{
"NDC": [
{
"NDCCode": "0378-6989-64",
"PackageDescription": "30 POUCH in 1 CARTON (0378-6989-64) > 1 VIAL in 1 POUCH > 2.5 mL in 1 VIAL",
"NDC11Code": "00378-6989-64",
"ProductNDC": "0378-6989",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ipratropium Bromide",
"NonProprietaryName": "Ipratropium Bromide",
"DosageFormName": "SOLUTION",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20101109",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075693",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "IPRATROPIUM BROMIDE",
"StrengthNumber": "500",
"StrengthUnit": "ug/2.5mL",
"Pharm_Classes": "Anticholinergic [EPC],Cholinergic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2014-04-03"
},
{
"NDCCode": "0378-6989-62",
"PackageDescription": "25 POUCH in 1 CARTON (0378-6989-62) > 1 VIAL in 1 POUCH > 2.5 mL in 1 VIAL",
"NDC11Code": "00378-6989-62",
"ProductNDC": "0378-6989",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ipratropium Bromide",
"NonProprietaryName": "Ipratropium Bromide",
"DosageFormName": "SOLUTION",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20101109",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075693",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "IPRATROPIUM BROMIDE",
"StrengthNumber": "500",
"StrengthUnit": "ug/2.5mL",
"Pharm_Classes": "Anticholinergic [EPC],Cholinergic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2014-04-03"
},
{
"NDCCode": "0378-6989-66",
"PackageDescription": "2 POUCH in 1 CARTON (0378-6989-66) > 30 VIAL in 1 POUCH > 2.5 mL in 1 VIAL",
"NDC11Code": "00378-6989-66",
"ProductNDC": "0378-6989",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ipratropium Bromide",
"NonProprietaryName": "Ipratropium Bromide",
"DosageFormName": "SOLUTION",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20101109",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075693",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "IPRATROPIUM BROMIDE",
"StrengthNumber": "500",
"StrengthUnit": "ug/2.5mL",
"Pharm_Classes": "Anticholinergic [EPC],Cholinergic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2014-04-03"
},
{
"NDCCode": "0378-6989-93",
"PackageDescription": "30 POUCH in 1 CARTON (0378-6989-93) > 1 VIAL in 1 POUCH > 2.5 mL in 1 VIAL",
"NDC11Code": "00378-6989-93",
"ProductNDC": "0378-6989",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ipratropium Bromide",
"NonProprietaryName": "Ipratropium Bromide",
"DosageFormName": "SOLUTION",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19970110",
"EndMarketingDate": "20150517",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074755",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "IPRATROPIUM BROMIDE",
"StrengthNumber": "500",
"StrengthUnit": "ug/2.5mL",
"Pharm_Classes": "Anticholinergic [EPC],Cholinergic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2015-05-22"
},
{
"NDCCode": "0378-7970-93",
"PackageDescription": "1 POUCH in 1 CARTON (0378-7970-93) > 30 AMPULE in 1 POUCH (0378-7970-64) > 2.5 mL in 1 AMPULE",
"NDC11Code": "00378-7970-93",
"ProductNDC": "0378-7970",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ipratropium Bromide",
"NonProprietaryName": "Ipratropium Bromide",
"DosageFormName": "SOLUTION",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20101109",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075693",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "IPRATROPIUM BROMIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/2.5mL",
"Pharm_Classes": "Anticholinergic [EPC], Cholinergic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2019-05-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20101109",
"SamplePackage": "N",
"IndicationAndUsage": "Ipratropium Bromide Inhalation Solution administered either alone or with other bronchodilators, especially beta adrenergics, is indicated as a bronchodilator for maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema.",
"Description": "The active ingredient, ipratropium bromide monohydrate, USP, is an anticholinergic bronchodilator chemically described as 8-azoniabicyclo [3.2.1]- octane, 3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-, bromide, monohydrate (endo, syn)-, (±)-; a synthetic quaternary ammonium compound, chemically related to atropine. Ipratropium Bromide Monohydrate C20H30BrNO3H2O Mol.Wt. 430.4. Ipratropium bromide is a white crystalline substance, freely soluble in water and lower alcohols. It is a quaternary ammonium compound and thus exists in an ionized state in aqueous solutions. It is relatively insoluble in non-polar media. Ipratropium Bromide Inhalation Solution is administered by oral inhalation with the aid of a nebulizer. It contains ipratropium bromide, USP 0.02% (anhydrous basis) in a sterile, preservative-free, isotonic saline solution, pH-adjusted to 3.4 (3 to 4) with hydrochloric acid."
},
{
"NDCCode": "0378-8270-91",
"PackageDescription": "2 POUCH in 1 CARTON (0378-8270-91) / 30 AMPULE in 1 POUCH (0378-8270-64) / 3 mL in 1 AMPULE",
"NDC11Code": "00378-8270-91",
"ProductNDC": "0378-8270",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Albuterol Sulfate",
"NonProprietaryName": "Albuterol Sulfate",
"DosageFormName": "SOLUTION",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20121015",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077839",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "ALBUTEROL SULFATE",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/3mL",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130411",
"SamplePackage": "N",
"IndicationAndUsage": "Albuterol inhalation solution is indicated for the relief of bronchospasm in patients 2 years of age and older with reversible obstructive airway disease and acute attacks of bronchospasm.",
"Description": "Albuterol inhalation solution is a relatively selective beta2-adrenergic bronchodilator (see CLINICAL PHARMACOLOGY section below). Albuterol sulfate, the racemic form of albuterol, has the chemical name α1-[(tert- Butylamino)methyl]-4-hydroxy-m-xylene-α,α'-diol sulfate (2:1) (salt), and the following structural formula. Albuterol sulfate has a molecular weight of 576.70 and the molecular formula (C13H21NO3)2H2SO4. Albuterol sulfate is a white or practically white powder, freely soluble in water and slightly soluble in alcohol. The World Health Organization recommended name for albuterol base is salbutamol. Albuterol inhalation solution 0.083% requires no dilution before administration. Each milliliter of Albuterol Inhalation Solution, USP 0.083% contains 0.83 mg of albuterol (as 1 mg of albuterol sulfate) in an isotonic, sterile, aqueous solution containing sodium chloride; sulfuric acid is used to adjust the pH to between 3 and 5. Albuterol Inhalation Solution, USP 0.083% contains no sulfiting agents or preservatives. Albuterol inhalation solution is a clear, colorless to light yellow solution."
},
{
"NDCCode": "0378-9671-30",
"PackageDescription": "1 POUCH in 1 CARTON (0378-9671-30) > 30 AMPULE in 1 POUCH (0378-9671-64) > 3 mL in 1 AMPULE",
"NDC11Code": "00378-9671-30",
"ProductNDC": "0378-9671",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ipratropium Bromide And Albuterol Sulfate",
"NonProprietaryName": "Ipratropium Bromide And Albuterol Sulfate",
"DosageFormName": "SOLUTION",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20130301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202496",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "IPRATROPIUM BROMIDE; ALBUTEROL SULFATE",
"StrengthNumber": ".5; 2.5",
"StrengthUnit": "mg/3mL; mg/3mL",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], beta2-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2019-05-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130301",
"SamplePackage": "N",
"IndicationAndUsage": "Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is indicated for the treatment of bronchospasm associated with COPD in patients requiring more than one bronchodilator.",
"Description": "The active components in Ipratropium Bromide and Albuterol Sulfate Inhalation Solution are albuterol sulfate and ipratropium bromide. Albuterol sulfate, is a salt of racemic albuterol and a relatively selective β -adrenergic bronchodilator chemically described as α 1-[( tert-butylamino) methyl]-4- hydroxy- m-xylene-α, α'-diol sulfate (2:1) (salt). It has a molecular weight of 576.7 and the empirical formula is (C 13H 21NO 3) 2H 2SO 4. It is a white crystalline powder, soluble in water and slightly soluble in ethanol. The World Health Organization recommended name for albuterol base is salbutamol. Figure 3.1-1. Chemical structure of albuterol sulfate. Ipratropium bromide is an anticholinergic bronchodilator chemically described as 8-azoniabicyclo [3.2.1]-octane, 3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8methyl-8-(1-methylethyl)-, bromide, monohydrate ( endo, syn)-, (±)-; a synthetic quaternary ammonium compound, chemically related to atropine. It has a molecular weight of 430.4 and the empirical formula is C 20H 30BrNO 3H 2O. It is a white crystalline substance, freely soluble in water and lower alcohols, and insoluble in lipophilic solvents such as ether, chloroform, and fluorocarbons. Figure 3.1-2. Chemical structure of ipratropium bromide. Each 3 mL Sterile Unit-dose Vial contains 0.5 mg of ipratropium bromide (0.017%) and 3 mg Equivalent to 2.5 mg albuterol base albuterol sulfate (0.083%) in an isotonic, sterile, aqueous solution containing sodium chloride and 1 N hydrochloric acid to adjust to pH 4. Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is a clear, colorless solution. It does not require dilution prior to administration by nebulization. For Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance. Using the Pari-LC-Plus nebulizer (with face mask or mouthpiece) connected to a PRONEB compressor system, under in vitro conditions, the mean delivered dose from the mouth piece (% nominal dose) was approximately 46% of albuterol and 42% of ipratropium bromide at a mean flow rate of 3.6 L/min. The mean nebulization time was 15 minutes or less. Ipratropium Bromide and Albuterol Sulfate Inhalation Solution should be administered from jet nebulizers at adequate flow rates, via face masks or mouthpieces (see DOSAGE AND ADMINISTRATION)."
},
{
"NDCCode": "0378-4619-26",
"PackageDescription": "8 POUCH in 1 CARTON (0378-4619-26) / 1 PATCH in 1 POUCH (0378-4619-16) / 3.5 d in 1 PATCH",
"NDC11Code": "00378-4619-26",
"ProductNDC": "0378-4619",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Estradiol",
"NonProprietaryName": "Estradiol",
"DosageFormName": "PATCH",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20181101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206685",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "ESTRADIOL",
"StrengthNumber": ".025",
"StrengthUnit": "mg/d",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181101",
"SamplePackage": "N",
"IndicationAndUsage": "Estradiol transdermal system (twice-weekly) is indicated for:.",
"Description": "Estradiol transdermal system, USP (twice-weekly) contains estradiol hemihydrate in a multipolymeric adhesive. The system is designed to release estradiol continuously upon application to intact skin. Five dosage strengths of estradiol transdermal system (twice-weekly) are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol per day via the skin. Each corresponding system has an active surface area of 2.5, 3.75, 5.0, 7.5, or 10.0 cm² and contains estradiol, USP hemihydrate equivalent to 0.41, 0.62, 0.82, 1.23, or 1.64 mg of estradiol, respectively. The composition of the systems per unit area is identical. Estradiol, USP hemihydrate is a white, crystalline powder, chemically described as Estra-1,3,5(10)-triene-3,17β-diol-hemihydrate. The structural formula is. The molecular formula of estradiol hemihydrate is C18H24O2 ½ H2O. The molecular weight is 281.39. Meets USP Drug Release Test 4. Estradiol transdermal system (twice-weekly) is comprised of three layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) a translucent polyolefin backing film printed with brown ink, (2) an adhesive formulation containing estradiol, silicone adhesive, acrylic adhesive, dipropylene glycol, povidone, oleyl alcohol, and (3) an oversized slit polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol. The remaining components of the system are pharmacologically inactive."
},
{
"NDCCode": "0378-4620-26",
"PackageDescription": "8 POUCH in 1 CARTON (0378-4620-26) / 1 PATCH in 1 POUCH (0378-4620-16) / 3.5 d in 1 PATCH",
"NDC11Code": "00378-4620-26",
"ProductNDC": "0378-4620",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Estradiol",
"NonProprietaryName": "Estradiol",
"DosageFormName": "PATCH",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20181101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206685",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "ESTRADIOL",
"StrengthNumber": ".0375",
"StrengthUnit": "mg/d",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181101",
"SamplePackage": "N",
"IndicationAndUsage": "Estradiol transdermal system (twice-weekly) is indicated for:.",
"Description": "Estradiol transdermal system, USP (twice-weekly) contains estradiol hemihydrate in a multipolymeric adhesive. The system is designed to release estradiol continuously upon application to intact skin. Five dosage strengths of estradiol transdermal system (twice-weekly) are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol per day via the skin. Each corresponding system has an active surface area of 2.5, 3.75, 5.0, 7.5, or 10.0 cm² and contains estradiol, USP hemihydrate equivalent to 0.41, 0.62, 0.82, 1.23, or 1.64 mg of estradiol, respectively. The composition of the systems per unit area is identical. Estradiol, USP hemihydrate is a white, crystalline powder, chemically described as Estra-1,3,5(10)-triene-3,17β-diol-hemihydrate. The structural formula is. The molecular formula of estradiol hemihydrate is C18H24O2 ½ H2O. The molecular weight is 281.39. Meets USP Drug Release Test 4. Estradiol transdermal system (twice-weekly) is comprised of three layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) a translucent polyolefin backing film printed with brown ink, (2) an adhesive formulation containing estradiol, silicone adhesive, acrylic adhesive, dipropylene glycol, povidone, oleyl alcohol, and (3) an oversized slit polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol. The remaining components of the system are pharmacologically inactive."
},
{
"NDCCode": "0378-4621-26",
"PackageDescription": "8 POUCH in 1 CARTON (0378-4621-26) / 1 PATCH in 1 POUCH (0378-4621-16) / 3.5 d in 1 PATCH",
"NDC11Code": "00378-4621-26",
"ProductNDC": "0378-4621",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Estradiol",
"NonProprietaryName": "Estradiol",
"DosageFormName": "PATCH",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20181101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206685",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "ESTRADIOL",
"StrengthNumber": ".05",
"StrengthUnit": "mg/d",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181101",
"SamplePackage": "N",
"IndicationAndUsage": "Estradiol transdermal system (twice-weekly) is indicated for:.",
"Description": "Estradiol transdermal system, USP (twice-weekly) contains estradiol hemihydrate in a multipolymeric adhesive. The system is designed to release estradiol continuously upon application to intact skin. Five dosage strengths of estradiol transdermal system (twice-weekly) are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol per day via the skin. Each corresponding system has an active surface area of 2.5, 3.75, 5.0, 7.5, or 10.0 cm² and contains estradiol, USP hemihydrate equivalent to 0.41, 0.62, 0.82, 1.23, or 1.64 mg of estradiol, respectively. The composition of the systems per unit area is identical. Estradiol, USP hemihydrate is a white, crystalline powder, chemically described as Estra-1,3,5(10)-triene-3,17β-diol-hemihydrate. The structural formula is. The molecular formula of estradiol hemihydrate is C18H24O2 ½ H2O. The molecular weight is 281.39. Meets USP Drug Release Test 4. Estradiol transdermal system (twice-weekly) is comprised of three layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) a translucent polyolefin backing film printed with brown ink, (2) an adhesive formulation containing estradiol, silicone adhesive, acrylic adhesive, dipropylene glycol, povidone, oleyl alcohol, and (3) an oversized slit polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol. The remaining components of the system are pharmacologically inactive."
},
{
"NDCCode": "0378-4622-26",
"PackageDescription": "8 POUCH in 1 CARTON (0378-4622-26) / 1 PATCH in 1 POUCH (0378-4622-16) / 3.5 d in 1 PATCH",
"NDC11Code": "00378-4622-26",
"ProductNDC": "0378-4622",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Estradiol",
"NonProprietaryName": "Estradiol",
"DosageFormName": "PATCH",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20181101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206685",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "ESTRADIOL",
"StrengthNumber": ".075",
"StrengthUnit": "mg/d",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181101",
"SamplePackage": "N",
"IndicationAndUsage": "Estradiol transdermal system (twice-weekly) is indicated for:.",
"Description": "Estradiol transdermal system, USP (twice-weekly) contains estradiol hemihydrate in a multipolymeric adhesive. The system is designed to release estradiol continuously upon application to intact skin. Five dosage strengths of estradiol transdermal system (twice-weekly) are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol per day via the skin. Each corresponding system has an active surface area of 2.5, 3.75, 5.0, 7.5, or 10.0 cm² and contains estradiol, USP hemihydrate equivalent to 0.41, 0.62, 0.82, 1.23, or 1.64 mg of estradiol, respectively. The composition of the systems per unit area is identical. Estradiol, USP hemihydrate is a white, crystalline powder, chemically described as Estra-1,3,5(10)-triene-3,17β-diol-hemihydrate. The structural formula is. The molecular formula of estradiol hemihydrate is C18H24O2 ½ H2O. The molecular weight is 281.39. Meets USP Drug Release Test 4. Estradiol transdermal system (twice-weekly) is comprised of three layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) a translucent polyolefin backing film printed with brown ink, (2) an adhesive formulation containing estradiol, silicone adhesive, acrylic adhesive, dipropylene glycol, povidone, oleyl alcohol, and (3) an oversized slit polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol. The remaining components of the system are pharmacologically inactive."
},
{
"NDCCode": "0378-4623-26",
"PackageDescription": "8 POUCH in 1 CARTON (0378-4623-26) / 1 PATCH in 1 POUCH (0378-4623-16) / 3.5 d in 1 PATCH",
"NDC11Code": "00378-4623-26",
"ProductNDC": "0378-4623",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Estradiol",
"NonProprietaryName": "Estradiol",
"DosageFormName": "PATCH",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20181101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206685",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "ESTRADIOL",
"StrengthNumber": ".1",
"StrengthUnit": "mg/d",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181101",
"SamplePackage": "N",
"IndicationAndUsage": "Estradiol transdermal system (twice-weekly) is indicated for:.",
"Description": "Estradiol transdermal system, USP (twice-weekly) contains estradiol hemihydrate in a multipolymeric adhesive. The system is designed to release estradiol continuously upon application to intact skin. Five dosage strengths of estradiol transdermal system (twice-weekly) are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol per day via the skin. Each corresponding system has an active surface area of 2.5, 3.75, 5.0, 7.5, or 10.0 cm² and contains estradiol, USP hemihydrate equivalent to 0.41, 0.62, 0.82, 1.23, or 1.64 mg of estradiol, respectively. The composition of the systems per unit area is identical. Estradiol, USP hemihydrate is a white, crystalline powder, chemically described as Estra-1,3,5(10)-triene-3,17β-diol-hemihydrate. The structural formula is. The molecular formula of estradiol hemihydrate is C18H24O2 ½ H2O. The molecular weight is 281.39. Meets USP Drug Release Test 4. Estradiol transdermal system (twice-weekly) is comprised of three layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) a translucent polyolefin backing film printed with brown ink, (2) an adhesive formulation containing estradiol, silicone adhesive, acrylic adhesive, dipropylene glycol, povidone, oleyl alcohol, and (3) an oversized slit polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol. The remaining components of the system are pharmacologically inactive."
},
{
"NDCCode": "0378-4640-26",
"PackageDescription": "8 POUCH in 1 CARTON (0378-4640-26) / 1 PATCH in 1 POUCH (0378-4640-16) / 3.5 d in 1 PATCH",
"NDC11Code": "00378-4640-26",
"ProductNDC": "0378-4640",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Estradiol",
"NonProprietaryName": "Estradiol",
"DosageFormName": "PATCH",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20141219",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201675",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "ESTRADIOL",
"StrengthNumber": ".1",
"StrengthUnit": "mg/d",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20141219",
"SamplePackage": "N",
"IndicationAndUsage": "Estradiol transdermal system (twice-weekly) is indicated for.",
"Description": "Estradiol Transdermal System, USP (twice-weekly) contains estradiol hemihydrate in a multipolymeric adhesive. The system is designed to release estradiol continuously upon application to intact skin. Five dosage strengths of estradiol transdermal system (twice-weekly) are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol per day via the skin. Each corresponding system has an active surface area of 2.5, 3.75, 5.0, 7.5, or 10.0 cm2 and contains estradiol, USP hemihydrate equivalent to 0.41, 0.62, 0.82, 1.23, or 1.64 mg of estradiol, respectively. The composition of the systems per unit area is identical. Estradiol, USP hemihydrate is a white, crystalline powder, chemically described as Estra-1,3,5(10)-triene-3,17β-diol-hemihydrate. The structural formula is. The molecular formula of estradiol hemihydrate is C18H24O2 ½ H2O. The molecular weight is 281.39. Meets USP Drug Release Test 4. Estradiol transdermal system (twice-weekly) is comprised of 3 layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) a translucent polyolefin film printed with brown ink, (2) an adhesive formulation containing estradiol, silicone adhesive, acrylic adhesive, dipropylene glycol, povidone and oleyl alcohol, and (3) an oversized slit polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol. The remaining components of the system are pharmacologically inactive."
},
{
"NDCCode": "0378-4641-26",
"PackageDescription": "8 POUCH in 1 CARTON (0378-4641-26) / 1 PATCH in 1 POUCH (0378-4641-16) / 3.5 d in 1 PATCH",
"NDC11Code": "00378-4641-26",
"ProductNDC": "0378-4641",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Estradiol",
"NonProprietaryName": "Estradiol",
"DosageFormName": "PATCH",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20141219",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201675",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "ESTRADIOL",
"StrengthNumber": ".075",
"StrengthUnit": "mg/d",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20141219",
"SamplePackage": "N",
"IndicationAndUsage": "Estradiol transdermal system (twice-weekly) is indicated for.",
"Description": "Estradiol Transdermal System, USP (twice-weekly) contains estradiol hemihydrate in a multipolymeric adhesive. The system is designed to release estradiol continuously upon application to intact skin. Five dosage strengths of estradiol transdermal system (twice-weekly) are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol per day via the skin. Each corresponding system has an active surface area of 2.5, 3.75, 5.0, 7.5, or 10.0 cm2 and contains estradiol, USP hemihydrate equivalent to 0.41, 0.62, 0.82, 1.23, or 1.64 mg of estradiol, respectively. The composition of the systems per unit area is identical. Estradiol, USP hemihydrate is a white, crystalline powder, chemically described as Estra-1,3,5(10)-triene-3,17β-diol-hemihydrate. The structural formula is. The molecular formula of estradiol hemihydrate is C18H24O2 ½ H2O. The molecular weight is 281.39. Meets USP Drug Release Test 4. Estradiol transdermal system (twice-weekly) is comprised of 3 layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) a translucent polyolefin film printed with brown ink, (2) an adhesive formulation containing estradiol, silicone adhesive, acrylic adhesive, dipropylene glycol, povidone and oleyl alcohol, and (3) an oversized slit polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol. The remaining components of the system are pharmacologically inactive."
},
{
"NDCCode": "0378-4642-26",
"PackageDescription": "8 POUCH in 1 CARTON (0378-4642-26) / 1 PATCH in 1 POUCH (0378-4642-16) / 3.5 d in 1 PATCH",
"NDC11Code": "00378-4642-26",
"ProductNDC": "0378-4642",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Estradiol",
"NonProprietaryName": "Estradiol",
"DosageFormName": "PATCH",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20141219",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201675",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "ESTRADIOL",
"StrengthNumber": ".05",
"StrengthUnit": "mg/d",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20141219",
"SamplePackage": "N",
"IndicationAndUsage": "Estradiol transdermal system (twice-weekly) is indicated for.",
"Description": "Estradiol Transdermal System, USP (twice-weekly) contains estradiol hemihydrate in a multipolymeric adhesive. The system is designed to release estradiol continuously upon application to intact skin. Five dosage strengths of estradiol transdermal system (twice-weekly) are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol per day via the skin. Each corresponding system has an active surface area of 2.5, 3.75, 5.0, 7.5, or 10.0 cm2 and contains estradiol, USP hemihydrate equivalent to 0.41, 0.62, 0.82, 1.23, or 1.64 mg of estradiol, respectively. The composition of the systems per unit area is identical. Estradiol, USP hemihydrate is a white, crystalline powder, chemically described as Estra-1,3,5(10)-triene-3,17β-diol-hemihydrate. The structural formula is. The molecular formula of estradiol hemihydrate is C18H24O2 ½ H2O. The molecular weight is 281.39. Meets USP Drug Release Test 4. Estradiol transdermal system (twice-weekly) is comprised of 3 layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) a translucent polyolefin film printed with brown ink, (2) an adhesive formulation containing estradiol, silicone adhesive, acrylic adhesive, dipropylene glycol, povidone and oleyl alcohol, and (3) an oversized slit polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol. The remaining components of the system are pharmacologically inactive."
},
{
"NDCCode": "0378-4643-26",
"PackageDescription": "8 POUCH in 1 CARTON (0378-4643-26) / 1 PATCH in 1 POUCH (0378-4643-16) / 3.5 d in 1 PATCH",
"NDC11Code": "00378-4643-26",
"ProductNDC": "0378-4643",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Estradiol",
"NonProprietaryName": "Estradiol",
"DosageFormName": "PATCH",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20141219",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201675",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "ESTRADIOL",
"StrengthNumber": ".0375",
"StrengthUnit": "mg/d",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20141219",
"SamplePackage": "N",
"IndicationAndUsage": "Estradiol transdermal system (twice-weekly) is indicated for.",
"Description": "Estradiol Transdermal System, USP (twice-weekly) contains estradiol hemihydrate in a multipolymeric adhesive. The system is designed to release estradiol continuously upon application to intact skin. Five dosage strengths of estradiol transdermal system (twice-weekly) are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol per day via the skin. Each corresponding system has an active surface area of 2.5, 3.75, 5.0, 7.5, or 10.0 cm2 and contains estradiol, USP hemihydrate equivalent to 0.41, 0.62, 0.82, 1.23, or 1.64 mg of estradiol, respectively. The composition of the systems per unit area is identical. Estradiol, USP hemihydrate is a white, crystalline powder, chemically described as Estra-1,3,5(10)-triene-3,17β-diol-hemihydrate. The structural formula is. The molecular formula of estradiol hemihydrate is C18H24O2 ½ H2O. The molecular weight is 281.39. Meets USP Drug Release Test 4. Estradiol transdermal system (twice-weekly) is comprised of 3 layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) a translucent polyolefin film printed with brown ink, (2) an adhesive formulation containing estradiol, silicone adhesive, acrylic adhesive, dipropylene glycol, povidone and oleyl alcohol, and (3) an oversized slit polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol. The remaining components of the system are pharmacologically inactive."
},
{
"NDCCode": "0378-4644-26",
"PackageDescription": "8 POUCH in 1 CARTON (0378-4644-26) / 1 PATCH in 1 POUCH (0378-4644-16) / 3.5 d in 1 PATCH",
"NDC11Code": "00378-4644-26",
"ProductNDC": "0378-4644",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Estradiol",
"NonProprietaryName": "Estradiol",
"DosageFormName": "PATCH",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20141219",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201675",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "ESTRADIOL",
"StrengthNumber": ".025",
"StrengthUnit": "mg/d",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20141219",
"SamplePackage": "N",
"IndicationAndUsage": "Estradiol transdermal system (twice-weekly) is indicated for.",
"Description": "Estradiol Transdermal System, USP (twice-weekly) contains estradiol hemihydrate in a multipolymeric adhesive. The system is designed to release estradiol continuously upon application to intact skin. Five dosage strengths of estradiol transdermal system (twice-weekly) are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol per day via the skin. Each corresponding system has an active surface area of 2.5, 3.75, 5.0, 7.5, or 10.0 cm2 and contains estradiol, USP hemihydrate equivalent to 0.41, 0.62, 0.82, 1.23, or 1.64 mg of estradiol, respectively. The composition of the systems per unit area is identical. Estradiol, USP hemihydrate is a white, crystalline powder, chemically described as Estra-1,3,5(10)-triene-3,17β-diol-hemihydrate. The structural formula is. The molecular formula of estradiol hemihydrate is C18H24O2 ½ H2O. The molecular weight is 281.39. Meets USP Drug Release Test 4. Estradiol transdermal system (twice-weekly) is comprised of 3 layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) a translucent polyolefin film printed with brown ink, (2) an adhesive formulation containing estradiol, silicone adhesive, acrylic adhesive, dipropylene glycol, povidone and oleyl alcohol, and (3) an oversized slit polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol. The remaining components of the system are pharmacologically inactive."
},
{
"NDCCode": "0378-5510-93",
"PackageDescription": "30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (0378-5510-93) ",
"NDC11Code": "00378-5510-93",
"ProductNDC": "0378-5510",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20140512",
"EndMarketingDate": "20251130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202285",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20140512",
"EndMarketingDatePackage": "20251130",
"SamplePackage": "N",
"IndicationAndUsage": "Olanzapine orally disintegrating tablets are an atypical antipsychotic indicated:. As oral formulation for the: : 1 Treatment of schizophrenia. (1.1)Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1) Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1), 2 Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2)Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2)Adolescents (ages 13-17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2) , 3 Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3) , 4 Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2) Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated. .",
"Description": "Olanzapine orally disintegrating tablets, USP are an atypical antipsychotic that belong to the thienobenzodiazepine class. The chemical designation is 2-Methyl-4-(4-methyl-1-piperazinyl)-10H-thieno-[2,3-b][1,5] benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine, USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine orally disintegrating tablets are intended for oral administration only. Each orally disintegrating tablet contains olanzapine equivalent to 5 mg (16 µmol), 10 mg (32 µmol), 15 mg (48 µmol) or 20 mg (64 µmol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. Olanzapine orally disintegrating tablets also contain the following inactive ingredients: aspartame, colloidal silicon dioxide, crospovidone, guar gum, magnesium stearate, mannitol, microcrystalline cellulose and sodium lauryl sulfate. Meets USP Disintegration Test 2."
},
{
"NDCCode": "0378-5511-93",
"PackageDescription": "30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (0378-5511-93) ",
"NDC11Code": "00378-5511-93",
"ProductNDC": "0378-5511",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20140512",
"EndMarketingDate": "20251130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202285",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20140512",
"EndMarketingDatePackage": "20251130",
"SamplePackage": "N",
"IndicationAndUsage": "Olanzapine orally disintegrating tablets are an atypical antipsychotic indicated:. As oral formulation for the: : 1 Treatment of schizophrenia. (1.1)Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1) Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1), 2 Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2)Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2)Adolescents (ages 13-17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2) , 3 Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3) , 4 Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2) Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated. .",
"Description": "Olanzapine orally disintegrating tablets, USP are an atypical antipsychotic that belong to the thienobenzodiazepine class. The chemical designation is 2-Methyl-4-(4-methyl-1-piperazinyl)-10H-thieno-[2,3-b][1,5] benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine, USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine orally disintegrating tablets are intended for oral administration only. Each orally disintegrating tablet contains olanzapine equivalent to 5 mg (16 µmol), 10 mg (32 µmol), 15 mg (48 µmol) or 20 mg (64 µmol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. Olanzapine orally disintegrating tablets also contain the following inactive ingredients: aspartame, colloidal silicon dioxide, crospovidone, guar gum, magnesium stearate, mannitol, microcrystalline cellulose and sodium lauryl sulfate. Meets USP Disintegration Test 2."
},
{
"NDCCode": "0378-5512-93",
"PackageDescription": "30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (0378-5512-93) ",
"NDC11Code": "00378-5512-93",
"ProductNDC": "0378-5512",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20140512",
"EndMarketingDate": "20260131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202285",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20140512",
"EndMarketingDatePackage": "20260131",
"SamplePackage": "N",
"IndicationAndUsage": "Olanzapine orally disintegrating tablets are an atypical antipsychotic indicated:. As oral formulation for the: : 1 Treatment of schizophrenia. (1.1)Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1) Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1), 2 Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2)Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2)Adolescents (ages 13-17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2) , 3 Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3) , 4 Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2) Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated. .",
"Description": "Olanzapine orally disintegrating tablets, USP are an atypical antipsychotic that belong to the thienobenzodiazepine class. The chemical designation is 2-Methyl-4-(4-methyl-1-piperazinyl)-10H-thieno-[2,3-b][1,5] benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine, USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine orally disintegrating tablets are intended for oral administration only. Each orally disintegrating tablet contains olanzapine equivalent to 5 mg (16 µmol), 10 mg (32 µmol), 15 mg (48 µmol) or 20 mg (64 µmol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. Olanzapine orally disintegrating tablets also contain the following inactive ingredients: aspartame, colloidal silicon dioxide, crospovidone, guar gum, magnesium stearate, mannitol, microcrystalline cellulose and sodium lauryl sulfate. Meets USP Disintegration Test 2."
},
{
"NDCCode": "0378-5513-93",
"PackageDescription": "30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (0378-5513-93) ",
"NDC11Code": "00378-5513-93",
"ProductNDC": "0378-5513",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20140512",
"EndMarketingDate": "20260131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202285",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20140512",
"EndMarketingDatePackage": "20260131",
"SamplePackage": "N",
"IndicationAndUsage": "Olanzapine orally disintegrating tablets are an atypical antipsychotic indicated:. As oral formulation for the: : 1 Treatment of schizophrenia. (1.1)Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1) Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1), 2 Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2)Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2)Adolescents (ages 13-17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2) , 3 Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3) , 4 Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2) Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated. .",
"Description": "Olanzapine orally disintegrating tablets, USP are an atypical antipsychotic that belong to the thienobenzodiazepine class. The chemical designation is 2-Methyl-4-(4-methyl-1-piperazinyl)-10H-thieno-[2,3-b][1,5] benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine, USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine orally disintegrating tablets are intended for oral administration only. Each orally disintegrating tablet contains olanzapine equivalent to 5 mg (16 µmol), 10 mg (32 µmol), 15 mg (48 µmol) or 20 mg (64 µmol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. Olanzapine orally disintegrating tablets also contain the following inactive ingredients: aspartame, colloidal silicon dioxide, crospovidone, guar gum, magnesium stearate, mannitol, microcrystalline cellulose and sodium lauryl sulfate. Meets USP Disintegration Test 2."
},
{
"NDCCode": "0904-6989-30",
"PackageDescription": "1 TUBE in 1 CARTON (0904-6989-30) > 30 g in 1 TUBE",
"NDC11Code": "00904-6989-30",
"ProductNDC": "0904-6989",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine And Prilocaine",
"NonProprietaryName": "Lidocaine And Prilocaine",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190506",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205887",
"LabelerName": "MAJOR Pharmaceuticals",
"SubstanceName": "LIDOCAINE; PRILOCAINE",
"StrengthNumber": "25; 25",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE],Amide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2019-10-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "0904-6989-31",
"PackageDescription": "1 TUBE in 1 CARTON (0904-6989-31) > 30 g in 1 TUBE",
"NDC11Code": "00904-6989-31",
"ProductNDC": "0904-6989",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine And Prilocaine",
"NonProprietaryName": "Lidocaine And Prilocaine",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190506",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205887",
"LabelerName": "MAJOR Pharmaceuticals",
"SubstanceName": "LIDOCAINE; PRILOCAINE",
"StrengthNumber": "25; 25",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amide Local Anesthetic [EPC], Amides [CS], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE], Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N",
"IndicationAndUsage": "Lidocaine and Prilocaine Cream USP, 2.5%/2.5% (a eutectic mixture of lidocaine 2.5% and prilocaine 2.5%) is indicated as a topical anesthetic for use on: 1 -normal intact skin for local analgesia., 2 -Genital mucous membranes for superficial minor surgery and as pretreatment for infiltration anesthesia.",
"Description": "Lidocaine and Prilocaine Cream USP, 2.5%/2.5% is an emulsion in which the oil phase is a eutectic mixture of lidocaine and prilocaine in a ratio of 1:1 by weight. This eutectic mixture has a melting point below room temperature and therefore both local anesthetics exist as a liquid oil rather than as crystals. It is packaged in 5 gram and 30 gram tubes. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), has an octanol: water partition ratio of 43 at pH 7.4, and has the following structure. Prilocaine is chemically designated as propanamide, N-(2-methylphenyl)-2-(propylamino), has an octanol: water partition ratio of 25 at pH 7.4, and has the following structure. Each gram of lidocaine and prilocaine cream, 2.5%/2.5% contains lidocaine 25 mg, prilocaine 25 mg, PEG-60 hydrogenated castor oil (as emulsifiers), carboxypolymethylene (as a thickening agent), sodium hydroxide to adjust to a pH approximating 9, and purified water to 1 gram. Lidocaine and prilocaine cream, 2.5%/2.5% contains no preservative, however it passes the USP antimicrobial effectiveness test due to the pH. The specific gravity of lidocaine and prilocaine cream, 2.5%/2.5% is 1.00."
},
{
"NDCCode": "50090-6989-0",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (50090-6989-0) ",
"NDC11Code": "50090-6989-00",
"ProductNDC": "50090-6989",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rosuvastatin Calcium",
"NonProprietaryName": "Rosuvastatin Calcium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20171122",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208898",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "ROSUVASTATIN CALCIUM",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-12-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231227",
"SamplePackage": "N",
"IndicationAndUsage": "Rosuvastatin tablets are indicated: 1 To reduce the risk of stroke, myocardial infarction, and arterial revascularization procedures in adults without established coronary heart disease who are at increased risk of cardiovascular (CV) disease based on age, hsCRP ≥2 mg/L, and at least one additional CV risk factor. , 2 As an adjunct to diet to: o Reduce LDL-C in adults with primary hyperlipidemia. o Reduce low-density lipoprotein cholesterol (LDL-C) and slow the progression of atherosclerosis in adults. o Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). , 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH). , 4 As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia. .",
"Description": "Rosuvastatin calcium, USP is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is bis [(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2- [methyl (methylsulfonyl) amino] pyrimidin-5-yl] (3R, 5S)-3, 5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula. The molecular formula for rosuvastatin calcium, USP is (C22H27FN3O6S)2 Ca and the molecular weight is 1001.14. Rosuvastatin calcium is a white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Rosuvastatin tablets, USP for oral use contain rosuvastatin 5 mg, 10 mg, 20 mg, or 40 mg (equivalent to 5.2 mg, 10.4 mg, 20.8 mg, and 41.6 mg rosuvastatin calcium) and the following inactive ingredients: crospovidone, hypromellose, lactose monohydrate, magnesium stearate, mannitol, meglumine, microcrystalline cellulose, pregelatinized starch, titanium dioxide and triacetin. Additionally, 10 mg, 20 mg and 40 mg tablets contain FD&C red No. 40/allura red AC aluminum lake, FD&C blue No. 2/indigo carmine aluminum lake and FD&C yellow No.6/sunset yellow FCF aluminum lake. Meets USP Dissolution Test 2."
},
{
"NDCCode": "51393-6989-1",
"PackageDescription": "11 mL in 1 BOTTLE, DISPENSING (51393-6989-1) ",
"NDC11Code": "51393-6989-01",
"ProductNDC": "51393-6989",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nail Fungus Control",
"ProprietaryNameSuffix": "Extra Strength",
"NonProprietaryName": "Calendula Officinalis Flowering Top, Silicon Dioxide, And Hypericum Perforatum",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110406",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "�Forces of Nature",
"SubstanceName": "CALENDULA OFFICINALIS FLOWERING TOP; SILICON DIOXIDE; HYPERICUM PERFORATUM WHOLE",
"StrengthNumber": "8; 8; 8",
"StrengthUnit": "[hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL",
"Status": "Active",
"LastUpdate": "2026-06-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20110406",
"SamplePackage": "N",
"IndicationAndUsage": "for the relief and treatment of pain, soreness and inflammation from nail fungus. Symptoms: Discolored nails, Brittle nails, Distorted nails."
},
{
"NDCCode": "51393-6989-2",
"PackageDescription": "33 mL in 1 BOTTLE, DISPENSING (51393-6989-2) ",
"NDC11Code": "51393-6989-02",
"ProductNDC": "51393-6989",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nail Fungus Control",
"ProprietaryNameSuffix": "Extra Strength",
"NonProprietaryName": "Calendula Officinalis Flowering Top, Silicon Dioxide, And Hypericum Perforatum",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110406",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "�Forces of Nature",
"SubstanceName": "CALENDULA OFFICINALIS FLOWERING TOP; SILICON DIOXIDE; HYPERICUM PERFORATUM WHOLE",
"StrengthNumber": "8; 8; 8",
"StrengthUnit": "[hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL",
"Status": "Active",
"LastUpdate": "2026-06-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20110406",
"SamplePackage": "N",
"IndicationAndUsage": "for the relief and treatment of pain, soreness and inflammation from nail fungus. Symptoms: Discolored nails, Brittle nails, Distorted nails."
},
{
"NDCCode": "51393-6989-3",
"PackageDescription": "30 mL in 1 BOTTLE, DISPENSING (51393-6989-3) ",
"NDC11Code": "51393-6989-03",
"ProductNDC": "51393-6989",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nail Fungus Control",
"ProprietaryNameSuffix": "Extra Strength",
"NonProprietaryName": "Calendula Officinalis Flowering Top, Silicon Dioxide, And Hypericum Perforatum",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110406",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "�Forces of Nature",
"SubstanceName": "CALENDULA OFFICINALIS FLOWERING TOP; SILICON DIOXIDE; HYPERICUM PERFORATUM WHOLE",
"StrengthNumber": "8; 8; 8",
"StrengthUnit": "[hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL",
"Status": "Active",
"LastUpdate": "2026-06-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210601",
"SamplePackage": "N",
"IndicationAndUsage": "for the relief and treatment of pain, soreness and inflammation from nail fungus. Symptoms: Discolored nails, Brittle nails, Distorted nails."
},
{
"NDCCode": "55154-6989-8",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 BAG (55154-6989-8) > 1 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "55154-6989-08",
"ProductNDC": "55154-6989",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Heparin Sodium",
"NonProprietaryName": "Heparin Sodium",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20090831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090571",
"LabelerName": "Cardinal Health",
"SubstanceName": "HEPARIN SODIUM",
"StrengthNumber": "1000",
"StrengthUnit": "[USP'U]/mL",
"Pharm_Classes": "Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-11-03",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "62106-6989-4",
"PackageDescription": "10 TUBE in 1 CARTON (62106-6989-4) > 140 GRANULE in 1 TUBE",
"NDC11Code": "62106-6989-04",
"ProductNDC": "62106-6989",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Duodeninum",
"NonProprietaryName": "Duodenum",
"DosageFormName": "GRANULE",
"RouteName": "ORAL",
"StartMarketingDate": "20151201",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Seroyal USA",
"SubstanceName": "ORYCTOLAGUS CUNICULUS DUODENUM",
"StrengthNumber": "4",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2023-09-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20151201",
"SamplePackage": "N"
},
{
"NDCCode": "62670-6989-2",
"PackageDescription": "29 mL in 1 BOTTLE, SPRAY (62670-6989-2) ",
"NDC11Code": "62670-6989-02",
"ProductNDC": "62670-6989",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anti-bacterialhandspray",
"ProprietaryNameSuffix": "Raspberry Tangerine",
"NonProprietaryName": "Alcohol",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20251117",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Bath & Body Works, Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "72",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2026-03-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251117",
"SamplePackage": "N"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>0378-6989-64</NDCCode>
<PackageDescription>30 POUCH in 1 CARTON (0378-6989-64) > 1 VIAL in 1 POUCH > 2.5 mL in 1 VIAL</PackageDescription>
<NDC11Code>00378-6989-64</NDC11Code>
<ProductNDC>0378-6989</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ipratropium Bromide</ProprietaryName>
<NonProprietaryName>Ipratropium Bromide</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20101109</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075693</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>IPRATROPIUM BROMIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>ug/2.5mL</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC],Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-04-03</LastUpdate>
</NDC>
<NDC>
<NDCCode>0378-6989-62</NDCCode>
<PackageDescription>25 POUCH in 1 CARTON (0378-6989-62) > 1 VIAL in 1 POUCH > 2.5 mL in 1 VIAL</PackageDescription>
<NDC11Code>00378-6989-62</NDC11Code>
<ProductNDC>0378-6989</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ipratropium Bromide</ProprietaryName>
<NonProprietaryName>Ipratropium Bromide</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20101109</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075693</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>IPRATROPIUM BROMIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>ug/2.5mL</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC],Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-04-03</LastUpdate>
</NDC>
<NDC>
<NDCCode>0378-6989-66</NDCCode>
<PackageDescription>2 POUCH in 1 CARTON (0378-6989-66) > 30 VIAL in 1 POUCH > 2.5 mL in 1 VIAL</PackageDescription>
<NDC11Code>00378-6989-66</NDC11Code>
<ProductNDC>0378-6989</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ipratropium Bromide</ProprietaryName>
<NonProprietaryName>Ipratropium Bromide</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20101109</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075693</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>IPRATROPIUM BROMIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>ug/2.5mL</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC],Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-04-03</LastUpdate>
</NDC>
<NDC>
<NDCCode>0378-6989-93</NDCCode>
<PackageDescription>30 POUCH in 1 CARTON (0378-6989-93) > 1 VIAL in 1 POUCH > 2.5 mL in 1 VIAL</PackageDescription>
<NDC11Code>00378-6989-93</NDC11Code>
<ProductNDC>0378-6989</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ipratropium Bromide</ProprietaryName>
<NonProprietaryName>Ipratropium Bromide</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19970110</StartMarketingDate>
<EndMarketingDate>20150517</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074755</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>IPRATROPIUM BROMIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>ug/2.5mL</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC],Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2015-05-22</LastUpdate>
</NDC>
<NDC>
<NDCCode>0378-7970-93</NDCCode>
<PackageDescription>1 POUCH in 1 CARTON (0378-7970-93) > 30 AMPULE in 1 POUCH (0378-7970-64) > 2.5 mL in 1 AMPULE</PackageDescription>
<NDC11Code>00378-7970-93</NDC11Code>
<ProductNDC>0378-7970</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ipratropium Bromide</ProprietaryName>
<NonProprietaryName>Ipratropium Bromide</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20101109</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075693</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>IPRATROPIUM BROMIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/2.5mL</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2019-05-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101109</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ipratropium Bromide Inhalation Solution administered either alone or with other bronchodilators, especially beta adrenergics, is indicated as a bronchodilator for maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema.</IndicationAndUsage>
<Description>The active ingredient, ipratropium bromide monohydrate, USP, is an anticholinergic bronchodilator chemically described as 8-azoniabicyclo [3.2.1]- octane, 3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-, bromide, monohydrate (endo, syn)-, (±)-; a synthetic quaternary ammonium compound, chemically related to atropine. Ipratropium Bromide Monohydrate C20H30BrNO3H2O Mol.Wt. 430.4. Ipratropium bromide is a white crystalline substance, freely soluble in water and lower alcohols. It is a quaternary ammonium compound and thus exists in an ionized state in aqueous solutions. It is relatively insoluble in non-polar media. Ipratropium Bromide Inhalation Solution is administered by oral inhalation with the aid of a nebulizer. It contains ipratropium bromide, USP 0.02% (anhydrous basis) in a sterile, preservative-free, isotonic saline solution, pH-adjusted to 3.4 (3 to 4) with hydrochloric acid.</Description>
</NDC>
<NDC>
<NDCCode>0378-8270-91</NDCCode>
<PackageDescription>2 POUCH in 1 CARTON (0378-8270-91) / 30 AMPULE in 1 POUCH (0378-8270-64) / 3 mL in 1 AMPULE</PackageDescription>
<NDC11Code>00378-8270-91</NDC11Code>
<ProductNDC>0378-8270</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Albuterol Sulfate</ProprietaryName>
<NonProprietaryName>Albuterol Sulfate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20121015</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077839</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ALBUTEROL SULFATE</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/3mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130411</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Albuterol inhalation solution is indicated for the relief of bronchospasm in patients 2 years of age and older with reversible obstructive airway disease and acute attacks of bronchospasm.</IndicationAndUsage>
<Description>Albuterol inhalation solution is a relatively selective beta2-adrenergic bronchodilator (see CLINICAL PHARMACOLOGY section below). Albuterol sulfate, the racemic form of albuterol, has the chemical name α1-[(tert- Butylamino)methyl]-4-hydroxy-m-xylene-α,α'-diol sulfate (2:1) (salt), and the following structural formula. Albuterol sulfate has a molecular weight of 576.70 and the molecular formula (C13H21NO3)2H2SO4. Albuterol sulfate is a white or practically white powder, freely soluble in water and slightly soluble in alcohol. The World Health Organization recommended name for albuterol base is salbutamol. Albuterol inhalation solution 0.083% requires no dilution before administration. Each milliliter of Albuterol Inhalation Solution, USP 0.083% contains 0.83 mg of albuterol (as 1 mg of albuterol sulfate) in an isotonic, sterile, aqueous solution containing sodium chloride; sulfuric acid is used to adjust the pH to between 3 and 5. Albuterol Inhalation Solution, USP 0.083% contains no sulfiting agents or preservatives. Albuterol inhalation solution is a clear, colorless to light yellow solution.</Description>
</NDC>
<NDC>
<NDCCode>0378-9671-30</NDCCode>
<PackageDescription>1 POUCH in 1 CARTON (0378-9671-30) > 30 AMPULE in 1 POUCH (0378-9671-64) > 3 mL in 1 AMPULE</PackageDescription>
<NDC11Code>00378-9671-30</NDC11Code>
<ProductNDC>0378-9671</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ipratropium Bromide And Albuterol Sulfate</ProprietaryName>
<NonProprietaryName>Ipratropium Bromide And Albuterol Sulfate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20130301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202496</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>IPRATROPIUM BROMIDE; ALBUTEROL SULFATE</SubstanceName>
<StrengthNumber>.5; 2.5</StrengthNumber>
<StrengthUnit>mg/3mL; mg/3mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2019-05-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is indicated for the treatment of bronchospasm associated with COPD in patients requiring more than one bronchodilator.</IndicationAndUsage>
<Description>The active components in Ipratropium Bromide and Albuterol Sulfate Inhalation Solution are albuterol sulfate and ipratropium bromide. Albuterol sulfate, is a salt of racemic albuterol and a relatively selective β -adrenergic bronchodilator chemically described as α 1-[( tert-butylamino) methyl]-4- hydroxy- m-xylene-α, α'-diol sulfate (2:1) (salt). It has a molecular weight of 576.7 and the empirical formula is (C 13H 21NO 3) 2H 2SO 4. It is a white crystalline powder, soluble in water and slightly soluble in ethanol. The World Health Organization recommended name for albuterol base is salbutamol. Figure 3.1-1. Chemical structure of albuterol sulfate. Ipratropium bromide is an anticholinergic bronchodilator chemically described as 8-azoniabicyclo [3.2.1]-octane, 3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8methyl-8-(1-methylethyl)-, bromide, monohydrate ( endo, syn)-, (±)-; a synthetic quaternary ammonium compound, chemically related to atropine. It has a molecular weight of 430.4 and the empirical formula is C 20H 30BrNO 3H 2O. It is a white crystalline substance, freely soluble in water and lower alcohols, and insoluble in lipophilic solvents such as ether, chloroform, and fluorocarbons. Figure 3.1-2. Chemical structure of ipratropium bromide. Each 3 mL Sterile Unit-dose Vial contains 0.5 mg of ipratropium bromide (0.017%) and 3 mg Equivalent to 2.5 mg albuterol base albuterol sulfate (0.083%) in an isotonic, sterile, aqueous solution containing sodium chloride and 1 N hydrochloric acid to adjust to pH 4. Ipratropium Bromide and Albuterol Sulfate Inhalation Solution is a clear, colorless solution. It does not require dilution prior to administration by nebulization. For Ipratropium Bromide and Albuterol Sulfate Inhalation Solution, like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance. Using the Pari-LC-Plus nebulizer (with face mask or mouthpiece) connected to a PRONEB compressor system, under in vitro conditions, the mean delivered dose from the mouth piece (% nominal dose) was approximately 46% of albuterol and 42% of ipratropium bromide at a mean flow rate of 3.6 L/min. The mean nebulization time was 15 minutes or less. Ipratropium Bromide and Albuterol Sulfate Inhalation Solution should be administered from jet nebulizers at adequate flow rates, via face masks or mouthpieces (see DOSAGE AND ADMINISTRATION).</Description>
</NDC>
<NDC>
<NDCCode>0378-4619-26</NDCCode>
<PackageDescription>8 POUCH in 1 CARTON (0378-4619-26) / 1 PATCH in 1 POUCH (0378-4619-16) / 3.5 d in 1 PATCH</PackageDescription>
<NDC11Code>00378-4619-26</NDC11Code>
<ProductNDC>0378-4619</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Estradiol</ProprietaryName>
<NonProprietaryName>Estradiol</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20181101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206685</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ESTRADIOL</SubstanceName>
<StrengthNumber>.025</StrengthNumber>
<StrengthUnit>mg/d</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Estradiol transdermal system (twice-weekly) is indicated for:.</IndicationAndUsage>
<Description>Estradiol transdermal system, USP (twice-weekly) contains estradiol hemihydrate in a multipolymeric adhesive. The system is designed to release estradiol continuously upon application to intact skin. Five dosage strengths of estradiol transdermal system (twice-weekly) are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol per day via the skin. Each corresponding system has an active surface area of 2.5, 3.75, 5.0, 7.5, or 10.0 cm² and contains estradiol, USP hemihydrate equivalent to 0.41, 0.62, 0.82, 1.23, or 1.64 mg of estradiol, respectively. The composition of the systems per unit area is identical. Estradiol, USP hemihydrate is a white, crystalline powder, chemically described as Estra-1,3,5(10)-triene-3,17β-diol-hemihydrate. The structural formula is. The molecular formula of estradiol hemihydrate is C18H24O2 ½ H2O. The molecular weight is 281.39. Meets USP Drug Release Test 4. Estradiol transdermal system (twice-weekly) is comprised of three layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) a translucent polyolefin backing film printed with brown ink, (2) an adhesive formulation containing estradiol, silicone adhesive, acrylic adhesive, dipropylene glycol, povidone, oleyl alcohol, and (3) an oversized slit polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol. The remaining components of the system are pharmacologically inactive.</Description>
</NDC>
<NDC>
<NDCCode>0378-4620-26</NDCCode>
<PackageDescription>8 POUCH in 1 CARTON (0378-4620-26) / 1 PATCH in 1 POUCH (0378-4620-16) / 3.5 d in 1 PATCH</PackageDescription>
<NDC11Code>00378-4620-26</NDC11Code>
<ProductNDC>0378-4620</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Estradiol</ProprietaryName>
<NonProprietaryName>Estradiol</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20181101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206685</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ESTRADIOL</SubstanceName>
<StrengthNumber>.0375</StrengthNumber>
<StrengthUnit>mg/d</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Estradiol transdermal system (twice-weekly) is indicated for:.</IndicationAndUsage>
<Description>Estradiol transdermal system, USP (twice-weekly) contains estradiol hemihydrate in a multipolymeric adhesive. The system is designed to release estradiol continuously upon application to intact skin. Five dosage strengths of estradiol transdermal system (twice-weekly) are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol per day via the skin. Each corresponding system has an active surface area of 2.5, 3.75, 5.0, 7.5, or 10.0 cm² and contains estradiol, USP hemihydrate equivalent to 0.41, 0.62, 0.82, 1.23, or 1.64 mg of estradiol, respectively. The composition of the systems per unit area is identical. Estradiol, USP hemihydrate is a white, crystalline powder, chemically described as Estra-1,3,5(10)-triene-3,17β-diol-hemihydrate. The structural formula is. The molecular formula of estradiol hemihydrate is C18H24O2 ½ H2O. The molecular weight is 281.39. Meets USP Drug Release Test 4. Estradiol transdermal system (twice-weekly) is comprised of three layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) a translucent polyolefin backing film printed with brown ink, (2) an adhesive formulation containing estradiol, silicone adhesive, acrylic adhesive, dipropylene glycol, povidone, oleyl alcohol, and (3) an oversized slit polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol. The remaining components of the system are pharmacologically inactive.</Description>
</NDC>
<NDC>
<NDCCode>0378-4621-26</NDCCode>
<PackageDescription>8 POUCH in 1 CARTON (0378-4621-26) / 1 PATCH in 1 POUCH (0378-4621-16) / 3.5 d in 1 PATCH</PackageDescription>
<NDC11Code>00378-4621-26</NDC11Code>
<ProductNDC>0378-4621</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Estradiol</ProprietaryName>
<NonProprietaryName>Estradiol</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20181101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206685</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ESTRADIOL</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>mg/d</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Estradiol transdermal system (twice-weekly) is indicated for:.</IndicationAndUsage>
<Description>Estradiol transdermal system, USP (twice-weekly) contains estradiol hemihydrate in a multipolymeric adhesive. The system is designed to release estradiol continuously upon application to intact skin. Five dosage strengths of estradiol transdermal system (twice-weekly) are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol per day via the skin. Each corresponding system has an active surface area of 2.5, 3.75, 5.0, 7.5, or 10.0 cm² and contains estradiol, USP hemihydrate equivalent to 0.41, 0.62, 0.82, 1.23, or 1.64 mg of estradiol, respectively. The composition of the systems per unit area is identical. Estradiol, USP hemihydrate is a white, crystalline powder, chemically described as Estra-1,3,5(10)-triene-3,17β-diol-hemihydrate. The structural formula is. The molecular formula of estradiol hemihydrate is C18H24O2 ½ H2O. The molecular weight is 281.39. Meets USP Drug Release Test 4. Estradiol transdermal system (twice-weekly) is comprised of three layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) a translucent polyolefin backing film printed with brown ink, (2) an adhesive formulation containing estradiol, silicone adhesive, acrylic adhesive, dipropylene glycol, povidone, oleyl alcohol, and (3) an oversized slit polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol. The remaining components of the system are pharmacologically inactive.</Description>
</NDC>
<NDC>
<NDCCode>0378-4622-26</NDCCode>
<PackageDescription>8 POUCH in 1 CARTON (0378-4622-26) / 1 PATCH in 1 POUCH (0378-4622-16) / 3.5 d in 1 PATCH</PackageDescription>
<NDC11Code>00378-4622-26</NDC11Code>
<ProductNDC>0378-4622</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Estradiol</ProprietaryName>
<NonProprietaryName>Estradiol</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20181101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206685</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ESTRADIOL</SubstanceName>
<StrengthNumber>.075</StrengthNumber>
<StrengthUnit>mg/d</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Estradiol transdermal system (twice-weekly) is indicated for:.</IndicationAndUsage>
<Description>Estradiol transdermal system, USP (twice-weekly) contains estradiol hemihydrate in a multipolymeric adhesive. The system is designed to release estradiol continuously upon application to intact skin. Five dosage strengths of estradiol transdermal system (twice-weekly) are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol per day via the skin. Each corresponding system has an active surface area of 2.5, 3.75, 5.0, 7.5, or 10.0 cm² and contains estradiol, USP hemihydrate equivalent to 0.41, 0.62, 0.82, 1.23, or 1.64 mg of estradiol, respectively. The composition of the systems per unit area is identical. Estradiol, USP hemihydrate is a white, crystalline powder, chemically described as Estra-1,3,5(10)-triene-3,17β-diol-hemihydrate. The structural formula is. The molecular formula of estradiol hemihydrate is C18H24O2 ½ H2O. The molecular weight is 281.39. Meets USP Drug Release Test 4. Estradiol transdermal system (twice-weekly) is comprised of three layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) a translucent polyolefin backing film printed with brown ink, (2) an adhesive formulation containing estradiol, silicone adhesive, acrylic adhesive, dipropylene glycol, povidone, oleyl alcohol, and (3) an oversized slit polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol. The remaining components of the system are pharmacologically inactive.</Description>
</NDC>
<NDC>
<NDCCode>0378-4623-26</NDCCode>
<PackageDescription>8 POUCH in 1 CARTON (0378-4623-26) / 1 PATCH in 1 POUCH (0378-4623-16) / 3.5 d in 1 PATCH</PackageDescription>
<NDC11Code>00378-4623-26</NDC11Code>
<ProductNDC>0378-4623</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Estradiol</ProprietaryName>
<NonProprietaryName>Estradiol</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20181101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206685</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ESTRADIOL</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>mg/d</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Estradiol transdermal system (twice-weekly) is indicated for:.</IndicationAndUsage>
<Description>Estradiol transdermal system, USP (twice-weekly) contains estradiol hemihydrate in a multipolymeric adhesive. The system is designed to release estradiol continuously upon application to intact skin. Five dosage strengths of estradiol transdermal system (twice-weekly) are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol per day via the skin. Each corresponding system has an active surface area of 2.5, 3.75, 5.0, 7.5, or 10.0 cm² and contains estradiol, USP hemihydrate equivalent to 0.41, 0.62, 0.82, 1.23, or 1.64 mg of estradiol, respectively. The composition of the systems per unit area is identical. Estradiol, USP hemihydrate is a white, crystalline powder, chemically described as Estra-1,3,5(10)-triene-3,17β-diol-hemihydrate. The structural formula is. The molecular formula of estradiol hemihydrate is C18H24O2 ½ H2O. The molecular weight is 281.39. Meets USP Drug Release Test 4. Estradiol transdermal system (twice-weekly) is comprised of three layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) a translucent polyolefin backing film printed with brown ink, (2) an adhesive formulation containing estradiol, silicone adhesive, acrylic adhesive, dipropylene glycol, povidone, oleyl alcohol, and (3) an oversized slit polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol. The remaining components of the system are pharmacologically inactive.</Description>
</NDC>
<NDC>
<NDCCode>0378-4640-26</NDCCode>
<PackageDescription>8 POUCH in 1 CARTON (0378-4640-26) / 1 PATCH in 1 POUCH (0378-4640-16) / 3.5 d in 1 PATCH</PackageDescription>
<NDC11Code>00378-4640-26</NDC11Code>
<ProductNDC>0378-4640</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Estradiol</ProprietaryName>
<NonProprietaryName>Estradiol</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20141219</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201675</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ESTRADIOL</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>mg/d</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Estradiol transdermal system (twice-weekly) is indicated for.</IndicationAndUsage>
<Description>Estradiol Transdermal System, USP (twice-weekly) contains estradiol hemihydrate in a multipolymeric adhesive. The system is designed to release estradiol continuously upon application to intact skin. Five dosage strengths of estradiol transdermal system (twice-weekly) are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol per day via the skin. Each corresponding system has an active surface area of 2.5, 3.75, 5.0, 7.5, or 10.0 cm2 and contains estradiol, USP hemihydrate equivalent to 0.41, 0.62, 0.82, 1.23, or 1.64 mg of estradiol, respectively. The composition of the systems per unit area is identical. Estradiol, USP hemihydrate is a white, crystalline powder, chemically described as Estra-1,3,5(10)-triene-3,17β-diol-hemihydrate. The structural formula is. The molecular formula of estradiol hemihydrate is C18H24O2 ½ H2O. The molecular weight is 281.39. Meets USP Drug Release Test 4. Estradiol transdermal system (twice-weekly) is comprised of 3 layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) a translucent polyolefin film printed with brown ink, (2) an adhesive formulation containing estradiol, silicone adhesive, acrylic adhesive, dipropylene glycol, povidone and oleyl alcohol, and (3) an oversized slit polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol. The remaining components of the system are pharmacologically inactive.</Description>
</NDC>
<NDC>
<NDCCode>0378-4641-26</NDCCode>
<PackageDescription>8 POUCH in 1 CARTON (0378-4641-26) / 1 PATCH in 1 POUCH (0378-4641-16) / 3.5 d in 1 PATCH</PackageDescription>
<NDC11Code>00378-4641-26</NDC11Code>
<ProductNDC>0378-4641</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Estradiol</ProprietaryName>
<NonProprietaryName>Estradiol</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20141219</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201675</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ESTRADIOL</SubstanceName>
<StrengthNumber>.075</StrengthNumber>
<StrengthUnit>mg/d</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Estradiol transdermal system (twice-weekly) is indicated for.</IndicationAndUsage>
<Description>Estradiol Transdermal System, USP (twice-weekly) contains estradiol hemihydrate in a multipolymeric adhesive. The system is designed to release estradiol continuously upon application to intact skin. Five dosage strengths of estradiol transdermal system (twice-weekly) are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol per day via the skin. Each corresponding system has an active surface area of 2.5, 3.75, 5.0, 7.5, or 10.0 cm2 and contains estradiol, USP hemihydrate equivalent to 0.41, 0.62, 0.82, 1.23, or 1.64 mg of estradiol, respectively. The composition of the systems per unit area is identical. Estradiol, USP hemihydrate is a white, crystalline powder, chemically described as Estra-1,3,5(10)-triene-3,17β-diol-hemihydrate. The structural formula is. The molecular formula of estradiol hemihydrate is C18H24O2 ½ H2O. The molecular weight is 281.39. Meets USP Drug Release Test 4. Estradiol transdermal system (twice-weekly) is comprised of 3 layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) a translucent polyolefin film printed with brown ink, (2) an adhesive formulation containing estradiol, silicone adhesive, acrylic adhesive, dipropylene glycol, povidone and oleyl alcohol, and (3) an oversized slit polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol. The remaining components of the system are pharmacologically inactive.</Description>
</NDC>
<NDC>
<NDCCode>0378-4642-26</NDCCode>
<PackageDescription>8 POUCH in 1 CARTON (0378-4642-26) / 1 PATCH in 1 POUCH (0378-4642-16) / 3.5 d in 1 PATCH</PackageDescription>
<NDC11Code>00378-4642-26</NDC11Code>
<ProductNDC>0378-4642</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Estradiol</ProprietaryName>
<NonProprietaryName>Estradiol</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20141219</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201675</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ESTRADIOL</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>mg/d</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Estradiol transdermal system (twice-weekly) is indicated for.</IndicationAndUsage>
<Description>Estradiol Transdermal System, USP (twice-weekly) contains estradiol hemihydrate in a multipolymeric adhesive. The system is designed to release estradiol continuously upon application to intact skin. Five dosage strengths of estradiol transdermal system (twice-weekly) are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol per day via the skin. Each corresponding system has an active surface area of 2.5, 3.75, 5.0, 7.5, or 10.0 cm2 and contains estradiol, USP hemihydrate equivalent to 0.41, 0.62, 0.82, 1.23, or 1.64 mg of estradiol, respectively. The composition of the systems per unit area is identical. Estradiol, USP hemihydrate is a white, crystalline powder, chemically described as Estra-1,3,5(10)-triene-3,17β-diol-hemihydrate. The structural formula is. The molecular formula of estradiol hemihydrate is C18H24O2 ½ H2O. The molecular weight is 281.39. Meets USP Drug Release Test 4. Estradiol transdermal system (twice-weekly) is comprised of 3 layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) a translucent polyolefin film printed with brown ink, (2) an adhesive formulation containing estradiol, silicone adhesive, acrylic adhesive, dipropylene glycol, povidone and oleyl alcohol, and (3) an oversized slit polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol. The remaining components of the system are pharmacologically inactive.</Description>
</NDC>
<NDC>
<NDCCode>0378-4643-26</NDCCode>
<PackageDescription>8 POUCH in 1 CARTON (0378-4643-26) / 1 PATCH in 1 POUCH (0378-4643-16) / 3.5 d in 1 PATCH</PackageDescription>
<NDC11Code>00378-4643-26</NDC11Code>
<ProductNDC>0378-4643</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Estradiol</ProprietaryName>
<NonProprietaryName>Estradiol</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20141219</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201675</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ESTRADIOL</SubstanceName>
<StrengthNumber>.0375</StrengthNumber>
<StrengthUnit>mg/d</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Estradiol transdermal system (twice-weekly) is indicated for.</IndicationAndUsage>
<Description>Estradiol Transdermal System, USP (twice-weekly) contains estradiol hemihydrate in a multipolymeric adhesive. The system is designed to release estradiol continuously upon application to intact skin. Five dosage strengths of estradiol transdermal system (twice-weekly) are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol per day via the skin. Each corresponding system has an active surface area of 2.5, 3.75, 5.0, 7.5, or 10.0 cm2 and contains estradiol, USP hemihydrate equivalent to 0.41, 0.62, 0.82, 1.23, or 1.64 mg of estradiol, respectively. The composition of the systems per unit area is identical. Estradiol, USP hemihydrate is a white, crystalline powder, chemically described as Estra-1,3,5(10)-triene-3,17β-diol-hemihydrate. The structural formula is. The molecular formula of estradiol hemihydrate is C18H24O2 ½ H2O. The molecular weight is 281.39. Meets USP Drug Release Test 4. Estradiol transdermal system (twice-weekly) is comprised of 3 layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) a translucent polyolefin film printed with brown ink, (2) an adhesive formulation containing estradiol, silicone adhesive, acrylic adhesive, dipropylene glycol, povidone and oleyl alcohol, and (3) an oversized slit polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol. The remaining components of the system are pharmacologically inactive.</Description>
</NDC>
<NDC>
<NDCCode>0378-4644-26</NDCCode>
<PackageDescription>8 POUCH in 1 CARTON (0378-4644-26) / 1 PATCH in 1 POUCH (0378-4644-16) / 3.5 d in 1 PATCH</PackageDescription>
<NDC11Code>00378-4644-26</NDC11Code>
<ProductNDC>0378-4644</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Estradiol</ProprietaryName>
<NonProprietaryName>Estradiol</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20141219</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201675</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ESTRADIOL</SubstanceName>
<StrengthNumber>.025</StrengthNumber>
<StrengthUnit>mg/d</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Estradiol transdermal system (twice-weekly) is indicated for.</IndicationAndUsage>
<Description>Estradiol Transdermal System, USP (twice-weekly) contains estradiol hemihydrate in a multipolymeric adhesive. The system is designed to release estradiol continuously upon application to intact skin. Five dosage strengths of estradiol transdermal system (twice-weekly) are available to provide nominal in vivo delivery rates of 0.025, 0.0375, 0.05, 0.075, or 0.1 mg of estradiol per day via the skin. Each corresponding system has an active surface area of 2.5, 3.75, 5.0, 7.5, or 10.0 cm2 and contains estradiol, USP hemihydrate equivalent to 0.41, 0.62, 0.82, 1.23, or 1.64 mg of estradiol, respectively. The composition of the systems per unit area is identical. Estradiol, USP hemihydrate is a white, crystalline powder, chemically described as Estra-1,3,5(10)-triene-3,17β-diol-hemihydrate. The structural formula is. The molecular formula of estradiol hemihydrate is C18H24O2 ½ H2O. The molecular weight is 281.39. Meets USP Drug Release Test 4. Estradiol transdermal system (twice-weekly) is comprised of 3 layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are (1) a translucent polyolefin film printed with brown ink, (2) an adhesive formulation containing estradiol, silicone adhesive, acrylic adhesive, dipropylene glycol, povidone and oleyl alcohol, and (3) an oversized slit polyester release liner which is attached to the adhesive surface and must be removed before the system can be used. The active component of the system is estradiol. The remaining components of the system are pharmacologically inactive.</Description>
</NDC>
<NDC>
<NDCCode>0378-5510-93</NDCCode>
<PackageDescription>30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (0378-5510-93) </PackageDescription>
<NDC11Code>00378-5510-93</NDC11Code>
<ProductNDC>0378-5510</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140512</StartMarketingDate>
<EndMarketingDate>20251130</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202285</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20140512</StartMarketingDatePackage>
<EndMarketingDatePackage>20251130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olanzapine orally disintegrating tablets are an atypical antipsychotic indicated:. As oral formulation for the: : 1 Treatment of schizophrenia. (1.1)Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1) Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1), 2 Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2)Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2)Adolescents (ages 13-17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2) , 3 Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3) , 4 Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2) Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated. .</IndicationAndUsage>
<Description>Olanzapine orally disintegrating tablets, USP are an atypical antipsychotic that belong to the thienobenzodiazepine class. The chemical designation is 2-Methyl-4-(4-methyl-1-piperazinyl)-10H-thieno-[2,3-b][1,5] benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine, USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine orally disintegrating tablets are intended for oral administration only. Each orally disintegrating tablet contains olanzapine equivalent to 5 mg (16 µmol), 10 mg (32 µmol), 15 mg (48 µmol) or 20 mg (64 µmol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. Olanzapine orally disintegrating tablets also contain the following inactive ingredients: aspartame, colloidal silicon dioxide, crospovidone, guar gum, magnesium stearate, mannitol, microcrystalline cellulose and sodium lauryl sulfate. Meets USP Disintegration Test 2.</Description>
</NDC>
<NDC>
<NDCCode>0378-5511-93</NDCCode>
<PackageDescription>30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (0378-5511-93) </PackageDescription>
<NDC11Code>00378-5511-93</NDC11Code>
<ProductNDC>0378-5511</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140512</StartMarketingDate>
<EndMarketingDate>20251130</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202285</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20140512</StartMarketingDatePackage>
<EndMarketingDatePackage>20251130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olanzapine orally disintegrating tablets are an atypical antipsychotic indicated:. As oral formulation for the: : 1 Treatment of schizophrenia. (1.1)Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1) Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1), 2 Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2)Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2)Adolescents (ages 13-17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2) , 3 Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3) , 4 Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2) Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated. .</IndicationAndUsage>
<Description>Olanzapine orally disintegrating tablets, USP are an atypical antipsychotic that belong to the thienobenzodiazepine class. The chemical designation is 2-Methyl-4-(4-methyl-1-piperazinyl)-10H-thieno-[2,3-b][1,5] benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine, USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine orally disintegrating tablets are intended for oral administration only. Each orally disintegrating tablet contains olanzapine equivalent to 5 mg (16 µmol), 10 mg (32 µmol), 15 mg (48 µmol) or 20 mg (64 µmol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. Olanzapine orally disintegrating tablets also contain the following inactive ingredients: aspartame, colloidal silicon dioxide, crospovidone, guar gum, magnesium stearate, mannitol, microcrystalline cellulose and sodium lauryl sulfate. Meets USP Disintegration Test 2.</Description>
</NDC>
<NDC>
<NDCCode>0378-5512-93</NDCCode>
<PackageDescription>30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (0378-5512-93) </PackageDescription>
<NDC11Code>00378-5512-93</NDC11Code>
<ProductNDC>0378-5512</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140512</StartMarketingDate>
<EndMarketingDate>20260131</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202285</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20140512</StartMarketingDatePackage>
<EndMarketingDatePackage>20260131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olanzapine orally disintegrating tablets are an atypical antipsychotic indicated:. As oral formulation for the: : 1 Treatment of schizophrenia. (1.1)Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1) Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1), 2 Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2)Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2)Adolescents (ages 13-17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2) , 3 Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3) , 4 Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2) Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated. .</IndicationAndUsage>
<Description>Olanzapine orally disintegrating tablets, USP are an atypical antipsychotic that belong to the thienobenzodiazepine class. The chemical designation is 2-Methyl-4-(4-methyl-1-piperazinyl)-10H-thieno-[2,3-b][1,5] benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine, USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine orally disintegrating tablets are intended for oral administration only. Each orally disintegrating tablet contains olanzapine equivalent to 5 mg (16 µmol), 10 mg (32 µmol), 15 mg (48 µmol) or 20 mg (64 µmol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. Olanzapine orally disintegrating tablets also contain the following inactive ingredients: aspartame, colloidal silicon dioxide, crospovidone, guar gum, magnesium stearate, mannitol, microcrystalline cellulose and sodium lauryl sulfate. Meets USP Disintegration Test 2.</Description>
</NDC>
<NDC>
<NDCCode>0378-5513-93</NDCCode>
<PackageDescription>30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (0378-5513-93) </PackageDescription>
<NDC11Code>00378-5513-93</NDC11Code>
<ProductNDC>0378-5513</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140512</StartMarketingDate>
<EndMarketingDate>20260131</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202285</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20140512</StartMarketingDatePackage>
<EndMarketingDatePackage>20260131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olanzapine orally disintegrating tablets are an atypical antipsychotic indicated:. As oral formulation for the: : 1 Treatment of schizophrenia. (1.1)Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1) Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1), 2 Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2)Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2)Adolescents (ages 13-17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2) , 3 Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3) , 4 Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2) Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated. .</IndicationAndUsage>
<Description>Olanzapine orally disintegrating tablets, USP are an atypical antipsychotic that belong to the thienobenzodiazepine class. The chemical designation is 2-Methyl-4-(4-methyl-1-piperazinyl)-10H-thieno-[2,3-b][1,5] benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine, USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine orally disintegrating tablets are intended for oral administration only. Each orally disintegrating tablet contains olanzapine equivalent to 5 mg (16 µmol), 10 mg (32 µmol), 15 mg (48 µmol) or 20 mg (64 µmol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. Olanzapine orally disintegrating tablets also contain the following inactive ingredients: aspartame, colloidal silicon dioxide, crospovidone, guar gum, magnesium stearate, mannitol, microcrystalline cellulose and sodium lauryl sulfate. Meets USP Disintegration Test 2.</Description>
</NDC>
<NDC>
<NDCCode>0904-6989-30</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0904-6989-30) > 30 g in 1 TUBE</PackageDescription>
<NDC11Code>00904-6989-30</NDC11Code>
<ProductNDC>0904-6989</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine And Prilocaine</ProprietaryName>
<NonProprietaryName>Lidocaine And Prilocaine</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190506</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205887</ApplicationNumber>
<LabelerName>MAJOR Pharmaceuticals</LabelerName>
<SubstanceName>LIDOCAINE; PRILOCAINE</SubstanceName>
<StrengthNumber>25; 25</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE],Amide Local Anesthetic [EPC],Amides [CS],Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-10-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0904-6989-31</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0904-6989-31) > 30 g in 1 TUBE</PackageDescription>
<NDC11Code>00904-6989-31</NDC11Code>
<ProductNDC>0904-6989</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine And Prilocaine</ProprietaryName>
<NonProprietaryName>Lidocaine And Prilocaine</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190506</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205887</ApplicationNumber>
<LabelerName>MAJOR Pharmaceuticals</LabelerName>
<SubstanceName>LIDOCAINE; PRILOCAINE</SubstanceName>
<StrengthNumber>25; 25</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amide Local Anesthetic [EPC], Amides [CS], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE], Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lidocaine and Prilocaine Cream USP, 2.5%/2.5% (a eutectic mixture of lidocaine 2.5% and prilocaine 2.5%) is indicated as a topical anesthetic for use on: 1 -normal intact skin for local analgesia., 2 -Genital mucous membranes for superficial minor surgery and as pretreatment for infiltration anesthesia.</IndicationAndUsage>
<Description>Lidocaine and Prilocaine Cream USP, 2.5%/2.5% is an emulsion in which the oil phase is a eutectic mixture of lidocaine and prilocaine in a ratio of 1:1 by weight. This eutectic mixture has a melting point below room temperature and therefore both local anesthetics exist as a liquid oil rather than as crystals. It is packaged in 5 gram and 30 gram tubes. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), has an octanol: water partition ratio of 43 at pH 7.4, and has the following structure. Prilocaine is chemically designated as propanamide, N-(2-methylphenyl)-2-(propylamino), has an octanol: water partition ratio of 25 at pH 7.4, and has the following structure. Each gram of lidocaine and prilocaine cream, 2.5%/2.5% contains lidocaine 25 mg, prilocaine 25 mg, PEG-60 hydrogenated castor oil (as emulsifiers), carboxypolymethylene (as a thickening agent), sodium hydroxide to adjust to a pH approximating 9, and purified water to 1 gram. Lidocaine and prilocaine cream, 2.5%/2.5% contains no preservative, however it passes the USP antimicrobial effectiveness test due to the pH. The specific gravity of lidocaine and prilocaine cream, 2.5%/2.5% is 1.00.</Description>
</NDC>
<NDC>
<NDCCode>50090-6989-0</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (50090-6989-0) </PackageDescription>
<NDC11Code>50090-6989-00</NDC11Code>
<ProductNDC>50090-6989</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rosuvastatin Calcium</ProprietaryName>
<NonProprietaryName>Rosuvastatin Calcium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171122</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208898</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>ROSUVASTATIN CALCIUM</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rosuvastatin tablets are indicated: 1 To reduce the risk of stroke, myocardial infarction, and arterial revascularization procedures in adults without established coronary heart disease who are at increased risk of cardiovascular (CV) disease based on age, hsCRP ≥2 mg/L, and at least one additional CV risk factor. , 2 As an adjunct to diet to: o Reduce LDL-C in adults with primary hyperlipidemia. o Reduce low-density lipoprotein cholesterol (LDL-C) and slow the progression of atherosclerosis in adults. o Reduce LDL-C in adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH). , 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 7 years and older with homozygous familial hypercholesterolemia (HoFH). , 4 As an adjunct to diet for the treatment of adults with: o Primary dysbetalipoproteinemia. o Hypertriglyceridemia. .</IndicationAndUsage>
<Description>Rosuvastatin calcium, USP is a 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA)-reductase inhibitor. The chemical name for rosuvastatin calcium is bis [(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2- [methyl (methylsulfonyl) amino] pyrimidin-5-yl] (3R, 5S)-3, 5-dihydroxyhept-6-enoic acid] calcium salt with the following structural formula. The molecular formula for rosuvastatin calcium, USP is (C22H27FN3O6S)2 Ca and the molecular weight is 1001.14. Rosuvastatin calcium is a white amorphous powder that is sparingly soluble in water and methanol, and slightly soluble in ethanol. Rosuvastatin calcium is a hydrophilic compound with a partition coefficient (octanol/water) of 0.13 at pH of 7.0. Rosuvastatin tablets, USP for oral use contain rosuvastatin 5 mg, 10 mg, 20 mg, or 40 mg (equivalent to 5.2 mg, 10.4 mg, 20.8 mg, and 41.6 mg rosuvastatin calcium) and the following inactive ingredients: crospovidone, hypromellose, lactose monohydrate, magnesium stearate, mannitol, meglumine, microcrystalline cellulose, pregelatinized starch, titanium dioxide and triacetin. Additionally, 10 mg, 20 mg and 40 mg tablets contain FD&C red No. 40/allura red AC aluminum lake, FD&C blue No. 2/indigo carmine aluminum lake and FD&C yellow No.6/sunset yellow FCF aluminum lake. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>51393-6989-1</NDCCode>
<PackageDescription>11 mL in 1 BOTTLE, DISPENSING (51393-6989-1) </PackageDescription>
<NDC11Code>51393-6989-01</NDC11Code>
<ProductNDC>51393-6989</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nail Fungus Control</ProprietaryName>
<ProprietaryNameSuffix>Extra Strength</ProprietaryNameSuffix>
<NonProprietaryName>Calendula Officinalis Flowering Top, Silicon Dioxide, And Hypericum Perforatum</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110406</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>�Forces of Nature</LabelerName>
<SubstanceName>CALENDULA OFFICINALIS FLOWERING TOP; SILICON DIOXIDE; HYPERICUM PERFORATUM WHOLE</SubstanceName>
<StrengthNumber>8; 8; 8</StrengthNumber>
<StrengthUnit>[hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-06-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110406</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the relief and treatment of pain, soreness and inflammation from nail fungus. Symptoms: Discolored nails, Brittle nails, Distorted nails.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>51393-6989-2</NDCCode>
<PackageDescription>33 mL in 1 BOTTLE, DISPENSING (51393-6989-2) </PackageDescription>
<NDC11Code>51393-6989-02</NDC11Code>
<ProductNDC>51393-6989</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nail Fungus Control</ProprietaryName>
<ProprietaryNameSuffix>Extra Strength</ProprietaryNameSuffix>
<NonProprietaryName>Calendula Officinalis Flowering Top, Silicon Dioxide, And Hypericum Perforatum</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110406</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>�Forces of Nature</LabelerName>
<SubstanceName>CALENDULA OFFICINALIS FLOWERING TOP; SILICON DIOXIDE; HYPERICUM PERFORATUM WHOLE</SubstanceName>
<StrengthNumber>8; 8; 8</StrengthNumber>
<StrengthUnit>[hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-06-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110406</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the relief and treatment of pain, soreness and inflammation from nail fungus. Symptoms: Discolored nails, Brittle nails, Distorted nails.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>51393-6989-3</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DISPENSING (51393-6989-3) </PackageDescription>
<NDC11Code>51393-6989-03</NDC11Code>
<ProductNDC>51393-6989</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nail Fungus Control</ProprietaryName>
<ProprietaryNameSuffix>Extra Strength</ProprietaryNameSuffix>
<NonProprietaryName>Calendula Officinalis Flowering Top, Silicon Dioxide, And Hypericum Perforatum</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110406</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>�Forces of Nature</LabelerName>
<SubstanceName>CALENDULA OFFICINALIS FLOWERING TOP; SILICON DIOXIDE; HYPERICUM PERFORATUM WHOLE</SubstanceName>
<StrengthNumber>8; 8; 8</StrengthNumber>
<StrengthUnit>[hp_X]/1000mL; [hp_X]/1000mL; [hp_X]/1000mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-06-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the relief and treatment of pain, soreness and inflammation from nail fungus. Symptoms: Discolored nails, Brittle nails, Distorted nails.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55154-6989-8</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 BAG (55154-6989-8) > 1 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>55154-6989-08</NDC11Code>
<ProductNDC>55154-6989</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Heparin Sodium</ProprietaryName>
<NonProprietaryName>Heparin Sodium</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20090831</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090571</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>HEPARIN SODIUM</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>[USP'U]/mL</StrengthUnit>
<Pharm_Classes>Anti-coagulant [EPC],Heparin [Chemical/Ingredient],Unfractionated Heparin [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-11-03</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>62106-6989-4</NDCCode>
<PackageDescription>10 TUBE in 1 CARTON (62106-6989-4) > 140 GRANULE in 1 TUBE</PackageDescription>
<NDC11Code>62106-6989-04</NDC11Code>
<ProductNDC>62106-6989</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Duodeninum</ProprietaryName>
<NonProprietaryName>Duodenum</NonProprietaryName>
<DosageFormName>GRANULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151201</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Seroyal USA</LabelerName>
<SubstanceName>ORYCTOLAGUS CUNICULUS DUODENUM</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-09-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62670-6989-2</NDCCode>
<PackageDescription>29 mL in 1 BOTTLE, SPRAY (62670-6989-2) </PackageDescription>
<NDC11Code>62670-6989-02</NDC11Code>
<ProductNDC>62670-6989</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti-bacterialhandspray</ProprietaryName>
<ProprietaryNameSuffix>Raspberry Tangerine</ProprietaryNameSuffix>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20251117</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Bath & Body Works, Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>72</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-03-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251117</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>