{
"NDC": [
{
"NDCCode": "72789-431-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-431-60) ",
"NDC11Code": "72789-0431-60",
"ProductNDC": "72789-431",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carvedilol",
"NonProprietaryName": "Carvedilol",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210729",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078165",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "CARVEDILOL",
"StrengthNumber": "6.25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240919",
"SamplePackage": "N",
"IndicationAndUsage": "Carvedilol is an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure ( 1.1) , 2 left ventricular dysfunction following myocardial infarction in clinically stable patients ( 1.2) , 3 hypertension ( 1.3) .",
"Description": "Carvedilol is a nonselective β-adrenergic blocking agent with α 1-blocking activity. It is (±)-1-(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol is a racemic mixture with the following structure:. Carvedilol tablets is a white, oval, film-coated tablet containing 3.125 mg, 6.25 mg, 12.5 mg, or 25 mg of carvedilol. The 3.125mg, 6.25-mg, 12.5-mg, and 25-mg tablets are film coated tablets. Inactive ingredients consist of anhydrous lactose, microcrystalline cellulose, croscarmellose sodium, hydroxyethyl cellulose, magnesium stearate, polyethylene glycol 800 NF and titanium dioxide. Carvedilol is a white to off-white powder with a molecular weight of 406.5 and a molecular formula of C 24H 26N 2O 4. It is freely soluble in dimethyl sulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS without pancreatin, pH 7.5)."
},
{
"NDCCode": "11673-431-01",
"PackageDescription": "1 CAN in 1 CARTON (11673-431-01) > 60 g in 1 CAN",
"NDC11Code": "11673-0431-01",
"ProductNDC": "11673-431",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Up And Up Hair Regrowth Treatment For Women",
"NonProprietaryName": "Minoxidil",
"DosageFormName": "AEROSOL, FOAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20181230",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091344",
"LabelerName": "Target Corporation",
"SubstanceName": "MINOXIDIL",
"StrengthNumber": "50",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181230",
"SamplePackage": "N",
"IndicationAndUsage": "to regrow hair on the top of the scalp (see pictures on side of this carton)."
},
{
"NDCCode": "11673-431-02",
"PackageDescription": "2 CAN in 1 CARTON (11673-431-02) > 60 g in 1 CAN",
"NDC11Code": "11673-0431-02",
"ProductNDC": "11673-431",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Up And Up Hair Regrowth Treatment For Women",
"NonProprietaryName": "Minoxidil",
"DosageFormName": "AEROSOL, FOAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20181230",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091344",
"LabelerName": "Target Corporation",
"SubstanceName": "MINOXIDIL",
"StrengthNumber": "50",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181230",
"SamplePackage": "N",
"IndicationAndUsage": "to regrow hair on the top of the scalp (see pictures on side of this carton)."
},
{
"NDCCode": "13668-431-60",
"PackageDescription": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-431-60) ",
"NDC11Code": "13668-0431-60",
"ProductNDC": "13668-431",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20141031",
"EndMarketingDate": "20210731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203969",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-10-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20141031",
"EndMarketingDatePackage": "20210731",
"SamplePackage": "N"
},
{
"NDCCode": "20276-431-60",
"PackageDescription": "60 SWAB in 1 PACKAGE (20276-431-60) ",
"NDC11Code": "20276-0431-60",
"ProductNDC": "20276-431",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Wet Wipes",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "SWAB",
"RouteName": "TOPICAL",
"StartMarketingDate": "20070123",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Delta Brands, Inc",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".1",
"StrengthUnit": "g/1",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20200427",
"SamplePackage": "N",
"IndicationAndUsage": "decreases bacteria on the skin."
},
{
"NDCCode": "33342-431-09",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (33342-431-09) ",
"NDC11Code": "33342-0431-09",
"ProductNDC": "33342-431",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ticagrelor",
"NonProprietaryName": "Ticagrelor",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20251028",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212258",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "TICAGRELOR",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 3A4 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P-Glycoprotein Inhibitors [MoA], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251028",
"SamplePackage": "N",
"IndicationAndUsage": "Ticagrelor is a P2Y12 platelet inhibitor indicated.",
"Description": "Ticagrelor tablets contains ticagrelor, a cyclopentyltriazolopyrimidine, inhibitor of platelet activation and aggregation mediated by the P2Y12 ADP-receptor. Chemically it is (1S,2S,3R,5S)-3-[7-{[(1R,2S)-2-(3,4-Difluorophenyl)cyclopropyl]amino}-5(propylthio)-3H-[1,2,3]-triazolo[4,5-d]pyrimidin-3-yl]-5-(2-hydroxyethoxy)cyclopentane-1,2-diol. The empirical formula of ticagrelor is C23H28F2N6O4S and its molecular weight is 522.57. The chemical structure of ticagrelor is: Ticagrelor is a crystalline powder with an aqueous solubility of approximately 10 μg/mL at room temperature. Ticagrelor 90 mg tablets for oral administration contain 90 mg of ticagrelor and the following ingredients: mannitol, microcrystalline cellulose, sodium starch glycolate, povidone, magnesium stearate, hydroxypropyl methylcellulose, polyethylene glycol 400, talc, titanium dioxide, and yellow iron oxide. Ticagrelor 60 mg tablets for oral administration contain 60 mg of ticagrelor and the following ingredients: mannitol, microcrystalline cellulose, sodium starch glycolate, povidone, magnesium stearate, hydroxypropyl methylcellulose, polyethylene glycol 400, talc, titanium dioxide, black iron oxide, and red iron oxide."
},
{
"NDCCode": "43598-431-60",
"PackageDescription": "1 TUBE in 1 CARTON (43598-431-60) / 60 g in 1 TUBE",
"NDC11Code": "43598-0431-60",
"ProductNDC": "43598-431",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nystatin And Triamcinolone Acetonide",
"NonProprietaryName": "Nystatin And Triamcinolone Acetonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20161115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208326",
"LabelerName": "Dr. Reddy's Laboratories, Inc.",
"SubstanceName": "NYSTATIN; TRIAMCINOLONE ACETONIDE",
"StrengthNumber": "100000; 1",
"StrengthUnit": "[USP'U]/g; mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20161115",
"SamplePackage": "N",
"IndicationAndUsage": "Nystatin and Triamcinolone Acetonide Cream, USP is indicated for the treatment of cutaneous candidiasis; it has been demonstrated that the nystatin-steroid combination provides greater benefit than the nystatin component alone during the first few days of treatment.",
"Description": "Nystatin and Triamcinolone Acetonide Cream, USP for dermatologic use contain the antifungal agent nystatin and the synthetic corticosteroid triamcinolone acetonide. Nystatin, USP is a polyene antimycotic obtained from Streptomyces noursei. It is a yellow to light tan powder with a cereallike odor, slightly soluble in methanol, and freely soluble in dimethylformamide, dimethyl sulfoxide, and practically insoluble in n-propyl alcohol, n-butyl alcohol, water, alcohol, chloroform, ether. Structural formula:. Triamcinolone acetonide, USP is designated chemically as 9-fluoro-11β, 16α, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione cyclic 16, 17-acetal with acetone. The white to cream crystalline powder has a slight odor, is practically insoluble in water, and sparingly soluble in dehydrated alcohol, chloroform, and slightly soluble in methanol. Structural formula. Nystatin and Triamcinolone Acetonide Cream, USP is a yellow color soft, smooth cream. Each gram provides 100,000 USP Nystatin units and 1 mg Triamcinolone Acetonide in an aqueous vanishing cream base with aluminum hydroxide, methylparaben, mono & diglycerides, polyethylene glycol monostearate, polyoxyl 20 cetostearyl ether, propylparaben, polysorbate 60, propylene glycol, simethicone emulsion, sorbic acid, sorbitol, titanium dioxide and white petrolatum."
},
{
"NDCCode": "43744-431-60",
"PackageDescription": "750 g in 1 DRUM (43744-431-60)",
"NDC11Code": "43744-0431-60",
"ProductNDC": "43744-431",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Formoterol Fumarate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20110808",
"EndMarketingDate": "20130624",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "CBSCHEM LIMITED",
"SubstanceName": "FORMOTEROL FUMARATE ANHYDROUS",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20130624"
},
{
"NDCCode": "45865-431-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (45865-431-60) ",
"NDC11Code": "45865-0431-60",
"ProductNDC": "45865-431",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trazodone Hydrochloride",
"NonProprietaryName": "Trazodone Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20100530",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072192",
"LabelerName": "Medsource Pharmaceuticals",
"SubstanceName": "TRAZODONE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20180101",
"SamplePackage": "N",
"IndicationAndUsage": "Trazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults .",
"Description": "Trazodone hydrochloride tablets for oral administration contain trazodone hydrochloride, a selective serotonin reuptake inhibitor and 5HT2 receptor antagonist. Trazodone hydrochloride tablets are a triazolopyridine derivative designated as 2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]-1,2,4-triazolo [4,3-a]pyridin-3(2 H)-one hydrochloride. It is a white odorless crystalline powder which is freely soluble in water. The structural formula is represented as follows:. Molecular Formula: C 19H 22ClN 5OHCl. Molecular Weight: 408.33. Each tablet, for oral administration, contains 50 mg or 100 mg of trazodone hydrochloride, USP. In addition, each tablet contains hypromellose, lactose monohydrate, magnesium stearate, polydextrose, polyethylene glycol, povidone, pregelatinized corn starch, silicon dioxide, and titanium dioxide."
},
{
"NDCCode": "55700-431-60",
"PackageDescription": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (55700-431-60)",
"NDC11Code": "55700-0431-60",
"ProductNDC": "55700-431",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20160222",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022272",
"LabelerName": "Lake Erie Medical DBA Quality Care Products LLC",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA],Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2019-11-05",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "60429-431-60",
"PackageDescription": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (60429-431-60) ",
"NDC11Code": "60429-0431-60",
"ProductNDC": "60429-431",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clonidine Hydrochloride",
"ProprietaryNameSuffix": "Extended-release",
"NonProprietaryName": "Clonidine Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130930",
"EndMarketingDate": "20230430",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202984",
"LabelerName": "Golden State Medical Supply, Inc.",
"SubstanceName": "CLONIDINE HYDROCHLORIDE",
"StrengthNumber": ".1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-05-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20150904",
"EndMarketingDatePackage": "20230430",
"SamplePackage": "N"
},
{
"NDCCode": "63187-431-60",
"PackageDescription": "60 CAPSULE in 1 BOTTLE (63187-431-60) ",
"NDC11Code": "63187-0431-60",
"ProductNDC": "63187-431",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ziprasidone Hydrochloride",
"NonProprietaryName": "Ziprasidone Hcl",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20120514",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077561",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "ZIPRASIDONE HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2021-01-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20150202",
"SamplePackage": "N",
"IndicationAndUsage": "Ziprasidone hydrochloride capsules are indicated for the treatment of schizophrenia. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone’ s greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs [see Warnings and Precautions (5.2)]. Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [see Warnings and Precautions (5.2)].",
"Description": "Ziprasidone is available as ziprasidone hydrochloride capsules for oral administration. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents. It has a molecular weight of 412.94 (free base), with the following chemical name: 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one. The molecular formula of C21H21ClN4OS (free base of ziprasidone) represents the following structural formula:. Ziprasidone hydrochloride capsules contain a monohydrochloride salt of ziprasidone. Chemically, ziprasidone hydrochloride is 5-[2-[4-(1,2-‑benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, monohydrochloride. The molecular formula is C21H21ClN4OS · HCl and its molecular weight is 449.40. Ziprasidone hydrochloride is an off white to beige brown powder. Ziprasidone hydrochloride capsules are supplied for oral administration in 20 mg (of ziprasidone free base), 40 mg (of ziprasidone free base), 60 mg (of ziprasidone free base), and 80 mg (of ziprasidone free base) capsules. Ziprasidone hydrochloride capsules contain ziprasidone hydrochloride, colloidal silicon dioxide, crospovidone, sodium starch glycolate, and magnesium stearate. Each capsule shell contains the following inactive ingredients: gelatin and titanium dioxide. The 20 mg, 40 mg and 80 mg capsule shells also contain the following inactive ingredients: D&C Red #28, FD&C Blue #1, FD&C Yellow #6. The capsule imprinting ink contains ammonium hydroxide, black iron oxide, ethyl alcohol, isopropyl alcohol, butyl alcohol, potassium hydroxide, propylene glycol and shellac."
},
{
"NDCCode": "65162-431-06",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (65162-431-06) ",
"NDC11Code": "65162-0431-06",
"ProductNDC": "65162-431",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quetiapine",
"NonProprietaryName": "Quetiapine Extended-release",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20181026",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211405",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "QUETIAPINE FUMARATE",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-01-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181026",
"SamplePackage": "N",
"IndicationAndUsage": "Quetiapine is an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia. (1.1), 2 Bipolar I disorder, manic, or mixed episodes. (1.2), 3 Bipolar disorder, depressive episodes. (1.2), 4 Major depressive disorder, adjunctive therapy with antidepressants. (1.3).",
"Description": "Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f ] [1,4] thiazepin-11-yl-1-piperazinyl) ethoxy]ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is (C21H25N3O2S)2C4H4O4 and it has a molecular weight of 883.09 g/mol (fumarate salt). The structural formula is. Quetiapine fumarate, USP is a white to off-white crystalline powder which is soluble in 0.1 N hydrochloric acid; slightly soluble in water, in alcohol, and in methanol. Quetiapine extended-release tablets, USP are supplied for oral administration as 400 mg (white to off white). Quetiapine extended-release tablets USP, 400 mg tablets are film-coated and modified capsule shaped. Each 400 mg tablet contains 460.530 mg of quetiapine fumarate, USP equivalent to 400 mg quetiapine as active ingredient. Inactive Ingredients: hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, sodium citrate and titanium dioxide. Meets USP Dissolution Test 7."
},
{
"NDCCode": "67046-431-60",
"PackageDescription": "60 CAPSULE in 1 BLISTER PACK (67046-431-60)",
"NDC11Code": "67046-0431-60",
"ProductNDC": "67046-431",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lithium Carbonate",
"NonProprietaryName": "Lithium Carbonate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100406",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076243",
"LabelerName": "Contract Pharmacy Services-PA",
"SubstanceName": "LITHIUM CARBONATE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Mood Stabilizer [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Lithium is indicated in the treatment of manic episodes of Bipolar Disorder. Bipolar Disorder, Manic (DSM-III) is equivalent to Manic Depressive illness, Manic, in the older DSM-II terminology. Lithium is also indicated as a maintenance treatment for individuals with a diagnosis of Bipolar Disorder. Maintenance therapy reduces the frequency of manic episodes and diminishes the intensity of those episodes which may occur. Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, elation, poor judgment, aggressiveness, and possibly hostility. When given to a patient experiencing a manic episode, lithium may produce a normalization of symptomatology within 1 to 3 weeks.",
"Description": "Each capsule for oral administration contains 150 mg or 300 mg of lithium carbonate. In addition, each capsule contains the following inactive ingredient: Talc. Capsule shell for the 150 mg potency contains: Gelatin and Titanium Dioxide. Capsule shell for the 300 mg potency contains: D&C Yellow #10, FD&C Green #3, FD&C Red #40, FD&C Yellow #6, Gelatin and Titanium Dioxide. The printing ink contains: D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, n-Butyl Alcohol, Pharmaceutical Glaze, Propylene Glycol, SDA-3A Alcohol, and Synthetic Black Iron Oxide. Lithium Carbonate is a white, light, alkaline powder with molecular formula Li2CO3 and molecular weight 73.89. Lithium is an element of the alkali-metal group with atomic number 3, atomic weight 6.94 and an emission line at 671 nm on the flame photometer."
},
{
"NDCCode": "67544-431-53",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (67544-431-53)",
"NDC11Code": "67544-0431-53",
"ProductNDC": "67544-431",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fosinopril Sodium",
"NonProprietaryName": "Fosinopril Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20050621",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077222",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "FOSINOPRIL SODIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Fosinopril sodium tablets, USP are indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics. Fosinopril sodium tablets, USP are indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics with or without digitalis (see DOSAGE AND ADMINISTRATION). In using fosinopril sodium, consideration should be given to the fact that another angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that fosinopril sodium does not have a similar risk (see WARNINGS). In considering use of fosinopril sodium, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non- blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see WARNINGS: Head and Neck Angioedema and Intestinal Angioedema).",
"Description": "Fosinopril sodium tablet, USP is the sodium salt of fosinopril USP, the ester prodrug of an angiotensin converting enzyme (ACE) inhibitor, fosinoprilat. It contains a phosphinate group capable of specific binding to the active site of angiotensin converting enzyme. Fosinopril sodium, USP is designated chemically as:L-proline,4-cyclohexyl-1-[[[2-methyl-1-(1-oxopropoxy)propoxy](4- phenylbutyl)phosphinyl]acetyl]-, sodium salt, trans-. Fosinopril sodium,USP is a white to off-white crystalline powder. It is soluble in water (100 mg/mL), methanol, and ethanol and slightly soluble in hexane. Its structural formula is. Its empirical formula is C30H45NNaO7P, and its molecular weight is 585.65. Fosinopril Sodium, USP is available for oral administrations as 10 mg, 20 mg, and 40 mg tablets. Inactive ingredients include: crospovidone, lactose, microcrystalline cellulose, magnesium stearate, and povidone."
},
{
"NDCCode": "67544-431-60",
"PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (67544-431-60)",
"NDC11Code": "67544-0431-60",
"ProductNDC": "67544-431",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fosinopril Sodium",
"NonProprietaryName": "Fosinopril Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20050621",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077222",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "FOSINOPRIL SODIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Fosinopril sodium tablets, USP are indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics. Fosinopril sodium tablets, USP are indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics with or without digitalis (see DOSAGE AND ADMINISTRATION). In using fosinopril sodium, consideration should be given to the fact that another angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that fosinopril sodium does not have a similar risk (see WARNINGS). In considering use of fosinopril sodium, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non- blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see WARNINGS: Head and Neck Angioedema and Intestinal Angioedema).",
"Description": "Fosinopril sodium tablet, USP is the sodium salt of fosinopril USP, the ester prodrug of an angiotensin converting enzyme (ACE) inhibitor, fosinoprilat. It contains a phosphinate group capable of specific binding to the active site of angiotensin converting enzyme. Fosinopril sodium, USP is designated chemically as:L-proline,4-cyclohexyl-1-[[[2-methyl-1-(1-oxopropoxy)propoxy](4- phenylbutyl)phosphinyl]acetyl]-, sodium salt, trans-. Fosinopril sodium,USP is a white to off-white crystalline powder. It is soluble in water (100 mg/mL), methanol, and ethanol and slightly soluble in hexane. Its structural formula is. Its empirical formula is C30H45NNaO7P, and its molecular weight is 585.65. Fosinopril Sodium, USP is available for oral administrations as 10 mg, 20 mg, and 40 mg tablets. Inactive ingredients include: crospovidone, lactose, microcrystalline cellulose, magnesium stearate, and povidone."
},
{
"NDCCode": "69113-431-00",
"PackageDescription": "1 BOTTLE in 1 BOX (69113-431-00) / 60 mL in 1 BOTTLE",
"NDC11Code": "69113-0431-00",
"ProductNDC": "69113-431",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bosley Man 5 Minoxidil Topical Solution",
"NonProprietaryName": "Minoxidil",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20231103",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076239",
"LabelerName": "Scientific Hair Research, LLC",
"SubstanceName": "MINOXIDIL",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
"Status": "Active",
"LastUpdate": "2023-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231103",
"SamplePackage": "N",
"IndicationAndUsage": "to regrow hair on the top of the scalp (vertex only, see picture on side of carton)."
},
{
"NDCCode": "71610-431-60",
"PackageDescription": "90 TABLET in 1 BOTTLE (71610-431-60) ",
"NDC11Code": "71610-0431-60",
"ProductNDC": "71610-431",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triamterene And Hydrochlorothiazide",
"NonProprietaryName": "Triamterene And Hydrochlorothiazide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090921",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071251",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "TRIAMTERENE; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "75; 50",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Decreased Renal K+ Excretion [PE], Increased Diuresis [PE], Increased Diuresis [PE], Potassium-sparing Diuretic [EPC], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Active",
"LastUpdate": "2020-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201023",
"SamplePackage": "N",
"IndicationAndUsage": "This fixed combination drug is not indicated for the initial therapy of edema or hypertension except in individuals in whom the development of hypokalemia cannot be risked. : 1 Triamterene and hydrochlorothiazide tablets are indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone. , 2 Triamterene and hydrochlorothiazide is also indicated for those patients who require a thiazide diuretic and in whom the development of hypokalemia cannot be risked (e.g., patients on concomitant digitalis preparations, or with a history of cardiac arryhthmias, etc.). .",
"Description": "Triamterene and hydrochlorothiazide combines triamterene, a potassium-conserving diuretic, with the natriuretic agent, hydrochlorothiazide. Each Triamterene and Hydrochlorothiazide 37.5 mg/25 mg Tablet, USP contains 37.5 mg of Triamterene, USP and 25 mg of Hydrochlorothiazide, USP. Each Triamterene and Hydrochlorothiazide 75 mg/50 mg Tablet, USP contains 75 mg of Triamterene, USP and 50 mg of Hydrochlorothiazide, USP. Triamterene and hydrochlorothiazide tablets for oral administration contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. In addition, the 37.5 mg/25 mg tablets contain D&C Yellow No.10 Aluminum Lake and FD&C Blue No.1 Aluminum Lake. Triamterene is 2,4,7-triamino-6-phenylpteridine. Triamterene is practically insoluble in water, benzene, chloroform, ether and dilute alkali hydroxides. It is soluble in formic acid and sparingly soluble in methoxyethanol. Triamterene is very slightly soluble in acetic acid, alcohol and dilute mineral acids. The following is the structural formula. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H -1,2,4, benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide is slightly soluble in water and freely soluble in sodium hydroxide solution, n-butylamine and dimethylformamide. It is sparingly soluble in methanol and insoluble in ether, chloroform and dilute mineral acids. Its molecular weight is 297.73. The following is the structural formula."
},
{
"NDCCode": "72189-431-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (72189-431-60) ",
"NDC11Code": "72189-0431-60",
"ProductNDC": "72189-431",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amitriptyline Hcl",
"NonProprietaryName": "Amitriptyline Hcl",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230313",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214548",
"LabelerName": "Direct_Rx",
"SubstanceName": "AMITRIPTYLINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230313",
"SamplePackage": "N",
"IndicationAndUsage": "For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.",
"Description": "Amitriptyline hydrochloride, USP, a dibenzocycloheptadiene derivative, is a white, or practically white, odorless, crystalline compound which is freely soluble in water and alcohol. It is designated chemically as 10,11-Dihydro-N,N-dimethyl-5H-dibenzo[a, d] cycloheptene-Δ5 , γ-propylamine hydrochloride. It has the following structural formula. [Image]. C20H23N.HCl. M.W. 313.90. Each tablet for oral administration contains 10, 25, 50, 75, 100, or 150 mg amitriptyline hydrochloride, USP. Inactive ingredients include lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, hypromellose, titanium dioxide and polyethylene glycol. In addition, the following product specific coloring agents are included. 10 mg-D&C Red #27 Phloxine Aluminum Lake, D&C Yellow #10 Aluminum Lake and FD&C Blue #1 Aluminum Lake;. 25 mg-Yellow iron oxide;. 50 mg-D&C Yellow #10 Aluminum Lake, FD&C Red #40 Aluminum Lake and FD&C Blue #2 Aluminum Lake;. 75 mg-Yellow iron oxide;. 100 mg-D&C Yellow #10 Aluminum Lake and D&C Red #30 Aluminum Lake;. 150 mg-Yellow iron oxide, Black iron oxide, D&C Yellow #10 Aluminum Lake and FD&C Blue #1 Aluminum Lake."
},
{
"NDCCode": "98132-431-60",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (98132-431-60) / 34.65 g in 1 BOTTLE, GLASS",
"NDC11Code": "98132-0431-60",
"ProductNDC": "98132-431",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bareminerals Barepro 24hr Wear Skin-perfecting Matte Liquid Foundation",
"ProprietaryNameSuffix": "Deep 50 Neutral",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240501",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Orveon Global US LLC",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": "2.1483",
"StrengthUnit": "g/34.65g",
"Status": "Active",
"LastUpdate": "2024-06-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240501",
"SamplePackage": "N",
"IndicationAndUsage": " helps prevent sunburn if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "72789-003-60",
"PackageDescription": "60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72789-003-60) ",
"NDC11Code": "72789-0003-60",
"ProductNDC": "72789-003",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naproxen",
"NonProprietaryName": "Naproxen",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20160705",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091432",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "NAPROXEN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190820",
"SamplePackage": "N",
"IndicationAndUsage": "Naproxen delayed-release tablets are indicated for. The relief of the signs and symptoms of: 1 rheumatoid arthritis, 2 osteoarthritis, 3 ankylosing spondylitis, 4 polyarticular juvenile idiopathic arthritis.",
"Description": "Naproxen delayed-release tablets are nonsteroidal anti-inflammatory drugs available as follows. Naproxen delayed-release tablets USP are available as enteric coated, white tablets containing 375 mg of naproxen or 500 mg of naproxen, USP for oral administration. Naproxen, USP is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical name for naproxen, USP is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen, USP has a molecular weight of 230.26 and a molecular formula of C 14H 14O 3. Naproxen has the following structural formula:. Naproxen, USP is an odorless, white to off-white crystalline substance. It is lipid-soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen, USP at pH 7.4 is 1.6 to 1.8. The inactive ingredients are croscarmellose sodium, povidone, colloidal silicon dioxide and magnesium stearate. The enteric coating dispersion contains methacrylic acid copolymer dispersion, talc, titanium dioxide, triethyl citrate and purified water. The dissolution of this enteric-coated naproxen tablet is pH dependent with rapid dissolution above pH 6. There is no dissolution below pH 4."
},
{
"NDCCode": "72789-004-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-004-60) ",
"NDC11Code": "72789-0004-60",
"ProductNDC": "72789-004",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
"NonProprietaryName": "Topiramate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20141215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090278",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190317",
"SamplePackage": "N",
"IndicationAndUsage": "Topiramate is indicated for: 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox- Gastaut syndrome in patients 2 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3).",
"Description": "Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Topiramate is a white crystalline powder with a bitter taste. Topiramate USP is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate has the molecular formula C 12H 21NO 8S and a molecular weight of 339.37. Topiramate is designated chemically as 2,3:4,5-Di- O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:. Topiramate tablets, USP contain the following inactive ingredients: anhydrous lactose, microcrystalline cellulose, pregelatinized maize starch, sodium starch glycolate type A potato, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. In addition, individual tablets contain: 50 mg tablets: iron oxide yellow 100 mg tablets: iron oxide yellow, and D&C Yellow # 10 Aluminum Lake 200 mg tablets: iron oxide red, lecithin (soya), and iron oxide black."
},
{
"NDCCode": "72789-009-60",
"PackageDescription": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-009-60) ",
"NDC11Code": "72789-0009-60",
"ProductNDC": "72789-009",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride Extended Release",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20160512",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090295",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190920",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin Hydrochloride Extended-Release Tablets, USP is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Metformin Hydrochloride Extended-Release Tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride.The chemical name of Metformin hydrochloride is N, N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below:. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5 HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pK aof metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin Hydrochloride Extended-Release Tablets, USP contain 500 mg or 750 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 584.90 mg metformin base, respectively. Metformin Hydrochloride Extended-Release Tablets, 500 mg or 750 mg contains the inactive ingredients colloidal silicon dioxide, hypromellose and magnesium stearate."
},
{
"NDCCode": "72789-013-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-013-60) ",
"NDC11Code": "72789-0013-60",
"ProductNDC": "72789-013",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hydrochloride",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077206",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-01-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201106",
"SamplePackage": "N",
"IndicationAndUsage": "Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)] :.",
"Description": "Sertraline hydrochloride tablets USP contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C 17H 17NCl 2HCl is represented by the following structural formula: Sertraline hydrochloride USP is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloridetablets USPare supplied for oral administration as scored tablets contain 28 mg, 56 mg and 112 mg sertraline hydrochloride USP equivalent to 25 mg, 50 mg, and 100 mg of sertraline and the following inactive ingredients: microcrystalline cellulose, sodium starch glycolate, hydroxypropyl cellulose, dibasic calcium phosphate dihydrate, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, and polysorbate 80. Besides, 25 mg contains D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake; 50 mg contains FD&C blue #2 aluminum lake; and 100 mg contains iron oxide yellow. Meets USP dissolution test 3."
},
{
"NDCCode": "72789-018-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (72789-018-60) ",
"NDC11Code": "72789-0018-60",
"ProductNDC": "72789-018",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulfamethoxazole And Trimethoprim",
"NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100216",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090624",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
"StrengthNumber": "800; 160",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]",
"Status": "Active",
"LastUpdate": "2025-04-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191017",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy.",
"Description": "Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product available in DS (double strength) tablets, each containing 800 mg sulfamethoxazole and 160 mg trimethoprim; in tablets, each containing 400 mg sulfamethoxazole and 80 mg trimethoprim for oral administration. Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl) sulfanilamide; the molecular formula is C 10H 11N 3O 3S. It is a white to off-white, practically odorless, crystalline powder, tasteless compound with a molecular weight of 253.28 and the following structural formula:. Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine; the molecular formula is C 14H 18N 4O 3. It is a white or cream-colored crystals or crystalline powder with a molecular weight of 290.3 and the following structural formula:. Inactive ingredients: Docusate sodium, magnesium stearate, pregelatinized starch (maize), sodium benzoate, and sodium starch glycolate."
},
{
"NDCCode": "72789-021-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-021-60) ",
"NDC11Code": "72789-0021-60",
"ProductNDC": "72789-021",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methocarbamol",
"NonProprietaryName": "Methocarbamol",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208507",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "METHOCARBAMOL",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230912",
"SamplePackage": "N",
"IndicationAndUsage": "Methocarbamol Tablets USP, 500 mg and 750 mg are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.",
"Description": "Methocarbamol Tablets USP, a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is 3 - (2-methoxyphenoxy) -1, 2- propanediol 1-carbamate and has the empirical formula C 11H 15NO 5. Its molecular weight is 241.24. The structural formula is shown below. Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane. Methocarbamol Tablets USP, 500 mg is available as a light orange colored, round, film-coated tablets, engraved with 'B134' on one side and scored on the other side, containing 500 mg of methocarbamol, USP for oral administration. The inactive ingredients present are corn starch, low substituted hydroxypropyl cellulose, hydroxyprolyl cellulose, sodium starch glycolate, povidone, sodium lauryl sulfate, colloidal silicon dioxide, stearic acid, magnesium stearate, and purified water. Methocarbamol Tablets USP, 500 mg contains Opadry 13H530000 (Orange) (hypromellose, titanium dioxide, propylene glycol, FD&C yellow #6/Sunset Yellow FCF Aluminum Lake, polysorbate 20) as coating material. Methocarbamol Tablets USP, 750 mg is available as an orange colored, capsule shaped, film coated tablets, engraved with 'B135' on one side and plain on the other side, containing 750 mg of methocarbamol, USP for oral administration. It contains Opadry 13H530001 (Orange) as coating material. The inactive ingredients present are corn starch, low substituted hydroxypropyl cellulose, hydroxyprolyl cellulose, sodium starch glycolate, povidone, sodium lauryl sulfate, colloidal silicon dioxide, stearic acid, magnesium stearate, and purified water. Methocarbamol Tablets USP, 750 mg contain Opadry 13H530001 (Orange) (hypromellose, titanium dioxide, propylene glycol, D&C Yellow #10 Aluminum Lake, FD&C yellow #6/Sunset Yellow FCC Aluminum Lake, polysorbate 20) as coating material."
},
{
"NDCCode": "72789-024-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (72789-024-60) ",
"NDC11Code": "72789-0024-60",
"ProductNDC": "72789-024",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Alprazolam",
"NonProprietaryName": "Alprazolam",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180709",
"EndMarketingDate": "20251031",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207507",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "ALPRAZOLAM",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200310",
"EndMarketingDatePackage": "20251031",
"SamplePackage": "N",
"IndicationAndUsage": "Alprazolam tablets are indicated for the: 1 acute treatment of generalized anxiety disorder (GAD) in adults., 2 treatment of panic disorder (PD), with or without agoraphobia in adults.",
"Description": "Alprazolam Tablets, USP, contain alprazolam which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine. The structural formula is. Alprazolam is a white crystalline powder, which is soluble in methanol or ethanol but which has no appreciable solubility in water at physiological pH. Each Alprazolam tablet, USP, for oral administration, contains 0.25 mg, 0.5 mg, 1 mg, or 2 mg of alprazolam. Alprazolam Tablets, USP, 2 mg, are multi-scored and may be divided as shown below. Inactive ingredients: Lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, hydroxyl propyl cellulose, sodium lauryl sulfate and magnesium stearate. In addition, the 0.5 mg tablet contains FD&C Yellow 6 lake and the 1 mg and 2 mg tablets contain FD&C Blue 2 lake."
},
{
"NDCCode": "72789-027-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (72789-027-60) ",
"NDC11Code": "72789-0027-60",
"ProductNDC": "72789-027",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Famotidine",
"NonProprietaryName": "Famotidine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20010416",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075805",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "FAMOTIDINE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-03-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191211",
"SamplePackage": "N",
"IndicationAndUsage": "Famotidine tablets are indicated in adult and pediatric patients 40 kg and above for the treatment of. active duodenal ulcer (DU). active gastric ulcer(GU). symptomatic non-erosive gastroesophageal reflux disease (GERD). erosive esophagitis due to GERD, diagnosed by biopsy. Famotidine tablets are indicated in adults for the: treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison Syndrome, multiple endocrine neoplasias). reduction of the risk of duodenal ulcer recurrence.",
"Description": "The active ingredient in Famotidine tablets is a histamine-2 (H2) receptor antagonist. Famotidine is N’-(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]propanimidamide. The empirical formula of famotidine is C 8H 15N 7O 2S 3and its molecular weight is 337.43. Its structural formula is:. Each Famotidine tablet for oral administration contains either 20 mg or 40 mg of famotidine and the following inactive ingredients: hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch (modified corn starch), sodium starch glycolate, talc, titanium dioxide and triacetin. Famotidine is a white to pale yellow crystalline compound that is freely soluble in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, and practically insoluble in ethanol."
},
{
"NDCCode": "72789-030-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (72789-030-60) ",
"NDC11Code": "72789-0030-60",
"ProductNDC": "72789-030",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Furosemide",
"NonProprietaryName": "Furosemide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20040326",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076796",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "FUROSEMIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]",
"Status": "Active",
"LastUpdate": "2025-08-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191205",
"SamplePackage": "N",
"Description": "Furosemide is a diuretic which is an anthranilic acid derivative. Furosemide Tablets for oral administration contain furosemide as the active ingredient and the following inactive ingredients: corn starch NF, lactose monohydrate NF, magnesium stearate NF, pregelatinized starch NF, and talc USP. Chemically, it is 4-chloro-N-furfuryl-5-sulfamoylanthranilic acid. Furosemide is available as white-off white tablets for oral administration in dosage strengths of 20, 40 and 80 mg. Furosemide is a white to off-white odorless crystalline powder. It is practically insoluble in water, sparingly soluble in alcohol, freely soluble in dilute alkali solutions and insoluble in dilute acids. The CAS Registry Number is 54-31-9. The structural formula is as follows. Tested by USP Dissolution Test 1."
},
{
"NDCCode": "72789-032-60",
"PackageDescription": "60 TABLET in 1 BOTTLE, PLASTIC (72789-032-60) ",
"NDC11Code": "72789-0032-60",
"ProductNDC": "72789-032",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Furosemide",
"NonProprietaryName": "Furosemide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20040326",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076796",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "FUROSEMIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]",
"Status": "Active",
"LastUpdate": "2025-08-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191209",
"SamplePackage": "N",
"Description": "Furosemide is a diuretic which is an anthranilic acid derivative. Furosemide Tablets for oral administration contain furosemide as the active ingredient and the following inactive ingredients: corn starch NF, lactose monohydrate NF, magnesium stearate NF, pregelatinized starch NF, and talc USP. Chemically, it is 4-chloro-N-furfuryl-5-sulfamoylanthranilic acid. Furosemide is available as white-off white tablets for oral administration in dosage strengths of 20, 40 and 80 mg. Furosemide is a white to off-white odorless crystalline powder. It is practically insoluble in water, sparingly soluble in alcohol, freely soluble in dilute alkali solutions and insoluble in dilute acids. The CAS Registry Number is 54-31-9. The structural formula is as follows. Tested by USP Dissolution Test 1."
}
]
}
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<NDCList>
<NDC>
<NDCCode>72789-431-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-431-60) </PackageDescription>
<NDC11Code>72789-0431-60</NDC11Code>
<ProductNDC>72789-431</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carvedilol</ProprietaryName>
<NonProprietaryName>Carvedilol</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210729</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078165</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CARVEDILOL</SubstanceName>
<StrengthNumber>6.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA], Adrenergic beta1-Antagonists [MoA], Adrenergic beta2-Antagonists [MoA], alpha-Adrenergic Blocker [EPC], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240919</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carvedilol is an alpha-/beta-adrenergic blocking agent indicated for the treatment of: 1 mild to severe chronic heart failure ( 1.1) , 2 left ventricular dysfunction following myocardial infarction in clinically stable patients ( 1.2) , 3 hypertension ( 1.3) .</IndicationAndUsage>
<Description>Carvedilol is a nonselective β-adrenergic blocking agent with α 1-blocking activity. It is (±)-1-(Carbazol-4-yloxy)-3-[[2-(o-methoxyphenoxy)ethyl]amino]-2-propanol. Carvedilol is a racemic mixture with the following structure:. Carvedilol tablets is a white, oval, film-coated tablet containing 3.125 mg, 6.25 mg, 12.5 mg, or 25 mg of carvedilol. The 3.125mg, 6.25-mg, 12.5-mg, and 25-mg tablets are film coated tablets. Inactive ingredients consist of anhydrous lactose, microcrystalline cellulose, croscarmellose sodium, hydroxyethyl cellulose, magnesium stearate, polyethylene glycol 800 NF and titanium dioxide. Carvedilol is a white to off-white powder with a molecular weight of 406.5 and a molecular formula of C 24H 26N 2O 4. It is freely soluble in dimethyl sulfoxide; soluble in methylene chloride and methanol; sparingly soluble in 95% ethanol and isopropanol; slightly soluble in ethyl ether; and practically insoluble in water, gastric fluid (simulated, TS, pH 1.1), and intestinal fluid (simulated, TS without pancreatin, pH 7.5).</Description>
</NDC>
<NDC>
<NDCCode>11673-431-01</NDCCode>
<PackageDescription>1 CAN in 1 CARTON (11673-431-01) > 60 g in 1 CAN</PackageDescription>
<NDC11Code>11673-0431-01</NDC11Code>
<ProductNDC>11673-431</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Up And Up Hair Regrowth Treatment For Women</ProprietaryName>
<NonProprietaryName>Minoxidil</NonProprietaryName>
<DosageFormName>AEROSOL, FOAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20181230</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091344</ApplicationNumber>
<LabelerName>Target Corporation</LabelerName>
<SubstanceName>MINOXIDIL</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181230</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>to regrow hair on the top of the scalp (see pictures on side of this carton).</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>11673-431-02</NDCCode>
<PackageDescription>2 CAN in 1 CARTON (11673-431-02) > 60 g in 1 CAN</PackageDescription>
<NDC11Code>11673-0431-02</NDC11Code>
<ProductNDC>11673-431</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Up And Up Hair Regrowth Treatment For Women</ProprietaryName>
<NonProprietaryName>Minoxidil</NonProprietaryName>
<DosageFormName>AEROSOL, FOAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20181230</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091344</ApplicationNumber>
<LabelerName>Target Corporation</LabelerName>
<SubstanceName>MINOXIDIL</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181230</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>to regrow hair on the top of the scalp (see pictures on side of this carton).</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>13668-431-60</NDCCode>
<PackageDescription>60 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-431-60) </PackageDescription>
<NDC11Code>13668-0431-60</NDC11Code>
<ProductNDC>13668-431</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141031</StartMarketingDate>
<EndMarketingDate>20210731</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203969</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-10-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20141031</StartMarketingDatePackage>
<EndMarketingDatePackage>20210731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>20276-431-60</NDCCode>
<PackageDescription>60 SWAB in 1 PACKAGE (20276-431-60) </PackageDescription>
<NDC11Code>20276-0431-60</NDC11Code>
<ProductNDC>20276-431</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Wet Wipes</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>SWAB</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20070123</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Delta Brands, Inc</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200427</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>decreases bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>33342-431-09</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (33342-431-09) </PackageDescription>
<NDC11Code>33342-0431-09</NDC11Code>
<ProductNDC>33342-431</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ticagrelor</ProprietaryName>
<NonProprietaryName>Ticagrelor</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251028</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212258</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>TICAGRELOR</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 3A4 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P-Glycoprotein Inhibitors [MoA], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251028</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ticagrelor is a P2Y12 platelet inhibitor indicated.</IndicationAndUsage>
<Description>Ticagrelor tablets contains ticagrelor, a cyclopentyltriazolopyrimidine, inhibitor of platelet activation and aggregation mediated by the P2Y12 ADP-receptor. Chemically it is (1S,2S,3R,5S)-3-[7-{[(1R,2S)-2-(3,4-Difluorophenyl)cyclopropyl]amino}-5(propylthio)-3H-[1,2,3]-triazolo[4,5-d]pyrimidin-3-yl]-5-(2-hydroxyethoxy)cyclopentane-1,2-diol. The empirical formula of ticagrelor is C23H28F2N6O4S and its molecular weight is 522.57. The chemical structure of ticagrelor is: Ticagrelor is a crystalline powder with an aqueous solubility of approximately 10 μg/mL at room temperature. Ticagrelor 90 mg tablets for oral administration contain 90 mg of ticagrelor and the following ingredients: mannitol, microcrystalline cellulose, sodium starch glycolate, povidone, magnesium stearate, hydroxypropyl methylcellulose, polyethylene glycol 400, talc, titanium dioxide, and yellow iron oxide. Ticagrelor 60 mg tablets for oral administration contain 60 mg of ticagrelor and the following ingredients: mannitol, microcrystalline cellulose, sodium starch glycolate, povidone, magnesium stearate, hydroxypropyl methylcellulose, polyethylene glycol 400, talc, titanium dioxide, black iron oxide, and red iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>43598-431-60</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (43598-431-60) / 60 g in 1 TUBE</PackageDescription>
<NDC11Code>43598-0431-60</NDC11Code>
<ProductNDC>43598-431</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nystatin And Triamcinolone Acetonide</ProprietaryName>
<NonProprietaryName>Nystatin And Triamcinolone Acetonide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20161115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208326</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories, Inc.</LabelerName>
<SubstanceName>NYSTATIN; TRIAMCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>100000; 1</StrengthNumber>
<StrengthUnit>[USP'U]/g; mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nystatin and Triamcinolone Acetonide Cream, USP is indicated for the treatment of cutaneous candidiasis; it has been demonstrated that the nystatin-steroid combination provides greater benefit than the nystatin component alone during the first few days of treatment.</IndicationAndUsage>
<Description>Nystatin and Triamcinolone Acetonide Cream, USP for dermatologic use contain the antifungal agent nystatin and the synthetic corticosteroid triamcinolone acetonide. Nystatin, USP is a polyene antimycotic obtained from Streptomyces noursei. It is a yellow to light tan powder with a cereallike odor, slightly soluble in methanol, and freely soluble in dimethylformamide, dimethyl sulfoxide, and practically insoluble in n-propyl alcohol, n-butyl alcohol, water, alcohol, chloroform, ether. Structural formula:. Triamcinolone acetonide, USP is designated chemically as 9-fluoro-11β, 16α, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione cyclic 16, 17-acetal with acetone. The white to cream crystalline powder has a slight odor, is practically insoluble in water, and sparingly soluble in dehydrated alcohol, chloroform, and slightly soluble in methanol. Structural formula. Nystatin and Triamcinolone Acetonide Cream, USP is a yellow color soft, smooth cream. Each gram provides 100,000 USP Nystatin units and 1 mg Triamcinolone Acetonide in an aqueous vanishing cream base with aluminum hydroxide, methylparaben, mono & diglycerides, polyethylene glycol monostearate, polyoxyl 20 cetostearyl ether, propylparaben, polysorbate 60, propylene glycol, simethicone emulsion, sorbic acid, sorbitol, titanium dioxide and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>43744-431-60</NDCCode>
<PackageDescription>750 g in 1 DRUM (43744-431-60)</PackageDescription>
<NDC11Code>43744-0431-60</NDC11Code>
<ProductNDC>43744-431</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Formoterol Fumarate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20110808</StartMarketingDate>
<EndMarketingDate>20130624</EndMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>CBSCHEM LIMITED</LabelerName>
<SubstanceName>FORMOTEROL FUMARATE ANHYDROUS</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20130624</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>45865-431-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (45865-431-60) </PackageDescription>
<NDC11Code>45865-0431-60</NDC11Code>
<ProductNDC>45865-431</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Trazodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Trazodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100530</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072192</ApplicationNumber>
<LabelerName>Medsource Pharmaceuticals</LabelerName>
<SubstanceName>TRAZODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Trazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults .</IndicationAndUsage>
<Description>Trazodone hydrochloride tablets for oral administration contain trazodone hydrochloride, a selective serotonin reuptake inhibitor and 5HT2 receptor antagonist. Trazodone hydrochloride tablets are a triazolopyridine derivative designated as 2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]-1,2,4-triazolo [4,3-a]pyridin-3(2 H)-one hydrochloride. It is a white odorless crystalline powder which is freely soluble in water. The structural formula is represented as follows:. Molecular Formula: C 19H 22ClN 5OHCl. Molecular Weight: 408.33. Each tablet, for oral administration, contains 50 mg or 100 mg of trazodone hydrochloride, USP. In addition, each tablet contains hypromellose, lactose monohydrate, magnesium stearate, polydextrose, polyethylene glycol, povidone, pregelatinized corn starch, silicon dioxide, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>55700-431-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (55700-431-60)</PackageDescription>
<NDC11Code>55700-0431-60</NDC11Code>
<ProductNDC>55700-431</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160222</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022272</ApplicationNumber>
<LabelerName>Lake Erie Medical DBA Quality Care Products LLC</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA],Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2019-11-05</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>60429-431-60</NDCCode>
<PackageDescription>60 TABLET, EXTENDED RELEASE in 1 BOTTLE (60429-431-60) </PackageDescription>
<NDC11Code>60429-0431-60</NDC11Code>
<ProductNDC>60429-431</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clonidine Hydrochloride</ProprietaryName>
<ProprietaryNameSuffix>Extended-release</ProprietaryNameSuffix>
<NonProprietaryName>Clonidine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130930</StartMarketingDate>
<EndMarketingDate>20230430</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202984</ApplicationNumber>
<LabelerName>Golden State Medical Supply, Inc.</LabelerName>
<SubstanceName>CLONIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-05-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20150904</StartMarketingDatePackage>
<EndMarketingDatePackage>20230430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63187-431-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE (63187-431-60) </PackageDescription>
<NDC11Code>63187-0431-60</NDC11Code>
<ProductNDC>63187-431</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ziprasidone Hydrochloride</ProprietaryName>
<NonProprietaryName>Ziprasidone Hcl</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120514</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077561</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>ZIPRASIDONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-01-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ziprasidone hydrochloride capsules are indicated for the treatment of schizophrenia. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone’ s greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs [see Warnings and Precautions (5.2)]. Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [see Warnings and Precautions (5.2)].</IndicationAndUsage>
<Description>Ziprasidone is available as ziprasidone hydrochloride capsules for oral administration. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents. It has a molecular weight of 412.94 (free base), with the following chemical name: 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one. The molecular formula of C21H21ClN4OS (free base of ziprasidone) represents the following structural formula:. Ziprasidone hydrochloride capsules contain a monohydrochloride salt of ziprasidone. Chemically, ziprasidone hydrochloride is 5-[2-[4-(1,2-‑benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, monohydrochloride. The molecular formula is C21H21ClN4OS · HCl and its molecular weight is 449.40. Ziprasidone hydrochloride is an off white to beige brown powder. Ziprasidone hydrochloride capsules are supplied for oral administration in 20 mg (of ziprasidone free base), 40 mg (of ziprasidone free base), 60 mg (of ziprasidone free base), and 80 mg (of ziprasidone free base) capsules. Ziprasidone hydrochloride capsules contain ziprasidone hydrochloride, colloidal silicon dioxide, crospovidone, sodium starch glycolate, and magnesium stearate. Each capsule shell contains the following inactive ingredients: gelatin and titanium dioxide. The 20 mg, 40 mg and 80 mg capsule shells also contain the following inactive ingredients: D&C Red #28, FD&C Blue #1, FD&C Yellow #6. The capsule imprinting ink contains ammonium hydroxide, black iron oxide, ethyl alcohol, isopropyl alcohol, butyl alcohol, potassium hydroxide, propylene glycol and shellac.</Description>
</NDC>
<NDC>
<NDCCode>65162-431-06</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (65162-431-06) </PackageDescription>
<NDC11Code>65162-0431-06</NDC11Code>
<ProductNDC>65162-431</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quetiapine</ProprietaryName>
<NonProprietaryName>Quetiapine Extended-release</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181026</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211405</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>QUETIAPINE FUMARATE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181026</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Quetiapine is an atypical antipsychotic indicated for the treatment of: 1 Schizophrenia. (1.1), 2 Bipolar I disorder, manic, or mixed episodes. (1.2), 3 Bipolar disorder, depressive episodes. (1.2), 4 Major depressive disorder, adjunctive therapy with antidepressants. (1.3).</IndicationAndUsage>
<Description>Quetiapine is an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [b,f ] [1,4] thiazepin-11-yl-1-piperazinyl) ethoxy]ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt. All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is (C21H25N3O2S)2C4H4O4 and it has a molecular weight of 883.09 g/mol (fumarate salt). The structural formula is. Quetiapine fumarate, USP is a white to off-white crystalline powder which is soluble in 0.1 N hydrochloric acid; slightly soluble in water, in alcohol, and in methanol. Quetiapine extended-release tablets, USP are supplied for oral administration as 400 mg (white to off white). Quetiapine extended-release tablets USP, 400 mg tablets are film-coated and modified capsule shaped. Each 400 mg tablet contains 460.530 mg of quetiapine fumarate, USP equivalent to 400 mg quetiapine as active ingredient. Inactive Ingredients: hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, sodium citrate and titanium dioxide. Meets USP Dissolution Test 7.</Description>
</NDC>
<NDC>
<NDCCode>67046-431-60</NDCCode>
<PackageDescription>60 CAPSULE in 1 BLISTER PACK (67046-431-60)</PackageDescription>
<NDC11Code>67046-0431-60</NDC11Code>
<ProductNDC>67046-431</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lithium Carbonate</ProprietaryName>
<NonProprietaryName>Lithium Carbonate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100406</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076243</ApplicationNumber>
<LabelerName>Contract Pharmacy Services-PA</LabelerName>
<SubstanceName>LITHIUM CARBONATE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Lithium is indicated in the treatment of manic episodes of Bipolar Disorder. Bipolar Disorder, Manic (DSM-III) is equivalent to Manic Depressive illness, Manic, in the older DSM-II terminology. Lithium is also indicated as a maintenance treatment for individuals with a diagnosis of Bipolar Disorder. Maintenance therapy reduces the frequency of manic episodes and diminishes the intensity of those episodes which may occur. Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, elation, poor judgment, aggressiveness, and possibly hostility. When given to a patient experiencing a manic episode, lithium may produce a normalization of symptomatology within 1 to 3 weeks.</IndicationAndUsage>
<Description>Each capsule for oral administration contains 150 mg or 300 mg of lithium carbonate. In addition, each capsule contains the following inactive ingredient: Talc. Capsule shell for the 150 mg potency contains: Gelatin and Titanium Dioxide. Capsule shell for the 300 mg potency contains: D&C Yellow #10, FD&C Green #3, FD&C Red #40, FD&C Yellow #6, Gelatin and Titanium Dioxide. The printing ink contains: D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, n-Butyl Alcohol, Pharmaceutical Glaze, Propylene Glycol, SDA-3A Alcohol, and Synthetic Black Iron Oxide. Lithium Carbonate is a white, light, alkaline powder with molecular formula Li2CO3 and molecular weight 73.89. Lithium is an element of the alkali-metal group with atomic number 3, atomic weight 6.94 and an emission line at 671 nm on the flame photometer.</Description>
</NDC>
<NDC>
<NDCCode>67544-431-53</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (67544-431-53)</PackageDescription>
<NDC11Code>67544-0431-53</NDC11Code>
<ProductNDC>67544-431</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fosinopril Sodium</ProprietaryName>
<NonProprietaryName>Fosinopril Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050621</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077222</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>FOSINOPRIL SODIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Fosinopril sodium tablets, USP are indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics. Fosinopril sodium tablets, USP are indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics with or without digitalis (see DOSAGE AND ADMINISTRATION). In using fosinopril sodium, consideration should be given to the fact that another angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that fosinopril sodium does not have a similar risk (see WARNINGS). In considering use of fosinopril sodium, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non- blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see WARNINGS: Head and Neck Angioedema and Intestinal Angioedema).</IndicationAndUsage>
<Description>Fosinopril sodium tablet, USP is the sodium salt of fosinopril USP, the ester prodrug of an angiotensin converting enzyme (ACE) inhibitor, fosinoprilat. It contains a phosphinate group capable of specific binding to the active site of angiotensin converting enzyme. Fosinopril sodium, USP is designated chemically as:L-proline,4-cyclohexyl-1-[[[2-methyl-1-(1-oxopropoxy)propoxy](4- phenylbutyl)phosphinyl]acetyl]-, sodium salt, trans-. Fosinopril sodium,USP is a white to off-white crystalline powder. It is soluble in water (100 mg/mL), methanol, and ethanol and slightly soluble in hexane. Its structural formula is. Its empirical formula is C30H45NNaO7P, and its molecular weight is 585.65. Fosinopril Sodium, USP is available for oral administrations as 10 mg, 20 mg, and 40 mg tablets. Inactive ingredients include: crospovidone, lactose, microcrystalline cellulose, magnesium stearate, and povidone.</Description>
</NDC>
<NDC>
<NDCCode>67544-431-60</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (67544-431-60)</PackageDescription>
<NDC11Code>67544-0431-60</NDC11Code>
<ProductNDC>67544-431</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fosinopril Sodium</ProprietaryName>
<NonProprietaryName>Fosinopril Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20050621</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077222</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>FOSINOPRIL SODIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Fosinopril sodium tablets, USP are indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics. Fosinopril sodium tablets, USP are indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics with or without digitalis (see DOSAGE AND ADMINISTRATION). In using fosinopril sodium, consideration should be given to the fact that another angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that fosinopril sodium does not have a similar risk (see WARNINGS). In considering use of fosinopril sodium, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non- blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see WARNINGS: Head and Neck Angioedema and Intestinal Angioedema).</IndicationAndUsage>
<Description>Fosinopril sodium tablet, USP is the sodium salt of fosinopril USP, the ester prodrug of an angiotensin converting enzyme (ACE) inhibitor, fosinoprilat. It contains a phosphinate group capable of specific binding to the active site of angiotensin converting enzyme. Fosinopril sodium, USP is designated chemically as:L-proline,4-cyclohexyl-1-[[[2-methyl-1-(1-oxopropoxy)propoxy](4- phenylbutyl)phosphinyl]acetyl]-, sodium salt, trans-. Fosinopril sodium,USP is a white to off-white crystalline powder. It is soluble in water (100 mg/mL), methanol, and ethanol and slightly soluble in hexane. Its structural formula is. Its empirical formula is C30H45NNaO7P, and its molecular weight is 585.65. Fosinopril Sodium, USP is available for oral administrations as 10 mg, 20 mg, and 40 mg tablets. Inactive ingredients include: crospovidone, lactose, microcrystalline cellulose, magnesium stearate, and povidone.</Description>
</NDC>
<NDC>
<NDCCode>69113-431-00</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (69113-431-00) / 60 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>69113-0431-00</NDC11Code>
<ProductNDC>69113-431</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bosley Man 5 Minoxidil Topical Solution</ProprietaryName>
<NonProprietaryName>Minoxidil</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20231103</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076239</ApplicationNumber>
<LabelerName>Scientific Hair Research, LLC</LabelerName>
<SubstanceName>MINOXIDIL</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231103</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>to regrow hair on the top of the scalp (vertex only, see picture on side of carton).</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71610-431-60</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (71610-431-60) </PackageDescription>
<NDC11Code>71610-0431-60</NDC11Code>
<ProductNDC>71610-431</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Triamterene And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Triamterene And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090921</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071251</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>TRIAMTERENE; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>75; 50</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Decreased Renal K+ Excretion [PE], Increased Diuresis [PE], Increased Diuresis [PE], Potassium-sparing Diuretic [EPC], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2020-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201023</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>This fixed combination drug is not indicated for the initial therapy of edema or hypertension except in individuals in whom the development of hypokalemia cannot be risked. : 1 Triamterene and hydrochlorothiazide tablets are indicated for the treatment of hypertension or edema in patients who develop hypokalemia on hydrochlorothiazide alone. , 2 Triamterene and hydrochlorothiazide is also indicated for those patients who require a thiazide diuretic and in whom the development of hypokalemia cannot be risked (e.g., patients on concomitant digitalis preparations, or with a history of cardiac arryhthmias, etc.). .</IndicationAndUsage>
<Description>Triamterene and hydrochlorothiazide combines triamterene, a potassium-conserving diuretic, with the natriuretic agent, hydrochlorothiazide. Each Triamterene and Hydrochlorothiazide 37.5 mg/25 mg Tablet, USP contains 37.5 mg of Triamterene, USP and 25 mg of Hydrochlorothiazide, USP. Each Triamterene and Hydrochlorothiazide 75 mg/50 mg Tablet, USP contains 75 mg of Triamterene, USP and 50 mg of Hydrochlorothiazide, USP. Triamterene and hydrochlorothiazide tablets for oral administration contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. In addition, the 37.5 mg/25 mg tablets contain D&C Yellow No.10 Aluminum Lake and FD&C Blue No.1 Aluminum Lake. Triamterene is 2,4,7-triamino-6-phenylpteridine. Triamterene is practically insoluble in water, benzene, chloroform, ether and dilute alkali hydroxides. It is soluble in formic acid and sparingly soluble in methoxyethanol. Triamterene is very slightly soluble in acetic acid, alcohol and dilute mineral acids. The following is the structural formula. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H -1,2,4, benzothiadiazine-7-sulfonamide 1,1-dioxide. Hydrochlorothiazide is slightly soluble in water and freely soluble in sodium hydroxide solution, n-butylamine and dimethylformamide. It is sparingly soluble in methanol and insoluble in ether, chloroform and dilute mineral acids. Its molecular weight is 297.73. The following is the structural formula.</Description>
</NDC>
<NDC>
<NDCCode>72189-431-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (72189-431-60) </PackageDescription>
<NDC11Code>72189-0431-60</NDC11Code>
<ProductNDC>72189-431</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amitriptyline Hcl</ProprietaryName>
<NonProprietaryName>Amitriptyline Hcl</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230313</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214548</ApplicationNumber>
<LabelerName>Direct_Rx</LabelerName>
<SubstanceName>AMITRIPTYLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230313</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.</IndicationAndUsage>
<Description>Amitriptyline hydrochloride, USP, a dibenzocycloheptadiene derivative, is a white, or practically white, odorless, crystalline compound which is freely soluble in water and alcohol. It is designated chemically as 10,11-Dihydro-N,N-dimethyl-5H-dibenzo[a, d] cycloheptene-Δ5 , γ-propylamine hydrochloride. It has the following structural formula. [Image]. C20H23N.HCl. M.W. 313.90. Each tablet for oral administration contains 10, 25, 50, 75, 100, or 150 mg amitriptyline hydrochloride, USP. Inactive ingredients include lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, hypromellose, titanium dioxide and polyethylene glycol. In addition, the following product specific coloring agents are included. 10 mg-D&C Red #27 Phloxine Aluminum Lake, D&C Yellow #10 Aluminum Lake and FD&C Blue #1 Aluminum Lake;. 25 mg-Yellow iron oxide;. 50 mg-D&C Yellow #10 Aluminum Lake, FD&C Red #40 Aluminum Lake and FD&C Blue #2 Aluminum Lake;. 75 mg-Yellow iron oxide;. 100 mg-D&C Yellow #10 Aluminum Lake and D&C Red #30 Aluminum Lake;. 150 mg-Yellow iron oxide, Black iron oxide, D&C Yellow #10 Aluminum Lake and FD&C Blue #1 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>98132-431-60</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (98132-431-60) / 34.65 g in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>98132-0431-60</NDC11Code>
<ProductNDC>98132-431</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bareminerals Barepro 24hr Wear Skin-perfecting Matte Liquid Foundation</ProprietaryName>
<ProprietaryNameSuffix>Deep 50 Neutral</ProprietaryNameSuffix>
<NonProprietaryName>Zinc Oxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240501</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Orveon Global US LLC</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
<StrengthNumber>2.1483</StrengthNumber>
<StrengthUnit>g/34.65g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-06-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> helps prevent sunburn if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72789-003-60</NDCCode>
<PackageDescription>60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72789-003-60) </PackageDescription>
<NDC11Code>72789-0003-60</NDC11Code>
<ProductNDC>72789-003</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naproxen</ProprietaryName>
<NonProprietaryName>Naproxen</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160705</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091432</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>NAPROXEN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190820</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Naproxen delayed-release tablets are indicated for. The relief of the signs and symptoms of: 1 rheumatoid arthritis, 2 osteoarthritis, 3 ankylosing spondylitis, 4 polyarticular juvenile idiopathic arthritis.</IndicationAndUsage>
<Description>Naproxen delayed-release tablets are nonsteroidal anti-inflammatory drugs available as follows. Naproxen delayed-release tablets USP are available as enteric coated, white tablets containing 375 mg of naproxen or 500 mg of naproxen, USP for oral administration. Naproxen, USP is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical name for naproxen, USP is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen, USP has a molecular weight of 230.26 and a molecular formula of C 14H 14O 3. Naproxen has the following structural formula:. Naproxen, USP is an odorless, white to off-white crystalline substance. It is lipid-soluble, practically insoluble in water at low pH and freely soluble in water at high pH. The octanol/water partition coefficient of naproxen, USP at pH 7.4 is 1.6 to 1.8. The inactive ingredients are croscarmellose sodium, povidone, colloidal silicon dioxide and magnesium stearate. The enteric coating dispersion contains methacrylic acid copolymer dispersion, talc, titanium dioxide, triethyl citrate and purified water. The dissolution of this enteric-coated naproxen tablet is pH dependent with rapid dissolution above pH 6. There is no dissolution below pH 4.</Description>
</NDC>
<NDC>
<NDCCode>72789-004-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-004-60) </PackageDescription>
<NDC11Code>72789-0004-60</NDC11Code>
<ProductNDC>72789-004</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Topiramate</ProprietaryName>
<NonProprietaryName>Topiramate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090278</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>TOPIRAMATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190317</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topiramate is indicated for: 1 Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox- Gastaut syndrome in patients 2 years of age and older (1.2), 2 Preventive treatment of migraine in patients 12 years of age and older (1.3).</IndicationAndUsage>
<Description>Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Topiramate is a white crystalline powder with a bitter taste. Topiramate USP is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate has the molecular formula C 12H 21NO 8S and a molecular weight of 339.37. Topiramate is designated chemically as 2,3:4,5-Di- O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:. Topiramate tablets, USP contain the following inactive ingredients: anhydrous lactose, microcrystalline cellulose, pregelatinized maize starch, sodium starch glycolate type A potato, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. In addition, individual tablets contain: 50 mg tablets: iron oxide yellow 100 mg tablets: iron oxide yellow, and D&C Yellow # 10 Aluminum Lake 200 mg tablets: iron oxide red, lecithin (soya), and iron oxide black.</Description>
</NDC>
<NDC>
<NDCCode>72789-009-60</NDCCode>
<PackageDescription>60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-009-60) </PackageDescription>
<NDC11Code>72789-0009-60</NDC11Code>
<ProductNDC>72789-009</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride Extended Release</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160512</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090295</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190920</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metformin Hydrochloride Extended-Release Tablets, USP is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Metformin Hydrochloride Extended-Release Tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride.The chemical name of Metformin hydrochloride is N, N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below:. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C 4H 11N 5 HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pK aof metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin Hydrochloride Extended-Release Tablets, USP contain 500 mg or 750 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 584.90 mg metformin base, respectively. Metformin Hydrochloride Extended-Release Tablets, 500 mg or 750 mg contains the inactive ingredients colloidal silicon dioxide, hypromellose and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>72789-013-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-013-60) </PackageDescription>
<NDC11Code>72789-0013-60</NDC11Code>
<ProductNDC>72789-013</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077206</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201106</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies (14)] :.</IndicationAndUsage>
<Description>Sertraline hydrochloride tablets USP contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C 17H 17NCl 2HCl is represented by the following structural formula: Sertraline hydrochloride USP is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol. Sertraline hydrochloridetablets USPare supplied for oral administration as scored tablets contain 28 mg, 56 mg and 112 mg sertraline hydrochloride USP equivalent to 25 mg, 50 mg, and 100 mg of sertraline and the following inactive ingredients: microcrystalline cellulose, sodium starch glycolate, hydroxypropyl cellulose, dibasic calcium phosphate dihydrate, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, and polysorbate 80. Besides, 25 mg contains D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake; 50 mg contains FD&C blue #2 aluminum lake; and 100 mg contains iron oxide yellow. Meets USP dissolution test 3.</Description>
</NDC>
<NDC>
<NDCCode>72789-018-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (72789-018-60) </PackageDescription>
<NDC11Code>72789-0018-60</NDC11Code>
<ProductNDC>72789-018</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName>
<NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100216</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090624</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>SULFAMETHOXAZOLE; TRIMETHOPRIM</SubstanceName>
<StrengthNumber>800; 160</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191017</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy.</IndicationAndUsage>
<Description>Sulfamethoxazole and trimethoprim is a synthetic antibacterial combination product available in DS (double strength) tablets, each containing 800 mg sulfamethoxazole and 160 mg trimethoprim; in tablets, each containing 400 mg sulfamethoxazole and 80 mg trimethoprim for oral administration. Sulfamethoxazole is N1-(5-methyl-3-isoxazolyl) sulfanilamide; the molecular formula is C 10H 11N 3O 3S. It is a white to off-white, practically odorless, crystalline powder, tasteless compound with a molecular weight of 253.28 and the following structural formula:. Trimethoprim is 2,4-diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine; the molecular formula is C 14H 18N 4O 3. It is a white or cream-colored crystals or crystalline powder with a molecular weight of 290.3 and the following structural formula:. Inactive ingredients: Docusate sodium, magnesium stearate, pregelatinized starch (maize), sodium benzoate, and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>72789-021-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-021-60) </PackageDescription>
<NDC11Code>72789-0021-60</NDC11Code>
<ProductNDC>72789-021</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methocarbamol</ProprietaryName>
<NonProprietaryName>Methocarbamol</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208507</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>METHOCARBAMOL</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230912</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methocarbamol Tablets USP, 500 mg and 750 mg are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.</IndicationAndUsage>
<Description>Methocarbamol Tablets USP, a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is 3 - (2-methoxyphenoxy) -1, 2- propanediol 1-carbamate and has the empirical formula C 11H 15NO 5. Its molecular weight is 241.24. The structural formula is shown below. Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane. Methocarbamol Tablets USP, 500 mg is available as a light orange colored, round, film-coated tablets, engraved with 'B134' on one side and scored on the other side, containing 500 mg of methocarbamol, USP for oral administration. The inactive ingredients present are corn starch, low substituted hydroxypropyl cellulose, hydroxyprolyl cellulose, sodium starch glycolate, povidone, sodium lauryl sulfate, colloidal silicon dioxide, stearic acid, magnesium stearate, and purified water. Methocarbamol Tablets USP, 500 mg contains Opadry 13H530000 (Orange) (hypromellose, titanium dioxide, propylene glycol, FD&C yellow #6/Sunset Yellow FCF Aluminum Lake, polysorbate 20) as coating material. Methocarbamol Tablets USP, 750 mg is available as an orange colored, capsule shaped, film coated tablets, engraved with 'B135' on one side and plain on the other side, containing 750 mg of methocarbamol, USP for oral administration. It contains Opadry 13H530001 (Orange) as coating material. The inactive ingredients present are corn starch, low substituted hydroxypropyl cellulose, hydroxyprolyl cellulose, sodium starch glycolate, povidone, sodium lauryl sulfate, colloidal silicon dioxide, stearic acid, magnesium stearate, and purified water. Methocarbamol Tablets USP, 750 mg contain Opadry 13H530001 (Orange) (hypromellose, titanium dioxide, propylene glycol, D&C Yellow #10 Aluminum Lake, FD&C yellow #6/Sunset Yellow FCC Aluminum Lake, polysorbate 20) as coating material.</Description>
</NDC>
<NDC>
<NDCCode>72789-024-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (72789-024-60) </PackageDescription>
<NDC11Code>72789-0024-60</NDC11Code>
<ProductNDC>72789-024</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Alprazolam</ProprietaryName>
<NonProprietaryName>Alprazolam</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180709</StartMarketingDate>
<EndMarketingDate>20251031</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207507</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ALPRAZOLAM</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200310</StartMarketingDatePackage>
<EndMarketingDatePackage>20251031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Alprazolam tablets are indicated for the: 1 acute treatment of generalized anxiety disorder (GAD) in adults., 2 treatment of panic disorder (PD), with or without agoraphobia in adults.</IndicationAndUsage>
<Description>Alprazolam Tablets, USP, contain alprazolam which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine. The structural formula is. Alprazolam is a white crystalline powder, which is soluble in methanol or ethanol but which has no appreciable solubility in water at physiological pH. Each Alprazolam tablet, USP, for oral administration, contains 0.25 mg, 0.5 mg, 1 mg, or 2 mg of alprazolam. Alprazolam Tablets, USP, 2 mg, are multi-scored and may be divided as shown below. Inactive ingredients: Lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, hydroxyl propyl cellulose, sodium lauryl sulfate and magnesium stearate. In addition, the 0.5 mg tablet contains FD&C Yellow 6 lake and the 1 mg and 2 mg tablets contain FD&C Blue 2 lake.</Description>
</NDC>
<NDC>
<NDCCode>72789-027-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (72789-027-60) </PackageDescription>
<NDC11Code>72789-0027-60</NDC11Code>
<ProductNDC>72789-027</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Famotidine</ProprietaryName>
<NonProprietaryName>Famotidine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20010416</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075805</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>FAMOTIDINE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-03-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Famotidine tablets are indicated in adult and pediatric patients 40 kg and above for the treatment of. active duodenal ulcer (DU). active gastric ulcer(GU). symptomatic non-erosive gastroesophageal reflux disease (GERD). erosive esophagitis due to GERD, diagnosed by biopsy. Famotidine tablets are indicated in adults for the: treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison Syndrome, multiple endocrine neoplasias). reduction of the risk of duodenal ulcer recurrence.</IndicationAndUsage>
<Description>The active ingredient in Famotidine tablets is a histamine-2 (H2) receptor antagonist. Famotidine is N’-(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]propanimidamide. The empirical formula of famotidine is C 8H 15N 7O 2S 3and its molecular weight is 337.43. Its structural formula is:. Each Famotidine tablet for oral administration contains either 20 mg or 40 mg of famotidine and the following inactive ingredients: hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch (modified corn starch), sodium starch glycolate, talc, titanium dioxide and triacetin. Famotidine is a white to pale yellow crystalline compound that is freely soluble in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, and practically insoluble in ethanol.</Description>
</NDC>
<NDC>
<NDCCode>72789-030-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (72789-030-60) </PackageDescription>
<NDC11Code>72789-0030-60</NDC11Code>
<ProductNDC>72789-030</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Furosemide</ProprietaryName>
<NonProprietaryName>Furosemide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040326</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076796</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>FUROSEMIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<StartMarketingDatePackage>20191205</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Furosemide is a diuretic which is an anthranilic acid derivative. Furosemide Tablets for oral administration contain furosemide as the active ingredient and the following inactive ingredients: corn starch NF, lactose monohydrate NF, magnesium stearate NF, pregelatinized starch NF, and talc USP. Chemically, it is 4-chloro-N-furfuryl-5-sulfamoylanthranilic acid. Furosemide is available as white-off white tablets for oral administration in dosage strengths of 20, 40 and 80 mg. Furosemide is a white to off-white odorless crystalline powder. It is practically insoluble in water, sparingly soluble in alcohol, freely soluble in dilute alkali solutions and insoluble in dilute acids. The CAS Registry Number is 54-31-9. The structural formula is as follows. Tested by USP Dissolution Test 1.</Description>
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<NDC>
<NDCCode>72789-032-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE, PLASTIC (72789-032-60) </PackageDescription>
<NDC11Code>72789-0032-60</NDC11Code>
<ProductNDC>72789-032</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Furosemide</ProprietaryName>
<NonProprietaryName>Furosemide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040326</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076796</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>FUROSEMIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<SamplePackage>N</SamplePackage>
<Description>Furosemide is a diuretic which is an anthranilic acid derivative. Furosemide Tablets for oral administration contain furosemide as the active ingredient and the following inactive ingredients: corn starch NF, lactose monohydrate NF, magnesium stearate NF, pregelatinized starch NF, and talc USP. Chemically, it is 4-chloro-N-furfuryl-5-sulfamoylanthranilic acid. Furosemide is available as white-off white tablets for oral administration in dosage strengths of 20, 40 and 80 mg. Furosemide is a white to off-white odorless crystalline powder. It is practically insoluble in water, sparingly soluble in alcohol, freely soluble in dilute alkali solutions and insoluble in dilute acids. The CAS Registry Number is 54-31-9. The structural formula is as follows. Tested by USP Dissolution Test 1.</Description>
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