{
"NDC": [
{
"NDCCode": "62756-700-84",
"PackageDescription": "28 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (62756-700-84)",
"NDC11Code": "62756-0700-84",
"ProductNDC": "62756-700",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risperidone",
"NonProprietaryName": "Risperidone",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20130413",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078464",
"LabelerName": "Sun Pharmaceutical Industries Limited",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-01-18"
},
{
"NDCCode": "12213-700-84",
"PackageDescription": "1698 L in 1 CYLINDER (12213-700-84) ",
"NDC11Code": "12213-0700-84",
"ProductNDC": "12213-700",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Air",
"NonProprietaryName": "Air",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19960601",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205859",
"LabelerName": "NexAir, LLC",
"SubstanceName": "AIR",
"StrengthNumber": "1000",
"StrengthUnit": "mL/L",
"Status": "Active",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19960601",
"SamplePackage": "N"
},
{
"NDCCode": "59467-700-84",
"PackageDescription": "12 CARTON in 1 BOX (59467-700-84) / 1 BOTTLE, SPRAY in 1 CARTON / 56 SPRAY, METERED in 1 BOTTLE, SPRAY",
"NDC11Code": "59467-0700-84",
"ProductNDC": "59467-700",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ryaltris",
"NonProprietaryName": "Olopatadine Hydrochloride And Mometasone Furoate",
"DosageFormName": "SPRAY, METERED",
"RouteName": "NASAL",
"StartMarketingDate": "20220815",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA211746",
"LabelerName": "HIKMA SPECIALTY USA INC.",
"SubstanceName": "OLOPATADINE HYDROCHLORIDE; MOMETASONE FUROATE MONOHYDRATE",
"StrengthNumber": "665; 25",
"StrengthUnit": "ug/1; ug/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Decreased Histamine Release [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Histamine-1 Receptor Inhibitor [EPC], Mast Cell Stabilizer [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220815",
"SamplePackage": "N",
"IndicationAndUsage": "RYALTRIS is indicated for the treatment of symptoms of seasonal allergic rhinitis in adult and pediatric patients 12 years of age and older.",
"Description": "RYALTRIS is a metered-dose manual nasal spray unit containing an aqueous suspension of a fixed‑dose combination of a histamine-1 (H1) receptor inhibitor (olopatadine hydrochloride) and a corticosteroid (mometasone furoate monohydrate). Olopatadine hydrochloride is a white, sparingly water‑soluble crystalline powder. The chemical name for olopatadine hydrochloride is 2‑[(11Z)-11-[3-(dimethylamino)propylidene]-6H-benzo[c][1]benzoxepin-2-yl]acetic acid hydrochloride. It has a molecular weight of 373.88, and its molecular formula is C21H23NO3HCl with the following chemical structure. Mometasone furoate monohydrate is an anti-inflammatory corticosteroid having the chemical name [(8S,9R,10S,11S,13S,14S,16R,17R)-9-chloro-17-(2-chloroacetyl)-11-hydroxy-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl] furan-2-carboxylate;hydrate and the following chemical structure. Mometasone furoate monohydrate is a white powder, with an empirical formula of C27H30Cl2O6H2O and a molecular weight of 539.45. It is practically insoluble in water; slightly soluble in methanol, ethanol, and isopropanol; soluble in acetone and chloroform; and freely soluble in tetrahydrofuran. Its partition coefficient between octanol and water is >5000. RYALTRIS is a nasal spray containing an isotonic aqueous suspension of olopatadine hydrochloride (equivalent to 0.6% w/v olopatadine base) and mometasone furoate monohydrate (equivalent to 0.025% w/w mometasone furoate on the anhydrous basis). After initial priming (6 sprays), each metered spray delivers 100 microliters of suspension containing 665 mcg of olopatadine hydrochloride (equivalent to 600 mcg olopatadine base) and 25 mcg of mometasone furoate. RYALTRIS also contains benzalkonium chloride, carboxymethyl cellulose sodium, dibasic sodium phosphate heptahydrate, edetate disodium, hydrochloric acid, microcrystalline cellulose, polysorbate 80, sodium chloride, sodium hydroxide, and water. It has a pH of approximately 3.7 [see How Supplied/Storage and Handling (16)]."
},
{
"NDCCode": "76348-700-03",
"PackageDescription": "84 g in 1 BOTTLE, WITH APPLICATOR (76348-700-03) ",
"NDC11Code": "76348-0700-03",
"ProductNDC": "76348-700",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Just Chill Pain Relief",
"NonProprietaryName": "Menthol 5 Percent",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210921",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "RENU LABORATORIES, INC.",
"SubstanceName": "MENTHOL",
"StrengthNumber": "4.2",
"StrengthUnit": "g/84g",
"Status": "Deprecated",
"LastUpdate": "2023-10-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20210921",
"SamplePackage": "N"
},
{
"NDCCode": "62756-633-84",
"PackageDescription": "28 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (62756-633-84)",
"NDC11Code": "62756-0633-84",
"ProductNDC": "62756-633",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risperidone",
"NonProprietaryName": "Risperidone",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20130413",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078464",
"LabelerName": "Sun Pharmaceutical Industries Limited",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": "3",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-01-18"
},
{
"NDCCode": "62756-634-84",
"PackageDescription": "28 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (62756-634-84)",
"NDC11Code": "62756-0634-84",
"ProductNDC": "62756-634",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risperidone",
"NonProprietaryName": "Risperidone",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20130413",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078464",
"LabelerName": "Sun Pharmaceutical Industries Limited",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-01-18"
},
{
"NDCCode": "62756-701-84",
"PackageDescription": "28 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (62756-701-84)",
"NDC11Code": "62756-0701-84",
"ProductNDC": "62756-701",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risperidone",
"NonProprietaryName": "Risperidone",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20130413",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078464",
"LabelerName": "Sun Pharmaceutical Industries Limited",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-01-18"
},
{
"NDCCode": "62756-702-84",
"PackageDescription": "28 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (62756-702-84)",
"NDC11Code": "62756-0702-84",
"ProductNDC": "62756-702",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risperidone",
"NonProprietaryName": "Risperidone",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20130413",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078464",
"LabelerName": "Sun Pharmaceutical Industries Limited",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-01-18"
},
{
"NDCCode": "62756-700-08",
"PackageDescription": "100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (62756-700-08)",
"NDC11Code": "62756-0700-08",
"ProductNDC": "62756-700",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risperidone",
"NonProprietaryName": "Risperidone",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20130413",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078464",
"LabelerName": "Sun Pharmaceutical Industries Limited",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-01-18"
},
{
"NDCCode": "62756-700-18",
"PackageDescription": "1000 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (62756-700-18)",
"NDC11Code": "62756-0700-18",
"ProductNDC": "62756-700",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risperidone",
"NonProprietaryName": "Risperidone",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20130413",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078464",
"LabelerName": "Sun Pharmaceutical Industries Limited",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-01-18"
},
{
"NDCCode": "62756-700-64",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (62756-700-64) > 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK",
"NDC11Code": "62756-0700-64",
"ProductNDC": "62756-700",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risperidone",
"NonProprietaryName": "Risperidone",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20130413",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078464",
"LabelerName": "Sun Pharmaceutical Industries Limited",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-01-18"
},
{
"NDCCode": "62756-700-83",
"PackageDescription": "30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (62756-700-83)",
"NDC11Code": "62756-0700-83",
"ProductNDC": "62756-700",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risperidone",
"NonProprietaryName": "Risperidone",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20130413",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078464",
"LabelerName": "Sun Pharmaceutical Industries Limited",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-01-18"
},
{
"NDCCode": "62756-700-88",
"PackageDescription": "100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (62756-700-88)",
"NDC11Code": "62756-0700-88",
"ProductNDC": "62756-700",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Risperidone",
"NonProprietaryName": "Risperidone",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20130413",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078464",
"LabelerName": "Sun Pharmaceutical Industries Limited",
"SubstanceName": "RISPERIDONE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-01-18"
},
{
"NDCCode": "62756-233-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (62756-233-01) / 1 INJECTABLE, LIPOSOMAL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "62756-0233-01",
"ProductNDC": "62756-233",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amphotericin B",
"NonProprietaryName": "Amphotericin B",
"DosageFormName": "INJECTABLE, LIPOSOMAL",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220209",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212514",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "AMPHOTERICIN B",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Lipid-based Polyene Antifungal [EPC], Polyene Antifungal [EPC], Polyenes [CS]",
"Status": "Active",
"LastUpdate": "2026-04-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220209",
"SamplePackage": "N",
"IndicationAndUsage": "Amphotericin B liposome for injection is indicated for the following: 1 Empirical therapy for presumed fungal infection in febrile, neutropenic patients., 2 Treatment of Cryptococcal Meningitis in HIV infected patients (see DESCRIPTION OF CLINICAL STUDIES)., 3 Treatment of patients with Aspergillus species, Candida species and/or Cryptococcus species infections (see above for the treatment of Cryptococcal Meningitis) refractory to amphotericin B deoxycholate, or in patients where renal impairment or unacceptable toxicity precludes the use of amphotericin B deoxycholate., 4 Treatment of visceral leishmaniasis. In immunocompromised patients with visceral leishmaniasis treated with amphotericin B liposome for injection, relapse rates were high following initial clearance of parasites (see DESCRIPTION OF CLINICAL STUDIES).",
"Description": "Amphotericin B liposome for injection is a sterile, non-pyrogenic lyophilized product for intravenous infusion. Each vial contains amphotericin B, USP 50 milligrams (mg), intercalated into a liposomal membrane consisting of alpha tocopherol approximately 0.64 mg; cholesterol 52 mg; distearoylphosphatidylglycerol, sodium salt 84 mg; hydrogenated soy phosphatidylcholine 213 mg, together with disodium succinate hexahydrate 27 mg; and sucrose 900 mg. Amphotericin B liposome for injection may also contain hydrochloric acid and/or sodium hydroxide as pH adjusters. Following reconstitution with Sterile Water for Injection, the resulting pH of the suspension is between 5.0 to 6.0. Amphotericin B liposome for injection is a true single bilayer liposomal drug delivery system. Liposomes are closed, spherical vesicles created by mixing specific proportions of amphophilic substances such as phospholipids and cholesterol so that they arrange themselves into multiple concentric bilayer membranes when hydrated in aqueous solutions. Single bilayer liposomes are then formed by microemulsification of multilamellar vesicles using a homogenizer. Amphotericin B liposome for injection consists of these unilamellar bilayer liposomes with amphotericin B intercalated within the membrane. Due to the nature and quantity of amphophilic substances used, and the lipophilic moiety in the amphotericin B molecule, the drug is an integral part of the overall structure of the Amphotericin B liposomes. Amphotericin B liposome for injection contains true liposomes that are less than 100 nm in diameter. A schematic depiction of the liposome is presented below. Note: Liposomal encapsulation or incorporation into a lipid complex can substantially affect a drug’s functional properties relative to those of the unencapsulated drug or non-lipid associated drug. In addition, different liposomal or lipid-complex products with a common active ingredient may vary from one another in the chemical composition and physical form of the lipid component. Such differences may affect the functional properties of these drug products. Amphotericin B is a macrocyclic, polyene, antifungal antibiotic produced from a strain of Streptomyces nodosus. Amphotericin B is designated chemically as: [1R-(1R*,3S*,5R*,6R*,9R*,11R*,15S*,16R*,17R*,18S*, 19E,21E,23E,25E,27E,29E,31E,33R*,35S*,36R*,37S*)]-33-[(3-Amino-3,6-dideoxy-ß-D-mannopyranosyl)oxy]-1,3,5,6,9,11,17,37-octahydroxy-15,16,18-trimethyl-13-oxo-14,39-dioxabicyclo-[33.3.1]nonatriaconta-19,21,23,25,27,29,31-heptaene-36-carboxylic acid (CAS No.1397-89-3). Amphotericin B has a molecular formula of C47H73NO17 and a molecular weight of 924.09 g/mol. The structure of amphotericin B is shown below."
},
{
"NDCCode": "62756-233-02",
"PackageDescription": "10 CARTON in 1 CARTON (62756-233-02) / 1 VIAL, SINGLE-DOSE in 1 CARTON / 1 INJECTABLE, LIPOSOMAL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "62756-0233-02",
"ProductNDC": "62756-233",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amphotericin B",
"NonProprietaryName": "Amphotericin B",
"DosageFormName": "INJECTABLE, LIPOSOMAL",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220209",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212514",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "AMPHOTERICIN B",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Lipid-based Polyene Antifungal [EPC], Polyene Antifungal [EPC], Polyenes [CS]",
"Status": "Active",
"LastUpdate": "2026-04-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220209",
"SamplePackage": "N",
"IndicationAndUsage": "Amphotericin B liposome for injection is indicated for the following: 1 Empirical therapy for presumed fungal infection in febrile, neutropenic patients., 2 Treatment of Cryptococcal Meningitis in HIV infected patients (see DESCRIPTION OF CLINICAL STUDIES)., 3 Treatment of patients with Aspergillus species, Candida species and/or Cryptococcus species infections (see above for the treatment of Cryptococcal Meningitis) refractory to amphotericin B deoxycholate, or in patients where renal impairment or unacceptable toxicity precludes the use of amphotericin B deoxycholate., 4 Treatment of visceral leishmaniasis. In immunocompromised patients with visceral leishmaniasis treated with amphotericin B liposome for injection, relapse rates were high following initial clearance of parasites (see DESCRIPTION OF CLINICAL STUDIES).",
"Description": "Amphotericin B liposome for injection is a sterile, non-pyrogenic lyophilized product for intravenous infusion. Each vial contains amphotericin B, USP 50 milligrams (mg), intercalated into a liposomal membrane consisting of alpha tocopherol approximately 0.64 mg; cholesterol 52 mg; distearoylphosphatidylglycerol, sodium salt 84 mg; hydrogenated soy phosphatidylcholine 213 mg, together with disodium succinate hexahydrate 27 mg; and sucrose 900 mg. Amphotericin B liposome for injection may also contain hydrochloric acid and/or sodium hydroxide as pH adjusters. Following reconstitution with Sterile Water for Injection, the resulting pH of the suspension is between 5.0 to 6.0. Amphotericin B liposome for injection is a true single bilayer liposomal drug delivery system. Liposomes are closed, spherical vesicles created by mixing specific proportions of amphophilic substances such as phospholipids and cholesterol so that they arrange themselves into multiple concentric bilayer membranes when hydrated in aqueous solutions. Single bilayer liposomes are then formed by microemulsification of multilamellar vesicles using a homogenizer. Amphotericin B liposome for injection consists of these unilamellar bilayer liposomes with amphotericin B intercalated within the membrane. Due to the nature and quantity of amphophilic substances used, and the lipophilic moiety in the amphotericin B molecule, the drug is an integral part of the overall structure of the Amphotericin B liposomes. Amphotericin B liposome for injection contains true liposomes that are less than 100 nm in diameter. A schematic depiction of the liposome is presented below. Note: Liposomal encapsulation or incorporation into a lipid complex can substantially affect a drug’s functional properties relative to those of the unencapsulated drug or non-lipid associated drug. In addition, different liposomal or lipid-complex products with a common active ingredient may vary from one another in the chemical composition and physical form of the lipid component. Such differences may affect the functional properties of these drug products. Amphotericin B is a macrocyclic, polyene, antifungal antibiotic produced from a strain of Streptomyces nodosus. Amphotericin B is designated chemically as: [1R-(1R*,3S*,5R*,6R*,9R*,11R*,15S*,16R*,17R*,18S*, 19E,21E,23E,25E,27E,29E,31E,33R*,35S*,36R*,37S*)]-33-[(3-Amino-3,6-dideoxy-ß-D-mannopyranosyl)oxy]-1,3,5,6,9,11,17,37-octahydroxy-15,16,18-trimethyl-13-oxo-14,39-dioxabicyclo-[33.3.1]nonatriaconta-19,21,23,25,27,29,31-heptaene-36-carboxylic acid (CAS No.1397-89-3). Amphotericin B has a molecular formula of C47H73NO17 and a molecular weight of 924.09 g/mol. The structure of amphotericin B is shown below."
},
{
"NDCCode": "62756-954-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (62756-954-01) / 1 INJECTABLE, LIPOSOMAL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "62756-0954-01",
"ProductNDC": "62756-954",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amphotericin B",
"NonProprietaryName": "Amphotericin B",
"DosageFormName": "INJECTABLE, LIPOSOMAL",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20241201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212514",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "AMPHOTERICIN B",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Lipid-based Polyene Antifungal [EPC], Polyene Antifungal [EPC], Polyenes [CS]",
"Status": "Active",
"LastUpdate": "2026-04-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241201",
"SamplePackage": "N",
"IndicationAndUsage": "Amphotericin B liposome for injection is indicated for the following: 1 Empirical therapy for presumed fungal infection in febrile, neutropenic patients., 2 Treatment of Cryptococcal Meningitis in HIV-infected patients (see DESCRIPTION OF CLINICAL STUDIES)., 3 Treatment of patients with Aspergillus species, Candida species and/or Cryptococcus species infections (see above for the treatment of Cryptococcal Meningitis) refractory to amphotericin B deoxycholate, or in patients where renal impairment or unacceptable toxicity precludes the use of amphotericin B deoxycholate., 4 Treatment of visceral leishmaniasis. In immunocompromised patients with visceral leishmaniasis treated with amphotericin B liposome for injection, relapse rates were high following initial clearance of parasites (see DESCRIPTION OF CLINICAL STUDIES).",
"Description": "Amphotericin B liposome for injection is a sterile, non-pyrogenic lyophilized product for intravenous infusion. Each vial contains amphotericin B, USP 50 milligrams (mg), intercalated into a liposomal membrane consisting of alpha tocopherol approximately 0.64 mg; cholesterol 52 mg; distearoylphosphatidylglycerol, sodium salt 84 mg; hydrogenated soy phosphatidylcholine 213 mg, together with disodium succinate hexahydrate 27 mg; and sucrose 900 mg. Amphotericin B liposome for injection may also contain hydrochloric acid and/or sodium hydroxide as pH adjusters. Following reconstitution with Sterile Water for Injection, the resulting pH of the suspension is between 5.0 to 6.0. Amphotericin B liposome for injection is a true single bilayer liposomal drug delivery system. Liposomes are closed, spherical vesicles created by mixing specific proportions of amphophilic substances such as phospholipids and cholesterol so that they arrange themselves into multiple concentric bilayer membranes when hydrated in aqueous solutions. Single bilayer liposomes are then formed by microemulsification of multilamellar vesicles using a homogenizer. Amphotericin B liposome for injection consists of these unilamellar bilayer liposomes with amphotericin B intercalated within the membrane. Due to the nature and quantity of amphophilic substances used, and the lipophilic moiety in the amphotericin B molecule, the drug is an integral part of the overall structure of the Amphotericin B liposomes. Amphotericin B liposome for injection contains true liposomes that are less than 100 nm in diameter. A schematic depiction of the liposome is presented below. Note: Liposomal encapsulation or incorporation into a lipid complex can substantially affect a drug’s functional properties relative to those of the unencapsulated drug or non-lipid associated drug. In addition, different liposomal or lipid-complex products with a common active ingredient may vary from one another in the chemical composition and physical form of the lipid component. Such differences may affect the functional properties of these drug products. Amphotericin B is a macrocyclic, polyene, antifungal antibiotic produced from a strain of Streptomyces nodosus. Amphotericin B is designated chemically as: [1R-(1R*,3S*,5R*,6R*,9R*,11R*,15S*,16R*,17R*,18S*, 19E,21E,23E,25E,27E,29E,31E,33R*,35S*,36R*,37S*)]-33-[(3-Amino-3,6-dideoxy-ß-D-mannopyranosyl)oxy]-1,3,5,6,9,11,17,37-octahydroxy-15,16,18-trimethyl-13-oxo-14,39-dioxabicyclo-[33.3.1]nonatriaconta-19,21,23,25,27,29,31-heptaene-36-carboxylic acid (CAS No.1397-89-3). Amphotericin B has a molecular formula of C47H73NO17 and a molecular weight of 924.09 g/mol. The structure of amphotericin B is shown below."
},
{
"NDCCode": "62756-954-02",
"PackageDescription": "10 CARTON in 1 CARTON (62756-954-02) / 1 VIAL, SINGLE-DOSE in 1 CARTON / 1 INJECTABLE, LIPOSOMAL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "62756-0954-02",
"ProductNDC": "62756-954",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amphotericin B",
"NonProprietaryName": "Amphotericin B",
"DosageFormName": "INJECTABLE, LIPOSOMAL",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20241201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212514",
"LabelerName": "Sun Pharmaceutical Industries, Inc.",
"SubstanceName": "AMPHOTERICIN B",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Lipid-based Polyene Antifungal [EPC], Polyene Antifungal [EPC], Polyenes [CS]",
"Status": "Active",
"LastUpdate": "2026-04-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241201",
"SamplePackage": "N",
"IndicationAndUsage": "Amphotericin B liposome for injection is indicated for the following: 1 Empirical therapy for presumed fungal infection in febrile, neutropenic patients., 2 Treatment of Cryptococcal Meningitis in HIV-infected patients (see DESCRIPTION OF CLINICAL STUDIES)., 3 Treatment of patients with Aspergillus species, Candida species and/or Cryptococcus species infections (see above for the treatment of Cryptococcal Meningitis) refractory to amphotericin B deoxycholate, or in patients where renal impairment or unacceptable toxicity precludes the use of amphotericin B deoxycholate., 4 Treatment of visceral leishmaniasis. In immunocompromised patients with visceral leishmaniasis treated with amphotericin B liposome for injection, relapse rates were high following initial clearance of parasites (see DESCRIPTION OF CLINICAL STUDIES).",
"Description": "Amphotericin B liposome for injection is a sterile, non-pyrogenic lyophilized product for intravenous infusion. Each vial contains amphotericin B, USP 50 milligrams (mg), intercalated into a liposomal membrane consisting of alpha tocopherol approximately 0.64 mg; cholesterol 52 mg; distearoylphosphatidylglycerol, sodium salt 84 mg; hydrogenated soy phosphatidylcholine 213 mg, together with disodium succinate hexahydrate 27 mg; and sucrose 900 mg. Amphotericin B liposome for injection may also contain hydrochloric acid and/or sodium hydroxide as pH adjusters. Following reconstitution with Sterile Water for Injection, the resulting pH of the suspension is between 5.0 to 6.0. Amphotericin B liposome for injection is a true single bilayer liposomal drug delivery system. Liposomes are closed, spherical vesicles created by mixing specific proportions of amphophilic substances such as phospholipids and cholesterol so that they arrange themselves into multiple concentric bilayer membranes when hydrated in aqueous solutions. Single bilayer liposomes are then formed by microemulsification of multilamellar vesicles using a homogenizer. Amphotericin B liposome for injection consists of these unilamellar bilayer liposomes with amphotericin B intercalated within the membrane. Due to the nature and quantity of amphophilic substances used, and the lipophilic moiety in the amphotericin B molecule, the drug is an integral part of the overall structure of the Amphotericin B liposomes. Amphotericin B liposome for injection contains true liposomes that are less than 100 nm in diameter. A schematic depiction of the liposome is presented below. Note: Liposomal encapsulation or incorporation into a lipid complex can substantially affect a drug’s functional properties relative to those of the unencapsulated drug or non-lipid associated drug. In addition, different liposomal or lipid-complex products with a common active ingredient may vary from one another in the chemical composition and physical form of the lipid component. Such differences may affect the functional properties of these drug products. Amphotericin B is a macrocyclic, polyene, antifungal antibiotic produced from a strain of Streptomyces nodosus. Amphotericin B is designated chemically as: [1R-(1R*,3S*,5R*,6R*,9R*,11R*,15S*,16R*,17R*,18S*, 19E,21E,23E,25E,27E,29E,31E,33R*,35S*,36R*,37S*)]-33-[(3-Amino-3,6-dideoxy-ß-D-mannopyranosyl)oxy]-1,3,5,6,9,11,17,37-octahydroxy-15,16,18-trimethyl-13-oxo-14,39-dioxabicyclo-[33.3.1]nonatriaconta-19,21,23,25,27,29,31-heptaene-36-carboxylic acid (CAS No.1397-89-3). Amphotericin B has a molecular formula of C47H73NO17 and a molecular weight of 924.09 g/mol. The structure of amphotericin B is shown below."
},
{
"NDCCode": "52268-700-01",
"PackageDescription": "4 L in 1 PACKET (52268-700-01) ",
"NDC11Code": "52268-0700-01",
"ProductNDC": "52268-700",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Golytely",
"NonProprietaryName": "Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "19840713",
"EndMarketingDate": "20220531",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019011",
"LabelerName": "Braintree Laboratories, Inc.",
"SubstanceName": "POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS",
"StrengthNumber": "227.1; .754; 6.36; 5.53; 21.5",
"StrengthUnit": "g/L; g/L; g/L; g/L; g/L",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2022-06-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19840713",
"EndMarketingDatePackage": "20220531",
"SamplePackage": "N",
"IndicationAndUsage": "GoLYTELY is indicated for bowel cleansing prior to colonoscopy and barium enema X-ray examination in adults.",
"Description": "GoLYTELY is a combination of polyethylene glycol 3350, an osmotic laxative, and electrolytes (sodium sulfate, sodium chloride, sodium bicarbonate and potassium chloride) for oral solution supplied in a 4-liter disposable jug containing 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride, and 2.97 g potassium chloride as a white powder. Polyethylene Glycol 3350, USP. Sodium Sulfate, USP. The chemical name is Na 2SO 4. The average Molecular Weight is 142.04. The structural formula is:. Sodium Bicarbonate, USP. The chemical name is NaHCO 3. The average Molecular Weight is 84.01. The structural formula is:. Sodium Chloride, USP. The chemical name is NaCl. The average Molecular Weight: 58.44. The structural formula is. Na + Cl -. Potassium Chloride, USP. The chemical name is KCl. The average Molecular Weight: 74.55. The structural formula is. K-Cl."
},
{
"NDCCode": "59088-396-54",
"PackageDescription": "30 POUCH in 1 CARTON (59088-396-54) / .7 g in 1 POUCH (59088-396-84) ",
"NDC11Code": "59088-0396-54",
"ProductNDC": "59088-396",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine",
"NonProprietaryName": "Lidocaine",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130915",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200675",
"LabelerName": "PureTek Corporation",
"SubstanceName": "LIDOCAINE",
"StrengthNumber": "50",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160229",
"SamplePackage": "N",
"IndicationAndUsage": "Lidocaine patch 5% is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin.",
"Description": "Lidocaine patch 5% is comprised of an adhesive material containing 5% lidocaine, which is applied to a white non-woven polyethylene terephthalate (PET) material backing and covered with a transparent PET release liner. The release liner is removed prior to application to the skin. The size of the patch is 10 cm x 14 cm. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), has an octanol:water partition ratio of 43 at pH 7.4, and has the following structure. Each adhesive patch contains 700 mg of lidocaine (50 mg per gram adhesive) in an aqueous base. It also contains the following inactive ingredients: glycerin, D-sorbitol, propylene glycol, polyvinyl alcohol, urea, sodium polyacrylate, carboxymethylcellulose sodium, gelatin, polyacrylic acid, kaolin, tartaric acid, dihydroxyaluminum aminoacetate, methylparaben, propylparaben, and edetate disodium."
},
{
"NDCCode": "59088-396-82",
"PackageDescription": "15 POUCH in 1 CARTON (59088-396-82) / .7 g in 1 POUCH (59088-396-84) ",
"NDC11Code": "59088-0396-82",
"ProductNDC": "59088-396",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine",
"NonProprietaryName": "Lidocaine",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130915",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200675",
"LabelerName": "PureTek Corporation",
"SubstanceName": "LIDOCAINE",
"StrengthNumber": "50",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160229",
"SamplePackage": "N",
"IndicationAndUsage": "Lidocaine patch 5% is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin.",
"Description": "Lidocaine patch 5% is comprised of an adhesive material containing 5% lidocaine, which is applied to a white non-woven polyethylene terephthalate (PET) material backing and covered with a transparent PET release liner. The release liner is removed prior to application to the skin. The size of the patch is 10 cm x 14 cm. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), has an octanol:water partition ratio of 43 at pH 7.4, and has the following structure. Each adhesive patch contains 700 mg of lidocaine (50 mg per gram adhesive) in an aqueous base. It also contains the following inactive ingredients: glycerin, D-sorbitol, propylene glycol, polyvinyl alcohol, urea, sodium polyacrylate, carboxymethylcellulose sodium, gelatin, polyacrylic acid, kaolin, tartaric acid, dihydroxyaluminum aminoacetate, methylparaben, propylparaben, and edetate disodium."
},
{
"NDCCode": "59088-712-00",
"PackageDescription": "1 KIT in 1 PACKAGE (59088-712-00) * 30 POUCH in 1 CARTON (59088-396-54) > .7 g in 1 POUCH (59088-396-84) ",
"NDC11Code": "59088-0712-00",
"ProductNDC": "59088-712",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidopure Patch",
"NonProprietaryName": "Lidocaine",
"DosageFormName": "KIT",
"StartMarketingDate": "20180606",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"Status": "Active",
"LastUpdate": "2020-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180606",
"SamplePackage": "N",
"IndicationAndUsage": "Lidocaine patch 5% is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin.",
"Description": "Lidocaine patch 5% is comprised of an adhesive material containing 5% lidocaine, which is applied to a white non-woven polyethylene terephthalate (PET) material backing and covered with a transparent PET release liner. The release liner is removed prior to application to the skin. The size of the patch is 10 cm x 14 cm. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), has an octanol:water partition ratio of 43 at pH 7.4, and has the following structure. Each adhesive patch contains 700 mg of lidocaine (50 mg per gram adhesive) in an aqueous base. It also contains the following inactive ingredients: glycerin, D-sorbitol, propylene glycol, polyvinyl alcohol, urea, sodium polyacrylate, carboxymethylcellulose sodium, gelatin, polyacrylic acid, kaolin, tartaric acid, dihydroxyaluminum aminoacetate, methylparaben, propylparaben, and edetate disodium."
},
{
"NDCCode": "59088-731-00",
"PackageDescription": "1 KIT in 1 KIT (59088-731-00) * 30 POUCH in 1 PACKAGE (59088-905-54) / 1 PATCH in 1 POUCH (59088-905-84) * 200 PACKET in 1 BOX (53329-805-60) / 1 APPLICATOR in 1 PACKET / 5 mL in 1 APPLICATOR",
"NDC11Code": "59088-0731-00",
"ProductNDC": "59088-731",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Xyliderm",
"NonProprietaryName": "Lidocaine, Isopropyl Alcohol",
"DosageFormName": "KIT",
"StartMarketingDate": "20230705",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"Status": "Active",
"LastUpdate": "2024-12-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230705",
"SamplePackage": "N",
"Description": "Lidocan is comprised of an adhesive material containing 5% lidocaine, which is applied to a white non-woven polyethylene terephthalate (PET) material backing and covered with a transparent PET release liner. The release liner is removed prior to application to the skin. The size of the patch is 10 cm x 14 cm. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), has an octanol:water partition ratio of 43 at pH 7.4, and has the following structure. Each adhesive patch contains 700 mg of lidocaine (50 mg per gram adhesive) in an aqueous base. It also contains the following inactive ingredients: purified water, glycerin, sorbitol, polyacrylic acid, sodium carboxymethylcellulose, sodium polyacrylate, propylene glycol, urea, kaolin, tartaric acid, gelatin, polyvinyl alcohol, dihydroxyaluminum aminoacetate, edetate disodium, methylparaben, and propylparaben."
},
{
"NDCCode": "59088-900-54",
"PackageDescription": "30 POUCH in 1 PACKAGE (59088-900-54) / 14 g in 1 POUCH (59088-900-84) ",
"NDC11Code": "59088-0900-54",
"ProductNDC": "59088-900",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocan Vii",
"NonProprietaryName": "Lidocaine 5%",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230615",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209190",
"LabelerName": "PURETEK CORPORATION",
"SubstanceName": "LIDOCAINE",
"StrengthNumber": "50",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2025-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240808",
"SamplePackage": "N",
"IndicationAndUsage": "Lidocan VII is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin.",
"Description": "Lidocan VII is comprised of an adhesive material containing 5% lidocaine, which is applied to a non-woven polyester felt backing and covered with a polyethylene terephthalate (PET) film release liner. The release liner is removed prior to application to the skin. The size of the patch is 10 cm x 14 cm. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), has an octanol:water partition ratio of 43 at pH 7.4, and has the following structure:. Each adhesive patch contains 700 mg of lidocaine (50 mg per gram adhesive) in an aqueous base. It also contains the following inactive ingredients: purified water, glycerin, sorbitol, polyacrylic acid, sodium carboxymethylcellulose, sodium polyacrylate, propylene glycol, urea, kaolin, tartaric acid, gelatin, polyvinyl alcohol, dihydroxyaluminum aminoacetate, edetate disodium, methylparaben, and propylparaben."
},
{
"NDCCode": "59088-905-54",
"PackageDescription": "30 POUCH in 1 PACKAGE (59088-905-54) / 1 PATCH in 1 POUCH (59088-905-84) ",
"NDC11Code": "59088-0905-54",
"ProductNDC": "59088-905",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocan",
"NonProprietaryName": "Lidocaine 5%",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200514",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209190",
"LabelerName": "PURETEK CORPORATION",
"SubstanceName": "LIDOCAINE",
"StrengthNumber": "700",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2026-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230714",
"SamplePackage": "N",
"IndicationAndUsage": "LIDOCAN is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin.",
"Description": "LIDOCAN is comprised of an adhesive material containing 5% lidocaine, which is applied to a non-woven polyester felt backing and covered with a polyethylene terephthalate (PET) film release liner. The release liner is removed prior to application to the skin. The size of the patch is 10 cm x 14 cm. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), has an octanol:water partition ratio of 43 at pH 7.4, and has the following structure:. Each adhesive patch contains 700 mg of lidocaine (50 mg per gram adhesive) in an aqueous base. It also contains the following inactive ingredients: purified water, glycerin, sorbitol, polyacrylic acid, sodium carboxymethylcellulose, sodium polyacrylate, propylene glycol, urea, kaolin, tartaric acid, gelatin, polyvinyl alcohol, dihydroxyaluminum aminoacetate, edetate disodium, methylparaben, and propylparaben."
},
{
"NDCCode": "59088-905-82",
"PackageDescription": "15 POUCH in 1 PACKAGE (59088-905-82) / 1 PATCH in 1 POUCH (59088-905-84) ",
"NDC11Code": "59088-0905-82",
"ProductNDC": "59088-905",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocan",
"NonProprietaryName": "Lidocaine 5%",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200514",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209190",
"LabelerName": "PURETEK CORPORATION",
"SubstanceName": "LIDOCAINE",
"StrengthNumber": "700",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2026-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260127",
"SamplePackage": "N",
"IndicationAndUsage": "LIDOCAN is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin.",
"Description": "LIDOCAN is comprised of an adhesive material containing 5% lidocaine, which is applied to a non-woven polyester felt backing and covered with a polyethylene terephthalate (PET) film release liner. The release liner is removed prior to application to the skin. The size of the patch is 10 cm x 14 cm. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), has an octanol:water partition ratio of 43 at pH 7.4, and has the following structure:. Each adhesive patch contains 700 mg of lidocaine (50 mg per gram adhesive) in an aqueous base. It also contains the following inactive ingredients: purified water, glycerin, sorbitol, polyacrylic acid, sodium carboxymethylcellulose, sodium polyacrylate, propylene glycol, urea, kaolin, tartaric acid, gelatin, polyvinyl alcohol, dihydroxyaluminum aminoacetate, edetate disodium, methylparaben, and propylparaben."
},
{
"NDCCode": "59088-907-54",
"PackageDescription": "30 POUCH in 1 PACKAGE (59088-907-54) / 14 g in 1 POUCH (59088-907-84) ",
"NDC11Code": "59088-0907-54",
"ProductNDC": "59088-907",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocan Iii",
"NonProprietaryName": "Lidocaine 5%",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200514",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209190",
"LabelerName": "PURETEK CORPORATION",
"SubstanceName": "LIDOCAINE",
"StrengthNumber": "50",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2025-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200514",
"SamplePackage": "N",
"IndicationAndUsage": "LIDOCAN III is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin.",
"Description": "LIDOCAN III is comprised of an adhesive material containing 5% lidocaine, which is applied to a non-woven polyester felt backing and covered with a polyethylene terephthalate (PET) film release liner. The release liner is removed prior to application to the skin. The size of the patch is 10 cm x 14 cm. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), has an octanol:water partition ratio of 43 at pH 7.4, and has the following structure:. Each adhesive patch contains 700 mg of lidocaine (50 mg per gram adhesive) in an aqueous base. It also contains the following inactive ingredients: purified water, glycerin, sorbitol, polyacrylic acid, sodium carboxymethylcellulose, sodium polyacrylate, propylene glycol, urea, kaolin, tartaric acid, gelatin, polyvinyl alcohol, dihydroxyaluminum aminoacetate, edetate disodium, methylparaben, and propylparaben."
},
{
"NDCCode": "59088-909-54",
"PackageDescription": "30 POUCH in 1 PACKAGE (59088-909-54) / 14 g in 1 POUCH (59088-909-84) ",
"NDC11Code": "59088-0909-54",
"ProductNDC": "59088-909",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocan V",
"NonProprietaryName": "Lidocaine 5%",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200514",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209190",
"LabelerName": "PURETEK CORPORATION",
"SubstanceName": "LIDOCAINE",
"StrengthNumber": "50",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2025-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200514",
"SamplePackage": "N",
"IndicationAndUsage": "Lidocan V is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin.",
"Description": "Lidocan V is comprised of an adhesive material containing 5% lidocaine, which is applied to a non-woven polyester felt backing and covered with a polyethylene terephthalate (PET) film release liner. The release liner is removed prior to application to the skin. The size of the patch is 10 cm x 14 cm. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), has an octanol:water partition ratio of 43 at pH 7.4, and has the following structure:. Each adhesive patch contains 700 mg of lidocaine (50 mg per gram adhesive) in an aqueous base. It also contains the following inactive ingredients: purified water, glycerin, sorbitol, polyacrylic acid, sodium carboxymethylcellulose, sodium polyacrylate, propylene glycol, urea, kaolin, tartaric acid, gelatin, polyvinyl alcohol, dihydroxyaluminum aminoacetate, edetate disodium, methylparaben, and propylparaben."
},
{
"NDCCode": "59088-910-54",
"PackageDescription": "30 POUCH in 1 PACKAGE (59088-910-54) / 14 g in 1 POUCH (59088-910-84) ",
"NDC11Code": "59088-0910-54",
"ProductNDC": "59088-910",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocan Iv",
"NonProprietaryName": "Lidocaine 5%",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230615",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209190",
"LabelerName": "PURETEK CORPORATION",
"SubstanceName": "LIDOCAINE",
"StrengthNumber": "50",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2024-11-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230615",
"SamplePackage": "N",
"IndicationAndUsage": "Lidocan IV is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin.",
"Description": "Lidocan IV is comprised of an adhesive material containing 5% lidocaine, which is applied to a non-woven polyester felt backing and covered with a polyethylene terephthalate (PET) film release liner. The release liner is removed prior to application to the skin. The size of the patch is 10 cm x 14 cm. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), has an octanol:water partition ratio of 43 at pH 7.4, and has the following structure:. Each adhesive patch contains 700 mg of lidocaine (50 mg per gram adhesive) in an aqueous base. It also contains the following inactive ingredients: purified water, glycerin, sorbitol, polyacrylic acid, sodium carboxymethylcellulose, sodium polyacrylate, propylene glycol, urea, kaolin, tartaric acid, gelatin, polyvinyl alcohol, dihydroxyaluminum aminoacetate, edetate disodium, methylparaben, and propylparaben."
},
{
"NDCCode": "59088-911-54",
"PackageDescription": "30 POUCH in 1 PACKAGE (59088-911-54) / 14 g in 1 POUCH (59088-911-84) ",
"NDC11Code": "59088-0911-54",
"ProductNDC": "59088-911",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocan Vi",
"NonProprietaryName": "Lidocaine 5%",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230615",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209190",
"LabelerName": "PURETEK CORPORATION",
"SubstanceName": "LIDOCAINE",
"StrengthNumber": "50",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2025-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240621",
"SamplePackage": "N",
"IndicationAndUsage": "Lidocan VI is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin.",
"Description": "Lidocan VI is comprised of an adhesive material containing 5% lidocaine, which is applied to a non-woven polyester felt backing and covered with a polyethylene terephthalate (PET) film release liner. The release liner is removed prior to application to the skin. The size of the patch is 10 cm x 14 cm. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), has an octanol:water partition ratio of 43 at pH 7.4, and has the following structure:. Each adhesive patch contains 700 mg of lidocaine (50 mg per gram adhesive) in an aqueous base. It also contains the following inactive ingredients: purified water, glycerin, sorbitol, polyacrylic acid, sodium carboxymethylcellulose, sodium polyacrylate, propylene glycol, urea, kaolin, tartaric acid, gelatin, polyvinyl alcohol, dihydroxyaluminum aminoacetate, edetate disodium, methylparaben, and propylparaben."
},
{
"NDCCode": "59746-700-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE, PLASTIC (59746-700-01) ",
"NDC11Code": "59746-0700-01",
"ProductNDC": "59746-700",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxepin Hydrochloride",
"NonProprietaryName": "Doxepin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20211201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215483",
"LabelerName": "JUBILANT CADISTA PHARMACEUTICALS INC.",
"SubstanceName": "DOXEPIN HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-07-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20211201",
"SamplePackage": "N",
"IndicationAndUsage": "Doxepin Hydrochloride Capsules, USP are recommended for the treatment of: 1 Psychoneurotic patients with depression and/or anxiety. , 2 Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol). , 3 Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly)., 4 Psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders.",
"Description": "Doxepin hydrochloride is one of a class of psychotherapeutic agents known as dibenzoxepin tricyclic compounds. The molecular formula of the compound is C19H21NOHCl having a molecular weight of 315.84. It is a white crystalline powder freely soluble in water, in alcohol, and methylene chloride. Each 10 mg, 25 mg, 50 mg, 75 mg and 100 mg doxepin hydrochloride capsule for oral administration contains doxepin hydrochloride USP equivalent to 10 mg, 25 mg, 50 mg, 75 mg and 100 mg of doxepin, respectively and the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch and sodium lauryl sulfate. The empty gelatin capsule shells contain gelatin, sodium lauryl sulfate, and titanium dioxide. In addition, the 25 mg and 50 mg empty gelatin capsule shells contain iron oxide yellow, 75 mg, and 100 mg empty gelatin capsule shells contain iron oxide black, iron oxide yellow, and FD&C Blue 1. The imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol and shellac glaze. Doxepin hydrochloride capsules complies with USP Dissolution test 3."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>62756-700-84</NDCCode>
<PackageDescription>28 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (62756-700-84)</PackageDescription>
<NDC11Code>62756-0700-84</NDC11Code>
<ProductNDC>62756-700</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Risperidone</ProprietaryName>
<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130413</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078464</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries Limited</LabelerName>
<SubstanceName>RISPERIDONE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-01-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>12213-700-84</NDCCode>
<PackageDescription>1698 L in 1 CYLINDER (12213-700-84) </PackageDescription>
<NDC11Code>12213-0700-84</NDC11Code>
<ProductNDC>12213-700</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Air</ProprietaryName>
<NonProprietaryName>Air</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19960601</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205859</ApplicationNumber>
<LabelerName>NexAir, LLC</LabelerName>
<SubstanceName>AIR</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mL/L</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19960601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>59467-700-84</NDCCode>
<PackageDescription>12 CARTON in 1 BOX (59467-700-84) / 1 BOTTLE, SPRAY in 1 CARTON / 56 SPRAY, METERED in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>59467-0700-84</NDC11Code>
<ProductNDC>59467-700</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ryaltris</ProprietaryName>
<NonProprietaryName>Olopatadine Hydrochloride And Mometasone Furoate</NonProprietaryName>
<DosageFormName>SPRAY, METERED</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20220815</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA211746</ApplicationNumber>
<LabelerName>HIKMA SPECIALTY USA INC.</LabelerName>
<SubstanceName>OLOPATADINE HYDROCHLORIDE; MOMETASONE FUROATE MONOHYDRATE</SubstanceName>
<StrengthNumber>665; 25</StrengthNumber>
<StrengthUnit>ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Decreased Histamine Release [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Histamine-1 Receptor Inhibitor [EPC], Mast Cell Stabilizer [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>RYALTRIS is indicated for the treatment of symptoms of seasonal allergic rhinitis in adult and pediatric patients 12 years of age and older.</IndicationAndUsage>
<Description>RYALTRIS is a metered-dose manual nasal spray unit containing an aqueous suspension of a fixed‑dose combination of a histamine-1 (H1) receptor inhibitor (olopatadine hydrochloride) and a corticosteroid (mometasone furoate monohydrate). Olopatadine hydrochloride is a white, sparingly water‑soluble crystalline powder. The chemical name for olopatadine hydrochloride is 2‑[(11Z)-11-[3-(dimethylamino)propylidene]-6H-benzo[c][1]benzoxepin-2-yl]acetic acid hydrochloride. It has a molecular weight of 373.88, and its molecular formula is C21H23NO3HCl with the following chemical structure. Mometasone furoate monohydrate is an anti-inflammatory corticosteroid having the chemical name [(8S,9R,10S,11S,13S,14S,16R,17R)-9-chloro-17-(2-chloroacetyl)-11-hydroxy-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl] furan-2-carboxylate;hydrate and the following chemical structure. Mometasone furoate monohydrate is a white powder, with an empirical formula of C27H30Cl2O6H2O and a molecular weight of 539.45. It is practically insoluble in water; slightly soluble in methanol, ethanol, and isopropanol; soluble in acetone and chloroform; and freely soluble in tetrahydrofuran. Its partition coefficient between octanol and water is >5000. RYALTRIS is a nasal spray containing an isotonic aqueous suspension of olopatadine hydrochloride (equivalent to 0.6% w/v olopatadine base) and mometasone furoate monohydrate (equivalent to 0.025% w/w mometasone furoate on the anhydrous basis). After initial priming (6 sprays), each metered spray delivers 100 microliters of suspension containing 665 mcg of olopatadine hydrochloride (equivalent to 600 mcg olopatadine base) and 25 mcg of mometasone furoate. RYALTRIS also contains benzalkonium chloride, carboxymethyl cellulose sodium, dibasic sodium phosphate heptahydrate, edetate disodium, hydrochloric acid, microcrystalline cellulose, polysorbate 80, sodium chloride, sodium hydroxide, and water. It has a pH of approximately 3.7 [see How Supplied/Storage and Handling (16)].</Description>
</NDC>
<NDC>
<NDCCode>76348-700-03</NDCCode>
<PackageDescription>84 g in 1 BOTTLE, WITH APPLICATOR (76348-700-03) </PackageDescription>
<NDC11Code>76348-0700-03</NDC11Code>
<ProductNDC>76348-700</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Just Chill Pain Relief</ProprietaryName>
<NonProprietaryName>Menthol 5 Percent</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210921</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>RENU LABORATORIES, INC.</LabelerName>
<SubstanceName>MENTHOL</SubstanceName>
<StrengthNumber>4.2</StrengthNumber>
<StrengthUnit>g/84g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-10-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210921</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62756-633-84</NDCCode>
<PackageDescription>28 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (62756-633-84)</PackageDescription>
<NDC11Code>62756-0633-84</NDC11Code>
<ProductNDC>62756-633</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Risperidone</ProprietaryName>
<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130413</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078464</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries Limited</LabelerName>
<SubstanceName>RISPERIDONE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-01-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>62756-634-84</NDCCode>
<PackageDescription>28 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (62756-634-84)</PackageDescription>
<NDC11Code>62756-0634-84</NDC11Code>
<ProductNDC>62756-634</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Risperidone</ProprietaryName>
<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130413</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078464</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries Limited</LabelerName>
<SubstanceName>RISPERIDONE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-01-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>62756-701-84</NDCCode>
<PackageDescription>28 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (62756-701-84)</PackageDescription>
<NDC11Code>62756-0701-84</NDC11Code>
<ProductNDC>62756-701</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Risperidone</ProprietaryName>
<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130413</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078464</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries Limited</LabelerName>
<SubstanceName>RISPERIDONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-01-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>62756-702-84</NDCCode>
<PackageDescription>28 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (62756-702-84)</PackageDescription>
<NDC11Code>62756-0702-84</NDC11Code>
<ProductNDC>62756-702</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Risperidone</ProprietaryName>
<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130413</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078464</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries Limited</LabelerName>
<SubstanceName>RISPERIDONE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-01-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>62756-700-08</NDCCode>
<PackageDescription>100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (62756-700-08)</PackageDescription>
<NDC11Code>62756-0700-08</NDC11Code>
<ProductNDC>62756-700</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Risperidone</ProprietaryName>
<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130413</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078464</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries Limited</LabelerName>
<SubstanceName>RISPERIDONE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-01-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>62756-700-18</NDCCode>
<PackageDescription>1000 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (62756-700-18)</PackageDescription>
<NDC11Code>62756-0700-18</NDC11Code>
<ProductNDC>62756-700</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Risperidone</ProprietaryName>
<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130413</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078464</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries Limited</LabelerName>
<SubstanceName>RISPERIDONE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-01-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>62756-700-64</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (62756-700-64) > 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK</PackageDescription>
<NDC11Code>62756-0700-64</NDC11Code>
<ProductNDC>62756-700</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Risperidone</ProprietaryName>
<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130413</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078464</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries Limited</LabelerName>
<SubstanceName>RISPERIDONE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-01-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>62756-700-83</NDCCode>
<PackageDescription>30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (62756-700-83)</PackageDescription>
<NDC11Code>62756-0700-83</NDC11Code>
<ProductNDC>62756-700</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Risperidone</ProprietaryName>
<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130413</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078464</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries Limited</LabelerName>
<SubstanceName>RISPERIDONE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-01-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>62756-700-88</NDCCode>
<PackageDescription>100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (62756-700-88)</PackageDescription>
<NDC11Code>62756-0700-88</NDC11Code>
<ProductNDC>62756-700</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Risperidone</ProprietaryName>
<NonProprietaryName>Risperidone</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130413</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078464</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries Limited</LabelerName>
<SubstanceName>RISPERIDONE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-01-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>62756-233-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (62756-233-01) / 1 INJECTABLE, LIPOSOMAL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>62756-0233-01</NDC11Code>
<ProductNDC>62756-233</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amphotericin B</ProprietaryName>
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<StartMarketingDate>20220209</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212514</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>AMPHOTERICIN B</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Lipid-based Polyene Antifungal [EPC], Polyene Antifungal [EPC], Polyenes [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220209</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amphotericin B liposome for injection is indicated for the following: 1 Empirical therapy for presumed fungal infection in febrile, neutropenic patients., 2 Treatment of Cryptococcal Meningitis in HIV infected patients (see DESCRIPTION OF CLINICAL STUDIES)., 3 Treatment of patients with Aspergillus species, Candida species and/or Cryptococcus species infections (see above for the treatment of Cryptococcal Meningitis) refractory to amphotericin B deoxycholate, or in patients where renal impairment or unacceptable toxicity precludes the use of amphotericin B deoxycholate., 4 Treatment of visceral leishmaniasis. In immunocompromised patients with visceral leishmaniasis treated with amphotericin B liposome for injection, relapse rates were high following initial clearance of parasites (see DESCRIPTION OF CLINICAL STUDIES).</IndicationAndUsage>
<Description>Amphotericin B liposome for injection is a sterile, non-pyrogenic lyophilized product for intravenous infusion. Each vial contains amphotericin B, USP 50 milligrams (mg), intercalated into a liposomal membrane consisting of alpha tocopherol approximately 0.64 mg; cholesterol 52 mg; distearoylphosphatidylglycerol, sodium salt 84 mg; hydrogenated soy phosphatidylcholine 213 mg, together with disodium succinate hexahydrate 27 mg; and sucrose 900 mg. Amphotericin B liposome for injection may also contain hydrochloric acid and/or sodium hydroxide as pH adjusters. Following reconstitution with Sterile Water for Injection, the resulting pH of the suspension is between 5.0 to 6.0. Amphotericin B liposome for injection is a true single bilayer liposomal drug delivery system. Liposomes are closed, spherical vesicles created by mixing specific proportions of amphophilic substances such as phospholipids and cholesterol so that they arrange themselves into multiple concentric bilayer membranes when hydrated in aqueous solutions. Single bilayer liposomes are then formed by microemulsification of multilamellar vesicles using a homogenizer. Amphotericin B liposome for injection consists of these unilamellar bilayer liposomes with amphotericin B intercalated within the membrane. Due to the nature and quantity of amphophilic substances used, and the lipophilic moiety in the amphotericin B molecule, the drug is an integral part of the overall structure of the Amphotericin B liposomes. Amphotericin B liposome for injection contains true liposomes that are less than 100 nm in diameter. A schematic depiction of the liposome is presented below. Note: Liposomal encapsulation or incorporation into a lipid complex can substantially affect a drug’s functional properties relative to those of the unencapsulated drug or non-lipid associated drug. In addition, different liposomal or lipid-complex products with a common active ingredient may vary from one another in the chemical composition and physical form of the lipid component. Such differences may affect the functional properties of these drug products. Amphotericin B is a macrocyclic, polyene, antifungal antibiotic produced from a strain of Streptomyces nodosus. Amphotericin B is designated chemically as: [1R-(1R*,3S*,5R*,6R*,9R*,11R*,15S*,16R*,17R*,18S*, 19E,21E,23E,25E,27E,29E,31E,33R*,35S*,36R*,37S*)]-33-[(3-Amino-3,6-dideoxy-ß-D-mannopyranosyl)oxy]-1,3,5,6,9,11,17,37-octahydroxy-15,16,18-trimethyl-13-oxo-14,39-dioxabicyclo-[33.3.1]nonatriaconta-19,21,23,25,27,29,31-heptaene-36-carboxylic acid (CAS No.1397-89-3). Amphotericin B has a molecular formula of C47H73NO17 and a molecular weight of 924.09 g/mol. The structure of amphotericin B is shown below.</Description>
</NDC>
<NDC>
<NDCCode>62756-233-02</NDCCode>
<PackageDescription>10 CARTON in 1 CARTON (62756-233-02) / 1 VIAL, SINGLE-DOSE in 1 CARTON / 1 INJECTABLE, LIPOSOMAL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>62756-0233-02</NDC11Code>
<ProductNDC>62756-233</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amphotericin B</ProprietaryName>
<NonProprietaryName>Amphotericin B</NonProprietaryName>
<DosageFormName>INJECTABLE, LIPOSOMAL</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20220209</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212514</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>AMPHOTERICIN B</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Lipid-based Polyene Antifungal [EPC], Polyene Antifungal [EPC], Polyenes [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220209</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amphotericin B liposome for injection is indicated for the following: 1 Empirical therapy for presumed fungal infection in febrile, neutropenic patients., 2 Treatment of Cryptococcal Meningitis in HIV infected patients (see DESCRIPTION OF CLINICAL STUDIES)., 3 Treatment of patients with Aspergillus species, Candida species and/or Cryptococcus species infections (see above for the treatment of Cryptococcal Meningitis) refractory to amphotericin B deoxycholate, or in patients where renal impairment or unacceptable toxicity precludes the use of amphotericin B deoxycholate., 4 Treatment of visceral leishmaniasis. In immunocompromised patients with visceral leishmaniasis treated with amphotericin B liposome for injection, relapse rates were high following initial clearance of parasites (see DESCRIPTION OF CLINICAL STUDIES).</IndicationAndUsage>
<Description>Amphotericin B liposome for injection is a sterile, non-pyrogenic lyophilized product for intravenous infusion. Each vial contains amphotericin B, USP 50 milligrams (mg), intercalated into a liposomal membrane consisting of alpha tocopherol approximately 0.64 mg; cholesterol 52 mg; distearoylphosphatidylglycerol, sodium salt 84 mg; hydrogenated soy phosphatidylcholine 213 mg, together with disodium succinate hexahydrate 27 mg; and sucrose 900 mg. Amphotericin B liposome for injection may also contain hydrochloric acid and/or sodium hydroxide as pH adjusters. Following reconstitution with Sterile Water for Injection, the resulting pH of the suspension is between 5.0 to 6.0. Amphotericin B liposome for injection is a true single bilayer liposomal drug delivery system. Liposomes are closed, spherical vesicles created by mixing specific proportions of amphophilic substances such as phospholipids and cholesterol so that they arrange themselves into multiple concentric bilayer membranes when hydrated in aqueous solutions. Single bilayer liposomes are then formed by microemulsification of multilamellar vesicles using a homogenizer. Amphotericin B liposome for injection consists of these unilamellar bilayer liposomes with amphotericin B intercalated within the membrane. Due to the nature and quantity of amphophilic substances used, and the lipophilic moiety in the amphotericin B molecule, the drug is an integral part of the overall structure of the Amphotericin B liposomes. Amphotericin B liposome for injection contains true liposomes that are less than 100 nm in diameter. A schematic depiction of the liposome is presented below. Note: Liposomal encapsulation or incorporation into a lipid complex can substantially affect a drug’s functional properties relative to those of the unencapsulated drug or non-lipid associated drug. In addition, different liposomal or lipid-complex products with a common active ingredient may vary from one another in the chemical composition and physical form of the lipid component. Such differences may affect the functional properties of these drug products. Amphotericin B is a macrocyclic, polyene, antifungal antibiotic produced from a strain of Streptomyces nodosus. Amphotericin B is designated chemically as: [1R-(1R*,3S*,5R*,6R*,9R*,11R*,15S*,16R*,17R*,18S*, 19E,21E,23E,25E,27E,29E,31E,33R*,35S*,36R*,37S*)]-33-[(3-Amino-3,6-dideoxy-ß-D-mannopyranosyl)oxy]-1,3,5,6,9,11,17,37-octahydroxy-15,16,18-trimethyl-13-oxo-14,39-dioxabicyclo-[33.3.1]nonatriaconta-19,21,23,25,27,29,31-heptaene-36-carboxylic acid (CAS No.1397-89-3). Amphotericin B has a molecular formula of C47H73NO17 and a molecular weight of 924.09 g/mol. The structure of amphotericin B is shown below.</Description>
</NDC>
<NDC>
<NDCCode>62756-954-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (62756-954-01) / 1 INJECTABLE, LIPOSOMAL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>62756-0954-01</NDC11Code>
<ProductNDC>62756-954</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amphotericin B</ProprietaryName>
<NonProprietaryName>Amphotericin B</NonProprietaryName>
<DosageFormName>INJECTABLE, LIPOSOMAL</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20241201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212514</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>AMPHOTERICIN B</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Lipid-based Polyene Antifungal [EPC], Polyene Antifungal [EPC], Polyenes [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amphotericin B liposome for injection is indicated for the following: 1 Empirical therapy for presumed fungal infection in febrile, neutropenic patients., 2 Treatment of Cryptococcal Meningitis in HIV-infected patients (see DESCRIPTION OF CLINICAL STUDIES)., 3 Treatment of patients with Aspergillus species, Candida species and/or Cryptococcus species infections (see above for the treatment of Cryptococcal Meningitis) refractory to amphotericin B deoxycholate, or in patients where renal impairment or unacceptable toxicity precludes the use of amphotericin B deoxycholate., 4 Treatment of visceral leishmaniasis. In immunocompromised patients with visceral leishmaniasis treated with amphotericin B liposome for injection, relapse rates were high following initial clearance of parasites (see DESCRIPTION OF CLINICAL STUDIES).</IndicationAndUsage>
<Description>Amphotericin B liposome for injection is a sterile, non-pyrogenic lyophilized product for intravenous infusion. Each vial contains amphotericin B, USP 50 milligrams (mg), intercalated into a liposomal membrane consisting of alpha tocopherol approximately 0.64 mg; cholesterol 52 mg; distearoylphosphatidylglycerol, sodium salt 84 mg; hydrogenated soy phosphatidylcholine 213 mg, together with disodium succinate hexahydrate 27 mg; and sucrose 900 mg. Amphotericin B liposome for injection may also contain hydrochloric acid and/or sodium hydroxide as pH adjusters. Following reconstitution with Sterile Water for Injection, the resulting pH of the suspension is between 5.0 to 6.0. Amphotericin B liposome for injection is a true single bilayer liposomal drug delivery system. Liposomes are closed, spherical vesicles created by mixing specific proportions of amphophilic substances such as phospholipids and cholesterol so that they arrange themselves into multiple concentric bilayer membranes when hydrated in aqueous solutions. Single bilayer liposomes are then formed by microemulsification of multilamellar vesicles using a homogenizer. Amphotericin B liposome for injection consists of these unilamellar bilayer liposomes with amphotericin B intercalated within the membrane. Due to the nature and quantity of amphophilic substances used, and the lipophilic moiety in the amphotericin B molecule, the drug is an integral part of the overall structure of the Amphotericin B liposomes. Amphotericin B liposome for injection contains true liposomes that are less than 100 nm in diameter. A schematic depiction of the liposome is presented below. Note: Liposomal encapsulation or incorporation into a lipid complex can substantially affect a drug’s functional properties relative to those of the unencapsulated drug or non-lipid associated drug. In addition, different liposomal or lipid-complex products with a common active ingredient may vary from one another in the chemical composition and physical form of the lipid component. Such differences may affect the functional properties of these drug products. Amphotericin B is a macrocyclic, polyene, antifungal antibiotic produced from a strain of Streptomyces nodosus. Amphotericin B is designated chemically as: [1R-(1R*,3S*,5R*,6R*,9R*,11R*,15S*,16R*,17R*,18S*, 19E,21E,23E,25E,27E,29E,31E,33R*,35S*,36R*,37S*)]-33-[(3-Amino-3,6-dideoxy-ß-D-mannopyranosyl)oxy]-1,3,5,6,9,11,17,37-octahydroxy-15,16,18-trimethyl-13-oxo-14,39-dioxabicyclo-[33.3.1]nonatriaconta-19,21,23,25,27,29,31-heptaene-36-carboxylic acid (CAS No.1397-89-3). Amphotericin B has a molecular formula of C47H73NO17 and a molecular weight of 924.09 g/mol. The structure of amphotericin B is shown below.</Description>
</NDC>
<NDC>
<NDCCode>62756-954-02</NDCCode>
<PackageDescription>10 CARTON in 1 CARTON (62756-954-02) / 1 VIAL, SINGLE-DOSE in 1 CARTON / 1 INJECTABLE, LIPOSOMAL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>62756-0954-02</NDC11Code>
<ProductNDC>62756-954</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amphotericin B</ProprietaryName>
<NonProprietaryName>Amphotericin B</NonProprietaryName>
<DosageFormName>INJECTABLE, LIPOSOMAL</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20241201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212514</ApplicationNumber>
<LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
<SubstanceName>AMPHOTERICIN B</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Lipid-based Polyene Antifungal [EPC], Polyene Antifungal [EPC], Polyenes [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amphotericin B liposome for injection is indicated for the following: 1 Empirical therapy for presumed fungal infection in febrile, neutropenic patients., 2 Treatment of Cryptococcal Meningitis in HIV-infected patients (see DESCRIPTION OF CLINICAL STUDIES)., 3 Treatment of patients with Aspergillus species, Candida species and/or Cryptococcus species infections (see above for the treatment of Cryptococcal Meningitis) refractory to amphotericin B deoxycholate, or in patients where renal impairment or unacceptable toxicity precludes the use of amphotericin B deoxycholate., 4 Treatment of visceral leishmaniasis. In immunocompromised patients with visceral leishmaniasis treated with amphotericin B liposome for injection, relapse rates were high following initial clearance of parasites (see DESCRIPTION OF CLINICAL STUDIES).</IndicationAndUsage>
<Description>Amphotericin B liposome for injection is a sterile, non-pyrogenic lyophilized product for intravenous infusion. Each vial contains amphotericin B, USP 50 milligrams (mg), intercalated into a liposomal membrane consisting of alpha tocopherol approximately 0.64 mg; cholesterol 52 mg; distearoylphosphatidylglycerol, sodium salt 84 mg; hydrogenated soy phosphatidylcholine 213 mg, together with disodium succinate hexahydrate 27 mg; and sucrose 900 mg. Amphotericin B liposome for injection may also contain hydrochloric acid and/or sodium hydroxide as pH adjusters. Following reconstitution with Sterile Water for Injection, the resulting pH of the suspension is between 5.0 to 6.0. Amphotericin B liposome for injection is a true single bilayer liposomal drug delivery system. Liposomes are closed, spherical vesicles created by mixing specific proportions of amphophilic substances such as phospholipids and cholesterol so that they arrange themselves into multiple concentric bilayer membranes when hydrated in aqueous solutions. Single bilayer liposomes are then formed by microemulsification of multilamellar vesicles using a homogenizer. Amphotericin B liposome for injection consists of these unilamellar bilayer liposomes with amphotericin B intercalated within the membrane. Due to the nature and quantity of amphophilic substances used, and the lipophilic moiety in the amphotericin B molecule, the drug is an integral part of the overall structure of the Amphotericin B liposomes. Amphotericin B liposome for injection contains true liposomes that are less than 100 nm in diameter. A schematic depiction of the liposome is presented below. Note: Liposomal encapsulation or incorporation into a lipid complex can substantially affect a drug’s functional properties relative to those of the unencapsulated drug or non-lipid associated drug. In addition, different liposomal or lipid-complex products with a common active ingredient may vary from one another in the chemical composition and physical form of the lipid component. Such differences may affect the functional properties of these drug products. Amphotericin B is a macrocyclic, polyene, antifungal antibiotic produced from a strain of Streptomyces nodosus. Amphotericin B is designated chemically as: [1R-(1R*,3S*,5R*,6R*,9R*,11R*,15S*,16R*,17R*,18S*, 19E,21E,23E,25E,27E,29E,31E,33R*,35S*,36R*,37S*)]-33-[(3-Amino-3,6-dideoxy-ß-D-mannopyranosyl)oxy]-1,3,5,6,9,11,17,37-octahydroxy-15,16,18-trimethyl-13-oxo-14,39-dioxabicyclo-[33.3.1]nonatriaconta-19,21,23,25,27,29,31-heptaene-36-carboxylic acid (CAS No.1397-89-3). Amphotericin B has a molecular formula of C47H73NO17 and a molecular weight of 924.09 g/mol. The structure of amphotericin B is shown below.</Description>
</NDC>
<NDC>
<NDCCode>52268-700-01</NDCCode>
<PackageDescription>4 L in 1 PACKET (52268-700-01) </PackageDescription>
<NDC11Code>52268-0700-01</NDC11Code>
<ProductNDC>52268-700</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Golytely</ProprietaryName>
<NonProprietaryName>Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19840713</StartMarketingDate>
<EndMarketingDate>20220531</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019011</ApplicationNumber>
<LabelerName>Braintree Laboratories, Inc.</LabelerName>
<SubstanceName>POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS</SubstanceName>
<StrengthNumber>227.1; .754; 6.36; 5.53; 21.5</StrengthNumber>
<StrengthUnit>g/L; g/L; g/L; g/L; g/L</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-06-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19840713</StartMarketingDatePackage>
<EndMarketingDatePackage>20220531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>GoLYTELY is indicated for bowel cleansing prior to colonoscopy and barium enema X-ray examination in adults.</IndicationAndUsage>
<Description>GoLYTELY is a combination of polyethylene glycol 3350, an osmotic laxative, and electrolytes (sodium sulfate, sodium chloride, sodium bicarbonate and potassium chloride) for oral solution supplied in a 4-liter disposable jug containing 236 g polyethylene glycol 3350, 22.74 g sodium sulfate (anhydrous), 6.74 g sodium bicarbonate, 5.86 g sodium chloride, and 2.97 g potassium chloride as a white powder. Polyethylene Glycol 3350, USP. Sodium Sulfate, USP. The chemical name is Na 2SO 4. The average Molecular Weight is 142.04. The structural formula is:. Sodium Bicarbonate, USP. The chemical name is NaHCO 3. The average Molecular Weight is 84.01. The structural formula is:. Sodium Chloride, USP. The chemical name is NaCl. The average Molecular Weight: 58.44. The structural formula is. Na + Cl -. Potassium Chloride, USP. The chemical name is KCl. The average Molecular Weight: 74.55. The structural formula is. K-Cl.</Description>
</NDC>
<NDC>
<NDCCode>59088-396-54</NDCCode>
<PackageDescription>30 POUCH in 1 CARTON (59088-396-54) / .7 g in 1 POUCH (59088-396-84) </PackageDescription>
<NDC11Code>59088-0396-54</NDC11Code>
<ProductNDC>59088-396</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine</ProprietaryName>
<NonProprietaryName>Lidocaine</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130915</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200675</ApplicationNumber>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>LIDOCAINE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160229</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lidocaine patch 5% is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin.</IndicationAndUsage>
<Description>Lidocaine patch 5% is comprised of an adhesive material containing 5% lidocaine, which is applied to a white non-woven polyethylene terephthalate (PET) material backing and covered with a transparent PET release liner. The release liner is removed prior to application to the skin. The size of the patch is 10 cm x 14 cm. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), has an octanol:water partition ratio of 43 at pH 7.4, and has the following structure. Each adhesive patch contains 700 mg of lidocaine (50 mg per gram adhesive) in an aqueous base. It also contains the following inactive ingredients: glycerin, D-sorbitol, propylene glycol, polyvinyl alcohol, urea, sodium polyacrylate, carboxymethylcellulose sodium, gelatin, polyacrylic acid, kaolin, tartaric acid, dihydroxyaluminum aminoacetate, methylparaben, propylparaben, and edetate disodium.</Description>
</NDC>
<NDC>
<NDCCode>59088-396-82</NDCCode>
<PackageDescription>15 POUCH in 1 CARTON (59088-396-82) / .7 g in 1 POUCH (59088-396-84) </PackageDescription>
<NDC11Code>59088-0396-82</NDC11Code>
<ProductNDC>59088-396</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine</ProprietaryName>
<NonProprietaryName>Lidocaine</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130915</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200675</ApplicationNumber>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>LIDOCAINE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160229</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lidocaine patch 5% is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin.</IndicationAndUsage>
<Description>Lidocaine patch 5% is comprised of an adhesive material containing 5% lidocaine, which is applied to a white non-woven polyethylene terephthalate (PET) material backing and covered with a transparent PET release liner. The release liner is removed prior to application to the skin. The size of the patch is 10 cm x 14 cm. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), has an octanol:water partition ratio of 43 at pH 7.4, and has the following structure. Each adhesive patch contains 700 mg of lidocaine (50 mg per gram adhesive) in an aqueous base. It also contains the following inactive ingredients: glycerin, D-sorbitol, propylene glycol, polyvinyl alcohol, urea, sodium polyacrylate, carboxymethylcellulose sodium, gelatin, polyacrylic acid, kaolin, tartaric acid, dihydroxyaluminum aminoacetate, methylparaben, propylparaben, and edetate disodium.</Description>
</NDC>
<NDC>
<NDCCode>59088-712-00</NDCCode>
<PackageDescription>1 KIT in 1 PACKAGE (59088-712-00) * 30 POUCH in 1 CARTON (59088-396-54) > .7 g in 1 POUCH (59088-396-84) </PackageDescription>
<NDC11Code>59088-0712-00</NDC11Code>
<ProductNDC>59088-712</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidopure Patch</ProprietaryName>
<NonProprietaryName>Lidocaine</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20180606</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<Status>Active</Status>
<LastUpdate>2020-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180606</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lidocaine patch 5% is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin.</IndicationAndUsage>
<Description>Lidocaine patch 5% is comprised of an adhesive material containing 5% lidocaine, which is applied to a white non-woven polyethylene terephthalate (PET) material backing and covered with a transparent PET release liner. The release liner is removed prior to application to the skin. The size of the patch is 10 cm x 14 cm. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), has an octanol:water partition ratio of 43 at pH 7.4, and has the following structure. Each adhesive patch contains 700 mg of lidocaine (50 mg per gram adhesive) in an aqueous base. It also contains the following inactive ingredients: glycerin, D-sorbitol, propylene glycol, polyvinyl alcohol, urea, sodium polyacrylate, carboxymethylcellulose sodium, gelatin, polyacrylic acid, kaolin, tartaric acid, dihydroxyaluminum aminoacetate, methylparaben, propylparaben, and edetate disodium.</Description>
</NDC>
<NDC>
<NDCCode>59088-731-00</NDCCode>
<PackageDescription>1 KIT in 1 KIT (59088-731-00) * 30 POUCH in 1 PACKAGE (59088-905-54) / 1 PATCH in 1 POUCH (59088-905-84) * 200 PACKET in 1 BOX (53329-805-60) / 1 APPLICATOR in 1 PACKET / 5 mL in 1 APPLICATOR</PackageDescription>
<NDC11Code>59088-0731-00</NDC11Code>
<ProductNDC>59088-731</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Xyliderm</ProprietaryName>
<NonProprietaryName>Lidocaine, Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20230705</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<Status>Active</Status>
<LastUpdate>2024-12-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230705</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Lidocan is comprised of an adhesive material containing 5% lidocaine, which is applied to a white non-woven polyethylene terephthalate (PET) material backing and covered with a transparent PET release liner. The release liner is removed prior to application to the skin. The size of the patch is 10 cm x 14 cm. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), has an octanol:water partition ratio of 43 at pH 7.4, and has the following structure. Each adhesive patch contains 700 mg of lidocaine (50 mg per gram adhesive) in an aqueous base. It also contains the following inactive ingredients: purified water, glycerin, sorbitol, polyacrylic acid, sodium carboxymethylcellulose, sodium polyacrylate, propylene glycol, urea, kaolin, tartaric acid, gelatin, polyvinyl alcohol, dihydroxyaluminum aminoacetate, edetate disodium, methylparaben, and propylparaben.</Description>
</NDC>
<NDC>
<NDCCode>59088-900-54</NDCCode>
<PackageDescription>30 POUCH in 1 PACKAGE (59088-900-54) / 14 g in 1 POUCH (59088-900-84) </PackageDescription>
<NDC11Code>59088-0900-54</NDC11Code>
<ProductNDC>59088-900</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocan Vii</ProprietaryName>
<NonProprietaryName>Lidocaine 5%</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230615</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209190</ApplicationNumber>
<LabelerName>PURETEK CORPORATION</LabelerName>
<SubstanceName>LIDOCAINE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240808</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lidocan VII is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin.</IndicationAndUsage>
<Description>Lidocan VII is comprised of an adhesive material containing 5% lidocaine, which is applied to a non-woven polyester felt backing and covered with a polyethylene terephthalate (PET) film release liner. The release liner is removed prior to application to the skin. The size of the patch is 10 cm x 14 cm. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), has an octanol:water partition ratio of 43 at pH 7.4, and has the following structure:. Each adhesive patch contains 700 mg of lidocaine (50 mg per gram adhesive) in an aqueous base. It also contains the following inactive ingredients: purified water, glycerin, sorbitol, polyacrylic acid, sodium carboxymethylcellulose, sodium polyacrylate, propylene glycol, urea, kaolin, tartaric acid, gelatin, polyvinyl alcohol, dihydroxyaluminum aminoacetate, edetate disodium, methylparaben, and propylparaben.</Description>
</NDC>
<NDC>
<NDCCode>59088-905-54</NDCCode>
<PackageDescription>30 POUCH in 1 PACKAGE (59088-905-54) / 1 PATCH in 1 POUCH (59088-905-84) </PackageDescription>
<NDC11Code>59088-0905-54</NDC11Code>
<ProductNDC>59088-905</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocan</ProprietaryName>
<NonProprietaryName>Lidocaine 5%</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200514</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209190</ApplicationNumber>
<LabelerName>PURETEK CORPORATION</LabelerName>
<SubstanceName>LIDOCAINE</SubstanceName>
<StrengthNumber>700</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230714</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LIDOCAN is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin.</IndicationAndUsage>
<Description>LIDOCAN is comprised of an adhesive material containing 5% lidocaine, which is applied to a non-woven polyester felt backing and covered with a polyethylene terephthalate (PET) film release liner. The release liner is removed prior to application to the skin. The size of the patch is 10 cm x 14 cm. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), has an octanol:water partition ratio of 43 at pH 7.4, and has the following structure:. Each adhesive patch contains 700 mg of lidocaine (50 mg per gram adhesive) in an aqueous base. It also contains the following inactive ingredients: purified water, glycerin, sorbitol, polyacrylic acid, sodium carboxymethylcellulose, sodium polyacrylate, propylene glycol, urea, kaolin, tartaric acid, gelatin, polyvinyl alcohol, dihydroxyaluminum aminoacetate, edetate disodium, methylparaben, and propylparaben.</Description>
</NDC>
<NDC>
<NDCCode>59088-905-82</NDCCode>
<PackageDescription>15 POUCH in 1 PACKAGE (59088-905-82) / 1 PATCH in 1 POUCH (59088-905-84) </PackageDescription>
<NDC11Code>59088-0905-82</NDC11Code>
<ProductNDC>59088-905</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocan</ProprietaryName>
<NonProprietaryName>Lidocaine 5%</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200514</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209190</ApplicationNumber>
<LabelerName>PURETEK CORPORATION</LabelerName>
<SubstanceName>LIDOCAINE</SubstanceName>
<StrengthNumber>700</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LIDOCAN is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin.</IndicationAndUsage>
<Description>LIDOCAN is comprised of an adhesive material containing 5% lidocaine, which is applied to a non-woven polyester felt backing and covered with a polyethylene terephthalate (PET) film release liner. The release liner is removed prior to application to the skin. The size of the patch is 10 cm x 14 cm. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), has an octanol:water partition ratio of 43 at pH 7.4, and has the following structure:. Each adhesive patch contains 700 mg of lidocaine (50 mg per gram adhesive) in an aqueous base. It also contains the following inactive ingredients: purified water, glycerin, sorbitol, polyacrylic acid, sodium carboxymethylcellulose, sodium polyacrylate, propylene glycol, urea, kaolin, tartaric acid, gelatin, polyvinyl alcohol, dihydroxyaluminum aminoacetate, edetate disodium, methylparaben, and propylparaben.</Description>
</NDC>
<NDC>
<NDCCode>59088-907-54</NDCCode>
<PackageDescription>30 POUCH in 1 PACKAGE (59088-907-54) / 14 g in 1 POUCH (59088-907-84) </PackageDescription>
<NDC11Code>59088-0907-54</NDC11Code>
<ProductNDC>59088-907</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocan Iii</ProprietaryName>
<NonProprietaryName>Lidocaine 5%</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200514</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209190</ApplicationNumber>
<LabelerName>PURETEK CORPORATION</LabelerName>
<SubstanceName>LIDOCAINE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200514</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LIDOCAN III is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin.</IndicationAndUsage>
<Description>LIDOCAN III is comprised of an adhesive material containing 5% lidocaine, which is applied to a non-woven polyester felt backing and covered with a polyethylene terephthalate (PET) film release liner. The release liner is removed prior to application to the skin. The size of the patch is 10 cm x 14 cm. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), has an octanol:water partition ratio of 43 at pH 7.4, and has the following structure:. Each adhesive patch contains 700 mg of lidocaine (50 mg per gram adhesive) in an aqueous base. It also contains the following inactive ingredients: purified water, glycerin, sorbitol, polyacrylic acid, sodium carboxymethylcellulose, sodium polyacrylate, propylene glycol, urea, kaolin, tartaric acid, gelatin, polyvinyl alcohol, dihydroxyaluminum aminoacetate, edetate disodium, methylparaben, and propylparaben.</Description>
</NDC>
<NDC>
<NDCCode>59088-909-54</NDCCode>
<PackageDescription>30 POUCH in 1 PACKAGE (59088-909-54) / 14 g in 1 POUCH (59088-909-84) </PackageDescription>
<NDC11Code>59088-0909-54</NDC11Code>
<ProductNDC>59088-909</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocan V</ProprietaryName>
<NonProprietaryName>Lidocaine 5%</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200514</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209190</ApplicationNumber>
<LabelerName>PURETEK CORPORATION</LabelerName>
<SubstanceName>LIDOCAINE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200514</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lidocan V is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin.</IndicationAndUsage>
<Description>Lidocan V is comprised of an adhesive material containing 5% lidocaine, which is applied to a non-woven polyester felt backing and covered with a polyethylene terephthalate (PET) film release liner. The release liner is removed prior to application to the skin. The size of the patch is 10 cm x 14 cm. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), has an octanol:water partition ratio of 43 at pH 7.4, and has the following structure:. Each adhesive patch contains 700 mg of lidocaine (50 mg per gram adhesive) in an aqueous base. It also contains the following inactive ingredients: purified water, glycerin, sorbitol, polyacrylic acid, sodium carboxymethylcellulose, sodium polyacrylate, propylene glycol, urea, kaolin, tartaric acid, gelatin, polyvinyl alcohol, dihydroxyaluminum aminoacetate, edetate disodium, methylparaben, and propylparaben.</Description>
</NDC>
<NDC>
<NDCCode>59088-910-54</NDCCode>
<PackageDescription>30 POUCH in 1 PACKAGE (59088-910-54) / 14 g in 1 POUCH (59088-910-84) </PackageDescription>
<NDC11Code>59088-0910-54</NDC11Code>
<ProductNDC>59088-910</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocan Iv</ProprietaryName>
<NonProprietaryName>Lidocaine 5%</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230615</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209190</ApplicationNumber>
<LabelerName>PURETEK CORPORATION</LabelerName>
<SubstanceName>LIDOCAINE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230615</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lidocan IV is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin.</IndicationAndUsage>
<Description>Lidocan IV is comprised of an adhesive material containing 5% lidocaine, which is applied to a non-woven polyester felt backing and covered with a polyethylene terephthalate (PET) film release liner. The release liner is removed prior to application to the skin. The size of the patch is 10 cm x 14 cm. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), has an octanol:water partition ratio of 43 at pH 7.4, and has the following structure:. Each adhesive patch contains 700 mg of lidocaine (50 mg per gram adhesive) in an aqueous base. It also contains the following inactive ingredients: purified water, glycerin, sorbitol, polyacrylic acid, sodium carboxymethylcellulose, sodium polyacrylate, propylene glycol, urea, kaolin, tartaric acid, gelatin, polyvinyl alcohol, dihydroxyaluminum aminoacetate, edetate disodium, methylparaben, and propylparaben.</Description>
</NDC>
<NDC>
<NDCCode>59088-911-54</NDCCode>
<PackageDescription>30 POUCH in 1 PACKAGE (59088-911-54) / 14 g in 1 POUCH (59088-911-84) </PackageDescription>
<NDC11Code>59088-0911-54</NDC11Code>
<ProductNDC>59088-911</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocan Vi</ProprietaryName>
<NonProprietaryName>Lidocaine 5%</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230615</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209190</ApplicationNumber>
<LabelerName>PURETEK CORPORATION</LabelerName>
<SubstanceName>LIDOCAINE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240621</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lidocan VI is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin.</IndicationAndUsage>
<Description>Lidocan VI is comprised of an adhesive material containing 5% lidocaine, which is applied to a non-woven polyester felt backing and covered with a polyethylene terephthalate (PET) film release liner. The release liner is removed prior to application to the skin. The size of the patch is 10 cm x 14 cm. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), has an octanol:water partition ratio of 43 at pH 7.4, and has the following structure:. Each adhesive patch contains 700 mg of lidocaine (50 mg per gram adhesive) in an aqueous base. It also contains the following inactive ingredients: purified water, glycerin, sorbitol, polyacrylic acid, sodium carboxymethylcellulose, sodium polyacrylate, propylene glycol, urea, kaolin, tartaric acid, gelatin, polyvinyl alcohol, dihydroxyaluminum aminoacetate, edetate disodium, methylparaben, and propylparaben.</Description>
</NDC>
<NDC>
<NDCCode>59746-700-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE, PLASTIC (59746-700-01) </PackageDescription>
<NDC11Code>59746-0700-01</NDC11Code>
<ProductNDC>59746-700</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxepin Hydrochloride</ProprietaryName>
<NonProprietaryName>Doxepin Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215483</ApplicationNumber>
<LabelerName>JUBILANT CADISTA PHARMACEUTICALS INC.</LabelerName>
<SubstanceName>DOXEPIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-07-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxepin Hydrochloride Capsules, USP are recommended for the treatment of: 1 Psychoneurotic patients with depression and/or anxiety. , 2 Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol). , 3 Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly)., 4 Psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders.</IndicationAndUsage>
<Description>Doxepin hydrochloride is one of a class of psychotherapeutic agents known as dibenzoxepin tricyclic compounds. The molecular formula of the compound is C19H21NOHCl having a molecular weight of 315.84. It is a white crystalline powder freely soluble in water, in alcohol, and methylene chloride. Each 10 mg, 25 mg, 50 mg, 75 mg and 100 mg doxepin hydrochloride capsule for oral administration contains doxepin hydrochloride USP equivalent to 10 mg, 25 mg, 50 mg, 75 mg and 100 mg of doxepin, respectively and the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch and sodium lauryl sulfate. The empty gelatin capsule shells contain gelatin, sodium lauryl sulfate, and titanium dioxide. In addition, the 25 mg and 50 mg empty gelatin capsule shells contain iron oxide yellow, 75 mg, and 100 mg empty gelatin capsule shells contain iron oxide black, iron oxide yellow, and FD&C Blue 1. The imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol and shellac glaze. Doxepin hydrochloride capsules complies with USP Dissolution test 3.</Description>
</NDC>
</NDCList>