more than 2,500 mcg/L of aluminum and has a calculated osmolarity of 157.2 mOsmol/L. Zinc sulfate heptahydrate has a molecular weight of 287.56 g/mol and a formula of ZnSO4·7H2O.</Description>
</NDC>
<NDC>
<NDCCode>58809-063-60</NDCCode>
<PackageDescription>57 mL in 1 BOTTLE, PLASTIC (58809-063-60) </PackageDescription>
<NDC11Code>58809-0063-60</NDC11Code>
<ProductNDC>58809-063</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Texaclear Fast Acting Allergy Relief</ProprietaryName>
<NonProprietaryName>Chlophedianol Hydrochloride, Pyrilamine Maleate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141021</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>GM Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CHLOPHEDIANOL HYDROCHLORIDE; PYRILAMINE MALEATE</SubstanceName>
<StrengthNumber>25; 50</StrengthNumber>
<StrengthUnit>mg/57mL; mg/57mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-07-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141021</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: 1 cough due to minor throat and bronchial irritation, 2 runny nose, 3 sneezing, 4 itching of the nose or throat, 5 itchy, watery eyes.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58809-111-30</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (58809-111-30) </PackageDescription>
<NDC11Code>58809-0111-30</NDC11Code>
<ProductNDC>58809-111</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dayclear Allergy Immune Therapy</ProprietaryName>
<NonProprietaryName>Dayclear</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180813</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>GM Pharmaceuticals, INC</LabelerName>
<SubstanceName>ACACIA POLLEN; ACER NEGUNDO POLLEN; ACER SACCHARINUM POLLEN; ACER SACCHARUM POLLEN; AGROSTIS GIGANTEA POLLEN; AILANTHUS ALTISSIMA POLLEN; ALLENROLFEA OCCIDENTALIS POLLEN; ALNUS INCANA SUBSP. RUGOSA POLLEN; AMARANTHUS HYBRIDUS POLLEN; AMARANTHUS PALMERI POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMARANTHUS SPINOSUS POLLEN; AMARANTHUS TUBERCULATUS POLLEN; AMBROSIA ACANTHICARPA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA BIDENTATA POLLEN; AMBROSIA CONFERTIFLORA POLLEN; AMBROSIA DUMOSA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; ARTEMISIA ANNUA POLLEN; ARTEMISIA LUDOVICIANA WHOLE; ARTEMISIA TRIDENTATA POLLEN; ARTEMISIA VULGARIS WHOLE; ATRIPLEX CANESCENS POLLEN; AVENA SATIVA POLLEN; BACCHARIS HALIMIFOLIA WHOLE; BAPTISIA TINCTORIA ROOT; BASSIA SCOPARIA POLLEN; BETULA NIGRA POLLEN; BETULA OCCIDENTALIS WHOLE; BROMUS INERMIS POLLEN; BROUSSONETIA PAPYRIFERA POLLEN; CARPINUS CAROLINIANA WHOLE; CARYA ALBA POLLEN; CARYA CORDIFORMIS WHOLE; CARYA GLABRA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA LACINIOSA POLLEN; CARYA OVATA POLLEN; CELTIS OCCIDENTALIS POLLEN; CHENOPODIUM ALBUM POLLEN; CUPRESSUS ARIZONICA POLLEN; CYCLACHAENA XANTHIFOLIA POLLEN; CYNODON DACTYLON POLLEN; DACTYLIS GLOMERATA POLLEN; DISTICHLIS SPICATA POLLEN; ECHINACEA, UNSPECIFIED; ELYMUS REPENS POLLEN; FAGUS GRANDIFOLIA POLLEN; FESTUCA PRATENSIS POLLEN; FRAXINUS AMERICANA POLLEN; FRAXINUS PENNSYLVANICA POLLEN; FRAXINUS VELUTINA POLLEN; GUTIERREZIA SAROTHRAE WHOLE; HOLCUS LANATUS POLLEN; HYDRASTIS CANADENSIS WHOLE; IVA ANGUSTIFOLIA POLLEN; IVA ANNUA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS ASHEI POLLEN; JUNIPERUS DEPPEANA WHOLE; JUNIPERUS MONOSPERMA POLLEN; JUNIPERUS OSTEOSPERMA POLLEN; JUNIPERUS PINCHOTII POLLEN; JUNIPERUS SCOPULORUM POLLEN; JUNIPERUS VIRGINIANA POLLEN; LIGUSTRUM LUCIDUM WHOLE; LIQUIDAMBAR STYRACIFLUA POLLEN; LOLIUM MULTIFLORUM POLLEN; LOLIUM PERENNE POLLEN; MELALEUCA QUINQUENERVIA POLLEN; MORUS ALBA WHOLE; MORUS RUBRA POLLEN; MYRRH; OSTRYA VIRGINIANA WHOLE; PASPALUM NOTATUM POLLEN; PHALARIS ARUNDINACEA POLLEN; PHLEUM PRATENSE POLLEN; PHYTOLACCA AMERICANA ROOT; PINUS NIGRA POLLEN; PINUS PONDEROSA POLLEN; PINUS STROBUS POLLEN; PINUS SYLVESTRIS POLLEN; PINUS TAEDA POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POA ANNUA POLLEN; POA PRATENSIS POLLEN; POPULUS ALBA POLLEN; POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN; POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN; POPULUS FREMONTII POLLEN; POPULUS NIGRA POLLEN; PROSOPIS PALLIDA POLLEN; QUERCUS ALBA WHOLE; QUERCUS GAMBELII POLLEN; QUERCUS MACROCARPA POLLEN; QUERCUS NIGRA POLLEN; QUERCUS RUBRA BARK; QUERCUS STELLATA POLLEN; QUERCUS VELUTINA WHOLE; QUERCUS VIRGINIANA POLLEN; RORIPPA NASTURTIUM-AQUATICUM; RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS POLLEN; SALIX NIGRA WHOLE; SALSOLA KALI WHOLE; SECALE CEREALE POLLEN; SOLIDAGO CANADENSIS WHOLE; SORGHUM HALEPENSE POLLEN; SORGHUM X DRUMMONDII WHOLE; TAMARIX GALLICA POLLEN; TAXODIUM DISTICHUM POLLEN; TRIADICA SEBIFERA WHOLE; TRIGONELLA FOENUM-GRAECUM WHOLE; TRITICUM AESTIVUM POLLEN; ULMUS AMERICANA POLLEN; ULMUS CRASSIFOLIA POLLEN; ULMUS CRASSIFOLIA WHOLE; ULMUS PUMILA POLLEN; URTICA DIOICA POLLEN; XANTHIUM STRUMARIUM POLLEN; ZEA MAYS POLLEN</SubstanceName>
<StrengthNumber>12; 12; 12; 12; 6; 12; 30; 12; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 6; 30; 30; 6; 30; 30; 6; 12; 3; 30; 12; 12; 6; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30; 12; 30; 6; 6; 6; 3; 6; 12; 6; 12; 12; 12; 30; 6; 3; 30; 30; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 6; 6; 12; 12; 12; 3; 12; 6; 6; 6; 3; 12; 12; 12; 12; 12; 30; 12; 6; 6; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30; 12; 3; 30; 30; 12; 30; 6; 30; 6; 12; 12; 12; 12; 3; 6; 12; 12; 12; 12; 30; 30; 6</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-11-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180813</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>58809-116-08</NDCCode>
<PackageDescription>237 mL in 1 BOTTLE (58809-116-08) </PackageDescription>
<NDC11Code>58809-0116-08</NDC11Code>
<ProductNDC>58809-116</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Texaclear Nighttime Sleep-aid</ProprietaryName>
<NonProprietaryName>Diphenhydramine Hcl</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160615</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M010</ApplicationNumber>
<LabelerName>GM Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/30mL</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160615</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the relief of occasional sleeplessnes.</IndicationAndUsage>
</NDC>
</NDCList>