{
"NDC": [
{
"NDCCode": "70752-166-11",
"PackageDescription": "1000 TABLET in 1 BOTTLE (70752-166-11) ",
"NDC11Code": "70752-0166-11",
"ProductNDC": "70752-166",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenobarbital",
"NonProprietaryName": "Phenobarbital",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200930",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "QUAGEN PHARMACEUTICALS LLC",
"SubstanceName": "PHENOBARBITAL",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2023-02-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200930",
"SamplePackage": "N",
"IndicationAndUsage": "Phenobarbital Tablets, USP are indicated for use as a sedative or anticonvulsant.",
"Description": "Phenobarbital is a barbituric acid derivative for oral administration and occurs as a white, odorless, slightly bitter powder that is soluble in chloroform, freely soluble in alcohol or ether, and slightly soluble in water. Its saturated solution has a pH of about 5.6. Chemically, it is 5-ethyl-5- phenylbarbituric acid with the molecular formula C12H12N2O3 (232.24). The structural formula is as follows. Each Phenobarbital Tablet, USP contains 15 mg, 30 mg, 60 mg or 100 mg of phenobarbital, USP. Inactive ingredients include: colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and magnesium stearate."
},
{
"NDCCode": "70752-166-10",
"PackageDescription": "100 TABLET in 1 BOTTLE (70752-166-10) ",
"NDC11Code": "70752-0166-10",
"ProductNDC": "70752-166",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenobarbital",
"NonProprietaryName": "Phenobarbital",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200930",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "QUAGEN PHARMACEUTICALS LLC",
"SubstanceName": "PHENOBARBITAL",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2023-02-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200930",
"SamplePackage": "N",
"IndicationAndUsage": "Phenobarbital Tablets, USP are indicated for use as a sedative or anticonvulsant.",
"Description": "Phenobarbital is a barbituric acid derivative for oral administration and occurs as a white, odorless, slightly bitter powder that is soluble in chloroform, freely soluble in alcohol or ether, and slightly soluble in water. Its saturated solution has a pH of about 5.6. Chemically, it is 5-ethyl-5- phenylbarbituric acid with the molecular formula C12H12N2O3 (232.24). The structural formula is as follows. Each Phenobarbital Tablet, USP contains 15 mg, 30 mg, 60 mg or 100 mg of phenobarbital, USP. Inactive ingredients include: colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and magnesium stearate."
},
{
"NDCCode": "70752-166-14",
"PackageDescription": "500 TABLET in 1 BOTTLE (70752-166-14) ",
"NDC11Code": "70752-0166-14",
"ProductNDC": "70752-166",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenobarbital",
"NonProprietaryName": "Phenobarbital",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200930",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "QUAGEN PHARMACEUTICALS LLC",
"SubstanceName": "PHENOBARBITAL",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2023-02-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200930",
"SamplePackage": "N",
"IndicationAndUsage": "Phenobarbital Tablets, USP are indicated for use as a sedative or anticonvulsant.",
"Description": "Phenobarbital is a barbituric acid derivative for oral administration and occurs as a white, odorless, slightly bitter powder that is soluble in chloroform, freely soluble in alcohol or ether, and slightly soluble in water. Its saturated solution has a pH of about 5.6. Chemically, it is 5-ethyl-5- phenylbarbituric acid with the molecular formula C12H12N2O3 (232.24). The structural formula is as follows. Each Phenobarbital Tablet, USP contains 15 mg, 30 mg, 60 mg or 100 mg of phenobarbital, USP. Inactive ingredients include: colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and magnesium stearate."
},
{
"NDCCode": "50268-166-12",
"PackageDescription": "20 BLISTER PACK in 1 BOX (50268-166-12) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-166-11) ",
"NDC11Code": "50268-0166-12",
"ProductNDC": "50268-166",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Chlorpromazine Hydrochloride",
"NonProprietaryName": "Chlorpromazine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200214",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209755",
"LabelerName": "AvPAK",
"SubstanceName": "CHLORPROMAZINE HYDROCHLORIDE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phenothiazine [EPC], Phenothiazines [CS]",
"Status": "Active",
"LastUpdate": "2026-01-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200214",
"SamplePackage": "N",
"IndicationAndUsage": "For the management of manifestations of psychotic disorders. For the treatment of schizophrenia. To control nausea and vomiting. For relief of restlessness and apprehension before surgery. For acute intermittent porphyria. As an adjunct in the treatment of tetanus. To control the manifestations of the manic type of manic-depressive illness. For relief of intractable hiccups. For the treatment of severe behavioral problems in children (1 to 12 years of age) marked by combativeness and/or explosive hyperexcitable behavior (out of proportion to immediate provocations), and in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability and poor frustration tolerance.",
"Description": "Chlorpromazine hydrochloride, a dimethylamine derivative of phenothiazine, has a chemical formula of 2-chloro-10-[3-(dimethylamino) propyl] phenothiazine monohydrochloride. It is available in tablets for oral administration. It has the following structural formula. Chlorpromazine hydrochloride, USP is a white to almost white crystalline powder. It is very soluble in water, freely soluble in ethanol (96%). Each tablet for oral administration contains 10 mg, 25 mg, 50 mg, 100 mg, or 200 mg of chlorpromazine hydrochloride, USP. Inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, sodium lauryl sulfate and titanium dioxide. Each tablet is imprinted with black pharmaceutical ink which contains: ammonium hydroxide, ferrosoferric oxide, isopropyl alcohol, N-butyl alcohol, propylene glycol and shellac."
},
{
"NDCCode": "68084-166-01",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (68084-166-01) > 10 TABLET in 1 BLISTER PACK (68084-166-11)",
"NDC11Code": "68084-0166-01",
"ProductNDC": "68084-166",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bethanechol Chloride",
"NonProprietaryName": "Bethanechol Chloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070220",
"EndMarketingDate": "20160430",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040533",
"LabelerName": "American Health Packaging",
"SubstanceName": "BETHANECHOL CHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "71052-166-11",
"PackageDescription": "1000 g in 1 CONTAINER (71052-166-11) ",
"NDC11Code": "71052-0166-11",
"ProductNDC": "71052-166",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Tranexamic Acid",
"DosageFormName": "POWDER",
"StartMarketingDate": "20200514",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "DARMERICA, LLC",
"SubstanceName": "TRANEXAMIC ACID",
"StrengthNumber": "10000",
"StrengthUnit": "g/10000g",
"Status": "Unfinished",
"LastUpdate": "2025-03-26",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "12-OCT-20"
},
{
"NDCCode": "72205-166-99",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (72205-166-99) / 10 TABLET, FILM COATED in 1 BLISTER PACK (72205-166-11) ",
"NDC11Code": "72205-0166-99",
"ProductNDC": "72205-166",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olmesartan Medoxomil",
"NonProprietaryName": "Olmesartan Medoxomil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230118",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217399",
"LabelerName": "Novadoz Pharmaceuticals LLC",
"SubstanceName": "OLMESARTAN MEDOXOMIL",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-02-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231218",
"SamplePackage": "N",
"IndicationAndUsage": "Olmesartan medoxomil tablets are indicated for the treatment of hypertension in adults and children six years of age and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. It may be used alone or in combination with other antihypertensive agents.",
"Description": "Olmesartan medoxomil tablets USP, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT1 subtype angiotensin II receptor antagonist. Olmesartan medoxomil tablets, USP is described chemically as 1H-imidazole-5-carboxylic acid, 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[[2'-(1H-tetrazol-5-yl) [1, 1’-biphenyl]-4-yl] methyl]-, (5-methyl-2-oxo-1, 3-dioxol-4-yl) methyl ester. Its molecular formula is C29H30N6O6 and its structural formula is. Olmesartan medoxomil USP, is a white to off-white, crystalline powder with a molecular weight of 558.59. It is sparingly soluble in methanol and practically insoluble in water. Olmesartan medoxomil USP is available for oral use as film-coated tablets containing 5 mg, 20 mg, or 40 mg of olmesartan medoxomil and the following inactive ingredients: hydroxypropyl cellulose, hypromellose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide, and (5 mg only) yellow iron oxide. Meets USP Dissolution Test 7."
},
{
"NDCCode": "70752-107-11",
"PackageDescription": "1000 TABLET in 1 BOTTLE, PLASTIC (70752-107-11) ",
"NDC11Code": "70752-0107-11",
"ProductNDC": "70752-107",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyproheptadine Hydrochloride",
"NonProprietaryName": "Cyproheptadine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210224",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212491",
"LabelerName": "QUAGEN PHARMACEUTICALS LLC",
"SubstanceName": "CYPROHEPTADINE HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2022-07-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210224",
"SamplePackage": "N",
"IndicationAndUsage": "Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Cold urticaria. Dermatographism. As therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled.",
"Description": "Cyproheptadine HCl USP, is an antihistaminic and antiserotonergic agent. Cyproheptadine hydrochloride USP is a white to slightly yellowish crystalline solid, with a molecular weight of 350.89, which is soluble in water, freely soluble in methanol, sparingly soluble in ethanol, soluble in chloroform, and practically insoluble in ether. It is the sesquihydrate of 4-(5H-dibenzo[a,d]cyclohepten-5-ylidene)-1-methylpiperidine hydrochloride. The molecular formula of the anhydrous salt is C21H21NHCl and the structural formula of the anhydrous salt is. Cyproheptadine hydrochloride USP is available for oral administration in 4 mg tablets. Inactive ingredients include: lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate."
},
{
"NDCCode": "70752-108-11",
"PackageDescription": "1000 TABLET in 1 BOTTLE, PLASTIC (70752-108-11) ",
"NDC11Code": "70752-0108-11",
"ProductNDC": "70752-108",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glycopyrrolate",
"NonProprietaryName": "Glycopyrrolate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20241010",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212696",
"LabelerName": "QUAGEN PHARMACEUTICALS LLC",
"SubstanceName": "GLYCOPYRROLATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-06-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241010",
"SamplePackage": "N",
"IndicationAndUsage": "Glycopyrrolate tablets are indicated in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer. Limitations of Use. Glycopyrrolate tablets are not indicated as monotherapy for the treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established.",
"Description": "Glycopyrrolate tablets USP for oral use contain synthetic anticholinergic glycopyrrolate. Glycopyrrolate is a quaternary ammonium compound with the following chemical name: 3-[(cyclopentyl hydroxyphenylacetyl)oxy]-1,1-dimethylpyrrolidinium bromide. The molecular formula for glycopyrrolate is C19H28BrNO3, the molecular weight is 398.3 g/mol, and the structural formula is. Each Glycopyrrolate tablet USP for oral use contains glycopyrrolate, USP 1 mg, or 2 mg as the active ingredient. The inactive ingredients are dibasic calcium phosphate, lactose monohydrate, magnesium stearate, povidone, and sodium starch glycolate."
},
{
"NDCCode": "70752-109-11",
"PackageDescription": "1000 TABLET in 1 BOTTLE, PLASTIC (70752-109-11) ",
"NDC11Code": "70752-0109-11",
"ProductNDC": "70752-109",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glycopyrrolate",
"NonProprietaryName": "Glycopyrrolate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20241010",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212696",
"LabelerName": "QUAGEN PHARMACEUTICALS LLC",
"SubstanceName": "GLYCOPYRROLATE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-06-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241010",
"SamplePackage": "N",
"IndicationAndUsage": "Glycopyrrolate tablets are indicated in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer. Limitations of Use. Glycopyrrolate tablets are not indicated as monotherapy for the treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established.",
"Description": "Glycopyrrolate tablets USP for oral use contain synthetic anticholinergic glycopyrrolate. Glycopyrrolate is a quaternary ammonium compound with the following chemical name: 3-[(cyclopentyl hydroxyphenylacetyl)oxy]-1,1-dimethylpyrrolidinium bromide. The molecular formula for glycopyrrolate is C19H28BrNO3, the molecular weight is 398.3 g/mol, and the structural formula is. Each Glycopyrrolate tablet USP for oral use contains glycopyrrolate, USP 1 mg, or 2 mg as the active ingredient. The inactive ingredients are dibasic calcium phosphate, lactose monohydrate, magnesium stearate, povidone, and sodium starch glycolate."
},
{
"NDCCode": "70752-123-11",
"PackageDescription": "1000 TABLET in 1 BOTTLE, PLASTIC (70752-123-11) ",
"NDC11Code": "70752-0123-11",
"ProductNDC": "70752-123",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benztropine Mesylate",
"NonProprietaryName": "Benztropine Mesylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250811",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212694",
"LabelerName": "QUAGEN PHARMACEUTICALS LLC",
"SubstanceName": "BENZTROPINE MESYLATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC], Antihistamine [EPC], Cholinergic Antagonists [MoA], Histamine Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-08-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250811",
"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, USP is a synthetic compound containing structural features found in atropine and diphenhydramine. It is a crystalline white powder, very soluble in water, designated as 3α- (Diphenylmethoxy)-1αH, 5αH-tropane methanesulfonate, with the following structural formula. Each benztropine mesylate tablet, USP for oral administration contains benztropine mesylate 0.5 mg, 1 mg or 2 mg. Each tablet contains the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, magnesium stearate."
},
{
"NDCCode": "70752-124-11",
"PackageDescription": "1000 TABLET in 1 BOTTLE, PLASTIC (70752-124-11) ",
"NDC11Code": "70752-0124-11",
"ProductNDC": "70752-124",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benztropine Mesylate",
"NonProprietaryName": "Benztropine Mesylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250811",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212694",
"LabelerName": "QUAGEN PHARMACEUTICALS LLC",
"SubstanceName": "BENZTROPINE MESYLATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC], Antihistamine [EPC], Cholinergic Antagonists [MoA], Histamine Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-08-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250811",
"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, USP is a synthetic compound containing structural features found in atropine and diphenhydramine. It is a crystalline white powder, very soluble in water, designated as 3α- (Diphenylmethoxy)-1αH, 5αH-tropane methanesulfonate, with the following structural formula. Each benztropine mesylate tablet, USP for oral administration contains benztropine mesylate 0.5 mg, 1 mg or 2 mg. Each tablet contains the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, magnesium stearate."
},
{
"NDCCode": "70752-125-11",
"PackageDescription": "1000 TABLET in 1 BOTTLE, PLASTIC (70752-125-11) ",
"NDC11Code": "70752-0125-11",
"ProductNDC": "70752-125",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benztropine Mesylate",
"NonProprietaryName": "Benztropine Mesylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250811",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212694",
"LabelerName": "QUAGEN PHARMACEUTICALS LLC",
"SubstanceName": "BENZTROPINE MESYLATE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC], Antihistamine [EPC], Cholinergic Antagonists [MoA], Histamine Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-08-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250811",
"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, USP is a synthetic compound containing structural features found in atropine and diphenhydramine. It is a crystalline white powder, very soluble in water, designated as 3α- (Diphenylmethoxy)-1αH, 5αH-tropane methanesulfonate, with the following structural formula. Each benztropine mesylate tablet, USP for oral administration contains benztropine mesylate 0.5 mg, 1 mg or 2 mg. Each tablet contains the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, magnesium stearate."
},
{
"NDCCode": "70752-161-11",
"PackageDescription": "1000 TABLET in 1 BOTTLE (70752-161-11) ",
"NDC11Code": "70752-0161-11",
"ProductNDC": "70752-161",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenobarbital",
"NonProprietaryName": "Phenobarbital",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200915",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "QUAGEN PHARMACEUTICALS LLC",
"SubstanceName": "PHENOBARBITAL",
"StrengthNumber": "16.2",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2023-02-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200915",
"SamplePackage": "N",
"IndicationAndUsage": "Sedative. Anticonvulsant – For the treatment of generalized and partial seizures.",
"Description": "The barbiturates are nonselective central nervous system (CNS) depressants that are primarily used as sedative-hypnotics. In subhypnotic doses, they are also used as anticonvulsants. The barbiturates and their sodium salts are subject to control under the Federal Controlled Substances Act. Phenobarbital is a barbituric acid derivative and occurs as white, odorless, small crystals or crystalline powder that is very slightly soluble in water; soluble in alcohol, in ether, and in solutions of fixed alkali hydroxides and carbonates; sparingly soluble in chloroform. Phenobarbital is 5-ethyl-5- phenylbarbituric acid. Phenobarbital is a substituted pyrimidine derivative in which the basic structure is barbituric acid, a substance that has no CNS activity. CNS activity is obtained by substituting alkyl, alkenyl, or aryl groups on the pyrimidine ring. It has the following structural formula. C12H12N2O3 M.W. = 232.24. Each phenobarbital tablet contains 16.2 mg, 32.4 mg, 64.8 mg, or 97.2 mg of phenobarbital, USP. Inactive ingredients include: colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and magnesium stearate."
},
{
"NDCCode": "70752-162-11",
"PackageDescription": "1000 TABLET in 1 BOTTLE (70752-162-11) ",
"NDC11Code": "70752-0162-11",
"ProductNDC": "70752-162",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenobarbital",
"NonProprietaryName": "Phenobarbital",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200915",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "QUAGEN PHARMACEUTICALS LLC",
"SubstanceName": "PHENOBARBITAL",
"StrengthNumber": "32.4",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2023-02-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200915",
"SamplePackage": "N",
"IndicationAndUsage": "Sedative. Anticonvulsant – For the treatment of generalized and partial seizures.",
"Description": "The barbiturates are nonselective central nervous system (CNS) depressants that are primarily used as sedative-hypnotics. In subhypnotic doses, they are also used as anticonvulsants. The barbiturates and their sodium salts are subject to control under the Federal Controlled Substances Act. Phenobarbital is a barbituric acid derivative and occurs as white, odorless, small crystals or crystalline powder that is very slightly soluble in water; soluble in alcohol, in ether, and in solutions of fixed alkali hydroxides and carbonates; sparingly soluble in chloroform. Phenobarbital is 5-ethyl-5- phenylbarbituric acid. Phenobarbital is a substituted pyrimidine derivative in which the basic structure is barbituric acid, a substance that has no CNS activity. CNS activity is obtained by substituting alkyl, alkenyl, or aryl groups on the pyrimidine ring. It has the following structural formula. C12H12N2O3 M.W. = 232.24. Each phenobarbital tablet contains 16.2 mg, 32.4 mg, 64.8 mg, or 97.2 mg of phenobarbital, USP. Inactive ingredients include: colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and magnesium stearate."
},
{
"NDCCode": "70752-163-11",
"PackageDescription": "1000 TABLET in 1 BOTTLE (70752-163-11) ",
"NDC11Code": "70752-0163-11",
"ProductNDC": "70752-163",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenobarbital",
"NonProprietaryName": "Phenobarbital",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200915",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "QUAGEN PHARMACEUTICALS LLC",
"SubstanceName": "PHENOBARBITAL",
"StrengthNumber": "64.8",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2023-02-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200915",
"SamplePackage": "N",
"IndicationAndUsage": "Sedative. Anticonvulsant – For the treatment of generalized and partial seizures.",
"Description": "The barbiturates are nonselective central nervous system (CNS) depressants that are primarily used as sedative-hypnotics. In subhypnotic doses, they are also used as anticonvulsants. The barbiturates and their sodium salts are subject to control under the Federal Controlled Substances Act. Phenobarbital is a barbituric acid derivative and occurs as white, odorless, small crystals or crystalline powder that is very slightly soluble in water; soluble in alcohol, in ether, and in solutions of fixed alkali hydroxides and carbonates; sparingly soluble in chloroform. Phenobarbital is 5-ethyl-5- phenylbarbituric acid. Phenobarbital is a substituted pyrimidine derivative in which the basic structure is barbituric acid, a substance that has no CNS activity. CNS activity is obtained by substituting alkyl, alkenyl, or aryl groups on the pyrimidine ring. It has the following structural formula. C12H12N2O3 M.W. = 232.24. Each phenobarbital tablet contains 16.2 mg, 32.4 mg, 64.8 mg, or 97.2 mg of phenobarbital, USP. Inactive ingredients include: colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and magnesium stearate."
},
{
"NDCCode": "70752-164-11",
"PackageDescription": "1000 TABLET in 1 BOTTLE (70752-164-11) ",
"NDC11Code": "70752-0164-11",
"ProductNDC": "70752-164",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenobarbital",
"NonProprietaryName": "Phenobarbital",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200915",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "QUAGEN PHARMACEUTICALS LLC",
"SubstanceName": "PHENOBARBITAL",
"StrengthNumber": "97.2",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2023-02-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200915",
"SamplePackage": "N",
"IndicationAndUsage": "Sedative. Anticonvulsant – For the treatment of generalized and partial seizures.",
"Description": "The barbiturates are nonselective central nervous system (CNS) depressants that are primarily used as sedative-hypnotics. In subhypnotic doses, they are also used as anticonvulsants. The barbiturates and their sodium salts are subject to control under the Federal Controlled Substances Act. Phenobarbital is a barbituric acid derivative and occurs as white, odorless, small crystals or crystalline powder that is very slightly soluble in water; soluble in alcohol, in ether, and in solutions of fixed alkali hydroxides and carbonates; sparingly soluble in chloroform. Phenobarbital is 5-ethyl-5- phenylbarbituric acid. Phenobarbital is a substituted pyrimidine derivative in which the basic structure is barbituric acid, a substance that has no CNS activity. CNS activity is obtained by substituting alkyl, alkenyl, or aryl groups on the pyrimidine ring. It has the following structural formula. C12H12N2O3 M.W. = 232.24. Each phenobarbital tablet contains 16.2 mg, 32.4 mg, 64.8 mg, or 97.2 mg of phenobarbital, USP. Inactive ingredients include: colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and magnesium stearate."
},
{
"NDCCode": "70752-165-11",
"PackageDescription": "1000 TABLET in 1 BOTTLE (70752-165-11) ",
"NDC11Code": "70752-0165-11",
"ProductNDC": "70752-165",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenobarbital",
"NonProprietaryName": "Phenobarbital",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200930",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "QUAGEN PHARMACEUTICALS LLC",
"SubstanceName": "PHENOBARBITAL",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2023-02-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200930",
"SamplePackage": "N",
"IndicationAndUsage": "Phenobarbital Tablets, USP are indicated for use as a sedative or anticonvulsant.",
"Description": "Phenobarbital is a barbituric acid derivative for oral administration and occurs as a white, odorless, slightly bitter powder that is soluble in chloroform, freely soluble in alcohol or ether, and slightly soluble in water. Its saturated solution has a pH of about 5.6. Chemically, it is 5-ethyl-5- phenylbarbituric acid with the molecular formula C12H12N2O3 (232.24). The structural formula is as follows. Each Phenobarbital Tablet, USP contains 15 mg, 30 mg, 60 mg or 100 mg of phenobarbital, USP. Inactive ingredients include: colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and magnesium stearate."
},
{
"NDCCode": "70752-167-11",
"PackageDescription": "1000 TABLET in 1 BOTTLE (70752-167-11) ",
"NDC11Code": "70752-0167-11",
"ProductNDC": "70752-167",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenobarbital",
"NonProprietaryName": "Phenobarbital",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200930",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "QUAGEN PHARMACEUTICALS LLC",
"SubstanceName": "PHENOBARBITAL",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2023-02-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200930",
"SamplePackage": "N",
"IndicationAndUsage": "Phenobarbital Tablets, USP are indicated for use as a sedative or anticonvulsant.",
"Description": "Phenobarbital is a barbituric acid derivative for oral administration and occurs as a white, odorless, slightly bitter powder that is soluble in chloroform, freely soluble in alcohol or ether, and slightly soluble in water. Its saturated solution has a pH of about 5.6. Chemically, it is 5-ethyl-5- phenylbarbituric acid with the molecular formula C12H12N2O3 (232.24). The structural formula is as follows. Each Phenobarbital Tablet, USP contains 15 mg, 30 mg, 60 mg or 100 mg of phenobarbital, USP. Inactive ingredients include: colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and magnesium stearate."
},
{
"NDCCode": "70752-168-11",
"PackageDescription": "1000 TABLET in 1 BOTTLE (70752-168-11) ",
"NDC11Code": "70752-0168-11",
"ProductNDC": "70752-168",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phenobarbital",
"NonProprietaryName": "Phenobarbital",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200930",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "QUAGEN PHARMACEUTICALS LLC",
"SubstanceName": "PHENOBARBITAL",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2023-02-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200930",
"SamplePackage": "N",
"IndicationAndUsage": "Phenobarbital Tablets, USP are indicated for use as a sedative or anticonvulsant.",
"Description": "Phenobarbital is a barbituric acid derivative for oral administration and occurs as a white, odorless, slightly bitter powder that is soluble in chloroform, freely soluble in alcohol or ether, and slightly soluble in water. Its saturated solution has a pH of about 5.6. Chemically, it is 5-ethyl-5- phenylbarbituric acid with the molecular formula C12H12N2O3 (232.24). The structural formula is as follows. Each Phenobarbital Tablet, USP contains 15 mg, 30 mg, 60 mg or 100 mg of phenobarbital, USP. Inactive ingredients include: colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and magnesium stearate."
},
{
"NDCCode": "70752-171-11",
"PackageDescription": "1000 TABLET in 1 BOTTLE (70752-171-11) ",
"NDC11Code": "70752-0171-11",
"ProductNDC": "70752-171",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propylthiouracil",
"NonProprietaryName": "Propylthiouracil",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210318",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA080154",
"LabelerName": "QUAGEN PHARMACEUTICALS LLC",
"SubstanceName": "PROPYLTHIOURACIL",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Thyroid Hormone Synthesis Inhibitor [EPC], Thyroid Hormone Synthesis Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-02-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210318",
"SamplePackage": "N",
"IndicationAndUsage": "Propylthiouracil is indicated: 1 in patients with Graves’ disease with hyperthyroidism or toxic multinodular goiter who are intolerant of methimazole and for whom surgery or radioactive iodine therapy is not an appropriate treatment option., 2 to ameliorate symptoms of hyperthyroidism in preparation for thyroidectomy or radioactive iodine therapy in patients who are intolerant of methimazole.",
"Description": "Propylthiouracil is one of the thiocarbamide compounds. It is a white, crystalline substance that has a bitter taste and is very slightly soluble in water. Propylthiouracil is an antithyroid drug administered orally. The structural formula is. Each tablet contains propylthiouracil 50 mg and the following inactive ingredients: anhydrous lactose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium starch glycolate."
},
{
"NDCCode": "70752-204-11",
"PackageDescription": "1000 TABLET in 1 BOTTLE (70752-204-11) ",
"NDC11Code": "70752-0204-11",
"ProductNDC": "70752-204",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Folic Acid",
"NonProprietaryName": "Folic Acid",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230710",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091145",
"LabelerName": "QUAGEN PHARMACEUTICALS LLC",
"SubstanceName": "FOLIC ACID",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2025-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20230710",
"SamplePackage": "N",
"IndicationAndUsage": "Folic acid is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, or childhood.",
"Description": "Folic acid, N-[ p-[[(2-amino-4-hydroxy-6-pteridinyl) methyl]-amino]benzoyl]-L-glutamic acid, is a B complex vitamin containing a pteridine moiety linked by a methylene bridge to para-aminobenzoic acid, which is joined by a peptide linkage to glutamic acid. Conjugates of folic acid are present in a wide variety of foods, particularly liver, kidneys, yeast, and leafy green vegetables. Commercially available folic acid is prepared synthetically. Folic acid occurs as a yellow or yellowish-orange crystalline powder and is very slightly soluble in water and insoluble in alcohol. Folic acid is readily soluble in dilute solutions of alkali hydroxides and carbonates, and solutions of the drug may be prepared with the aid of sodium hydroxide or sodium carbonate, thereby forming the soluble sodium salt of folic acid (sodium folate). Aqueous solutions of folic acid are heat sensitive and rapidly decompose in the presence of light and/or riboflavin; solutions should be stored in a cool place protected from light. The structural formula of folic acid is as follows. Each tablet, for oral administration, contains 1 mg folic acid. Folic Acid Tablets, USP 1 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and magnesium stearate."
},
{
"NDCCode": "70752-231-11",
"PackageDescription": "1000 TABLET in 1 BOTTLE (70752-231-11) ",
"NDC11Code": "70752-0231-11",
"ProductNDC": "70752-231",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Folic Acid",
"NonProprietaryName": "Folic Acid",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230710",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091145",
"LabelerName": "QUAGEN PHARMACEUTICALS LLC",
"SubstanceName": "FOLIC ACID",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-05-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230710",
"SamplePackage": "N",
"IndicationAndUsage": "Folic acid is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, or childhood.",
"Description": "Folic acid, N-[ p-[[(2-amino-4-hydroxy-6-pteridinyl) methyl]-amino]benzoyl]-L-glutamic acid, is a B complex vitamin containing a pteridine moiety linked by a methylene bridge to para-aminobenzoic acid, which is joined by a peptide linkage to glutamic acid. Conjugates of folic acid are present in a wide variety of foods, particularly liver, kidneys, yeast, and leafy green vegetables. Commercially available folic acid is prepared synthetically. Folic acid occurs as a yellow or yellowish-orange crystalline powder and is very slightly soluble in water and insoluble in alcohol. Folic acid is readily soluble in dilute solutions of alkali hydroxides and carbonates, and solutions of the drug may be prepared with the aid of sodium hydroxide or sodium carbonate, thereby forming the soluble sodium salt of folic acid (sodium folate). Aqueous solutions of folic acid are heat sensitive and rapidly decompose in the presence of light and/or riboflavin; solutions should be stored in a cool place protected from light. The structural formula of folic acid is as follows. Each tablet, for oral administration, contains 1 mg folic acid. Folic Acid Tablets, USP 1 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and magnesium stearate."
},
{
"NDCCode": "70752-123-10",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (70752-123-10) ",
"NDC11Code": "70752-0123-10",
"ProductNDC": "70752-123",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benztropine Mesylate",
"NonProprietaryName": "Benztropine Mesylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250811",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212694",
"LabelerName": "QUAGEN PHARMACEUTICALS LLC",
"SubstanceName": "BENZTROPINE MESYLATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC], Antihistamine [EPC], Cholinergic Antagonists [MoA], Histamine Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-08-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250811",
"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, USP is a synthetic compound containing structural features found in atropine and diphenhydramine. It is a crystalline white powder, very soluble in water, designated as 3α- (Diphenylmethoxy)-1αH, 5αH-tropane methanesulfonate, with the following structural formula. Each benztropine mesylate tablet, USP for oral administration contains benztropine mesylate 0.5 mg, 1 mg or 2 mg. Each tablet contains the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, magnesium stearate."
},
{
"NDCCode": "70752-124-10",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (70752-124-10) ",
"NDC11Code": "70752-0124-10",
"ProductNDC": "70752-124",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benztropine Mesylate",
"NonProprietaryName": "Benztropine Mesylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250811",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212694",
"LabelerName": "QUAGEN PHARMACEUTICALS LLC",
"SubstanceName": "BENZTROPINE MESYLATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC], Antihistamine [EPC], Cholinergic Antagonists [MoA], Histamine Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-08-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250811",
"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, USP is a synthetic compound containing structural features found in atropine and diphenhydramine. It is a crystalline white powder, very soluble in water, designated as 3α- (Diphenylmethoxy)-1αH, 5αH-tropane methanesulfonate, with the following structural formula. Each benztropine mesylate tablet, USP for oral administration contains benztropine mesylate 0.5 mg, 1 mg or 2 mg. Each tablet contains the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, magnesium stearate."
},
{
"NDCCode": "70752-125-10",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (70752-125-10) ",
"NDC11Code": "70752-0125-10",
"ProductNDC": "70752-125",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benztropine Mesylate",
"NonProprietaryName": "Benztropine Mesylate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250811",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212694",
"LabelerName": "QUAGEN PHARMACEUTICALS LLC",
"SubstanceName": "BENZTROPINE MESYLATE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC], Antihistamine [EPC], Cholinergic Antagonists [MoA], Histamine Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-08-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250811",
"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, USP is a synthetic compound containing structural features found in atropine and diphenhydramine. It is a crystalline white powder, very soluble in water, designated as 3α- (Diphenylmethoxy)-1αH, 5αH-tropane methanesulfonate, with the following structural formula. Each benztropine mesylate tablet, USP for oral administration contains benztropine mesylate 0.5 mg, 1 mg or 2 mg. Each tablet contains the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, magnesium stearate."
},
{
"NDCCode": "70752-154-05",
"PackageDescription": "1 BOTTLE in 1 CARTON (70752-154-05) / 60 mL in 1 BOTTLE",
"NDC11Code": "70752-0154-05",
"ProductNDC": "70752-154",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluocinonide",
"NonProprietaryName": "Fluocinonide",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250315",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216389",
"LabelerName": "QUAGEN PHARMACEUTICALS LLC",
"SubstanceName": "FLUOCINONIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250315",
"SamplePackage": "N",
"IndicationAndUsage": "Fluocinonide topical solution USP, 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Fluocinonide topical solution USP, 0.05% is intended for topical administration. The active component is the corticosteroid fluocinonide, which is the 21-acetate ester of fluocinolone acetonide and has the chemical name pregna-1,4-diene-3,20-dione,21-(acetyloxy)-6,9-difluoro-11-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(6α,11β,16α)-. It has the following chemical structure. Fluocinonide topical solution USP, 0.05% contains fluocinonide 0.5 mg/mL in a clear, colorless to pale yellow solution of alcohol (35%), citric acid anhydrous, diisopropyl adipate, and propylene glycol."
},
{
"NDCCode": "70752-156-06",
"PackageDescription": "1 BOTTLE in 1 CARTON (70752-156-06) / 118.28 mL in 1 BOTTLE",
"NDC11Code": "70752-0156-06",
"ProductNDC": "70752-156",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluocinolone Acetonide",
"NonProprietaryName": "Fluocinolone Acetonide",
"DosageFormName": "OIL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210402",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212760",
"LabelerName": "Quagen Pharmaceuticals LLC",
"SubstanceName": "FLUOCINOLONE ACETONIDE",
"StrengthNumber": ".11",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2023-02-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210402",
"SamplePackage": "N",
"IndicationAndUsage": "Fluocinolone acetonide topical oil, 0.01% is a corticosteroid indicated for the : 1 topical treatment of atopic dermatitis in adult patients (1.1), 2 topical treatment of moderato to severe atopic dermatitis in pediatric patients 3 months and older for up to 4 weeks (1.2).",
"Description": "Fluocinolone acetonide topical oil, 0.01% (body oil) contains fluocinolone acetonide [(6α, 11β, 16α)-6, 9-difluoro-11, 21-dihydroxy-16, 17 [(1-methylethylidene)bis(oxy)]-pregna-1,4-diene-3,20-dione, cyclic 16,17 acetal with acetone], a synthetic corticosteroid for topical dermatologic use. This formulation is also marketed as fluocinolone acetonide topical oil, 0.01% (scalp oil) for use with shower caps for treatment of scalp psoriasis in adults, and as fluocinolone acetonide oil, 0.01% (ear drops) for treatment of chronic eczematous external otitis. Chemically, fluocinolone acetonide is C24H30F2O6. It has the following structural formula. Fluocinolone acetonide has a molecular weight of 452.50. It is a white crystalline powder that is odorless, stable in light, and melts at 270°C with decomposition; soluble in alcohol, acetone and methanol; slightly soluble in chloroform; insoluble in water. Each gram of fluocinolone acetonide topical oil, 0.01% (body oil) contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2 and refined peanut oil NF. Fluocinolone acetonide topical oil, 0.01% (body oil) is formulated with 48% refined peanut oil NF."
},
{
"NDCCode": "70752-158-06",
"PackageDescription": "1 BOTTLE in 1 CARTON (70752-158-06) / 118.28 mL in 1 BOTTLE",
"NDC11Code": "70752-0158-06",
"ProductNDC": "70752-158",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluocinolone Acetonide",
"NonProprietaryName": "Fluocinolone Acetonide",
"DosageFormName": "OIL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210402",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212761",
"LabelerName": "Quagen Pharmaceuticals LLC",
"SubstanceName": "FLUOCINOLONE ACETONIDE",
"StrengthNumber": ".11",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2023-02-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210402",
"SamplePackage": "N",
"IndicationAndUsage": "Fluocinolone acetonide topical oil, 0.01% is a low to medium potency corticosteroid indicated:. In adult patients for the treatment of psoriasis of the scalp (scalp oil).",
"Description": "Fluocinolone acetonide topical oil, 0.01% (scalp oil) contains fluocinolone acetonide {(6α, 11β, 16α)-6,9-difluoro-11,21-dihydroxy-16,17[(1-methylethylidene)bis(oxy)]-pregna-1,4-diene-3,20-dione, cyclic 16,17 acetal with acetone}, a synthetic corticosteroid for topical dermatologic use. This formulation is also marketed as fluocinolone acetonide topical oil, 0.01% (body oil) for use as body oil for atopic dermatitis in adults and for moderate to severe atopic dermatitis in pediatric patients 2 years and older, and as fluocinolone acetonide oil, 0.01% (ear drops) for chronic eczematous external otitis. Chemically, fluocinolone acetonide is C24H30F2O6. It has the following structural formula. Fluocinolone acetonide has a molecular weight of 452.50. It is a white crystalline powder that is odorless, stable in light, and melts at 270°C with decomposition; soluble in alcohol, acetone and methanol; slightly soluble in chloroform; insoluble in water. Each gram of fluocinolone acetonide topical oil, 0.01% (scalp oil) contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contain isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2 and refined peanut oil NF. Each packaged product contains 2 shower caps. The shower cap is made of low density polyethylene material with rubber elastic."
},
{
"NDCCode": "70752-159-20",
"PackageDescription": "1 BOTTLE in 1 CARTON (70752-159-20) / 20 mL in 1 BOTTLE",
"NDC11Code": "70752-0159-20",
"ProductNDC": "70752-159",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluocinolone Acetonide",
"NonProprietaryName": "Fluocinolone Acetonide",
"DosageFormName": "OIL",
"RouteName": "AURICULAR (OTIC)",
"StartMarketingDate": "20210402",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212762",
"LabelerName": "Quagen Pharmaceuticals LLC",
"SubstanceName": "FLUOCINOLONE ACETONIDE",
"StrengthNumber": ".11",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2023-02-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210402",
"SamplePackage": "N",
"IndicationAndUsage": "Fluocinolone acetonide oil, 0.01% is a low to medium potency corticosteroid indicated for the treatment of chronic eczematous external otitis in adults and pediatric patients 2 years and older.",
"Description": "Fluocinolone acetonide oil, 0.01% (ear drops) contain fluocinolone acetonide {(6α, 11β, 16α)-6,9- difluoro-11,21-dihydroxy-16,17[(1-methylethylidene)bis(oxy)]-pregna-1,4-diene-3,20-dione, cyclic 16,17 acetal with acetone}, a synthetic corticosteroid. This formulation is also marketed as fluocinolone acetonide topical oil, 0.01% (body oil) for the treatment of atopic dermatitis and fluocinolone acetonide topical oil, 0.01% (scalp oil) for the treatment of psoriasis of scalp. Chemically, fluocinolone acetonide is C24H30F2O6. It has the following structural formula. Fluocinolone acetonide has a molecular weight of 452.50. It is a white crystalline powder that is odorless, stable in light, and melts at 270°C with decomposition; soluble in alcohol, acetone and methanol; slightly soluble in chloroform; insoluble in water. Each gram of fluocinolone acetonide oil, 0.01% (ear drops) contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2 and refined peanut oil NF."
}
]
}
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<ProductNDC>70752-166</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phenobarbital</ProprietaryName>
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<DEASchedule>CIV</DEASchedule>
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<IndicationAndUsage>Phenobarbital Tablets, USP are indicated for use as a sedative or anticonvulsant.</IndicationAndUsage>
<Description>Phenobarbital is a barbituric acid derivative for oral administration and occurs as a white, odorless, slightly bitter powder that is soluble in chloroform, freely soluble in alcohol or ether, and slightly soluble in water. Its saturated solution has a pH of about 5.6. Chemically, it is 5-ethyl-5- phenylbarbituric acid with the molecular formula C12H12N2O3 (232.24). The structural formula is as follows. Each Phenobarbital Tablet, USP contains 15 mg, 30 mg, 60 mg or 100 mg of phenobarbital, USP. Inactive ingredients include: colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and magnesium stearate.</Description>
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<IndicationAndUsage>Phenobarbital Tablets, USP are indicated for use as a sedative or anticonvulsant.</IndicationAndUsage>
<Description>Phenobarbital is a barbituric acid derivative for oral administration and occurs as a white, odorless, slightly bitter powder that is soluble in chloroform, freely soluble in alcohol or ether, and slightly soluble in water. Its saturated solution has a pH of about 5.6. Chemically, it is 5-ethyl-5- phenylbarbituric acid with the molecular formula C12H12N2O3 (232.24). The structural formula is as follows. Each Phenobarbital Tablet, USP contains 15 mg, 30 mg, 60 mg or 100 mg of phenobarbital, USP. Inactive ingredients include: colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and magnesium stearate.</Description>
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<PackageDescription>500 TABLET in 1 BOTTLE (70752-166-14) </PackageDescription>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200930</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>QUAGEN PHARMACEUTICALS LLC</LabelerName>
<SubstanceName>PHENOBARBITAL</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2023-02-18</LastUpdate>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Phenobarbital Tablets, USP are indicated for use as a sedative or anticonvulsant.</IndicationAndUsage>
<Description>Phenobarbital is a barbituric acid derivative for oral administration and occurs as a white, odorless, slightly bitter powder that is soluble in chloroform, freely soluble in alcohol or ether, and slightly soluble in water. Its saturated solution has a pH of about 5.6. Chemically, it is 5-ethyl-5- phenylbarbituric acid with the molecular formula C12H12N2O3 (232.24). The structural formula is as follows. Each Phenobarbital Tablet, USP contains 15 mg, 30 mg, 60 mg or 100 mg of phenobarbital, USP. Inactive ingredients include: colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>50268-166-12</NDCCode>
<PackageDescription>20 BLISTER PACK in 1 BOX (50268-166-12) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-166-11) </PackageDescription>
<NDC11Code>50268-0166-12</NDC11Code>
<ProductNDC>50268-166</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Chlorpromazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Chlorpromazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200214</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209755</ApplicationNumber>
<LabelerName>AvPAK</LabelerName>
<SubstanceName>CHLORPROMAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phenothiazine [EPC], Phenothiazines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the management of manifestations of psychotic disorders. For the treatment of schizophrenia. To control nausea and vomiting. For relief of restlessness and apprehension before surgery. For acute intermittent porphyria. As an adjunct in the treatment of tetanus. To control the manifestations of the manic type of manic-depressive illness. For relief of intractable hiccups. For the treatment of severe behavioral problems in children (1 to 12 years of age) marked by combativeness and/or explosive hyperexcitable behavior (out of proportion to immediate provocations), and in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability and poor frustration tolerance.</IndicationAndUsage>
<Description>Chlorpromazine hydrochloride, a dimethylamine derivative of phenothiazine, has a chemical formula of 2-chloro-10-[3-(dimethylamino) propyl] phenothiazine monohydrochloride. It is available in tablets for oral administration. It has the following structural formula. Chlorpromazine hydrochloride, USP is a white to almost white crystalline powder. It is very soluble in water, freely soluble in ethanol (96%). Each tablet for oral administration contains 10 mg, 25 mg, 50 mg, 100 mg, or 200 mg of chlorpromazine hydrochloride, USP. Inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, sodium lauryl sulfate and titanium dioxide. Each tablet is imprinted with black pharmaceutical ink which contains: ammonium hydroxide, ferrosoferric oxide, isopropyl alcohol, N-butyl alcohol, propylene glycol and shellac.</Description>
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<NDC>
<NDCCode>68084-166-01</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (68084-166-01) > 10 TABLET in 1 BLISTER PACK (68084-166-11)</PackageDescription>
<NDC11Code>68084-0166-01</NDC11Code>
<ProductNDC>68084-166</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bethanechol Chloride</ProprietaryName>
<NonProprietaryName>Bethanechol Chloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070220</StartMarketingDate>
<EndMarketingDate>20160430</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040533</ApplicationNumber>
<LabelerName>American Health Packaging</LabelerName>
<SubstanceName>BETHANECHOL CHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
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<NDC>
<NDCCode>71052-166-11</NDCCode>
<PackageDescription>1000 g in 1 CONTAINER (71052-166-11) </PackageDescription>
<NDC11Code>71052-0166-11</NDC11Code>
<ProductNDC>71052-166</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Tranexamic Acid</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20200514</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>DARMERICA, LLC</LabelerName>
<SubstanceName>TRANEXAMIC ACID</SubstanceName>
<StrengthNumber>10000</StrengthNumber>
<StrengthUnit>g/10000g</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-03-26</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>12-OCT-20</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>72205-166-99</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (72205-166-99) / 10 TABLET, FILM COATED in 1 BLISTER PACK (72205-166-11) </PackageDescription>
<NDC11Code>72205-0166-99</NDC11Code>
<ProductNDC>72205-166</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olmesartan Medoxomil</ProprietaryName>
<NonProprietaryName>Olmesartan Medoxomil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230118</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217399</ApplicationNumber>
<LabelerName>Novadoz Pharmaceuticals LLC</LabelerName>
<SubstanceName>OLMESARTAN MEDOXOMIL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-02-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231218</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olmesartan medoxomil tablets are indicated for the treatment of hypertension in adults and children six years of age and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. It may be used alone or in combination with other antihypertensive agents.</IndicationAndUsage>
<Description>Olmesartan medoxomil tablets USP, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract. Olmesartan is a selective AT1 subtype angiotensin II receptor antagonist. Olmesartan medoxomil tablets, USP is described chemically as 1H-imidazole-5-carboxylic acid, 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[[2'-(1H-tetrazol-5-yl) [1, 1’-biphenyl]-4-yl] methyl]-, (5-methyl-2-oxo-1, 3-dioxol-4-yl) methyl ester. Its molecular formula is C29H30N6O6 and its structural formula is. Olmesartan medoxomil USP, is a white to off-white, crystalline powder with a molecular weight of 558.59. It is sparingly soluble in methanol and practically insoluble in water. Olmesartan medoxomil USP is available for oral use as film-coated tablets containing 5 mg, 20 mg, or 40 mg of olmesartan medoxomil and the following inactive ingredients: hydroxypropyl cellulose, hypromellose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide, and (5 mg only) yellow iron oxide. Meets USP Dissolution Test 7.</Description>
</NDC>
<NDC>
<NDCCode>70752-107-11</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE, PLASTIC (70752-107-11) </PackageDescription>
<NDC11Code>70752-0107-11</NDC11Code>
<ProductNDC>70752-107</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyproheptadine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cyproheptadine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210224</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212491</ApplicationNumber>
<LabelerName>QUAGEN PHARMACEUTICALS LLC</LabelerName>
<SubstanceName>CYPROHEPTADINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-07-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210224</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Perennial and seasonal allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma. Cold urticaria. Dermatographism. As therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled.</IndicationAndUsage>
<Description>Cyproheptadine HCl USP, is an antihistaminic and antiserotonergic agent. Cyproheptadine hydrochloride USP is a white to slightly yellowish crystalline solid, with a molecular weight of 350.89, which is soluble in water, freely soluble in methanol, sparingly soluble in ethanol, soluble in chloroform, and practically insoluble in ether. It is the sesquihydrate of 4-(5H-dibenzo[a,d]cyclohepten-5-ylidene)-1-methylpiperidine hydrochloride. The molecular formula of the anhydrous salt is C21H21NHCl and the structural formula of the anhydrous salt is. Cyproheptadine hydrochloride USP is available for oral administration in 4 mg tablets. Inactive ingredients include: lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>70752-108-11</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE, PLASTIC (70752-108-11) </PackageDescription>
<NDC11Code>70752-0108-11</NDC11Code>
<ProductNDC>70752-108</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glycopyrrolate</ProprietaryName>
<NonProprietaryName>Glycopyrrolate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241010</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212696</ApplicationNumber>
<LabelerName>QUAGEN PHARMACEUTICALS LLC</LabelerName>
<SubstanceName>GLYCOPYRROLATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241010</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Glycopyrrolate tablets are indicated in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer. Limitations of Use. Glycopyrrolate tablets are not indicated as monotherapy for the treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established.</IndicationAndUsage>
<Description>Glycopyrrolate tablets USP for oral use contain synthetic anticholinergic glycopyrrolate. Glycopyrrolate is a quaternary ammonium compound with the following chemical name: 3-[(cyclopentyl hydroxyphenylacetyl)oxy]-1,1-dimethylpyrrolidinium bromide. The molecular formula for glycopyrrolate is C19H28BrNO3, the molecular weight is 398.3 g/mol, and the structural formula is. Each Glycopyrrolate tablet USP for oral use contains glycopyrrolate, USP 1 mg, or 2 mg as the active ingredient. The inactive ingredients are dibasic calcium phosphate, lactose monohydrate, magnesium stearate, povidone, and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>70752-109-11</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE, PLASTIC (70752-109-11) </PackageDescription>
<NDC11Code>70752-0109-11</NDC11Code>
<ProductNDC>70752-109</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glycopyrrolate</ProprietaryName>
<NonProprietaryName>Glycopyrrolate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241010</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212696</ApplicationNumber>
<LabelerName>QUAGEN PHARMACEUTICALS LLC</LabelerName>
<SubstanceName>GLYCOPYRROLATE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241010</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Glycopyrrolate tablets are indicated in adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer. Limitations of Use. Glycopyrrolate tablets are not indicated as monotherapy for the treatment of peptic ulcer because effectiveness in peptic ulcer healing has not been established.</IndicationAndUsage>
<Description>Glycopyrrolate tablets USP for oral use contain synthetic anticholinergic glycopyrrolate. Glycopyrrolate is a quaternary ammonium compound with the following chemical name: 3-[(cyclopentyl hydroxyphenylacetyl)oxy]-1,1-dimethylpyrrolidinium bromide. The molecular formula for glycopyrrolate is C19H28BrNO3, the molecular weight is 398.3 g/mol, and the structural formula is. Each Glycopyrrolate tablet USP for oral use contains glycopyrrolate, USP 1 mg, or 2 mg as the active ingredient. The inactive ingredients are dibasic calcium phosphate, lactose monohydrate, magnesium stearate, povidone, and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>70752-123-11</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE, PLASTIC (70752-123-11) </PackageDescription>
<NDC11Code>70752-0123-11</NDC11Code>
<ProductNDC>70752-123</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benztropine Mesylate</ProprietaryName>
<NonProprietaryName>Benztropine Mesylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250811</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212694</ApplicationNumber>
<LabelerName>QUAGEN PHARMACEUTICALS LLC</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>2025-08-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250811</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, USP is a synthetic compound containing structural features found in atropine and diphenhydramine. It is a crystalline white powder, very soluble in water, designated as 3α- (Diphenylmethoxy)-1αH, 5αH-tropane methanesulfonate, with the following structural formula. Each benztropine mesylate tablet, USP for oral administration contains benztropine mesylate 0.5 mg, 1 mg or 2 mg. Each tablet contains the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>70752-124-11</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE, PLASTIC (70752-124-11) </PackageDescription>
<NDC11Code>70752-0124-11</NDC11Code>
<ProductNDC>70752-124</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benztropine Mesylate</ProprietaryName>
<NonProprietaryName>Benztropine Mesylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250811</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212694</ApplicationNumber>
<LabelerName>QUAGEN PHARMACEUTICALS LLC</LabelerName>
<SubstanceName>BENZTROPINE MESYLATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Antihistamine [EPC], Cholinergic Antagonists [MoA], Histamine Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250811</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, USP is a synthetic compound containing structural features found in atropine and diphenhydramine. It is a crystalline white powder, very soluble in water, designated as 3α- (Diphenylmethoxy)-1αH, 5αH-tropane methanesulfonate, with the following structural formula. Each benztropine mesylate tablet, USP for oral administration contains benztropine mesylate 0.5 mg, 1 mg or 2 mg. Each tablet contains the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>70752-125-11</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE, PLASTIC (70752-125-11) </PackageDescription>
<NDC11Code>70752-0125-11</NDC11Code>
<ProductNDC>70752-125</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benztropine Mesylate</ProprietaryName>
<NonProprietaryName>Benztropine Mesylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250811</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212694</ApplicationNumber>
<LabelerName>QUAGEN PHARMACEUTICALS LLC</LabelerName>
<SubstanceName>BENZTROPINE MESYLATE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Antihistamine [EPC], Cholinergic Antagonists [MoA], Histamine Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250811</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, USP is a synthetic compound containing structural features found in atropine and diphenhydramine. It is a crystalline white powder, very soluble in water, designated as 3α- (Diphenylmethoxy)-1αH, 5αH-tropane methanesulfonate, with the following structural formula. Each benztropine mesylate tablet, USP for oral administration contains benztropine mesylate 0.5 mg, 1 mg or 2 mg. Each tablet contains the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>70752-161-11</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (70752-161-11) </PackageDescription>
<NDC11Code>70752-0161-11</NDC11Code>
<ProductNDC>70752-161</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phenobarbital</ProprietaryName>
<NonProprietaryName>Phenobarbital</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200915</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>QUAGEN PHARMACEUTICALS LLC</LabelerName>
<SubstanceName>PHENOBARBITAL</SubstanceName>
<StrengthNumber>16.2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2023-02-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sedative. Anticonvulsant – For the treatment of generalized and partial seizures.</IndicationAndUsage>
<Description>The barbiturates are nonselective central nervous system (CNS) depressants that are primarily used as sedative-hypnotics. In subhypnotic doses, they are also used as anticonvulsants. The barbiturates and their sodium salts are subject to control under the Federal Controlled Substances Act. Phenobarbital is a barbituric acid derivative and occurs as white, odorless, small crystals or crystalline powder that is very slightly soluble in water; soluble in alcohol, in ether, and in solutions of fixed alkali hydroxides and carbonates; sparingly soluble in chloroform. Phenobarbital is 5-ethyl-5- phenylbarbituric acid. Phenobarbital is a substituted pyrimidine derivative in which the basic structure is barbituric acid, a substance that has no CNS activity. CNS activity is obtained by substituting alkyl, alkenyl, or aryl groups on the pyrimidine ring. It has the following structural formula. C12H12N2O3 M.W. = 232.24. Each phenobarbital tablet contains 16.2 mg, 32.4 mg, 64.8 mg, or 97.2 mg of phenobarbital, USP. Inactive ingredients include: colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>70752-162-11</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (70752-162-11) </PackageDescription>
<NDC11Code>70752-0162-11</NDC11Code>
<ProductNDC>70752-162</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phenobarbital</ProprietaryName>
<NonProprietaryName>Phenobarbital</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200915</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>QUAGEN PHARMACEUTICALS LLC</LabelerName>
<SubstanceName>PHENOBARBITAL</SubstanceName>
<StrengthNumber>32.4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2023-02-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sedative. Anticonvulsant – For the treatment of generalized and partial seizures.</IndicationAndUsage>
<Description>The barbiturates are nonselective central nervous system (CNS) depressants that are primarily used as sedative-hypnotics. In subhypnotic doses, they are also used as anticonvulsants. The barbiturates and their sodium salts are subject to control under the Federal Controlled Substances Act. Phenobarbital is a barbituric acid derivative and occurs as white, odorless, small crystals or crystalline powder that is very slightly soluble in water; soluble in alcohol, in ether, and in solutions of fixed alkali hydroxides and carbonates; sparingly soluble in chloroform. Phenobarbital is 5-ethyl-5- phenylbarbituric acid. Phenobarbital is a substituted pyrimidine derivative in which the basic structure is barbituric acid, a substance that has no CNS activity. CNS activity is obtained by substituting alkyl, alkenyl, or aryl groups on the pyrimidine ring. It has the following structural formula. C12H12N2O3 M.W. = 232.24. Each phenobarbital tablet contains 16.2 mg, 32.4 mg, 64.8 mg, or 97.2 mg of phenobarbital, USP. Inactive ingredients include: colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>70752-163-11</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (70752-163-11) </PackageDescription>
<NDC11Code>70752-0163-11</NDC11Code>
<ProductNDC>70752-163</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phenobarbital</ProprietaryName>
<NonProprietaryName>Phenobarbital</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200915</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>QUAGEN PHARMACEUTICALS LLC</LabelerName>
<SubstanceName>PHENOBARBITAL</SubstanceName>
<StrengthNumber>64.8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2023-02-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sedative. Anticonvulsant – For the treatment of generalized and partial seizures.</IndicationAndUsage>
<Description>The barbiturates are nonselective central nervous system (CNS) depressants that are primarily used as sedative-hypnotics. In subhypnotic doses, they are also used as anticonvulsants. The barbiturates and their sodium salts are subject to control under the Federal Controlled Substances Act. Phenobarbital is a barbituric acid derivative and occurs as white, odorless, small crystals or crystalline powder that is very slightly soluble in water; soluble in alcohol, in ether, and in solutions of fixed alkali hydroxides and carbonates; sparingly soluble in chloroform. Phenobarbital is 5-ethyl-5- phenylbarbituric acid. Phenobarbital is a substituted pyrimidine derivative in which the basic structure is barbituric acid, a substance that has no CNS activity. CNS activity is obtained by substituting alkyl, alkenyl, or aryl groups on the pyrimidine ring. It has the following structural formula. C12H12N2O3 M.W. = 232.24. Each phenobarbital tablet contains 16.2 mg, 32.4 mg, 64.8 mg, or 97.2 mg of phenobarbital, USP. Inactive ingredients include: colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>70752-164-11</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (70752-164-11) </PackageDescription>
<NDC11Code>70752-0164-11</NDC11Code>
<ProductNDC>70752-164</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phenobarbital</ProprietaryName>
<NonProprietaryName>Phenobarbital</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200915</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>QUAGEN PHARMACEUTICALS LLC</LabelerName>
<SubstanceName>PHENOBARBITAL</SubstanceName>
<StrengthNumber>97.2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2023-02-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sedative. Anticonvulsant – For the treatment of generalized and partial seizures.</IndicationAndUsage>
<Description>The barbiturates are nonselective central nervous system (CNS) depressants that are primarily used as sedative-hypnotics. In subhypnotic doses, they are also used as anticonvulsants. The barbiturates and their sodium salts are subject to control under the Federal Controlled Substances Act. Phenobarbital is a barbituric acid derivative and occurs as white, odorless, small crystals or crystalline powder that is very slightly soluble in water; soluble in alcohol, in ether, and in solutions of fixed alkali hydroxides and carbonates; sparingly soluble in chloroform. Phenobarbital is 5-ethyl-5- phenylbarbituric acid. Phenobarbital is a substituted pyrimidine derivative in which the basic structure is barbituric acid, a substance that has no CNS activity. CNS activity is obtained by substituting alkyl, alkenyl, or aryl groups on the pyrimidine ring. It has the following structural formula. C12H12N2O3 M.W. = 232.24. Each phenobarbital tablet contains 16.2 mg, 32.4 mg, 64.8 mg, or 97.2 mg of phenobarbital, USP. Inactive ingredients include: colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>70752-165-11</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (70752-165-11) </PackageDescription>
<NDC11Code>70752-0165-11</NDC11Code>
<ProductNDC>70752-165</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phenobarbital</ProprietaryName>
<NonProprietaryName>Phenobarbital</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200930</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>QUAGEN PHARMACEUTICALS LLC</LabelerName>
<SubstanceName>PHENOBARBITAL</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2023-02-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Phenobarbital Tablets, USP are indicated for use as a sedative or anticonvulsant.</IndicationAndUsage>
<Description>Phenobarbital is a barbituric acid derivative for oral administration and occurs as a white, odorless, slightly bitter powder that is soluble in chloroform, freely soluble in alcohol or ether, and slightly soluble in water. Its saturated solution has a pH of about 5.6. Chemically, it is 5-ethyl-5- phenylbarbituric acid with the molecular formula C12H12N2O3 (232.24). The structural formula is as follows. Each Phenobarbital Tablet, USP contains 15 mg, 30 mg, 60 mg or 100 mg of phenobarbital, USP. Inactive ingredients include: colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>70752-167-11</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (70752-167-11) </PackageDescription>
<NDC11Code>70752-0167-11</NDC11Code>
<ProductNDC>70752-167</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phenobarbital</ProprietaryName>
<NonProprietaryName>Phenobarbital</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200930</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>QUAGEN PHARMACEUTICALS LLC</LabelerName>
<SubstanceName>PHENOBARBITAL</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2023-02-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Phenobarbital Tablets, USP are indicated for use as a sedative or anticonvulsant.</IndicationAndUsage>
<Description>Phenobarbital is a barbituric acid derivative for oral administration and occurs as a white, odorless, slightly bitter powder that is soluble in chloroform, freely soluble in alcohol or ether, and slightly soluble in water. Its saturated solution has a pH of about 5.6. Chemically, it is 5-ethyl-5- phenylbarbituric acid with the molecular formula C12H12N2O3 (232.24). The structural formula is as follows. Each Phenobarbital Tablet, USP contains 15 mg, 30 mg, 60 mg or 100 mg of phenobarbital, USP. Inactive ingredients include: colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>70752-168-11</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (70752-168-11) </PackageDescription>
<NDC11Code>70752-0168-11</NDC11Code>
<ProductNDC>70752-168</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phenobarbital</ProprietaryName>
<NonProprietaryName>Phenobarbital</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200930</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>QUAGEN PHARMACEUTICALS LLC</LabelerName>
<SubstanceName>PHENOBARBITAL</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2023-02-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Phenobarbital Tablets, USP are indicated for use as a sedative or anticonvulsant.</IndicationAndUsage>
<Description>Phenobarbital is a barbituric acid derivative for oral administration and occurs as a white, odorless, slightly bitter powder that is soluble in chloroform, freely soluble in alcohol or ether, and slightly soluble in water. Its saturated solution has a pH of about 5.6. Chemically, it is 5-ethyl-5- phenylbarbituric acid with the molecular formula C12H12N2O3 (232.24). The structural formula is as follows. Each Phenobarbital Tablet, USP contains 15 mg, 30 mg, 60 mg or 100 mg of phenobarbital, USP. Inactive ingredients include: colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>70752-171-11</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (70752-171-11) </PackageDescription>
<NDC11Code>70752-0171-11</NDC11Code>
<ProductNDC>70752-171</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propylthiouracil</ProprietaryName>
<NonProprietaryName>Propylthiouracil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210318</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA080154</ApplicationNumber>
<LabelerName>QUAGEN PHARMACEUTICALS LLC</LabelerName>
<SubstanceName>PROPYLTHIOURACIL</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Thyroid Hormone Synthesis Inhibitor [EPC], Thyroid Hormone Synthesis Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-02-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210318</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Propylthiouracil is indicated: 1 in patients with Graves’ disease with hyperthyroidism or toxic multinodular goiter who are intolerant of methimazole and for whom surgery or radioactive iodine therapy is not an appropriate treatment option., 2 to ameliorate symptoms of hyperthyroidism in preparation for thyroidectomy or radioactive iodine therapy in patients who are intolerant of methimazole.</IndicationAndUsage>
<Description>Propylthiouracil is one of the thiocarbamide compounds. It is a white, crystalline substance that has a bitter taste and is very slightly soluble in water. Propylthiouracil is an antithyroid drug administered orally. The structural formula is. Each tablet contains propylthiouracil 50 mg and the following inactive ingredients: anhydrous lactose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>70752-204-11</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (70752-204-11) </PackageDescription>
<NDC11Code>70752-0204-11</NDC11Code>
<ProductNDC>70752-204</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Folic Acid</ProprietaryName>
<NonProprietaryName>Folic Acid</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230710</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091145</ApplicationNumber>
<LabelerName>QUAGEN PHARMACEUTICALS LLC</LabelerName>
<SubstanceName>FOLIC ACID</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-06-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230710</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Folic acid is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, or childhood.</IndicationAndUsage>
<Description>Folic acid, N-[ p-[[(2-amino-4-hydroxy-6-pteridinyl) methyl]-amino]benzoyl]-L-glutamic acid, is a B complex vitamin containing a pteridine moiety linked by a methylene bridge to para-aminobenzoic acid, which is joined by a peptide linkage to glutamic acid. Conjugates of folic acid are present in a wide variety of foods, particularly liver, kidneys, yeast, and leafy green vegetables. Commercially available folic acid is prepared synthetically. Folic acid occurs as a yellow or yellowish-orange crystalline powder and is very slightly soluble in water and insoluble in alcohol. Folic acid is readily soluble in dilute solutions of alkali hydroxides and carbonates, and solutions of the drug may be prepared with the aid of sodium hydroxide or sodium carbonate, thereby forming the soluble sodium salt of folic acid (sodium folate). Aqueous solutions of folic acid are heat sensitive and rapidly decompose in the presence of light and/or riboflavin; solutions should be stored in a cool place protected from light. The structural formula of folic acid is as follows. Each tablet, for oral administration, contains 1 mg folic acid. Folic Acid Tablets, USP 1 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>70752-231-11</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (70752-231-11) </PackageDescription>
<NDC11Code>70752-0231-11</NDC11Code>
<ProductNDC>70752-231</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Folic Acid</ProprietaryName>
<NonProprietaryName>Folic Acid</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230710</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091145</ApplicationNumber>
<LabelerName>QUAGEN PHARMACEUTICALS LLC</LabelerName>
<SubstanceName>FOLIC ACID</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-05-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230710</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Folic acid is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, or childhood.</IndicationAndUsage>
<Description>Folic acid, N-[ p-[[(2-amino-4-hydroxy-6-pteridinyl) methyl]-amino]benzoyl]-L-glutamic acid, is a B complex vitamin containing a pteridine moiety linked by a methylene bridge to para-aminobenzoic acid, which is joined by a peptide linkage to glutamic acid. Conjugates of folic acid are present in a wide variety of foods, particularly liver, kidneys, yeast, and leafy green vegetables. Commercially available folic acid is prepared synthetically. Folic acid occurs as a yellow or yellowish-orange crystalline powder and is very slightly soluble in water and insoluble in alcohol. Folic acid is readily soluble in dilute solutions of alkali hydroxides and carbonates, and solutions of the drug may be prepared with the aid of sodium hydroxide or sodium carbonate, thereby forming the soluble sodium salt of folic acid (sodium folate). Aqueous solutions of folic acid are heat sensitive and rapidly decompose in the presence of light and/or riboflavin; solutions should be stored in a cool place protected from light. The structural formula of folic acid is as follows. Each tablet, for oral administration, contains 1 mg folic acid. Folic Acid Tablets, USP 1 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>70752-123-10</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (70752-123-10) </PackageDescription>
<NDC11Code>70752-0123-10</NDC11Code>
<ProductNDC>70752-123</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benztropine Mesylate</ProprietaryName>
<NonProprietaryName>Benztropine Mesylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250811</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212694</ApplicationNumber>
<LabelerName>QUAGEN PHARMACEUTICALS LLC</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>2025-08-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250811</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, USP is a synthetic compound containing structural features found in atropine and diphenhydramine. It is a crystalline white powder, very soluble in water, designated as 3α- (Diphenylmethoxy)-1αH, 5αH-tropane methanesulfonate, with the following structural formula. Each benztropine mesylate tablet, USP for oral administration contains benztropine mesylate 0.5 mg, 1 mg or 2 mg. Each tablet contains the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>70752-124-10</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (70752-124-10) </PackageDescription>
<NDC11Code>70752-0124-10</NDC11Code>
<ProductNDC>70752-124</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benztropine Mesylate</ProprietaryName>
<NonProprietaryName>Benztropine Mesylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250811</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212694</ApplicationNumber>
<LabelerName>QUAGEN PHARMACEUTICALS LLC</LabelerName>
<SubstanceName>BENZTROPINE MESYLATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Antihistamine [EPC], Cholinergic Antagonists [MoA], Histamine Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250811</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, USP is a synthetic compound containing structural features found in atropine and diphenhydramine. It is a crystalline white powder, very soluble in water, designated as 3α- (Diphenylmethoxy)-1αH, 5αH-tropane methanesulfonate, with the following structural formula. Each benztropine mesylate tablet, USP for oral administration contains benztropine mesylate 0.5 mg, 1 mg or 2 mg. Each tablet contains the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>70752-125-10</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (70752-125-10) </PackageDescription>
<NDC11Code>70752-0125-10</NDC11Code>
<ProductNDC>70752-125</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benztropine Mesylate</ProprietaryName>
<NonProprietaryName>Benztropine Mesylate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250811</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212694</ApplicationNumber>
<LabelerName>QUAGEN PHARMACEUTICALS LLC</LabelerName>
<SubstanceName>BENZTROPINE MESYLATE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Antihistamine [EPC], Cholinergic Antagonists [MoA], Histamine Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250811</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, USP is a synthetic compound containing structural features found in atropine and diphenhydramine. It is a crystalline white powder, very soluble in water, designated as 3α- (Diphenylmethoxy)-1αH, 5αH-tropane methanesulfonate, with the following structural formula. Each benztropine mesylate tablet, USP for oral administration contains benztropine mesylate 0.5 mg, 1 mg or 2 mg. Each tablet contains the following inactive ingredients: microcrystalline cellulose, pregelatinized starch, magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>70752-154-05</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (70752-154-05) / 60 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>70752-0154-05</NDC11Code>
<ProductNDC>70752-154</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluocinonide</ProprietaryName>
<NonProprietaryName>Fluocinonide</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250315</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216389</ApplicationNumber>
<LabelerName>QUAGEN PHARMACEUTICALS LLC</LabelerName>
<SubstanceName>FLUOCINONIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250315</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluocinonide topical solution USP, 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Fluocinonide topical solution USP, 0.05% is intended for topical administration. The active component is the corticosteroid fluocinonide, which is the 21-acetate ester of fluocinolone acetonide and has the chemical name pregna-1,4-diene-3,20-dione,21-(acetyloxy)-6,9-difluoro-11-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(6α,11β,16α)-. It has the following chemical structure. Fluocinonide topical solution USP, 0.05% contains fluocinonide 0.5 mg/mL in a clear, colorless to pale yellow solution of alcohol (35%), citric acid anhydrous, diisopropyl adipate, and propylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>70752-156-06</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (70752-156-06) / 118.28 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>70752-0156-06</NDC11Code>
<ProductNDC>70752-156</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluocinolone Acetonide</ProprietaryName>
<NonProprietaryName>Fluocinolone Acetonide</NonProprietaryName>
<DosageFormName>OIL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210402</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212760</ApplicationNumber>
<LabelerName>Quagen Pharmaceuticals LLC</LabelerName>
<SubstanceName>FLUOCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>.11</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-02-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210402</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluocinolone acetonide topical oil, 0.01% is a corticosteroid indicated for the : 1 topical treatment of atopic dermatitis in adult patients (1.1), 2 topical treatment of moderato to severe atopic dermatitis in pediatric patients 3 months and older for up to 4 weeks (1.2).</IndicationAndUsage>
<Description>Fluocinolone acetonide topical oil, 0.01% (body oil) contains fluocinolone acetonide [(6α, 11β, 16α)-6, 9-difluoro-11, 21-dihydroxy-16, 17 [(1-methylethylidene)bis(oxy)]-pregna-1,4-diene-3,20-dione, cyclic 16,17 acetal with acetone], a synthetic corticosteroid for topical dermatologic use. This formulation is also marketed as fluocinolone acetonide topical oil, 0.01% (scalp oil) for use with shower caps for treatment of scalp psoriasis in adults, and as fluocinolone acetonide oil, 0.01% (ear drops) for treatment of chronic eczematous external otitis. Chemically, fluocinolone acetonide is C24H30F2O6. It has the following structural formula. Fluocinolone acetonide has a molecular weight of 452.50. It is a white crystalline powder that is odorless, stable in light, and melts at 270°C with decomposition; soluble in alcohol, acetone and methanol; slightly soluble in chloroform; insoluble in water. Each gram of fluocinolone acetonide topical oil, 0.01% (body oil) contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2 and refined peanut oil NF. Fluocinolone acetonide topical oil, 0.01% (body oil) is formulated with 48% refined peanut oil NF.</Description>
</NDC>
<NDC>
<NDCCode>70752-158-06</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (70752-158-06) / 118.28 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>70752-0158-06</NDC11Code>
<ProductNDC>70752-158</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluocinolone Acetonide</ProprietaryName>
<NonProprietaryName>Fluocinolone Acetonide</NonProprietaryName>
<DosageFormName>OIL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210402</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212761</ApplicationNumber>
<LabelerName>Quagen Pharmaceuticals LLC</LabelerName>
<SubstanceName>FLUOCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>.11</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-02-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210402</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluocinolone acetonide topical oil, 0.01% is a low to medium potency corticosteroid indicated:. In adult patients for the treatment of psoriasis of the scalp (scalp oil).</IndicationAndUsage>
<Description>Fluocinolone acetonide topical oil, 0.01% (scalp oil) contains fluocinolone acetonide {(6α, 11β, 16α)-6,9-difluoro-11,21-dihydroxy-16,17[(1-methylethylidene)bis(oxy)]-pregna-1,4-diene-3,20-dione, cyclic 16,17 acetal with acetone}, a synthetic corticosteroid for topical dermatologic use. This formulation is also marketed as fluocinolone acetonide topical oil, 0.01% (body oil) for use as body oil for atopic dermatitis in adults and for moderate to severe atopic dermatitis in pediatric patients 2 years and older, and as fluocinolone acetonide oil, 0.01% (ear drops) for chronic eczematous external otitis. Chemically, fluocinolone acetonide is C24H30F2O6. It has the following structural formula. Fluocinolone acetonide has a molecular weight of 452.50. It is a white crystalline powder that is odorless, stable in light, and melts at 270°C with decomposition; soluble in alcohol, acetone and methanol; slightly soluble in chloroform; insoluble in water. Each gram of fluocinolone acetonide topical oil, 0.01% (scalp oil) contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contain isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2 and refined peanut oil NF. Each packaged product contains 2 shower caps. The shower cap is made of low density polyethylene material with rubber elastic.</Description>
</NDC>
<NDC>
<NDCCode>70752-159-20</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (70752-159-20) / 20 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>70752-0159-20</NDC11Code>
<ProductNDC>70752-159</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluocinolone Acetonide</ProprietaryName>
<NonProprietaryName>Fluocinolone Acetonide</NonProprietaryName>
<DosageFormName>OIL</DosageFormName>
<RouteName>AURICULAR (OTIC)</RouteName>
<StartMarketingDate>20210402</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212762</ApplicationNumber>
<LabelerName>Quagen Pharmaceuticals LLC</LabelerName>
<SubstanceName>FLUOCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>.11</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-02-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210402</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluocinolone acetonide oil, 0.01% is a low to medium potency corticosteroid indicated for the treatment of chronic eczematous external otitis in adults and pediatric patients 2 years and older.</IndicationAndUsage>
<Description>Fluocinolone acetonide oil, 0.01% (ear drops) contain fluocinolone acetonide {(6α, 11β, 16α)-6,9- difluoro-11,21-dihydroxy-16,17[(1-methylethylidene)bis(oxy)]-pregna-1,4-diene-3,20-dione, cyclic 16,17 acetal with acetone}, a synthetic corticosteroid. This formulation is also marketed as fluocinolone acetonide topical oil, 0.01% (body oil) for the treatment of atopic dermatitis and fluocinolone acetonide topical oil, 0.01% (scalp oil) for the treatment of psoriasis of scalp. Chemically, fluocinolone acetonide is C24H30F2O6. It has the following structural formula. Fluocinolone acetonide has a molecular weight of 452.50. It is a white crystalline powder that is odorless, stable in light, and melts at 270°C with decomposition; soluble in alcohol, acetone and methanol; slightly soluble in chloroform; insoluble in water. Each gram of fluocinolone acetonide oil, 0.01% (ear drops) contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2 and refined peanut oil NF.</Description>
</NDC>
</NDCList>