RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>68462-625-94</NDCCode>
    <PackageDescription>100 g in 1 CAN (68462-625-94) </PackageDescription>
    <NDC11Code>68462-0625-94</NDC11Code>
    <ProductNDC>68462-625</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Clobetasol Propionate</ProprietaryName>
    <NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
    <DosageFormName>AEROSOL, FOAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20190909</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211450</ApplicationNumber>
    <LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
    <SubstanceName>CLOBETASOL PROPIONATE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190909</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Clobetasol propionate emulsion foam is indicated for the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years and older.</IndicationAndUsage>
    <Description>Clobetasol Propionate Emulsion Foam, 0.05% is a white to off-white emulsion aerosol foam containing the active ingredient clobetasol propionate, USP, a synthetic corticosteroid for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Clobetasol propionate, USP is 21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate, with the empirical formula C25H32ClFO5, and a molecular weight of 467 g/mol. The following is the chemical structure. Clobetasol Propionate, USP. Clobetasol propionate, USP is a white to almost white crystalline powder, practically insoluble in water, slightly soluble in benzene and diethyl ether; sparingly soluble in ethanol; freely soluble in acetone, in dimethylsulfoxide, in chloroform, in methanol and in dioxane. Each gram of Clobetasol Propionate Emulsion Foam, 0.05% contains 0.5 mg clobetasol propionate, USP. The foam also contains anhydrous citric acid, cetyl alcohol, cyclomethicone, isopropyl myristate, light mineral oil, polyoxyl-20 cetostearyl ether, potassium citrate, propylene glycol, purified water, sorbitan monolaurate, white petrolatum, and phenoxyethanol as a preservative. Clobetasol Propionate Emulsion Foam is dispensed from an aluminum can pressurized with a hydrocarbon (propane/butane) propellant.</Description>
  </NDC>
  <NDC>
    <NDCCode>68462-625-27</NDCCode>
    <PackageDescription>50 g in 1 CAN (68462-625-27) </PackageDescription>
    <NDC11Code>68462-0625-27</NDC11Code>
    <ProductNDC>68462-625</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Clobetasol Propionate</ProprietaryName>
    <NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
    <DosageFormName>AEROSOL, FOAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20190909</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211450</ApplicationNumber>
    <LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
    <SubstanceName>CLOBETASOL PROPIONATE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190909</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Clobetasol propionate emulsion foam is indicated for the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 12 years and older.</IndicationAndUsage>
    <Description>Clobetasol Propionate Emulsion Foam, 0.05% is a white to off-white emulsion aerosol foam containing the active ingredient clobetasol propionate, USP, a synthetic corticosteroid for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Clobetasol propionate, USP is 21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate, with the empirical formula C25H32ClFO5, and a molecular weight of 467 g/mol. The following is the chemical structure. Clobetasol Propionate, USP. Clobetasol propionate, USP is a white to almost white crystalline powder, practically insoluble in water, slightly soluble in benzene and diethyl ether; sparingly soluble in ethanol; freely soluble in acetone, in dimethylsulfoxide, in chloroform, in methanol and in dioxane. Each gram of Clobetasol Propionate Emulsion Foam, 0.05% contains 0.5 mg clobetasol propionate, USP. The foam also contains anhydrous citric acid, cetyl alcohol, cyclomethicone, isopropyl myristate, light mineral oil, polyoxyl-20 cetostearyl ether, potassium citrate, propylene glycol, purified water, sorbitan monolaurate, white petrolatum, and phenoxyethanol as a preservative. Clobetasol Propionate Emulsion Foam is dispensed from an aluminum can pressurized with a hydrocarbon (propane/butane) propellant.</Description>
  </NDC>
  <NDC>
    <NDCCode>49035-625-94</NDCCode>
    <PackageDescription>118 mL in 1 CONTAINER (49035-625-94) </PackageDescription>
    <NDC11Code>49035-0625-94</NDC11Code>
    <ProductNDC>49035-625</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Equate Itch Relief Gel</ProprietaryName>
    <NonProprietaryName>Itch Relief Gel</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20181220</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M017</ApplicationNumber>
    <LabelerName>Walmart, Inc</LabelerName>
    <SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/100mL</StrengthUnit>
    <Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181220</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Temporarily relieves pain due to: Minor burns, insect bites, sunburn, minor skin irritation, minor cuts, scrapes, rashes due to poison ivy, poison oak and poison sumac.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>61314-625-94</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (61314-625-94)  / .05 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>61314-0625-94</NDC11Code>
    <ProductNDC>61314-625</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Cimerli</ProprietaryName>
    <NonProprietaryName>Ranibizumab-eqrn</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVITREAL</RouteName>
    <StartMarketingDate>20241212</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761165</ApplicationNumber>
    <LabelerName>Sandoz Inc</LabelerName>
    <SubstanceName>RANIBIZUMAB</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/.05mL</StrengthUnit>
    <Pharm_Classes>Vascular Endothelial Growth Factor Inhibitor [EPC], Vascular Endothelial Growth Factor Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-08-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241212</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>CIMERLI is indicated for the treatment of patients with.</IndicationAndUsage>
    <Description>Ranibizumab-eqrn is a recombinant humanized IgG1 kappa isotype monoclonal antibody fragment designed for intraocular use. Ranibizumab-eqrn binds to and inhibits the biologic activity of human vascular endothelial growth factor A (VEGF-A). Ranibizumab-eqrn, which lacks an Fc region, has a molecular weight of approximately 48 kilodaltons and is produced by an E. coli expression system. CIMERLI (ranibizumab-eqrn) injection is a sterile, colorless to pale yellow solution in a single-dose glass vial for intravitreal injection. CIMERLI is supplied as a preservative-free, sterile solution in a single-dose container designed to deliver 0.05 mL of 10 mg/mL ranibizumab-eqrn (0.5 mg dose vial) or 6 mg/mL ranibizumab-eqrn (0.3 mg dose vial) aqueous solution with 10 mM histidine HCl, 10% α,α trehalose dihydrate, 0.01% polysorbate 20, pH 5.5.</Description>
  </NDC>
  <NDC>
    <NDCCode>68462-355-94</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (68462-355-94)  / 100 g in 1 TUBE</PackageDescription>
    <NDC11Code>68462-0355-94</NDC11Code>
    <ProductNDC>68462-355</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Diclofenac Sodium</ProprietaryName>
    <NonProprietaryName>Diclofenac Sodium</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20160913</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208301</ApplicationNumber>
    <LabelerName>GLENMARK PHARMACEUTICALS INC., USA</LabelerName>
    <SubstanceName>DICLOFENAC SODIUM</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160913</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Diclofenac sodium gel is indicated for the topical treatment of actinic keratoses (AK).</IndicationAndUsage>
    <Description>Diclofenac Sodium Topical Gel, 3%, intended for dermatologic use, contains the active ingredient, diclofenac sodium, USP in a clear, transparent, colorless to slightly yellow gel base. Diclofenac sodium, USP is a white to slightly yellowish, hygroscopic crystalline powder, and melts at about 284°C. It is freely soluble in methanol, soluble in ethanol, sparingly soluble in water, slightly soluble in acetone, and partially insoluble in chloroform and ether. The chemical name for diclofenac sodium is. Sodium [o-(2,6-dichloranilino) phenyl] acetate. Diclofenac sodium has a molecular weight of 318.13. The CAS number is CAS-15307-79-6. The structural formula is represented below. Diclofenac Sodium Gel, 3% also contains benzyl alcohol, sodium hyaluronate, polyethylene glycol monomethyl ether, and purified water. 1 g of Diclofenac Sodium Topical Gel, 3% contains 30 mg of the active substance, diclofenac sodium, USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>68462-455-94</NDCCode>
    <PackageDescription>100 g in 1 TUBE (68462-455-94) </PackageDescription>
    <NDC11Code>68462-0455-94</NDC11Code>
    <ProductNDC>68462-455</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ciclopirox</ProprietaryName>
    <NonProprietaryName>Ciclopirox</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20120229</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091595</ApplicationNumber>
    <LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
    <SubstanceName>CICLOPIROX</SubstanceName>
    <StrengthNumber>7.7</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Decreased DNA Replication [PE], Decreased Protein Synthesis [PE], Decreased RNA Replication [PE], Protein Synthesis Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20120229</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Superficial Dermatophyte Infections. Ciclopirox gel is indicated for the topical treatment of interdigital tinea pedis and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum. Seborrheic Dermatitis. Ciclopirox gel is indicated for the topical treatment of seborrheic dermatitis of the scalp.</IndicationAndUsage>
    <Description>Ciclopirox gel 0.77% contains a synthetic antifungal agent, ciclopirox USP. It is intended for topical dermatologic use only. Each gram of ciclopirox gel contains 7.70 mg of ciclopirox USP in a gel consisting of carbomer 940, isopropyl alcohol, and medium chain triglycerides, sodium hydroxide, sodium lauryl sulfate, and purified water. Ciclopirox gel is a white, slightly fluid gel. The chemical name for ciclopirox USP is 6-cyclohexyl-1-hydroxy-4-methyl-2(1H)-pyridinone, with the empirical formula C12H17NO2 and a molecular weight of 207.27. The CAS Registry Number is [29342-05-0]. The chemical structure is.</Description>
  </NDC>
  <NDC>
    <NDCCode>68462-534-94</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (68462-534-94)  / 100 g in 1 TUBE</PackageDescription>
    <NDC11Code>68462-0534-94</NDC11Code>
    <ProductNDC>68462-534</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tacrolimus</ProprietaryName>
    <NonProprietaryName>Tacrolimus</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20180416</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210393</ApplicationNumber>
    <LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
    <SubstanceName>TACROLIMUS</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180416</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tacrolimus ointment, both 0.03% and 0.1% for adults, and only 0.03% for children aged 2 to 15 years, is indicated as second-line therapy for the short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised adults and children who have failed to respond adequately to other topical prescription treatments for atopic dermatitis, or when those treatments are not advisable. Tacrolimus ointment is not indicated for children younger than 2 years of age (see boxed WARNING, WARNINGS and PRECAUTIONS: Pediatric Use).</IndicationAndUsage>
    <Description>Tacrolimus Ointment contains tacrolimus, USP a macrolide immunosuppressant produced by Streptomyces tsukubaensis. It is for topical dermatologic use only. Chemically, tacrolimus, USP is designated as (-)-(3S,4R,5S,8R,9E,12S,14S,15R,16S,18R,19R,26aS)-8-Allyl-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[(E)-2-[(1R,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylvinyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-15,19-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone,monohydrate. It has the following structural formula. Tacrolimus, USP has a molecular formula of C44H69NO12H2O and a formula weight of 822.03. Each gram of tacrolimus ointment contains either 0.03% or 0.1% w/w of tacrolimus, USP in a base of mineral oil, paraffin, propylene carbonate, white petrolatum and white wax.</Description>
  </NDC>
  <NDC>
    <NDCCode>68462-605-94</NDCCode>
    <PackageDescription>1 CAN in 1 CARTON (68462-605-94)  / 100 g in 1 CAN</PackageDescription>
    <NDC11Code>68462-0605-94</NDC11Code>
    <ProductNDC>68462-605</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Clindamycin Phosphate</ProprietaryName>
    <NonProprietaryName>Clindamycin Phosphate</NonProprietaryName>
    <DosageFormName>AEROSOL, FOAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20240123</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210778</ApplicationNumber>
    <LabelerName>GLENMARK PHARMACEUTICALS INC., USA</LabelerName>
    <SubstanceName>CLINDAMYCIN PHOSPHATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240123</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Clindamycin phosphate foam is indicated for topical application in the treatment of acne vulgaris in patients 12 years and older.</IndicationAndUsage>
    <Description>Clindamycin Phosphate Foam contains clindamycin (1%) as clindamycin phosphate, USP. Clindamycin phosphate, USP is a water-soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic, lincomycin. The chemical name for clindamycin phosphate, USP is methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo-α-D-galacto-octopyranoside 2-(dihydrogen phosphate). The structural formula for clindamycin phosphate, USP is represented below. Molecular Formula: C18H34ClN2O8PS                                     Molecular Weight: 504.96 g/mol. Clindamycin Phosphate Foam contains clindamycin (1%) as clindamycin phosphate, USP at a concentration equivalent to 10 mg clindamycin per gram in a thermolabile hydroethanolic foam vehicle consisting of cetyl alcohol, ethanol (58%), polysorbate 60, propylene glycol, purified water, and stearyl alcohol pressurized with a hydrocarbon (propane/butane) propellant.</Description>
  </NDC>
  <NDC>
    <NDCCode>68462-608-94</NDCCode>
    <PackageDescription>100 g in 1 CAN (68462-608-94) </PackageDescription>
    <NDC11Code>68462-0608-94</NDC11Code>
    <ProductNDC>68462-608</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Clobetasol Propionate</ProprietaryName>
    <NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
    <DosageFormName>AEROSOL, FOAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20190216</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210809</ApplicationNumber>
    <LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
    <SubstanceName>CLOBETASOL PROPIONATE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190216</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Clobetasol propionate foam is a corticosteroid indicated for treatment of moderate to severe plaque psoriasis of the scalp and mild to moderate plaque psoriasis of non-scalp regions of the body excluding the face and intertriginous areas in patients 12 years and older.</IndicationAndUsage>
    <Description>Clobetasol Propionate Foam, 0.05%, is a white thermolabile hydroethanolic aerosol foam containing the active ingredient, clobetasol propionate, USP, a synthetic corticosteroid, for topical use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Clobetasol propionate, USP is 21-chloro-9-fluoro-11ß,17-dihydroxy-16ß-methylpregna-1,4-diene-3,20-dione 17-propionate, with the molecular formula C25H32CIFO5, a molecular weight of 466.97 g/mol. The following is the chemical structure. Clobetasol propionate, USP is a white to almost white crystalline powder, practically insoluble in water, slightly soluble in benzene and diethyl ether; sparingly soluble in ethanol; freely soluble in acetone, in dimethylsulfoxide, in chloroform, in methanol and in dioxane. Each gram of Clobetasol Propionate Foam, 0.05% contains 0.5 mg clobetasol propionate, USP. The foam also contains cetyl alcohol, citric acid, ethanol (60%), polysorbate 60, potassium citrate, propylene glycol, purified water, and stearyl alcohol pressurized with a hydrocarbon (propane/butane) propellant.</Description>
  </NDC>
  <NDC>
    <NDCCode>68462-609-94</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (68462-609-94)  / 100 g in 1 TUBE</PackageDescription>
    <NDC11Code>68462-0609-94</NDC11Code>
    <ProductNDC>68462-609</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pimecrolimus</ProprietaryName>
    <NonProprietaryName>Pimecrolimus</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20190829</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211769</ApplicationNumber>
    <LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
    <SubstanceName>PIMECROLIMUS</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190829</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pimecrolimus cream, 1% is indicated as second-line therapy for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adults and children 2 years of age and older, who have failed to respond adequately to other topical prescription treatments, or when those treatments are not advisable. Pimecrolimus cream, 1% is not indicated for use in children less than 2 years of age [see Warnings and Precautions (5.1), Use in Specific Populations (8.4)].</IndicationAndUsage>
    <Description>Pimecrolimus Cream, 1%, for topical use, contains the compound pimecrolimus, the immunosuppressant 33-epi-chloro-derivative of the macrolactam ascomycin. Chemically, pimecrolimus is (1R,9S,12S,13S,14S,17R,21S,23S,24R,25S,27R)-12-[(1E)-1-[(1R,3R,4S)-4-chloro-3-methoxycyclohexyl]prop-1-en-2-yl]-17-ethyl-1,14-dihydroxy-23,25-dimethoxy-13,19, 21,27-tetramethyl-11,28-dioxa-4-azatricyclo[22.3.1.04,9]octacos-18-ene-2,3,10,16-tetrone. The compound has the empirical formula C43H68CINO11 and the molecular weight of 810.45. The structural formula is. Pimecrolimus is a white to off-white powder. It is freely soluble in methylethylketone, methylisobutylketone, dichloromethane and tetrahydrofuran, soluble in acetone, methanol, ethanol, acetonitrile and toluene, sparingly soluble in isopropanol and practically insoluble in water. Each gram of Pimecrolimus Cream, 1% contains 10 mg of pimecrolimus in a white to off-white cream base of benzyl alcohol, cetyl alcohol, citric acid anhydrous, mono- and di-glycerides, oleyl alcohol, propylene glycol, purified water, sodium cetostearyl sulfate, sodium hydroxide, stearyl alcohol, and triglycerides.</Description>
  </NDC>
  <NDC>
    <NDCCode>68462-881-94</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (68462-881-94)  / 100 g in 1 TUBE</PackageDescription>
    <NDC11Code>68462-0881-94</NDC11Code>
    <ProductNDC>68462-881</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tacrolimus</ProprietaryName>
    <NonProprietaryName>Tacrolimus</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20230816</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210393</ApplicationNumber>
    <LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
    <SubstanceName>TACROLIMUS</SubstanceName>
    <StrengthNumber>.3</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230816</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tacrolimus ointment, both 0.03% and 0.1% for adults, and only 0.03% for children aged 2 to 15 years, is indicated as second-line therapy for the short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised adults and children who have failed to respond adequately to other topical prescription treatments for atopic dermatitis, or when those treatments are not advisable. Tacrolimus ointment is not indicated for children younger than 2 years of age (see boxed WARNING, WARNINGS and PRECAUTIONS: Pediatric Use).</IndicationAndUsage>
    <Description>Tacrolimus Ointment contains tacrolimus, USP a macrolide immunosuppressant produced by Streptomyces tsukubaensis. It is for topical dermatologic use only. Chemically, tacrolimus, USP is designated as (-)-(3S,4R,5S,8R,9E,12S,14S,15R,16S,18R,19R,26aS)-8-Allyl-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[(E)-2-[(1R,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylvinyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-15,19-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone,monohydrate. It has the following structural formula. Tacrolimus, USP has a molecular formula of C44H69NO12H2O and a formula weight of 822.03. Each gram of tacrolimus ointment contains either 0.03% or 0.1% w/w of tacrolimus, USP in a base of mineral oil, paraffin, propylene carbonate, white petrolatum and white wax.</Description>
  </NDC>
  <NDC>
    <NDCCode>68462-433-18</NDCCode>
    <PackageDescription>180 TABLET, FILM COATED in 1 BOTTLE (68462-433-18) </PackageDescription>
    <NDC11Code>68462-0433-18</NDC11Code>
    <ProductNDC>68462-433</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Colesevelam Hydrochloride</ProprietaryName>
    <NonProprietaryName>Colesevelam Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180518</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203480</ApplicationNumber>
    <LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
    <SubstanceName>COLESEVELAM HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>625</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Bile Acid Sequestrant [EPC], Bile-acid Binding Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180518</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Colesevelam hydrochloride tablets are a bile acid sequestrant indicated as an adjunct to diet and exercise to: 1 reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia (1.1)., 2 reduce LDL-C levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia (HeFH), unable to reach LDL-C target levels despite an adequate trial of diet and lifestyle modification (1.1)., 3 improve glycemic control in adults with type 2 diabetes mellitus (1.2).</IndicationAndUsage>
    <Description>Colesevelam hydrochloride is a non-absorbed, polymeric, lipid-lowering and glucose-lowering agent for oral administration. Colesevelam hydrochloride is a high-capacity bile acid-binding molecule. Colesevelam hydrochloride is poly(allylamine hydrochloride) cross-linked with epichlorohydrin and alkylated with 1-bromodecane and (6-bromohexyl)-trimethylammonium bromide. The chemical name (IUPAC) of colesevelam hydrochloride is 1-Hexaminium, N,N,N-Trimethyl-6-(2-propenylamino)-, chloride, polymer with (chloromethyl) oxirane, 2-propen-4-amine and N-2-propenyl-1-decanamine, hydrochloride. The chemical structure of colesevelam hydrochloride is represented by the following formula. wherein (a) represents allyl amine monomer units that have not been alkylated by either of the 1-bromodecane or (6-bromohexyl)-trimethylammonium bromide alkylating agents or cross-linked by epichlorohydrin; (b) represents allyl amine units that have undergone cross-linking with epichlorohydrin; (c) represents allyl amine units that have been alkylated with a decyl group; (d) represents allyl amine units that have been alkylated with a (6-trimethylammonium) hexyl group, and m represents a number ≥100 to indicate an extended polymer network. A small amount of the amines are dialkylated and are not depicted in the formula above. No regular order of the groups is implied by the structure; cross-linking and alkylation are expected to occur randomly along the polymer chains. A large amount of the amines are protonated. The polymer is depicted in the hydrochloride form; a small amount of the halides are bromide. Colesevelam hydrochloride is hydrophilic and insoluble in water. Colesevelam hydrochloride tablets are off-white to pale yellow capsule shaped, biconvex, film-coated tablets each containing 625 mg colesevelam hydrochloride. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, diacetylated monoglycerides, hypromellose, magnesium stearate, microcrystalline cellulose, and pregelatinized starch. The tablets are imprinted using a water-soluble black ink which contains ammonium hydroxide, ferric oxide black, propylene glycol and shellac.</Description>
  </NDC>
  <NDC>
    <NDCCode>68462-433-90</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (68462-433-90) </PackageDescription>
    <NDC11Code>68462-0433-90</NDC11Code>
    <ProductNDC>68462-433</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Colesevelam Hydrochloride</ProprietaryName>
    <NonProprietaryName>Colesevelam Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180518</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA203480</ApplicationNumber>
    <LabelerName>Glenmark Pharmaceuticals Inc., USA</LabelerName>
    <SubstanceName>COLESEVELAM HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>625</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Bile Acid Sequestrant [EPC], Bile-acid Binding Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-31</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180518</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Colesevelam hydrochloride tablets are a bile acid sequestrant indicated as an adjunct to diet and exercise to: 1 reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia (1.1)., 2 reduce LDL-C levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia (HeFH), unable to reach LDL-C target levels despite an adequate trial of diet and lifestyle modification (1.1)., 3 improve glycemic control in adults with type 2 diabetes mellitus (1.2).</IndicationAndUsage>
    <Description>Colesevelam hydrochloride is a non-absorbed, polymeric, lipid-lowering and glucose-lowering agent for oral administration. Colesevelam hydrochloride is a high-capacity bile acid-binding molecule. Colesevelam hydrochloride is poly(allylamine hydrochloride) cross-linked with epichlorohydrin and alkylated with 1-bromodecane and (6-bromohexyl)-trimethylammonium bromide. The chemical name (IUPAC) of colesevelam hydrochloride is 1-Hexaminium, N,N,N-Trimethyl-6-(2-propenylamino)-, chloride, polymer with (chloromethyl) oxirane, 2-propen-4-amine and N-2-propenyl-1-decanamine, hydrochloride. The chemical structure of colesevelam hydrochloride is represented by the following formula. wherein (a) represents allyl amine monomer units that have not been alkylated by either of the 1-bromodecane or (6-bromohexyl)-trimethylammonium bromide alkylating agents or cross-linked by epichlorohydrin; (b) represents allyl amine units that have undergone cross-linking with epichlorohydrin; (c) represents allyl amine units that have been alkylated with a decyl group; (d) represents allyl amine units that have been alkylated with a (6-trimethylammonium) hexyl group, and m represents a number ≥100 to indicate an extended polymer network. A small amount of the amines are dialkylated and are not depicted in the formula above. No regular order of the groups is implied by the structure; cross-linking and alkylation are expected to occur randomly along the polymer chains. A large amount of the amines are protonated. The polymer is depicted in the hydrochloride form; a small amount of the halides are bromide. Colesevelam hydrochloride is hydrophilic and insoluble in water. Colesevelam hydrochloride tablets are off-white to pale yellow capsule shaped, biconvex, film-coated tablets each containing 625 mg colesevelam hydrochloride. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, diacetylated monoglycerides, hypromellose, magnesium stearate, microcrystalline cellulose, and pregelatinized starch. The tablets are imprinted using a water-soluble black ink which contains ammonium hydroxide, ferric oxide black, propylene glycol and shellac.</Description>
  </NDC>
  <NDC>
    <NDCCode>0378-3349-99</NDCCode>
    <PackageDescription>4 POUCH in 1 CARTON (0378-3349-99)  / 1 PATCH in 1 POUCH (0378-3349-16)  / 7 d in 1 PATCH</PackageDescription>
    <NDC11Code>00378-3349-99</NDC11Code>
    <ProductNDC>0378-3349</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Estradiol</ProprietaryName>
    <NonProprietaryName>Estradiol</NonProprietaryName>
    <DosageFormName>PATCH</DosageFormName>
    <RouteName>TRANSDERMAL</RouteName>
    <StartMarketingDate>20050407</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075182</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>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20050407</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Estradiol transdermal system continuous delivery (once-weekly) is indicated for.</IndicationAndUsage>
    <Description>Estradiol transdermal system, USP continuous delivery (once-weekly) is designed to release estradiol continuously upon application to intact skin. Six (7.75, 11.625, 15.5, 18.6, 23.25 and 31 cm2) systems are available to provide nominal in vivo delivery of 0.025, 0.0375, 0.05, 0.06, 0.075 or 0.1 mg respectively of estradiol per day. The period of use is 7 days. Each system has a contact surface area of either 7.75, 11.625, 15.5, 18.6, 23.25 or 31 cm2, and contains estradiol, USP hemihydrate equivalent to 0.97, 1.46, 1.94, 2.33, 2.91 or 3.88 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. It has a molecular formula of C18 H24O2  ½ H2O and molecular weight of 281.39. The structural formula is. Meets USP Drug Release Test 2. The estradiol transdermal system continuous delivery (once-weekly) comprises four layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are. (1) A foam backing with adhesive layer. (2) A polyester film. (3) An acrylate adhesive matrix containing estradiol. (4) A protective liner of siliconized polyester film is attached to the adhesive surface and must be removed before the system can be used. The active component of the transdermal system is estradiol. The remaining components of the transdermal system (propylene glycol, povidone, anhydrous colloidal silicon dioxide, pressure sensitive acrylic adhesive, copolymer foam, polyester film, and brown ink) are pharmacologically inactive.</Description>
  </NDC>
  <NDC>
    <NDCCode>0378-3350-99</NDCCode>
    <PackageDescription>4 POUCH in 1 CARTON (0378-3350-99)  / 1 PATCH in 1 POUCH (0378-3350-16)  / 7 d in 1 PATCH</PackageDescription>
    <NDC11Code>00378-3350-99</NDC11Code>
    <ProductNDC>0378-3350</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Estradiol</ProprietaryName>
    <NonProprietaryName>Estradiol</NonProprietaryName>
    <DosageFormName>PATCH</DosageFormName>
    <RouteName>TRANSDERMAL</RouteName>
    <StartMarketingDate>20000301</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075182</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>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20000301</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Estradiol transdermal system continuous delivery (once-weekly) is indicated for.</IndicationAndUsage>
    <Description>Estradiol transdermal system, USP continuous delivery (once-weekly) is designed to release estradiol continuously upon application to intact skin. Six (7.75, 11.625, 15.5, 18.6, 23.25 and 31 cm2) systems are available to provide nominal in vivo delivery of 0.025, 0.0375, 0.05, 0.06, 0.075 or 0.1 mg respectively of estradiol per day. The period of use is 7 days. Each system has a contact surface area of either 7.75, 11.625, 15.5, 18.6, 23.25 or 31 cm2, and contains estradiol, USP hemihydrate equivalent to 0.97, 1.46, 1.94, 2.33, 2.91 or 3.88 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. It has a molecular formula of C18 H24O2  ½ H2O and molecular weight of 281.39. The structural formula is. Meets USP Drug Release Test 2. The estradiol transdermal system continuous delivery (once-weekly) comprises four layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are. (1) A foam backing with adhesive layer. (2) A polyester film. (3) An acrylate adhesive matrix containing estradiol. (4) A protective liner of siliconized polyester film is attached to the adhesive surface and must be removed before the system can be used. The active component of the transdermal system is estradiol. The remaining components of the transdermal system (propylene glycol, povidone, anhydrous colloidal silicon dioxide, pressure sensitive acrylic adhesive, copolymer foam, polyester film, and brown ink) are pharmacologically inactive.</Description>
  </NDC>
  <NDC>
    <NDCCode>0378-3351-99</NDCCode>
    <PackageDescription>4 POUCH in 1 CARTON (0378-3351-99)  / 1 PATCH in 1 POUCH (0378-3351-16)  / 7 d in 1 PATCH</PackageDescription>
    <NDC11Code>00378-3351-99</NDC11Code>
    <ProductNDC>0378-3351</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Estradiol</ProprietaryName>
    <NonProprietaryName>Estradiol</NonProprietaryName>
    <DosageFormName>PATCH</DosageFormName>
    <RouteName>TRANSDERMAL</RouteName>
    <StartMarketingDate>20050407</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075182</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>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20050407</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Estradiol transdermal system continuous delivery (once-weekly) is indicated for.</IndicationAndUsage>
    <Description>Estradiol transdermal system, USP continuous delivery (once-weekly) is designed to release estradiol continuously upon application to intact skin. Six (7.75, 11.625, 15.5, 18.6, 23.25 and 31 cm2) systems are available to provide nominal in vivo delivery of 0.025, 0.0375, 0.05, 0.06, 0.075 or 0.1 mg respectively of estradiol per day. The period of use is 7 days. Each system has a contact surface area of either 7.75, 11.625, 15.5, 18.6, 23.25 or 31 cm2, and contains estradiol, USP hemihydrate equivalent to 0.97, 1.46, 1.94, 2.33, 2.91 or 3.88 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. It has a molecular formula of C18 H24O2  ½ H2O and molecular weight of 281.39. The structural formula is. Meets USP Drug Release Test 2. The estradiol transdermal system continuous delivery (once-weekly) comprises four layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are. (1) A foam backing with adhesive layer. (2) A polyester film. (3) An acrylate adhesive matrix containing estradiol. (4) A protective liner of siliconized polyester film is attached to the adhesive surface and must be removed before the system can be used. The active component of the transdermal system is estradiol. The remaining components of the transdermal system (propylene glycol, povidone, anhydrous colloidal silicon dioxide, pressure sensitive acrylic adhesive, copolymer foam, polyester film, and brown ink) are pharmacologically inactive.</Description>
  </NDC>
  <NDC>
    <NDCCode>0378-3352-99</NDCCode>
    <PackageDescription>4 POUCH in 1 CARTON (0378-3352-99)  / 1 PATCH in 1 POUCH (0378-3352-16)  / 7 d in 1 PATCH</PackageDescription>
    <NDC11Code>00378-3352-99</NDC11Code>
    <ProductNDC>0378-3352</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Estradiol</ProprietaryName>
    <NonProprietaryName>Estradiol</NonProprietaryName>
    <DosageFormName>PATCH</DosageFormName>
    <RouteName>TRANSDERMAL</RouteName>
    <StartMarketingDate>20000301</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075182</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>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20000301</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Estradiol transdermal system continuous delivery (once-weekly) is indicated for.</IndicationAndUsage>
    <Description>Estradiol transdermal system, USP continuous delivery (once-weekly) is designed to release estradiol continuously upon application to intact skin. Six (7.75, 11.625, 15.5, 18.6, 23.25 and 31 cm2) systems are available to provide nominal in vivo delivery of 0.025, 0.0375, 0.05, 0.06, 0.075 or 0.1 mg respectively of estradiol per day. The period of use is 7 days. Each system has a contact surface area of either 7.75, 11.625, 15.5, 18.6, 23.25 or 31 cm2, and contains estradiol, USP hemihydrate equivalent to 0.97, 1.46, 1.94, 2.33, 2.91 or 3.88 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. It has a molecular formula of C18 H24O2  ½ H2O and molecular weight of 281.39. The structural formula is. Meets USP Drug Release Test 2. The estradiol transdermal system continuous delivery (once-weekly) comprises four layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are. (1) A foam backing with adhesive layer. (2) A polyester film. (3) An acrylate adhesive matrix containing estradiol. (4) A protective liner of siliconized polyester film is attached to the adhesive surface and must be removed before the system can be used. The active component of the transdermal system is estradiol. The remaining components of the transdermal system (propylene glycol, povidone, anhydrous colloidal silicon dioxide, pressure sensitive acrylic adhesive, copolymer foam, polyester film, and brown ink) are pharmacologically inactive.</Description>
  </NDC>
  <NDC>
    <NDCCode>0378-3360-99</NDCCode>
    <PackageDescription>4 POUCH in 1 CARTON (0378-3360-99)  / 1 PATCH in 1 POUCH (0378-3360-16)  / 7 d in 1 PATCH</PackageDescription>
    <NDC11Code>00378-3360-99</NDC11Code>
    <ProductNDC>0378-3360</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Estradiol</ProprietaryName>
    <NonProprietaryName>Estradiol</NonProprietaryName>
    <DosageFormName>PATCH</DosageFormName>
    <RouteName>TRANSDERMAL</RouteName>
    <StartMarketingDate>20060809</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075182</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>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20060809</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Estradiol transdermal system continuous delivery (once-weekly) is indicated for.</IndicationAndUsage>
    <Description>Estradiol transdermal system, USP continuous delivery (once-weekly) is designed to release estradiol continuously upon application to intact skin. Six (7.75, 11.625, 15.5, 18.6, 23.25 and 31 cm2) systems are available to provide nominal in vivo delivery of 0.025, 0.0375, 0.05, 0.06, 0.075 or 0.1 mg respectively of estradiol per day. The period of use is 7 days. Each system has a contact surface area of either 7.75, 11.625, 15.5, 18.6, 23.25 or 31 cm2, and contains estradiol, USP hemihydrate equivalent to 0.97, 1.46, 1.94, 2.33, 2.91 or 3.88 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. It has a molecular formula of C18 H24O2  ½ H2O and molecular weight of 281.39. The structural formula is. Meets USP Drug Release Test 2. The estradiol transdermal system continuous delivery (once-weekly) comprises four layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are. (1) A foam backing with adhesive layer. (2) A polyester film. (3) An acrylate adhesive matrix containing estradiol. (4) A protective liner of siliconized polyester film is attached to the adhesive surface and must be removed before the system can be used. The active component of the transdermal system is estradiol. The remaining components of the transdermal system (propylene glycol, povidone, anhydrous colloidal silicon dioxide, pressure sensitive acrylic adhesive, copolymer foam, polyester film, and brown ink) are pharmacologically inactive.</Description>
  </NDC>
  <NDC>
    <NDCCode>0378-3361-99</NDCCode>
    <PackageDescription>4 POUCH in 1 CARTON (0378-3361-99)  / 1 PATCH in 1 POUCH (0378-3361-16)  / 7 d in 1 PATCH</PackageDescription>
    <NDC11Code>00378-3361-99</NDC11Code>
    <ProductNDC>0378-3361</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Estradiol</ProprietaryName>
    <NonProprietaryName>Estradiol</NonProprietaryName>
    <DosageFormName>PATCH</DosageFormName>
    <RouteName>TRANSDERMAL</RouteName>
    <StartMarketingDate>20060809</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075182</ApplicationNumber>
    <LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>ESTRADIOL</SubstanceName>
    <StrengthNumber>.06</StrengthNumber>
    <StrengthUnit>mg/d</StrengthUnit>
    <Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20060809</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Estradiol transdermal system continuous delivery (once-weekly) is indicated for.</IndicationAndUsage>
    <Description>Estradiol transdermal system, USP continuous delivery (once-weekly) is designed to release estradiol continuously upon application to intact skin. Six (7.75, 11.625, 15.5, 18.6, 23.25 and 31 cm2) systems are available to provide nominal in vivo delivery of 0.025, 0.0375, 0.05, 0.06, 0.075 or 0.1 mg respectively of estradiol per day. The period of use is 7 days. Each system has a contact surface area of either 7.75, 11.625, 15.5, 18.6, 23.25 or 31 cm2, and contains estradiol, USP hemihydrate equivalent to 0.97, 1.46, 1.94, 2.33, 2.91 or 3.88 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. It has a molecular formula of C18 H24O2  ½ H2O and molecular weight of 281.39. The structural formula is. Meets USP Drug Release Test 2. The estradiol transdermal system continuous delivery (once-weekly) comprises four layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are. (1) A foam backing with adhesive layer. (2) A polyester film. (3) An acrylate adhesive matrix containing estradiol. (4) A protective liner of siliconized polyester film is attached to the adhesive surface and must be removed before the system can be used. The active component of the transdermal system is estradiol. The remaining components of the transdermal system (propylene glycol, povidone, anhydrous colloidal silicon dioxide, pressure sensitive acrylic adhesive, copolymer foam, polyester film, and brown ink) are pharmacologically inactive.</Description>
  </NDC>
  <NDC>
    <NDCCode>21130-147-94</NDCCode>
    <PackageDescription>140 TABLET in 1 BOTTLE (21130-147-94)</PackageDescription>
    <NDC11Code>21130-0147-94</NDC11Code>
    <ProductNDC>21130-147</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Fiber Laxative</ProprietaryName>
    <NonProprietaryName>Calcium Polycarbophil</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150505</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part334</ApplicationNumber>
    <LabelerName>Safeway</LabelerName>
    <SubstanceName>CALCIUM POLYCARBOPHIL</SubstanceName>
    <StrengthNumber>625</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>relieves occasional constipation. this product generally produces bowel movement in 12 to 72 hours.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>24338-001-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (24338-001-30) </PackageDescription>
    <NDC11Code>24338-0001-30</NDC11Code>
    <ProductNDC>24338-001</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Widaplik</ProprietaryName>
    <NonProprietaryName>Telmisartan, Amlodipine And Indapamide</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20251020</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA219423</ApplicationNumber>
    <LabelerName>Azurity Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>TELMISARTAN; AMLODIPINE BESYLATE; INDAPAMIDE</SubstanceName>
    <StrengthNumber>10; 1.25; .625</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide-like Diuretic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251020</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Widaplik (telmisartan/amlodipine/indapamide) is indicated for the treatment of hypertension in adult patients, to lower blood pressure. Widaplik may be used as initial therapy in patients likely to need multiple drugs to achieve blood pressure goals. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including angiotensin II receptor blockers, dihydropyridine calcium channel blockers and thiazide-like diuretics. There are no controlled trials demonstrating risk reduction with Widaplik. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Patients with moderate or severe hypertension are at relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. Consider the patient's baseline blood pressure, the target goal, and the incremental likelihood of achieving the goal with a triple combination product compared with mono- or dual therapy when deciding whether to use Widaplik as initial therapy. Individual blood pressure goals may vary based upon the patient’s risk.</IndicationAndUsage>
    <Description>Widaplik is a fixed dose combination of telmisartan, amlodipine and indapamide. Widaplik contains telmisartan, a non-peptide angiotensin II receptor (type AT1) antagonist. Telmisartan is chemically described as 4'-[(1,4'-dimethyl-2'-propyl [2,6'-bi-1H-benzimidazol]-1'-yl)methyl]-[1,1'-biphenyl]-2-carboxylic acid. Its empirical formula is C33H30N4O2, its molecular weight is 514.63, and the structural formula is:. Telmisartan is a white to slightly yellowish solid. It is practically insoluble in water, slightly soluble in methanol and soluble in strong base. Widaplik contains the besylate salt of amlodipine, a dihydropyridine calcium-channel blocker. Amlodipine besylate is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulfonate. Its empirical formula is C20H25ClN2O5C6H6O3S, its molecular weight is 567.1, and the structural formula is:. Amlodipine besylate is a white crystalline powder. It is slightly soluble in water and sparingly soluble in ethanol. Widaplik contains indapamide, a thiazide-like diuretic. Indapamide is chemically described as 4-chloro-N-(2-methyl-1-indolinyl)-3-sulfamoylbenzamide. Its empirical formula is C16H16ClN3O3S, its molecular weight is 365.84, and the structural formula is:. Indapamide is a white to off-white, crystalline powder. It is soluble in ethyl alcohol and practically insoluble in water. Widaplik tablets are formulated in 3 strengths for oral administration: 1 10 mg/1.25 mg/0.625 mg: combination of 10 mg telmisartan, with 1.25 mg amlodipine (equivalent to 1.73 mg amlodipine besylate), with 0.625 mg indapamide, 2 20 mg/2.5 mg/1.25 mg: combination of 20 mg telmisartan, with 2.5 mg amlodipine (equivalent to 3.47 mg amlodipine besylate), with 1.25 mg indapamide, 3 40 mg/5 mg/2.5 mg: combination of 40 mg telmisartan, with 5 mg amlodipine (equivalent to 6.94 mg amlodipine besylate), with 2.5 mg of indapamide.</Description>
  </NDC>
  <NDC>
    <NDCCode>24338-002-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (24338-002-30) </PackageDescription>
    <NDC11Code>24338-0002-30</NDC11Code>
    <ProductNDC>24338-002</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Widaplik</ProprietaryName>
    <NonProprietaryName>Telmisartan, Amlodipine And Indapamide</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20251020</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA219423</ApplicationNumber>
    <LabelerName>Azurity Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>TELMISARTAN; AMLODIPINE BESYLATE; INDAPAMIDE</SubstanceName>
    <StrengthNumber>20; 2.5; 1.25</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide-like Diuretic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251020</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Widaplik (telmisartan/amlodipine/indapamide) is indicated for the treatment of hypertension in adult patients, to lower blood pressure. Widaplik may be used as initial therapy in patients likely to need multiple drugs to achieve blood pressure goals. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including angiotensin II receptor blockers, dihydropyridine calcium channel blockers and thiazide-like diuretics. There are no controlled trials demonstrating risk reduction with Widaplik. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Patients with moderate or severe hypertension are at relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. Consider the patient's baseline blood pressure, the target goal, and the incremental likelihood of achieving the goal with a triple combination product compared with mono- or dual therapy when deciding whether to use Widaplik as initial therapy. Individual blood pressure goals may vary based upon the patient’s risk.</IndicationAndUsage>
    <Description>Widaplik is a fixed dose combination of telmisartan, amlodipine and indapamide. Widaplik contains telmisartan, a non-peptide angiotensin II receptor (type AT1) antagonist. Telmisartan is chemically described as 4'-[(1,4'-dimethyl-2'-propyl [2,6'-bi-1H-benzimidazol]-1'-yl)methyl]-[1,1'-biphenyl]-2-carboxylic acid. Its empirical formula is C33H30N4O2, its molecular weight is 514.63, and the structural formula is:. Telmisartan is a white to slightly yellowish solid. It is practically insoluble in water, slightly soluble in methanol and soluble in strong base. Widaplik contains the besylate salt of amlodipine, a dihydropyridine calcium-channel blocker. Amlodipine besylate is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulfonate. Its empirical formula is C20H25ClN2O5C6H6O3S, its molecular weight is 567.1, and the structural formula is:. Amlodipine besylate is a white crystalline powder. It is slightly soluble in water and sparingly soluble in ethanol. Widaplik contains indapamide, a thiazide-like diuretic. Indapamide is chemically described as 4-chloro-N-(2-methyl-1-indolinyl)-3-sulfamoylbenzamide. Its empirical formula is C16H16ClN3O3S, its molecular weight is 365.84, and the structural formula is:. Indapamide is a white to off-white, crystalline powder. It is soluble in ethyl alcohol and practically insoluble in water. Widaplik tablets are formulated in 3 strengths for oral administration: 1 10 mg/1.25 mg/0.625 mg: combination of 10 mg telmisartan, with 1.25 mg amlodipine (equivalent to 1.73 mg amlodipine besylate), with 0.625 mg indapamide, 2 20 mg/2.5 mg/1.25 mg: combination of 20 mg telmisartan, with 2.5 mg amlodipine (equivalent to 3.47 mg amlodipine besylate), with 1.25 mg indapamide, 3 40 mg/5 mg/2.5 mg: combination of 40 mg telmisartan, with 5 mg amlodipine (equivalent to 6.94 mg amlodipine besylate), with 2.5 mg of indapamide.</Description>
  </NDC>
  <NDC>
    <NDCCode>24338-003-30</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (24338-003-30) </PackageDescription>
    <NDC11Code>24338-0003-30</NDC11Code>
    <ProductNDC>24338-003</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Widaplik</ProprietaryName>
    <NonProprietaryName>Telmisartan, Amlodipine And Indapamide</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20251020</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA219423</ApplicationNumber>
    <LabelerName>Azurity Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>TELMISARTAN; AMLODIPINE BESYLATE; INDAPAMIDE</SubstanceName>
    <StrengthNumber>40; 5; 2.5</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide-like Diuretic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251020</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Widaplik (telmisartan/amlodipine/indapamide) is indicated for the treatment of hypertension in adult patients, to lower blood pressure. Widaplik may be used as initial therapy in patients likely to need multiple drugs to achieve blood pressure goals. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including angiotensin II receptor blockers, dihydropyridine calcium channel blockers and thiazide-like diuretics. There are no controlled trials demonstrating risk reduction with Widaplik. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Patients with moderate or severe hypertension are at relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. Consider the patient's baseline blood pressure, the target goal, and the incremental likelihood of achieving the goal with a triple combination product compared with mono- or dual therapy when deciding whether to use Widaplik as initial therapy. Individual blood pressure goals may vary based upon the patient’s risk.</IndicationAndUsage>
    <Description>Widaplik is a fixed dose combination of telmisartan, amlodipine and indapamide. Widaplik contains telmisartan, a non-peptide angiotensin II receptor (type AT1) antagonist. Telmisartan is chemically described as 4'-[(1,4'-dimethyl-2'-propyl [2,6'-bi-1H-benzimidazol]-1'-yl)methyl]-[1,1'-biphenyl]-2-carboxylic acid. Its empirical formula is C33H30N4O2, its molecular weight is 514.63, and the structural formula is:. Telmisartan is a white to slightly yellowish solid. It is practically insoluble in water, slightly soluble in methanol and soluble in strong base. Widaplik contains the besylate salt of amlodipine, a dihydropyridine calcium-channel blocker. Amlodipine besylate is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulfonate. Its empirical formula is C20H25ClN2O5C6H6O3S, its molecular weight is 567.1, and the structural formula is:. Amlodipine besylate is a white crystalline powder. It is slightly soluble in water and sparingly soluble in ethanol. Widaplik contains indapamide, a thiazide-like diuretic. Indapamide is chemically described as 4-chloro-N-(2-methyl-1-indolinyl)-3-sulfamoylbenzamide. Its empirical formula is C16H16ClN3O3S, its molecular weight is 365.84, and the structural formula is:. Indapamide is a white to off-white, crystalline powder. It is soluble in ethyl alcohol and practically insoluble in water. Widaplik tablets are formulated in 3 strengths for oral administration: 1 10 mg/1.25 mg/0.625 mg: combination of 10 mg telmisartan, with 1.25 mg amlodipine (equivalent to 1.73 mg amlodipine besylate), with 0.625 mg indapamide, 2 20 mg/2.5 mg/1.25 mg: combination of 20 mg telmisartan, with 2.5 mg amlodipine (equivalent to 3.47 mg amlodipine besylate), with 1.25 mg indapamide, 3 40 mg/5 mg/2.5 mg: combination of 40 mg telmisartan, with 5 mg amlodipine (equivalent to 6.94 mg amlodipine besylate), with 2.5 mg of indapamide.</Description>
  </NDC>
  <NDC>
    <NDCCode>41163-147-94</NDCCode>
    <PackageDescription>140 TABLET in 1 BOTTLE (41163-147-94) </PackageDescription>
    <NDC11Code>41163-0147-94</NDC11Code>
    <ProductNDC>41163-147</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Fiber Laxative</ProprietaryName>
    <NonProprietaryName>Calcium Polycarbophil</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180824</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M007</ApplicationNumber>
    <LabelerName>UNITED NATURAL FOODS, INC. DBA UNFI</LabelerName>
    <SubstanceName>CALCIUM POLYCARBOPHIL</SubstanceName>
    <StrengthNumber>625</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-12-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180824</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>relieves occasional constipation. this product generally produces bowel movement in 12 to 72 hours.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>49035-147-94</NDCCode>
    <PackageDescription>140 TABLET in 1 BOTTLE (49035-147-94) </PackageDescription>
    <NDC11Code>49035-0147-94</NDC11Code>
    <ProductNDC>49035-147</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Fiber Therapy</ProprietaryName>
    <NonProprietaryName>Calcium Polycarbophil</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20131101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M007</ApplicationNumber>
    <LabelerName>Wal-Mart Stores, Inc.</LabelerName>
    <SubstanceName>CALCIUM POLYCARBOPHIL</SubstanceName>
    <StrengthNumber>625</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-12-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20131101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>relieves occasional constipation. this product generally produces bowel movement in 12 to 72 hours.</IndicationAndUsage>
  </NDC>
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    <NDCCode>50090-7611-0</NDCCode>
    <PackageDescription>4 POUCH in 1 CARTON (50090-7611-0)  / 1 PATCH in 1 POUCH / 7 d in 1 PATCH</PackageDescription>
    <NDC11Code>50090-7611-00</NDC11Code>
    <ProductNDC>50090-7611</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Estradiol</ProprietaryName>
    <NonProprietaryName>Estradiol</NonProprietaryName>
    <DosageFormName>PATCH</DosageFormName>
    <RouteName>TRANSDERMAL</RouteName>
    <StartMarketingDate>20000301</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075182</ApplicationNumber>
    <LabelerName>A-S Medication Solutions</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>2025-07-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250722</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Estradiol transdermal system continuous delivery (once-weekly) is indicated for.</IndicationAndUsage>
    <Description>Estradiol transdermal system, USP continuous delivery (once-weekly) is designed to release estradiol continuously upon application to intact skin. Six (7.75, 11.625, 15.5, 18.6, 23.25 and 31 cm2) systems are available to provide nominal in vivo delivery of 0.025, 0.0375, 0.05, 0.06, 0.075 or 0.1 mg respectively of estradiol per day. The period of use is 7 days. Each system has a contact surface area of either 7.75, 11.625, 15.5, 18.6, 23.25 or 31 cm2, and contains estradiol, USP hemihydrate equivalent to 0.97, 1.46, 1.94, 2.33, 2.91 or 3.88 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. It has a molecular formula of C18 H24O2  ½ H2O and molecular weight of 281.39. The structural formula is. Meets USP Drug Release Test 2. The estradiol transdermal system continuous delivery (once-weekly) comprises four layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are. (1) A foam backing with adhesive layer. (2) A polyester film. (3) An acrylate adhesive matrix containing estradiol. (4) A protective liner of siliconized polyester film is attached to the adhesive surface and must be removed before the system can be used. The active component of the transdermal system is estradiol. The remaining components of the transdermal system (propylene glycol, povidone, anhydrous colloidal silicon dioxide, pressure sensitive acrylic adhesive, copolymer foam, polyester film, and brown ink) are pharmacologically inactive.</Description>
  </NDC>
  <NDC>
    <NDCCode>50090-7984-0</NDCCode>
    <PackageDescription>4 POUCH in 1 CARTON (50090-7984-0)  / 1 d in 1 POUCH</PackageDescription>
    <NDC11Code>50090-7984-00</NDC11Code>
    <ProductNDC>50090-7984</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Estradiol</ProprietaryName>
    <NonProprietaryName>Estradiol</NonProprietaryName>
    <DosageFormName>PATCH</DosageFormName>
    <RouteName>TRANSDERMAL</RouteName>
    <StartMarketingDate>20000301</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075182</ApplicationNumber>
    <LabelerName>A-S Medication Solutions</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>2026-06-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260601</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Estradiol transdermal system continuous delivery (once-weekly) is indicated for.</IndicationAndUsage>
    <Description>Estradiol transdermal system, USP continuous delivery (once-weekly) is designed to release estradiol continuously upon application to intact skin. Six (7.75, 11.625, 15.5, 18.6, 23.25 and 31 cm2) systems are available to provide nominal in vivo delivery of 0.025, 0.0375, 0.05, 0.06, 0.075 or 0.1 mg respectively of estradiol per day. The period of use is 7 days. Each system has a contact surface area of either 7.75, 11.625, 15.5, 18.6, 23.25 or 31 cm2, and contains estradiol, USP hemihydrate equivalent to 0.97, 1.46, 1.94, 2.33, 2.91 or 3.88 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. It has a molecular formula of C18 H24O2  ½ H2O and molecular weight of 281.39. The structural formula is. Meets USP Drug Release Test 2. The estradiol transdermal system continuous delivery (once-weekly) comprises four layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are. (1) A foam backing with adhesive layer. (2) A polyester film. (3) An acrylate adhesive matrix containing estradiol. (4) A protective liner of siliconized polyester film is attached to the adhesive surface and must be removed before the system can be used. The active component of the transdermal system is estradiol. The remaining components of the transdermal system (propylene glycol, povidone, anhydrous colloidal silicon dioxide, pressure sensitive acrylic adhesive, copolymer foam, polyester film, and brown ink) are pharmacologically inactive.</Description>
  </NDC>
  <NDC>
    <NDCCode>50090-7985-0</NDCCode>
    <PackageDescription>4 POUCH in 1 CARTON (50090-7985-0)  / 1 d in 1 POUCH</PackageDescription>
    <NDC11Code>50090-7985-00</NDC11Code>
    <ProductNDC>50090-7985</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Estradiol</ProprietaryName>
    <NonProprietaryName>Estradiol</NonProprietaryName>
    <DosageFormName>PATCH</DosageFormName>
    <RouteName>TRANSDERMAL</RouteName>
    <StartMarketingDate>20050407</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075182</ApplicationNumber>
    <LabelerName>A-S Medication Solutions</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>2026-06-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260602</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Estradiol transdermal system continuous delivery (once-weekly) is indicated for.</IndicationAndUsage>
    <Description>Estradiol transdermal system, USP continuous delivery (once-weekly) is designed to release estradiol continuously upon application to intact skin. Six (7.75, 11.625, 15.5, 18.6, 23.25 and 31 cm2) systems are available to provide nominal in vivo delivery of 0.025, 0.0375, 0.05, 0.06, 0.075 or 0.1 mg respectively of estradiol per day. The period of use is 7 days. Each system has a contact surface area of either 7.75, 11.625, 15.5, 18.6, 23.25 or 31 cm2, and contains estradiol, USP hemihydrate equivalent to 0.97, 1.46, 1.94, 2.33, 2.91 or 3.88 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. It has a molecular formula of C18 H24O2  ½ H2O and molecular weight of 281.39. The structural formula is. Meets USP Drug Release Test 2. The estradiol transdermal system continuous delivery (once-weekly) comprises four layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are. (1) A foam backing with adhesive layer. (2) A polyester film. (3) An acrylate adhesive matrix containing estradiol. (4) A protective liner of siliconized polyester film is attached to the adhesive surface and must be removed before the system can be used. The active component of the transdermal system is estradiol. The remaining components of the transdermal system (propylene glycol, povidone, anhydrous colloidal silicon dioxide, pressure sensitive acrylic adhesive, copolymer foam, polyester film, and brown ink) are pharmacologically inactive.</Description>
  </NDC>
  <NDC>
    <NDCCode>50090-7986-0</NDCCode>
    <PackageDescription>4 POUCH in 1 CARTON (50090-7986-0)  / 1 d in 1 POUCH</PackageDescription>
    <NDC11Code>50090-7986-00</NDC11Code>
    <ProductNDC>50090-7986</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Estradiol</ProprietaryName>
    <NonProprietaryName>Estradiol</NonProprietaryName>
    <DosageFormName>PATCH</DosageFormName>
    <RouteName>TRANSDERMAL</RouteName>
    <StartMarketingDate>20050407</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075182</ApplicationNumber>
    <LabelerName>A-S Medication Solutions</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>2026-06-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260603</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Estradiol transdermal system continuous delivery (once-weekly) is indicated for.</IndicationAndUsage>
    <Description>Estradiol transdermal system, USP continuous delivery (once-weekly) is designed to release estradiol continuously upon application to intact skin. Six (7.75, 11.625, 15.5, 18.6, 23.25 and 31 cm2) systems are available to provide nominal in vivo delivery of 0.025, 0.0375, 0.05, 0.06, 0.075 or 0.1 mg respectively of estradiol per day. The period of use is 7 days. Each system has a contact surface area of either 7.75, 11.625, 15.5, 18.6, 23.25 or 31 cm2, and contains estradiol, USP hemihydrate equivalent to 0.97, 1.46, 1.94, 2.33, 2.91 or 3.88 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. It has a molecular formula of C18 H24O2  ½ H2O and molecular weight of 281.39. The structural formula is. Meets USP Drug Release Test 2. The estradiol transdermal system continuous delivery (once-weekly) comprises four layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are. (1) A foam backing with adhesive layer. (2) A polyester film. (3) An acrylate adhesive matrix containing estradiol. (4) A protective liner of siliconized polyester film is attached to the adhesive surface and must be removed before the system can be used. The active component of the transdermal system is estradiol. The remaining components of the transdermal system (propylene glycol, povidone, anhydrous colloidal silicon dioxide, pressure sensitive acrylic adhesive, copolymer foam, polyester film, and brown ink) are pharmacologically inactive.</Description>
  </NDC>
  <NDC>
    <NDCCode>50090-7987-0</NDCCode>
    <PackageDescription>4 POUCH in 1 CARTON (50090-7987-0)  / 1 d in 1 POUCH</PackageDescription>
    <NDC11Code>50090-7987-00</NDC11Code>
    <ProductNDC>50090-7987</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Estradiol</ProprietaryName>
    <NonProprietaryName>Estradiol</NonProprietaryName>
    <DosageFormName>PATCH</DosageFormName>
    <RouteName>TRANSDERMAL</RouteName>
    <StartMarketingDate>20060809</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA075182</ApplicationNumber>
    <LabelerName>A-S Medication Solutions</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>2026-06-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260603</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Estradiol transdermal system continuous delivery (once-weekly) is indicated for.</IndicationAndUsage>
    <Description>Estradiol transdermal system, USP continuous delivery (once-weekly) is designed to release estradiol continuously upon application to intact skin. Six (7.75, 11.625, 15.5, 18.6, 23.25 and 31 cm2) systems are available to provide nominal in vivo delivery of 0.025, 0.0375, 0.05, 0.06, 0.075 or 0.1 mg respectively of estradiol per day. The period of use is 7 days. Each system has a contact surface area of either 7.75, 11.625, 15.5, 18.6, 23.25 or 31 cm2, and contains estradiol, USP hemihydrate equivalent to 0.97, 1.46, 1.94, 2.33, 2.91 or 3.88 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. It has a molecular formula of C18 H24O2  ½ H2O and molecular weight of 281.39. The structural formula is. Meets USP Drug Release Test 2. The estradiol transdermal system continuous delivery (once-weekly) comprises four layers. Proceeding from the visible surface toward the surface attached to the skin, these layers are. (1) A foam backing with adhesive layer. (2) A polyester film. (3) An acrylate adhesive matrix containing estradiol. (4) A protective liner of siliconized polyester film is attached to the adhesive surface and must be removed before the system can be used. The active component of the transdermal system is estradiol. The remaining components of the transdermal system (propylene glycol, povidone, anhydrous colloidal silicon dioxide, pressure sensitive acrylic adhesive, copolymer foam, polyester film, and brown ink) are pharmacologically inactive.</Description>
  </NDC>
</NDCList>