{
"NDC": [
{
"NDCCode": "33342-215-58",
"PackageDescription": "270 TABLET, FILM COATED in 1 BOTTLE (33342-215-58) ",
"NDC11Code": "33342-0215-58",
"ProductNDC": "33342-215",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sevelamer Carbonate",
"NonProprietaryName": "Sevelamer Carbonate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230419",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206100",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "SEVELAMER CARBONATE",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230419",
"SamplePackage": "N",
"IndicationAndUsage": "Sevelamer carbonate tablets are indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease (CKD) on dialysis.",
"Description": "The active ingredient in sevelamer carbonate tablets is sevelamer carbonate, a polymeric amine that binds phosphate and is meant for oral administration. It was developed as a pharmaceutical alternative to sevelamer hydrochloride. Sevelamer carbonate is an anion exchange resin, with the same polymeric structure as sevelamer hydrochloride, in which carbonate replaces chloride as the counterion. While the counterions differ for the two salts, the polymer itself, the active moiety involved in phosphate binding, is the same. Sevelamer carbonate is known chemically as poly(allylamine-co-N,N’-diallyl-1,3-diamino-2-hydroxypropane) carbonate salt. Sevelamer carbonate is hygroscopic, but insoluble in water. The structure is represented in Figure 1. Figure 1: Chemical Structure of Sevelamer Carbonate a, b = number of primary amine groups a + b = 9 c = number of cross-linking groups c = 1 m = large number to indicate extended polymer network Sevelamer Carbonate Tablets: Each film-coated tablet of sevelamer carbonate contains 800 mg of sevelamer carbonate on an anhydrous basis. The inactive ingredients are microcrystalline cellulose, hydroxy propyl cellulose, colloidal silicon dioxide, zinc stearate, hypromellose, diacetylated monoglycerides. Imprinting ink contains ammonium hydroxide, iron oxide black, propylene glycol and shellac."
},
{
"NDCCode": "33342-215-56",
"PackageDescription": "14 BLISTER PACK in 1 CARTON (33342-215-56) / 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "33342-0215-56",
"ProductNDC": "33342-215",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sevelamer Carbonate",
"NonProprietaryName": "Sevelamer Carbonate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230419",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206100",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "SEVELAMER CARBONATE",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251031",
"SamplePackage": "N",
"IndicationAndUsage": "Sevelamer carbonate tablets are indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease (CKD) on dialysis.",
"Description": "The active ingredient in sevelamer carbonate tablets is sevelamer carbonate, a polymeric amine that binds phosphate and is meant for oral administration. It was developed as a pharmaceutical alternative to sevelamer hydrochloride. Sevelamer carbonate is an anion exchange resin, with the same polymeric structure as sevelamer hydrochloride, in which carbonate replaces chloride as the counterion. While the counterions differ for the two salts, the polymer itself, the active moiety involved in phosphate binding, is the same. Sevelamer carbonate is known chemically as poly(allylamine-co-N,N’-diallyl-1,3-diamino-2-hydroxypropane) carbonate salt. Sevelamer carbonate is hygroscopic, but insoluble in water. The structure is represented in Figure 1. Figure 1: Chemical Structure of Sevelamer Carbonate a, b = number of primary amine groups a + b = 9 c = number of cross-linking groups c = 1 m = large number to indicate extended polymer network Sevelamer Carbonate Tablets: Each film-coated tablet of sevelamer carbonate contains 800 mg of sevelamer carbonate on an anhydrous basis. The inactive ingredients are microcrystalline cellulose, hydroxy propyl cellulose, colloidal silicon dioxide, zinc stearate, hypromellose, diacetylated monoglycerides. Imprinting ink contains ammonium hydroxide, iron oxide black, propylene glycol and shellac."
},
{
"NDCCode": "33342-215-57",
"PackageDescription": "180 TABLET, FILM COATED in 1 BOTTLE (33342-215-57) ",
"NDC11Code": "33342-0215-57",
"ProductNDC": "33342-215",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sevelamer Carbonate",
"NonProprietaryName": "Sevelamer Carbonate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20230419",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206100",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "SEVELAMER CARBONATE",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260313",
"SamplePackage": "N",
"IndicationAndUsage": "Sevelamer carbonate tablets are indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease (CKD) on dialysis.",
"Description": "The active ingredient in sevelamer carbonate tablets is sevelamer carbonate, a polymeric amine that binds phosphate and is meant for oral administration. It was developed as a pharmaceutical alternative to sevelamer hydrochloride. Sevelamer carbonate is an anion exchange resin, with the same polymeric structure as sevelamer hydrochloride, in which carbonate replaces chloride as the counterion. While the counterions differ for the two salts, the polymer itself, the active moiety involved in phosphate binding, is the same. Sevelamer carbonate is known chemically as poly(allylamine-co-N,N’-diallyl-1,3-diamino-2-hydroxypropane) carbonate salt. Sevelamer carbonate is hygroscopic, but insoluble in water. The structure is represented in Figure 1. Figure 1: Chemical Structure of Sevelamer Carbonate a, b = number of primary amine groups a + b = 9 c = number of cross-linking groups c = 1 m = large number to indicate extended polymer network Sevelamer Carbonate Tablets: Each film-coated tablet of sevelamer carbonate contains 800 mg of sevelamer carbonate on an anhydrous basis. The inactive ingredients are microcrystalline cellulose, hydroxy propyl cellulose, colloidal silicon dioxide, zinc stearate, hypromellose, diacetylated monoglycerides. Imprinting ink contains ammonium hydroxide, iron oxide black, propylene glycol and shellac."
},
{
"NDCCode": "33342-461-58",
"PackageDescription": "270 CAPSULE in 1 BOTTLE (33342-461-58) ",
"NDC11Code": "33342-0461-58",
"ProductNDC": "33342-461",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pirfenidone Capsule, 267 Mg",
"NonProprietaryName": "Pirfenidone Capsule, 267 Mg",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20200720",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212748",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "PIRFENIDONE",
"StrengthNumber": "267",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Pyridone [EPC], Pyridones [CS]",
"Status": "Active",
"LastUpdate": "2025-04-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200720",
"SamplePackage": "N",
"IndicationAndUsage": "Pirfenidone capsules are indicated for the treatment of idiopathic pulmonary fibrosis (IPF).",
"Description": "Pirfenidone belongs to the chemical class of pyridone. Pirfenidone capsules USP are available as a white to off-white hard gelatin capsule containing 267 mg of pirfenidone for oral administration. Pirfenidone has a molecular formula of C12H11NO and a molecular weight of 185.23. Pirfenidone has the following structural formula, which has been referred to as 5-methyl-1-phenyl-2-1(H)-pyridone or 5-methyl-1-phenyl-2-(1H)-pyridone. Pirfenidone is a white to pale yellow, non-hygroscopic powder. It is more soluble in methanol, ethyl alcohol, acetone and chloroform than in water and 1.0 N HCl. The melting point is approximately 109°C. Pirfenidone capsules, USP contains pirfenidone and the following inactive ingredients: croscarmellose sodium, magnesium stearate, and pregelatinized starch. In addition, the capsule shell contains gelatin and titanium dioxide. The capsule brown printing ink includes ammonium hydroxide, iron oxide black, iron oxide brown, potassium hydroxide, propylene glycol, shellac."
},
{
"NDCCode": "33342-536-58",
"PackageDescription": "6500 TABLET, FILM COATED in 1 POUCH (33342-536-58) ",
"NDC11Code": "33342-0536-58",
"ProductNDC": "33342-536",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sildenafil",
"NonProprietaryName": "Sildenafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140103",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203814",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "SILDENAFIL CITRATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-04-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220113",
"SamplePackage": "N",
"IndicationAndUsage": "Adults. Sildenafil tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening [see Clinical Studies (14)]. Pediatric use information is approved for Viatris Specialty LLC's, REVATIO (sildenafil) tablets. However, due to Viatris Specialty LLC's marketing exclusivity rights, this drug product is not labeled with that information.",
"Description": "Sildenafil Tablets, USP phosphodiesterase-5 (PDE-5) inhibitor, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type-5 (PDE-5). Sildenafil is also marketed as VIAGRA® for erectile dysfunction. Sildenafil citrate, USP is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo [4,3-d] pyrimidin-5-yl)-4-ethoxyphenyl] sulfonyl]-4-methylpiperazine citrate and has the following structural formula. Sildenafil citrate, USP is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7. Sildenafil Tablets USP, 20 mg: Sildenafil tablets are formulated as white to off white, film-coated round tablets for oral administration. Each tablet contains sildenafil citrate equivalent to 20 mg of sildenafil. In addition to the active ingredient, sildenafil citrate, USP each tablet contains the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate dihydrate, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide and triacetin."
},
{
"NDCCode": "30142-215-58",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (30142-215-58) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
"NDC11Code": "30142-0215-58",
"ProductNDC": "30142-215",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Daytime",
"ProprietaryNameSuffix": "Non Drowsy",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20080830",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Kroger Company",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "325; 10; 5",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2017-12-13",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "49035-215-58",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (49035-215-58) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
"NDC11Code": "49035-0215-58",
"ProductNDC": "49035-215",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Equate Daytime",
"ProprietaryNameSuffix": "Cold And Flu",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20061030",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Wal-Mart Stores Inc",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "325; 10; 5",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2017-12-18",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "49281-215-10",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 PACKAGE (49281-215-10) / .5 mL in 1 VIAL, SINGLE-DOSE (49281-215-58) ",
"NDC11Code": "49281-0215-10",
"ProductNDC": "49281-215",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Tenivac",
"NonProprietaryName": "Clostridium Tetani Toxoid Antigen (formaldehyde Inactivated) And Corynebacterium Diphtheriae Toxoid Antigen (formaldehyde Inactivated)",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20101208",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103171",
"LabelerName": "Sanofi Vaccines US Inc.",
"SubstanceName": "CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)",
"StrengthNumber": "5; 2",
"StrengthUnit": "[Lf]/.5mL; [Lf]/.5mL",
"Pharm_Classes": "Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Diphtheria Toxoid [CS], Inactivated Clostridium Tetani Vaccine [EPC], Inactivated Corynebacterium Diphtheriae Vaccine [EPC], Tetanus Toxoid [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS]",
"Status": "Active",
"LastUpdate": "2026-09-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20101208",
"SamplePackage": "N",
"IndicationAndUsage": "TENIVAC® is a vaccine indicated for active immunization for the prevention of tetanus and diphtheria in persons 7 years of age and older.",
"Description": "TENIVAC, Tetanus and Diphtheria Toxoids Adsorbed, is a sterile isotonic suspension of tetanus and diphtheria toxoids adsorbed on aluminum phosphate. Each 0.5 mL dose of TENIVAC contains the following active ingredients. Other ingredients per 0.5 mL dose include 1.5 mg of aluminum phosphate (0.33 mg of aluminum) as the adjuvant and ≤5.0 mcg of residual formaldehyde. Clostridium tetani is grown in modified Mueller-Miller casamino acid medium without beef heart infusion. (3) Tetanus toxin is detoxified with formaldehyde and purified by ammonium sulfate fractionation and diafiltration. Corynebacterium diphtheriae is grown in modified Mueller's growth medium. (4) After purification by ammonium sulfate fractionation, diphtheria toxin is detoxified with formaldehyde and diafiltered. Tetanus and diphtheria toxoids are individually adsorbed onto aluminum phosphate. The adsorbed tetanus and diphtheria toxoids are combined with aluminum phosphate (as adjuvant), sodium chloride and water for injection. This product contains no preservative. The potency of tetanus and diphtheria toxoids is measured by in vitro antigenicity enzyme-linked immunosorbent assays (ELISAs), which detect immunologically relevant epitopes. The tip caps of the prefilled syringes may contain natural rubber latex. The vial stoppers do not contain latex."
},
{
"NDCCode": "33342-066-28",
"PackageDescription": "240 mL in 1 BOTTLE (33342-066-28) ",
"NDC11Code": "33342-0066-28",
"ProductNDC": "33342-066",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Memantine Hydrochloride",
"NonProprietaryName": "Memantine Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20151013",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202790",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "MEMANTINE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2024-04-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20151013",
"SamplePackage": "N",
"IndicationAndUsage": "Memantine hydrochloride solution is indicated for the treatment of moderate to severe dementia of the Alzheimer's type.",
"Description": "Memantine hydrochloride, USP is an orally active NMDA receptor antagonist. 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 HCl occurs as a fine white to off-white powder and is soluble in water. Memantine hydrochloride oral solution contains memantine hydrochloride in a strength equivalent to 2 mg of memantine hydrochloride in each mL. The oral solution also contains the following inactive ingredients: sorbitol solution (70%), methyl paraben, propylparaben, propylene glycol, glycerin, natural peppermint flavor #104, citric acid, sodium citrate, and purified water."
},
{
"NDCCode": "33342-219-07",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-219-07) ",
"NDC11Code": "33342-0219-07",
"ProductNDC": "33342-219",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Memantine Hydrochloride",
"NonProprietaryName": "Memantine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20250828",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206310",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "MEMANTINE HYDROCHLORIDE",
"StrengthNumber": "7",
"StrengthUnit": "mg/1",
"Pharm_Classes": "N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250828",
"SamplePackage": "N",
"IndicationAndUsage": "Memantine hydrochloride extended-release capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.",
"Description": "Memantine hydrochloride USP is an orally active NMDA receptor antagonist. 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 and is soluble in water. Memantine hydrochloride extended-release capsules are supplied for oral administration as 7 mg, 14 mg, 21 mg, and 28 mg capsules. Each capsule contains extended-release beads with the labeled amount of memantine hydrochloride USP and the following inactive ingredients: ethylcellulose, hydroxylpropylmethyl cellullose, sugar spheres and talc. Sugar spheres consist of sucrose and corn starch. Capsule shell consists of gelatin, sodium lauryl Sulphate, titanium dioxide with iron oxide yellow and FD & C blue no. 2 as colors. The capsules are imprinted with black ink and white ink. The inks consist of shellac, potassium hydroxide, titanium dioxide (only in white ink) and black iron oxide (only in black ink)."
},
{
"NDCCode": "33342-219-12",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (33342-219-12) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "33342-0219-12",
"ProductNDC": "33342-219",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Memantine Hydrochloride",
"NonProprietaryName": "Memantine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20250828",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206310",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "MEMANTINE HYDROCHLORIDE",
"StrengthNumber": "7",
"StrengthUnit": "mg/1",
"Pharm_Classes": "N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250828",
"SamplePackage": "N",
"IndicationAndUsage": "Memantine hydrochloride extended-release capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.",
"Description": "Memantine hydrochloride USP is an orally active NMDA receptor antagonist. 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 and is soluble in water. Memantine hydrochloride extended-release capsules are supplied for oral administration as 7 mg, 14 mg, 21 mg, and 28 mg capsules. Each capsule contains extended-release beads with the labeled amount of memantine hydrochloride USP and the following inactive ingredients: ethylcellulose, hydroxylpropylmethyl cellullose, sugar spheres and talc. Sugar spheres consist of sucrose and corn starch. Capsule shell consists of gelatin, sodium lauryl Sulphate, titanium dioxide with iron oxide yellow and FD & C blue no. 2 as colors. The capsules are imprinted with black ink and white ink. The inks consist of shellac, potassium hydroxide, titanium dioxide (only in white ink) and black iron oxide (only in black ink)."
},
{
"NDCCode": "33342-220-07",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-220-07) ",
"NDC11Code": "33342-0220-07",
"ProductNDC": "33342-220",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Memantine Hydrochloride",
"NonProprietaryName": "Memantine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20250828",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206310",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "MEMANTINE HYDROCHLORIDE",
"StrengthNumber": "14",
"StrengthUnit": "mg/1",
"Pharm_Classes": "N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250828",
"SamplePackage": "N",
"IndicationAndUsage": "Memantine hydrochloride extended-release capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.",
"Description": "Memantine hydrochloride USP is an orally active NMDA receptor antagonist. 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 and is soluble in water. Memantine hydrochloride extended-release capsules are supplied for oral administration as 7 mg, 14 mg, 21 mg, and 28 mg capsules. Each capsule contains extended-release beads with the labeled amount of memantine hydrochloride USP and the following inactive ingredients: ethylcellulose, hydroxylpropylmethyl cellullose, sugar spheres and talc. Sugar spheres consist of sucrose and corn starch. Capsule shell consists of gelatin, sodium lauryl Sulphate, titanium dioxide with iron oxide yellow and FD & C blue no. 2 as colors. The capsules are imprinted with black ink and white ink. The inks consist of shellac, potassium hydroxide, titanium dioxide (only in white ink) and black iron oxide (only in black ink)."
},
{
"NDCCode": "33342-220-12",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (33342-220-12) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "33342-0220-12",
"ProductNDC": "33342-220",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Memantine Hydrochloride",
"NonProprietaryName": "Memantine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20250828",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206310",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "MEMANTINE HYDROCHLORIDE",
"StrengthNumber": "14",
"StrengthUnit": "mg/1",
"Pharm_Classes": "N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250828",
"SamplePackage": "N",
"IndicationAndUsage": "Memantine hydrochloride extended-release capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.",
"Description": "Memantine hydrochloride USP is an orally active NMDA receptor antagonist. 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 and is soluble in water. Memantine hydrochloride extended-release capsules are supplied for oral administration as 7 mg, 14 mg, 21 mg, and 28 mg capsules. Each capsule contains extended-release beads with the labeled amount of memantine hydrochloride USP and the following inactive ingredients: ethylcellulose, hydroxylpropylmethyl cellullose, sugar spheres and talc. Sugar spheres consist of sucrose and corn starch. Capsule shell consists of gelatin, sodium lauryl Sulphate, titanium dioxide with iron oxide yellow and FD & C blue no. 2 as colors. The capsules are imprinted with black ink and white ink. The inks consist of shellac, potassium hydroxide, titanium dioxide (only in white ink) and black iron oxide (only in black ink)."
},
{
"NDCCode": "33342-221-07",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-221-07) ",
"NDC11Code": "33342-0221-07",
"ProductNDC": "33342-221",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Memantine Hydrochloride",
"NonProprietaryName": "Memantine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20250828",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206310",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "MEMANTINE HYDROCHLORIDE",
"StrengthNumber": "21",
"StrengthUnit": "mg/1",
"Pharm_Classes": "N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250828",
"SamplePackage": "N",
"IndicationAndUsage": "Memantine hydrochloride extended-release capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.",
"Description": "Memantine hydrochloride USP is an orally active NMDA receptor antagonist. 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 and is soluble in water. Memantine hydrochloride extended-release capsules are supplied for oral administration as 7 mg, 14 mg, 21 mg, and 28 mg capsules. Each capsule contains extended-release beads with the labeled amount of memantine hydrochloride USP and the following inactive ingredients: ethylcellulose, hydroxylpropylmethyl cellullose, sugar spheres and talc. Sugar spheres consist of sucrose and corn starch. Capsule shell consists of gelatin, sodium lauryl Sulphate, titanium dioxide with iron oxide yellow and FD & C blue no. 2 as colors. The capsules are imprinted with black ink and white ink. The inks consist of shellac, potassium hydroxide, titanium dioxide (only in white ink) and black iron oxide (only in black ink)."
},
{
"NDCCode": "33342-221-12",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (33342-221-12) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "33342-0221-12",
"ProductNDC": "33342-221",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Memantine Hydrochloride",
"NonProprietaryName": "Memantine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20250828",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206310",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "MEMANTINE HYDROCHLORIDE",
"StrengthNumber": "21",
"StrengthUnit": "mg/1",
"Pharm_Classes": "N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250828",
"SamplePackage": "N",
"IndicationAndUsage": "Memantine hydrochloride extended-release capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.",
"Description": "Memantine hydrochloride USP is an orally active NMDA receptor antagonist. 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 and is soluble in water. Memantine hydrochloride extended-release capsules are supplied for oral administration as 7 mg, 14 mg, 21 mg, and 28 mg capsules. Each capsule contains extended-release beads with the labeled amount of memantine hydrochloride USP and the following inactive ingredients: ethylcellulose, hydroxylpropylmethyl cellullose, sugar spheres and talc. Sugar spheres consist of sucrose and corn starch. Capsule shell consists of gelatin, sodium lauryl Sulphate, titanium dioxide with iron oxide yellow and FD & C blue no. 2 as colors. The capsules are imprinted with black ink and white ink. The inks consist of shellac, potassium hydroxide, titanium dioxide (only in white ink) and black iron oxide (only in black ink)."
},
{
"NDCCode": "33342-222-07",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-222-07) ",
"NDC11Code": "33342-0222-07",
"ProductNDC": "33342-222",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Memantine Hydrochloride",
"NonProprietaryName": "Memantine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20250828",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206310",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "MEMANTINE HYDROCHLORIDE",
"StrengthNumber": "28",
"StrengthUnit": "mg/1",
"Pharm_Classes": "N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250828",
"SamplePackage": "N",
"IndicationAndUsage": "Memantine hydrochloride extended-release capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.",
"Description": "Memantine hydrochloride USP is an orally active NMDA receptor antagonist. 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 and is soluble in water. Memantine hydrochloride extended-release capsules are supplied for oral administration as 7 mg, 14 mg, 21 mg, and 28 mg capsules. Each capsule contains extended-release beads with the labeled amount of memantine hydrochloride USP and the following inactive ingredients: ethylcellulose, hydroxylpropylmethyl cellullose, sugar spheres and talc. Sugar spheres consist of sucrose and corn starch. Capsule shell consists of gelatin, sodium lauryl Sulphate, titanium dioxide with iron oxide yellow and FD & C blue no. 2 as colors. The capsules are imprinted with black ink and white ink. The inks consist of shellac, potassium hydroxide, titanium dioxide (only in white ink) and black iron oxide (only in black ink)."
},
{
"NDCCode": "33342-222-12",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (33342-222-12) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "33342-0222-12",
"ProductNDC": "33342-222",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Memantine Hydrochloride",
"NonProprietaryName": "Memantine Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20250828",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206310",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "MEMANTINE HYDROCHLORIDE",
"StrengthNumber": "28",
"StrengthUnit": "mg/1",
"Pharm_Classes": "N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250828",
"SamplePackage": "N",
"IndicationAndUsage": "Memantine hydrochloride extended-release capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.",
"Description": "Memantine hydrochloride USP is an orally active NMDA receptor antagonist. 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 and is soluble in water. Memantine hydrochloride extended-release capsules are supplied for oral administration as 7 mg, 14 mg, 21 mg, and 28 mg capsules. Each capsule contains extended-release beads with the labeled amount of memantine hydrochloride USP and the following inactive ingredients: ethylcellulose, hydroxylpropylmethyl cellullose, sugar spheres and talc. Sugar spheres consist of sucrose and corn starch. Capsule shell consists of gelatin, sodium lauryl Sulphate, titanium dioxide with iron oxide yellow and FD & C blue no. 2 as colors. The capsules are imprinted with black ink and white ink. The inks consist of shellac, potassium hydroxide, titanium dioxide (only in white ink) and black iron oxide (only in black ink)."
},
{
"NDCCode": "33342-297-09",
"PackageDescription": "60 TABLET in 1 BOTTLE (33342-297-09) ",
"NDC11Code": "33342-0297-09",
"ProductNDC": "33342-297",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Memantine Hydrochloride",
"NonProprietaryName": "Memantine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151013",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202840",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "MEMANTINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20151013",
"SamplePackage": "N",
"IndicationAndUsage": "Memantine hydrochloride USP is indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.",
"Description": "Memantine hydrochloride USP is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride USP 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 and is soluble in water.Memantine hydrochloride USP is for oral administration as capsule-shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride. The tablets also contain the following inactive ingredients: microcrystalline cellulose/colloidal silicon dioxide, talc, croscarmellose sodium, and magnesium stearate. In addition the following inactive ingredients are also present as components of the film coat: hypromellose, titanium dioxide, polyethylene glycol 400, FD&C yellow #6 and FD&C blue #2 (5 mg tablets), and hypromellose, titanium dioxide, macrogol/polyethylene glycol 400 and iron oxide black (10 mg tablets)."
},
{
"NDCCode": "33342-297-12",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (33342-297-12) > 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "33342-0297-12",
"ProductNDC": "33342-297",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Memantine Hydrochloride",
"NonProprietaryName": "Memantine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151013",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202840",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "MEMANTINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20151013",
"SamplePackage": "N",
"IndicationAndUsage": "Memantine hydrochloride USP is indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.",
"Description": "Memantine hydrochloride USP is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride USP 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 and is soluble in water.Memantine hydrochloride USP is for oral administration as capsule-shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride. The tablets also contain the following inactive ingredients: microcrystalline cellulose/colloidal silicon dioxide, talc, croscarmellose sodium, and magnesium stearate. In addition the following inactive ingredients are also present as components of the film coat: hypromellose, titanium dioxide, polyethylene glycol 400, FD&C yellow #6 and FD&C blue #2 (5 mg tablets), and hypromellose, titanium dioxide, macrogol/polyethylene glycol 400 and iron oxide black (10 mg tablets)."
},
{
"NDCCode": "33342-297-15",
"PackageDescription": "500 TABLET in 1 BOTTLE (33342-297-15) ",
"NDC11Code": "33342-0297-15",
"ProductNDC": "33342-297",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Memantine Hydrochloride",
"NonProprietaryName": "Memantine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151013",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202840",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "MEMANTINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20151013",
"SamplePackage": "N",
"IndicationAndUsage": "Memantine hydrochloride USP is indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.",
"Description": "Memantine hydrochloride USP is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride USP 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 and is soluble in water.Memantine hydrochloride USP is for oral administration as capsule-shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride. The tablets also contain the following inactive ingredients: microcrystalline cellulose/colloidal silicon dioxide, talc, croscarmellose sodium, and magnesium stearate. In addition the following inactive ingredients are also present as components of the film coat: hypromellose, titanium dioxide, polyethylene glycol 400, FD&C yellow #6 and FD&C blue #2 (5 mg tablets), and hypromellose, titanium dioxide, macrogol/polyethylene glycol 400 and iron oxide black (10 mg tablets)."
},
{
"NDCCode": "33342-298-09",
"PackageDescription": "60 TABLET in 1 BOTTLE (33342-298-09) ",
"NDC11Code": "33342-0298-09",
"ProductNDC": "33342-298",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Memantine Hydrochloride",
"NonProprietaryName": "Memantine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151013",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202840",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "MEMANTINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20151013",
"SamplePackage": "N",
"IndicationAndUsage": "Memantine hydrochloride USP is indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.",
"Description": "Memantine hydrochloride USP is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride USP 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 and is soluble in water.Memantine hydrochloride USP is for oral administration as capsule-shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride. The tablets also contain the following inactive ingredients: microcrystalline cellulose/colloidal silicon dioxide, talc, croscarmellose sodium, and magnesium stearate. In addition the following inactive ingredients are also present as components of the film coat: hypromellose, titanium dioxide, polyethylene glycol 400, FD&C yellow #6 and FD&C blue #2 (5 mg tablets), and hypromellose, titanium dioxide, macrogol/polyethylene glycol 400 and iron oxide black (10 mg tablets)."
},
{
"NDCCode": "33342-298-12",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (33342-298-12) > 10 TABLET in 1 BLISTER PACK",
"NDC11Code": "33342-0298-12",
"ProductNDC": "33342-298",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Memantine Hydrochloride",
"NonProprietaryName": "Memantine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151013",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202840",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "MEMANTINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20151013",
"SamplePackage": "N",
"IndicationAndUsage": "Memantine hydrochloride USP is indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.",
"Description": "Memantine hydrochloride USP is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride USP 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 and is soluble in water.Memantine hydrochloride USP is for oral administration as capsule-shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride. The tablets also contain the following inactive ingredients: microcrystalline cellulose/colloidal silicon dioxide, talc, croscarmellose sodium, and magnesium stearate. In addition the following inactive ingredients are also present as components of the film coat: hypromellose, titanium dioxide, polyethylene glycol 400, FD&C yellow #6 and FD&C blue #2 (5 mg tablets), and hypromellose, titanium dioxide, macrogol/polyethylene glycol 400 and iron oxide black (10 mg tablets)."
},
{
"NDCCode": "33342-298-15",
"PackageDescription": "500 TABLET in 1 BOTTLE (33342-298-15) ",
"NDC11Code": "33342-0298-15",
"ProductNDC": "33342-298",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Memantine Hydrochloride",
"NonProprietaryName": "Memantine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151013",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202840",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "MEMANTINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20151013",
"SamplePackage": "N",
"IndicationAndUsage": "Memantine hydrochloride USP is indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.",
"Description": "Memantine hydrochloride USP is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride USP 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 and is soluble in water.Memantine hydrochloride USP is for oral administration as capsule-shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride. The tablets also contain the following inactive ingredients: microcrystalline cellulose/colloidal silicon dioxide, talc, croscarmellose sodium, and magnesium stearate. In addition the following inactive ingredients are also present as components of the film coat: hypromellose, titanium dioxide, polyethylene glycol 400, FD&C yellow #6 and FD&C blue #2 (5 mg tablets), and hypromellose, titanium dioxide, macrogol/polyethylene glycol 400 and iron oxide black (10 mg tablets)."
},
{
"NDCCode": "33342-312-07",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-312-07) ",
"NDC11Code": "33342-0312-07",
"ProductNDC": "33342-312",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Memantine And Donepezil",
"NonProprietaryName": "Memantine And Donepezil",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20250715",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208672",
"LabelerName": "Macleods Pharmaceuticals Limited",
"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": "2025-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250715",
"SamplePackage": "N",
"IndicationAndUsage": "Memantine and donepezil hydrochlorides extended-release capsules are 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": "Memantine and donepezil hydrochlorides extended-release capsules contain 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 HydrochlorideThe 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. Memantine and donepezil hydrochlorides extended-release capsules. Memantine and donepezil hydrochlorides extended-release capsules for oral administration, containing 14 mg memantine hydrochloride extended-release and 10 mg donepezil hydrochloride (14 mg/10 mg) or 28 mg memantine hydrochloride extended-release and 10 mg donepezil hydrochloride (28 mg/10 mg). All doses of memantine and donepezil hydrochlorides extended-release capsules contain the following inactive ingredients: colloidal silicon dioxide, ethyl cellulose, hydroxypropylmethyl cellulose, lactose monohydrate, microcrystalline cellulose, sugar sphere, talc. The hard gelatin capsules contain gelatin, sodium lauryl sulfate and titanium dioxide; colorants are iron oxide red (28 mg/10 mg). The black ink contains black iron oxide, propylene glycol and shellac."
},
{
"NDCCode": "33342-312-10",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-312-10) ",
"NDC11Code": "33342-0312-10",
"ProductNDC": "33342-312",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Memantine And Donepezil",
"NonProprietaryName": "Memantine And Donepezil",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20250715",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208672",
"LabelerName": "Macleods Pharmaceuticals Limited",
"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": "2025-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250715",
"SamplePackage": "N",
"IndicationAndUsage": "Memantine and donepezil hydrochlorides extended-release capsules are 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": "Memantine and donepezil hydrochlorides extended-release capsules contain 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 HydrochlorideThe 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. Memantine and donepezil hydrochlorides extended-release capsules. Memantine and donepezil hydrochlorides extended-release capsules for oral administration, containing 14 mg memantine hydrochloride extended-release and 10 mg donepezil hydrochloride (14 mg/10 mg) or 28 mg memantine hydrochloride extended-release and 10 mg donepezil hydrochloride (28 mg/10 mg). All doses of memantine and donepezil hydrochlorides extended-release capsules contain the following inactive ingredients: colloidal silicon dioxide, ethyl cellulose, hydroxypropylmethyl cellulose, lactose monohydrate, microcrystalline cellulose, sugar sphere, talc. The hard gelatin capsules contain gelatin, sodium lauryl sulfate and titanium dioxide; colorants are iron oxide red (28 mg/10 mg). The black ink contains black iron oxide, propylene glycol and shellac."
},
{
"NDCCode": "33342-312-12",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (33342-312-12) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "33342-0312-12",
"ProductNDC": "33342-312",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Memantine And Donepezil",
"NonProprietaryName": "Memantine And Donepezil",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20250715",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208672",
"LabelerName": "Macleods Pharmaceuticals Limited",
"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": "2025-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250715",
"SamplePackage": "N",
"IndicationAndUsage": "Memantine and donepezil hydrochlorides extended-release capsules are 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": "Memantine and donepezil hydrochlorides extended-release capsules contain 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 HydrochlorideThe 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. Memantine and donepezil hydrochlorides extended-release capsules. Memantine and donepezil hydrochlorides extended-release capsules for oral administration, containing 14 mg memantine hydrochloride extended-release and 10 mg donepezil hydrochloride (14 mg/10 mg) or 28 mg memantine hydrochloride extended-release and 10 mg donepezil hydrochloride (28 mg/10 mg). All doses of memantine and donepezil hydrochlorides extended-release capsules contain the following inactive ingredients: colloidal silicon dioxide, ethyl cellulose, hydroxypropylmethyl cellulose, lactose monohydrate, microcrystalline cellulose, sugar sphere, talc. The hard gelatin capsules contain gelatin, sodium lauryl sulfate and titanium dioxide; colorants are iron oxide red (28 mg/10 mg). The black ink contains black iron oxide, propylene glycol and shellac."
},
{
"NDCCode": "33342-313-07",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-313-07) ",
"NDC11Code": "33342-0313-07",
"ProductNDC": "33342-313",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Memantine And Donepezil",
"NonProprietaryName": "Memantine And Donepezil",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20250715",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208672",
"LabelerName": "Macleods Pharmaceuticals Limited",
"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": "2025-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250715",
"SamplePackage": "N",
"IndicationAndUsage": "Memantine and donepezil hydrochlorides extended-release capsules are 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": "Memantine and donepezil hydrochlorides extended-release capsules contain 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 HydrochlorideThe 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. Memantine and donepezil hydrochlorides extended-release capsules. Memantine and donepezil hydrochlorides extended-release capsules for oral administration, containing 14 mg memantine hydrochloride extended-release and 10 mg donepezil hydrochloride (14 mg/10 mg) or 28 mg memantine hydrochloride extended-release and 10 mg donepezil hydrochloride (28 mg/10 mg). All doses of memantine and donepezil hydrochlorides extended-release capsules contain the following inactive ingredients: colloidal silicon dioxide, ethyl cellulose, hydroxypropylmethyl cellulose, lactose monohydrate, microcrystalline cellulose, sugar sphere, talc. The hard gelatin capsules contain gelatin, sodium lauryl sulfate and titanium dioxide; colorants are iron oxide red (28 mg/10 mg). The black ink contains black iron oxide, propylene glycol and shellac."
},
{
"NDCCode": "33342-313-10",
"PackageDescription": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-313-10) ",
"NDC11Code": "33342-0313-10",
"ProductNDC": "33342-313",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Memantine And Donepezil",
"NonProprietaryName": "Memantine And Donepezil",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20250715",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208672",
"LabelerName": "Macleods Pharmaceuticals Limited",
"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": "2025-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250715",
"SamplePackage": "N",
"IndicationAndUsage": "Memantine and donepezil hydrochlorides extended-release capsules are 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": "Memantine and donepezil hydrochlorides extended-release capsules contain 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 HydrochlorideThe 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. Memantine and donepezil hydrochlorides extended-release capsules. Memantine and donepezil hydrochlorides extended-release capsules for oral administration, containing 14 mg memantine hydrochloride extended-release and 10 mg donepezil hydrochloride (14 mg/10 mg) or 28 mg memantine hydrochloride extended-release and 10 mg donepezil hydrochloride (28 mg/10 mg). All doses of memantine and donepezil hydrochlorides extended-release capsules contain the following inactive ingredients: colloidal silicon dioxide, ethyl cellulose, hydroxypropylmethyl cellulose, lactose monohydrate, microcrystalline cellulose, sugar sphere, talc. The hard gelatin capsules contain gelatin, sodium lauryl sulfate and titanium dioxide; colorants are iron oxide red (28 mg/10 mg). The black ink contains black iron oxide, propylene glycol and shellac."
},
{
"NDCCode": "33342-313-56",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (33342-313-56) / 14 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK",
"NDC11Code": "33342-0313-56",
"ProductNDC": "33342-313",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Memantine And Donepezil",
"NonProprietaryName": "Memantine And Donepezil",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20250715",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208672",
"LabelerName": "Macleods Pharmaceuticals Limited",
"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": "2025-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250715",
"SamplePackage": "N",
"IndicationAndUsage": "Memantine and donepezil hydrochlorides extended-release capsules are 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": "Memantine and donepezil hydrochlorides extended-release capsules contain 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 HydrochlorideThe 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. Memantine and donepezil hydrochlorides extended-release capsules. Memantine and donepezil hydrochlorides extended-release capsules for oral administration, containing 14 mg memantine hydrochloride extended-release and 10 mg donepezil hydrochloride (14 mg/10 mg) or 28 mg memantine hydrochloride extended-release and 10 mg donepezil hydrochloride (28 mg/10 mg). All doses of memantine and donepezil hydrochlorides extended-release capsules contain the following inactive ingredients: colloidal silicon dioxide, ethyl cellulose, hydroxypropylmethyl cellulose, lactose monohydrate, microcrystalline cellulose, sugar sphere, talc. The hard gelatin capsules contain gelatin, sodium lauryl sulfate and titanium dioxide; colorants are iron oxide red (28 mg/10 mg). The black ink contains black iron oxide, propylene glycol and shellac."
},
{
"NDCCode": "33342-555-11",
"PackageDescription": "100 CAPSULE in 1 CONTAINER (33342-555-11) ",
"NDC11Code": "33342-0555-11",
"ProductNDC": "33342-555",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mexiletine Hydrochloride",
"NonProprietaryName": "Mexiletine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20260323",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219987",
"LabelerName": "Macleods Pharmaceuticals Limited",
"SubstanceName": "MEXILETINE HYDROCHLORIDE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260323",
"SamplePackage": "N",
"IndicationAndUsage": "Mexiletine hydrochloride capsules are indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgment of the physician, are life-threatening. Because of the proarrhythmic effects of mexiletine, its use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided.Initiation of mexiletine treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital.Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias.",
"Description": "Mexiletine hydrochloride, USP is an orally active antiarrhythmic agent. It is a white to off-white crystalline powder with slightly bitter taste, freely soluble in water and in alcohol. Mexiletine hydrochloride, USP has a pKa of 9.2. The chemical name of mexiletine hydrochloride, USP is 1-methyl-2-(2,6-xylyloxy)ethylamine hydrochloride and its structural formula is. C11H17NOHCl M.W. 215.72. Each capsule for oral administration, contains 150 mg, 200 mg, or 250 mg of mexiletine hydrochloride, USP. 100 mg of mexiletine hydrochloride, USP is equivalent to 83.31 mg of mexiletine base. In addition, each capsule contains the following excipients: colloidal silicon dioxide, magnesium stearate, pregelatinized starch. The capsule shell contains: FD&C Yellow #6,gelatin, titanium dioxide and sodium lauryl sulphate. The 150 mg capsule also contains: D&C Red 28, FD&C Blue #1 and the 250 mg capsule also contains: D&C Yellow #10 and FD&C Blue #1. The imprinting ink contains: butyl alcohol, black iron oxide, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, strong ammonia solution, propylene glycol and shellac.FDA approved dissolution test specifications differ from USP."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>33342-215-58</NDCCode>
<PackageDescription>270 TABLET, FILM COATED in 1 BOTTLE (33342-215-58) </PackageDescription>
<NDC11Code>33342-0215-58</NDC11Code>
<ProductNDC>33342-215</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sevelamer Carbonate</ProprietaryName>
<NonProprietaryName>Sevelamer Carbonate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230419</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206100</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>SEVELAMER CARBONATE</SubstanceName>
<StrengthNumber>800</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230419</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sevelamer carbonate tablets are indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease (CKD) on dialysis.</IndicationAndUsage>
<Description>The active ingredient in sevelamer carbonate tablets is sevelamer carbonate, a polymeric amine that binds phosphate and is meant for oral administration. It was developed as a pharmaceutical alternative to sevelamer hydrochloride. Sevelamer carbonate is an anion exchange resin, with the same polymeric structure as sevelamer hydrochloride, in which carbonate replaces chloride as the counterion. While the counterions differ for the two salts, the polymer itself, the active moiety involved in phosphate binding, is the same. Sevelamer carbonate is known chemically as poly(allylamine-co-N,N’-diallyl-1,3-diamino-2-hydroxypropane) carbonate salt. Sevelamer carbonate is hygroscopic, but insoluble in water. The structure is represented in Figure 1. Figure 1: Chemical Structure of Sevelamer Carbonate a, b = number of primary amine groups a + b = 9 c = number of cross-linking groups c = 1 m = large number to indicate extended polymer network Sevelamer Carbonate Tablets: Each film-coated tablet of sevelamer carbonate contains 800 mg of sevelamer carbonate on an anhydrous basis. The inactive ingredients are microcrystalline cellulose, hydroxy propyl cellulose, colloidal silicon dioxide, zinc stearate, hypromellose, diacetylated monoglycerides. Imprinting ink contains ammonium hydroxide, iron oxide black, propylene glycol and shellac.</Description>
</NDC>
<NDC>
<NDCCode>33342-215-56</NDCCode>
<PackageDescription>14 BLISTER PACK in 1 CARTON (33342-215-56) / 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>33342-0215-56</NDC11Code>
<ProductNDC>33342-215</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sevelamer Carbonate</ProprietaryName>
<NonProprietaryName>Sevelamer Carbonate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230419</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206100</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>SEVELAMER CARBONATE</SubstanceName>
<StrengthNumber>800</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251031</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sevelamer carbonate tablets are indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease (CKD) on dialysis.</IndicationAndUsage>
<Description>The active ingredient in sevelamer carbonate tablets is sevelamer carbonate, a polymeric amine that binds phosphate and is meant for oral administration. It was developed as a pharmaceutical alternative to sevelamer hydrochloride. Sevelamer carbonate is an anion exchange resin, with the same polymeric structure as sevelamer hydrochloride, in which carbonate replaces chloride as the counterion. While the counterions differ for the two salts, the polymer itself, the active moiety involved in phosphate binding, is the same. Sevelamer carbonate is known chemically as poly(allylamine-co-N,N’-diallyl-1,3-diamino-2-hydroxypropane) carbonate salt. Sevelamer carbonate is hygroscopic, but insoluble in water. The structure is represented in Figure 1. Figure 1: Chemical Structure of Sevelamer Carbonate a, b = number of primary amine groups a + b = 9 c = number of cross-linking groups c = 1 m = large number to indicate extended polymer network Sevelamer Carbonate Tablets: Each film-coated tablet of sevelamer carbonate contains 800 mg of sevelamer carbonate on an anhydrous basis. The inactive ingredients are microcrystalline cellulose, hydroxy propyl cellulose, colloidal silicon dioxide, zinc stearate, hypromellose, diacetylated monoglycerides. Imprinting ink contains ammonium hydroxide, iron oxide black, propylene glycol and shellac.</Description>
</NDC>
<NDC>
<NDCCode>33342-215-57</NDCCode>
<PackageDescription>180 TABLET, FILM COATED in 1 BOTTLE (33342-215-57) </PackageDescription>
<NDC11Code>33342-0215-57</NDC11Code>
<ProductNDC>33342-215</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sevelamer Carbonate</ProprietaryName>
<NonProprietaryName>Sevelamer Carbonate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230419</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206100</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>SEVELAMER CARBONATE</SubstanceName>
<StrengthNumber>800</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260313</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sevelamer carbonate tablets are indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease (CKD) on dialysis.</IndicationAndUsage>
<Description>The active ingredient in sevelamer carbonate tablets is sevelamer carbonate, a polymeric amine that binds phosphate and is meant for oral administration. It was developed as a pharmaceutical alternative to sevelamer hydrochloride. Sevelamer carbonate is an anion exchange resin, with the same polymeric structure as sevelamer hydrochloride, in which carbonate replaces chloride as the counterion. While the counterions differ for the two salts, the polymer itself, the active moiety involved in phosphate binding, is the same. Sevelamer carbonate is known chemically as poly(allylamine-co-N,N’-diallyl-1,3-diamino-2-hydroxypropane) carbonate salt. Sevelamer carbonate is hygroscopic, but insoluble in water. The structure is represented in Figure 1. Figure 1: Chemical Structure of Sevelamer Carbonate a, b = number of primary amine groups a + b = 9 c = number of cross-linking groups c = 1 m = large number to indicate extended polymer network Sevelamer Carbonate Tablets: Each film-coated tablet of sevelamer carbonate contains 800 mg of sevelamer carbonate on an anhydrous basis. The inactive ingredients are microcrystalline cellulose, hydroxy propyl cellulose, colloidal silicon dioxide, zinc stearate, hypromellose, diacetylated monoglycerides. Imprinting ink contains ammonium hydroxide, iron oxide black, propylene glycol and shellac.</Description>
</NDC>
<NDC>
<NDCCode>33342-461-58</NDCCode>
<PackageDescription>270 CAPSULE in 1 BOTTLE (33342-461-58) </PackageDescription>
<NDC11Code>33342-0461-58</NDC11Code>
<ProductNDC>33342-461</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pirfenidone Capsule, 267 Mg</ProprietaryName>
<NonProprietaryName>Pirfenidone Capsule, 267 Mg</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200720</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212748</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>PIRFENIDONE</SubstanceName>
<StrengthNumber>267</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Pyridone [EPC], Pyridones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200720</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pirfenidone capsules are indicated for the treatment of idiopathic pulmonary fibrosis (IPF).</IndicationAndUsage>
<Description>Pirfenidone belongs to the chemical class of pyridone. Pirfenidone capsules USP are available as a white to off-white hard gelatin capsule containing 267 mg of pirfenidone for oral administration. Pirfenidone has a molecular formula of C12H11NO and a molecular weight of 185.23. Pirfenidone has the following structural formula, which has been referred to as 5-methyl-1-phenyl-2-1(H)-pyridone or 5-methyl-1-phenyl-2-(1H)-pyridone. Pirfenidone is a white to pale yellow, non-hygroscopic powder. It is more soluble in methanol, ethyl alcohol, acetone and chloroform than in water and 1.0 N HCl. The melting point is approximately 109°C. Pirfenidone capsules, USP contains pirfenidone and the following inactive ingredients: croscarmellose sodium, magnesium stearate, and pregelatinized starch. In addition, the capsule shell contains gelatin and titanium dioxide. The capsule brown printing ink includes ammonium hydroxide, iron oxide black, iron oxide brown, potassium hydroxide, propylene glycol, shellac.</Description>
</NDC>
<NDC>
<NDCCode>33342-536-58</NDCCode>
<PackageDescription>6500 TABLET, FILM COATED in 1 POUCH (33342-536-58) </PackageDescription>
<NDC11Code>33342-0536-58</NDC11Code>
<ProductNDC>33342-536</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sildenafil</ProprietaryName>
<NonProprietaryName>Sildenafil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140103</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203814</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>SILDENAFIL CITRATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-04-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220113</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adults. Sildenafil tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening [see Clinical Studies (14)]. Pediatric use information is approved for Viatris Specialty LLC's, REVATIO (sildenafil) tablets. However, due to Viatris Specialty LLC's marketing exclusivity rights, this drug product is not labeled with that information.</IndicationAndUsage>
<Description>Sildenafil Tablets, USP phosphodiesterase-5 (PDE-5) inhibitor, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type-5 (PDE-5). Sildenafil is also marketed as VIAGRA® for erectile dysfunction. Sildenafil citrate, USP is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo [4,3-d] pyrimidin-5-yl)-4-ethoxyphenyl] sulfonyl]-4-methylpiperazine citrate and has the following structural formula. Sildenafil citrate, USP is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7. Sildenafil Tablets USP, 20 mg: Sildenafil tablets are formulated as white to off white, film-coated round tablets for oral administration. Each tablet contains sildenafil citrate equivalent to 20 mg of sildenafil. In addition to the active ingredient, sildenafil citrate, USP each tablet contains the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate dihydrate, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>30142-215-58</NDCCode>
<PackageDescription>4 BLISTER PACK in 1 CARTON (30142-215-58) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>30142-0215-58</NDC11Code>
<ProductNDC>30142-215</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Daytime</ProprietaryName>
<ProprietaryNameSuffix>Non Drowsy</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080830</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Kroger Company</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 10; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-12-13</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>49035-215-58</NDCCode>
<PackageDescription>4 BLISTER PACK in 1 CARTON (49035-215-58) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>49035-0215-58</NDC11Code>
<ProductNDC>49035-215</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Equate Daytime</ProprietaryName>
<ProprietaryNameSuffix>Cold And Flu</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20061030</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Wal-Mart Stores Inc</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 10; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-12-18</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>49281-215-10</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 PACKAGE (49281-215-10) / .5 mL in 1 VIAL, SINGLE-DOSE (49281-215-58) </PackageDescription>
<NDC11Code>49281-0215-10</NDC11Code>
<ProductNDC>49281-215</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Tenivac</ProprietaryName>
<NonProprietaryName>Clostridium Tetani Toxoid Antigen (formaldehyde Inactivated) And Corynebacterium Diphtheriae Toxoid Antigen (formaldehyde Inactivated)</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20101208</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103171</ApplicationNumber>
<LabelerName>Sanofi Vaccines US Inc.</LabelerName>
<SubstanceName>CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
<StrengthNumber>5; 2</StrengthNumber>
<StrengthUnit>[Lf]/.5mL; [Lf]/.5mL</StrengthUnit>
<Pharm_Classes>Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Diphtheria Toxoid [CS], Inactivated Clostridium Tetani Vaccine [EPC], Inactivated Corynebacterium Diphtheriae Vaccine [EPC], Tetanus Toxoid [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101208</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TENIVAC® is a vaccine indicated for active immunization for the prevention of tetanus and diphtheria in persons 7 years of age and older.</IndicationAndUsage>
<Description>TENIVAC, Tetanus and Diphtheria Toxoids Adsorbed, is a sterile isotonic suspension of tetanus and diphtheria toxoids adsorbed on aluminum phosphate. Each 0.5 mL dose of TENIVAC contains the following active ingredients. Other ingredients per 0.5 mL dose include 1.5 mg of aluminum phosphate (0.33 mg of aluminum) as the adjuvant and ≤5.0 mcg of residual formaldehyde. Clostridium tetani is grown in modified Mueller-Miller casamino acid medium without beef heart infusion. (3) Tetanus toxin is detoxified with formaldehyde and purified by ammonium sulfate fractionation and diafiltration. Corynebacterium diphtheriae is grown in modified Mueller's growth medium. (4) After purification by ammonium sulfate fractionation, diphtheria toxin is detoxified with formaldehyde and diafiltered. Tetanus and diphtheria toxoids are individually adsorbed onto aluminum phosphate. The adsorbed tetanus and diphtheria toxoids are combined with aluminum phosphate (as adjuvant), sodium chloride and water for injection. This product contains no preservative. The potency of tetanus and diphtheria toxoids is measured by in vitro antigenicity enzyme-linked immunosorbent assays (ELISAs), which detect immunologically relevant epitopes. The tip caps of the prefilled syringes may contain natural rubber latex. The vial stoppers do not contain latex.</Description>
</NDC>
<NDC>
<NDCCode>33342-066-28</NDCCode>
<PackageDescription>240 mL in 1 BOTTLE (33342-066-28) </PackageDescription>
<NDC11Code>33342-0066-28</NDC11Code>
<ProductNDC>33342-066</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Memantine Hydrochloride</ProprietaryName>
<NonProprietaryName>Memantine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151013</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202790</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>MEMANTINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-04-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151013</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Memantine hydrochloride solution is indicated for the treatment of moderate to severe dementia of the Alzheimer's type.</IndicationAndUsage>
<Description>Memantine hydrochloride, USP is an orally active NMDA receptor antagonist. 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 HCl occurs as a fine white to off-white powder and is soluble in water. Memantine hydrochloride oral solution contains memantine hydrochloride in a strength equivalent to 2 mg of memantine hydrochloride in each mL. The oral solution also contains the following inactive ingredients: sorbitol solution (70%), methyl paraben, propylparaben, propylene glycol, glycerin, natural peppermint flavor #104, citric acid, sodium citrate, and purified water.</Description>
</NDC>
<NDC>
<NDCCode>33342-219-07</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-219-07) </PackageDescription>
<NDC11Code>33342-0219-07</NDC11Code>
<ProductNDC>33342-219</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Memantine Hydrochloride</ProprietaryName>
<NonProprietaryName>Memantine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250828</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206310</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>MEMANTINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>7</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250828</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Memantine hydrochloride extended-release capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.</IndicationAndUsage>
<Description>Memantine hydrochloride USP is an orally active NMDA receptor antagonist. 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 and is soluble in water. Memantine hydrochloride extended-release capsules are supplied for oral administration as 7 mg, 14 mg, 21 mg, and 28 mg capsules. Each capsule contains extended-release beads with the labeled amount of memantine hydrochloride USP and the following inactive ingredients: ethylcellulose, hydroxylpropylmethyl cellullose, sugar spheres and talc. Sugar spheres consist of sucrose and corn starch. Capsule shell consists of gelatin, sodium lauryl Sulphate, titanium dioxide with iron oxide yellow and FD & C blue no. 2 as colors. The capsules are imprinted with black ink and white ink. The inks consist of shellac, potassium hydroxide, titanium dioxide (only in white ink) and black iron oxide (only in black ink).</Description>
</NDC>
<NDC>
<NDCCode>33342-219-12</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (33342-219-12) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>33342-0219-12</NDC11Code>
<ProductNDC>33342-219</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Memantine Hydrochloride</ProprietaryName>
<NonProprietaryName>Memantine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250828</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206310</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>MEMANTINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>7</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250828</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Memantine hydrochloride extended-release capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.</IndicationAndUsage>
<Description>Memantine hydrochloride USP is an orally active NMDA receptor antagonist. 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 and is soluble in water. Memantine hydrochloride extended-release capsules are supplied for oral administration as 7 mg, 14 mg, 21 mg, and 28 mg capsules. Each capsule contains extended-release beads with the labeled amount of memantine hydrochloride USP and the following inactive ingredients: ethylcellulose, hydroxylpropylmethyl cellullose, sugar spheres and talc. Sugar spheres consist of sucrose and corn starch. Capsule shell consists of gelatin, sodium lauryl Sulphate, titanium dioxide with iron oxide yellow and FD & C blue no. 2 as colors. The capsules are imprinted with black ink and white ink. The inks consist of shellac, potassium hydroxide, titanium dioxide (only in white ink) and black iron oxide (only in black ink).</Description>
</NDC>
<NDC>
<NDCCode>33342-220-07</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-220-07) </PackageDescription>
<NDC11Code>33342-0220-07</NDC11Code>
<ProductNDC>33342-220</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Memantine Hydrochloride</ProprietaryName>
<NonProprietaryName>Memantine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250828</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206310</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>MEMANTINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>14</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250828</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Memantine hydrochloride extended-release capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.</IndicationAndUsage>
<Description>Memantine hydrochloride USP is an orally active NMDA receptor antagonist. 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 and is soluble in water. Memantine hydrochloride extended-release capsules are supplied for oral administration as 7 mg, 14 mg, 21 mg, and 28 mg capsules. Each capsule contains extended-release beads with the labeled amount of memantine hydrochloride USP and the following inactive ingredients: ethylcellulose, hydroxylpropylmethyl cellullose, sugar spheres and talc. Sugar spheres consist of sucrose and corn starch. Capsule shell consists of gelatin, sodium lauryl Sulphate, titanium dioxide with iron oxide yellow and FD & C blue no. 2 as colors. The capsules are imprinted with black ink and white ink. The inks consist of shellac, potassium hydroxide, titanium dioxide (only in white ink) and black iron oxide (only in black ink).</Description>
</NDC>
<NDC>
<NDCCode>33342-220-12</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (33342-220-12) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>33342-0220-12</NDC11Code>
<ProductNDC>33342-220</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Memantine Hydrochloride</ProprietaryName>
<NonProprietaryName>Memantine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250828</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206310</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>MEMANTINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>14</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250828</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Memantine hydrochloride extended-release capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.</IndicationAndUsage>
<Description>Memantine hydrochloride USP is an orally active NMDA receptor antagonist. 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 and is soluble in water. Memantine hydrochloride extended-release capsules are supplied for oral administration as 7 mg, 14 mg, 21 mg, and 28 mg capsules. Each capsule contains extended-release beads with the labeled amount of memantine hydrochloride USP and the following inactive ingredients: ethylcellulose, hydroxylpropylmethyl cellullose, sugar spheres and talc. Sugar spheres consist of sucrose and corn starch. Capsule shell consists of gelatin, sodium lauryl Sulphate, titanium dioxide with iron oxide yellow and FD & C blue no. 2 as colors. The capsules are imprinted with black ink and white ink. The inks consist of shellac, potassium hydroxide, titanium dioxide (only in white ink) and black iron oxide (only in black ink).</Description>
</NDC>
<NDC>
<NDCCode>33342-221-07</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-221-07) </PackageDescription>
<NDC11Code>33342-0221-07</NDC11Code>
<ProductNDC>33342-221</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Memantine Hydrochloride</ProprietaryName>
<NonProprietaryName>Memantine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250828</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206310</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>MEMANTINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>21</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250828</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Memantine hydrochloride extended-release capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.</IndicationAndUsage>
<Description>Memantine hydrochloride USP is an orally active NMDA receptor antagonist. 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 and is soluble in water. Memantine hydrochloride extended-release capsules are supplied for oral administration as 7 mg, 14 mg, 21 mg, and 28 mg capsules. Each capsule contains extended-release beads with the labeled amount of memantine hydrochloride USP and the following inactive ingredients: ethylcellulose, hydroxylpropylmethyl cellullose, sugar spheres and talc. Sugar spheres consist of sucrose and corn starch. Capsule shell consists of gelatin, sodium lauryl Sulphate, titanium dioxide with iron oxide yellow and FD & C blue no. 2 as colors. The capsules are imprinted with black ink and white ink. The inks consist of shellac, potassium hydroxide, titanium dioxide (only in white ink) and black iron oxide (only in black ink).</Description>
</NDC>
<NDC>
<NDCCode>33342-221-12</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (33342-221-12) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>33342-0221-12</NDC11Code>
<ProductNDC>33342-221</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Memantine Hydrochloride</ProprietaryName>
<NonProprietaryName>Memantine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250828</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206310</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>MEMANTINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>21</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250828</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Memantine hydrochloride extended-release capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.</IndicationAndUsage>
<Description>Memantine hydrochloride USP is an orally active NMDA receptor antagonist. 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 and is soluble in water. Memantine hydrochloride extended-release capsules are supplied for oral administration as 7 mg, 14 mg, 21 mg, and 28 mg capsules. Each capsule contains extended-release beads with the labeled amount of memantine hydrochloride USP and the following inactive ingredients: ethylcellulose, hydroxylpropylmethyl cellullose, sugar spheres and talc. Sugar spheres consist of sucrose and corn starch. Capsule shell consists of gelatin, sodium lauryl Sulphate, titanium dioxide with iron oxide yellow and FD & C blue no. 2 as colors. The capsules are imprinted with black ink and white ink. The inks consist of shellac, potassium hydroxide, titanium dioxide (only in white ink) and black iron oxide (only in black ink).</Description>
</NDC>
<NDC>
<NDCCode>33342-222-07</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-222-07) </PackageDescription>
<NDC11Code>33342-0222-07</NDC11Code>
<ProductNDC>33342-222</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Memantine Hydrochloride</ProprietaryName>
<NonProprietaryName>Memantine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250828</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206310</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>MEMANTINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>28</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250828</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Memantine hydrochloride extended-release capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.</IndicationAndUsage>
<Description>Memantine hydrochloride USP is an orally active NMDA receptor antagonist. 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 and is soluble in water. Memantine hydrochloride extended-release capsules are supplied for oral administration as 7 mg, 14 mg, 21 mg, and 28 mg capsules. Each capsule contains extended-release beads with the labeled amount of memantine hydrochloride USP and the following inactive ingredients: ethylcellulose, hydroxylpropylmethyl cellullose, sugar spheres and talc. Sugar spheres consist of sucrose and corn starch. Capsule shell consists of gelatin, sodium lauryl Sulphate, titanium dioxide with iron oxide yellow and FD & C blue no. 2 as colors. The capsules are imprinted with black ink and white ink. The inks consist of shellac, potassium hydroxide, titanium dioxide (only in white ink) and black iron oxide (only in black ink).</Description>
</NDC>
<NDC>
<NDCCode>33342-222-12</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (33342-222-12) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>33342-0222-12</NDC11Code>
<ProductNDC>33342-222</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Memantine Hydrochloride</ProprietaryName>
<NonProprietaryName>Memantine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250828</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206310</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>MEMANTINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>28</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250828</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Memantine hydrochloride extended-release capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.</IndicationAndUsage>
<Description>Memantine hydrochloride USP is an orally active NMDA receptor antagonist. 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 and is soluble in water. Memantine hydrochloride extended-release capsules are supplied for oral administration as 7 mg, 14 mg, 21 mg, and 28 mg capsules. Each capsule contains extended-release beads with the labeled amount of memantine hydrochloride USP and the following inactive ingredients: ethylcellulose, hydroxylpropylmethyl cellullose, sugar spheres and talc. Sugar spheres consist of sucrose and corn starch. Capsule shell consists of gelatin, sodium lauryl Sulphate, titanium dioxide with iron oxide yellow and FD & C blue no. 2 as colors. The capsules are imprinted with black ink and white ink. The inks consist of shellac, potassium hydroxide, titanium dioxide (only in white ink) and black iron oxide (only in black ink).</Description>
</NDC>
<NDC>
<NDCCode>33342-297-09</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (33342-297-09) </PackageDescription>
<NDC11Code>33342-0297-09</NDC11Code>
<ProductNDC>33342-297</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Memantine Hydrochloride</ProprietaryName>
<NonProprietaryName>Memantine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151013</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202840</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>MEMANTINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151013</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Memantine hydrochloride USP is indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.</IndicationAndUsage>
<Description>Memantine hydrochloride USP is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride USP 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 and is soluble in water.Memantine hydrochloride USP is for oral administration as capsule-shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride. The tablets also contain the following inactive ingredients: microcrystalline cellulose/colloidal silicon dioxide, talc, croscarmellose sodium, and magnesium stearate. In addition the following inactive ingredients are also present as components of the film coat: hypromellose, titanium dioxide, polyethylene glycol 400, FD&C yellow #6 and FD&C blue #2 (5 mg tablets), and hypromellose, titanium dioxide, macrogol/polyethylene glycol 400 and iron oxide black (10 mg tablets).</Description>
</NDC>
<NDC>
<NDCCode>33342-297-12</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (33342-297-12) > 10 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>33342-0297-12</NDC11Code>
<ProductNDC>33342-297</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Memantine Hydrochloride</ProprietaryName>
<NonProprietaryName>Memantine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151013</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202840</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>MEMANTINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151013</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Memantine hydrochloride USP is indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.</IndicationAndUsage>
<Description>Memantine hydrochloride USP is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride USP 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 and is soluble in water.Memantine hydrochloride USP is for oral administration as capsule-shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride. The tablets also contain the following inactive ingredients: microcrystalline cellulose/colloidal silicon dioxide, talc, croscarmellose sodium, and magnesium stearate. In addition the following inactive ingredients are also present as components of the film coat: hypromellose, titanium dioxide, polyethylene glycol 400, FD&C yellow #6 and FD&C blue #2 (5 mg tablets), and hypromellose, titanium dioxide, macrogol/polyethylene glycol 400 and iron oxide black (10 mg tablets).</Description>
</NDC>
<NDC>
<NDCCode>33342-297-15</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (33342-297-15) </PackageDescription>
<NDC11Code>33342-0297-15</NDC11Code>
<ProductNDC>33342-297</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Memantine Hydrochloride</ProprietaryName>
<NonProprietaryName>Memantine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151013</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202840</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>MEMANTINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151013</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Memantine hydrochloride USP is indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.</IndicationAndUsage>
<Description>Memantine hydrochloride USP is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride USP 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 and is soluble in water.Memantine hydrochloride USP is for oral administration as capsule-shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride. The tablets also contain the following inactive ingredients: microcrystalline cellulose/colloidal silicon dioxide, talc, croscarmellose sodium, and magnesium stearate. In addition the following inactive ingredients are also present as components of the film coat: hypromellose, titanium dioxide, polyethylene glycol 400, FD&C yellow #6 and FD&C blue #2 (5 mg tablets), and hypromellose, titanium dioxide, macrogol/polyethylene glycol 400 and iron oxide black (10 mg tablets).</Description>
</NDC>
<NDC>
<NDCCode>33342-298-09</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (33342-298-09) </PackageDescription>
<NDC11Code>33342-0298-09</NDC11Code>
<ProductNDC>33342-298</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Memantine Hydrochloride</ProprietaryName>
<NonProprietaryName>Memantine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151013</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202840</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>MEMANTINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151013</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Memantine hydrochloride USP is indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.</IndicationAndUsage>
<Description>Memantine hydrochloride USP is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride USP 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 and is soluble in water.Memantine hydrochloride USP is for oral administration as capsule-shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride. The tablets also contain the following inactive ingredients: microcrystalline cellulose/colloidal silicon dioxide, talc, croscarmellose sodium, and magnesium stearate. In addition the following inactive ingredients are also present as components of the film coat: hypromellose, titanium dioxide, polyethylene glycol 400, FD&C yellow #6 and FD&C blue #2 (5 mg tablets), and hypromellose, titanium dioxide, macrogol/polyethylene glycol 400 and iron oxide black (10 mg tablets).</Description>
</NDC>
<NDC>
<NDCCode>33342-298-12</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (33342-298-12) > 10 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>33342-0298-12</NDC11Code>
<ProductNDC>33342-298</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Memantine Hydrochloride</ProprietaryName>
<NonProprietaryName>Memantine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151013</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202840</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>MEMANTINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151013</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Memantine hydrochloride USP is indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.</IndicationAndUsage>
<Description>Memantine hydrochloride USP is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride USP 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 and is soluble in water.Memantine hydrochloride USP is for oral administration as capsule-shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride. The tablets also contain the following inactive ingredients: microcrystalline cellulose/colloidal silicon dioxide, talc, croscarmellose sodium, and magnesium stearate. In addition the following inactive ingredients are also present as components of the film coat: hypromellose, titanium dioxide, polyethylene glycol 400, FD&C yellow #6 and FD&C blue #2 (5 mg tablets), and hypromellose, titanium dioxide, macrogol/polyethylene glycol 400 and iron oxide black (10 mg tablets).</Description>
</NDC>
<NDC>
<NDCCode>33342-298-15</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (33342-298-15) </PackageDescription>
<NDC11Code>33342-0298-15</NDC11Code>
<ProductNDC>33342-298</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Memantine Hydrochloride</ProprietaryName>
<NonProprietaryName>Memantine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151013</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202840</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>MEMANTINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151013</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Memantine hydrochloride USP is indicated for the treatment of moderate to severe dementia of the Alzheimer’s type.</IndicationAndUsage>
<Description>Memantine hydrochloride USP is an orally active NMDA receptor antagonist. The chemical name for memantine hydrochloride USP 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 and is soluble in water.Memantine hydrochloride USP is for oral administration as capsule-shaped, film-coated tablets containing 5 mg and 10 mg of memantine hydrochloride. The tablets also contain the following inactive ingredients: microcrystalline cellulose/colloidal silicon dioxide, talc, croscarmellose sodium, and magnesium stearate. In addition the following inactive ingredients are also present as components of the film coat: hypromellose, titanium dioxide, polyethylene glycol 400, FD&C yellow #6 and FD&C blue #2 (5 mg tablets), and hypromellose, titanium dioxide, macrogol/polyethylene glycol 400 and iron oxide black (10 mg tablets).</Description>
</NDC>
<NDC>
<NDCCode>33342-312-07</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-312-07) </PackageDescription>
<NDC11Code>33342-0312-07</NDC11Code>
<ProductNDC>33342-312</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Memantine And Donepezil</ProprietaryName>
<NonProprietaryName>Memantine And Donepezil</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250715</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208672</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</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>2025-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250715</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Memantine and donepezil hydrochlorides extended-release capsules are 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>Memantine and donepezil hydrochlorides extended-release capsules contain 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 HydrochlorideThe 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. Memantine and donepezil hydrochlorides extended-release capsules. Memantine and donepezil hydrochlorides extended-release capsules for oral administration, containing 14 mg memantine hydrochloride extended-release and 10 mg donepezil hydrochloride (14 mg/10 mg) or 28 mg memantine hydrochloride extended-release and 10 mg donepezil hydrochloride (28 mg/10 mg). All doses of memantine and donepezil hydrochlorides extended-release capsules contain the following inactive ingredients: colloidal silicon dioxide, ethyl cellulose, hydroxypropylmethyl cellulose, lactose monohydrate, microcrystalline cellulose, sugar sphere, talc. The hard gelatin capsules contain gelatin, sodium lauryl sulfate and titanium dioxide; colorants are iron oxide red (28 mg/10 mg). The black ink contains black iron oxide, propylene glycol and shellac.</Description>
</NDC>
<NDC>
<NDCCode>33342-312-10</NDCCode>
<PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-312-10) </PackageDescription>
<NDC11Code>33342-0312-10</NDC11Code>
<ProductNDC>33342-312</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Memantine And Donepezil</ProprietaryName>
<NonProprietaryName>Memantine And Donepezil</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250715</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208672</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</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>2025-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250715</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Memantine and donepezil hydrochlorides extended-release capsules are 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>Memantine and donepezil hydrochlorides extended-release capsules contain 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 HydrochlorideThe 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. Memantine and donepezil hydrochlorides extended-release capsules. Memantine and donepezil hydrochlorides extended-release capsules for oral administration, containing 14 mg memantine hydrochloride extended-release and 10 mg donepezil hydrochloride (14 mg/10 mg) or 28 mg memantine hydrochloride extended-release and 10 mg donepezil hydrochloride (28 mg/10 mg). All doses of memantine and donepezil hydrochlorides extended-release capsules contain the following inactive ingredients: colloidal silicon dioxide, ethyl cellulose, hydroxypropylmethyl cellulose, lactose monohydrate, microcrystalline cellulose, sugar sphere, talc. The hard gelatin capsules contain gelatin, sodium lauryl sulfate and titanium dioxide; colorants are iron oxide red (28 mg/10 mg). The black ink contains black iron oxide, propylene glycol and shellac.</Description>
</NDC>
<NDC>
<NDCCode>33342-312-12</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (33342-312-12) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>33342-0312-12</NDC11Code>
<ProductNDC>33342-312</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Memantine And Donepezil</ProprietaryName>
<NonProprietaryName>Memantine And Donepezil</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250715</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208672</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</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>2025-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250715</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Memantine and donepezil hydrochlorides extended-release capsules are 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>Memantine and donepezil hydrochlorides extended-release capsules contain 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 HydrochlorideThe 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. Memantine and donepezil hydrochlorides extended-release capsules. Memantine and donepezil hydrochlorides extended-release capsules for oral administration, containing 14 mg memantine hydrochloride extended-release and 10 mg donepezil hydrochloride (14 mg/10 mg) or 28 mg memantine hydrochloride extended-release and 10 mg donepezil hydrochloride (28 mg/10 mg). All doses of memantine and donepezil hydrochlorides extended-release capsules contain the following inactive ingredients: colloidal silicon dioxide, ethyl cellulose, hydroxypropylmethyl cellulose, lactose monohydrate, microcrystalline cellulose, sugar sphere, talc. The hard gelatin capsules contain gelatin, sodium lauryl sulfate and titanium dioxide; colorants are iron oxide red (28 mg/10 mg). The black ink contains black iron oxide, propylene glycol and shellac.</Description>
</NDC>
<NDC>
<NDCCode>33342-313-07</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-313-07) </PackageDescription>
<NDC11Code>33342-0313-07</NDC11Code>
<ProductNDC>33342-313</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Memantine And Donepezil</ProprietaryName>
<NonProprietaryName>Memantine And Donepezil</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250715</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208672</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</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>2025-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250715</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Memantine and donepezil hydrochlorides extended-release capsules are 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>Memantine and donepezil hydrochlorides extended-release capsules contain 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 HydrochlorideThe 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. Memantine and donepezil hydrochlorides extended-release capsules. Memantine and donepezil hydrochlorides extended-release capsules for oral administration, containing 14 mg memantine hydrochloride extended-release and 10 mg donepezil hydrochloride (14 mg/10 mg) or 28 mg memantine hydrochloride extended-release and 10 mg donepezil hydrochloride (28 mg/10 mg). All doses of memantine and donepezil hydrochlorides extended-release capsules contain the following inactive ingredients: colloidal silicon dioxide, ethyl cellulose, hydroxypropylmethyl cellulose, lactose monohydrate, microcrystalline cellulose, sugar sphere, talc. The hard gelatin capsules contain gelatin, sodium lauryl sulfate and titanium dioxide; colorants are iron oxide red (28 mg/10 mg). The black ink contains black iron oxide, propylene glycol and shellac.</Description>
</NDC>
<NDC>
<NDCCode>33342-313-10</NDCCode>
<PackageDescription>90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-313-10) </PackageDescription>
<NDC11Code>33342-0313-10</NDC11Code>
<ProductNDC>33342-313</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Memantine And Donepezil</ProprietaryName>
<NonProprietaryName>Memantine And Donepezil</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250715</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208672</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</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>2025-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250715</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Memantine and donepezil hydrochlorides extended-release capsules are 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>Memantine and donepezil hydrochlorides extended-release capsules contain 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 HydrochlorideThe 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. Memantine and donepezil hydrochlorides extended-release capsules. Memantine and donepezil hydrochlorides extended-release capsules for oral administration, containing 14 mg memantine hydrochloride extended-release and 10 mg donepezil hydrochloride (14 mg/10 mg) or 28 mg memantine hydrochloride extended-release and 10 mg donepezil hydrochloride (28 mg/10 mg). All doses of memantine and donepezil hydrochlorides extended-release capsules contain the following inactive ingredients: colloidal silicon dioxide, ethyl cellulose, hydroxypropylmethyl cellulose, lactose monohydrate, microcrystalline cellulose, sugar sphere, talc. The hard gelatin capsules contain gelatin, sodium lauryl sulfate and titanium dioxide; colorants are iron oxide red (28 mg/10 mg). The black ink contains black iron oxide, propylene glycol and shellac.</Description>
</NDC>
<NDC>
<NDCCode>33342-313-56</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (33342-313-56) / 14 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>33342-0313-56</NDC11Code>
<ProductNDC>33342-313</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Memantine And Donepezil</ProprietaryName>
<NonProprietaryName>Memantine And Donepezil</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250715</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208672</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</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>2025-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250715</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Memantine and donepezil hydrochlorides extended-release capsules are 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>Memantine and donepezil hydrochlorides extended-release capsules contain 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 HydrochlorideThe 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. Memantine and donepezil hydrochlorides extended-release capsules. Memantine and donepezil hydrochlorides extended-release capsules for oral administration, containing 14 mg memantine hydrochloride extended-release and 10 mg donepezil hydrochloride (14 mg/10 mg) or 28 mg memantine hydrochloride extended-release and 10 mg donepezil hydrochloride (28 mg/10 mg). All doses of memantine and donepezil hydrochlorides extended-release capsules contain the following inactive ingredients: colloidal silicon dioxide, ethyl cellulose, hydroxypropylmethyl cellulose, lactose monohydrate, microcrystalline cellulose, sugar sphere, talc. The hard gelatin capsules contain gelatin, sodium lauryl sulfate and titanium dioxide; colorants are iron oxide red (28 mg/10 mg). The black ink contains black iron oxide, propylene glycol and shellac.</Description>
</NDC>
<NDC>
<NDCCode>33342-555-11</NDCCode>
<PackageDescription>100 CAPSULE in 1 CONTAINER (33342-555-11) </PackageDescription>
<NDC11Code>33342-0555-11</NDC11Code>
<ProductNDC>33342-555</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mexiletine Hydrochloride</ProprietaryName>
<NonProprietaryName>Mexiletine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260323</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219987</ApplicationNumber>
<LabelerName>Macleods Pharmaceuticals Limited</LabelerName>
<SubstanceName>MEXILETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260323</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mexiletine hydrochloride capsules are indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgment of the physician, are life-threatening. Because of the proarrhythmic effects of mexiletine, its use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided.Initiation of mexiletine treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital.Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias.</IndicationAndUsage>
<Description>Mexiletine hydrochloride, USP is an orally active antiarrhythmic agent. It is a white to off-white crystalline powder with slightly bitter taste, freely soluble in water and in alcohol. Mexiletine hydrochloride, USP has a pKa of 9.2. The chemical name of mexiletine hydrochloride, USP is 1-methyl-2-(2,6-xylyloxy)ethylamine hydrochloride and its structural formula is. C11H17NOHCl M.W. 215.72. Each capsule for oral administration, contains 150 mg, 200 mg, or 250 mg of mexiletine hydrochloride, USP. 100 mg of mexiletine hydrochloride, USP is equivalent to 83.31 mg of mexiletine base. In addition, each capsule contains the following excipients: colloidal silicon dioxide, magnesium stearate, pregelatinized starch. The capsule shell contains: FD&C Yellow #6,gelatin, titanium dioxide and sodium lauryl sulphate. The 150 mg capsule also contains: D&C Red 28, FD&C Blue #1 and the 250 mg capsule also contains: D&C Yellow #10 and FD&C Blue #1. The imprinting ink contains: butyl alcohol, black iron oxide, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, strong ammonia solution, propylene glycol and shellac.FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
</NDCList>