{
"NDC": [
{
"NDCCode": "63545-459-04",
"PackageDescription": "10000 PELLET in 1 BOTTLE, GLASS (63545-459-04) ",
"NDC11Code": "63545-0459-04",
"ProductNDC": "63545-459",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Beryllium Metallicum",
"NonProprietaryName": "Beryllium Metallicum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220425",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "BERYLLIUM",
"StrengthNumber": "1",
"StrengthUnit": "[hp_M]/1",
"Status": "Active",
"LastUpdate": "2022-04-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220425",
"SamplePackage": "N"
},
{
"NDCCode": "63545-459-01",
"PackageDescription": "200 PELLET in 1 VIAL, GLASS (63545-459-01) ",
"NDC11Code": "63545-0459-01",
"ProductNDC": "63545-459",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Beryllium Metallicum",
"NonProprietaryName": "Beryllium Metallicum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220425",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "BERYLLIUM",
"StrengthNumber": "1",
"StrengthUnit": "[hp_M]/1",
"Status": "Active",
"LastUpdate": "2022-04-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220425",
"SamplePackage": "N"
},
{
"NDCCode": "63545-459-02",
"PackageDescription": "500 PELLET in 1 VIAL, GLASS (63545-459-02) ",
"NDC11Code": "63545-0459-02",
"ProductNDC": "63545-459",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Beryllium Metallicum",
"NonProprietaryName": "Beryllium Metallicum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220425",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "BERYLLIUM",
"StrengthNumber": "1",
"StrengthUnit": "[hp_M]/1",
"Status": "Active",
"LastUpdate": "2022-04-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220425",
"SamplePackage": "N"
},
{
"NDCCode": "63545-459-03",
"PackageDescription": "3000 PELLET in 1 BOTTLE, GLASS (63545-459-03) ",
"NDC11Code": "63545-0459-03",
"ProductNDC": "63545-459",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Beryllium Metallicum",
"NonProprietaryName": "Beryllium Metallicum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220425",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "BERYLLIUM",
"StrengthNumber": "1",
"StrengthUnit": "[hp_M]/1",
"Status": "Active",
"LastUpdate": "2022-04-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220425",
"SamplePackage": "N"
},
{
"NDCCode": "37000-459-04",
"PackageDescription": "3 CARTON in 1 CARTON (37000-459-04) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK",
"NDC11Code": "37000-0459-04",
"ProductNDC": "37000-459",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Prilosec Otc",
"NonProprietaryName": "Omeprazole Magnesium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120815",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021229",
"LabelerName": "The Procter & Gamble Manufacturing Company",
"SubstanceName": "OMEPRAZOLE MAGNESIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120815",
"SamplePackage": "N",
"IndicationAndUsage": "treats frequent heartburn (occurs 2 or moredays a week) . not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect."
},
{
"NDCCode": "50419-459-04",
"PackageDescription": "4 PATCH in 1 CARTON (50419-459-04) / 7 d in 1 PATCH (50419-459-01) ",
"NDC11Code": "50419-0459-04",
"ProductNDC": "50419-459",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Climara",
"NonProprietaryName": "Estradiol",
"DosageFormName": "PATCH",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20080103",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020375",
"LabelerName": "Bayer HealthCare Pharmaceuticals Inc.",
"SubstanceName": "ESTRADIOL",
"StrengthNumber": ".06",
"StrengthUnit": "mg/d",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20080103",
"SamplePackage": "N",
"IndicationAndUsage": "Climara is indicated for.",
"Description": "Climara (estradiol transdermal system), is designed to release estradiol continuously upon application to intact skin. Six (6.5, 9.375, 12.5, 15, 18.75 and 25 cm2) systems are available to provide nominal in vivo delivery of 0.025, 0.0375, 0.05, 0.06, 0.075 or 0.1 mg respectively of estradiol per day. The period of use is 7 days. Each system has a contact surface area of either 6.5, 9.375, 12.5, 15, 18.75 or 25 cm2, and contains 2, 2.85, 3.8, 4.55, 5.7 or 7.6 mg of estradiol USP respectively. The composition of the systems per unit area is identical. Estradiol USP is a white, crystalline powder, chemically described as estra-1,3,5(10)-triene-3, 17β-diol. It has an empirical formula of C18 H24 O2 and molecular weight of 272.38. The structural formula is. The Climara transdermal system comprises three layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are: 1 A translucent polyethylene film., 2 An acrylate adhesive matrix containing estradiol USP., 3 A protective liner of siliconized or fluoropolymer-coated polyester film is attached to the adhesive surface and must be removed before the system can be used."
},
{
"NDCCode": "63323-459-14",
"PackageDescription": "25 VIAL, MULTI-DOSE in 1 TRAY (63323-459-14) > 4 mL in 1 VIAL, MULTI-DOSE (63323-459-04) ",
"NDC11Code": "63323-0459-14",
"ProductNDC": "63323-459",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Heparin Sodium",
"NonProprietaryName": "Heparin Sodium",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20191104",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017029",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "HEPARIN SODIUM",
"StrengthNumber": "10000",
"StrengthUnit": "[USP'U]/mL",
"Pharm_Classes": "Anti-coagulant [EPC], Heparin [CS], Unfractionated Heparin [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-12-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191104",
"SamplePackage": "N",
"IndicationAndUsage": "Heparin Sodium Injection is indicated for: : 1 Prophylaxis and treatment of venous thrombosis and pulmonary embolism; , 2 Prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease; , 3 Atrial fibrillation with embolization; , 4 Treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation); , 5 Prevention of clotting in arterial and cardiac surgery; , 6 Prophylaxis and treatment of peripheral arterial embolism. , 7 Anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures. .",
"Description": "Heparin is a heterogeneous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans, having anticoagulant properties. Although others may be present, the main sugars occurring in heparin are: (1) α-L-iduronic acid 2-sulfate, (2) 2-deoxy-2-sulfamino-α-D-glucose 6-sulfate, (3) β-D-glucuronic acid, (4) 2-acetamido-2-deoxy-α-D-glucose and (5) α-L-iduronic acid. These sugars are present in decreasing amounts, usually in the order (2)> (1)> (4)> (3)> (5), and are joined by glycosidic linkages, forming polymers of varying sizes. Heparin is strongly acidic because of its content of covalently linked sulfate and carboxylic acid groups. In heparin sodium, the acidic protons of the sulfate units are partially replaced by sodium ions. Heparin Sodium Injection, USP is a sterile solution of heparin sodium derived from porcine intestinal mucosa, standardized for anticoagulant activity, in water for injection. It is to be administered by intravenous or deep subcutaneous routes. The potency is determined by a biological assay using a USP reference standard based on units of heparin activity per milligram. Structure of Heparin Sodium (representative subunits):."
},
{
"NDCCode": "72789-459-04",
"PackageDescription": "4 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-459-04) ",
"NDC11Code": "72789-0459-04",
"ProductNDC": "72789-459",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin And Clavulanate Potassium",
"NonProprietaryName": "Amoxicillin And Clavulanate Potassium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120120",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091568",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "AMOXICILLIN; CLAVULANATE POTASSIUM",
"StrengthNumber": "875; 125",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-10-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20261001",
"SamplePackage": "N"
},
{
"NDCCode": "76420-459-04",
"PackageDescription": "4 TABLET, FILM COATED in 1 BOTTLE (76420-459-04) ",
"NDC11Code": "76420-0459-04",
"ProductNDC": "76420-459",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valacyclovir Hydrochloride",
"NonProprietaryName": "Valacyclovir Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20100524",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090682",
"LabelerName": "ASCLEMED USA INC.",
"SubstanceName": "VALACYCLOVIR HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]",
"Status": "Deprecated",
"LastUpdate": "2026-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250817",
"SamplePackage": "N",
"IndicationAndUsage": "Valacyclovir hydrochloride is a deoxynucleoside analogue DNA polymerase inhibitor indicated for: Adult Patients(1.1): 1 Cold Sores (Herpes Labialis), 2 Genital Herpes Treatment in immunocompetent patients (initial or recurrent episode)Suppression in immunocompetent or HIV-1-infected patientsReduction of transmission, 3 Herpes Zoster .",
"Description": "Valacyclovir hydrochloride is the hydrochloride salt of the L-valyl ester of the antiviral drug acyclovir. Valacyclovir tablets, USP are for oral administration. Each tablet contains 556 mg of valacyclovir hydrochloride USP (hydrous) equivalent to 500 mg of valacyclovir, and the inactive ingredients crospovidone, FD&C blue #2/indigo carmine aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, and titanium dioxide. The chemical name of valacyclovir hydrochloride is L-valine, 2-[(2-amino-1,6-dihydro-6-oxo-9 H-purin-9-yl)methoxy]ethyl ester, monohydrochloride. It has the following structural formula:. Valacyclovir hydrochloride USP (hydrous) is a white or almost white powder with the molecular formula C 13H 20N 6O 4HCl and a molecular weight of 360.80. The maximum solubility in water at 25°C is 174 mg/mL. The pk as for valacyclovir hydrochloride are 1.90, 7.47, and 9.43."
},
{
"NDCCode": "84522-459-04",
"PackageDescription": "50 mL in 1 BOTTLE (84522-459-04) ",
"NDC11Code": "84522-0459-04",
"ProductNDC": "84522-459",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Eye Firming Wrinkle Essence Oil",
"NonProprietaryName": "Eye Firming Wrinkle Essence Oil",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241213",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Yiwu Ziqiu Import Export Co Ltd",
"SubstanceName": "NIACINAMIDE",
"StrengthNumber": "5",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20241213",
"SamplePackage": "N",
"IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
},
{
"NDCCode": "84756-459-04",
"PackageDescription": "50 g in 1 BOX (84756-459-04) ",
"NDC11Code": "84756-0459-04",
"ProductNDC": "84756-459",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anti Aging Cream",
"NonProprietaryName": "Anti Aging Cream",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241126",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Yiwu Luoxin E �Commerce Co Ltd",
"SubstanceName": "NIACINAMIDE",
"StrengthNumber": "5",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20241126",
"SamplePackage": "N",
"IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
},
{
"NDCCode": "0093-0308-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (0093-0308-01) ",
"NDC11Code": "00093-0308-01",
"ProductNDC": "0093-0308",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clemastine Fumarate",
"NonProprietaryName": "Clemastine Fumarate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19920401",
"EndMarketingDate": "20260331",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA073283",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "CLEMASTINE FUMARATE",
"StrengthNumber": "2.68",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2026-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19920401",
"EndMarketingDatePackage": "20260331",
"SamplePackage": "N",
"IndicationAndUsage": "Clemastine Fumarate Tablets USP, 2.68 mg are indicated for the relief of symptoms associated with allergic rhinitis such as sneezing, rhinorrhea, pruritus, and lacrimation. Clemastine Fumarate Tablets USP, 2.68 mg are also indicated for the relief of mild, uncomplicated allergic skin manifestations of urticaria and angioedema. It should be noted that clemastine fumarate is indicated for the dermatologic indications at the 2.68 mg dosage level only.",
"Description": "Clemastine belongs to the benzhydryl ether group of antihistaminic compounds. The chemical name is (+)-(2R)-2-[2-[[(R)-p-Chloro-α-methyl-α-phenylbenzyl]-oxy]ethyl]-1-methylpyrrolidine fumarate (1:1). C21H26C1NO.C4H4O4 M.W. 459.97. Each tablet for oral administration contains 2.68 mg of clemastine fumarate, USP. Inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, povidone, pregelatinized starch and stearic acid."
},
{
"NDCCode": "0115-1721-01",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (0115-1721-01) / 10 TABLET, FILM COATED in 1 BLISTER PACK (0115-1721-15) ",
"NDC11Code": "00115-1721-01",
"ProductNDC": "0115-1721",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Apixaban",
"NonProprietaryName": "Apixaban",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209810",
"LabelerName": "Amneal Pharmaceuticals of New York LLC",
"SubstanceName": "APIXABAN",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-02-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180831",
"SamplePackage": "N",
"IndicationAndUsage": "Apixaban tablets are a factor Xa inhibitor indicated: 1 to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. (1.1), 2 for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery. (1.2), 3 for the treatment of DVT and PE, and for the reduction in the risk of recurrent DVT and PE following initial therapy. (1.3, 1.4, 1.5).",
"Description": "Apixaban, a factor Xa (FXa) inhibitor, is chemically described as 1-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxamide. Its molecular formula is C25H25N5O4, which corresponds to a molecular weight of 459.5. Apixaban has the following structural formula. Apixaban is a white to pale-yellow powder. At physiological pH (1.2–6.8), apixaban does not ionize; its aqueous solubility across the physiological pH range is ~0.04 mg/mL. Apixaban tablets are available for oral administration in strengths of 2.5 mg and 5 mg of apixaban with the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, and magnesium stearate. The film coating contains hypromellose, lactose monohydrate, titanium dioxide, triacetin, and iron oxide yellow (2.5 mg tablets) or iron oxide red (5 mg tablets)."
},
{
"NDCCode": "0115-1721-03",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0115-1721-03) ",
"NDC11Code": "00115-1721-03",
"ProductNDC": "0115-1721",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Apixaban",
"NonProprietaryName": "Apixaban",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209810",
"LabelerName": "Amneal Pharmaceuticals of New York LLC",
"SubstanceName": "APIXABAN",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-02-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180831",
"SamplePackage": "N",
"IndicationAndUsage": "Apixaban tablets are a factor Xa inhibitor indicated: 1 to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. (1.1), 2 for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery. (1.2), 3 for the treatment of DVT and PE, and for the reduction in the risk of recurrent DVT and PE following initial therapy. (1.3, 1.4, 1.5).",
"Description": "Apixaban, a factor Xa (FXa) inhibitor, is chemically described as 1-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxamide. Its molecular formula is C25H25N5O4, which corresponds to a molecular weight of 459.5. Apixaban has the following structural formula. Apixaban is a white to pale-yellow powder. At physiological pH (1.2–6.8), apixaban does not ionize; its aqueous solubility across the physiological pH range is ~0.04 mg/mL. Apixaban tablets are available for oral administration in strengths of 2.5 mg and 5 mg of apixaban with the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, and magnesium stearate. The film coating contains hypromellose, lactose monohydrate, titanium dioxide, triacetin, and iron oxide yellow (2.5 mg tablets) or iron oxide red (5 mg tablets)."
},
{
"NDCCode": "0115-1721-13",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0115-1721-13) ",
"NDC11Code": "00115-1721-13",
"ProductNDC": "0115-1721",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Apixaban",
"NonProprietaryName": "Apixaban",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209810",
"LabelerName": "Amneal Pharmaceuticals of New York LLC",
"SubstanceName": "APIXABAN",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-02-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180831",
"SamplePackage": "N",
"IndicationAndUsage": "Apixaban tablets are a factor Xa inhibitor indicated: 1 to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. (1.1), 2 for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery. (1.2), 3 for the treatment of DVT and PE, and for the reduction in the risk of recurrent DVT and PE following initial therapy. (1.3, 1.4, 1.5).",
"Description": "Apixaban, a factor Xa (FXa) inhibitor, is chemically described as 1-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxamide. Its molecular formula is C25H25N5O4, which corresponds to a molecular weight of 459.5. Apixaban has the following structural formula. Apixaban is a white to pale-yellow powder. At physiological pH (1.2–6.8), apixaban does not ionize; its aqueous solubility across the physiological pH range is ~0.04 mg/mL. Apixaban tablets are available for oral administration in strengths of 2.5 mg and 5 mg of apixaban with the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, and magnesium stearate. The film coating contains hypromellose, lactose monohydrate, titanium dioxide, triacetin, and iron oxide yellow (2.5 mg tablets) or iron oxide red (5 mg tablets)."
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"Description": "Apixaban, a factor Xa (FXa) inhibitor, is chemically described as 1-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxamide. Its molecular formula is C25H25N5O4, which corresponds to a molecular weight of 459.5. Apixaban has the following structural formula. Apixaban is a white to pale-yellow powder. At physiological pH (1.2–6.8), apixaban does not ionize; its aqueous solubility across the physiological pH range is ~0.04 mg/mL. Apixaban tablets are available for oral administration in strengths of 2.5 mg and 5 mg of apixaban with the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, and magnesium stearate. The film coating contains hypromellose, lactose monohydrate, titanium dioxide, triacetin, and iron oxide yellow (2.5 mg tablets) or iron oxide red (5 mg tablets)."
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"Description": "Apixaban, a factor Xa (FXa) inhibitor, is chemically described as 1-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxamide. Its molecular formula is C25H25N5O4, which corresponds to a molecular weight of 459.5. Apixaban has the following structural formula. Apixaban is a white to pale-yellow powder. At physiological pH (1.2–6.8), apixaban does not ionize; its aqueous solubility across the physiological pH range is ~0.04 mg/mL. Apixaban tablets are available for oral administration in strengths of 2.5 mg and 5 mg of apixaban with the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, and magnesium stearate. The film coating contains hypromellose, lactose monohydrate, titanium dioxide, triacetin, and iron oxide yellow (2.5 mg tablets) or iron oxide red (5 mg tablets)."
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"Description": "Apixaban, a factor Xa (FXa) inhibitor, is chemically described as 1-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxamide. Its molecular formula is C25H25N5O4, which corresponds to a molecular weight of 459.5. Apixaban has the following structural formula. Apixaban is a white to pale-yellow powder. At physiological pH (1.2–6.8), apixaban does not ionize; its aqueous solubility across the physiological pH range is ~0.04 mg/mL. Apixaban tablets are available for oral administration in strengths of 2.5 mg and 5 mg of apixaban with the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, and magnesium stearate. The film coating contains hypromellose, lactose monohydrate, titanium dioxide, triacetin, and iron oxide yellow (2.5 mg tablets) or iron oxide red (5 mg tablets)."
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"Description": "Apixaban, a factor Xa (FXa) inhibitor, is chemically described as 1-(4- methoxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-4,5,6,7-tetrahydro-1H-pyrazolo[3,4 c]pyridine-3-carboxamide. Its molecular formula is C25H25N5O4, which corresponds to a molecular weight of 459.5. Apixaban has the following structural formula. Apixaban is a white to off white crystalline powder. At physiological pH (1.2 - 6.8), apixaban does not ionize; its aqueous solubility across the physiological pH range is ~0.04 mg/mL. Apixaban tablets are available for oral administration in strengths of 2.5 mg and 5 mg of apixaban with the following inactive ingredients: anhydrous lactose, microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, and magnesium stearate. The film coating contains lactose monohydrate, hypromellose, titanium dioxide, triacetin, and yellow iron oxide (2.5 mg tablets) or red iron oxide (5 mg tablets)."
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"Description": "Apixaban, a factor Xa (FXa) inhibitor, is chemically described as 1-(4- methoxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-4,5,6,7-tetrahydro-1H-pyrazolo[3,4 c]pyridine-3-carboxamide. Its molecular formula is C25H25N5O4, which corresponds to a molecular weight of 459.5. Apixaban has the following structural formula. Apixaban is a white to off white crystalline powder. At physiological pH (1.2 - 6.8), apixaban does not ionize; its aqueous solubility across the physiological pH range is ~0.04 mg/mL. Apixaban tablets are available for oral administration in strengths of 2.5 mg and 5 mg of apixaban with the following inactive ingredients: anhydrous lactose, microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, and magnesium stearate. The film coating contains lactose monohydrate, hypromellose, titanium dioxide, triacetin, and yellow iron oxide (2.5 mg tablets) or red iron oxide (5 mg tablets)."
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"Description": "Apixaban, a factor Xa (FXa) inhibitor, is chemically described as 1-(4- methoxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-4,5,6,7-tetrahydro-1H-pyrazolo[3,4 c]pyridine-3-carboxamide. Its molecular formula is C25H25N5O4, which corresponds to a molecular weight of 459.5. Apixaban has the following structural formula. Apixaban is a white to off white crystalline powder. At physiological pH (1.2 - 6.8), apixaban does not ionize; its aqueous solubility across the physiological pH range is ~0.04 mg/mL. Apixaban tablets are available for oral administration in strengths of 2.5 mg and 5 mg of apixaban with the following inactive ingredients: anhydrous lactose, microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, and magnesium stearate. The film coating contains lactose monohydrate, hypromellose, titanium dioxide, triacetin, and yellow iron oxide (2.5 mg tablets) or red iron oxide (5 mg tablets)."
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"Description": "Apixaban, a factor Xa (FXa) inhibitor, is chemically described as 1-(4- methoxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-4,5,6,7-tetrahydro-1H-pyrazolo[3,4 c]pyridine-3-carboxamide. Its molecular formula is C25H25N5O4, which corresponds to a molecular weight of 459.5. Apixaban has the following structural formula. Apixaban is a white to off white crystalline powder. At physiological pH (1.2 - 6.8), apixaban does not ionize; its aqueous solubility across the physiological pH range is ~0.04 mg/mL. Apixaban tablets are available for oral administration in strengths of 2.5 mg and 5 mg of apixaban with the following inactive ingredients: anhydrous lactose, microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, and magnesium stearate. The film coating contains lactose monohydrate, hypromellose, titanium dioxide, triacetin, and yellow iron oxide (2.5 mg tablets) or red iron oxide (5 mg tablets)."
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"Description": "Apixaban, a factor Xa (FXa) inhibitor, is chemically described as 1-(4- methoxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-4,5,6,7-tetrahydro-1H-pyrazolo[3,4 c]pyridine-3-carboxamide. Its molecular formula is C25H25N5O4, which corresponds to a molecular weight of 459.5. Apixaban has the following structural formula. Apixaban is a white to off white crystalline powder. At physiological pH (1.2 - 6.8), apixaban does not ionize; its aqueous solubility across the physiological pH range is ~0.04 mg/mL. Apixaban tablets are available for oral administration in strengths of 2.5 mg and 5 mg of apixaban with the following inactive ingredients: anhydrous lactose, microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, and magnesium stearate. The film coating contains lactose monohydrate, hypromellose, titanium dioxide, triacetin, and yellow iron oxide (2.5 mg tablets) or red iron oxide (5 mg tablets)."
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"IndicationAndUsage": "Apixaban is a factor Xa inhibitor indicated:.",
"Description": "Apixaban, a factor Xa (FXa) inhibitor, is chemically described as 1-(4- methoxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-4,5,6,7-tetrahydro-1H-pyrazolo[3,4 c]pyridine-3-carboxamide. Its molecular formula is C25H25N5O4, which corresponds to a molecular weight of 459.5. Apixaban has the following structural formula. Apixaban is a white to off white crystalline powder. At physiological pH (1.2 - 6.8), apixaban does not ionize; its aqueous solubility across the physiological pH range is ~0.04 mg/mL. Apixaban tablets are available for oral administration in strengths of 2.5 mg and 5 mg of apixaban with the following inactive ingredients: anhydrous lactose, microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, and magnesium stearate. The film coating contains lactose monohydrate, hypromellose, titanium dioxide, triacetin, and yellow iron oxide (2.5 mg tablets) or red iron oxide (5 mg tablets)."
},
{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"RouteName": "ORAL",
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"MarketingCategoryName": "ANDA",
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"LabelerName": "Indoco Remedies Limited",
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"IndicationAndUsage": "Apixaban is a factor Xa inhibitor indicated:.",
"Description": "Apixaban, a factor Xa (FXa) inhibitor, is chemically described as 1-(4- methoxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-4,5,6,7-tetrahydro-1H-pyrazolo[3,4 c]pyridine-3-carboxamide. Its molecular formula is C25H25N5O4, which corresponds to a molecular weight of 459.5. Apixaban has the following structural formula. Apixaban is a white to off white crystalline powder. At physiological pH (1.2 - 6.8), apixaban does not ionize; its aqueous solubility across the physiological pH range is ~0.04 mg/mL. Apixaban tablets are available for oral administration in strengths of 2.5 mg and 5 mg of apixaban with the following inactive ingredients: anhydrous lactose, microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, and magnesium stearate. The film coating contains lactose monohydrate, hypromellose, titanium dioxide, triacetin, and yellow iron oxide (2.5 mg tablets) or red iron oxide (5 mg tablets)."
},
{
"NDCCode": "14445-150-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (14445-150-60) ",
"NDC11Code": "14445-0150-60",
"ProductNDC": "14445-150",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Apixaban",
"NonProprietaryName": "Apixaban",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200916",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209898",
"LabelerName": "Indoco Remedies Limited",
"SubstanceName": "APIXABAN",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2021-06-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200916",
"SamplePackage": "N",
"IndicationAndUsage": "Apixaban is a factor Xa inhibitor indicated:.",
"Description": "Apixaban, a factor Xa (FXa) inhibitor, is chemically described as 1-(4- methoxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-4,5,6,7-tetrahydro-1H-pyrazolo[3,4 c]pyridine-3-carboxamide. Its molecular formula is C25H25N5O4, which corresponds to a molecular weight of 459.5. Apixaban has the following structural formula. Apixaban is a white to off white crystalline powder. At physiological pH (1.2 - 6.8), apixaban does not ionize; its aqueous solubility across the physiological pH range is ~0.04 mg/mL. Apixaban tablets are available for oral administration in strengths of 2.5 mg and 5 mg of apixaban with the following inactive ingredients: anhydrous lactose, microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, and magnesium stearate. The film coating contains lactose monohydrate, hypromellose, titanium dioxide, triacetin, and yellow iron oxide (2.5 mg tablets) or red iron oxide (5 mg tablets)."
}
]
}
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<NDC>
<NDCCode>63545-459-04</NDCCode>
<PackageDescription>10000 PELLET in 1 BOTTLE, GLASS (63545-459-04) </PackageDescription>
<NDC11Code>63545-0459-04</NDC11Code>
<ProductNDC>63545-459</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Beryllium Metallicum</ProprietaryName>
<NonProprietaryName>Beryllium Metallicum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220425</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>BERYLLIUM</SubstanceName>
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<StrengthUnit>[hp_M]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-04-27</LastUpdate>
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<PackageDescription>200 PELLET in 1 VIAL, GLASS (63545-459-01) </PackageDescription>
<NDC11Code>63545-0459-01</NDC11Code>
<ProductNDC>63545-459</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Beryllium Metallicum</ProprietaryName>
<NonProprietaryName>Beryllium Metallicum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220425</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>BERYLLIUM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_M]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-04-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220425</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDCCode>63545-459-02</NDCCode>
<PackageDescription>500 PELLET in 1 VIAL, GLASS (63545-459-02) </PackageDescription>
<NDC11Code>63545-0459-02</NDC11Code>
<ProductNDC>63545-459</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Beryllium Metallicum</ProprietaryName>
<NonProprietaryName>Beryllium Metallicum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220425</StartMarketingDate>
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<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>BERYLLIUM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_M]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-04-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<NDC>
<NDCCode>63545-459-03</NDCCode>
<PackageDescription>3000 PELLET in 1 BOTTLE, GLASS (63545-459-03) </PackageDescription>
<NDC11Code>63545-0459-03</NDC11Code>
<ProductNDC>63545-459</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Beryllium Metallicum</ProprietaryName>
<NonProprietaryName>Beryllium Metallicum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220425</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>BERYLLIUM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_M]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-04-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220425</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>37000-459-04</NDCCode>
<PackageDescription>3 CARTON in 1 CARTON (37000-459-04) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>37000-0459-04</NDC11Code>
<ProductNDC>37000-459</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Prilosec Otc</ProprietaryName>
<NonProprietaryName>Omeprazole Magnesium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120815</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021229</ApplicationNumber>
<LabelerName>The Procter & Gamble Manufacturing Company</LabelerName>
<SubstanceName>OMEPRAZOLE MAGNESIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>treats frequent heartburn (occurs 2 or moredays a week) . not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50419-459-04</NDCCode>
<PackageDescription>4 PATCH in 1 CARTON (50419-459-04) / 7 d in 1 PATCH (50419-459-01) </PackageDescription>
<NDC11Code>50419-0459-04</NDC11Code>
<ProductNDC>50419-459</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Climara</ProprietaryName>
<NonProprietaryName>Estradiol</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20080103</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020375</ApplicationNumber>
<LabelerName>Bayer HealthCare Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ESTRADIOL</SubstanceName>
<StrengthNumber>.06</StrengthNumber>
<StrengthUnit>mg/d</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080103</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Climara is indicated for.</IndicationAndUsage>
<Description>Climara (estradiol transdermal system), is designed to release estradiol continuously upon application to intact skin. Six (6.5, 9.375, 12.5, 15, 18.75 and 25 cm2) systems are available to provide nominal in vivo delivery of 0.025, 0.0375, 0.05, 0.06, 0.075 or 0.1 mg respectively of estradiol per day. The period of use is 7 days. Each system has a contact surface area of either 6.5, 9.375, 12.5, 15, 18.75 or 25 cm2, and contains 2, 2.85, 3.8, 4.55, 5.7 or 7.6 mg of estradiol USP respectively. The composition of the systems per unit area is identical. Estradiol USP is a white, crystalline powder, chemically described as estra-1,3,5(10)-triene-3, 17β-diol. It has an empirical formula of C18 H24 O2 and molecular weight of 272.38. The structural formula is. The Climara transdermal system comprises three layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are: 1 A translucent polyethylene film., 2 An acrylate adhesive matrix containing estradiol USP., 3 A protective liner of siliconized or fluoropolymer-coated polyester film is attached to the adhesive surface and must be removed before the system can be used.</Description>
</NDC>
<NDC>
<NDCCode>63323-459-14</NDCCode>
<PackageDescription>25 VIAL, MULTI-DOSE in 1 TRAY (63323-459-14) > 4 mL in 1 VIAL, MULTI-DOSE (63323-459-04) </PackageDescription>
<NDC11Code>63323-0459-14</NDC11Code>
<ProductNDC>63323-459</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Heparin Sodium</ProprietaryName>
<NonProprietaryName>Heparin Sodium</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20191104</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017029</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>HEPARIN SODIUM</SubstanceName>
<StrengthNumber>10000</StrengthNumber>
<StrengthUnit>[USP'U]/mL</StrengthUnit>
<Pharm_Classes>Anti-coagulant [EPC], Heparin [CS], Unfractionated Heparin [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Heparin Sodium Injection is indicated for: : 1 Prophylaxis and treatment of venous thrombosis and pulmonary embolism; , 2 Prevention of postoperative deep venous thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease; , 3 Atrial fibrillation with embolization; , 4 Treatment of acute and chronic consumptive coagulopathies (disseminated intravascular coagulation); , 5 Prevention of clotting in arterial and cardiac surgery; , 6 Prophylaxis and treatment of peripheral arterial embolism. , 7 Anticoagulant use in blood transfusions, extracorporeal circulation, and dialysis procedures. .</IndicationAndUsage>
<Description>Heparin is a heterogeneous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans, having anticoagulant properties. Although others may be present, the main sugars occurring in heparin are: (1) α-L-iduronic acid 2-sulfate, (2) 2-deoxy-2-sulfamino-α-D-glucose 6-sulfate, (3) β-D-glucuronic acid, (4) 2-acetamido-2-deoxy-α-D-glucose and (5) α-L-iduronic acid. These sugars are present in decreasing amounts, usually in the order (2)> (1)> (4)> (3)> (5), and are joined by glycosidic linkages, forming polymers of varying sizes. Heparin is strongly acidic because of its content of covalently linked sulfate and carboxylic acid groups. In heparin sodium, the acidic protons of the sulfate units are partially replaced by sodium ions. Heparin Sodium Injection, USP is a sterile solution of heparin sodium derived from porcine intestinal mucosa, standardized for anticoagulant activity, in water for injection. It is to be administered by intravenous or deep subcutaneous routes. The potency is determined by a biological assay using a USP reference standard based on units of heparin activity per milligram. Structure of Heparin Sodium (representative subunits):.</Description>
</NDC>
<NDC>
<NDCCode>72789-459-04</NDCCode>
<PackageDescription>4 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-459-04) </PackageDescription>
<NDC11Code>72789-0459-04</NDC11Code>
<ProductNDC>72789-459</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin And Clavulanate Potassium</ProprietaryName>
<NonProprietaryName>Amoxicillin And Clavulanate Potassium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120120</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091568</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>AMOXICILLIN; CLAVULANATE POTASSIUM</SubstanceName>
<StrengthNumber>875; 125</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20261001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>76420-459-04</NDCCode>
<PackageDescription>4 TABLET, FILM COATED in 1 BOTTLE (76420-459-04) </PackageDescription>
<NDC11Code>76420-0459-04</NDC11Code>
<ProductNDC>76420-459</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valacyclovir Hydrochloride</ProprietaryName>
<NonProprietaryName>Valacyclovir Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100524</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090682</ApplicationNumber>
<LabelerName>ASCLEMED USA INC.</LabelerName>
<SubstanceName>VALACYCLOVIR HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250817</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Valacyclovir hydrochloride is a deoxynucleoside analogue DNA polymerase inhibitor indicated for: Adult Patients(1.1): 1 Cold Sores (Herpes Labialis), 2 Genital Herpes Treatment in immunocompetent patients (initial or recurrent episode)Suppression in immunocompetent or HIV-1-infected patientsReduction of transmission, 3 Herpes Zoster .</IndicationAndUsage>
<Description>Valacyclovir hydrochloride is the hydrochloride salt of the L-valyl ester of the antiviral drug acyclovir. Valacyclovir tablets, USP are for oral administration. Each tablet contains 556 mg of valacyclovir hydrochloride USP (hydrous) equivalent to 500 mg of valacyclovir, and the inactive ingredients crospovidone, FD&C blue #2/indigo carmine aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, and titanium dioxide. The chemical name of valacyclovir hydrochloride is L-valine, 2-[(2-amino-1,6-dihydro-6-oxo-9 H-purin-9-yl)methoxy]ethyl ester, monohydrochloride. It has the following structural formula:. Valacyclovir hydrochloride USP (hydrous) is a white or almost white powder with the molecular formula C 13H 20N 6O 4HCl and a molecular weight of 360.80. The maximum solubility in water at 25°C is 174 mg/mL. The pk as for valacyclovir hydrochloride are 1.90, 7.47, and 9.43.</Description>
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<NDCCode>84522-459-04</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE (84522-459-04) </PackageDescription>
<NDC11Code>84522-0459-04</NDC11Code>
<ProductNDC>84522-459</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Eye Firming Wrinkle Essence Oil</ProprietaryName>
<NonProprietaryName>Eye Firming Wrinkle Essence Oil</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241213</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Yiwu Ziqiu Import Export Co Ltd</LabelerName>
<SubstanceName>NIACINAMIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241213</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>84756-459-04</NDCCode>
<PackageDescription>50 g in 1 BOX (84756-459-04) </PackageDescription>
<NDC11Code>84756-0459-04</NDC11Code>
<ProductNDC>84756-459</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti Aging Cream</ProprietaryName>
<NonProprietaryName>Anti Aging Cream</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241126</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Yiwu Luoxin E �Commerce Co Ltd</LabelerName>
<SubstanceName>NIACINAMIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241126</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0093-0308-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0093-0308-01) </PackageDescription>
<NDC11Code>00093-0308-01</NDC11Code>
<ProductNDC>0093-0308</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clemastine Fumarate</ProprietaryName>
<NonProprietaryName>Clemastine Fumarate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19920401</StartMarketingDate>
<EndMarketingDate>20260331</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA073283</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>CLEMASTINE FUMARATE</SubstanceName>
<StrengthNumber>2.68</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19920401</StartMarketingDatePackage>
<EndMarketingDatePackage>20260331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clemastine Fumarate Tablets USP, 2.68 mg are indicated for the relief of symptoms associated with allergic rhinitis such as sneezing, rhinorrhea, pruritus, and lacrimation. Clemastine Fumarate Tablets USP, 2.68 mg are also indicated for the relief of mild, uncomplicated allergic skin manifestations of urticaria and angioedema. It should be noted that clemastine fumarate is indicated for the dermatologic indications at the 2.68 mg dosage level only.</IndicationAndUsage>
<Description>Clemastine belongs to the benzhydryl ether group of antihistaminic compounds. The chemical name is (+)-(2R)-2-[2-[[(R)-p-Chloro-α-methyl-α-phenylbenzyl]-oxy]ethyl]-1-methylpyrrolidine fumarate (1:1). C21H26C1NO.C4H4O4 M.W. 459.97. Each tablet for oral administration contains 2.68 mg of clemastine fumarate, USP. Inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, povidone, pregelatinized starch and stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>0115-1721-01</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (0115-1721-01) / 10 TABLET, FILM COATED in 1 BLISTER PACK (0115-1721-15) </PackageDescription>
<NDC11Code>00115-1721-01</NDC11Code>
<ProductNDC>0115-1721</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Apixaban</ProprietaryName>
<NonProprietaryName>Apixaban</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180831</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209810</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
<SubstanceName>APIXABAN</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180831</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apixaban tablets are a factor Xa inhibitor indicated: 1 to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. (1.1), 2 for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery. (1.2), 3 for the treatment of DVT and PE, and for the reduction in the risk of recurrent DVT and PE following initial therapy. (1.3, 1.4, 1.5).</IndicationAndUsage>
<Description>Apixaban, a factor Xa (FXa) inhibitor, is chemically described as 1-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxamide. Its molecular formula is C25H25N5O4, which corresponds to a molecular weight of 459.5. Apixaban has the following structural formula. Apixaban is a white to pale-yellow powder. At physiological pH (1.2–6.8), apixaban does not ionize; its aqueous solubility across the physiological pH range is ~0.04 mg/mL. Apixaban tablets are available for oral administration in strengths of 2.5 mg and 5 mg of apixaban with the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, and magnesium stearate. The film coating contains hypromellose, lactose monohydrate, titanium dioxide, triacetin, and iron oxide yellow (2.5 mg tablets) or iron oxide red (5 mg tablets).</Description>
</NDC>
<NDC>
<NDCCode>0115-1721-03</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0115-1721-03) </PackageDescription>
<NDC11Code>00115-1721-03</NDC11Code>
<ProductNDC>0115-1721</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Apixaban</ProprietaryName>
<NonProprietaryName>Apixaban</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180831</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209810</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
<SubstanceName>APIXABAN</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180831</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apixaban tablets are a factor Xa inhibitor indicated: 1 to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. (1.1), 2 for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery. (1.2), 3 for the treatment of DVT and PE, and for the reduction in the risk of recurrent DVT and PE following initial therapy. (1.3, 1.4, 1.5).</IndicationAndUsage>
<Description>Apixaban, a factor Xa (FXa) inhibitor, is chemically described as 1-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxamide. Its molecular formula is C25H25N5O4, which corresponds to a molecular weight of 459.5. Apixaban has the following structural formula. Apixaban is a white to pale-yellow powder. At physiological pH (1.2–6.8), apixaban does not ionize; its aqueous solubility across the physiological pH range is ~0.04 mg/mL. Apixaban tablets are available for oral administration in strengths of 2.5 mg and 5 mg of apixaban with the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, and magnesium stearate. The film coating contains hypromellose, lactose monohydrate, titanium dioxide, triacetin, and iron oxide yellow (2.5 mg tablets) or iron oxide red (5 mg tablets).</Description>
</NDC>
<NDC>
<NDCCode>0115-1721-13</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0115-1721-13) </PackageDescription>
<NDC11Code>00115-1721-13</NDC11Code>
<ProductNDC>0115-1721</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Apixaban</ProprietaryName>
<NonProprietaryName>Apixaban</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180831</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209810</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
<SubstanceName>APIXABAN</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180831</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apixaban tablets are a factor Xa inhibitor indicated: 1 to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. (1.1), 2 for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery. (1.2), 3 for the treatment of DVT and PE, and for the reduction in the risk of recurrent DVT and PE following initial therapy. (1.3, 1.4, 1.5).</IndicationAndUsage>
<Description>Apixaban, a factor Xa (FXa) inhibitor, is chemically described as 1-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxamide. Its molecular formula is C25H25N5O4, which corresponds to a molecular weight of 459.5. Apixaban has the following structural formula. Apixaban is a white to pale-yellow powder. At physiological pH (1.2–6.8), apixaban does not ionize; its aqueous solubility across the physiological pH range is ~0.04 mg/mL. Apixaban tablets are available for oral administration in strengths of 2.5 mg and 5 mg of apixaban with the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, and magnesium stearate. The film coating contains hypromellose, lactose monohydrate, titanium dioxide, triacetin, and iron oxide yellow (2.5 mg tablets) or iron oxide red (5 mg tablets).</Description>
</NDC>
<NDC>
<NDCCode>0115-1722-01</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (0115-1722-01) / 10 TABLET, FILM COATED in 1 BLISTER PACK (0115-1722-15) </PackageDescription>
<NDC11Code>00115-1722-01</NDC11Code>
<ProductNDC>0115-1722</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Apixaban</ProprietaryName>
<NonProprietaryName>Apixaban</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180831</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209810</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
<SubstanceName>APIXABAN</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180831</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apixaban tablets are a factor Xa inhibitor indicated: 1 to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. (1.1), 2 for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery. (1.2), 3 for the treatment of DVT and PE, and for the reduction in the risk of recurrent DVT and PE following initial therapy. (1.3, 1.4, 1.5).</IndicationAndUsage>
<Description>Apixaban, a factor Xa (FXa) inhibitor, is chemically described as 1-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxamide. Its molecular formula is C25H25N5O4, which corresponds to a molecular weight of 459.5. Apixaban has the following structural formula. Apixaban is a white to pale-yellow powder. At physiological pH (1.2–6.8), apixaban does not ionize; its aqueous solubility across the physiological pH range is ~0.04 mg/mL. Apixaban tablets are available for oral administration in strengths of 2.5 mg and 5 mg of apixaban with the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, and magnesium stearate. The film coating contains hypromellose, lactose monohydrate, titanium dioxide, triacetin, and iron oxide yellow (2.5 mg tablets) or iron oxide red (5 mg tablets).</Description>
</NDC>
<NDC>
<NDCCode>0115-1722-03</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0115-1722-03) </PackageDescription>
<NDC11Code>00115-1722-03</NDC11Code>
<ProductNDC>0115-1722</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Apixaban</ProprietaryName>
<NonProprietaryName>Apixaban</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180831</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209810</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
<SubstanceName>APIXABAN</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180831</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apixaban tablets are a factor Xa inhibitor indicated: 1 to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. (1.1), 2 for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery. (1.2), 3 for the treatment of DVT and PE, and for the reduction in the risk of recurrent DVT and PE following initial therapy. (1.3, 1.4, 1.5).</IndicationAndUsage>
<Description>Apixaban, a factor Xa (FXa) inhibitor, is chemically described as 1-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxamide. Its molecular formula is C25H25N5O4, which corresponds to a molecular weight of 459.5. Apixaban has the following structural formula. Apixaban is a white to pale-yellow powder. At physiological pH (1.2–6.8), apixaban does not ionize; its aqueous solubility across the physiological pH range is ~0.04 mg/mL. Apixaban tablets are available for oral administration in strengths of 2.5 mg and 5 mg of apixaban with the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, and magnesium stearate. The film coating contains hypromellose, lactose monohydrate, titanium dioxide, triacetin, and iron oxide yellow (2.5 mg tablets) or iron oxide red (5 mg tablets).</Description>
</NDC>
<NDC>
<NDCCode>0115-1722-13</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0115-1722-13) </PackageDescription>
<NDC11Code>00115-1722-13</NDC11Code>
<ProductNDC>0115-1722</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Apixaban</ProprietaryName>
<NonProprietaryName>Apixaban</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180831</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209810</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
<SubstanceName>APIXABAN</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180831</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apixaban tablets are a factor Xa inhibitor indicated: 1 to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. (1.1), 2 for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery. (1.2), 3 for the treatment of DVT and PE, and for the reduction in the risk of recurrent DVT and PE following initial therapy. (1.3, 1.4, 1.5).</IndicationAndUsage>
<Description>Apixaban, a factor Xa (FXa) inhibitor, is chemically described as 1-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxamide. Its molecular formula is C25H25N5O4, which corresponds to a molecular weight of 459.5. Apixaban has the following structural formula. Apixaban is a white to pale-yellow powder. At physiological pH (1.2–6.8), apixaban does not ionize; its aqueous solubility across the physiological pH range is ~0.04 mg/mL. Apixaban tablets are available for oral administration in strengths of 2.5 mg and 5 mg of apixaban with the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, and magnesium stearate. The film coating contains hypromellose, lactose monohydrate, titanium dioxide, triacetin, and iron oxide yellow (2.5 mg tablets) or iron oxide red (5 mg tablets).</Description>
</NDC>
<NDC>
<NDCCode>0869-0012-26</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0869-0012-26) > 113 g in 1 TUBE</PackageDescription>
<NDC11Code>00869-0012-26</NDC11Code>
<ProductNDC>0869-0012</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Vitamin A D</ProprietaryName>
<NonProprietaryName>Lanolin, Petrolatum</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL; TOPICAL</RouteName>
<StartMarketingDate>20130701</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>Vi-Jon</LabelerName>
<SubstanceName>LANOLIN; PETROLATUM</SubstanceName>
<StrengthNumber>133; 459</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170414</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps treat and prevent diaper rash. temporarily protects minor: cuts - scrapes - burns. temporarily protects and helps relieve chafed, chapped or cracked skin and lips. helps protect from the drying effects of wind and cold weather.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10812-459-01</NDCCode>
<PackageDescription>1 APPLICATOR in 1 BLISTER PACK (10812-459-01) > 4.9 g in 1 APPLICATOR</PackageDescription>
<NDC11Code>10812-0459-01</NDC11Code>
<ProductNDC>10812-459</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Neutrogena Healthy Skin Brightening Eye Perfector</ProprietaryName>
<ProprietaryNameSuffix>Sunscreen Broad Spectrum Spf25 - Buff 09</ProprietaryNameSuffix>
<NonProprietaryName>Titanium Dioxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130524</StartMarketingDate>
<EndMarketingDate>20181201</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Johnson & Johnson Consumer Inc.</LabelerName>
<SubstanceName>TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>18.8</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-12-04</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
</NDC>
<NDC>
<NDCCode>11054-004-18</NDCCode>
<PackageDescription>459 L in 1 CYLINDER (11054-004-18) </PackageDescription>
<NDC11Code>11054-0004-18</NDC11Code>
<ProductNDC>11054-004</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Helium</ProprietaryName>
<NonProprietaryName>Helium</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>INTRACORONARY; RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19971106</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205843</ApplicationNumber>
<LabelerName>AIRGAS USA, LLC</LabelerName>
<SubstanceName>HELIUM</SubstanceName>
<StrengthNumber>992</StrengthNumber>
<StrengthUnit>mL/L</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-09-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19971106</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>14445-149-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (14445-149-05) </PackageDescription>
<NDC11Code>14445-0149-05</NDC11Code>
<ProductNDC>14445-149</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Apixaban</ProprietaryName>
<NonProprietaryName>Apixaban</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200916</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209898</ApplicationNumber>
<LabelerName>Indoco Remedies Limited</LabelerName>
<SubstanceName>APIXABAN</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-06-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200916</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apixaban is a factor Xa inhibitor indicated:.</IndicationAndUsage>
<Description>Apixaban, a factor Xa (FXa) inhibitor, is chemically described as 1-(4- methoxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-4,5,6,7-tetrahydro-1H-pyrazolo[3,4 c]pyridine-3-carboxamide. Its molecular formula is C25H25N5O4, which corresponds to a molecular weight of 459.5. Apixaban has the following structural formula. Apixaban is a white to off white crystalline powder. At physiological pH (1.2 - 6.8), apixaban does not ionize; its aqueous solubility across the physiological pH range is ~0.04 mg/mL. Apixaban tablets are available for oral administration in strengths of 2.5 mg and 5 mg of apixaban with the following inactive ingredients: anhydrous lactose, microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, and magnesium stearate. The film coating contains lactose monohydrate, hypromellose, titanium dioxide, triacetin, and yellow iron oxide (2.5 mg tablets) or red iron oxide (5 mg tablets).</Description>
</NDC>
<NDC>
<NDCCode>14445-149-10</NDCCode>
<PackageDescription>1 TABLET, FILM COATED in 1 CARTON (14445-149-10) </PackageDescription>
<NDC11Code>14445-0149-10</NDC11Code>
<ProductNDC>14445-149</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Apixaban</ProprietaryName>
<NonProprietaryName>Apixaban</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200916</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209898</ApplicationNumber>
<LabelerName>Indoco Remedies Limited</LabelerName>
<SubstanceName>APIXABAN</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-06-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200916</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apixaban is a factor Xa inhibitor indicated:.</IndicationAndUsage>
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