{
"NDC": [
{
"NDCCode": "84612-055-01",
"PackageDescription": "1 VIAL in 1 CARTON (84612-055-01) / .5 mL in 1 VIAL",
"NDC11Code": "84612-0055-01",
"ProductNDC": "84612-055",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Wezlana",
"NonProprietaryName": "Ustekinumab-auub",
"DosageFormName": "INJECTION, SOLUTION",
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"StrengthUnit": "mg/.5mL",
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"IndicationAndUsage": "WEZLANA is a human interleukin -12 and -23 antagonist indicated for the treatment of: 1 Moderate to severe plaque psoriasis in adult and pediatric patients 6 years of age and older who are candidates for phototherapy or systemic therapy. (1.1), 2 Active psoriatic arthritis in adult and pediatric patients 6 years of age and older. (1.2), 3 Moderately to severely active Crohn's disease in adult patients. (1.3), 4 Moderately to severely active ulcerative colitis in adult patients. (1.4).",
"Description": "Ustekinumab-auub, a human IgG1κ monoclonal antibody, is a human interleukin -12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-auub is produced in a mammalian cell line (Chinese Hamster Ovary). The manufacturing process contains steps for the clearance of viruses. Ustekinumab-auub is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148 to 150 kDa. WEZLANA (ustekinumab-auub) injection is a sterile, preservative-free, clear to opalescent and colorless to light yellow solution with a pH of 6.0. WEZLANA for Subcutaneous Use. Available as 45 mg of ustekinumab-auub in 0.5 mL and 90 mg of ustekinumab-auub in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 27 gauge fixed ½ inch needle and as 45 mg of ustekinumab-auub in 0.5 mL in a single-dose Type I glass vial with a coated stopper. The syringe is fitted with a passive needle guard and a needle cap that does not contain dry natural rubber (a derivative of latex). Each 0.5 mL prefilled syringe or vial delivers 45 mg ustekinumab-auub, histidine (0.23 mg) and histidine hydrochloride monohydrate (0.36 mg), Polysorbate 80 (0.02 mg), and sucrose (38 mg). Each 1 mL prefilled syringe delivers 90 mg ustekinumab-auub, histidine (0.46 mg) and histidine hydrochloride monohydrate (0.72 mg), Polysorbate 80 (0.04 mg), and sucrose (76 mg). WEZLANA for Intravenous Infusion. Available as 130 mg of ustekinumab-auub in 26 mL, supplied as a single-dose Type I glass vial with a coated stopper. Each 26 mL vial delivers 130 mg ustekinumab-auub, edetate disodium (0.47 mg), histidine (20 mg), histidine hydrochloride monohydrate (27 mg), methionine (10.4 mg), Polysorbate 80 (10.4 mg), and sucrose (2210 mg)."
},
{
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"PackageDescription": "1 VIAL in 1 CARTON (84612-066-01) / 26 mL in 1 VIAL",
"NDC11Code": "84612-0066-01",
"ProductNDC": "84612-066",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Wezlana",
"NonProprietaryName": "Ustekinumab-auub",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
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"LabelerName": "Nuvaila Limited",
"SubstanceName": "USTEKINUMAB",
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"StrengthUnit": "mg/26mL",
"Pharm_Classes": "Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-10",
"PackageNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "WEZLANA is a human interleukin -12 and -23 antagonist indicated for the treatment of: 1 Moderate to severe plaque psoriasis in adult and pediatric patients 6 years of age and older who are candidates for phototherapy or systemic therapy. (1.1), 2 Active psoriatic arthritis in adult and pediatric patients 6 years of age and older. (1.2), 3 Moderately to severely active Crohn's disease in adult patients. (1.3), 4 Moderately to severely active ulcerative colitis in adult patients. (1.4).",
"Description": "Ustekinumab-auub, a human IgG1κ monoclonal antibody, is a human interleukin -12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-auub is produced in a mammalian cell line (Chinese Hamster Ovary). The manufacturing process contains steps for the clearance of viruses. Ustekinumab-auub is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148 to 150 kDa. WEZLANA (ustekinumab-auub) injection is a sterile, preservative-free, clear to opalescent and colorless to light yellow solution with a pH of 6.0. WEZLANA for Subcutaneous Use. Available as 45 mg of ustekinumab-auub in 0.5 mL and 90 mg of ustekinumab-auub in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 27 gauge fixed ½ inch needle and as 45 mg of ustekinumab-auub in 0.5 mL in a single-dose Type I glass vial with a coated stopper. The syringe is fitted with a passive needle guard and a needle cap that does not contain dry natural rubber (a derivative of latex). Each 0.5 mL prefilled syringe or vial delivers 45 mg ustekinumab-auub, histidine (0.23 mg) and histidine hydrochloride monohydrate (0.36 mg), Polysorbate 80 (0.02 mg), and sucrose (38 mg). Each 1 mL prefilled syringe delivers 90 mg ustekinumab-auub, histidine (0.46 mg) and histidine hydrochloride monohydrate (0.72 mg), Polysorbate 80 (0.04 mg), and sucrose (76 mg). WEZLANA for Intravenous Infusion. Available as 130 mg of ustekinumab-auub in 26 mL, supplied as a single-dose Type I glass vial with a coated stopper. Each 26 mL vial delivers 130 mg ustekinumab-auub, edetate disodium (0.47 mg), histidine (20 mg), histidine hydrochloride monohydrate (27 mg), methionine (10.4 mg), Polysorbate 80 (10.4 mg), and sucrose (2210 mg)."
},
{
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"PackageDescription": "1 SYRINGE in 1 CARTON (84612-076-01) / .5 mL in 1 SYRINGE",
"NDC11Code": "84612-0076-01",
"ProductNDC": "84612-076",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Wezlana",
"NonProprietaryName": "Ustekinumab-auub",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20250101",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761285",
"LabelerName": "Nuvaila Limited",
"SubstanceName": "USTEKINUMAB",
"StrengthNumber": "45",
"StrengthUnit": "mg/.5mL",
"Pharm_Classes": "Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250101",
"SamplePackage": "N",
"IndicationAndUsage": "WEZLANA is a human interleukin -12 and -23 antagonist indicated for the treatment of: 1 Moderate to severe plaque psoriasis in adult and pediatric patients 6 years of age and older who are candidates for phototherapy or systemic therapy. (1.1), 2 Active psoriatic arthritis in adult and pediatric patients 6 years of age and older. (1.2), 3 Moderately to severely active Crohn's disease in adult patients. (1.3), 4 Moderately to severely active ulcerative colitis in adult patients. (1.4).",
"Description": "Ustekinumab-auub, a human IgG1κ monoclonal antibody, is a human interleukin -12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-auub is produced in a mammalian cell line (Chinese Hamster Ovary). The manufacturing process contains steps for the clearance of viruses. Ustekinumab-auub is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148 to 150 kDa. WEZLANA (ustekinumab-auub) injection is a sterile, preservative-free, clear to opalescent and colorless to light yellow solution with a pH of 6.0. WEZLANA for Subcutaneous Use. Available as 45 mg of ustekinumab-auub in 0.5 mL and 90 mg of ustekinumab-auub in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 27 gauge fixed ½ inch needle and as 45 mg of ustekinumab-auub in 0.5 mL in a single-dose Type I glass vial with a coated stopper. The syringe is fitted with a passive needle guard and a needle cap that does not contain dry natural rubber (a derivative of latex). Each 0.5 mL prefilled syringe or vial delivers 45 mg ustekinumab-auub, histidine (0.23 mg) and histidine hydrochloride monohydrate (0.36 mg), Polysorbate 80 (0.02 mg), and sucrose (38 mg). Each 1 mL prefilled syringe delivers 90 mg ustekinumab-auub, histidine (0.46 mg) and histidine hydrochloride monohydrate (0.72 mg), Polysorbate 80 (0.04 mg), and sucrose (76 mg). WEZLANA for Intravenous Infusion. Available as 130 mg of ustekinumab-auub in 26 mL, supplied as a single-dose Type I glass vial with a coated stopper. Each 26 mL vial delivers 130 mg ustekinumab-auub, edetate disodium (0.47 mg), histidine (20 mg), histidine hydrochloride monohydrate (27 mg), methionine (10.4 mg), Polysorbate 80 (10.4 mg), and sucrose (2210 mg)."
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{
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"PackageDescription": "1 SYRINGE in 1 CARTON (84612-089-01) / 1 mL in 1 SYRINGE",
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"ProductNDC": "84612-089",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Wezlana",
"NonProprietaryName": "Ustekinumab-auub",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20250101",
"MarketingCategoryName": "BLA",
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"LabelerName": "Nuvaila Limited",
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"Pharm_Classes": "Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-10",
"PackageNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "WEZLANA is a human interleukin -12 and -23 antagonist indicated for the treatment of: 1 Moderate to severe plaque psoriasis in adult and pediatric patients 6 years of age and older who are candidates for phototherapy or systemic therapy. (1.1), 2 Active psoriatic arthritis in adult and pediatric patients 6 years of age and older. (1.2), 3 Moderately to severely active Crohn's disease in adult patients. (1.3), 4 Moderately to severely active ulcerative colitis in adult patients. (1.4).",
"Description": "Ustekinumab-auub, a human IgG1κ monoclonal antibody, is a human interleukin -12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-auub is produced in a mammalian cell line (Chinese Hamster Ovary). The manufacturing process contains steps for the clearance of viruses. Ustekinumab-auub is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148 to 150 kDa. WEZLANA (ustekinumab-auub) injection is a sterile, preservative-free, clear to opalescent and colorless to light yellow solution with a pH of 6.0. WEZLANA for Subcutaneous Use. Available as 45 mg of ustekinumab-auub in 0.5 mL and 90 mg of ustekinumab-auub in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 27 gauge fixed ½ inch needle and as 45 mg of ustekinumab-auub in 0.5 mL in a single-dose Type I glass vial with a coated stopper. The syringe is fitted with a passive needle guard and a needle cap that does not contain dry natural rubber (a derivative of latex). Each 0.5 mL prefilled syringe or vial delivers 45 mg ustekinumab-auub, histidine (0.23 mg) and histidine hydrochloride monohydrate (0.36 mg), Polysorbate 80 (0.02 mg), and sucrose (38 mg). Each 1 mL prefilled syringe delivers 90 mg ustekinumab-auub, histidine (0.46 mg) and histidine hydrochloride monohydrate (0.72 mg), Polysorbate 80 (0.04 mg), and sucrose (76 mg). WEZLANA for Intravenous Infusion. Available as 130 mg of ustekinumab-auub in 26 mL, supplied as a single-dose Type I glass vial with a coated stopper. Each 26 mL vial delivers 130 mg ustekinumab-auub, edetate disodium (0.47 mg), histidine (20 mg), histidine hydrochloride monohydrate (27 mg), methionine (10.4 mg), Polysorbate 80 (10.4 mg), and sucrose (2210 mg)."
},
{
"NDCCode": "84612-399-01",
"PackageDescription": "1 SYRINGE in 1 CARTON (84612-399-01) / .2 mL in 1 SYRINGE",
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"ProductNDC": "84612-399",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amjevita",
"NonProprietaryName": "Adalimumab-atto",
"DosageFormName": "INJECTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20250101",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761024",
"LabelerName": "Nuvaila Limited",
"SubstanceName": "ADALIMUMAB",
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"StrengthUnit": "mg/.2mL",
"Pharm_Classes": "Antibodies, Monoclonal [CS], Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-21",
"PackageNdcExcludeFlag": "N",
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"IndicationAndUsage": "AMJEVITA is a tumor necrosis factor (TNF) blocker indicated for: 1 Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1), 2 Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2), 3 Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3), 4 Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4), 5 Treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. (1.5), 6 Treatment of moderately to severely active ulcerative colitis in adult patients. (1.6).",
"Description": "Adalimumab-atto is a tumor necrosis factor blocker. Adalimumab-atto is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-atto is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. AMJEVITA® (adalimumab-atto) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled SureClick autoinjector, or as a single-dose, 1 mL prefilled glass syringe. Enclosed within the autoinjector is a single-dose, 1 mL prefilled glass syringe. The solution of AMJEVITA is clear, colorless to slightly yellow, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled syringe or prefilled autoinjector delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of AMJEVITA is formulated with L-lactic acid (1.7 mg), polysorbate 80 (0.8 mg), sodium hydroxide for pH adjustment, sucrose (67 mg), and Water for Injection, USP, pH 5.2. Each 40 mg/0.4 mL prefilled syringe or prefilled autoinjector delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of AMJEVITA is formulated with L-lactic acid (0.9 mg), polysorbate 80 (0.4 mg), sodium hydroxide for pH adjustment, sucrose (34 mg), and Water for Injection, USP, pH 5.2. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of AMJEVITA is formulated with L-lactic acid (0.4 mg), polysorbate 80 (0.2 mg), sodium hydroxide for pH adjustment, sucrose (17 mg), and Water for Injection, USP, pH 5.2."
},
{
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"LabelerName": "Nuvaila Limited",
"SubstanceName": "ADALIMUMAB",
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"IndicationAndUsage": "AMJEVITA is a tumor necrosis factor (TNF) blocker indicated for: 1 Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1), 2 Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2), 3 Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3), 4 Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4), 5 Treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. (1.5), 6 Treatment of moderately to severely active ulcerative colitis in adult patients. (1.6).",
"Description": "Adalimumab-atto is a tumor necrosis factor blocker. Adalimumab-atto is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-atto is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. AMJEVITA® (adalimumab-atto) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled SureClick autoinjector, or as a single-dose, 1 mL prefilled glass syringe. Enclosed within the autoinjector is a single-dose, 1 mL prefilled glass syringe. The solution of AMJEVITA is clear, colorless to slightly yellow, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled syringe or prefilled autoinjector delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of AMJEVITA is formulated with L-lactic acid (1.7 mg), polysorbate 80 (0.8 mg), sodium hydroxide for pH adjustment, sucrose (67 mg), and Water for Injection, USP, pH 5.2. Each 40 mg/0.4 mL prefilled syringe or prefilled autoinjector delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of AMJEVITA is formulated with L-lactic acid (0.9 mg), polysorbate 80 (0.4 mg), sodium hydroxide for pH adjustment, sucrose (34 mg), and Water for Injection, USP, pH 5.2. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of AMJEVITA is formulated with L-lactic acid (0.4 mg), polysorbate 80 (0.2 mg), sodium hydroxide for pH adjustment, sucrose (17 mg), and Water for Injection, USP, pH 5.2."
},
{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"LabelerName": "Nuvaila Limited",
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"IndicationAndUsage": "AMJEVITA is a tumor necrosis factor (TNF) blocker indicated for: 1 Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1), 2 Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2), 3 Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3), 4 Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4), 5 Treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. (1.5), 6 Treatment of moderately to severely active ulcerative colitis in adult patients. (1.6).",
"Description": "Adalimumab-atto is a tumor necrosis factor blocker. Adalimumab-atto is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-atto is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. AMJEVITA® (adalimumab-atto) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled SureClick autoinjector, or as a single-dose, 1 mL prefilled glass syringe. Enclosed within the autoinjector is a single-dose, 1 mL prefilled glass syringe. The solution of AMJEVITA is clear, colorless to slightly yellow, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled syringe or prefilled autoinjector delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of AMJEVITA is formulated with L-lactic acid (1.7 mg), polysorbate 80 (0.8 mg), sodium hydroxide for pH adjustment, sucrose (67 mg), and Water for Injection, USP, pH 5.2. Each 40 mg/0.4 mL prefilled syringe or prefilled autoinjector delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of AMJEVITA is formulated with L-lactic acid (0.9 mg), polysorbate 80 (0.4 mg), sodium hydroxide for pH adjustment, sucrose (34 mg), and Water for Injection, USP, pH 5.2. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of AMJEVITA is formulated with L-lactic acid (0.4 mg), polysorbate 80 (0.2 mg), sodium hydroxide for pH adjustment, sucrose (17 mg), and Water for Injection, USP, pH 5.2."
},
{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amjevita",
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"StartMarketingDate": "20250101",
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"LabelerName": "Nuvaila Limited",
"SubstanceName": "ADALIMUMAB",
"StrengthNumber": "40",
"StrengthUnit": "mg/.4mL",
"Pharm_Classes": "Antibodies, Monoclonal [CS], Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]",
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"LastUpdate": "2026-07-21",
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"SamplePackage": "N",
"IndicationAndUsage": "AMJEVITA is a tumor necrosis factor (TNF) blocker indicated for: 1 Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1), 2 Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2), 3 Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3), 4 Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4), 5 Treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. (1.5), 6 Treatment of moderately to severely active ulcerative colitis in adult patients. (1.6).",
"Description": "Adalimumab-atto is a tumor necrosis factor blocker. Adalimumab-atto is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-atto is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. AMJEVITA® (adalimumab-atto) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled SureClick autoinjector, or as a single-dose, 1 mL prefilled glass syringe. Enclosed within the autoinjector is a single-dose, 1 mL prefilled glass syringe. The solution of AMJEVITA is clear, colorless to slightly yellow, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled syringe or prefilled autoinjector delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of AMJEVITA is formulated with L-lactic acid (1.7 mg), polysorbate 80 (0.8 mg), sodium hydroxide for pH adjustment, sucrose (67 mg), and Water for Injection, USP, pH 5.2. Each 40 mg/0.4 mL prefilled syringe or prefilled autoinjector delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of AMJEVITA is formulated with L-lactic acid (0.9 mg), polysorbate 80 (0.4 mg), sodium hydroxide for pH adjustment, sucrose (34 mg), and Water for Injection, USP, pH 5.2. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of AMJEVITA is formulated with L-lactic acid (0.4 mg), polysorbate 80 (0.2 mg), sodium hydroxide for pH adjustment, sucrose (17 mg), and Water for Injection, USP, pH 5.2."
},
{
"NDCCode": "84612-855-01",
"PackageDescription": "1 VIAL in 1 CARTON (84612-855-01) / .5 mL in 1 VIAL",
"NDC11Code": "84612-0855-01",
"ProductNDC": "84612-855",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Wezlana",
"NonProprietaryName": "Ustekinumab-auub",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20250101",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761285",
"LabelerName": "Nuvaila Limited",
"SubstanceName": "USTEKINUMAB",
"StrengthNumber": "45",
"StrengthUnit": "mg/.5mL",
"Pharm_Classes": "Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250101",
"SamplePackage": "N",
"IndicationAndUsage": "WEZLANA is a human interleukin -12 and -23 antagonist indicated for the treatment of: 1 Moderate to severe plaque psoriasis in adult and pediatric patients 6 years of age and older who are candidates for phototherapy or systemic therapy. (1.1), 2 Active psoriatic arthritis in adult and pediatric patients 6 years of age and older. (1.2), 3 Moderately to severely active Crohn's disease in adult patients. (1.3), 4 Moderately to severely active ulcerative colitis in adult patients. (1.4).",
"Description": "Ustekinumab-auub, a human IgG1κ monoclonal antibody, is a human interleukin -12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-auub is produced in a mammalian cell line (Chinese Hamster Ovary). The manufacturing process contains steps for the clearance of viruses. Ustekinumab-auub is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148 to 150 kDa. WEZLANA (ustekinumab-auub) injection is a sterile, preservative-free, clear to opalescent and colorless to light yellow solution with a pH of 6.0. WEZLANA for Subcutaneous Use. Available as 45 mg of ustekinumab-auub in 0.5 mL and 90 mg of ustekinumab-auub in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 27 gauge fixed ½ inch needle and as 45 mg of ustekinumab-auub in 0.5 mL in a single-dose Type I glass vial with a coated stopper. The syringe is fitted with a passive needle guard and a needle cap that does not contain dry natural rubber (a derivative of latex). Each 0.5 mL prefilled syringe or vial delivers 45 mg ustekinumab-auub, histidine (0.23 mg) and histidine hydrochloride monohydrate (0.36 mg), Polysorbate 80 (0.02 mg), and sucrose (38 mg). Each 1 mL prefilled syringe delivers 90 mg ustekinumab-auub, histidine (0.46 mg) and histidine hydrochloride monohydrate (0.72 mg), Polysorbate 80 (0.04 mg), and sucrose (76 mg). WEZLANA for Intravenous Infusion. Available as 130 mg of ustekinumab-auub in 26 mL, supplied as a single-dose Type I glass vial with a coated stopper. Each 26 mL vial delivers 130 mg ustekinumab-auub, edetate disodium (0.47 mg), histidine (20 mg), histidine hydrochloride monohydrate (27 mg), methionine (10.4 mg), Polysorbate 80 (10.4 mg), and sucrose (2210 mg)."
},
{
"NDCCode": "84612-876-01",
"PackageDescription": "1 SYRINGE in 1 CARTON (84612-876-01) / .5 mL in 1 SYRINGE",
"NDC11Code": "84612-0876-01",
"ProductNDC": "84612-876",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Wezlana",
"NonProprietaryName": "Ustekinumab-auub",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20250101",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761285",
"LabelerName": "Nuvaila Limited",
"SubstanceName": "USTEKINUMAB",
"StrengthNumber": "45",
"StrengthUnit": "mg/.5mL",
"Pharm_Classes": "Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250101",
"SamplePackage": "N",
"IndicationAndUsage": "WEZLANA is a human interleukin -12 and -23 antagonist indicated for the treatment of: 1 Moderate to severe plaque psoriasis in adult and pediatric patients 6 years of age and older who are candidates for phototherapy or systemic therapy. (1.1), 2 Active psoriatic arthritis in adult and pediatric patients 6 years of age and older. (1.2), 3 Moderately to severely active Crohn's disease in adult patients. (1.3), 4 Moderately to severely active ulcerative colitis in adult patients. (1.4).",
"Description": "Ustekinumab-auub, a human IgG1κ monoclonal antibody, is a human interleukin -12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-auub is produced in a mammalian cell line (Chinese Hamster Ovary). The manufacturing process contains steps for the clearance of viruses. Ustekinumab-auub is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148 to 150 kDa. WEZLANA (ustekinumab-auub) injection is a sterile, preservative-free, clear to opalescent and colorless to light yellow solution with a pH of 6.0. WEZLANA for Subcutaneous Use. Available as 45 mg of ustekinumab-auub in 0.5 mL and 90 mg of ustekinumab-auub in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 27 gauge fixed ½ inch needle and as 45 mg of ustekinumab-auub in 0.5 mL in a single-dose Type I glass vial with a coated stopper. The syringe is fitted with a passive needle guard and a needle cap that does not contain dry natural rubber (a derivative of latex). Each 0.5 mL prefilled syringe or vial delivers 45 mg ustekinumab-auub, histidine (0.23 mg) and histidine hydrochloride monohydrate (0.36 mg), Polysorbate 80 (0.02 mg), and sucrose (38 mg). Each 1 mL prefilled syringe delivers 90 mg ustekinumab-auub, histidine (0.46 mg) and histidine hydrochloride monohydrate (0.72 mg), Polysorbate 80 (0.04 mg), and sucrose (76 mg). WEZLANA for Intravenous Infusion. Available as 130 mg of ustekinumab-auub in 26 mL, supplied as a single-dose Type I glass vial with a coated stopper. Each 26 mL vial delivers 130 mg ustekinumab-auub, edetate disodium (0.47 mg), histidine (20 mg), histidine hydrochloride monohydrate (27 mg), methionine (10.4 mg), Polysorbate 80 (10.4 mg), and sucrose (2210 mg)."
},
{
"NDCCode": "84612-889-01",
"PackageDescription": "1 SYRINGE in 1 CARTON (84612-889-01) / 1 mL in 1 SYRINGE",
"NDC11Code": "84612-0889-01",
"ProductNDC": "84612-889",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Wezlana",
"NonProprietaryName": "Ustekinumab-auub",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20250101",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761285",
"LabelerName": "Nuvaila Limited",
"SubstanceName": "USTEKINUMAB",
"StrengthNumber": "90",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-06-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250101",
"SamplePackage": "N",
"IndicationAndUsage": "WEZLANA is a human interleukin -12 and -23 antagonist indicated for the treatment of: 1 Moderate to severe plaque psoriasis in adult and pediatric patients 6 years of age and older who are candidates for phototherapy or systemic therapy. (1.1), 2 Active psoriatic arthritis in adult and pediatric patients 6 years of age and older. (1.2), 3 Moderately to severely active Crohn's disease in adult patients. (1.3), 4 Moderately to severely active ulcerative colitis in adult patients. (1.4).",
"Description": "Ustekinumab-auub, a human IgG1κ monoclonal antibody, is a human interleukin -12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-auub is produced in a mammalian cell line (Chinese Hamster Ovary). The manufacturing process contains steps for the clearance of viruses. Ustekinumab-auub is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148 to 150 kDa. WEZLANA (ustekinumab-auub) injection is a sterile, preservative-free, clear to opalescent and colorless to light yellow solution with a pH of 6.0. WEZLANA for Subcutaneous Use. Available as 45 mg of ustekinumab-auub in 0.5 mL and 90 mg of ustekinumab-auub in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 27 gauge fixed ½ inch needle and as 45 mg of ustekinumab-auub in 0.5 mL in a single-dose Type I glass vial with a coated stopper. The syringe is fitted with a passive needle guard and a needle cap that does not contain dry natural rubber (a derivative of latex). Each 0.5 mL prefilled syringe or vial delivers 45 mg ustekinumab-auub, histidine (0.23 mg) and histidine hydrochloride monohydrate (0.36 mg), Polysorbate 80 (0.02 mg), and sucrose (38 mg). Each 1 mL prefilled syringe delivers 90 mg ustekinumab-auub, histidine (0.46 mg) and histidine hydrochloride monohydrate (0.72 mg), Polysorbate 80 (0.04 mg), and sucrose (76 mg). WEZLANA for Intravenous Infusion. Available as 130 mg of ustekinumab-auub in 26 mL, supplied as a single-dose Type I glass vial with a coated stopper. Each 26 mL vial delivers 130 mg ustekinumab-auub, edetate disodium (0.47 mg), histidine (20 mg), histidine hydrochloride monohydrate (27 mg), methionine (10.4 mg), Polysorbate 80 (10.4 mg), and sucrose (2210 mg)."
},
{
"NDCCode": "10702-055-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (10702-055-01) ",
"NDC11Code": "10702-0055-01",
"ProductNDC": "10702-055",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydrocodone Bitartrate And Homatropine Methylbromide",
"NonProprietaryName": "Hydrocodone Bitartrate And Homatropine Methylbromide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170807",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207176",
"LabelerName": "KVK-Tech, Inc.",
"SubstanceName": "HYDROCODONE BITARTRATE; HOMATROPINE METHYLBROMIDE",
"StrengthNumber": "5; 1.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Opioid Agonist [EPC], Opioid Agonists [MoA]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-08-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170807",
"SamplePackage": "N",
"IndicationAndUsage": "Hydrocodone bitartrate and homatropine methylbromide is indicated for the symptomatic relief of cough in adult patients 18 years of age and older. Limitations of Use: : 1 Not indicated for pediatric patients under 18 years of age [see Use in Specific Populations (8.4)]. , 2 Contraindicated in pediatric patients less than 6 years of age [see Contraindications (4)]. , 3 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration, and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve hydrocodone bitartrate and homatropine methylbromide for use in adult patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of cough. .",
"Description": "Hydrocodone bitartrate and homatropine methylbromide tablets and oral solution contain hydrocodone, an opioid agonist; and homatropine, a muscarinic antagonist. Each tablet or spoonful (5 mL) of hydrocodone bitartrate and homatropine methylbromide contains 5 mg of hydrocodone bitartrate, USP and 1.5 mg of homatropine methylbromide, USP for oral administration. Hydrocodone bitartrate and homatropine methylbromide tablets, USP also contain: lactose anhydrous, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate and pregelatinized starch. Hydrocodone bitartrate and homatropine methylbromide oral solution also contains: cherry flavor, FD&C Red #40, glycerin, hydrochloric acid, maltitol syrup, purified water, sodium benzoate, sorbitol, and sucralose. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH. Hydrocodone Bitartrate The chemical name for hydrocodone bitartrate is morphinan-6-one, 4,5-epoxy-3-methoxy-17-methyl-, (5α)-, [R-(R*,R*)]-2,3-dihydroxybutanedioate (1:1), hydrate (2:5). It is also known as 4,5α-Epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It occurs as a fine white crystal or crystalline powder, which is derived from the opium alkaloid, thebaine. It has a molecular weight of 494.50 and has the following chemical structure:. Homatropine Methylbromide. The chemical name for homatropine methylbromide is 8-Azoniabicyclo [3.2.1]octane,3-[(hydroxyphenyl-acetyl)oxy]-8,8-dimethyl-,bromide, endo-. It occurs as a white crystal or fine white crystalline powder. It has a molecular weight of 370.29 and has the following chemical structure."
},
{
"NDCCode": "11559-055-01",
"PackageDescription": "1 JAR in 1 CARTON (11559-055-01) / 50 mL in 1 JAR",
"NDC11Code": "11559-0055-01",
"ProductNDC": "11559-055",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Daywear Anti Oxidant 72h-hydration Sorbet Creme Broad Spectrum Spf 15",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, And Octocrylene",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20181201",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "ESTEE LAUDER INC",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "20; 40; 45; 20",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Active",
"LastUpdate": "2026-01-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181201",
"SamplePackage": "N"
},
{
"NDCCode": "12120-055-01",
"PackageDescription": "300000 g in 1 DRUM (12120-055-01)",
"NDC11Code": "12120-0055-01",
"ProductNDC": "12120-055",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Zinc Oxide, Titanium Dioxide",
"DosageFormName": "POWDER",
"StartMarketingDate": "20140911",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Crystal Claire Cosmetics Inc.",
"SubstanceName": "ZINC OXIDE; TITANIUM DIOXIDE",
"StrengthNumber": "100; 150",
"StrengthUnit": "g/1000g; g/1000g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "13107-055-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (13107-055-01) ",
"NDC11Code": "13107-0055-01",
"ProductNDC": "13107-055",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120712",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202160",
"LabelerName": "Aurolife Pharma, LLC",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2025-12-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120712",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone Hydrochloride Tablets is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, [see Warnings and Precautions (5.1)], reserve Oxycodone Hydrochloride Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): Have not been tolerated or are not expected to be tolerated, Have not provided adequate analgesia or are not expected to provide adequate analgesia. Oxycodone Hydrochloride Tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.",
"Description": "Oxycodone Hydrochloride Tablets contains oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 15 mg, or 30 mg, of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6- one hydrochloride and has the following structural formula. C18H21NO4HCl MW = 351.82. All strengths of oxycodone hydrochloride tablets, USP contain following inactive ingredients: anhydrous lactose, corn starch, lactose monohydrate, microcrystalline cellulose and stearic acid. In addition, the 15 mg tablet contains FD&C blue no. 2 and D&C yellow no. 10; the 30 mg tablet contains FD&C Blue No. 2. The 5 mg, 15 mg and 30 mg tablets contain the equivalent of 4.5 mg, 13.5 mg and 27 mg, respectively, of oxycodone free base."
},
{
"NDCCode": "13537-055-02",
"PackageDescription": "1 TUBE in 1 BOX (13537-055-02) > 4 g in 1 TUBE (13537-055-01)",
"NDC11Code": "13537-0055-02",
"ProductNDC": "13537-055",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Esika",
"ProprietaryNameSuffix": "Ultra Softening Spf 15",
"NonProprietaryName": "Octinoxate And Oxybenzone",
"DosageFormName": "LIPSTICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110923",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura Corporation (San Juan, P.R)",
"SubstanceName": "OCTINOXATE; OXYBENZONE",
"StrengthNumber": ".065; .0182",
"StrengthUnit": "g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "14141-055-01",
"PackageDescription": "28 mL in 1 BOTTLE (14141-055-01) ",
"NDC11Code": "14141-0055-01",
"ProductNDC": "14141-055",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Esika Pro Hydra Smart Hydro-nutritive Foundation Spf 15 390-n",
"NonProprietaryName": "Octinoxate, Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20191210",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "BEL STAR S.A.",
"SubstanceName": "OCTINOXATE; ZINC OXIDE",
"StrengthNumber": ".065; .33",
"StrengthUnit": "g/mL; g/mL",
"Status": "Deprecated",
"LastUpdate": "2021-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20191210",
"SamplePackage": "N"
},
{
"NDCCode": "16714-055-01",
"PackageDescription": "1 TUBE in 1 CARTON (16714-055-01) / 15 g in 1 TUBE",
"NDC11Code": "16714-0055-01",
"ProductNDC": "16714-055",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mupirocin",
"NonProprietaryName": "Mupirocin Calcium",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20201125",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207116",
"LabelerName": "NORTHSTAR RX LLC",
"SubstanceName": "MUPIROCIN CALCIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/g",
"Pharm_Classes": "RNA Synthetase Inhibitor Antibacterial [EPC], RNA Synthetase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201125",
"SamplePackage": "N",
"IndicationAndUsage": "Mupirocin Cream USP, 2% is indicated for the treatment of secondarily infected traumatic skin lesions (up to 10 cm in length or 100 cm 2in area) due to susceptible isolates of Staphylococcus aureus (S. aureus)and Streptococcus pyogenes (S. pyogenes).",
"Description": "Mupirocin Cream USP, 2% contains the dihydrate crystalline calcium hemi-salt of the RNA synthetase inhibitor antibacterial, mupirocin. Chemically, it is (αE,2S,3R,4R,5S)-5-[(2S,3S,4S,5S)-2,3-epoxy-5-hydroxy-4-methylhexyl]tetrahydro-3,4-dihydroxy-ß-methyl-2H-pyran-2-crotonic acid, ester with 9-hydroxynonanoic acid, calcium salt (2:1), dihydrate. The molecular formula of mupirocin calcium is (C 26H 43O 9) 2Ca∙2H 2O, and the molecular weight is 1075.3. The molecular weight of mupirocin free acid is 500.6. The structural formula of mupirocin calcium is:. Each gram of mupirocin cream contains 20 mg (2% w/w) of mupirocin equivalent to 21.5 mg (2.15% w/w) of mupirocin calcium. The inactive ingredients are benzyl alcohol, cetomacrogol 1000, cetyl alcohol, mineral oil, phenoxyethanol, purified water, stearyl alcohol, and xanthan gum."
},
{
"NDCCode": "17518-055-01",
"PackageDescription": "12 BOTTLE, PUMP in 1 CASE (17518-055-01) / 500 mL in 1 BOTTLE, PUMP",
"NDC11Code": "17518-0055-01",
"ProductNDC": "17518-055",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "3m Avagard Foaming Instant Hand Antiseptic",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110527",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "Solventum US LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "548",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2025-12-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110527",
"SamplePackage": "N",
"IndicationAndUsage": "instant healthcare personnel hand antiseptic to reduce bacteria that potentially can cause disease : 1 instant hand antiseptic to decrease bacteria on the skin , 2 recommended for repeated use ."
},
{
"NDCCode": "20151-055-02",
"PackageDescription": "1 BOTTLE in 1 CARTON (20151-055-02) > 50 mL in 1 BOTTLE (20151-055-01)",
"NDC11Code": "20151-0055-02",
"ProductNDC": "20151-055",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Purifying Oxygenating Moisturizing Cream",
"NonProprietaryName": "Mineral Oil, Glycerin, Glyceryl Stearate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150702",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "Casmara Cosmetics, SA",
"SubstanceName": "GLYCERIN; MINERAL OIL",
"StrengthNumber": "6.5; 17",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2015-07-24"
},
{
"NDCCode": "24338-055-01",
"PackageDescription": "1 SYRINGE, GLASS in 1 CARTON (24338-055-01) / 1 mL in 1 SYRINGE, GLASS",
"NDC11Code": "24338-0055-01",
"ProductNDC": "24338-055",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azmiro",
"NonProprietaryName": "Testosterone Cypionate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20241004",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216318",
"LabelerName": "Azurity Pharmaceuticals, Inc.",
"SubstanceName": "TESTOSTERONE CYPIONATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2025-07-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241004",
"SamplePackage": "N",
"IndicationAndUsage": "AZMIRO is indicated for testosterone replacement therapy in males in conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchiectomy, Klinefelter’s syndrome, or toxic damage from alcohol or heavy metals, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle stimulating hormone (FSH), luteinizing hormone (LH)) above the normal range [ see Dosage and Administration ( 2.2) ]. Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range [ see Dosage and Administration (2.2)]. Limitations of Use Safety and efficacy of AZMIRO in men with “age- related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established. Safety and efficacy of AZMIRO in pediatric patients below the age of 12 years have not been established [ see Use in Specific Populations ( 8.4) ].",
"Description": "AZMIRO (testosterone cypionate) injection for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. It is insoluble in water, freely soluble in alcohol, chloroform, dioxane, ether, and soluble in vegetable oils. The chemical name for testosterone cypionate is androst-4-en-3-one, 17-(3-cyclopentyl-1-oxopropoxy)-, (17ß)-. Its molecular formula is C 27H 40O 3, and the molecular weight 412.61. The structural formula is shown in the following figure:. AZMIRO (testosterone cypionate) injection is provided as sterile, clear colorless to pale yellow solution containing 200 mg/mL testosterone cypionate in vials and prefilled syringes. Each mL of solution contains: Testosterone cypionate………………………………………..200 mg Benzyl alcohol………………………………………………….20 mg Benzyl benzoate……………………………………………….0.2 mL Cottonseed oil…………………………………………………542 mg."
},
{
"NDCCode": "27437-055-30",
"PackageDescription": "30 POUCH in 1 CARTON (27437-055-30) / 1 VIAL, SINGLE-DOSE in 1 POUCH (27437-055-01) / 2 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "27437-0055-30",
"ProductNDC": "27437-055",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Brovana",
"NonProprietaryName": "Arformoterol Tartrate",
"DosageFormName": "SOLUTION",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20231001",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021912",
"LabelerName": "Lupin Pharmaceuticals, Inc.",
"SubstanceName": "ARFORMOTEROL TARTRATE",
"StrengthNumber": "15",
"StrengthUnit": "ug/2mL",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-10-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20231001",
"SamplePackage": "N",
"IndicationAndUsage": "BROVANA Inhalation Solution is a long-acting beta2-adrenergic agonist (beta2-agonist) indicated for: 1 Long-term, twice daily (morning and evening) administration in the maintenance treatment of broncho-constriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. (1.1).",
"Description": "BROVANA (arformoterol tartrate) Inhalation Solution is a sterile, clear, colorless, aqueous solution of the tartrate salt of arformoterol, the (R,R)-enantiomer of formoterol. Arformoterol is a selective beta2-adrenergic bronchodilator. The chemical name for arformoterol tartrate is formamide, N-[2-hydroxy-5-[(1R)-1-hydroxy-2-[[(1R)-2-(4-methoxyphenyl)-1-methylethyl]amino]ethyl]phenyl]-, (2R,3R)-2,3-dihydroxybutanedioate (1:1 salt), and its established structural formula is as follows. The molecular weight of arformoterol tartrate is 494.5 g/mol, and its empirical formula is C19H24N2O4C4H6O6 (1:1 salt). It is a white to off-white solid that is slightly soluble in water. Arformoterol tartrate is the United States Adopted Name (USAN) for (R,R)-formoterol L-tartrate. BROVANA (arformoterol tartrate) Inhalation Solution is supplied as 2 mL of arformoterol tartrate solution packaged in 2.1 mL unit-dose, low-density polyethylene (LDPE) unit-dose vials. Each unit-dose vial contains 15 mcg of arformoterol (equivalent to 22 mcg of arformoterol tartrate) in a sterile, isotonic saline solution, pH-adjusted to 5.0 with citric acid and sodium citrate. BROVANA Inhalation Solution requires no dilution before administration by nebulization. Like all other nebulized treatments, the amount delivered to the lungs will depend upon patient factors, the nebulizer used, and compressor performance. Using the PARI LC® Plus nebulizer (with mouthpiece) connected to a PARI DURA NEB 3000 compressor under in vitro conditions, the mean delivered dose from the mouthpiece (% nominal) was approximately 4.1 mcg (27.6%) at a mean flow rate of 3.3 L/min. The mean nebulization time was 6 minutes or less. BROVANA Inhalation Solution should be administered from a standard jet nebulizer at adequate flow rates via face mask or mouthpiece. Patients should be carefully instructed on the correct use of this drug product (please refer to the accompanying Patient Information)."
},
{
"NDCCode": "29033-055-01",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (29033-055-01) ",
"NDC11Code": "29033-0055-01",
"ProductNDC": "29033-055",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200806",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076756",
"LabelerName": "Nostrum Laboratories Inc.",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20200806",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "Metformin hydrochloride extended-release tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below:. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C4H11N5 HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride extended-release tablets, USP contain 500 mg or 750 mg of metformin hydrochloride as the active ingredient. Each tablet contains the inactive ingredients hypromellose, silicified microcrystalline cellulose, xanthan gum, maltodextrin, colloidal silicon dioxide and stearic acid."
},
{
"NDCCode": "36800-055-01",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (36800-055-01) > 100 TABLET in 1 BOTTLE, PLASTIC",
"NDC11Code": "36800-0055-01",
"ProductNDC": "36800-055",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Naproxen Sodium",
"NonProprietaryName": "Naproxen Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140630",
"EndMarketingDate": "20201230",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091353",
"LabelerName": "TOP CARE (Topco Associates LLC)",
"SubstanceName": "NAPROXEN SODIUM",
"StrengthNumber": "220",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20140630",
"EndMarketingDatePackage": "20201230",
"SamplePackage": "N"
},
{
"NDCCode": "41366-055-01",
"PackageDescription": "59 mL in 1 BOTTLE (41366-055-01) ",
"NDC11Code": "41366-0055-01",
"ProductNDC": "41366-055",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Hand Sanitizer",
"DosageFormName": "GEL",
"RouteName": "EXTRACORPOREAL",
"StartMarketingDate": "20220418",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "Zhejiang Meimi Technology Co., Ltd.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220418",
"SamplePackage": "N",
"IndicationAndUsage": "Uses hand sanitizer to help reduce bacteria on skin."
},
{
"NDCCode": "42292-055-05",
"PackageDescription": "20 BLISTER PACK in 1 CARTON (42292-055-05) > 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (42292-055-01) ",
"NDC11Code": "42292-0055-05",
"ProductNDC": "42292-055",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Paliperidone",
"NonProprietaryName": "Paliperidone",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200306",
"EndMarketingDate": "20240130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203802",
"LabelerName": "Mylan Institutional Inc.",
"SubstanceName": "PALIPERIDONE",
"StrengthNumber": "9",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200306",
"EndMarketingDatePackage": "20240130",
"SamplePackage": "N",
"IndicationAndUsage": "Paliperidone extended-release tablets are an atypical antipsychotic agent indicated for. Treatment of schizophrenia ( 1.1) : 1 Adults: Efficacy was established in three 6-week trials and one maintenance trial. ( 14.1) , 2 Adolescents (ages 12-17): Efficacy was established in one 6-week trial. ( 14.1) .",
"Description": "Paliperidone Extended-Release Tablets contain paliperidone, USP, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. Paliperidone extended-release tablets contain a racemic mixture of (+)- and (-)- paliperidone. The chemical name is (9 RS)-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]]ethyl]-9-hydroxy-2-methyl-6,7,8,9-tetrahydro-4 H-pyrido[1,2- a]pyrimidin-4-one. Its molecular formula is C 23H 27FN 4O 3 and its molecular weight is 426.49. The structural formula is:. Paliperidone is sparingly soluble in 0.1N HCl and methylene chloride; practically insoluble in water, 0.1N NaOH, and hexane; and slightly soluble in N,N-dimethylformamide. Paliperidone extended-release tablets are intended for oral administration and are available in 1.5 mg (brown), 3 mg (white), 6 mg (light beige), and 9 mg (pink) strengths. Paliperidone extended-release tablets utilize osmotic drug-release technology [see Description (11)] . Inactive ingredients are butylated hydroxytoluene, cellulose acetate, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, polyethylene glycol, polyethylene oxide, red iron oxide, sodium chloride, sodium stearyl fumarate, talc, titanium dioxide and yellow iron oxide. The 1.5 mg tablets also contain black iron oxide and polydextrose. The 3 mg tablets also contain polyvinyl alcohol. The 6 mg tablets also contain black iron oxide, FD&C Blue No. 1 Aluminum Lake and polyvinyl alcohol. The 9 mg tablets also contain FD&C Blue No. 1 Aluminum Lake and polyvinyl alcohol. The imprinting ink contains the following: black iron oxide, hypromellose and propylene glycol. Delivery System Components and Performance. Paliperidone extended-release tablets contain a bi-layer core tablet that consists of a drug layer containing the entire amount of active ingredient in a hydrophilic polymer matrix and a push layer that contains an osmotic agent in a hydrophilic, swell-able polymer matrix. The bi-layer core tablet is coated with a release-controlling semi-permeable membrane (SPM). The SPM allows water permeation into the core without allowing components to quickly dissipate from the core. A laser-drilled aperture is present on the drug layer side of the SPM-coated tablet and is necessary for delivery. The tablets contain a water soluble cosmetic over-coating that is imprinted with an identifier. Once ingested, the cosmetic over-coating rapidly dissipates in the gastrointestinal tract. The SPM allows water to penetrate into the core as the osmotic agent in the push layer provides a driving force for water influx. Once hydrated, the swell-able polymer matrix in the push layer (high molecular weight polyethylene oxide) expands, exerting a pressure on the drug layer portion of the core tablet which forces it out of the laser-drilled aperture in a plug-flow fashion. After an initial lag time (about 2 to 4 hours), water influx into the core reaches a steady-state and the drug layer is released from the laser-drilled aperture at a constant rate for approximately 20 to 24 hours. As the release rate is controlled by the rate of water influx into the core (SPM permeability), the delivery is independent of pH or gastrointestinal motility. The biologically inert tablet core (ghost), containing residual push layer components, remains intact and is eliminated in the feces. Drug absorption is controlled by a combination of drug release from the tablet and subsequent dissolution in the gastrointestinal tract."
},
{
"NDCCode": "42361-055-01",
"PackageDescription": "70 g in 1 TUBE (42361-055-01)",
"NDC11Code": "42361-0055-01",
"ProductNDC": "42361-055",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sun Barrier Uv Aqua Gel",
"ProprietaryNameSuffix": "Broad Spectrum Spf 12",
"NonProprietaryName": "Octinoxate, Ocisalate",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20141202",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Dong Sung Pharm. Co., Ltd.",
"SubstanceName": "OCTINOXATE; OCTISALATE",
"StrengthNumber": "5.25; 3.15",
"StrengthUnit": "g/70g; g/70g",
"Status": "Deprecated",
"LastUpdate": "2015-12-11"
},
{
"NDCCode": "42858-055-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (42858-055-01) ",
"NDC11Code": "42858-0055-01",
"ProductNDC": "42858-055",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate Extended-release",
"NonProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20190822",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210651",
"LabelerName": "Rhodes Pharmaceuticals LLC",
"SubstanceName": "DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE",
"StrengthNumber": "1.25; 1.25; 1.25; 1.25",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-05-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190822",
"SamplePackage": "N",
"IndicationAndUsage": "Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules, a CNS stimulant, is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older. (1). Limitations of Use. The use of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage. (5.5, 8.4).",
"Description": "Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules contain mixed salts of a single-entity amphetamine, a CNS stimulant. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules contain equal amounts (by weight) of four salts: dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate. This results in a 3.1:1 mixture of dextro- to levo-amphetamine base equivalent. The 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg strength extended-release capsules are for oral administration. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules are a once daily extended-release, single-entity amphetamine product. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules combine the neutral sulfate salts of dextroamphetamine and amphetamine, with the dextro isomer of amphetamine saccharate and d, l-amphetamine aspartate monohydrate. The dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules are a dose proportional composition using a multi-layer fluid bed bead coating process, followed by encapsulation using hard gelatin capsules. The dosage utilizes a bead that is coated with an extended-release drug layer, that is then coated with an enteric polymer to control drug release, and finally coated with an immediate-release drug layer."
},
{
"NDCCode": "42961-055-01",
"PackageDescription": "18 LOZENGE in 1 BLISTER PACK (42961-055-01) ",
"NDC11Code": "42961-0055-01",
"ProductNDC": "42961-055",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cherry Throat Relief Lozenges",
"NonProprietaryName": "Benzocaine",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL",
"StartMarketingDate": "20210107",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M022",
"LabelerName": "Cintas Corporation",
"SubstanceName": "BENZOCAINE; MENTHOL",
"StrengthNumber": "15; 3.6",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20210107",
"SamplePackage": "N",
"IndicationAndUsage": "Uses temporarily relieves these symptoms. occasional minor irritation, pain, sore mouth and sore throat."
},
{
"NDCCode": "43473-055-01",
"PackageDescription": ".9 g in 1 PACKET (43473-055-01) ",
"NDC11Code": "43473-0055-01",
"ProductNDC": "43473-055",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aosi Healthcare Burn",
"NonProprietaryName": "Lidocaine Hydrochloride, Benzalkonium Chloride",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240925",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Nantong Health & Beyond Hygienic Products Inc.",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE; BENZALKONIUM CHLORIDE",
"StrengthNumber": ".5; .13",
"StrengthUnit": "g/100g; g/100g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2024-09-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240925",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. Temporary relief of pain associated with minor cuts, scrapes, and burns. Helps protect against harmful bacteria."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>84612-055-01</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (84612-055-01) / .5 mL in 1 VIAL</PackageDescription>
<NDC11Code>84612-0055-01</NDC11Code>
<ProductNDC>84612-055</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Wezlana</ProprietaryName>
<NonProprietaryName>Ustekinumab-auub</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20250101</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761285</ApplicationNumber>
<LabelerName>Nuvaila Limited</LabelerName>
<SubstanceName>USTEKINUMAB</SubstanceName>
<StrengthNumber>45</StrengthNumber>
<StrengthUnit>mg/.5mL</StrengthUnit>
<Pharm_Classes>Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250101</StartMarketingDatePackage>
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<IndicationAndUsage>WEZLANA is a human interleukin -12 and -23 antagonist indicated for the treatment of: 1 Moderate to severe plaque psoriasis in adult and pediatric patients 6 years of age and older who are candidates for phototherapy or systemic therapy. (1.1), 2 Active psoriatic arthritis in adult and pediatric patients 6 years of age and older. (1.2), 3 Moderately to severely active Crohn's disease in adult patients. (1.3), 4 Moderately to severely active ulcerative colitis in adult patients. (1.4).</IndicationAndUsage>
<Description>Ustekinumab-auub, a human IgG1κ monoclonal antibody, is a human interleukin -12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-auub is produced in a mammalian cell line (Chinese Hamster Ovary). The manufacturing process contains steps for the clearance of viruses. Ustekinumab-auub is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148 to 150 kDa. WEZLANA (ustekinumab-auub) injection is a sterile, preservative-free, clear to opalescent and colorless to light yellow solution with a pH of 6.0. WEZLANA for Subcutaneous Use. Available as 45 mg of ustekinumab-auub in 0.5 mL and 90 mg of ustekinumab-auub in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 27 gauge fixed ½ inch needle and as 45 mg of ustekinumab-auub in 0.5 mL in a single-dose Type I glass vial with a coated stopper. The syringe is fitted with a passive needle guard and a needle cap that does not contain dry natural rubber (a derivative of latex). Each 0.5 mL prefilled syringe or vial delivers 45 mg ustekinumab-auub, histidine (0.23 mg) and histidine hydrochloride monohydrate (0.36 mg), Polysorbate 80 (0.02 mg), and sucrose (38 mg). Each 1 mL prefilled syringe delivers 90 mg ustekinumab-auub, histidine (0.46 mg) and histidine hydrochloride monohydrate (0.72 mg), Polysorbate 80 (0.04 mg), and sucrose (76 mg). WEZLANA for Intravenous Infusion. Available as 130 mg of ustekinumab-auub in 26 mL, supplied as a single-dose Type I glass vial with a coated stopper. Each 26 mL vial delivers 130 mg ustekinumab-auub, edetate disodium (0.47 mg), histidine (20 mg), histidine hydrochloride monohydrate (27 mg), methionine (10.4 mg), Polysorbate 80 (10.4 mg), and sucrose (2210 mg).</Description>
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<IndicationAndUsage>WEZLANA is a human interleukin -12 and -23 antagonist indicated for the treatment of: 1 Moderate to severe plaque psoriasis in adult and pediatric patients 6 years of age and older who are candidates for phototherapy or systemic therapy. (1.1), 2 Active psoriatic arthritis in adult and pediatric patients 6 years of age and older. (1.2), 3 Moderately to severely active Crohn's disease in adult patients. (1.3), 4 Moderately to severely active ulcerative colitis in adult patients. (1.4).</IndicationAndUsage>
<Description>Ustekinumab-auub, a human IgG1κ monoclonal antibody, is a human interleukin -12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-auub is produced in a mammalian cell line (Chinese Hamster Ovary). The manufacturing process contains steps for the clearance of viruses. Ustekinumab-auub is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148 to 150 kDa. WEZLANA (ustekinumab-auub) injection is a sterile, preservative-free, clear to opalescent and colorless to light yellow solution with a pH of 6.0. WEZLANA for Subcutaneous Use. Available as 45 mg of ustekinumab-auub in 0.5 mL and 90 mg of ustekinumab-auub in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 27 gauge fixed ½ inch needle and as 45 mg of ustekinumab-auub in 0.5 mL in a single-dose Type I glass vial with a coated stopper. The syringe is fitted with a passive needle guard and a needle cap that does not contain dry natural rubber (a derivative of latex). Each 0.5 mL prefilled syringe or vial delivers 45 mg ustekinumab-auub, histidine (0.23 mg) and histidine hydrochloride monohydrate (0.36 mg), Polysorbate 80 (0.02 mg), and sucrose (38 mg). Each 1 mL prefilled syringe delivers 90 mg ustekinumab-auub, histidine (0.46 mg) and histidine hydrochloride monohydrate (0.72 mg), Polysorbate 80 (0.04 mg), and sucrose (76 mg). WEZLANA for Intravenous Infusion. Available as 130 mg of ustekinumab-auub in 26 mL, supplied as a single-dose Type I glass vial with a coated stopper. Each 26 mL vial delivers 130 mg ustekinumab-auub, edetate disodium (0.47 mg), histidine (20 mg), histidine hydrochloride monohydrate (27 mg), methionine (10.4 mg), Polysorbate 80 (10.4 mg), and sucrose (2210 mg).</Description>
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<IndicationAndUsage>WEZLANA is a human interleukin -12 and -23 antagonist indicated for the treatment of: 1 Moderate to severe plaque psoriasis in adult and pediatric patients 6 years of age and older who are candidates for phototherapy or systemic therapy. (1.1), 2 Active psoriatic arthritis in adult and pediatric patients 6 years of age and older. (1.2), 3 Moderately to severely active Crohn's disease in adult patients. (1.3), 4 Moderately to severely active ulcerative colitis in adult patients. (1.4).</IndicationAndUsage>
<Description>Ustekinumab-auub, a human IgG1κ monoclonal antibody, is a human interleukin -12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-auub is produced in a mammalian cell line (Chinese Hamster Ovary). The manufacturing process contains steps for the clearance of viruses. Ustekinumab-auub is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148 to 150 kDa. WEZLANA (ustekinumab-auub) injection is a sterile, preservative-free, clear to opalescent and colorless to light yellow solution with a pH of 6.0. WEZLANA for Subcutaneous Use. Available as 45 mg of ustekinumab-auub in 0.5 mL and 90 mg of ustekinumab-auub in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 27 gauge fixed ½ inch needle and as 45 mg of ustekinumab-auub in 0.5 mL in a single-dose Type I glass vial with a coated stopper. The syringe is fitted with a passive needle guard and a needle cap that does not contain dry natural rubber (a derivative of latex). Each 0.5 mL prefilled syringe or vial delivers 45 mg ustekinumab-auub, histidine (0.23 mg) and histidine hydrochloride monohydrate (0.36 mg), Polysorbate 80 (0.02 mg), and sucrose (38 mg). Each 1 mL prefilled syringe delivers 90 mg ustekinumab-auub, histidine (0.46 mg) and histidine hydrochloride monohydrate (0.72 mg), Polysorbate 80 (0.04 mg), and sucrose (76 mg). WEZLANA for Intravenous Infusion. Available as 130 mg of ustekinumab-auub in 26 mL, supplied as a single-dose Type I glass vial with a coated stopper. Each 26 mL vial delivers 130 mg ustekinumab-auub, edetate disodium (0.47 mg), histidine (20 mg), histidine hydrochloride monohydrate (27 mg), methionine (10.4 mg), Polysorbate 80 (10.4 mg), and sucrose (2210 mg).</Description>
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<IndicationAndUsage>WEZLANA is a human interleukin -12 and -23 antagonist indicated for the treatment of: 1 Moderate to severe plaque psoriasis in adult and pediatric patients 6 years of age and older who are candidates for phototherapy or systemic therapy. (1.1), 2 Active psoriatic arthritis in adult and pediatric patients 6 years of age and older. (1.2), 3 Moderately to severely active Crohn's disease in adult patients. (1.3), 4 Moderately to severely active ulcerative colitis in adult patients. (1.4).</IndicationAndUsage>
<Description>Ustekinumab-auub, a human IgG1κ monoclonal antibody, is a human interleukin -12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-auub is produced in a mammalian cell line (Chinese Hamster Ovary). The manufacturing process contains steps for the clearance of viruses. Ustekinumab-auub is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148 to 150 kDa. WEZLANA (ustekinumab-auub) injection is a sterile, preservative-free, clear to opalescent and colorless to light yellow solution with a pH of 6.0. WEZLANA for Subcutaneous Use. Available as 45 mg of ustekinumab-auub in 0.5 mL and 90 mg of ustekinumab-auub in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 27 gauge fixed ½ inch needle and as 45 mg of ustekinumab-auub in 0.5 mL in a single-dose Type I glass vial with a coated stopper. The syringe is fitted with a passive needle guard and a needle cap that does not contain dry natural rubber (a derivative of latex). Each 0.5 mL prefilled syringe or vial delivers 45 mg ustekinumab-auub, histidine (0.23 mg) and histidine hydrochloride monohydrate (0.36 mg), Polysorbate 80 (0.02 mg), and sucrose (38 mg). Each 1 mL prefilled syringe delivers 90 mg ustekinumab-auub, histidine (0.46 mg) and histidine hydrochloride monohydrate (0.72 mg), Polysorbate 80 (0.04 mg), and sucrose (76 mg). WEZLANA for Intravenous Infusion. Available as 130 mg of ustekinumab-auub in 26 mL, supplied as a single-dose Type I glass vial with a coated stopper. Each 26 mL vial delivers 130 mg ustekinumab-auub, edetate disodium (0.47 mg), histidine (20 mg), histidine hydrochloride monohydrate (27 mg), methionine (10.4 mg), Polysorbate 80 (10.4 mg), and sucrose (2210 mg).</Description>
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<ProprietaryName>Amjevita</ProprietaryName>
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<IndicationAndUsage>AMJEVITA is a tumor necrosis factor (TNF) blocker indicated for: 1 Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1), 2 Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2), 3 Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3), 4 Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4), 5 Treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. (1.5), 6 Treatment of moderately to severely active ulcerative colitis in adult patients. (1.6).</IndicationAndUsage>
<Description>Adalimumab-atto is a tumor necrosis factor blocker. Adalimumab-atto is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-atto is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. AMJEVITA® (adalimumab-atto) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled SureClick autoinjector, or as a single-dose, 1 mL prefilled glass syringe. Enclosed within the autoinjector is a single-dose, 1 mL prefilled glass syringe. The solution of AMJEVITA is clear, colorless to slightly yellow, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled syringe or prefilled autoinjector delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of AMJEVITA is formulated with L-lactic acid (1.7 mg), polysorbate 80 (0.8 mg), sodium hydroxide for pH adjustment, sucrose (67 mg), and Water for Injection, USP, pH 5.2. Each 40 mg/0.4 mL prefilled syringe or prefilled autoinjector delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of AMJEVITA is formulated with L-lactic acid (0.9 mg), polysorbate 80 (0.4 mg), sodium hydroxide for pH adjustment, sucrose (34 mg), and Water for Injection, USP, pH 5.2. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of AMJEVITA is formulated with L-lactic acid (0.4 mg), polysorbate 80 (0.2 mg), sodium hydroxide for pH adjustment, sucrose (17 mg), and Water for Injection, USP, pH 5.2.</Description>
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<IndicationAndUsage>AMJEVITA is a tumor necrosis factor (TNF) blocker indicated for: 1 Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1), 2 Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2), 3 Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3), 4 Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4), 5 Treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. (1.5), 6 Treatment of moderately to severely active ulcerative colitis in adult patients. (1.6).</IndicationAndUsage>
<Description>Adalimumab-atto is a tumor necrosis factor blocker. Adalimumab-atto is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-atto is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. AMJEVITA® (adalimumab-atto) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled SureClick autoinjector, or as a single-dose, 1 mL prefilled glass syringe. Enclosed within the autoinjector is a single-dose, 1 mL prefilled glass syringe. The solution of AMJEVITA is clear, colorless to slightly yellow, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled syringe or prefilled autoinjector delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of AMJEVITA is formulated with L-lactic acid (1.7 mg), polysorbate 80 (0.8 mg), sodium hydroxide for pH adjustment, sucrose (67 mg), and Water for Injection, USP, pH 5.2. Each 40 mg/0.4 mL prefilled syringe or prefilled autoinjector delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of AMJEVITA is formulated with L-lactic acid (0.9 mg), polysorbate 80 (0.4 mg), sodium hydroxide for pH adjustment, sucrose (34 mg), and Water for Injection, USP, pH 5.2. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of AMJEVITA is formulated with L-lactic acid (0.4 mg), polysorbate 80 (0.2 mg), sodium hydroxide for pH adjustment, sucrose (17 mg), and Water for Injection, USP, pH 5.2.</Description>
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<IndicationAndUsage>AMJEVITA is a tumor necrosis factor (TNF) blocker indicated for: 1 Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1), 2 Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2), 3 Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3), 4 Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4), 5 Treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. (1.5), 6 Treatment of moderately to severely active ulcerative colitis in adult patients. (1.6).</IndicationAndUsage>
<Description>Adalimumab-atto is a tumor necrosis factor blocker. Adalimumab-atto is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-atto is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. AMJEVITA® (adalimumab-atto) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled SureClick autoinjector, or as a single-dose, 1 mL prefilled glass syringe. Enclosed within the autoinjector is a single-dose, 1 mL prefilled glass syringe. The solution of AMJEVITA is clear, colorless to slightly yellow, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled syringe or prefilled autoinjector delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of AMJEVITA is formulated with L-lactic acid (1.7 mg), polysorbate 80 (0.8 mg), sodium hydroxide for pH adjustment, sucrose (67 mg), and Water for Injection, USP, pH 5.2. Each 40 mg/0.4 mL prefilled syringe or prefilled autoinjector delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of AMJEVITA is formulated with L-lactic acid (0.9 mg), polysorbate 80 (0.4 mg), sodium hydroxide for pH adjustment, sucrose (34 mg), and Water for Injection, USP, pH 5.2. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of AMJEVITA is formulated with L-lactic acid (0.4 mg), polysorbate 80 (0.2 mg), sodium hydroxide for pH adjustment, sucrose (17 mg), and Water for Injection, USP, pH 5.2.</Description>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>AMJEVITA is a tumor necrosis factor (TNF) blocker indicated for: 1 Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1), 2 Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2), 3 Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3), 4 Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4), 5 Treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. (1.5), 6 Treatment of moderately to severely active ulcerative colitis in adult patients. (1.6).</IndicationAndUsage>
<Description>Adalimumab-atto is a tumor necrosis factor blocker. Adalimumab-atto is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-atto is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. AMJEVITA® (adalimumab-atto) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled SureClick autoinjector, or as a single-dose, 1 mL prefilled glass syringe. Enclosed within the autoinjector is a single-dose, 1 mL prefilled glass syringe. The solution of AMJEVITA is clear, colorless to slightly yellow, with a pH of about 5.2. Each 80 mg/0.8 mL prefilled syringe or prefilled autoinjector delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of AMJEVITA is formulated with L-lactic acid (1.7 mg), polysorbate 80 (0.8 mg), sodium hydroxide for pH adjustment, sucrose (67 mg), and Water for Injection, USP, pH 5.2. Each 40 mg/0.4 mL prefilled syringe or prefilled autoinjector delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of AMJEVITA is formulated with L-lactic acid (0.9 mg), polysorbate 80 (0.4 mg), sodium hydroxide for pH adjustment, sucrose (34 mg), and Water for Injection, USP, pH 5.2. Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of AMJEVITA is formulated with L-lactic acid (0.4 mg), polysorbate 80 (0.2 mg), sodium hydroxide for pH adjustment, sucrose (17 mg), and Water for Injection, USP, pH 5.2.</Description>
</NDC>
<NDC>
<NDCCode>84612-855-01</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (84612-855-01) / .5 mL in 1 VIAL</PackageDescription>
<NDC11Code>84612-0855-01</NDC11Code>
<ProductNDC>84612-855</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Wezlana</ProprietaryName>
<NonProprietaryName>Ustekinumab-auub</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20250101</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761285</ApplicationNumber>
<LabelerName>Nuvaila Limited</LabelerName>
<SubstanceName>USTEKINUMAB</SubstanceName>
<StrengthNumber>45</StrengthNumber>
<StrengthUnit>mg/.5mL</StrengthUnit>
<Pharm_Classes>Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>WEZLANA is a human interleukin -12 and -23 antagonist indicated for the treatment of: 1 Moderate to severe plaque psoriasis in adult and pediatric patients 6 years of age and older who are candidates for phototherapy or systemic therapy. (1.1), 2 Active psoriatic arthritis in adult and pediatric patients 6 years of age and older. (1.2), 3 Moderately to severely active Crohn's disease in adult patients. (1.3), 4 Moderately to severely active ulcerative colitis in adult patients. (1.4).</IndicationAndUsage>
<Description>Ustekinumab-auub, a human IgG1κ monoclonal antibody, is a human interleukin -12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-auub is produced in a mammalian cell line (Chinese Hamster Ovary). The manufacturing process contains steps for the clearance of viruses. Ustekinumab-auub is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148 to 150 kDa. WEZLANA (ustekinumab-auub) injection is a sterile, preservative-free, clear to opalescent and colorless to light yellow solution with a pH of 6.0. WEZLANA for Subcutaneous Use. Available as 45 mg of ustekinumab-auub in 0.5 mL and 90 mg of ustekinumab-auub in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 27 gauge fixed ½ inch needle and as 45 mg of ustekinumab-auub in 0.5 mL in a single-dose Type I glass vial with a coated stopper. The syringe is fitted with a passive needle guard and a needle cap that does not contain dry natural rubber (a derivative of latex). Each 0.5 mL prefilled syringe or vial delivers 45 mg ustekinumab-auub, histidine (0.23 mg) and histidine hydrochloride monohydrate (0.36 mg), Polysorbate 80 (0.02 mg), and sucrose (38 mg). Each 1 mL prefilled syringe delivers 90 mg ustekinumab-auub, histidine (0.46 mg) and histidine hydrochloride monohydrate (0.72 mg), Polysorbate 80 (0.04 mg), and sucrose (76 mg). WEZLANA for Intravenous Infusion. Available as 130 mg of ustekinumab-auub in 26 mL, supplied as a single-dose Type I glass vial with a coated stopper. Each 26 mL vial delivers 130 mg ustekinumab-auub, edetate disodium (0.47 mg), histidine (20 mg), histidine hydrochloride monohydrate (27 mg), methionine (10.4 mg), Polysorbate 80 (10.4 mg), and sucrose (2210 mg).</Description>
</NDC>
<NDC>
<NDCCode>84612-876-01</NDCCode>
<PackageDescription>1 SYRINGE in 1 CARTON (84612-876-01) / .5 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>84612-0876-01</NDC11Code>
<ProductNDC>84612-876</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Wezlana</ProprietaryName>
<NonProprietaryName>Ustekinumab-auub</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20250101</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761285</ApplicationNumber>
<LabelerName>Nuvaila Limited</LabelerName>
<SubstanceName>USTEKINUMAB</SubstanceName>
<StrengthNumber>45</StrengthNumber>
<StrengthUnit>mg/.5mL</StrengthUnit>
<Pharm_Classes>Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>WEZLANA is a human interleukin -12 and -23 antagonist indicated for the treatment of: 1 Moderate to severe plaque psoriasis in adult and pediatric patients 6 years of age and older who are candidates for phototherapy or systemic therapy. (1.1), 2 Active psoriatic arthritis in adult and pediatric patients 6 years of age and older. (1.2), 3 Moderately to severely active Crohn's disease in adult patients. (1.3), 4 Moderately to severely active ulcerative colitis in adult patients. (1.4).</IndicationAndUsage>
<Description>Ustekinumab-auub, a human IgG1κ monoclonal antibody, is a human interleukin -12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-auub is produced in a mammalian cell line (Chinese Hamster Ovary). The manufacturing process contains steps for the clearance of viruses. Ustekinumab-auub is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148 to 150 kDa. WEZLANA (ustekinumab-auub) injection is a sterile, preservative-free, clear to opalescent and colorless to light yellow solution with a pH of 6.0. WEZLANA for Subcutaneous Use. Available as 45 mg of ustekinumab-auub in 0.5 mL and 90 mg of ustekinumab-auub in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 27 gauge fixed ½ inch needle and as 45 mg of ustekinumab-auub in 0.5 mL in a single-dose Type I glass vial with a coated stopper. The syringe is fitted with a passive needle guard and a needle cap that does not contain dry natural rubber (a derivative of latex). Each 0.5 mL prefilled syringe or vial delivers 45 mg ustekinumab-auub, histidine (0.23 mg) and histidine hydrochloride monohydrate (0.36 mg), Polysorbate 80 (0.02 mg), and sucrose (38 mg). Each 1 mL prefilled syringe delivers 90 mg ustekinumab-auub, histidine (0.46 mg) and histidine hydrochloride monohydrate (0.72 mg), Polysorbate 80 (0.04 mg), and sucrose (76 mg). WEZLANA for Intravenous Infusion. Available as 130 mg of ustekinumab-auub in 26 mL, supplied as a single-dose Type I glass vial with a coated stopper. Each 26 mL vial delivers 130 mg ustekinumab-auub, edetate disodium (0.47 mg), histidine (20 mg), histidine hydrochloride monohydrate (27 mg), methionine (10.4 mg), Polysorbate 80 (10.4 mg), and sucrose (2210 mg).</Description>
</NDC>
<NDC>
<NDCCode>84612-889-01</NDCCode>
<PackageDescription>1 SYRINGE in 1 CARTON (84612-889-01) / 1 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>84612-0889-01</NDC11Code>
<ProductNDC>84612-889</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Wezlana</ProprietaryName>
<NonProprietaryName>Ustekinumab-auub</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20250101</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761285</ApplicationNumber>
<LabelerName>Nuvaila Limited</LabelerName>
<SubstanceName>USTEKINUMAB</SubstanceName>
<StrengthNumber>90</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>WEZLANA is a human interleukin -12 and -23 antagonist indicated for the treatment of: 1 Moderate to severe plaque psoriasis in adult and pediatric patients 6 years of age and older who are candidates for phototherapy or systemic therapy. (1.1), 2 Active psoriatic arthritis in adult and pediatric patients 6 years of age and older. (1.2), 3 Moderately to severely active Crohn's disease in adult patients. (1.3), 4 Moderately to severely active ulcerative colitis in adult patients. (1.4).</IndicationAndUsage>
<Description>Ustekinumab-auub, a human IgG1κ monoclonal antibody, is a human interleukin -12 and -23 antagonist. Using DNA recombinant technology, ustekinumab-auub is produced in a mammalian cell line (Chinese Hamster Ovary). The manufacturing process contains steps for the clearance of viruses. Ustekinumab-auub is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148 to 150 kDa. WEZLANA (ustekinumab-auub) injection is a sterile, preservative-free, clear to opalescent and colorless to light yellow solution with a pH of 6.0. WEZLANA for Subcutaneous Use. Available as 45 mg of ustekinumab-auub in 0.5 mL and 90 mg of ustekinumab-auub in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 27 gauge fixed ½ inch needle and as 45 mg of ustekinumab-auub in 0.5 mL in a single-dose Type I glass vial with a coated stopper. The syringe is fitted with a passive needle guard and a needle cap that does not contain dry natural rubber (a derivative of latex). Each 0.5 mL prefilled syringe or vial delivers 45 mg ustekinumab-auub, histidine (0.23 mg) and histidine hydrochloride monohydrate (0.36 mg), Polysorbate 80 (0.02 mg), and sucrose (38 mg). Each 1 mL prefilled syringe delivers 90 mg ustekinumab-auub, histidine (0.46 mg) and histidine hydrochloride monohydrate (0.72 mg), Polysorbate 80 (0.04 mg), and sucrose (76 mg). WEZLANA for Intravenous Infusion. Available as 130 mg of ustekinumab-auub in 26 mL, supplied as a single-dose Type I glass vial with a coated stopper. Each 26 mL vial delivers 130 mg ustekinumab-auub, edetate disodium (0.47 mg), histidine (20 mg), histidine hydrochloride monohydrate (27 mg), methionine (10.4 mg), Polysorbate 80 (10.4 mg), and sucrose (2210 mg).</Description>
</NDC>
<NDC>
<NDCCode>10702-055-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (10702-055-01) </PackageDescription>
<NDC11Code>10702-0055-01</NDC11Code>
<ProductNDC>10702-055</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydrocodone Bitartrate And Homatropine Methylbromide</ProprietaryName>
<NonProprietaryName>Hydrocodone Bitartrate And Homatropine Methylbromide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170807</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207176</ApplicationNumber>
<LabelerName>KVK-Tech, Inc.</LabelerName>
<SubstanceName>HYDROCODONE BITARTRATE; HOMATROPINE METHYLBROMIDE</SubstanceName>
<StrengthNumber>5; 1.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Opioid Agonist [EPC], Opioid Agonists [MoA]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-08-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170807</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hydrocodone bitartrate and homatropine methylbromide is indicated for the symptomatic relief of cough in adult patients 18 years of age and older. Limitations of Use: : 1 Not indicated for pediatric patients under 18 years of age [see Use in Specific Populations (8.4)]. , 2 Contraindicated in pediatric patients less than 6 years of age [see Contraindications (4)]. , 3 Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration, and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve hydrocodone bitartrate and homatropine methylbromide for use in adult patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of cough. .</IndicationAndUsage>
<Description>Hydrocodone bitartrate and homatropine methylbromide tablets and oral solution contain hydrocodone, an opioid agonist; and homatropine, a muscarinic antagonist. Each tablet or spoonful (5 mL) of hydrocodone bitartrate and homatropine methylbromide contains 5 mg of hydrocodone bitartrate, USP and 1.5 mg of homatropine methylbromide, USP for oral administration. Hydrocodone bitartrate and homatropine methylbromide tablets, USP also contain: lactose anhydrous, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate and pregelatinized starch. Hydrocodone bitartrate and homatropine methylbromide oral solution also contains: cherry flavor, FD&C Red #40, glycerin, hydrochloric acid, maltitol syrup, purified water, sodium benzoate, sorbitol, and sucralose. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH. Hydrocodone Bitartrate The chemical name for hydrocodone bitartrate is morphinan-6-one, 4,5-epoxy-3-methoxy-17-methyl-, (5α)-, [R-(R*,R*)]-2,3-dihydroxybutanedioate (1:1), hydrate (2:5). It is also known as 4,5α-Epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). It occurs as a fine white crystal or crystalline powder, which is derived from the opium alkaloid, thebaine. It has a molecular weight of 494.50 and has the following chemical structure:. Homatropine Methylbromide. The chemical name for homatropine methylbromide is 8-Azoniabicyclo [3.2.1]octane,3-[(hydroxyphenyl-acetyl)oxy]-8,8-dimethyl-,bromide, endo-. It occurs as a white crystal or fine white crystalline powder. It has a molecular weight of 370.29 and has the following chemical structure.</Description>
</NDC>
<NDC>
<NDCCode>11559-055-01</NDCCode>
<PackageDescription>1 JAR in 1 CARTON (11559-055-01) / 50 mL in 1 JAR</PackageDescription>
<NDC11Code>11559-0055-01</NDC11Code>
<ProductNDC>11559-055</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Daywear Anti Oxidant 72h-hydration Sorbet Creme Broad Spectrum Spf 15</ProprietaryName>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, And Octocrylene</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20181201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>ESTEE LAUDER INC</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>20; 40; 45; 20</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>12120-055-01</NDCCode>
<PackageDescription>300000 g in 1 DRUM (12120-055-01)</PackageDescription>
<NDC11Code>12120-0055-01</NDC11Code>
<ProductNDC>12120-055</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Zinc Oxide, Titanium Dioxide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20140911</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Crystal Claire Cosmetics Inc.</LabelerName>
<SubstanceName>ZINC OXIDE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>100; 150</StrengthNumber>
<StrengthUnit>g/1000g; g/1000g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>13107-055-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (13107-055-01) </PackageDescription>
<NDC11Code>13107-0055-01</NDC11Code>
<ProductNDC>13107-055</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120712</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202160</ApplicationNumber>
<LabelerName>Aurolife Pharma, LLC</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-12-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120712</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone Hydrochloride Tablets is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, [see Warnings and Precautions (5.1)], reserve Oxycodone Hydrochloride Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): Have not been tolerated or are not expected to be tolerated, Have not provided adequate analgesia or are not expected to provide adequate analgesia. Oxycodone Hydrochloride Tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.</IndicationAndUsage>
<Description>Oxycodone Hydrochloride Tablets contains oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 15 mg, or 30 mg, of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7). Chemically, oxycodone hydrochloride is 4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6- one hydrochloride and has the following structural formula. C18H21NO4HCl MW = 351.82. All strengths of oxycodone hydrochloride tablets, USP contain following inactive ingredients: anhydrous lactose, corn starch, lactose monohydrate, microcrystalline cellulose and stearic acid. In addition, the 15 mg tablet contains FD&C blue no. 2 and D&C yellow no. 10; the 30 mg tablet contains FD&C Blue No. 2. The 5 mg, 15 mg and 30 mg tablets contain the equivalent of 4.5 mg, 13.5 mg and 27 mg, respectively, of oxycodone free base.</Description>
</NDC>
<NDC>
<NDCCode>13537-055-02</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (13537-055-02) > 4 g in 1 TUBE (13537-055-01)</PackageDescription>
<NDC11Code>13537-0055-02</NDC11Code>
<ProductNDC>13537-055</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Esika</ProprietaryName>
<ProprietaryNameSuffix>Ultra Softening Spf 15</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate And Oxybenzone</NonProprietaryName>
<DosageFormName>LIPSTICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110923</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura Corporation (San Juan, P.R)</LabelerName>
<SubstanceName>OCTINOXATE; OXYBENZONE</SubstanceName>
<StrengthNumber>.065; .0182</StrengthNumber>
<StrengthUnit>g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>14141-055-01</NDCCode>
<PackageDescription>28 mL in 1 BOTTLE (14141-055-01) </PackageDescription>
<NDC11Code>14141-0055-01</NDC11Code>
<ProductNDC>14141-055</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Esika Pro Hydra Smart Hydro-nutritive Foundation Spf 15 390-n</ProprietaryName>
<NonProprietaryName>Octinoxate, Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20191210</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>BEL STAR S.A.</LabelerName>
<SubstanceName>OCTINOXATE; ZINC OXIDE</SubstanceName>
<StrengthNumber>.065; .33</StrengthNumber>
<StrengthUnit>g/mL; g/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>16714-055-01</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (16714-055-01) / 15 g in 1 TUBE</PackageDescription>
<NDC11Code>16714-0055-01</NDC11Code>
<ProductNDC>16714-055</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mupirocin</ProprietaryName>
<NonProprietaryName>Mupirocin Calcium</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20201125</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207116</ApplicationNumber>
<LabelerName>NORTHSTAR RX LLC</LabelerName>
<SubstanceName>MUPIROCIN CALCIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>RNA Synthetase Inhibitor Antibacterial [EPC], RNA Synthetase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201125</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mupirocin Cream USP, 2% is indicated for the treatment of secondarily infected traumatic skin lesions (up to 10 cm in length or 100 cm 2in area) due to susceptible isolates of Staphylococcus aureus (S. aureus)and Streptococcus pyogenes (S. pyogenes).</IndicationAndUsage>
<Description>Mupirocin Cream USP, 2% contains the dihydrate crystalline calcium hemi-salt of the RNA synthetase inhibitor antibacterial, mupirocin. Chemically, it is (αE,2S,3R,4R,5S)-5-[(2S,3S,4S,5S)-2,3-epoxy-5-hydroxy-4-methylhexyl]tetrahydro-3,4-dihydroxy-ß-methyl-2H-pyran-2-crotonic acid, ester with 9-hydroxynonanoic acid, calcium salt (2:1), dihydrate. The molecular formula of mupirocin calcium is (C 26H 43O 9) 2Ca∙2H 2O, and the molecular weight is 1075.3. The molecular weight of mupirocin free acid is 500.6. The structural formula of mupirocin calcium is:. Each gram of mupirocin cream contains 20 mg (2% w/w) of mupirocin equivalent to 21.5 mg (2.15% w/w) of mupirocin calcium. The inactive ingredients are benzyl alcohol, cetomacrogol 1000, cetyl alcohol, mineral oil, phenoxyethanol, purified water, stearyl alcohol, and xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>17518-055-01</NDCCode>
<PackageDescription>12 BOTTLE, PUMP in 1 CASE (17518-055-01) / 500 mL in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>17518-0055-01</NDC11Code>
<ProductNDC>17518-055</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>3m Avagard Foaming Instant Hand Antiseptic</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110527</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>Solventum US LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>548</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-12-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110527</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>instant healthcare personnel hand antiseptic to reduce bacteria that potentially can cause disease : 1 instant hand antiseptic to decrease bacteria on the skin , 2 recommended for repeated use .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>20151-055-02</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (20151-055-02) > 50 mL in 1 BOTTLE (20151-055-01)</PackageDescription>
<NDC11Code>20151-0055-02</NDC11Code>
<ProductNDC>20151-055</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Purifying Oxygenating Moisturizing Cream</ProprietaryName>
<NonProprietaryName>Mineral Oil, Glycerin, Glyceryl Stearate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150702</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>Casmara Cosmetics, SA</LabelerName>
<SubstanceName>GLYCERIN; MINERAL OIL</SubstanceName>
<StrengthNumber>6.5; 17</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2015-07-24</LastUpdate>
</NDC>
<NDC>
<NDCCode>24338-055-01</NDCCode>
<PackageDescription>1 SYRINGE, GLASS in 1 CARTON (24338-055-01) / 1 mL in 1 SYRINGE, GLASS</PackageDescription>
<NDC11Code>24338-0055-01</NDC11Code>
<ProductNDC>24338-055</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Azmiro</ProprietaryName>
<NonProprietaryName>Testosterone Cypionate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20241004</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216318</ApplicationNumber>
<LabelerName>Azurity Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>TESTOSTERONE CYPIONATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-07-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241004</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>AZMIRO is indicated for testosterone replacement therapy in males in conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchiectomy, Klinefelter’s syndrome, or toxic damage from alcohol or heavy metals, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle stimulating hormone (FSH), luteinizing hormone (LH)) above the normal range [ see Dosage and Administration ( 2.2) ]. Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range [ see Dosage and Administration (2.2)]. Limitations of Use Safety and efficacy of AZMIRO in men with “age- related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established. Safety and efficacy of AZMIRO in pediatric patients below the age of 12 years have not been established [ see Use in Specific Populations ( 8.4) ].</IndicationAndUsage>
<Description>AZMIRO (testosterone cypionate) injection for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. It is insoluble in water, freely soluble in alcohol, chloroform, dioxane, ether, and soluble in vegetable oils. The chemical name for testosterone cypionate is androst-4-en-3-one, 17-(3-cyclopentyl-1-oxopropoxy)-, (17ß)-. Its molecular formula is C 27H 40O 3, and the molecular weight 412.61. The structural formula is shown in the following figure:. AZMIRO (testosterone cypionate) injection is provided as sterile, clear colorless to pale yellow solution containing 200 mg/mL testosterone cypionate in vials and prefilled syringes. Each mL of solution contains: Testosterone cypionate………………………………………..200 mg Benzyl alcohol………………………………………………….20 mg Benzyl benzoate……………………………………………….0.2 mL Cottonseed oil…………………………………………………542 mg.</Description>
</NDC>
<NDC>
<NDCCode>27437-055-30</NDCCode>
<PackageDescription>30 POUCH in 1 CARTON (27437-055-30) / 1 VIAL, SINGLE-DOSE in 1 POUCH (27437-055-01) / 2 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>27437-0055-30</NDC11Code>
<ProductNDC>27437-055</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Brovana</ProprietaryName>
<NonProprietaryName>Arformoterol Tartrate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20231001</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021912</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ARFORMOTEROL TARTRATE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>ug/2mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-10-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BROVANA Inhalation Solution is a long-acting beta2-adrenergic agonist (beta2-agonist) indicated for: 1 Long-term, twice daily (morning and evening) administration in the maintenance treatment of broncho-constriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. (1.1).</IndicationAndUsage>
<Description>BROVANA (arformoterol tartrate) Inhalation Solution is a sterile, clear, colorless, aqueous solution of the tartrate salt of arformoterol, the (R,R)-enantiomer of formoterol. Arformoterol is a selective beta2-adrenergic bronchodilator. The chemical name for arformoterol tartrate is formamide, N-[2-hydroxy-5-[(1R)-1-hydroxy-2-[[(1R)-2-(4-methoxyphenyl)-1-methylethyl]amino]ethyl]phenyl]-, (2R,3R)-2,3-dihydroxybutanedioate (1:1 salt), and its established structural formula is as follows. The molecular weight of arformoterol tartrate is 494.5 g/mol, and its empirical formula is C19H24N2O4C4H6O6 (1:1 salt). It is a white to off-white solid that is slightly soluble in water. Arformoterol tartrate is the United States Adopted Name (USAN) for (R,R)-formoterol L-tartrate. BROVANA (arformoterol tartrate) Inhalation Solution is supplied as 2 mL of arformoterol tartrate solution packaged in 2.1 mL unit-dose, low-density polyethylene (LDPE) unit-dose vials. Each unit-dose vial contains 15 mcg of arformoterol (equivalent to 22 mcg of arformoterol tartrate) in a sterile, isotonic saline solution, pH-adjusted to 5.0 with citric acid and sodium citrate. BROVANA Inhalation Solution requires no dilution before administration by nebulization. Like all other nebulized treatments, the amount delivered to the lungs will depend upon patient factors, the nebulizer used, and compressor performance. Using the PARI LC® Plus nebulizer (with mouthpiece) connected to a PARI DURA NEB 3000 compressor under in vitro conditions, the mean delivered dose from the mouthpiece (% nominal) was approximately 4.1 mcg (27.6%) at a mean flow rate of 3.3 L/min. The mean nebulization time was 6 minutes or less. BROVANA Inhalation Solution should be administered from a standard jet nebulizer at adequate flow rates via face mask or mouthpiece. Patients should be carefully instructed on the correct use of this drug product (please refer to the accompanying Patient Information).</Description>
</NDC>
<NDC>
<NDCCode>29033-055-01</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (29033-055-01) </PackageDescription>
<NDC11Code>29033-0055-01</NDC11Code>
<ProductNDC>29033-055</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200806</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076756</ApplicationNumber>
<LabelerName>Nostrum Laboratories Inc.</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200806</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Metformin hydrochloride extended-release tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below:. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C4H11N5 HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride extended-release tablets, USP contain 500 mg or 750 mg of metformin hydrochloride as the active ingredient. Each tablet contains the inactive ingredients hypromellose, silicified microcrystalline cellulose, xanthan gum, maltodextrin, colloidal silicon dioxide and stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>36800-055-01</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (36800-055-01) > 100 TABLET in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>36800-0055-01</NDC11Code>
<ProductNDC>36800-055</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Naproxen Sodium</ProprietaryName>
<NonProprietaryName>Naproxen Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140630</StartMarketingDate>
<EndMarketingDate>20201230</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091353</ApplicationNumber>
<LabelerName>TOP CARE (Topco Associates LLC)</LabelerName>
<SubstanceName>NAPROXEN SODIUM</SubstanceName>
<StrengthNumber>220</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20140630</StartMarketingDatePackage>
<EndMarketingDatePackage>20201230</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>41366-055-01</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE (41366-055-01) </PackageDescription>
<NDC11Code>41366-0055-01</NDC11Code>
<ProductNDC>41366-055</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Hand Sanitizer</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>EXTRACORPOREAL</RouteName>
<StartMarketingDate>20220418</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>Zhejiang Meimi Technology Co., Ltd.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220418</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses hand sanitizer to help reduce bacteria on skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>42292-055-05</NDCCode>
<PackageDescription>20 BLISTER PACK in 1 CARTON (42292-055-05) > 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (42292-055-01) </PackageDescription>
<NDC11Code>42292-0055-05</NDC11Code>
<ProductNDC>42292-055</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Paliperidone</ProprietaryName>
<NonProprietaryName>Paliperidone</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200306</StartMarketingDate>
<EndMarketingDate>20240130</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203802</ApplicationNumber>
<LabelerName>Mylan Institutional Inc.</LabelerName>
<SubstanceName>PALIPERIDONE</SubstanceName>
<StrengthNumber>9</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200306</StartMarketingDatePackage>
<EndMarketingDatePackage>20240130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Paliperidone extended-release tablets are an atypical antipsychotic agent indicated for. Treatment of schizophrenia ( 1.1) : 1 Adults: Efficacy was established in three 6-week trials and one maintenance trial. ( 14.1) , 2 Adolescents (ages 12-17): Efficacy was established in one 6-week trial. ( 14.1) .</IndicationAndUsage>
<Description>Paliperidone Extended-Release Tablets contain paliperidone, USP, an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. Paliperidone extended-release tablets contain a racemic mixture of (+)- and (-)- paliperidone. The chemical name is (9 RS)-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]]ethyl]-9-hydroxy-2-methyl-6,7,8,9-tetrahydro-4 H-pyrido[1,2- a]pyrimidin-4-one. Its molecular formula is C 23H 27FN 4O 3 and its molecular weight is 426.49. The structural formula is:. Paliperidone is sparingly soluble in 0.1N HCl and methylene chloride; practically insoluble in water, 0.1N NaOH, and hexane; and slightly soluble in N,N-dimethylformamide. Paliperidone extended-release tablets are intended for oral administration and are available in 1.5 mg (brown), 3 mg (white), 6 mg (light beige), and 9 mg (pink) strengths. Paliperidone extended-release tablets utilize osmotic drug-release technology [see Description (11)] . Inactive ingredients are butylated hydroxytoluene, cellulose acetate, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, polyethylene glycol, polyethylene oxide, red iron oxide, sodium chloride, sodium stearyl fumarate, talc, titanium dioxide and yellow iron oxide. The 1.5 mg tablets also contain black iron oxide and polydextrose. The 3 mg tablets also contain polyvinyl alcohol. The 6 mg tablets also contain black iron oxide, FD&C Blue No. 1 Aluminum Lake and polyvinyl alcohol. The 9 mg tablets also contain FD&C Blue No. 1 Aluminum Lake and polyvinyl alcohol. The imprinting ink contains the following: black iron oxide, hypromellose and propylene glycol. Delivery System Components and Performance. Paliperidone extended-release tablets contain a bi-layer core tablet that consists of a drug layer containing the entire amount of active ingredient in a hydrophilic polymer matrix and a push layer that contains an osmotic agent in a hydrophilic, swell-able polymer matrix. The bi-layer core tablet is coated with a release-controlling semi-permeable membrane (SPM). The SPM allows water permeation into the core without allowing components to quickly dissipate from the core. A laser-drilled aperture is present on the drug layer side of the SPM-coated tablet and is necessary for delivery. The tablets contain a water soluble cosmetic over-coating that is imprinted with an identifier. Once ingested, the cosmetic over-coating rapidly dissipates in the gastrointestinal tract. The SPM allows water to penetrate into the core as the osmotic agent in the push layer provides a driving force for water influx. Once hydrated, the swell-able polymer matrix in the push layer (high molecular weight polyethylene oxide) expands, exerting a pressure on the drug layer portion of the core tablet which forces it out of the laser-drilled aperture in a plug-flow fashion. After an initial lag time (about 2 to 4 hours), water influx into the core reaches a steady-state and the drug layer is released from the laser-drilled aperture at a constant rate for approximately 20 to 24 hours. As the release rate is controlled by the rate of water influx into the core (SPM permeability), the delivery is independent of pH or gastrointestinal motility. The biologically inert tablet core (ghost), containing residual push layer components, remains intact and is eliminated in the feces. Drug absorption is controlled by a combination of drug release from the tablet and subsequent dissolution in the gastrointestinal tract.</Description>
</NDC>
<NDC>
<NDCCode>42361-055-01</NDCCode>
<PackageDescription>70 g in 1 TUBE (42361-055-01)</PackageDescription>
<NDC11Code>42361-0055-01</NDC11Code>
<ProductNDC>42361-055</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sun Barrier Uv Aqua Gel</ProprietaryName>
<ProprietaryNameSuffix>Broad Spectrum Spf 12</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate, Ocisalate</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20141202</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Dong Sung Pharm. Co., Ltd.</LabelerName>
<SubstanceName>OCTINOXATE; OCTISALATE</SubstanceName>
<StrengthNumber>5.25; 3.15</StrengthNumber>
<StrengthUnit>g/70g; g/70g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2015-12-11</LastUpdate>
</NDC>
<NDC>
<NDCCode>42858-055-01</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (42858-055-01) </PackageDescription>
<NDC11Code>42858-0055-01</NDC11Code>
<ProductNDC>42858-055</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate Extended-release</ProprietaryName>
<NonProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190822</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210651</ApplicationNumber>
<LabelerName>Rhodes Pharmaceuticals LLC</LabelerName>
<SubstanceName>DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE</SubstanceName>
<StrengthNumber>1.25; 1.25; 1.25; 1.25</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-05-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190822</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules, a CNS stimulant, is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older. (1). Limitations of Use. The use of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage. (5.5, 8.4).</IndicationAndUsage>
<Description>Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules contain mixed salts of a single-entity amphetamine, a CNS stimulant. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules contain equal amounts (by weight) of four salts: dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate. This results in a 3.1:1 mixture of dextro- to levo-amphetamine base equivalent. The 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg strength extended-release capsules are for oral administration. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules are a once daily extended-release, single-entity amphetamine product. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules combine the neutral sulfate salts of dextroamphetamine and amphetamine, with the dextro isomer of amphetamine saccharate and d, l-amphetamine aspartate monohydrate. The dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules are a dose proportional composition using a multi-layer fluid bed bead coating process, followed by encapsulation using hard gelatin capsules. The dosage utilizes a bead that is coated with an extended-release drug layer, that is then coated with an enteric polymer to control drug release, and finally coated with an immediate-release drug layer.</Description>
</NDC>
<NDC>
<NDCCode>42961-055-01</NDCCode>
<PackageDescription>18 LOZENGE in 1 BLISTER PACK (42961-055-01) </PackageDescription>
<NDC11Code>42961-0055-01</NDC11Code>
<ProductNDC>42961-055</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cherry Throat Relief Lozenges</ProprietaryName>
<NonProprietaryName>Benzocaine</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210107</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M022</ApplicationNumber>
<LabelerName>Cintas Corporation</LabelerName>
<SubstanceName>BENZOCAINE; MENTHOL</SubstanceName>
<StrengthNumber>15; 3.6</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210107</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses temporarily relieves these symptoms. occasional minor irritation, pain, sore mouth and sore throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43473-055-01</NDCCode>
<PackageDescription>.9 g in 1 PACKET (43473-055-01) </PackageDescription>
<NDC11Code>43473-0055-01</NDC11Code>
<ProductNDC>43473-055</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aosi Healthcare Burn</ProprietaryName>
<NonProprietaryName>Lidocaine Hydrochloride, Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240925</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>Nantong Health & Beyond Hygienic Products Inc.</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE; BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.5; .13</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-09-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240925</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. Temporary relief of pain associated with minor cuts, scrapes, and burns. Helps protect against harmful bacteria.</IndicationAndUsage>
</NDC>
</NDCList>