{
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"PackageDescription": "1 CONTAINER in 1 CARTON (72288-694-83) / 27 LOZENGE in 1 CONTAINER",
"NDC11Code": "72288-0694-83",
"ProductNDC": "72288-694",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Amazon Basic Care Nicotine Polacrilex",
"NonProprietaryName": "Nicotine Polacrilex Mini",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL",
"StartMarketingDate": "20240515",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215357",
"LabelerName": "Amazon.com Services LLC",
"SubstanceName": "NICOTINE",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]",
"Status": "Active",
"LastUpdate": "2025-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240515",
"SamplePackage": "N"
},
{
"NDCCode": "72288-694-21",
"PackageDescription": "8 CONTAINER in 1 CARTON (72288-694-21) / 27 LOZENGE in 1 CONTAINER",
"NDC11Code": "72288-0694-21",
"ProductNDC": "72288-694",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Amazon Basic Care Nicotine Polacrilex",
"NonProprietaryName": "Nicotine Polacrilex Mini",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL",
"StartMarketingDate": "20240515",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215357",
"LabelerName": "Amazon.com Services LLC",
"SubstanceName": "NICOTINE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]",
"Status": "Active",
"LastUpdate": "2025-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240515",
"SamplePackage": "N"
},
{
"NDCCode": "72288-694-85",
"PackageDescription": "5 CONTAINER in 1 CARTON (72288-694-85) / 27 LOZENGE in 1 CONTAINER",
"NDC11Code": "72288-0694-85",
"ProductNDC": "72288-694",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Amazon Basic Care Nicotine Polacrilex",
"NonProprietaryName": "Nicotine Polacrilex Mini",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL",
"StartMarketingDate": "20240515",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215357",
"LabelerName": "Amazon.com Services LLC",
"SubstanceName": "NICOTINE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]",
"Status": "Active",
"LastUpdate": "2025-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240515",
"SamplePackage": "N"
},
{
"NDCCode": "72288-484-83",
"PackageDescription": "225 TABLET in 1 BOTTLE (72288-484-83) ",
"NDC11Code": "72288-0484-83",
"ProductNDC": "72288-484",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Basic Care Acetaminophen",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200415",
"EndMarketingDate": "20260228",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Amazon.com Services LLC",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2025-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20201008",
"EndMarketingDatePackage": "20250731",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to:. the common cold. headache. backache. minor pain of arthritis. toothache. muscular aches. premenstrual and menstrual cramps. temporarily reduces fever."
},
{
"NDCCode": "72288-690-83",
"PackageDescription": "1 CONTAINER in 1 CARTON (72288-690-83) / 27 LOZENGE in 1 CONTAINER",
"NDC11Code": "72288-0690-83",
"ProductNDC": "72288-690",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Amazon Basic Care Nicotine Polacrilex",
"NonProprietaryName": "Nicotine Polacrilex Mini",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL",
"StartMarketingDate": "20240515",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215357",
"LabelerName": "Amazon.com Services LLC",
"SubstanceName": "NICOTINE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]",
"Status": "Active",
"LastUpdate": "2025-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240515",
"SamplePackage": "N"
},
{
"NDCCode": "0065-0303-55",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (0065-0303-55) > 5 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "00065-0303-55",
"ProductNDC": "0065-0303",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isopto Atropine",
"NonProprietaryName": "Atropine Sulfate",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20180801",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208151",
"LabelerName": "Alcon Laboratories, Inc.",
"SubstanceName": "ATROPINE SULFATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180801",
"EndMarketingDatePackage": "20231031",
"SamplePackage": "N",
"IndicationAndUsage": "ISOPTO® Atropine 1% is indicated for:.",
"Description": "ISOPTO® Atropine 1% is a sterile topical ophthalmic solution. Each mL of ISOPTO® Atropine 1% contains 10 mg of atropine sulfate monohydrate equivalent to 9.7 mg/mL of atropine sulfate or 8.3 mg of atropine. Atropine sulfate monohydrate is designated chemically as benzeneacetic acid, α-(hydroxymethyl)-,8-methyl-8-aza-bicyclo-[3.2.1]oct-3-yl ester, endo-(+)-, sulfate(2:1) (salt), monohydrate. Its molecular formula is (C17H23NO3)2 H2SO4 H2O and it is represented by the chemical structure:. Atropine sulfate monohydrate is colorless crystals or white crystalline powder and has a molecular weight of 694.83. ISOPTO® Atropine 1% has a pH of 3.5 to 6.0. Active ingredient: atropine sulfate monohydrate 1.0% Preservative: benzalkonium chloride 0.01%. Inactive ingredients: hypromellose, boric acid, sodium hydroxide and/or hydrochloric acid (to adjust pH), purified water."
},
{
"NDCCode": "0065-0817-01",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (0065-0817-01) / 5 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "00065-0817-01",
"ProductNDC": "0065-0817",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atropine Sulfate",
"NonProprietaryName": "Atropine Sulfate",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20221101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208151",
"LabelerName": "Alcon Laboratories, Inc.",
"SubstanceName": "ATROPINE SULFATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20221101",
"SamplePackage": "N",
"IndicationAndUsage": "Atropine Sulfate Ophthalmic Solution, 1% is indicated for.",
"Description": "Atropine Sulfate Ophthalmic Solution, 1% is a sterile topical ophthalmic solution. Each mL of Atropine Sulfate Ophthalmic Solution, 1% contains 10 mg of atropine sulfate monohydrate equivalent to 9.7 mg/mL of atropine sulfate or 8.3 mg of atropine. Atropine sulfate monohydrate is designated chemically as benzeneacetic acid, α-(hydroxymethyl)-,8-methyl-8-aza-bicyclo-[3.2.1]oct-3-yl ester, endo-(+)-, sulfate(2:1) (salt), monohydrate. Its molecular formula is (C17H23NO3)2 H2SO4 H2O and it is represented by the chemical structure. Atropine sulfate monohydrate is colorless crystals or white crystalline powder and has a molecular weight of 694.83. Atropine Sulfate Ophthalmic Solution, 1% has a pH of 3.5 to 6.0. Active ingredient: atropine sulfate monohydrate 1%. Preservative: benzalkonium chloride 0.01%. Inactive ingredients: hypromellose, boric acid, sodium hydroxide and/or hydrochloric acid (to adjust pH), purified water."
},
{
"NDCCode": "0065-0817-02",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (0065-0817-02) / 2 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "00065-0817-02",
"ProductNDC": "0065-0817",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atropine Sulfate",
"NonProprietaryName": "Atropine Sulfate",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20221101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208151",
"LabelerName": "Alcon Laboratories, Inc.",
"SubstanceName": "ATROPINE SULFATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-03-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20221101",
"SamplePackage": "N",
"IndicationAndUsage": "Atropine Sulfate Ophthalmic Solution, 1% is indicated for.",
"Description": "Atropine Sulfate Ophthalmic Solution, 1% is a sterile topical ophthalmic solution. Each mL of Atropine Sulfate Ophthalmic Solution, 1% contains 10 mg of atropine sulfate monohydrate equivalent to 9.7 mg/mL of atropine sulfate or 8.3 mg of atropine. Atropine sulfate monohydrate is designated chemically as benzeneacetic acid, α-(hydroxymethyl)-,8-methyl-8-aza-bicyclo-[3.2.1]oct-3-yl ester, endo-(+)-, sulfate(2:1) (salt), monohydrate. Its molecular formula is (C17H23NO3)2 H2SO4 H2O and it is represented by the chemical structure. Atropine sulfate monohydrate is colorless crystals or white crystalline powder and has a molecular weight of 694.83. Atropine Sulfate Ophthalmic Solution, 1% has a pH of 3.5 to 6.0. Active ingredient: atropine sulfate monohydrate 1%. Preservative: benzalkonium chloride 0.01%. Inactive ingredients: hypromellose, boric acid, sodium hydroxide and/or hydrochloric acid (to adjust pH), purified water."
},
{
"NDCCode": "13985-606-05",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (13985-606-05) > 5 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "13985-0606-05",
"ProductNDC": "13985-606",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atropine",
"NonProprietaryName": "Atropine Sulfate",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20150323",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA206289",
"LabelerName": "MWI",
"SubstanceName": "ATROPINE SULFATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20150323",
"SamplePackage": "N",
"IndicationAndUsage": "Atropine Sulfate Ophthalmic Solution, USP 1% is indicated for:.",
"Description": "Atropine Sulfate Ophthalmic Solution, USP 1% is a sterile topical anticholinergic for ophthalmic use. The active ingredient is represented by the chemical structure:. Chemical Name: Benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo[3.2.1.]oct-3-yl ester, endo –(±)-, sulfate (2:1) (salt), monohydrate. Molecular Formula: (C17H23NO3)2 H2SO4 H2O. Molecular Weight: 694.83 g/mol. Each mL of Atropine Sulfate Ophthalmic Solution USP, 1% contains: Active: atropine sulfate 10 mg equivalent to 8.3 mg of atropine. Inactives: benzalkonium chloride 0.1 mg (0.01%), dibasic sodium phosphate, edetate disodium, hypromellose (2910), monobasic sodium phosphate, hydrochloric acid and/or sodium hydroxide may be added to adjust pH (3.5 to 6.0), and water for injection USP."
},
{
"NDCCode": "17478-215-02",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (17478-215-02) > 2 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "17478-0215-02",
"ProductNDC": "17478-215",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atropine",
"NonProprietaryName": "Atropine Sulfate",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20140718",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA206289",
"LabelerName": "Akorn",
"SubstanceName": "ATROPINE SULFATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20140718",
"SamplePackage": "N",
"IndicationAndUsage": "Atropine Sulfate Ophthalmic Solution, USP 1% is indicated for:.",
"Description": "Atropine Sulfate Ophthalmic Solution, USP 1% is a sterile topical anticholinergic for ophthalmic use. The active ingredient is represented by the chemical structure:. Chemical Name: Benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo[3.2.1.]oct-3-yl ester, endo –(±)-, sulfate (2:1) (salt), monohydrate. Molecular Formula: (C17H23NO3)2 H2SO4 H2O. Molecular Weight: 694.83 g/mol. Each mL of Atropine Sulfate Ophthalmic Solution USP, 1% contains: Active: atropine sulfate 10 mg equivalent to 8.3 mg of atropine. Inactives: benzalkonium chloride 0.1 mg (0.01%), dibasic sodium phosphate, edetate disodium, hypromellose (2910), monobasic sodium phosphate, hydrochloric acid and/or sodium hydroxide may be added to adjust pH (3.5 to 6. 0), and water for injection USP."
},
{
"NDCCode": "17478-215-05",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (17478-215-05) > 5 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "17478-0215-05",
"ProductNDC": "17478-215",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atropine",
"NonProprietaryName": "Atropine Sulfate",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20140718",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA206289",
"LabelerName": "Akorn",
"SubstanceName": "ATROPINE SULFATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20140718",
"SamplePackage": "N",
"IndicationAndUsage": "Atropine Sulfate Ophthalmic Solution, USP 1% is indicated for:.",
"Description": "Atropine Sulfate Ophthalmic Solution, USP 1% is a sterile topical anticholinergic for ophthalmic use. The active ingredient is represented by the chemical structure:. Chemical Name: Benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo[3.2.1.]oct-3-yl ester, endo –(±)-, sulfate (2:1) (salt), monohydrate. Molecular Formula: (C17H23NO3)2 H2SO4 H2O. Molecular Weight: 694.83 g/mol. Each mL of Atropine Sulfate Ophthalmic Solution USP, 1% contains: Active: atropine sulfate 10 mg equivalent to 8.3 mg of atropine. Inactives: benzalkonium chloride 0.1 mg (0.01%), dibasic sodium phosphate, edetate disodium, hypromellose (2910), monobasic sodium phosphate, hydrochloric acid and/or sodium hydroxide may be added to adjust pH (3.5 to 6. 0), and water for injection USP."
},
{
"NDCCode": "17478-215-15",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (17478-215-15) > 15 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "17478-0215-15",
"ProductNDC": "17478-215",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atropine",
"NonProprietaryName": "Atropine Sulfate",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20140718",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA206289",
"LabelerName": "Akorn",
"SubstanceName": "ATROPINE SULFATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20140718",
"SamplePackage": "N",
"IndicationAndUsage": "Atropine Sulfate Ophthalmic Solution, USP 1% is indicated for:.",
"Description": "Atropine Sulfate Ophthalmic Solution, USP 1% is a sterile topical anticholinergic for ophthalmic use. The active ingredient is represented by the chemical structure:. Chemical Name: Benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo[3.2.1.]oct-3-yl ester, endo –(±)-, sulfate (2:1) (salt), monohydrate. Molecular Formula: (C17H23NO3)2 H2SO4 H2O. Molecular Weight: 694.83 g/mol. Each mL of Atropine Sulfate Ophthalmic Solution USP, 1% contains: Active: atropine sulfate 10 mg equivalent to 8.3 mg of atropine. Inactives: benzalkonium chloride 0.1 mg (0.01%), dibasic sodium phosphate, edetate disodium, hypromellose (2910), monobasic sodium phosphate, hydrochloric acid and/or sodium hydroxide may be added to adjust pH (3.5 to 6. 0), and water for injection USP."
},
{
"NDCCode": "24208-825-55",
"PackageDescription": "1 TUBE in 1 CARTON (24208-825-55) / 3.5 g in 1 TUBE",
"NDC11Code": "24208-0825-55",
"ProductNDC": "24208-825",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atropine Sulfate",
"NonProprietaryName": "Atropine Sulfate",
"DosageFormName": "OINTMENT",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "19900930",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Bausch & Lomb Incorporated",
"SubstanceName": "ATROPINE SULFATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19900930",
"SamplePackage": "N",
"IndicationAndUsage": "For mydriasis and/or cycloplegia. For cycloplegic refraction, for pupillary dilation desired in inflammatory conditions of the iris and uveal tract.",
"Description": "Atropine Sulfate Ophthalmic Ointment, 1% is a sterile topical anticholinergic for ophthalmic use. The active ingredient is represented by the chemical structural formula. (C17H23NO3)2H2SO4H2O Mol. Wt. 694.83. Chemical Name. Benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo-[3.2.1]oct-3-yl ester, endo-(±)-, sulfate (2:1) (salt), monohydrate. Each gram contains. ACTIVE: Atropine Sulfate, 1% (10 mg); INACTIVES: Lanolin oil, mineral oil, purified water, and white petrolatum."
},
{
"NDCCode": "42799-826-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (42799-826-01) / 2 mL in 1 BOTTLE",
"NDC11Code": "42799-0826-01",
"ProductNDC": "42799-826",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atropine Sulfate",
"NonProprietaryName": "Atropine Sulfate",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20260506",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219013",
"LabelerName": "Edenbridge Pharmaceuticals LLC.",
"SubstanceName": "ATROPINE SULFATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260506",
"SamplePackage": "N",
"IndicationAndUsage": "Atropine Sulfate Ophthalmic Solution, 1% is indicated in adults and pediatric patients aged three (3) months and older for.",
"Description": "Atropine sulfate ophthalmic solution, 1% contains atropine, an anticholinergic, in a sterile colorless, clear solution for topical ophthalmic use. The active ingredient is represented by the chemical structure. Chemical Name: Benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo[3.2.1.]oct-3-yl ester, endo –(±)-, sulfate (2:1) (salt), monohydrate.Molecular Formula: (C17H23NO3)2 H2SO4 H2OMolecular Weight: 694.83 g/molEach mL of atropine sulfate ophthalmic solution USP, 1% contains: Active: atropine sulfate 10 mg (equivalent to 8.3 mg of atropine). Inactives: benzalkonium chloride 0.1 mg (0.01%), dibasic sodium phosphate, edetate disodium, hypromellose (2910), monobasic sodium phosphate, hydrochloric acid and/or sodium hydroxide may be added to adjust pH (3.5 to 6.0), and water for injection USP."
},
{
"NDCCode": "42799-826-02",
"PackageDescription": "1 BOTTLE in 1 CARTON (42799-826-02) / 5 mL in 1 BOTTLE",
"NDC11Code": "42799-0826-02",
"ProductNDC": "42799-826",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atropine Sulfate",
"NonProprietaryName": "Atropine Sulfate",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20260506",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219013",
"LabelerName": "Edenbridge Pharmaceuticals LLC.",
"SubstanceName": "ATROPINE SULFATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260506",
"SamplePackage": "N",
"IndicationAndUsage": "Atropine Sulfate Ophthalmic Solution, 1% is indicated in adults and pediatric patients aged three (3) months and older for.",
"Description": "Atropine sulfate ophthalmic solution, 1% contains atropine, an anticholinergic, in a sterile colorless, clear solution for topical ophthalmic use. The active ingredient is represented by the chemical structure. Chemical Name: Benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo[3.2.1.]oct-3-yl ester, endo –(±)-, sulfate (2:1) (salt), monohydrate.Molecular Formula: (C17H23NO3)2 H2SO4 H2OMolecular Weight: 694.83 g/molEach mL of atropine sulfate ophthalmic solution USP, 1% contains: Active: atropine sulfate 10 mg (equivalent to 8.3 mg of atropine). Inactives: benzalkonium chloride 0.1 mg (0.01%), dibasic sodium phosphate, edetate disodium, hypromellose (2910), monobasic sodium phosphate, hydrochloric acid and/or sodium hydroxide may be added to adjust pH (3.5 to 6.0), and water for injection USP."
},
{
"NDCCode": "42799-826-03",
"PackageDescription": "1 BOTTLE in 1 CARTON (42799-826-03) / 15 mL in 1 BOTTLE",
"NDC11Code": "42799-0826-03",
"ProductNDC": "42799-826",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atropine Sulfate",
"NonProprietaryName": "Atropine Sulfate",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20260506",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219013",
"LabelerName": "Edenbridge Pharmaceuticals LLC.",
"SubstanceName": "ATROPINE SULFATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260506",
"SamplePackage": "N",
"IndicationAndUsage": "Atropine Sulfate Ophthalmic Solution, 1% is indicated in adults and pediatric patients aged three (3) months and older for.",
"Description": "Atropine sulfate ophthalmic solution, 1% contains atropine, an anticholinergic, in a sterile colorless, clear solution for topical ophthalmic use. The active ingredient is represented by the chemical structure. Chemical Name: Benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo[3.2.1.]oct-3-yl ester, endo –(±)-, sulfate (2:1) (salt), monohydrate.Molecular Formula: (C17H23NO3)2 H2SO4 H2OMolecular Weight: 694.83 g/molEach mL of atropine sulfate ophthalmic solution USP, 1% contains: Active: atropine sulfate 10 mg (equivalent to 8.3 mg of atropine). Inactives: benzalkonium chloride 0.1 mg (0.01%), dibasic sodium phosphate, edetate disodium, hypromellose (2910), monobasic sodium phosphate, hydrochloric acid and/or sodium hydroxide may be added to adjust pH (3.5 to 6.0), and water for injection USP."
},
{
"NDCCode": "50090-3104-0",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (50090-3104-0) / 5 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "50090-3104-00",
"ProductNDC": "50090-3104",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atropine",
"NonProprietaryName": "Atropine Sulfate",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20140718",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA206289",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "ATROPINE SULFATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-03-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20170724",
"SamplePackage": "N",
"IndicationAndUsage": "Atropine Sulfate Ophthalmic Solution, USP 1% is indicated for:.",
"Description": "Atropine Sulfate Ophthalmic Solution, USP 1% is a sterile topical anticholinergic for ophthalmic use. The active ingredient is represented by the chemical structure:. Chemical Name: Benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo[3.2.1.]oct-3-yl ester, endo –(±)-, sulfate (2:1) (salt), monohydrate. Molecular Formula: (C17H23NO3)2 H2SO4 H2O. Molecular Weight: 694.83 g/mol. Each mL of Atropine Sulfate Ophthalmic Solution USP, 1% contains: Active: atropine sulfate 10 mg equivalent to 8.3 mg of atropine. Inactives: benzalkonium chloride 0.1 mg (0.01%), dibasic sodium phosphate, edetate disodium, hypromellose (2910), monobasic sodium phosphate, hydrochloric acid and/or sodium hydroxide may be added to adjust pH (3.5 to 6. 0), and water for injection USP."
},
{
"NDCCode": "50090-6295-0",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (50090-6295-0) > 5 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "50090-6295-00",
"ProductNDC": "50090-6295",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atropine",
"NonProprietaryName": "Atropine Sulfate",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20220502",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA206289",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "ATROPINE SULFATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20221223",
"SamplePackage": "N",
"IndicationAndUsage": "Atropine Sulfate Ophthalmic Solution, USP 1% is indicated for:.",
"Description": "Atropine Sulfate Ophthalmic Solution, USP 1% is a sterile topical anticholinergic for ophthalmic use. The active ingredient is represented by the chemical structure:. Chemical Name: Benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl- 8-azabicyclo[3.2.1.]oct-3-yl ester, endo -(±)-, sulfate (2:1) (salt), monohydrate. Molecular Formula: (C17H23NO3)2 H2SO4 H2O. Molecular Weight: 694.83 g/mol. Each mL of Atropine Sulfate Ophthalmic Solution USP, 1% contains:. Active: atropine sulfate 10 mg equivalent to 8.3 mg of atropine. Inactives: benzalkonium chloride 0.1 mg (0.01%), dibasic sodium phosphate, edetate disodium, hypromellose (2910), monobasic sodium phosphate, hydrochloric acid and/or sodium hydroxide may be added to adjust pH (3.5 to 6.0), and water for injection USP."
},
{
"NDCCode": "50090-7313-0",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (50090-7313-0) / 5 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "50090-7313-00",
"ProductNDC": "50090-7313",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atropine",
"NonProprietaryName": "Atropine Sulfate",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20220719",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214752",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "ATROPINE SULFATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241014",
"SamplePackage": "N",
"IndicationAndUsage": "Atropine sulfate ophthalmic solution, 1% is indicated in adults and pediatric patients aged three (3) months and older for:.",
"Description": "Atropine Sulfate Ophthalmic Solution USP, 1% contains atropine, an anticholinergic, in a sterile colorless, clear solution for topical ophthalmic use. The active ingredient is represented by the chemical structure. Chemical Name: Benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo-[3.2.1]oct-3-yl ester, endo –(±), sulfate (2:1) (salt), monohydrate. Molecular Formula: (C17H23NO3)2 H2SO4 H2O. Molecular Weight: 694.83 g/mol. Each mL of atropine sulfate ophthalmic solution USP, 1% contains:. Active: atropine sulfate, USP 10 mg equivalent to 8.3 mg of atropine. Inactives: benzalkonium chloride 0.1 mg (0.01%), dibasic sodium phosphate, edetate disodium, hypromellose (2910), monobasic sodium phosphate, hydrochloric acid and/or sodium hydroxide may be added to adjust pH (3.5 to 6.0) and water for injection USP."
},
{
"NDCCode": "50268-118-35",
"PackageDescription": "1 TUBE in 1 CARTON (50268-118-35) > 3.5 g in 1 TUBE",
"NDC11Code": "50268-0118-35",
"ProductNDC": "50268-118",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atropine Sulfate",
"NonProprietaryName": "Atropine Sulfate",
"DosageFormName": "OINTMENT",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20201118",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "AvPAK",
"SubstanceName": "ATROPINE SULFATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20201118",
"SamplePackage": "N",
"IndicationAndUsage": "For mydriasis and/or cycloplegia. For cycloplegic refraction, for pupillary dilation desired in inflammatory conditions of the iris and uveal tract.",
"Description": "Atropine Sulfate Ophthalmic Ointment, 1% is a sterile topical anticholinergic for ophthalmic use. The active ingredient is represented by the chemical structural formula. (C 17H 23NO 3) 2H 2SO 4H 2O Mol. Wt. 694.83. Chemical Name. Benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo-[3.2.1]oct-3-yl ester, endo-(±)-, sulfate (2:1) (salt), monohydrate. Each gram contains. ACTIVE: Atropine Sulfate, 1% (10 mg); INACTIVES: Lanolin oil, mineral oil, purified water, and white petrolatum."
},
{
"NDCCode": "60219-1748-2",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (60219-1748-2) / 2 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "60219-1748-02",
"ProductNDC": "60219-1748",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atropine",
"NonProprietaryName": "Atropine Sulfate",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20220719",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214752",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "ATROPINE SULFATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220719",
"SamplePackage": "N",
"IndicationAndUsage": "Atropine sulfate ophthalmic solution, 1% is indicated in adults and pediatric patients aged three (3) months and older for:.",
"Description": "Atropine Sulfate Ophthalmic Solution USP, 1% contains atropine, an anticholinergic, in a sterile colorless, clear solution for topical ophthalmic use. The active ingredient is represented by the chemical structure. Chemical Name: Benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo-[3.2.1]oct-3-yl ester, endo –(±), sulfate (2:1) (salt), monohydrate. Molecular Formula: (C17H23NO3)2 H2SO4 H2O. Molecular Weight: 694.83 g/mol. Each mL of atropine sulfate ophthalmic solution USP, 1% contains:. Active: atropine sulfate, USP 10 mg equivalent to 8.3 mg of atropine. Inactives: benzalkonium chloride 0.1 mg (0.01%), dibasic sodium phosphate, edetate disodium, hypromellose (2910), monobasic sodium phosphate, hydrochloric acid and/or sodium hydroxide may be added to adjust pH (3.5 to 6.0) and water for injection USP."
},
{
"NDCCode": "60219-1749-3",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (60219-1749-3) / 5 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "60219-1749-03",
"ProductNDC": "60219-1749",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atropine",
"NonProprietaryName": "Atropine Sulfate",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20220719",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214752",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "ATROPINE SULFATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220719",
"SamplePackage": "N",
"IndicationAndUsage": "Atropine sulfate ophthalmic solution, 1% is indicated in adults and pediatric patients aged three (3) months and older for:.",
"Description": "Atropine Sulfate Ophthalmic Solution USP, 1% contains atropine, an anticholinergic, in a sterile colorless, clear solution for topical ophthalmic use. The active ingredient is represented by the chemical structure. Chemical Name: Benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo-[3.2.1]oct-3-yl ester, endo –(±), sulfate (2:1) (salt), monohydrate. Molecular Formula: (C17H23NO3)2 H2SO4 H2O. Molecular Weight: 694.83 g/mol. Each mL of atropine sulfate ophthalmic solution USP, 1% contains:. Active: atropine sulfate, USP 10 mg equivalent to 8.3 mg of atropine. Inactives: benzalkonium chloride 0.1 mg (0.01%), dibasic sodium phosphate, edetate disodium, hypromellose (2910), monobasic sodium phosphate, hydrochloric acid and/or sodium hydroxide may be added to adjust pH (3.5 to 6.0) and water for injection USP."
},
{
"NDCCode": "60219-1750-8",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (60219-1750-8) / 15 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "60219-1750-08",
"ProductNDC": "60219-1750",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atropine",
"NonProprietaryName": "Atropine Sulfate",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20220719",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214752",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "ATROPINE SULFATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220719",
"SamplePackage": "N",
"IndicationAndUsage": "Atropine sulfate ophthalmic solution, 1% is indicated in adults and pediatric patients aged three (3) months and older for:.",
"Description": "Atropine Sulfate Ophthalmic Solution USP, 1% contains atropine, an anticholinergic, in a sterile colorless, clear solution for topical ophthalmic use. The active ingredient is represented by the chemical structure. Chemical Name: Benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo-[3.2.1]oct-3-yl ester, endo –(±), sulfate (2:1) (salt), monohydrate. Molecular Formula: (C17H23NO3)2 H2SO4 H2O. Molecular Weight: 694.83 g/mol. Each mL of atropine sulfate ophthalmic solution USP, 1% contains:. Active: atropine sulfate, USP 10 mg equivalent to 8.3 mg of atropine. Inactives: benzalkonium chloride 0.1 mg (0.01%), dibasic sodium phosphate, edetate disodium, hypromellose (2910), monobasic sodium phosphate, hydrochloric acid and/or sodium hydroxide may be added to adjust pH (3.5 to 6.0) and water for injection USP."
},
{
"NDCCode": "68083-669-01",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (68083-669-01) / 2 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "68083-0669-01",
"ProductNDC": "68083-669",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atropine",
"NonProprietaryName": "Atropine Sulfate",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20260731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219996",
"LabelerName": "Gland Pharma Limited",
"SubstanceName": "ATROPINE SULFATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260731",
"SamplePackage": "N",
"IndicationAndUsage": "Atropine Sulfate Ophthalmic Solution, 1% is indicated in adults and pediatric patients aged three (3) months and older for. 1.1 Cycloplegia 1.2 Mydriasis 1.3 Penalization of the Healthy Eye in the Treatment of Amblyopia.",
"Description": "Atropine Sulfate Ophthalmic Solution USP, 1% contains atropine, an anticholinergic, in a sterile colorless, clear solution for topical ophthalmic use. The active ingredient is represented by the chemical structure. Chemical Name: Benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo[3.2.1.]oct-3-yl ester, endo –(±)-, sulfate (2:1) (salt), monohydrate. Molecular Formula: (C17H23NO3)2 H2SO4 H2OMolecular Weight: 694.83 g/mol Each mL of Atropine Sulfate Ophthalmic Solution USP, 1% contains. Active: atropine sulfate 10 mg (equivalent to 8.3 mg of atropine). Inactives: benzalkonium chloride 0.1 mg (0.01%), dibasic sodium phosphate, edetate disodium, hypromellose (2910), monobasic sodium phosphate, hydrochloric acid and/or sodium hydroxide may be added to adjust pH (3.5 to 6.0), and water for injection USP."
},
{
"NDCCode": "68083-670-01",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (68083-670-01) / 5 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "68083-0670-01",
"ProductNDC": "68083-670",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atropine",
"NonProprietaryName": "Atropine Sulfate",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20260731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219996",
"LabelerName": "Gland Pharma Limited",
"SubstanceName": "ATROPINE SULFATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260731",
"SamplePackage": "N",
"IndicationAndUsage": "Atropine Sulfate Ophthalmic Solution, 1% is indicated in adults and pediatric patients aged three (3) months and older for. 1.1 Cycloplegia 1.2 Mydriasis 1.3 Penalization of the Healthy Eye in the Treatment of Amblyopia.",
"Description": "Atropine Sulfate Ophthalmic Solution USP, 1% contains atropine, an anticholinergic, in a sterile colorless, clear solution for topical ophthalmic use. The active ingredient is represented by the chemical structure. Chemical Name: Benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo[3.2.1.]oct-3-yl ester, endo –(±)-, sulfate (2:1) (salt), monohydrate. Molecular Formula: (C17H23NO3)2 H2SO4 H2OMolecular Weight: 694.83 g/mol Each mL of Atropine Sulfate Ophthalmic Solution USP, 1% contains. Active: atropine sulfate 10 mg (equivalent to 8.3 mg of atropine). Inactives: benzalkonium chloride 0.1 mg (0.01%), dibasic sodium phosphate, edetate disodium, hypromellose (2910), monobasic sodium phosphate, hydrochloric acid and/or sodium hydroxide may be added to adjust pH (3.5 to 6.0), and water for injection USP."
},
{
"NDCCode": "68083-671-01",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (68083-671-01) / 15 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "68083-0671-01",
"ProductNDC": "68083-671",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atropine",
"NonProprietaryName": "Atropine Sulfate",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20260731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219996",
"LabelerName": "Gland Pharma Limited",
"SubstanceName": "ATROPINE SULFATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260731",
"SamplePackage": "N",
"IndicationAndUsage": "Atropine Sulfate Ophthalmic Solution, 1% is indicated in adults and pediatric patients aged three (3) months and older for. 1.1 Cycloplegia 1.2 Mydriasis 1.3 Penalization of the Healthy Eye in the Treatment of Amblyopia.",
"Description": "Atropine Sulfate Ophthalmic Solution USP, 1% contains atropine, an anticholinergic, in a sterile colorless, clear solution for topical ophthalmic use. The active ingredient is represented by the chemical structure. Chemical Name: Benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo[3.2.1.]oct-3-yl ester, endo –(±)-, sulfate (2:1) (salt), monohydrate. Molecular Formula: (C17H23NO3)2 H2SO4 H2OMolecular Weight: 694.83 g/mol Each mL of Atropine Sulfate Ophthalmic Solution USP, 1% contains. Active: atropine sulfate 10 mg (equivalent to 8.3 mg of atropine). Inactives: benzalkonium chloride 0.1 mg (0.01%), dibasic sodium phosphate, edetate disodium, hypromellose (2910), monobasic sodium phosphate, hydrochloric acid and/or sodium hydroxide may be added to adjust pH (3.5 to 6.0), and water for injection USP."
},
{
"NDCCode": "70069-581-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (70069-581-01) / 2 mL in 1 BOTTLE",
"NDC11Code": "70069-0581-01",
"ProductNDC": "70069-581",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atropine Sulfate",
"NonProprietaryName": "Atropine Sulfate",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20240704",
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<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
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<IndicationAndUsage>Atropine Sulfate Ophthalmic Solution, USP 1% is indicated for:.</IndicationAndUsage>
<Description>Atropine Sulfate Ophthalmic Solution, USP 1% is a sterile topical anticholinergic for ophthalmic use. The active ingredient is represented by the chemical structure:. Chemical Name: Benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo[3.2.1.]oct-3-yl ester, endo –(±)-, sulfate (2:1) (salt), monohydrate. Molecular Formula: (C17H23NO3)2 H2SO4 H2O. Molecular Weight: 694.83 g/mol. Each mL of Atropine Sulfate Ophthalmic Solution USP, 1% contains: Active: atropine sulfate 10 mg equivalent to 8.3 mg of atropine. Inactives: benzalkonium chloride 0.1 mg (0.01%), dibasic sodium phosphate, edetate disodium, hypromellose (2910), monobasic sodium phosphate, hydrochloric acid and/or sodium hydroxide may be added to adjust pH (3.5 to 6. 0), and water for injection USP.</Description>
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<IndicationAndUsage>Atropine Sulfate Ophthalmic Solution, USP 1% is indicated for:.</IndicationAndUsage>
<Description>Atropine Sulfate Ophthalmic Solution, USP 1% is a sterile topical anticholinergic for ophthalmic use. The active ingredient is represented by the chemical structure:. Chemical Name: Benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo[3.2.1.]oct-3-yl ester, endo –(±)-, sulfate (2:1) (salt), monohydrate. Molecular Formula: (C17H23NO3)2 H2SO4 H2O. Molecular Weight: 694.83 g/mol. Each mL of Atropine Sulfate Ophthalmic Solution USP, 1% contains: Active: atropine sulfate 10 mg equivalent to 8.3 mg of atropine. Inactives: benzalkonium chloride 0.1 mg (0.01%), dibasic sodium phosphate, edetate disodium, hypromellose (2910), monobasic sodium phosphate, hydrochloric acid and/or sodium hydroxide may be added to adjust pH (3.5 to 6. 0), and water for injection USP.</Description>
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<LastUpdate>2024-01-02</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atropine Sulfate Ophthalmic Solution, USP 1% is indicated for:.</IndicationAndUsage>
<Description>Atropine Sulfate Ophthalmic Solution, USP 1% is a sterile topical anticholinergic for ophthalmic use. The active ingredient is represented by the chemical structure:. Chemical Name: Benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo[3.2.1.]oct-3-yl ester, endo –(±)-, sulfate (2:1) (salt), monohydrate. Molecular Formula: (C17H23NO3)2 H2SO4 H2O. Molecular Weight: 694.83 g/mol. Each mL of Atropine Sulfate Ophthalmic Solution USP, 1% contains: Active: atropine sulfate 10 mg equivalent to 8.3 mg of atropine. Inactives: benzalkonium chloride 0.1 mg (0.01%), dibasic sodium phosphate, edetate disodium, hypromellose (2910), monobasic sodium phosphate, hydrochloric acid and/or sodium hydroxide may be added to adjust pH (3.5 to 6. 0), and water for injection USP.</Description>
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<DosageFormName>OINTMENT</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
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<LabelerName>Bausch & Lomb Incorporated</LabelerName>
<SubstanceName>ATROPINE SULFATE</SubstanceName>
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<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For mydriasis and/or cycloplegia. For cycloplegic refraction, for pupillary dilation desired in inflammatory conditions of the iris and uveal tract.</IndicationAndUsage>
<Description>Atropine Sulfate Ophthalmic Ointment, 1% is a sterile topical anticholinergic for ophthalmic use. The active ingredient is represented by the chemical structural formula. (C17H23NO3)2H2SO4H2O Mol. Wt. 694.83. Chemical Name. Benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo-[3.2.1]oct-3-yl ester, endo-(±)-, sulfate (2:1) (salt), monohydrate. Each gram contains. ACTIVE: Atropine Sulfate, 1% (10 mg); INACTIVES: Lanolin oil, mineral oil, purified water, and white petrolatum.</Description>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20260506</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
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<LabelerName>Edenbridge Pharmaceuticals LLC.</LabelerName>
<SubstanceName>ATROPINE SULFATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atropine Sulfate Ophthalmic Solution, 1% is indicated in adults and pediatric patients aged three (3) months and older for.</IndicationAndUsage>
<Description>Atropine sulfate ophthalmic solution, 1% contains atropine, an anticholinergic, in a sterile colorless, clear solution for topical ophthalmic use. The active ingredient is represented by the chemical structure. Chemical Name: Benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo[3.2.1.]oct-3-yl ester, endo –(±)-, sulfate (2:1) (salt), monohydrate.Molecular Formula: (C17H23NO3)2 H2SO4 H2OMolecular Weight: 694.83 g/molEach mL of atropine sulfate ophthalmic solution USP, 1% contains: Active: atropine sulfate 10 mg (equivalent to 8.3 mg of atropine). Inactives: benzalkonium chloride 0.1 mg (0.01%), dibasic sodium phosphate, edetate disodium, hypromellose (2910), monobasic sodium phosphate, hydrochloric acid and/or sodium hydroxide may be added to adjust pH (3.5 to 6.0), and water for injection USP.</Description>
</NDC>
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<LabelerName>Edenbridge Pharmaceuticals LLC.</LabelerName>
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<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atropine Sulfate Ophthalmic Solution, 1% is indicated in adults and pediatric patients aged three (3) months and older for.</IndicationAndUsage>
<Description>Atropine sulfate ophthalmic solution, 1% contains atropine, an anticholinergic, in a sterile colorless, clear solution for topical ophthalmic use. The active ingredient is represented by the chemical structure. Chemical Name: Benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo[3.2.1.]oct-3-yl ester, endo –(±)-, sulfate (2:1) (salt), monohydrate.Molecular Formula: (C17H23NO3)2 H2SO4 H2OMolecular Weight: 694.83 g/molEach mL of atropine sulfate ophthalmic solution USP, 1% contains: Active: atropine sulfate 10 mg (equivalent to 8.3 mg of atropine). Inactives: benzalkonium chloride 0.1 mg (0.01%), dibasic sodium phosphate, edetate disodium, hypromellose (2910), monobasic sodium phosphate, hydrochloric acid and/or sodium hydroxide may be added to adjust pH (3.5 to 6.0), and water for injection USP.</Description>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
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<LabelerName>Edenbridge Pharmaceuticals LLC.</LabelerName>
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<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atropine Sulfate Ophthalmic Solution, 1% is indicated in adults and pediatric patients aged three (3) months and older for.</IndicationAndUsage>
<Description>Atropine sulfate ophthalmic solution, 1% contains atropine, an anticholinergic, in a sterile colorless, clear solution for topical ophthalmic use. The active ingredient is represented by the chemical structure. Chemical Name: Benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo[3.2.1.]oct-3-yl ester, endo –(±)-, sulfate (2:1) (salt), monohydrate.Molecular Formula: (C17H23NO3)2 H2SO4 H2OMolecular Weight: 694.83 g/molEach mL of atropine sulfate ophthalmic solution USP, 1% contains: Active: atropine sulfate 10 mg (equivalent to 8.3 mg of atropine). Inactives: benzalkonium chloride 0.1 mg (0.01%), dibasic sodium phosphate, edetate disodium, hypromellose (2910), monobasic sodium phosphate, hydrochloric acid and/or sodium hydroxide may be added to adjust pH (3.5 to 6.0), and water for injection USP.</Description>
</NDC>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<RouteName>OPHTHALMIC</RouteName>
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<MarketingCategoryName>NDA</MarketingCategoryName>
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<Status>Deprecated</Status>
<LastUpdate>2024-03-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170724</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atropine Sulfate Ophthalmic Solution, USP 1% is indicated for:.</IndicationAndUsage>
<Description>Atropine Sulfate Ophthalmic Solution, USP 1% is a sterile topical anticholinergic for ophthalmic use. The active ingredient is represented by the chemical structure:. Chemical Name: Benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo[3.2.1.]oct-3-yl ester, endo –(±)-, sulfate (2:1) (salt), monohydrate. Molecular Formula: (C17H23NO3)2 H2SO4 H2O. Molecular Weight: 694.83 g/mol. Each mL of Atropine Sulfate Ophthalmic Solution USP, 1% contains: Active: atropine sulfate 10 mg equivalent to 8.3 mg of atropine. Inactives: benzalkonium chloride 0.1 mg (0.01%), dibasic sodium phosphate, edetate disodium, hypromellose (2910), monobasic sodium phosphate, hydrochloric acid and/or sodium hydroxide may be added to adjust pH (3.5 to 6. 0), and water for injection USP.</Description>
</NDC>
<NDC>
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<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221223</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atropine Sulfate Ophthalmic Solution, USP 1% is indicated for:.</IndicationAndUsage>
<Description>Atropine Sulfate Ophthalmic Solution, USP 1% is a sterile topical anticholinergic for ophthalmic use. The active ingredient is represented by the chemical structure:. Chemical Name: Benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl- 8-azabicyclo[3.2.1.]oct-3-yl ester, endo -(±)-, sulfate (2:1) (salt), monohydrate. Molecular Formula: (C17H23NO3)2 H2SO4 H2O. Molecular Weight: 694.83 g/mol. Each mL of Atropine Sulfate Ophthalmic Solution USP, 1% contains:. Active: atropine sulfate 10 mg equivalent to 8.3 mg of atropine. Inactives: benzalkonium chloride 0.1 mg (0.01%), dibasic sodium phosphate, edetate disodium, hypromellose (2910), monobasic sodium phosphate, hydrochloric acid and/or sodium hydroxide may be added to adjust pH (3.5 to 6.0), and water for injection USP.</Description>
</NDC>
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<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20220719</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214752</ApplicationNumber>
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<Status>Active</Status>
<LastUpdate>2026-02-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241014</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atropine sulfate ophthalmic solution, 1% is indicated in adults and pediatric patients aged three (3) months and older for:.</IndicationAndUsage>
<Description>Atropine Sulfate Ophthalmic Solution USP, 1% contains atropine, an anticholinergic, in a sterile colorless, clear solution for topical ophthalmic use. The active ingredient is represented by the chemical structure. Chemical Name: Benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo-[3.2.1]oct-3-yl ester, endo –(±), sulfate (2:1) (salt), monohydrate. Molecular Formula: (C17H23NO3)2 H2SO4 H2O. Molecular Weight: 694.83 g/mol. Each mL of atropine sulfate ophthalmic solution USP, 1% contains:. Active: atropine sulfate, USP 10 mg equivalent to 8.3 mg of atropine. Inactives: benzalkonium chloride 0.1 mg (0.01%), dibasic sodium phosphate, edetate disodium, hypromellose (2910), monobasic sodium phosphate, hydrochloric acid and/or sodium hydroxide may be added to adjust pH (3.5 to 6.0) and water for injection USP.</Description>
</NDC>
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<DosageFormName>OINTMENT</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
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<LabelerName>AvPAK</LabelerName>
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<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201118</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For mydriasis and/or cycloplegia. For cycloplegic refraction, for pupillary dilation desired in inflammatory conditions of the iris and uveal tract.</IndicationAndUsage>
<Description>Atropine Sulfate Ophthalmic Ointment, 1% is a sterile topical anticholinergic for ophthalmic use. The active ingredient is represented by the chemical structural formula. (C 17H 23NO 3) 2H 2SO 4H 2O Mol. Wt. 694.83. Chemical Name. Benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo-[3.2.1]oct-3-yl ester, endo-(±)-, sulfate (2:1) (salt), monohydrate. Each gram contains. ACTIVE: Atropine Sulfate, 1% (10 mg); INACTIVES: Lanolin oil, mineral oil, purified water, and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>60219-1748-2</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (60219-1748-2) / 2 mL in 1 BOTTLE, DROPPER</PackageDescription>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atropine</ProprietaryName>
<NonProprietaryName>Atropine Sulfate</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20220719</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214752</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>ATROPINE SULFATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220719</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atropine sulfate ophthalmic solution, 1% is indicated in adults and pediatric patients aged three (3) months and older for:.</IndicationAndUsage>
<Description>Atropine Sulfate Ophthalmic Solution USP, 1% contains atropine, an anticholinergic, in a sterile colorless, clear solution for topical ophthalmic use. The active ingredient is represented by the chemical structure. Chemical Name: Benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo-[3.2.1]oct-3-yl ester, endo –(±), sulfate (2:1) (salt), monohydrate. Molecular Formula: (C17H23NO3)2 H2SO4 H2O. Molecular Weight: 694.83 g/mol. Each mL of atropine sulfate ophthalmic solution USP, 1% contains:. Active: atropine sulfate, USP 10 mg equivalent to 8.3 mg of atropine. Inactives: benzalkonium chloride 0.1 mg (0.01%), dibasic sodium phosphate, edetate disodium, hypromellose (2910), monobasic sodium phosphate, hydrochloric acid and/or sodium hydroxide may be added to adjust pH (3.5 to 6.0) and water for injection USP.</Description>
</NDC>
<NDC>
<NDCCode>60219-1749-3</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (60219-1749-3) / 5 mL in 1 BOTTLE, DROPPER</PackageDescription>
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<ProductNDC>60219-1749</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atropine</ProprietaryName>
<NonProprietaryName>Atropine Sulfate</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20220719</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214752</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>ATROPINE SULFATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220719</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atropine sulfate ophthalmic solution, 1% is indicated in adults and pediatric patients aged three (3) months and older for:.</IndicationAndUsage>
<Description>Atropine Sulfate Ophthalmic Solution USP, 1% contains atropine, an anticholinergic, in a sterile colorless, clear solution for topical ophthalmic use. The active ingredient is represented by the chemical structure. Chemical Name: Benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo-[3.2.1]oct-3-yl ester, endo –(±), sulfate (2:1) (salt), monohydrate. Molecular Formula: (C17H23NO3)2 H2SO4 H2O. Molecular Weight: 694.83 g/mol. Each mL of atropine sulfate ophthalmic solution USP, 1% contains:. Active: atropine sulfate, USP 10 mg equivalent to 8.3 mg of atropine. Inactives: benzalkonium chloride 0.1 mg (0.01%), dibasic sodium phosphate, edetate disodium, hypromellose (2910), monobasic sodium phosphate, hydrochloric acid and/or sodium hydroxide may be added to adjust pH (3.5 to 6.0) and water for injection USP.</Description>
</NDC>
<NDC>
<NDCCode>60219-1750-8</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (60219-1750-8) / 15 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>60219-1750-08</NDC11Code>
<ProductNDC>60219-1750</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atropine</ProprietaryName>
<NonProprietaryName>Atropine Sulfate</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20220719</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214752</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>ATROPINE SULFATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220719</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atropine sulfate ophthalmic solution, 1% is indicated in adults and pediatric patients aged three (3) months and older for:.</IndicationAndUsage>
<Description>Atropine Sulfate Ophthalmic Solution USP, 1% contains atropine, an anticholinergic, in a sterile colorless, clear solution for topical ophthalmic use. The active ingredient is represented by the chemical structure. Chemical Name: Benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo-[3.2.1]oct-3-yl ester, endo –(±), sulfate (2:1) (salt), monohydrate. Molecular Formula: (C17H23NO3)2 H2SO4 H2O. Molecular Weight: 694.83 g/mol. Each mL of atropine sulfate ophthalmic solution USP, 1% contains:. Active: atropine sulfate, USP 10 mg equivalent to 8.3 mg of atropine. Inactives: benzalkonium chloride 0.1 mg (0.01%), dibasic sodium phosphate, edetate disodium, hypromellose (2910), monobasic sodium phosphate, hydrochloric acid and/or sodium hydroxide may be added to adjust pH (3.5 to 6.0) and water for injection USP.</Description>
</NDC>
<NDC>
<NDCCode>68083-669-01</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (68083-669-01) / 2 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>68083-0669-01</NDC11Code>
<ProductNDC>68083-669</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atropine</ProprietaryName>
<NonProprietaryName>Atropine Sulfate</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20260731</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219996</ApplicationNumber>
<LabelerName>Gland Pharma Limited</LabelerName>
<SubstanceName>ATROPINE SULFATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260731</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atropine Sulfate Ophthalmic Solution, 1% is indicated in adults and pediatric patients aged three (3) months and older for. 1.1 Cycloplegia 1.2 Mydriasis 1.3 Penalization of the Healthy Eye in the Treatment of Amblyopia.</IndicationAndUsage>
<Description>Atropine Sulfate Ophthalmic Solution USP, 1% contains atropine, an anticholinergic, in a sterile colorless, clear solution for topical ophthalmic use. The active ingredient is represented by the chemical structure. Chemical Name: Benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo[3.2.1.]oct-3-yl ester, endo –(±)-, sulfate (2:1) (salt), monohydrate. Molecular Formula: (C17H23NO3)2 H2SO4 H2OMolecular Weight: 694.83 g/mol Each mL of Atropine Sulfate Ophthalmic Solution USP, 1% contains. Active: atropine sulfate 10 mg (equivalent to 8.3 mg of atropine). Inactives: benzalkonium chloride 0.1 mg (0.01%), dibasic sodium phosphate, edetate disodium, hypromellose (2910), monobasic sodium phosphate, hydrochloric acid and/or sodium hydroxide may be added to adjust pH (3.5 to 6.0), and water for injection USP.</Description>
</NDC>
<NDC>
<NDCCode>68083-670-01</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (68083-670-01) / 5 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>68083-0670-01</NDC11Code>
<ProductNDC>68083-670</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atropine</ProprietaryName>
<NonProprietaryName>Atropine Sulfate</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20260731</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219996</ApplicationNumber>
<LabelerName>Gland Pharma Limited</LabelerName>
<SubstanceName>ATROPINE SULFATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260731</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atropine Sulfate Ophthalmic Solution, 1% is indicated in adults and pediatric patients aged three (3) months and older for. 1.1 Cycloplegia 1.2 Mydriasis 1.3 Penalization of the Healthy Eye in the Treatment of Amblyopia.</IndicationAndUsage>
<Description>Atropine Sulfate Ophthalmic Solution USP, 1% contains atropine, an anticholinergic, in a sterile colorless, clear solution for topical ophthalmic use. The active ingredient is represented by the chemical structure. Chemical Name: Benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo[3.2.1.]oct-3-yl ester, endo –(±)-, sulfate (2:1) (salt), monohydrate. Molecular Formula: (C17H23NO3)2 H2SO4 H2OMolecular Weight: 694.83 g/mol Each mL of Atropine Sulfate Ophthalmic Solution USP, 1% contains. Active: atropine sulfate 10 mg (equivalent to 8.3 mg of atropine). Inactives: benzalkonium chloride 0.1 mg (0.01%), dibasic sodium phosphate, edetate disodium, hypromellose (2910), monobasic sodium phosphate, hydrochloric acid and/or sodium hydroxide may be added to adjust pH (3.5 to 6.0), and water for injection USP.</Description>
</NDC>
<NDC>
<NDCCode>68083-671-01</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (68083-671-01) / 15 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>68083-0671-01</NDC11Code>
<ProductNDC>68083-671</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atropine</ProprietaryName>
<NonProprietaryName>Atropine Sulfate</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20260731</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219996</ApplicationNumber>
<LabelerName>Gland Pharma Limited</LabelerName>
<SubstanceName>ATROPINE SULFATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260731</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atropine Sulfate Ophthalmic Solution, 1% is indicated in adults and pediatric patients aged three (3) months and older for. 1.1 Cycloplegia 1.2 Mydriasis 1.3 Penalization of the Healthy Eye in the Treatment of Amblyopia.</IndicationAndUsage>
<Description>Atropine Sulfate Ophthalmic Solution USP, 1% contains atropine, an anticholinergic, in a sterile colorless, clear solution for topical ophthalmic use. The active ingredient is represented by the chemical structure. Chemical Name: Benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo[3.2.1.]oct-3-yl ester, endo –(±)-, sulfate (2:1) (salt), monohydrate. Molecular Formula: (C17H23NO3)2 H2SO4 H2OMolecular Weight: 694.83 g/mol Each mL of Atropine Sulfate Ophthalmic Solution USP, 1% contains. Active: atropine sulfate 10 mg (equivalent to 8.3 mg of atropine). Inactives: benzalkonium chloride 0.1 mg (0.01%), dibasic sodium phosphate, edetate disodium, hypromellose (2910), monobasic sodium phosphate, hydrochloric acid and/or sodium hydroxide may be added to adjust pH (3.5 to 6.0), and water for injection USP.</Description>
</NDC>
<NDC>
<NDCCode>70069-581-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (70069-581-01) / 2 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>70069-0581-01</NDC11Code>
<ProductNDC>70069-581</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atropine Sulfate</ProprietaryName>
<NonProprietaryName>Atropine Sulfate</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20240704</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215618</ApplicationNumber>
<LabelerName>Somerset Therapeutics, LLC</LabelerName>
<SubstanceName>ATROPINE SULFATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240704</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atropine sulfate ophthalmic solution, 1% is indicated for.</IndicationAndUsage>
<Description>Atropine sulfate ophthalmic solution, USP 1% is a sterile topical anticholinergic for ophthalmic use. The active ingredient is represented by the chemical structure. Chemical Name: Benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo[3.2.1.]oct-3-yl ester, endo –(±)-, sulfate (2:1) (salt), monohydrate. Molecular Formula: (C17H23NO3)2 H2SO4 H2O. Molecular Weight: 694.83 g/mol. Each mL Contains: Active: Atropine sulfate, 10 mg (1%) equivalent to 8.3 mg of atropine. Inactives: benzalkonium chloride 0.1 mg (0.01%), dibasic sodium phosphate heptahydrate, edetate disodium dihydrate, hypromellose (2910), monobasic sodium phosphate monohydrate, hydrochloric acid and/or sodium hydroxide may be added to adjust pH (3.5 to 6. 0), and water for injection USP.</Description>
</NDC>
<NDC>
<NDCCode>70069-582-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (70069-582-01) / 5 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>70069-0582-01</NDC11Code>
<ProductNDC>70069-582</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atropine Sulfate</ProprietaryName>
<NonProprietaryName>Atropine Sulfate</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20240704</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215618</ApplicationNumber>
<LabelerName>Somerset Therapeutics, LLC</LabelerName>
<SubstanceName>ATROPINE SULFATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240704</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atropine sulfate ophthalmic solution, 1% is indicated for.</IndicationAndUsage>
<Description>Atropine sulfate ophthalmic solution, USP 1% is a sterile topical anticholinergic for ophthalmic use. The active ingredient is represented by the chemical structure. Chemical Name: Benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo[3.2.1.]oct-3-yl ester, endo –(±)-, sulfate (2:1) (salt), monohydrate. Molecular Formula: (C17H23NO3)2 H2SO4 H2O. Molecular Weight: 694.83 g/mol. Each mL Contains: Active: Atropine sulfate, 10 mg (1%) equivalent to 8.3 mg of atropine. Inactives: benzalkonium chloride 0.1 mg (0.01%), dibasic sodium phosphate heptahydrate, edetate disodium dihydrate, hypromellose (2910), monobasic sodium phosphate monohydrate, hydrochloric acid and/or sodium hydroxide may be added to adjust pH (3.5 to 6. 0), and water for injection USP.</Description>
</NDC>
<NDC>
<NDCCode>70069-583-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (70069-583-01) / 15 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>70069-0583-01</NDC11Code>
<ProductNDC>70069-583</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atropine Sulfate</ProprietaryName>
<NonProprietaryName>Atropine Sulfate</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20250212</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215618</ApplicationNumber>
<LabelerName>Somerset Therapeutics, LLC</LabelerName>
<SubstanceName>ATROPINE SULFATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250212</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atropine sulfate ophthalmic solution, 1% is indicated for.</IndicationAndUsage>
<Description>Atropine sulfate ophthalmic solution, USP 1% is a sterile topical anticholinergic for ophthalmic use. The active ingredient is represented by the chemical structure. Chemical Name: Benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo[3.2.1.]oct-3-yl ester, endo –(±)-, sulfate (2:1) (salt), monohydrate. Molecular Formula: (C17H23NO3)2 H2SO4 H2O. Molecular Weight: 694.83 g/mol. Each mL Contains: Active: Atropine sulfate, 10 mg (1%) equivalent to 8.3 mg of atropine. Inactives: benzalkonium chloride 0.1 mg (0.01%), dibasic sodium phosphate heptahydrate, edetate disodium dihydrate, hypromellose (2910), monobasic sodium phosphate monohydrate, hydrochloric acid and/or sodium hydroxide may be added to adjust pH (3.5 to 6. 0), and water for injection USP.</Description>
</NDC>
<NDC>
<NDCCode>70069-716-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (70069-716-01) / 5 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>70069-0716-01</NDC11Code>
<ProductNDC>70069-716</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atropine Sulfate</ProprietaryName>
<NonProprietaryName>Atropine Sulfate Monohydrate</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20240524</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217791</ApplicationNumber>
<LabelerName>Somerset Therapeutics, LLC</LabelerName>
<SubstanceName>ATROPINE SULFATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-05-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240524</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atropine sulfate ophthalmic solution 1% is indicated for.</IndicationAndUsage>
<Description>Atropine sulfate ophthalmic solution, USP 1% is a sterile topical ophthalmic solution. Each mL of atropine sulfate ophthalmic solution, USP 1% contains 10 mg of atropine sulfate monohydrate equivalent to 9.7 mg/mL of atropine sulfate or 8.3 mg of atropine. Atropine sulfate monohydrate is designated chemically as benzeneacetic acid, α-(hydroxymethyl)-,8-methyl-8-aza-bicyclo-[3.2.1]oct-3-yl ester, endo-(+)-, sulfate(2:1) (salt), monohydrate. Its molecular formula is (C17H23NO3)2 H2SO4 H2O and it is represented by the chemical structure. Atropine sulfate monohydrate is colorless, almost white to white solid and has a molecular weight of 694.83. Atropine sulfate ophthalmic solution, USP 1% has a pH of 3.5 to 6.0. Active ingredient: atropine sulfate monohydrate 1%. Preservative: benzalkonium chloride 0.01%. Inactive ingredients: hypromellose, boric acid, sodium hydroxide and/or hydrochloric acid (to adjust pH), water for injection.</Description>
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