{
"NDC": [
{
"NDCCode": "0456-2616-30",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0456-2616-30)",
"NDC11Code": "00456-2616-30",
"ProductNDC": "0456-2616",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tiazac",
"ProprietaryNameSuffix": "Extended Release",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20101225",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020401",
"LabelerName": "Forest Laboratories, Inc.",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "360",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2014-11-21"
},
{
"NDCCode": "0456-2616-00",
"PackageDescription": "1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0456-2616-00)",
"NDC11Code": "00456-2616-00",
"ProductNDC": "0456-2616",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tiazac",
"ProprietaryNameSuffix": "Extended Release",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20101225",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020401",
"LabelerName": "Forest Laboratories, Inc.",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "360",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2014-11-21"
},
{
"NDCCode": "0456-2616-07",
"PackageDescription": "7 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (0456-2616-07)",
"NDC11Code": "00456-2616-07",
"ProductNDC": "0456-2616",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tiazac",
"ProprietaryNameSuffix": "Extended Release",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20101225",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020401",
"LabelerName": "Forest Laboratories, Inc.",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "360",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2014-11-21"
},
{
"NDCCode": "0456-2616-63",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (0456-2616-63) > 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (0456-2616-11)",
"NDC11Code": "00456-2616-63",
"ProductNDC": "0456-2616",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tiazac",
"ProprietaryNameSuffix": "Extended Release",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20101225",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020401",
"LabelerName": "Forest Laboratories, Inc.",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "360",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2014-11-21"
},
{
"NDCCode": "0456-2616-90",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0456-2616-90)",
"NDC11Code": "00456-2616-90",
"ProductNDC": "0456-2616",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tiazac",
"ProprietaryNameSuffix": "Extended Release",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20101225",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020401",
"LabelerName": "Forest Laboratories, Inc.",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "360",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2014-11-21"
},
{
"NDCCode": "0187-2616-30",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0187-2616-30) ",
"NDC11Code": "00187-2616-30",
"ProductNDC": "0187-2616",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tiazac",
"ProprietaryNameSuffix": "Extended Release",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20140820",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020401",
"LabelerName": "Bausch Health US, LLC",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "360",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140820",
"SamplePackage": "N",
"IndicationAndUsage": "Tiazac is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications.",
"Description": "Tiazac® (diltiazem hydrochloride) is a calcium ion cellular influx inhibitor (slow channel blocker). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol and chloroform and has a molecular weight of 450.98. Tiazac capsules contain diltiazem hydrochloride in extended-release beads at doses of 120, 180, 240, 300, 360 and 420 mg. Tiazac also contains: black iron oxide, D&C Red No. 28, ethyl acrylate and methyl methacrylate copolymer dispersion, FD&C Blue No. 1, FD&C Green No. 3, FD&C Red No. 40, gelatin, hypromellose, magnesium stearate, microcrystalline cellulose, polysorbate, povidone, simethicone, sucrose stearate, talc, and titanium dioxide. USP Drug Release Test 6. For oral administration."
},
{
"NDCCode": "0220-2616-41",
"PackageDescription": "30 [hp_X] in 1 TUBE (0220-2616-41) ",
"NDC11Code": "00220-2616-41",
"ProductNDC": "0220-2616",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ignatia Amara",
"NonProprietaryName": "Strychnos Ignatii Seed",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "19830303",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Boiron",
"SubstanceName": "STRYCHNOS IGNATII SEED",
"StrengthNumber": "30",
"StrengthUnit": "[hp_X]/30[hp_X]",
"Status": "Active",
"LastUpdate": "2025-10-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19830303",
"SamplePackage": "N",
"IndicationAndUsage": "Relieves apprehension, hypersensitivity to stress *."
},
{
"NDCCode": "0527-2616-32",
"PackageDescription": "30 TABLET in 1 BOTTLE (0527-2616-32) ",
"NDC11Code": "00527-2616-32",
"ProductNDC": "0527-2616",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venlafaxine",
"NonProprietaryName": "Venlafaxine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20221231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213927",
"LabelerName": "Lannett Company, Inc.",
"SubstanceName": "VENLAFAXINE HYDROCHLORIDE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-11-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20221231",
"SamplePackage": "N",
"IndicationAndUsage": "Venlafaxine Extended-Release Tablets are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for: 1 Major Depressive Disorder (MDD) (1.1), 2 Social Anxiety Disorder (SAD) (1.2).",
"Description": "Venlafaxine Extended-Release Tablets (venlafaxine hydrochloride) are extended-release tablets for oral administration that contain venlafaxine hydrochloride, a structurally novel antidepressant. Venlafaxine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI). It is designated (R/S)-1-[2-(dimethylamino)-1-(4‑methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino) methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Venlafaxine Extended-Release Tablets are formulated as extended-release tablet for once-a-day oral administration. Venlafaxine Extended-Release Tablets use matrix core and extended release coating to deliver venlafaxine hydrochloride at a controlled rate over approximately 24 hours. The unitary tablet core is composed of the drug and excipients (including the matrix forming components). In an aqueous environment, such as the gastrointestinal tract, water permeates slowly through the coating into the tablet core, causing the hydrophilic matrix polymer to expand and to form a gel layer on the surface of the tablet. This gel acts as a barrier to the drug release; the drug is dissolved and is released by slow diffusion and erosion of the gel. The extended release coating layer controls the rate at which water permeates into the tablet core, which in turn controls also the rate of drug delivery. The controlled rate of drug delivery into the gastrointestinal lumen is thus independent of pH or gastrointestinal motility. Tablets contain venlafaxine hydrochloride equivalent to 75 mg venlafaxine. Inactive ingredients consist of dibasic calcium phosphate dihydrate, hypromellose, methacrylic acid copolymer, colloidal silicon dioxide, magnesium stearate, polyvinyl acetate dispersion, talc, polyvinyl alcohol graft polyethylene glycol copolymer, povidone, triethyl citrate, macrogol stearyl ether, sodium lauryl sulfate, carnauba wax, titanium dioxide, propylene glycol and FD&C blue #1."
},
{
"NDCCode": "15631-2616-1",
"PackageDescription": "30 mL in 1 BOTTLE (15631-2616-1) ",
"NDC11Code": "15631-2616-01",
"ProductNDC": "15631-2616",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aurum Met",
"NonProprietaryName": "Aurum Met",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20240523",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
"SubstanceName": "GOLD",
"StrengthNumber": "3",
"StrengthUnit": "[hp_X]/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]",
"Status": "Active",
"LastUpdate": "2024-05-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240523",
"SamplePackage": "N",
"IndicationAndUsage": "Condition listed above or as directed by the physician."
},
{
"NDCCode": "36987-2616-3",
"PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (36987-2616-3)",
"NDC11Code": "36987-2616-03",
"ProductNDC": "36987-2616",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Arizona Cypress",
"NonProprietaryName": "Arizona Cypress",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "CUPRESSUS ARIZONICA POLLEN",
"StrengthNumber": "20000",
"StrengthUnit": "[PNU]/mL",
"Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
"Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
},
{
"NDCCode": "60505-2616-3",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (60505-2616-3)",
"NDC11Code": "60505-2616-03",
"ProductNDC": "60505-2616",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clarithromycin",
"NonProprietaryName": "Clarithromycin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070913",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065384",
"LabelerName": "Apotex Corp",
"SubstanceName": "CLARITHROMYCIN",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-04-11",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "70518-2616-0",
"PackageDescription": "30 TABLET, FILM COATED in 1 BLISTER PACK (70518-2616-0) ",
"NDC11Code": "70518-2616-00",
"ProductNDC": "70518-2616",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200309",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200651",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200309",
"SamplePackage": "N",
"IndicationAndUsage": "Gabapentin tablets are indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.",
"Description": "The active ingredient in gabapentin tablets, USP is gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C 9H 17NO 2and the molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin USP is a white to off-white crystalline solid with a pK a1of 3.7 and a pK a2of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Each film-coated gabapentin tablet contains 600 mg or 800 mg of gabapentin USP and the following inactive ingredients:copovidone, corn starch, crospovidone, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, and talc."
},
{
"NDCCode": "70518-2616-3",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2616-3) ",
"NDC11Code": "70518-2616-03",
"ProductNDC": "70518-2616",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200309",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200651",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20220405",
"SamplePackage": "N",
"IndicationAndUsage": "Gabapentin tablets are indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.",
"Description": "The active ingredient in gabapentin tablets, USP is gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C 9H 17NO 2and the molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin USP is a white to off-white crystalline solid with a pK a1of 3.7 and a pK a2of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Each film-coated gabapentin tablet contains 600 mg or 800 mg of gabapentin USP and the following inactive ingredients:copovidone, corn starch, crospovidone, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, and talc."
},
{
"NDCCode": "71335-2616-2",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (71335-2616-2) ",
"NDC11Code": "71335-2616-02",
"ProductNDC": "71335-2616",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bisoprolol Fumarate And Hydrochlorothiazide",
"NonProprietaryName": "Bisoprolol Fumarate And Hydrochlorothiazide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220126",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215995",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "2.5; 6.25",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-05-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250529",
"SamplePackage": "N",
"IndicationAndUsage": "Bisoprolol fumarate and hydrochlorothiazide tablets are indicated in the management of hypertension.",
"Description": "Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP are indicated for the treatment of hypertension. It combines two antihypertensive agents in a once-daily dosage: a synthetic beta1‑selective (cardioselective) adrenoceptor blocking agent (bisoprolol fumarate) and a benzothiadiazine diuretic (hydrochlorothiazide). Bisoprolol fumarate, USP is chemically described as (±)-1-[4-[[2-(1‑methylethoxy)ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-2-propanol(E)-2-butenedioate (2:1) (salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its empirical formula is (C18H31NO4)2C4H4O4 and it has a molecular weight of 766.96 g/mol. Its structural formula is. Bisoprolol fumarate, USP is a white crystalline powder, approximately equally hydrophilic and lipophilic, and very soluble in water, methanol, freely soluble in alcohol, glacial acetic acid and chloroform and slightly soluble in acetone and ethyl acetate. Hydrochlorothiazide (HCTZ), USP is 6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. It is a white, or almost white, almost odorless crystalline powder. It is very slightly soluble in water, soluble in acetone, freely soluble in n-butylamine, N,N-dimethylformamide and diluted solutions of alkali hydroxides, sparingly soluble in methanol and ethanol, and practically insoluble in ether, chloroform, and dilute mineral acids. Its empirical formula is C7H8ClN3O4S2 and it has a molecular weight of 297.7 g/mol. Its structural formula is. Each Bisoprolol Fumarate and Hydrochlorothiazide Tablet, USP 2.5 mg/6.25 mg for oral administration contains:. Bisoprolol fumarate, USP----------------------------------------------------------------2.5 mg. Hydrochlorothiazide, USP---------------------------------------------------------------6.25 mg. Each Bisoprolol Fumarate and Hydrochlorothiazide Tablet, USP 5 mg/6.25 mg for oral administration contains. Bisoprolol fumarate, USP----------------------------------------------------------------5 mg. Hydrochlorothiazide, USP---------------------------------------------------------------6.25 mg. Each Bisoprolol Fumarate and Hydrochlorothiazide Tablet, USP 10 mg/6.25 mg for oral administration contains. Bisoprolol fumarate, USP----------------------------------------------------------------10 mg. Hydrochlorothiazide, USP---------------------------------------------------------------6.25 mg. Inactive ingredients include Colloidal Silicon Dioxide, Corn Starch, Dibasic Calcium Phosphate Dihydrate, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80, and Titanium Dioxide. The 5 mg/6.25 mg tablet also contains Red and Yellow Iron Oxide. The 2.5 mg/6.25 mg tablet also contains Yellow Iron Oxide."
},
{
"NDCCode": "0456-0095-30",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (0456-0095-30)",
"NDC11Code": "00456-0095-30",
"ProductNDC": "0456-0095",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Daliresp",
"NonProprietaryName": "Roflumilast",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110228",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022522",
"LabelerName": "Forest Laboratories, Inc.",
"SubstanceName": "ROFLUMILAST",
"StrengthNumber": "500",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Phosphodiesterase 4 Inhibitor [EPC],Phosphodiesterase 4 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-12-13",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "0456-0800-30",
"PackageDescription": "1 POUCH in 1 CARTON (0456-0800-30) > 1 INHALER in 1 POUCH > 30 INHALANT in 1 INHALER",
"NDC11Code": "00456-0800-30",
"ProductNDC": "0456-0800",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tudorza Pressair",
"NonProprietaryName": "Aclidinium Bromide",
"DosageFormName": "INHALANT",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20120723",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202450",
"LabelerName": "Forest Laboratories, Inc.",
"SubstanceName": "ACLIDINIUM BROMIDE",
"StrengthNumber": "400",
"StrengthUnit": "ug/1",
"Status": "Deprecated",
"LastUpdate": "2017-12-13",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "0456-0800-31",
"PackageDescription": "1 POUCH in 1 CARTON (0456-0800-31) > 1 INHALER in 1 POUCH > 30 INHALANT in 1 INHALER",
"NDC11Code": "00456-0800-31",
"ProductNDC": "0456-0800",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tudorza Pressair",
"NonProprietaryName": "Aclidinium Bromide",
"DosageFormName": "INHALANT",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20120723",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202450",
"LabelerName": "Forest Laboratories, Inc.",
"SubstanceName": "ACLIDINIUM BROMIDE",
"StrengthNumber": "400",
"StrengthUnit": "ug/1",
"Status": "Deprecated",
"LastUpdate": "2017-12-13",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "0456-1101-30",
"PackageDescription": "1 KIT in 1 BLISTER PACK (0456-1101-30) ",
"NDC11Code": "00456-1101-30",
"ProductNDC": "0456-1101",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viibryd",
"NonProprietaryName": "Vilazodone Hydrochloride",
"DosageFormName": "KIT",
"RouteName": "ORAL",
"StartMarketingDate": "20110429",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022567",
"LabelerName": "Allergan, Inc.",
"Status": "Deprecated",
"LastUpdate": "2023-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20110429",
"SamplePackage": "N"
},
{
"NDCCode": "0456-1110-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (0456-1110-30) ",
"NDC11Code": "00456-1110-30",
"ProductNDC": "0456-1110",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viibryd",
"NonProprietaryName": "Vilazodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110429",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022567",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "VILAZODONE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110429",
"SamplePackage": "N",
"IndicationAndUsage": "VIIBRYD® is indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].",
"Description": "VIIBRYD tablets for oral administration contain polymorph Form IV vilazodone hydrochloride (HCl), a selective serotonin reuptake inhibitor and a 5HT1A receptor partial agonist. Vilazodone HCl is 2-benzofurancarboxamide, 5-[4-[4-(5-cyano-1H-indol-3-yl)butyl]-1-piprazinyl]-, hydrochloride (1:1). Its molecular weight is 477.99. The structural formula is. VIIBRYD tablets are available as 10 mg, 20 mg, and 40 mg film-coated tablets containing 10 mg, 20 mg, and 40 mg of vilazodone HCl, respectively. In addition to the active ingredient, VIIBRYD tablets contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, FD&C Blue #1 (40 mg only), FD&C Red #40 (10 mg only), and FD&C Yellow #6 (20 mg only)."
},
{
"NDCCode": "0456-1120-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (0456-1120-30) ",
"NDC11Code": "00456-1120-30",
"ProductNDC": "0456-1120",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viibryd",
"NonProprietaryName": "Vilazodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110429",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022567",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "VILAZODONE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110429",
"SamplePackage": "N",
"IndicationAndUsage": "VIIBRYD® is indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].",
"Description": "VIIBRYD tablets for oral administration contain polymorph Form IV vilazodone hydrochloride (HCl), a selective serotonin reuptake inhibitor and a 5HT1A receptor partial agonist. Vilazodone HCl is 2-benzofurancarboxamide, 5-[4-[4-(5-cyano-1H-indol-3-yl)butyl]-1-piprazinyl]-, hydrochloride (1:1). Its molecular weight is 477.99. The structural formula is. VIIBRYD tablets are available as 10 mg, 20 mg, and 40 mg film-coated tablets containing 10 mg, 20 mg, and 40 mg of vilazodone HCl, respectively. In addition to the active ingredient, VIIBRYD tablets contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, FD&C Blue #1 (40 mg only), FD&C Red #40 (10 mg only), and FD&C Yellow #6 (20 mg only)."
},
{
"NDCCode": "0456-1140-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (0456-1140-30) ",
"NDC11Code": "00456-1140-30",
"ProductNDC": "0456-1140",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viibryd",
"NonProprietaryName": "Vilazodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110429",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022567",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "VILAZODONE HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2025-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110429",
"SamplePackage": "N",
"IndicationAndUsage": "VIIBRYD® is indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].",
"Description": "VIIBRYD tablets for oral administration contain polymorph Form IV vilazodone hydrochloride (HCl), a selective serotonin reuptake inhibitor and a 5HT1A receptor partial agonist. Vilazodone HCl is 2-benzofurancarboxamide, 5-[4-[4-(5-cyano-1H-indol-3-yl)butyl]-1-piprazinyl]-, hydrochloride (1:1). Its molecular weight is 477.99. The structural formula is. VIIBRYD tablets are available as 10 mg, 20 mg, and 40 mg film-coated tablets containing 10 mg, 20 mg, and 40 mg of vilazodone HCl, respectively. In addition to the active ingredient, VIIBRYD tablets contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, FD&C Blue #1 (40 mg only), FD&C Red #40 (10 mg only), and FD&C Yellow #6 (20 mg only)."
},
{
"NDCCode": "0456-1201-30",
"PackageDescription": "1 BOTTLE in 1 CARTON (0456-1201-30) / 30 CAPSULE, GELATIN COATED in 1 BOTTLE",
"NDC11Code": "00456-1201-30",
"ProductNDC": "0456-1201",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Linzess",
"NonProprietaryName": "Linaclotide",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120908",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202811",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "LINACLOTIDE",
"StrengthNumber": "145",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Guanylate Cyclase Activators [MoA], Guanylate Cyclase-C Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120908",
"SamplePackage": "N",
"IndicationAndUsage": "LINZESS is indicated for the treatment of. irritable bowel syndrome with constipation (IBS-C) in adults and pediatric patients 7 years of age and older. chronic idiopathic constipation (CIC) in adults. functional constipation (FC) in pediatric patients 2 years of age and older.",
"Description": "LINZESS (linaclotide) is a guanylate cyclase-C (GC-C) agonist. Linaclotide is a 14-amino acid peptide with the following chemical name: L-cysteinyl-L-cysteinyl-L-glutamyl-L-tyrosyl-L-cysteinyl-L-cysteinyl-L-asparaginyl-L-prolyl-L-alanyl-L-cysteinyl-L-threonyl-glycyl-L-cysteinyl-L-tyrosine, cyclic (1-6), (2-10), (5-13)-tris (disulfide). The molecular formula of linaclotide is C59H79N15O21S6 and its molecular weight is 1526.8. The amino acid sequence for linaclotide is shown below. Linaclotide is an amorphous, white to off-white powder. It is slightly soluble in water and aqueous sodium chloride (0.9%). LINZESS contains linaclotide-coated beads in hard gelatin capsules. LINZESS is available as 72 mcg, 145 mcg and 290 mcg capsules for oral administration. The inactive ingredients of LINZESS 72 mcg capsules include: calcium chloride dihydrate, L-histidine, microcrystalline cellulose, polyvinyl alcohol, and talc. The components of the capsule shell include gelatin and titanium dioxide. The inactive ingredients of LINZESS 145 mcg and 290 mcg capsules include: calcium chloride dihydrate, hypromellose, L-leucine, and microcrystalline cellulose. The components of the capsule shell include gelatin and titanium dioxide."
},
{
"NDCCode": "0456-1202-30",
"PackageDescription": "1 BOTTLE in 1 CARTON (0456-1202-30) / 30 CAPSULE, GELATIN COATED in 1 BOTTLE",
"NDC11Code": "00456-1202-30",
"ProductNDC": "0456-1202",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Linzess",
"NonProprietaryName": "Linaclotide",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120908",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202811",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "LINACLOTIDE",
"StrengthNumber": "290",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Guanylate Cyclase Activators [MoA], Guanylate Cyclase-C Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120908",
"SamplePackage": "N",
"IndicationAndUsage": "LINZESS is indicated for the treatment of. irritable bowel syndrome with constipation (IBS-C) in adults and pediatric patients 7 years of age and older. chronic idiopathic constipation (CIC) in adults. functional constipation (FC) in pediatric patients 2 years of age and older.",
"Description": "LINZESS (linaclotide) is a guanylate cyclase-C (GC-C) agonist. Linaclotide is a 14-amino acid peptide with the following chemical name: L-cysteinyl-L-cysteinyl-L-glutamyl-L-tyrosyl-L-cysteinyl-L-cysteinyl-L-asparaginyl-L-prolyl-L-alanyl-L-cysteinyl-L-threonyl-glycyl-L-cysteinyl-L-tyrosine, cyclic (1-6), (2-10), (5-13)-tris (disulfide). The molecular formula of linaclotide is C59H79N15O21S6 and its molecular weight is 1526.8. The amino acid sequence for linaclotide is shown below. Linaclotide is an amorphous, white to off-white powder. It is slightly soluble in water and aqueous sodium chloride (0.9%). LINZESS contains linaclotide-coated beads in hard gelatin capsules. LINZESS is available as 72 mcg, 145 mcg and 290 mcg capsules for oral administration. The inactive ingredients of LINZESS 72 mcg capsules include: calcium chloride dihydrate, L-histidine, microcrystalline cellulose, polyvinyl alcohol, and talc. The components of the capsule shell include gelatin and titanium dioxide. The inactive ingredients of LINZESS 145 mcg and 290 mcg capsules include: calcium chloride dihydrate, hypromellose, L-leucine, and microcrystalline cellulose. The components of the capsule shell include gelatin and titanium dioxide."
},
{
"NDCCode": "0456-1203-30",
"PackageDescription": "1 BOTTLE in 1 CARTON (0456-1203-30) / 30 CAPSULE, GELATIN COATED in 1 BOTTLE",
"NDC11Code": "00456-1203-30",
"ProductNDC": "0456-1203",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Linzess",
"NonProprietaryName": "Linaclotide",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170130",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202811",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "LINACLOTIDE",
"StrengthNumber": "72",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Guanylate Cyclase Activators [MoA], Guanylate Cyclase-C Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170130",
"SamplePackage": "N",
"IndicationAndUsage": "LINZESS is indicated for the treatment of. irritable bowel syndrome with constipation (IBS-C) in adults and pediatric patients 7 years of age and older. chronic idiopathic constipation (CIC) in adults. functional constipation (FC) in pediatric patients 2 years of age and older.",
"Description": "LINZESS (linaclotide) is a guanylate cyclase-C (GC-C) agonist. Linaclotide is a 14-amino acid peptide with the following chemical name: L-cysteinyl-L-cysteinyl-L-glutamyl-L-tyrosyl-L-cysteinyl-L-cysteinyl-L-asparaginyl-L-prolyl-L-alanyl-L-cysteinyl-L-threonyl-glycyl-L-cysteinyl-L-tyrosine, cyclic (1-6), (2-10), (5-13)-tris (disulfide). The molecular formula of linaclotide is C59H79N15O21S6 and its molecular weight is 1526.8. The amino acid sequence for linaclotide is shown below. Linaclotide is an amorphous, white to off-white powder. It is slightly soluble in water and aqueous sodium chloride (0.9%). LINZESS contains linaclotide-coated beads in hard gelatin capsules. LINZESS is available as 72 mcg, 145 mcg and 290 mcg capsules for oral administration. The inactive ingredients of LINZESS 72 mcg capsules include: calcium chloride dihydrate, L-histidine, microcrystalline cellulose, polyvinyl alcohol, and talc. The components of the capsule shell include gelatin and titanium dioxide. The inactive ingredients of LINZESS 145 mcg and 290 mcg capsules include: calcium chloride dihydrate, hypromellose, L-leucine, and microcrystalline cellulose. The components of the capsule shell include gelatin and titanium dioxide."
},
{
"NDCCode": "0456-1207-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (0456-1207-30) ",
"NDC11Code": "00456-1207-30",
"ProductNDC": "0456-1207",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Namzaric",
"NonProprietaryName": "Memantine Hydrochloride And Donepezil Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20160718",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA206439",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "MEMANTINE HYDROCHLORIDE; DONEPEZIL HYDROCHLORIDE",
"StrengthNumber": "7; 10",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA], N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160718",
"SamplePackage": "N",
"IndicationAndUsage": "NAMZARIC is indicated for the treatment of moderate to severe dementia of the Alzheimer’s type in patients stabilized on 10 mg of donepezil hydrochloride once daily.",
"Description": "NAMZARIC contains memantine, an orally active NMDA receptor antagonist, as the hydrochloride salt and donepezil, a reversible inhibitor of the enzyme acetylcholinesterase, as the hydrochloride salt. Memantine Hydrochloride. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride occurs as a fine white to off-white powder. Donepezil Hydrochloride. The chemical name for donepezil hydrochloride is 2,3-dihydro-5,6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. The molecular formula is C24H29NO3HCl and the molecular weight is 415.96. Donepezil hydrochloride is a white crystalline powder. NAMZARIC extended-release capsules contain 7 mg, 14 mg, 21 mg or 28 mg memantine hydrochloride, 10 mg donepezil hydrochloride, and the following inactive ingredients: colloidal silicon dioxide, corn starch, ethylcellulose, hypromellose, lactose monohydrate, magnesium stearate, medium chain triglycerides, microcrystalline cellulose, oleic acid, polyethylene glycol, povidone, sugar spheres, and talc. The capsule shells contain gelatin and titanium dioxide and are imprinted with shellac glaze and black iron oxide. Colorants are FD&C Blue No. 1 (7 mg/10 mg, 14 mg/10 mg, 28 mg/10 mg), FD&C Yellow No. 6 (7 mg/10 mg, 21 mg/10 mg), red iron oxide (7 mg/10 mg, 21 mg/10 mg), and yellow iron oxide (7 mg/10 mg, 14 mg/10 mg, 21 mg/10 mg)."
},
{
"NDCCode": "0456-1214-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (0456-1214-30) ",
"NDC11Code": "00456-1214-30",
"ProductNDC": "0456-1214",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Namzaric",
"NonProprietaryName": "Memantine Hydrochloride And Donepezil Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20141224",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA206439",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "MEMANTINE HYDROCHLORIDE; DONEPEZIL HYDROCHLORIDE",
"StrengthNumber": "14; 10",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA], N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20141224",
"SamplePackage": "N",
"IndicationAndUsage": "NAMZARIC is indicated for the treatment of moderate to severe dementia of the Alzheimer’s type in patients stabilized on 10 mg of donepezil hydrochloride once daily.",
"Description": "NAMZARIC contains memantine, an orally active NMDA receptor antagonist, as the hydrochloride salt and donepezil, a reversible inhibitor of the enzyme acetylcholinesterase, as the hydrochloride salt. Memantine Hydrochloride. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride occurs as a fine white to off-white powder. Donepezil Hydrochloride. The chemical name for donepezil hydrochloride is 2,3-dihydro-5,6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. The molecular formula is C24H29NO3HCl and the molecular weight is 415.96. Donepezil hydrochloride is a white crystalline powder. NAMZARIC extended-release capsules contain 7 mg, 14 mg, 21 mg or 28 mg memantine hydrochloride, 10 mg donepezil hydrochloride, and the following inactive ingredients: colloidal silicon dioxide, corn starch, ethylcellulose, hypromellose, lactose monohydrate, magnesium stearate, medium chain triglycerides, microcrystalline cellulose, oleic acid, polyethylene glycol, povidone, sugar spheres, and talc. The capsule shells contain gelatin and titanium dioxide and are imprinted with shellac glaze and black iron oxide. Colorants are FD&C Blue No. 1 (7 mg/10 mg, 14 mg/10 mg, 28 mg/10 mg), FD&C Yellow No. 6 (7 mg/10 mg, 21 mg/10 mg), red iron oxide (7 mg/10 mg, 21 mg/10 mg), and yellow iron oxide (7 mg/10 mg, 14 mg/10 mg, 21 mg/10 mg)."
},
{
"NDCCode": "0456-1221-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (0456-1221-30) ",
"NDC11Code": "00456-1221-30",
"ProductNDC": "0456-1221",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Namzaric",
"NonProprietaryName": "Memantine Hydrochloride And Donepezil Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20160718",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA206439",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "MEMANTINE HYDROCHLORIDE; DONEPEZIL HYDROCHLORIDE",
"StrengthNumber": "21; 10",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA], N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160718",
"SamplePackage": "N",
"IndicationAndUsage": "NAMZARIC is indicated for the treatment of moderate to severe dementia of the Alzheimer’s type in patients stabilized on 10 mg of donepezil hydrochloride once daily.",
"Description": "NAMZARIC contains memantine, an orally active NMDA receptor antagonist, as the hydrochloride salt and donepezil, a reversible inhibitor of the enzyme acetylcholinesterase, as the hydrochloride salt. Memantine Hydrochloride. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride occurs as a fine white to off-white powder. Donepezil Hydrochloride. The chemical name for donepezil hydrochloride is 2,3-dihydro-5,6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. The molecular formula is C24H29NO3HCl and the molecular weight is 415.96. Donepezil hydrochloride is a white crystalline powder. NAMZARIC extended-release capsules contain 7 mg, 14 mg, 21 mg or 28 mg memantine hydrochloride, 10 mg donepezil hydrochloride, and the following inactive ingredients: colloidal silicon dioxide, corn starch, ethylcellulose, hypromellose, lactose monohydrate, magnesium stearate, medium chain triglycerides, microcrystalline cellulose, oleic acid, polyethylene glycol, povidone, sugar spheres, and talc. The capsule shells contain gelatin and titanium dioxide and are imprinted with shellac glaze and black iron oxide. Colorants are FD&C Blue No. 1 (7 mg/10 mg, 14 mg/10 mg, 28 mg/10 mg), FD&C Yellow No. 6 (7 mg/10 mg, 21 mg/10 mg), red iron oxide (7 mg/10 mg, 21 mg/10 mg), and yellow iron oxide (7 mg/10 mg, 14 mg/10 mg, 21 mg/10 mg)."
},
{
"NDCCode": "0456-1228-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (0456-1228-30) ",
"NDC11Code": "00456-1228-30",
"ProductNDC": "0456-1228",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Namzaric",
"NonProprietaryName": "Memantine Hydrochloride And Donepezil Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20141224",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA206439",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "MEMANTINE HYDROCHLORIDE; DONEPEZIL HYDROCHLORIDE",
"StrengthNumber": "28; 10",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA], N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20141224",
"SamplePackage": "N",
"IndicationAndUsage": "NAMZARIC is indicated for the treatment of moderate to severe dementia of the Alzheimer’s type in patients stabilized on 10 mg of donepezil hydrochloride once daily.",
"Description": "NAMZARIC contains memantine, an orally active NMDA receptor antagonist, as the hydrochloride salt and donepezil, a reversible inhibitor of the enzyme acetylcholinesterase, as the hydrochloride salt. Memantine Hydrochloride. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride occurs as a fine white to off-white powder. Donepezil Hydrochloride. The chemical name for donepezil hydrochloride is 2,3-dihydro-5,6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. The molecular formula is C24H29NO3HCl and the molecular weight is 415.96. Donepezil hydrochloride is a white crystalline powder. NAMZARIC extended-release capsules contain 7 mg, 14 mg, 21 mg or 28 mg memantine hydrochloride, 10 mg donepezil hydrochloride, and the following inactive ingredients: colloidal silicon dioxide, corn starch, ethylcellulose, hypromellose, lactose monohydrate, magnesium stearate, medium chain triglycerides, microcrystalline cellulose, oleic acid, polyethylene glycol, povidone, sugar spheres, and talc. The capsule shells contain gelatin and titanium dioxide and are imprinted with shellac glaze and black iron oxide. Colorants are FD&C Blue No. 1 (7 mg/10 mg, 14 mg/10 mg, 28 mg/10 mg), FD&C Yellow No. 6 (7 mg/10 mg, 21 mg/10 mg), red iron oxide (7 mg/10 mg, 21 mg/10 mg), and yellow iron oxide (7 mg/10 mg, 14 mg/10 mg, 21 mg/10 mg)."
},
{
"NDCCode": "0456-1402-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (0456-1402-30) ",
"NDC11Code": "00456-1402-30",
"ProductNDC": "0456-1402",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bystolic",
"NonProprietaryName": "Nebivolol Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20080122",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021742",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "NEBIVOLOL HYDROCHLORIDE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20080122",
"SamplePackage": "N",
"IndicationAndUsage": "BYSTOLIC is a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1).",
"Description": "The chemical name for the active ingredient in BYSTOLIC (nebivolol) tablets is (1RS,1’RS)-1,1’-[(2RS,2’SR)-bis(6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl)]- 2,2’-iminodiethanol hydrochloride. Nebivolol is a racemate composed of d-Nebivolol and l-Nebivolol with the stereochemical designations of [SRRR]-nebivolol and [RSSS]-nebivolol, respectively. Nebivolol’s molecular formula is (C22H25F2NO4HCl) with the following structural formula. SRRR - or d-nebivolol hydrochloride. RSSS - or l-nebivolol hydrochloride. MW: 441.90 g/mol. Nebivolol hydrochloride is a white to almost white powder that is soluble in methanol, dimethylsulfoxide, and N,N-dimethylformamide, sparingly soluble in ethanol, propylene glycol, and polyethylene glycol, and very slightly soluble in hexane, dichloromethane, and methylbenzene. BYSTOLIC as tablets for oral administration contains nebivolol hydrochloride equivalent to 2.5, 5, 10, and 20 mg of nebivolol base. In addition, BYSTOLIC contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, D&C Red #27 Lake, FD&C Blue #2 Lake, FD&C Yellow #6 Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, polysorbate 80, and sodium lauryl sulfate."
},
{
"NDCCode": "0456-1405-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (0456-1405-30) ",
"NDC11Code": "00456-1405-30",
"ProductNDC": "0456-1405",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bystolic",
"NonProprietaryName": "Nebivolol Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20080122",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021742",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "NEBIVOLOL HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20080122",
"SamplePackage": "N",
"IndicationAndUsage": "BYSTOLIC is a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1).",
"Description": "The chemical name for the active ingredient in BYSTOLIC (nebivolol) tablets is (1RS,1’RS)-1,1’-[(2RS,2’SR)-bis(6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl)]- 2,2’-iminodiethanol hydrochloride. Nebivolol is a racemate composed of d-Nebivolol and l-Nebivolol with the stereochemical designations of [SRRR]-nebivolol and [RSSS]-nebivolol, respectively. Nebivolol’s molecular formula is (C22H25F2NO4HCl) with the following structural formula. SRRR - or d-nebivolol hydrochloride. RSSS - or l-nebivolol hydrochloride. MW: 441.90 g/mol. Nebivolol hydrochloride is a white to almost white powder that is soluble in methanol, dimethylsulfoxide, and N,N-dimethylformamide, sparingly soluble in ethanol, propylene glycol, and polyethylene glycol, and very slightly soluble in hexane, dichloromethane, and methylbenzene. BYSTOLIC as tablets for oral administration contains nebivolol hydrochloride equivalent to 2.5, 5, 10, and 20 mg of nebivolol base. In addition, BYSTOLIC contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, D&C Red #27 Lake, FD&C Blue #2 Lake, FD&C Yellow #6 Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, polysorbate 80, and sodium lauryl sulfate."
}
]
}
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<NDCList>
<NDC>
<NDCCode>0456-2616-30</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0456-2616-30)</PackageDescription>
<NDC11Code>00456-2616-30</NDC11Code>
<ProductNDC>0456-2616</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tiazac</ProprietaryName>
<ProprietaryNameSuffix>Extended Release</ProprietaryNameSuffix>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101225</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020401</ApplicationNumber>
<LabelerName>Forest Laboratories, Inc.</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>360</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-11-21</LastUpdate>
</NDC>
<NDC>
<NDCCode>0456-2616-00</NDCCode>
<PackageDescription>1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0456-2616-00)</PackageDescription>
<NDC11Code>00456-2616-00</NDC11Code>
<ProductNDC>0456-2616</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tiazac</ProprietaryName>
<ProprietaryNameSuffix>Extended Release</ProprietaryNameSuffix>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101225</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020401</ApplicationNumber>
<LabelerName>Forest Laboratories, Inc.</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>360</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-11-21</LastUpdate>
</NDC>
<NDC>
<NDCCode>0456-2616-07</NDCCode>
<PackageDescription>7 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (0456-2616-07)</PackageDescription>
<NDC11Code>00456-2616-07</NDC11Code>
<ProductNDC>0456-2616</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tiazac</ProprietaryName>
<ProprietaryNameSuffix>Extended Release</ProprietaryNameSuffix>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101225</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020401</ApplicationNumber>
<LabelerName>Forest Laboratories, Inc.</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>360</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-11-21</LastUpdate>
</NDC>
<NDC>
<NDCCode>0456-2616-63</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (0456-2616-63) > 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (0456-2616-11)</PackageDescription>
<NDC11Code>00456-2616-63</NDC11Code>
<ProductNDC>0456-2616</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tiazac</ProprietaryName>
<ProprietaryNameSuffix>Extended Release</ProprietaryNameSuffix>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101225</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020401</ApplicationNumber>
<LabelerName>Forest Laboratories, Inc.</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>360</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-11-21</LastUpdate>
</NDC>
<NDC>
<NDCCode>0456-2616-90</NDCCode>
<PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0456-2616-90)</PackageDescription>
<NDC11Code>00456-2616-90</NDC11Code>
<ProductNDC>0456-2616</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tiazac</ProprietaryName>
<ProprietaryNameSuffix>Extended Release</ProprietaryNameSuffix>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101225</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020401</ApplicationNumber>
<LabelerName>Forest Laboratories, Inc.</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>360</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-11-21</LastUpdate>
</NDC>
<NDC>
<NDCCode>0187-2616-30</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0187-2616-30) </PackageDescription>
<NDC11Code>00187-2616-30</NDC11Code>
<ProductNDC>0187-2616</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tiazac</ProprietaryName>
<ProprietaryNameSuffix>Extended Release</ProprietaryNameSuffix>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140820</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020401</ApplicationNumber>
<LabelerName>Bausch Health US, LLC</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>360</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140820</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tiazac is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications.</IndicationAndUsage>
<Description>Tiazac® (diltiazem hydrochloride) is a calcium ion cellular influx inhibitor (slow channel blocker). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol and chloroform and has a molecular weight of 450.98. Tiazac capsules contain diltiazem hydrochloride in extended-release beads at doses of 120, 180, 240, 300, 360 and 420 mg. Tiazac also contains: black iron oxide, D&C Red No. 28, ethyl acrylate and methyl methacrylate copolymer dispersion, FD&C Blue No. 1, FD&C Green No. 3, FD&C Red No. 40, gelatin, hypromellose, magnesium stearate, microcrystalline cellulose, polysorbate, povidone, simethicone, sucrose stearate, talc, and titanium dioxide. USP Drug Release Test 6. For oral administration.</Description>
</NDC>
<NDC>
<NDCCode>0220-2616-41</NDCCode>
<PackageDescription>30 [hp_X] in 1 TUBE (0220-2616-41) </PackageDescription>
<NDC11Code>00220-2616-41</NDC11Code>
<ProductNDC>0220-2616</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ignatia Amara</ProprietaryName>
<NonProprietaryName>Strychnos Ignatii Seed</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19830303</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Boiron</LabelerName>
<SubstanceName>STRYCHNOS IGNATII SEED</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_X]/30[hp_X]</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-10-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19830303</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Relieves apprehension, hypersensitivity to stress *.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0527-2616-32</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (0527-2616-32) </PackageDescription>
<NDC11Code>00527-2616-32</NDC11Code>
<ProductNDC>0527-2616</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venlafaxine</ProprietaryName>
<NonProprietaryName>Venlafaxine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221231</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213927</ApplicationNumber>
<LabelerName>Lannett Company, Inc.</LabelerName>
<SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221231</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Venlafaxine Extended-Release Tablets are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for: 1 Major Depressive Disorder (MDD) (1.1), 2 Social Anxiety Disorder (SAD) (1.2).</IndicationAndUsage>
<Description>Venlafaxine Extended-Release Tablets (venlafaxine hydrochloride) are extended-release tablets for oral administration that contain venlafaxine hydrochloride, a structurally novel antidepressant. Venlafaxine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI). It is designated (R/S)-1-[2-(dimethylamino)-1-(4‑methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino) methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.87. The structural formula is shown below. Venlafaxine hydrochloride is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Venlafaxine Extended-Release Tablets are formulated as extended-release tablet for once-a-day oral administration. Venlafaxine Extended-Release Tablets use matrix core and extended release coating to deliver venlafaxine hydrochloride at a controlled rate over approximately 24 hours. The unitary tablet core is composed of the drug and excipients (including the matrix forming components). In an aqueous environment, such as the gastrointestinal tract, water permeates slowly through the coating into the tablet core, causing the hydrophilic matrix polymer to expand and to form a gel layer on the surface of the tablet. This gel acts as a barrier to the drug release; the drug is dissolved and is released by slow diffusion and erosion of the gel. The extended release coating layer controls the rate at which water permeates into the tablet core, which in turn controls also the rate of drug delivery. The controlled rate of drug delivery into the gastrointestinal lumen is thus independent of pH or gastrointestinal motility. Tablets contain venlafaxine hydrochloride equivalent to 75 mg venlafaxine. Inactive ingredients consist of dibasic calcium phosphate dihydrate, hypromellose, methacrylic acid copolymer, colloidal silicon dioxide, magnesium stearate, polyvinyl acetate dispersion, talc, polyvinyl alcohol graft polyethylene glycol copolymer, povidone, triethyl citrate, macrogol stearyl ether, sodium lauryl sulfate, carnauba wax, titanium dioxide, propylene glycol and FD&C blue #1.</Description>
</NDC>
<NDC>
<NDCCode>15631-2616-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE (15631-2616-1) </PackageDescription>
<NDC11Code>15631-2616-01</NDC11Code>
<ProductNDC>15631-2616</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aurum Met</ProprietaryName>
<NonProprietaryName>Aurum Met</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240523</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
<SubstanceName>GOLD</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>[hp_X]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-05-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240523</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>36987-2616-3</NDCCode>
<PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (36987-2616-3)</PackageDescription>
<NDC11Code>36987-2616-03</NDC11Code>
<ProductNDC>36987-2616</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Arizona Cypress</ProprietaryName>
<NonProprietaryName>Arizona Cypress</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>CUPRESSUS ARIZONICA POLLEN</SubstanceName>
<StrengthNumber>20000</StrengthNumber>
<StrengthUnit>[PNU]/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
<Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
</NDC>
<NDC>
<NDCCode>60505-2616-3</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (60505-2616-3)</PackageDescription>
<NDC11Code>60505-2616-03</NDC11Code>
<ProductNDC>60505-2616</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clarithromycin</ProprietaryName>
<NonProprietaryName>Clarithromycin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070913</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065384</ApplicationNumber>
<LabelerName>Apotex Corp</LabelerName>
<SubstanceName>CLARITHROMYCIN</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-04-11</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>70518-2616-0</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BLISTER PACK (70518-2616-0) </PackageDescription>
<NDC11Code>70518-2616-00</NDC11Code>
<ProductNDC>70518-2616</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200309</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200651</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200309</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gabapentin tablets are indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.</IndicationAndUsage>
<Description>The active ingredient in gabapentin tablets, USP is gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C 9H 17NO 2and the molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin USP is a white to off-white crystalline solid with a pK a1of 3.7 and a pK a2of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Each film-coated gabapentin tablet contains 600 mg or 800 mg of gabapentin USP and the following inactive ingredients:copovidone, corn starch, crospovidone, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, and talc.</Description>
</NDC>
<NDC>
<NDCCode>70518-2616-3</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2616-3) </PackageDescription>
<NDC11Code>70518-2616-03</NDC11Code>
<ProductNDC>70518-2616</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200309</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200651</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-09-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220405</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gabapentin tablets are indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.</IndicationAndUsage>
<Description>The active ingredient in gabapentin tablets, USP is gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C 9H 17NO 2and the molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin USP is a white to off-white crystalline solid with a pK a1of 3.7 and a pK a2of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Each film-coated gabapentin tablet contains 600 mg or 800 mg of gabapentin USP and the following inactive ingredients:copovidone, corn starch, crospovidone, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, and talc.</Description>
</NDC>
<NDC>
<NDCCode>71335-2616-2</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (71335-2616-2) </PackageDescription>
<NDC11Code>71335-2616-02</NDC11Code>
<ProductNDC>71335-2616</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bisoprolol Fumarate And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Bisoprolol Fumarate And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220126</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215995</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>2.5; 6.25</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250529</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bisoprolol fumarate and hydrochlorothiazide tablets are indicated in the management of hypertension.</IndicationAndUsage>
<Description>Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP are indicated for the treatment of hypertension. It combines two antihypertensive agents in a once-daily dosage: a synthetic beta1‑selective (cardioselective) adrenoceptor blocking agent (bisoprolol fumarate) and a benzothiadiazine diuretic (hydrochlorothiazide). Bisoprolol fumarate, USP is chemically described as (±)-1-[4-[[2-(1‑methylethoxy)ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-2-propanol(E)-2-butenedioate (2:1) (salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its empirical formula is (C18H31NO4)2C4H4O4 and it has a molecular weight of 766.96 g/mol. Its structural formula is. Bisoprolol fumarate, USP is a white crystalline powder, approximately equally hydrophilic and lipophilic, and very soluble in water, methanol, freely soluble in alcohol, glacial acetic acid and chloroform and slightly soluble in acetone and ethyl acetate. Hydrochlorothiazide (HCTZ), USP is 6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. It is a white, or almost white, almost odorless crystalline powder. It is very slightly soluble in water, soluble in acetone, freely soluble in n-butylamine, N,N-dimethylformamide and diluted solutions of alkali hydroxides, sparingly soluble in methanol and ethanol, and practically insoluble in ether, chloroform, and dilute mineral acids. Its empirical formula is C7H8ClN3O4S2 and it has a molecular weight of 297.7 g/mol. Its structural formula is. Each Bisoprolol Fumarate and Hydrochlorothiazide Tablet, USP 2.5 mg/6.25 mg for oral administration contains:. Bisoprolol fumarate, USP----------------------------------------------------------------2.5 mg. Hydrochlorothiazide, USP---------------------------------------------------------------6.25 mg. Each Bisoprolol Fumarate and Hydrochlorothiazide Tablet, USP 5 mg/6.25 mg for oral administration contains. Bisoprolol fumarate, USP----------------------------------------------------------------5 mg. Hydrochlorothiazide, USP---------------------------------------------------------------6.25 mg. Each Bisoprolol Fumarate and Hydrochlorothiazide Tablet, USP 10 mg/6.25 mg for oral administration contains. Bisoprolol fumarate, USP----------------------------------------------------------------10 mg. Hydrochlorothiazide, USP---------------------------------------------------------------6.25 mg. Inactive ingredients include Colloidal Silicon Dioxide, Corn Starch, Dibasic Calcium Phosphate Dihydrate, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80, and Titanium Dioxide. The 5 mg/6.25 mg tablet also contains Red and Yellow Iron Oxide. The 2.5 mg/6.25 mg tablet also contains Yellow Iron Oxide.</Description>
</NDC>
<NDC>
<NDCCode>0456-0095-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (0456-0095-30)</PackageDescription>
<NDC11Code>00456-0095-30</NDC11Code>
<ProductNDC>0456-0095</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Daliresp</ProprietaryName>
<NonProprietaryName>Roflumilast</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110228</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022522</ApplicationNumber>
<LabelerName>Forest Laboratories, Inc.</LabelerName>
<SubstanceName>ROFLUMILAST</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 4 Inhibitor [EPC],Phosphodiesterase 4 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-12-13</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0456-0800-30</NDCCode>
<PackageDescription>1 POUCH in 1 CARTON (0456-0800-30) > 1 INHALER in 1 POUCH > 30 INHALANT in 1 INHALER</PackageDescription>
<NDC11Code>00456-0800-30</NDC11Code>
<ProductNDC>0456-0800</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tudorza Pressair</ProprietaryName>
<NonProprietaryName>Aclidinium Bromide</NonProprietaryName>
<DosageFormName>INHALANT</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20120723</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202450</ApplicationNumber>
<LabelerName>Forest Laboratories, Inc.</LabelerName>
<SubstanceName>ACLIDINIUM BROMIDE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-12-13</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0456-0800-31</NDCCode>
<PackageDescription>1 POUCH in 1 CARTON (0456-0800-31) > 1 INHALER in 1 POUCH > 30 INHALANT in 1 INHALER</PackageDescription>
<NDC11Code>00456-0800-31</NDC11Code>
<ProductNDC>0456-0800</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tudorza Pressair</ProprietaryName>
<NonProprietaryName>Aclidinium Bromide</NonProprietaryName>
<DosageFormName>INHALANT</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20120723</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202450</ApplicationNumber>
<LabelerName>Forest Laboratories, Inc.</LabelerName>
<SubstanceName>ACLIDINIUM BROMIDE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-12-13</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0456-1101-30</NDCCode>
<PackageDescription>1 KIT in 1 BLISTER PACK (0456-1101-30) </PackageDescription>
<NDC11Code>00456-1101-30</NDC11Code>
<ProductNDC>0456-1101</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viibryd</ProprietaryName>
<NonProprietaryName>Vilazodone Hydrochloride</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110429</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022567</ApplicationNumber>
<LabelerName>Allergan, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2023-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110429</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0456-1110-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (0456-1110-30) </PackageDescription>
<NDC11Code>00456-1110-30</NDC11Code>
<ProductNDC>0456-1110</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viibryd</ProprietaryName>
<NonProprietaryName>Vilazodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110429</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022567</ApplicationNumber>
<LabelerName>Allergan, Inc.</LabelerName>
<SubstanceName>VILAZODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110429</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VIIBRYD® is indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].</IndicationAndUsage>
<Description>VIIBRYD tablets for oral administration contain polymorph Form IV vilazodone hydrochloride (HCl), a selective serotonin reuptake inhibitor and a 5HT1A receptor partial agonist. Vilazodone HCl is 2-benzofurancarboxamide, 5-[4-[4-(5-cyano-1H-indol-3-yl)butyl]-1-piprazinyl]-, hydrochloride (1:1). Its molecular weight is 477.99. The structural formula is. VIIBRYD tablets are available as 10 mg, 20 mg, and 40 mg film-coated tablets containing 10 mg, 20 mg, and 40 mg of vilazodone HCl, respectively. In addition to the active ingredient, VIIBRYD tablets contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, FD&C Blue #1 (40 mg only), FD&C Red #40 (10 mg only), and FD&C Yellow #6 (20 mg only).</Description>
</NDC>
<NDC>
<NDCCode>0456-1120-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (0456-1120-30) </PackageDescription>
<NDC11Code>00456-1120-30</NDC11Code>
<ProductNDC>0456-1120</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viibryd</ProprietaryName>
<NonProprietaryName>Vilazodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110429</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022567</ApplicationNumber>
<LabelerName>Allergan, Inc.</LabelerName>
<SubstanceName>VILAZODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110429</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VIIBRYD® is indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].</IndicationAndUsage>
<Description>VIIBRYD tablets for oral administration contain polymorph Form IV vilazodone hydrochloride (HCl), a selective serotonin reuptake inhibitor and a 5HT1A receptor partial agonist. Vilazodone HCl is 2-benzofurancarboxamide, 5-[4-[4-(5-cyano-1H-indol-3-yl)butyl]-1-piprazinyl]-, hydrochloride (1:1). Its molecular weight is 477.99. The structural formula is. VIIBRYD tablets are available as 10 mg, 20 mg, and 40 mg film-coated tablets containing 10 mg, 20 mg, and 40 mg of vilazodone HCl, respectively. In addition to the active ingredient, VIIBRYD tablets contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, FD&C Blue #1 (40 mg only), FD&C Red #40 (10 mg only), and FD&C Yellow #6 (20 mg only).</Description>
</NDC>
<NDC>
<NDCCode>0456-1140-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (0456-1140-30) </PackageDescription>
<NDC11Code>00456-1140-30</NDC11Code>
<ProductNDC>0456-1140</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viibryd</ProprietaryName>
<NonProprietaryName>Vilazodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110429</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022567</ApplicationNumber>
<LabelerName>Allergan, Inc.</LabelerName>
<SubstanceName>VILAZODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110429</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VIIBRYD® is indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)].</IndicationAndUsage>
<Description>VIIBRYD tablets for oral administration contain polymorph Form IV vilazodone hydrochloride (HCl), a selective serotonin reuptake inhibitor and a 5HT1A receptor partial agonist. Vilazodone HCl is 2-benzofurancarboxamide, 5-[4-[4-(5-cyano-1H-indol-3-yl)butyl]-1-piprazinyl]-, hydrochloride (1:1). Its molecular weight is 477.99. The structural formula is. VIIBRYD tablets are available as 10 mg, 20 mg, and 40 mg film-coated tablets containing 10 mg, 20 mg, and 40 mg of vilazodone HCl, respectively. In addition to the active ingredient, VIIBRYD tablets contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, FD&C Blue #1 (40 mg only), FD&C Red #40 (10 mg only), and FD&C Yellow #6 (20 mg only).</Description>
</NDC>
<NDC>
<NDCCode>0456-1201-30</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0456-1201-30) / 30 CAPSULE, GELATIN COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>00456-1201-30</NDC11Code>
<ProductNDC>0456-1201</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Linzess</ProprietaryName>
<NonProprietaryName>Linaclotide</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120908</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202811</ApplicationNumber>
<LabelerName>Allergan, Inc.</LabelerName>
<SubstanceName>LINACLOTIDE</SubstanceName>
<StrengthNumber>145</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Guanylate Cyclase Activators [MoA], Guanylate Cyclase-C Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120908</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LINZESS is indicated for the treatment of. irritable bowel syndrome with constipation (IBS-C) in adults and pediatric patients 7 years of age and older. chronic idiopathic constipation (CIC) in adults. functional constipation (FC) in pediatric patients 2 years of age and older.</IndicationAndUsage>
<Description>LINZESS (linaclotide) is a guanylate cyclase-C (GC-C) agonist. Linaclotide is a 14-amino acid peptide with the following chemical name: L-cysteinyl-L-cysteinyl-L-glutamyl-L-tyrosyl-L-cysteinyl-L-cysteinyl-L-asparaginyl-L-prolyl-L-alanyl-L-cysteinyl-L-threonyl-glycyl-L-cysteinyl-L-tyrosine, cyclic (1-6), (2-10), (5-13)-tris (disulfide). The molecular formula of linaclotide is C59H79N15O21S6 and its molecular weight is 1526.8. The amino acid sequence for linaclotide is shown below. Linaclotide is an amorphous, white to off-white powder. It is slightly soluble in water and aqueous sodium chloride (0.9%). LINZESS contains linaclotide-coated beads in hard gelatin capsules. LINZESS is available as 72 mcg, 145 mcg and 290 mcg capsules for oral administration. The inactive ingredients of LINZESS 72 mcg capsules include: calcium chloride dihydrate, L-histidine, microcrystalline cellulose, polyvinyl alcohol, and talc. The components of the capsule shell include gelatin and titanium dioxide. The inactive ingredients of LINZESS 145 mcg and 290 mcg capsules include: calcium chloride dihydrate, hypromellose, L-leucine, and microcrystalline cellulose. The components of the capsule shell include gelatin and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0456-1202-30</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0456-1202-30) / 30 CAPSULE, GELATIN COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>00456-1202-30</NDC11Code>
<ProductNDC>0456-1202</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Linzess</ProprietaryName>
<NonProprietaryName>Linaclotide</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120908</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202811</ApplicationNumber>
<LabelerName>Allergan, Inc.</LabelerName>
<SubstanceName>LINACLOTIDE</SubstanceName>
<StrengthNumber>290</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Guanylate Cyclase Activators [MoA], Guanylate Cyclase-C Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120908</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LINZESS is indicated for the treatment of. irritable bowel syndrome with constipation (IBS-C) in adults and pediatric patients 7 years of age and older. chronic idiopathic constipation (CIC) in adults. functional constipation (FC) in pediatric patients 2 years of age and older.</IndicationAndUsage>
<Description>LINZESS (linaclotide) is a guanylate cyclase-C (GC-C) agonist. Linaclotide is a 14-amino acid peptide with the following chemical name: L-cysteinyl-L-cysteinyl-L-glutamyl-L-tyrosyl-L-cysteinyl-L-cysteinyl-L-asparaginyl-L-prolyl-L-alanyl-L-cysteinyl-L-threonyl-glycyl-L-cysteinyl-L-tyrosine, cyclic (1-6), (2-10), (5-13)-tris (disulfide). The molecular formula of linaclotide is C59H79N15O21S6 and its molecular weight is 1526.8. The amino acid sequence for linaclotide is shown below. Linaclotide is an amorphous, white to off-white powder. It is slightly soluble in water and aqueous sodium chloride (0.9%). LINZESS contains linaclotide-coated beads in hard gelatin capsules. LINZESS is available as 72 mcg, 145 mcg and 290 mcg capsules for oral administration. The inactive ingredients of LINZESS 72 mcg capsules include: calcium chloride dihydrate, L-histidine, microcrystalline cellulose, polyvinyl alcohol, and talc. The components of the capsule shell include gelatin and titanium dioxide. The inactive ingredients of LINZESS 145 mcg and 290 mcg capsules include: calcium chloride dihydrate, hypromellose, L-leucine, and microcrystalline cellulose. The components of the capsule shell include gelatin and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0456-1203-30</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0456-1203-30) / 30 CAPSULE, GELATIN COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>00456-1203-30</NDC11Code>
<ProductNDC>0456-1203</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Linzess</ProprietaryName>
<NonProprietaryName>Linaclotide</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170130</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202811</ApplicationNumber>
<LabelerName>Allergan, Inc.</LabelerName>
<SubstanceName>LINACLOTIDE</SubstanceName>
<StrengthNumber>72</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Guanylate Cyclase Activators [MoA], Guanylate Cyclase-C Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LINZESS is indicated for the treatment of. irritable bowel syndrome with constipation (IBS-C) in adults and pediatric patients 7 years of age and older. chronic idiopathic constipation (CIC) in adults. functional constipation (FC) in pediatric patients 2 years of age and older.</IndicationAndUsage>
<Description>LINZESS (linaclotide) is a guanylate cyclase-C (GC-C) agonist. Linaclotide is a 14-amino acid peptide with the following chemical name: L-cysteinyl-L-cysteinyl-L-glutamyl-L-tyrosyl-L-cysteinyl-L-cysteinyl-L-asparaginyl-L-prolyl-L-alanyl-L-cysteinyl-L-threonyl-glycyl-L-cysteinyl-L-tyrosine, cyclic (1-6), (2-10), (5-13)-tris (disulfide). The molecular formula of linaclotide is C59H79N15O21S6 and its molecular weight is 1526.8. The amino acid sequence for linaclotide is shown below. Linaclotide is an amorphous, white to off-white powder. It is slightly soluble in water and aqueous sodium chloride (0.9%). LINZESS contains linaclotide-coated beads in hard gelatin capsules. LINZESS is available as 72 mcg, 145 mcg and 290 mcg capsules for oral administration. The inactive ingredients of LINZESS 72 mcg capsules include: calcium chloride dihydrate, L-histidine, microcrystalline cellulose, polyvinyl alcohol, and talc. The components of the capsule shell include gelatin and titanium dioxide. The inactive ingredients of LINZESS 145 mcg and 290 mcg capsules include: calcium chloride dihydrate, hypromellose, L-leucine, and microcrystalline cellulose. The components of the capsule shell include gelatin and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0456-1207-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (0456-1207-30) </PackageDescription>
<NDC11Code>00456-1207-30</NDC11Code>
<ProductNDC>0456-1207</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Namzaric</ProprietaryName>
<NonProprietaryName>Memantine Hydrochloride And Donepezil Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160718</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA206439</ApplicationNumber>
<LabelerName>Allergan, Inc.</LabelerName>
<SubstanceName>MEMANTINE HYDROCHLORIDE; DONEPEZIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>7; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA], N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160718</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NAMZARIC is indicated for the treatment of moderate to severe dementia of the Alzheimer’s type in patients stabilized on 10 mg of donepezil hydrochloride once daily.</IndicationAndUsage>
<Description>NAMZARIC contains memantine, an orally active NMDA receptor antagonist, as the hydrochloride salt and donepezil, a reversible inhibitor of the enzyme acetylcholinesterase, as the hydrochloride salt. Memantine Hydrochloride. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride occurs as a fine white to off-white powder. Donepezil Hydrochloride. The chemical name for donepezil hydrochloride is 2,3-dihydro-5,6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. The molecular formula is C24H29NO3HCl and the molecular weight is 415.96. Donepezil hydrochloride is a white crystalline powder. NAMZARIC extended-release capsules contain 7 mg, 14 mg, 21 mg or 28 mg memantine hydrochloride, 10 mg donepezil hydrochloride, and the following inactive ingredients: colloidal silicon dioxide, corn starch, ethylcellulose, hypromellose, lactose monohydrate, magnesium stearate, medium chain triglycerides, microcrystalline cellulose, oleic acid, polyethylene glycol, povidone, sugar spheres, and talc. The capsule shells contain gelatin and titanium dioxide and are imprinted with shellac glaze and black iron oxide. Colorants are FD&C Blue No. 1 (7 mg/10 mg, 14 mg/10 mg, 28 mg/10 mg), FD&C Yellow No. 6 (7 mg/10 mg, 21 mg/10 mg), red iron oxide (7 mg/10 mg, 21 mg/10 mg), and yellow iron oxide (7 mg/10 mg, 14 mg/10 mg, 21 mg/10 mg).</Description>
</NDC>
<NDC>
<NDCCode>0456-1214-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (0456-1214-30) </PackageDescription>
<NDC11Code>00456-1214-30</NDC11Code>
<ProductNDC>0456-1214</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Namzaric</ProprietaryName>
<NonProprietaryName>Memantine Hydrochloride And Donepezil Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141224</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA206439</ApplicationNumber>
<LabelerName>Allergan, Inc.</LabelerName>
<SubstanceName>MEMANTINE HYDROCHLORIDE; DONEPEZIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>14; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA], N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141224</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NAMZARIC is indicated for the treatment of moderate to severe dementia of the Alzheimer’s type in patients stabilized on 10 mg of donepezil hydrochloride once daily.</IndicationAndUsage>
<Description>NAMZARIC contains memantine, an orally active NMDA receptor antagonist, as the hydrochloride salt and donepezil, a reversible inhibitor of the enzyme acetylcholinesterase, as the hydrochloride salt. Memantine Hydrochloride. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride occurs as a fine white to off-white powder. Donepezil Hydrochloride. The chemical name for donepezil hydrochloride is 2,3-dihydro-5,6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. The molecular formula is C24H29NO3HCl and the molecular weight is 415.96. Donepezil hydrochloride is a white crystalline powder. NAMZARIC extended-release capsules contain 7 mg, 14 mg, 21 mg or 28 mg memantine hydrochloride, 10 mg donepezil hydrochloride, and the following inactive ingredients: colloidal silicon dioxide, corn starch, ethylcellulose, hypromellose, lactose monohydrate, magnesium stearate, medium chain triglycerides, microcrystalline cellulose, oleic acid, polyethylene glycol, povidone, sugar spheres, and talc. The capsule shells contain gelatin and titanium dioxide and are imprinted with shellac glaze and black iron oxide. Colorants are FD&C Blue No. 1 (7 mg/10 mg, 14 mg/10 mg, 28 mg/10 mg), FD&C Yellow No. 6 (7 mg/10 mg, 21 mg/10 mg), red iron oxide (7 mg/10 mg, 21 mg/10 mg), and yellow iron oxide (7 mg/10 mg, 14 mg/10 mg, 21 mg/10 mg).</Description>
</NDC>
<NDC>
<NDCCode>0456-1221-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (0456-1221-30) </PackageDescription>
<NDC11Code>00456-1221-30</NDC11Code>
<ProductNDC>0456-1221</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Namzaric</ProprietaryName>
<NonProprietaryName>Memantine Hydrochloride And Donepezil Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160718</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA206439</ApplicationNumber>
<LabelerName>Allergan, Inc.</LabelerName>
<SubstanceName>MEMANTINE HYDROCHLORIDE; DONEPEZIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>21; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA], N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160718</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NAMZARIC is indicated for the treatment of moderate to severe dementia of the Alzheimer’s type in patients stabilized on 10 mg of donepezil hydrochloride once daily.</IndicationAndUsage>
<Description>NAMZARIC contains memantine, an orally active NMDA receptor antagonist, as the hydrochloride salt and donepezil, a reversible inhibitor of the enzyme acetylcholinesterase, as the hydrochloride salt. Memantine Hydrochloride. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride occurs as a fine white to off-white powder. Donepezil Hydrochloride. The chemical name for donepezil hydrochloride is 2,3-dihydro-5,6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. The molecular formula is C24H29NO3HCl and the molecular weight is 415.96. Donepezil hydrochloride is a white crystalline powder. NAMZARIC extended-release capsules contain 7 mg, 14 mg, 21 mg or 28 mg memantine hydrochloride, 10 mg donepezil hydrochloride, and the following inactive ingredients: colloidal silicon dioxide, corn starch, ethylcellulose, hypromellose, lactose monohydrate, magnesium stearate, medium chain triglycerides, microcrystalline cellulose, oleic acid, polyethylene glycol, povidone, sugar spheres, and talc. The capsule shells contain gelatin and titanium dioxide and are imprinted with shellac glaze and black iron oxide. Colorants are FD&C Blue No. 1 (7 mg/10 mg, 14 mg/10 mg, 28 mg/10 mg), FD&C Yellow No. 6 (7 mg/10 mg, 21 mg/10 mg), red iron oxide (7 mg/10 mg, 21 mg/10 mg), and yellow iron oxide (7 mg/10 mg, 14 mg/10 mg, 21 mg/10 mg).</Description>
</NDC>
<NDC>
<NDCCode>0456-1228-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (0456-1228-30) </PackageDescription>
<NDC11Code>00456-1228-30</NDC11Code>
<ProductNDC>0456-1228</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Namzaric</ProprietaryName>
<NonProprietaryName>Memantine Hydrochloride And Donepezil Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141224</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA206439</ApplicationNumber>
<LabelerName>Allergan, Inc.</LabelerName>
<SubstanceName>MEMANTINE HYDROCHLORIDE; DONEPEZIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>28; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA], N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141224</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>NAMZARIC is indicated for the treatment of moderate to severe dementia of the Alzheimer’s type in patients stabilized on 10 mg of donepezil hydrochloride once daily.</IndicationAndUsage>
<Description>NAMZARIC contains memantine, an orally active NMDA receptor antagonist, as the hydrochloride salt and donepezil, a reversible inhibitor of the enzyme acetylcholinesterase, as the hydrochloride salt. Memantine Hydrochloride. The chemical name for memantine hydrochloride is 1-amino-3,5-dimethyladamantane hydrochloride with the following structural formula. The molecular formula is C12H21NHCl and the molecular weight is 215.76. Memantine hydrochloride occurs as a fine white to off-white powder. Donepezil Hydrochloride. The chemical name for donepezil hydrochloride is 2,3-dihydro-5,6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride. The molecular formula is C24H29NO3HCl and the molecular weight is 415.96. Donepezil hydrochloride is a white crystalline powder. NAMZARIC extended-release capsules contain 7 mg, 14 mg, 21 mg or 28 mg memantine hydrochloride, 10 mg donepezil hydrochloride, and the following inactive ingredients: colloidal silicon dioxide, corn starch, ethylcellulose, hypromellose, lactose monohydrate, magnesium stearate, medium chain triglycerides, microcrystalline cellulose, oleic acid, polyethylene glycol, povidone, sugar spheres, and talc. The capsule shells contain gelatin and titanium dioxide and are imprinted with shellac glaze and black iron oxide. Colorants are FD&C Blue No. 1 (7 mg/10 mg, 14 mg/10 mg, 28 mg/10 mg), FD&C Yellow No. 6 (7 mg/10 mg, 21 mg/10 mg), red iron oxide (7 mg/10 mg, 21 mg/10 mg), and yellow iron oxide (7 mg/10 mg, 14 mg/10 mg, 21 mg/10 mg).</Description>
</NDC>
<NDC>
<NDCCode>0456-1402-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (0456-1402-30) </PackageDescription>
<NDC11Code>00456-1402-30</NDC11Code>
<ProductNDC>0456-1402</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bystolic</ProprietaryName>
<NonProprietaryName>Nebivolol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080122</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021742</ApplicationNumber>
<LabelerName>Allergan, Inc.</LabelerName>
<SubstanceName>NEBIVOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080122</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BYSTOLIC is a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1).</IndicationAndUsage>
<Description>The chemical name for the active ingredient in BYSTOLIC (nebivolol) tablets is (1RS,1’RS)-1,1’-[(2RS,2’SR)-bis(6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl)]- 2,2’-iminodiethanol hydrochloride. Nebivolol is a racemate composed of d-Nebivolol and l-Nebivolol with the stereochemical designations of [SRRR]-nebivolol and [RSSS]-nebivolol, respectively. Nebivolol’s molecular formula is (C22H25F2NO4HCl) with the following structural formula. SRRR - or d-nebivolol hydrochloride. RSSS - or l-nebivolol hydrochloride. MW: 441.90 g/mol. Nebivolol hydrochloride is a white to almost white powder that is soluble in methanol, dimethylsulfoxide, and N,N-dimethylformamide, sparingly soluble in ethanol, propylene glycol, and polyethylene glycol, and very slightly soluble in hexane, dichloromethane, and methylbenzene. BYSTOLIC as tablets for oral administration contains nebivolol hydrochloride equivalent to 2.5, 5, 10, and 20 mg of nebivolol base. In addition, BYSTOLIC contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, D&C Red #27 Lake, FD&C Blue #2 Lake, FD&C Yellow #6 Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, polysorbate 80, and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
<NDCCode>0456-1405-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (0456-1405-30) </PackageDescription>
<NDC11Code>00456-1405-30</NDC11Code>
<ProductNDC>0456-1405</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bystolic</ProprietaryName>
<NonProprietaryName>Nebivolol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080122</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021742</ApplicationNumber>
<LabelerName>Allergan, Inc.</LabelerName>
<SubstanceName>NEBIVOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080122</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BYSTOLIC is a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1).</IndicationAndUsage>
<Description>The chemical name for the active ingredient in BYSTOLIC (nebivolol) tablets is (1RS,1’RS)-1,1’-[(2RS,2’SR)-bis(6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl)]- 2,2’-iminodiethanol hydrochloride. Nebivolol is a racemate composed of d-Nebivolol and l-Nebivolol with the stereochemical designations of [SRRR]-nebivolol and [RSSS]-nebivolol, respectively. Nebivolol’s molecular formula is (C22H25F2NO4HCl) with the following structural formula. SRRR - or d-nebivolol hydrochloride. RSSS - or l-nebivolol hydrochloride. MW: 441.90 g/mol. Nebivolol hydrochloride is a white to almost white powder that is soluble in methanol, dimethylsulfoxide, and N,N-dimethylformamide, sparingly soluble in ethanol, propylene glycol, and polyethylene glycol, and very slightly soluble in hexane, dichloromethane, and methylbenzene. BYSTOLIC as tablets for oral administration contains nebivolol hydrochloride equivalent to 2.5, 5, 10, and 20 mg of nebivolol base. In addition, BYSTOLIC contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, D&C Red #27 Lake, FD&C Blue #2 Lake, FD&C Yellow #6 Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, polysorbate 80, and sodium lauryl sulfate.</Description>
</NDC>
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