RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>60219-2090-4</NDCCode>
    <PackageDescription>50 mL in 1 BOTTLE (60219-2090-4) </PackageDescription>
    <NDC11Code>60219-2090-04</NDC11Code>
    <ProductNDC>60219-2090</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Famotidine</ProprietaryName>
    <NonProprietaryName>Famotidine</NonProprietaryName>
    <DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240513</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216427</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>FAMOTIDINE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-05-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240513</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Famotidine for oral suspension is indicated in adults for the treatment of: : 1 active duodenal ulcer (DU). , 2 active gastric ulcer (GU). , 3 symptomatic nonerosive gastroesophageal reflux disease (GERD). , 4 erosive esophagitis due to GERD, diagnosed by biopsy. , 5 treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine neoplasias). , 6 reduction of the risk of duodenal ulcer recurrence. .</IndicationAndUsage>
    <Description>The active ingredient in famotidine for oral suspension, USP is a histamine-2 (H2) receptor antagonist. Famotidine, USP is propanimidamide, N'-(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]-. The empirical formula of famotidine, USP is C8H15N7O2S3 and its molecular weight is 337.45. Its structural formula is. Each 5 mL of famotidine for oral suspension, USP when prepared as directed contains 40 mg of famotidine, USP and the following inactive ingredients: citric acid monohydrate, flavors (cherry, banana, and peppermint), powdered cellulose, sucrose and xanthan gum. Added as preservatives are sodium benzoate 0.1%, methylparaben sodium 0.1% and propylparaben sodium 0.02%. Famotidine, USP is a white to pale yellowish white crystalline compound that is freely soluble in dimethyl formamide, glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, and practically insoluble in acetone, in alcohol, in chloroform, in ether and in ethyl acetate.</Description>
  </NDC>
  <NDC>
    <NDCCode>60219-1744-7</NDCCode>
    <PackageDescription>1 KIT in 1 KIT (60219-1744-7)  *  4 TABLET, FILM COATED in 1 BLISTER PACK *  19 TABLET, FILM COATED in 1 BLISTER PACK *  4 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>60219-1744-07</NDC11Code>
    <ProductNDC>60219-1744</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Apremilast</ProprietaryName>
    <NonProprietaryName>Apremilast</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210705</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211782</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210705</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Apremilast, an inhibitor of phosphodiesterase 4 (PDE4), is indicated for the treatment of: 1 Adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy. (1.2).</IndicationAndUsage>
    <Description>The active ingredient in apremilast tablets is apremilast. Apremilast is a phosphodiesterase 4 (PDE4) inhibitor. Apremilast is known chemically as N-[2-[(1S)-1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-2,3-dihydro-1,3-dioxo-1H-isoindol-4-yl]acetamide. Its molecular formula is C22H24N2O7S and the molecular weight is 460.50 g/mol. The chemical structure is. Apremilast is a white to pale yellow powder. It is soluble in acetone and practically insoluble in water. Apremilast tablets are supplied in 10 mg, 20 mg, and 30 mg strengths for oral administration. Each tablet contains apremilast as the active ingredient and the following inactive ingredients: croscarmellose sodium, ferrosoferric oxide (30 mg), iron oxide red, iron oxide yellow (20 mg and 30 mg), lactose monohydrate, magnesium stearate, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>60219-2149-4</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (60219-2149-4)  / 5 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>60219-2149-04</NDC11Code>
    <ProductNDC>60219-2149</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Bimatoprost</ProprietaryName>
    <NonProprietaryName>Bimatoprost</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20250922</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217289</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>BIMATOPROST</SubstanceName>
    <StrengthNumber>.1</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Prostaglandin Analog [EPC], Prostaglandins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-09-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250922</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Bimatoprost ophthalmic solution 0.01% is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.</IndicationAndUsage>
    <Description>Bimatoprost is a synthetic prostamide analog with ocular hypotensive activity. Its chemical name is (Z)-7-[(1R,2R,3R,5S)-3,5-Dihydroxy-2-[(1E,3S)-3-hydroxy-5-phenyl-1-pentenyl]cyclopentyl]-5-N-ethylheptenamide and its molecular weight is 415.58 g/mol. Its molecular formula is C25H37NO4. Its chemical structure is. Bimatoprost is a white to an off-white powder, which is soluble in methanol and alcohol. Bimatoprost ophthalmic solution, 0.01% is a clear, isotonic, colorless, sterile ophthalmic solution with an osmolality of approximately 290 mOsmol/kg (260 mOsmol/kg to 330 mOsmol/kg). Each mL of Bimatoprost ophthalmic solution 0.01% contains. Active: Bimatoprost, 0.1 mg. Preservative: Benzalkonium chloride, 0.15 mg. Inactives: Citric acid monohydrate; sodium chloride; sodium phosphate dibasic heptahydrate; and water for injection. Sodium hydroxide and/or hydrochloric acid may be added to adjust pH. The pH during its shelf life ranges from 6.8 to 7.8.</Description>
  </NDC>
  <NDC>
    <NDCCode>60219-2279-2</NDCCode>
    <PackageDescription>4 BLISTER PACK in 1 CARTON (60219-2279-2)  / 7 TABLET, FOR SUSPENSION in 1 BLISTER PACK (60219-2279-1) </PackageDescription>
    <NDC11Code>60219-2279-02</NDC11Code>
    <ProductNDC>60219-2279</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Everolimus</ProprietaryName>
    <NonProprietaryName>Everolimus</NonProprietaryName>
    <DosageFormName>TABLET, FOR SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250114</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA218863</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>EVEROLIMUS</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250114</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Everolimus tablets for oral suspension are kinase inhibitor indicated for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. (1.5). Everolimus tablets for oral suspension are a kinase inhibitor indicated for the adjunctive treatment of adult and pediatric patients aged 2 years and older with TSC-associated partial-onset seizures. (1.6).</IndicationAndUsage>
    <Description>Everolimus tablets for oral suspension are kinase inhibitors. The chemical name of everolimus is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18-Dihydroxy-12-[(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl]-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-azatricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.22 g/mol. The structural formula is. Everolimus tablets for oral suspension for oral administration contains 2 mg, 3 mg, or 5 mg of everolimus, USP and the following inactive ingredients: colloidal silicon dioxide, crospovidone Type-A, hypromellose, lactose monohydrate, magnesium stearate, mannitol and microcrystalline cellulose.</Description>
  </NDC>
  <NDC>
    <NDCCode>60219-2280-2</NDCCode>
    <PackageDescription>4 BLISTER PACK in 1 CARTON (60219-2280-2)  / 7 TABLET, FOR SUSPENSION in 1 BLISTER PACK (60219-2280-1) </PackageDescription>
    <NDC11Code>60219-2280-02</NDC11Code>
    <ProductNDC>60219-2280</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Everolimus</ProprietaryName>
    <NonProprietaryName>Everolimus</NonProprietaryName>
    <DosageFormName>TABLET, FOR SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250114</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA218863</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>EVEROLIMUS</SubstanceName>
    <StrengthNumber>3</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250114</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Everolimus tablets for oral suspension are kinase inhibitor indicated for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. (1.5). Everolimus tablets for oral suspension are a kinase inhibitor indicated for the adjunctive treatment of adult and pediatric patients aged 2 years and older with TSC-associated partial-onset seizures. (1.6).</IndicationAndUsage>
    <Description>Everolimus tablets for oral suspension are kinase inhibitors. The chemical name of everolimus is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18-Dihydroxy-12-[(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl]-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-azatricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.22 g/mol. The structural formula is. Everolimus tablets for oral suspension for oral administration contains 2 mg, 3 mg, or 5 mg of everolimus, USP and the following inactive ingredients: colloidal silicon dioxide, crospovidone Type-A, hypromellose, lactose monohydrate, magnesium stearate, mannitol and microcrystalline cellulose.</Description>
  </NDC>
  <NDC>
    <NDCCode>60219-2281-2</NDCCode>
    <PackageDescription>4 BLISTER PACK in 1 CARTON (60219-2281-2)  / 7 TABLET, FOR SUSPENSION in 1 BLISTER PACK (60219-2281-1) </PackageDescription>
    <NDC11Code>60219-2281-02</NDC11Code>
    <ProductNDC>60219-2281</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Everolimus</ProprietaryName>
    <NonProprietaryName>Everolimus</NonProprietaryName>
    <DosageFormName>TABLET, FOR SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250114</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA218863</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>EVEROLIMUS</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250114</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Everolimus tablets for oral suspension are kinase inhibitor indicated for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. (1.5). Everolimus tablets for oral suspension are a kinase inhibitor indicated for the adjunctive treatment of adult and pediatric patients aged 2 years and older with TSC-associated partial-onset seizures. (1.6).</IndicationAndUsage>
    <Description>Everolimus tablets for oral suspension are kinase inhibitors. The chemical name of everolimus is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18-Dihydroxy-12-[(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl]-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-azatricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.22 g/mol. The structural formula is. Everolimus tablets for oral suspension for oral administration contains 2 mg, 3 mg, or 5 mg of everolimus, USP and the following inactive ingredients: colloidal silicon dioxide, crospovidone Type-A, hypromellose, lactose monohydrate, magnesium stearate, mannitol and microcrystalline cellulose.</Description>
  </NDC>
  <NDC>
    <NDCCode>60219-2348-4</NDCCode>
    <PackageDescription>10 TABLET, COATED in 1 BOTTLE (60219-2348-4) </PackageDescription>
    <NDC11Code>60219-2348-04</NDC11Code>
    <ProductNDC>60219-2348</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tramadol Hydrochloride</ProprietaryName>
    <NonProprietaryName>Tramadol Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230213</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA076003</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>TRAMADOL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Active</Status>
    <LastUpdate>2026-09-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230213</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tramadol hydrochloride tablets are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including tramadol hydrochloride tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
    <Description>Tramadol hydrochloride tablets USP, for oral use, are an opioid agonist. The chemical name for tramadol hydrochloride is (±)cis-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol hydrochloride. The structural formula is. The molecular weight of tramadol hydrochloride is 299.8 g/mol. Tramadol hydrochloride, USP is a white or almost white crystalline powder. It is freely soluble in water and in methanol, very slightly soluble in acetone and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol hydrochloride tablets, USP contain 50 mg of tramadol hydrochloride, USP and are white in color. Inactive ingredients in the tablet are hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, sodium starch glycolate, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>11822-2090-2</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (11822-2090-2)  / 28.4 g in 1 TUBE</PackageDescription>
    <NDC11Code>11822-2090-02</NDC11Code>
    <ProductNDC>11822-2090</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hydrocortisone</ProprietaryName>
    <ProprietaryNameSuffix>Plus 12 Moisturizers</ProprietaryNameSuffix>
    <NonProprietaryName>Hydrocortisone</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20230721</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M017</ApplicationNumber>
    <LabelerName>RITE AID CORPORATION</LabelerName>
    <SubstanceName>HYDROCORTISONE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230721</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to: eczemapsoriasispoison ivy, oak, sumacinsect bitesdetergentsjewelrycosmeticssoapsseborrheic dermatitis. temporarily relieves external anal and genital itching. other uses of this product should only be under the advice and supervision of a doctor.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>36987-2090-4</NDCCode>
    <PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (36987-2090-4)</PackageDescription>
    <NDC11Code>36987-2090-04</NDC11Code>
    <ProductNDC>36987-2090</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rhodotorula Mucilaginosa</ProprietaryName>
    <NonProprietaryName>Rhodotorula Mucilaginosa</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19720829</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA102192</ApplicationNumber>
    <LabelerName>Nelco Laboratories, Inc.</LabelerName>
    <SubstanceName>RHODOTORULA MUCILAGINOSA</SubstanceName>
    <StrengthNumber>.1</StrengthNumber>
    <StrengthUnit>g/mL</StrengthUnit>
    <Pharm_Classes>Non-Standardized Fungal Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Fungal Proteins [CS],Allergens [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
    <Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
  </NDC>
  <NDC>
    <NDCCode>37662-2090-4</NDCCode>
    <PackageDescription>4000 PELLET in 1 BOTTLE, GLASS (37662-2090-4) </PackageDescription>
    <NDC11Code>37662-2090-04</NDC11Code>
    <ProductNDC>37662-2090</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Silicea</ProprietaryName>
    <NonProprietaryName>Silicea</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20221214</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Hahnemann Laboratories, INC.</LabelerName>
    <SubstanceName>SILICON DIOXIDE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>[hp_C]/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2022-12-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221214</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>61995-2090-4</NDCCode>
    <PackageDescription>113 g in 1 TUBE (61995-2090-4) </PackageDescription>
    <NDC11Code>61995-2090-04</NDC11Code>
    <ProductNDC>61995-2090</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Al0039006 Alba Sport Sunscreen Fragrance Free Spf45</ProprietaryName>
    <NonProprietaryName>Homosalate, Octinoxate, Ethylhexyl Salicylate, Octocrylene, Butul Methoxydibenzoylmethane, Titanium Dioxide</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20161121</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>The Hain Celestial Group, Inc.</LabelerName>
    <SubstanceName>HOMOSALATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE</SubstanceName>
    <StrengthNumber>10; 5; 10; 3</StrengthNumber>
    <StrengthUnit>g/100g; g/100g; g/100g; g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-03-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20161121</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>67296-2090-4</NDCCode>
    <PackageDescription>40 TABLET in 1 BOTTLE (67296-2090-4) </PackageDescription>
    <NDC11Code>67296-2090-04</NDC11Code>
    <ProductNDC>67296-2090</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sucralfate</ProprietaryName>
    <NonProprietaryName>Sucralfate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170925</StartMarketingDate>
    <MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
    <ApplicationNumber>NDA018333</ApplicationNumber>
    <LabelerName>Redpharm drug</LabelerName>
    <SubstanceName>SUCRALFATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/1</StrengthUnit>
    <Pharm_Classes>Aluminum Complex [EPC], Organometallic Compounds [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170925</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sucralfate is indicated in: 1 Short-term treatment (up to 8 weeks) of active duodenal ulcer. While healing with sucralfate may occur during the first week or two, treatment should be continued for 4 to 8 weeks unless healing has been demonstrated by x-ray or endoscopic examination. , 2 Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers.</IndicationAndUsage>
    <Description>Sucralfate Tablets contain sucralfate and sucralfate is an α-D-glucopyranoside, β-D-fructofuranosyl-, octakis-(hydrogen sulfate), aluminum complex. Tablets for oral administration contain 1 g of sucralfate. Also contain: D &amp; C Red #30 Lake, FD&amp;C Blue #1 Lake, magnesium stearate, microcrystalline cellulose, and starch. Therapeutic category: antiulcer.</Description>
  </NDC>
  <NDC>
    <NDCCode>69238-2090-4</NDCCode>
    <PackageDescription>50 mL in 1 BOTTLE (69238-2090-4) </PackageDescription>
    <NDC11Code>69238-2090-04</NDC11Code>
    <ProductNDC>69238-2090</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Famotidine</ProprietaryName>
    <NonProprietaryName>Famotidine</NonProprietaryName>
    <DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220805</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216427</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>FAMOTIDINE</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220805</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Famotidine for oral suspension is indicated in adults for the treatment of: : 1 active duodenal ulcer (DU). , 2 active gastric ulcer (GU). , 3 symptomatic nonerosive gastroesophageal reflux disease (GERD). , 4 erosive esophagitis due to GERD, diagnosed by biopsy. , 5 treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine neoplasias). , 6 reduction of the risk of duodenal ulcer recurrence. .</IndicationAndUsage>
    <Description>The active ingredient in famotidine for oral suspension, USP is a histamine-2 (H2) receptor antagonist. Famotidine, USP is propanimidamide, N'-(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]-. The empirical formula of famotidine, USP is C8H15N7O2S3 and its molecular weight is 337.45. Its structural formula is. Each 5 mL of famotidine for oral suspension, USP when prepared as directed contains 40 mg of famotidine, USP and the following inactive ingredients: citric acid monohydrate, flavors (cherry, banana, and peppermint), powdered cellulose, sucrose and xanthan gum. Added as preservatives are sodium benzoate 0.1%, methylparaben sodium 0.1% and propylparaben sodium 0.02%. Famotidine, USP is a white to pale yellow crystalline compound that is freely soluble in glacial acetic acid, slightly soluble in methanol, very slightly soluble in water, and practically insoluble in ethanol.</Description>
  </NDC>
  <NDC>
    <NDCCode>70710-2091-3</NDCCode>
    <PackageDescription>1 KIT in 1 KIT (70710-2091-3)  *  4 mL in 1 VIAL, GLASS (70710-2090-1)  *  50 mL in 1 VIAL, GLASS (64208-2512-4) </PackageDescription>
    <NDC11Code>70710-2091-03</NDC11Code>
    <ProductNDC>70710-2091</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Beizray</ProprietaryName>
    <NonProprietaryName>Docetaxel</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20250828</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA218711</ApplicationNumber>
    <LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2025-12-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250828</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>BEIZRAY is a microtubule inhibitor indicated for: : 1 Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC (1.1), 2 Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC (1.2), 3 Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer (1.3), 4 Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction (1.4), 5 Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN (1.5).</IndicationAndUsage>
    <Description>Docetaxel is an antineoplastic agent belonging to the taxoid family. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N-tert-butyl ester, 13-ester with 5β, 20-epoxy-1,2α,4,7β,10β,13α-hex-ahydroxytax-11-en-9-one 4-acetate 2-benzoate. Docetaxel has the following structural formula. Docetaxel is a white to almost-white powder with an empirical formula of C43H53NO14, and a molecular weight of 807.89. It is highly lipophilic and practically insoluble in water. BEIZRAY Injection for intravenous use is a sterile, non-pyrogenic, clear colorless liquid at 20 mg/mL concentration. Each mL contains 20 mg docetaxel (anhydrous) in 0.770 grams dehydrated alcohol (100% v/v) solution, with citric acid for pH adjustment. The BEIZRAY kit also contains a single dose vial of IV Solution Stabilizer, 50 mL of 25% Albumin Human USP solution. 25% Albumin Human USP is a clear, slightly viscous liquid; it is almost colorless or slightly yellow or green. The product contains 0.25 g Albumin Human USP per mL and is stabilized with 0.08 mmol sodium acetyltryptophanate and 0.08 mmol sodium caprylate per gram of albumin.</Description>
  </NDC>
  <NDC>
    <NDCCode>70710-2093-4</NDCCode>
    <PackageDescription>1 KIT in 1 KIT (70710-2093-4)  *  4 mL in 1 VIAL, GLASS (70710-2090-1)  *  50 mL in 1 VIAL, GLASS (64208-2512-4)  *  4 mL in 1 VIAL, GLASS (70710-2090-1) </PackageDescription>
    <NDC11Code>70710-2093-04</NDC11Code>
    <ProductNDC>70710-2093</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Beizray</ProprietaryName>
    <NonProprietaryName>Docetaxel</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20250828</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA218711</ApplicationNumber>
    <LabelerName>Zydus Pharmaceuticals USA Inc.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2025-12-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250828</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>BEIZRAY is a microtubule inhibitor indicated for: : 1 Breast Cancer (BC): single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC (1.1), 2 Non-small Cell Lung Cancer (NSCLC): single agent for locally advanced or metastatic NSCLC after platinum therapy failure; and with cisplatin for unresectable, locally advanced or metastatic untreated NSCLC (1.2), 3 Castration-Resistant Prostate Cancer (CRPC): with prednisone in metastatic castration-resistant prostate cancer (1.3), 4 Gastric Adenocarcinoma (GC): with cisplatin and fluorouracil for untreated, advanced GC, including the gastroesophageal junction (1.4), 5 Squamous Cell Carcinoma of the Head and Neck (SCCHN): with cisplatin and fluorouracil for induction treatment of locally advanced SCCHN (1.5).</IndicationAndUsage>
    <Description>Docetaxel is an antineoplastic agent belonging to the taxoid family. The chemical name for docetaxel is (2R,3S)-N-carboxy-3-phenylisoserine,N-tert-butyl ester, 13-ester with 5β, 20-epoxy-1,2α,4,7β,10β,13α-hex-ahydroxytax-11-en-9-one 4-acetate 2-benzoate. Docetaxel has the following structural formula. Docetaxel is a white to almost-white powder with an empirical formula of C43H53NO14, and a molecular weight of 807.89. It is highly lipophilic and practically insoluble in water. BEIZRAY Injection for intravenous use is a sterile, non-pyrogenic, clear colorless liquid at 20 mg/mL concentration. Each mL contains 20 mg docetaxel (anhydrous) in 0.770 grams dehydrated alcohol (100% v/v) solution, with citric acid for pH adjustment. The BEIZRAY kit also contains a single dose vial of IV Solution Stabilizer, 50 mL of 25% Albumin Human USP solution. 25% Albumin Human USP is a clear, slightly viscous liquid; it is almost colorless or slightly yellow or green. The product contains 0.25 g Albumin Human USP per mL and is stabilized with 0.08 mmol sodium acetyltryptophanate and 0.08 mmol sodium caprylate per gram of albumin.</Description>
  </NDC>
  <NDC>
    <NDCCode>71335-2090-4</NDCCode>
    <PackageDescription>60 TABLET in 1 BOTTLE (71335-2090-4) </PackageDescription>
    <NDC11Code>71335-2090-04</NDC11Code>
    <ProductNDC>71335-2090</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Levothyroxine Sodium</ProprietaryName>
    <NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20201203</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212399</ApplicationNumber>
    <LabelerName>Bryant Ranch Prepack</LabelerName>
    <SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>ug/1</StrengthUnit>
    <Pharm_Classes>Thyroxine [CS], l-Thyroxine [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-12-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241211</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hypothyroidism. Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid‑Stimulating Hormone, TSH) Suppression. Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: 1 Levothyroxine sodium tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with levothyroxine sodium may induce hyperthyroidism [see Warnings and Precautions(5.1)]. , 2 Levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.</IndicationAndUsage>
    <Description>Levothyroxine sodium tablets, USP is L-thyroxine (T4) and contains synthetic crystalline L-3,3’,5,5’-tetraiodothyronine sodium salt. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C 15H 10I 4N NaO 4 H 2O, molecular weight of 798.86 (anhydrous), and structural formula as shown:. Levothyroxine sodium tablets, USP for oral administration are supplied in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each levothyroxine sodium tablet contains the inactive ingredients microcrystalline sodium, light magnesium oxide, sodium starch glycolate and sodium stearyl fumarate. Levothyroxine sodium tablets, USP contain no ingredients made from a gluten-containing grain (wheat, barley, or rye). Table 9 provides a listing of the color additives by tablet strength. Levothyroxine sodium tablets, USP meets USP Dissolution Test 7.</Description>
  </NDC>
  <NDC>
    <NDCCode>53002-2090-1</NDCCode>
    <PackageDescription>80 mL in 1 BOTTLE (53002-2090-1) </PackageDescription>
    <NDC11Code>53002-2090-01</NDC11Code>
    <ProductNDC>53002-2090</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amoxicillin</ProprietaryName>
    <NonProprietaryName>Amoxicillin</NonProprietaryName>
    <DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070326</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065387</ApplicationNumber>
    <LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>AMOXICILLIN</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181001</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Amoxicillin is a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms. : 1 Infections of the ear, nose, throat, genitourinary tract, skin and skin structure, and lower respiratory tract. (1.1 – 1.4), 2 In combination for treatment of H. pylori infection and duodenal ulcer disease. (1.5).</IndicationAndUsage>
    <Description>Formulations of amoxicillin contain amoxicillin, a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2S,5R,6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4- thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as. The amoxicillin molecular formula is C16H19N3O5S  3H2O, and the molecular weight is 419.45. Amoxicillin Capsules, USP. Each amoxicillin capsule, with yellow opaque cap and body, contains 250 mg or 500 mg amoxicillin as the trihydrate. The 250 mg capsule is imprinted AMOX 250 on one side and GG 848 on the other side; the 500 mg capsule is imprinted AMOX 500 on one side and GG 849 on the other side. Inactive ingredients: Capsule shells - yellow ferric oxide, titanium dioxide, gelatin, black ferric oxide, shellac, propylene glycol, potassium hydroxide and ammonium hydroxide; Capsule contents - cellulose microcrystalline and magnesium stearate. Meets USP Dissolution Test 2. Amoxicillin Tablets, USP. Each film coated tablet contains 500 mg or 875 mg amoxicillin as the trihydrate. The tablets are oval-shaped and white to yellowish. The 500 mg tablet is unscored, embossed GG-961 on one side and 500 on the other side. The 875 mg tablet is scored and embossed GG-962 on one side and 875 on the other side. In addition each amoxicillin tablet contains these inactive ingredients: colloidal silicon dioxide, crospovidone, ethylcellulose aqueous dispersion, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, talc, triethyl citrate, and titanium dioxide. Amoxicillin for Oral Suspension, USP. Each 5 mL of reconstituted suspension contains 125 mg, 200 mg, 250 mg or 400 mg amoxicillin as the trihydrate. Each 5 mL of the 125 mg, 200 mg, 250 mg, and 400 mg reconstituted suspension contains 0.30 mEq (6.95 mg) of sodium. Amoxicillin trihydrate for oral suspension 125 mg/5 mL, 200 mg/5 mL, 250 mg/5 mL and 400 mg/5 mL are fruity flavored pink suspensions. Inactive ingredients: anhydrous citric acid, colloidal silicon dioxide, flavorings: raspberry, strawberry, refrachessement, FD&amp;C Red 40, sodium benzoate, sodium citrate, sucrose, and xantham gum.</Description>
  </NDC>
  <NDC>
    <NDCCode>53002-2090-2</NDCCode>
    <PackageDescription>100 mL in 1 BOTTLE (53002-2090-2) </PackageDescription>
    <NDC11Code>53002-2090-02</NDC11Code>
    <ProductNDC>53002-2090</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amoxicillin</ProprietaryName>
    <NonProprietaryName>Amoxicillin</NonProprietaryName>
    <DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070326</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065387</ApplicationNumber>
    <LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>AMOXICILLIN</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181001</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Amoxicillin is a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms. : 1 Infections of the ear, nose, throat, genitourinary tract, skin and skin structure, and lower respiratory tract. (1.1 – 1.4), 2 In combination for treatment of H. pylori infection and duodenal ulcer disease. (1.5).</IndicationAndUsage>
    <Description>Formulations of amoxicillin contain amoxicillin, a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2S,5R,6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4- thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as. The amoxicillin molecular formula is C16H19N3O5S  3H2O, and the molecular weight is 419.45. Amoxicillin Capsules, USP. Each amoxicillin capsule, with yellow opaque cap and body, contains 250 mg or 500 mg amoxicillin as the trihydrate. The 250 mg capsule is imprinted AMOX 250 on one side and GG 848 on the other side; the 500 mg capsule is imprinted AMOX 500 on one side and GG 849 on the other side. Inactive ingredients: Capsule shells - yellow ferric oxide, titanium dioxide, gelatin, black ferric oxide, shellac, propylene glycol, potassium hydroxide and ammonium hydroxide; Capsule contents - cellulose microcrystalline and magnesium stearate. Meets USP Dissolution Test 2. Amoxicillin Tablets, USP. Each film coated tablet contains 500 mg or 875 mg amoxicillin as the trihydrate. The tablets are oval-shaped and white to yellowish. The 500 mg tablet is unscored, embossed GG-961 on one side and 500 on the other side. The 875 mg tablet is scored and embossed GG-962 on one side and 875 on the other side. In addition each amoxicillin tablet contains these inactive ingredients: colloidal silicon dioxide, crospovidone, ethylcellulose aqueous dispersion, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, talc, triethyl citrate, and titanium dioxide. Amoxicillin for Oral Suspension, USP. Each 5 mL of reconstituted suspension contains 125 mg, 200 mg, 250 mg or 400 mg amoxicillin as the trihydrate. Each 5 mL of the 125 mg, 200 mg, 250 mg, and 400 mg reconstituted suspension contains 0.30 mEq (6.95 mg) of sodium. Amoxicillin trihydrate for oral suspension 125 mg/5 mL, 200 mg/5 mL, 250 mg/5 mL and 400 mg/5 mL are fruity flavored pink suspensions. Inactive ingredients: anhydrous citric acid, colloidal silicon dioxide, flavorings: raspberry, strawberry, refrachessement, FD&amp;C Red 40, sodium benzoate, sodium citrate, sucrose, and xantham gum.</Description>
  </NDC>
  <NDC>
    <NDCCode>53002-2090-3</NDCCode>
    <PackageDescription>150 mL in 1 BOTTLE (53002-2090-3) </PackageDescription>
    <NDC11Code>53002-2090-03</NDC11Code>
    <ProductNDC>53002-2090</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amoxicillin</ProprietaryName>
    <NonProprietaryName>Amoxicillin</NonProprietaryName>
    <DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070326</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065387</ApplicationNumber>
    <LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>AMOXICILLIN</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181001</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Amoxicillin is a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms. : 1 Infections of the ear, nose, throat, genitourinary tract, skin and skin structure, and lower respiratory tract. (1.1 – 1.4), 2 In combination for treatment of H. pylori infection and duodenal ulcer disease. (1.5).</IndicationAndUsage>
    <Description>Formulations of amoxicillin contain amoxicillin, a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2S,5R,6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4- thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as. The amoxicillin molecular formula is C16H19N3O5S  3H2O, and the molecular weight is 419.45. Amoxicillin Capsules, USP. Each amoxicillin capsule, with yellow opaque cap and body, contains 250 mg or 500 mg amoxicillin as the trihydrate. The 250 mg capsule is imprinted AMOX 250 on one side and GG 848 on the other side; the 500 mg capsule is imprinted AMOX 500 on one side and GG 849 on the other side. Inactive ingredients: Capsule shells - yellow ferric oxide, titanium dioxide, gelatin, black ferric oxide, shellac, propylene glycol, potassium hydroxide and ammonium hydroxide; Capsule contents - cellulose microcrystalline and magnesium stearate. Meets USP Dissolution Test 2. Amoxicillin Tablets, USP. Each film coated tablet contains 500 mg or 875 mg amoxicillin as the trihydrate. The tablets are oval-shaped and white to yellowish. The 500 mg tablet is unscored, embossed GG-961 on one side and 500 on the other side. The 875 mg tablet is scored and embossed GG-962 on one side and 875 on the other side. In addition each amoxicillin tablet contains these inactive ingredients: colloidal silicon dioxide, crospovidone, ethylcellulose aqueous dispersion, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, talc, triethyl citrate, and titanium dioxide. Amoxicillin for Oral Suspension, USP. Each 5 mL of reconstituted suspension contains 125 mg, 200 mg, 250 mg or 400 mg amoxicillin as the trihydrate. Each 5 mL of the 125 mg, 200 mg, 250 mg, and 400 mg reconstituted suspension contains 0.30 mEq (6.95 mg) of sodium. Amoxicillin trihydrate for oral suspension 125 mg/5 mL, 200 mg/5 mL, 250 mg/5 mL and 400 mg/5 mL are fruity flavored pink suspensions. Inactive ingredients: anhydrous citric acid, colloidal silicon dioxide, flavorings: raspberry, strawberry, refrachessement, FD&amp;C Red 40, sodium benzoate, sodium citrate, sucrose, and xantham gum.</Description>
  </NDC>
  <NDC>
    <NDCCode>60219-1031-7</NDCCode>
    <PackageDescription>3 BLISTER PACK in 1 CARTON (60219-1031-7)  / 1 KIT in 1 BLISTER PACK (60219-1031-6) </PackageDescription>
    <NDC11Code>60219-1031-07</NDC11Code>
    <ProductNDC>60219-1031</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate</ProprietaryName>
    <NonProprietaryName>Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20170921</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207514</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2023-08-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170921</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets are indicated for use by females of reproductive age to prevent pregnancy [see Clinical Studies (14)]. The efficacy of norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets in women with a body mass index (BMI) of more than 35 kg/m2 has not been evaluated.</IndicationAndUsage>
    <Description>Norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets provide an oral contraceptive regimen consisting of 24 white active chewable tablets that contain the active ingredients, followed by 4 brown non-hormonal placebo tablets as specified below: : 1 24 white, round tablets each containing 1 mg norethindrone acetate, USP and 20 mcg ethinyl estradiol, USP. , 2 4 brown, round tablets each containing 75 mg ferrous fumarate. .</Description>
  </NDC>
  <NDC>
    <NDCCode>60219-1076-1</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (60219-1076-1) </PackageDescription>
    <NDC11Code>60219-1076-01</NDC11Code>
    <ProductNDC>60219-1076</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Azathioprine</ProprietaryName>
    <NonProprietaryName>Azathioprine</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150202</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA074069</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>AZATHIOPRINE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA], Nucleosides [CS], Purine Antimetabolite [EPC], Purines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150202</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Azathioprine tablets are indicated as an adjunct for the prevention of rejection in renal homotransplantation. It is also indicated for the management of active rheumatoid arthritis to reduce signs and symptoms. Renal Homotransplantation: Azathioprine tablets are indicated as an adjunct for the prevention of rejection in renal homotransplantation. Experience with over 16,000 transplants shows a 5-year patient survival of 35% to 55%, but this is dependent on donor, match for HLA antigens, anti-donor or anti-B-cell alloantigen antibody, and other variables. The effect of azathioprine on these variables has not been tested in controlled trials. Rheumatoid Arthritis: Azathioprine tablets are indicated for the treatment of active rheumatoid arthritis (RA) to reduce signs and symptoms. Aspirin, non-steroidal anti-inflammatory drugs and/or low dose glucocorticoids may be continued during treatment with azathioprine. The combined use of azathioprine with disease modifying anti-rheumatic drugs (DMARDs) has not been studied for either added benefit or unexpected adverse effects. The use of azathioprine tablets with these agents cannot be recommended.</IndicationAndUsage>
    <Description>Azathioprine, an immunosuppressive antimetabolite, is available in tablet form for oral administration. Each scored tablet contains 50 mg, 75 mg or 100 mg azathioprine, USP and the inactive ingredients anhydrous lactose, magnesium stearate, povidone, pregelatinized starch (corn starch), and stearic acid. Azathioprine is chemically 1H-Purine, 6-[(1-methyl-4-nitro-1H-imidazol-5-yl)thio]. The structural formula of azathioprine is. It is an imidazolyl derivative of 6-mercaptopurine and many of its biological effects are similar to those of the parent compound. Azathioprine, USP is insoluble in water, but may be dissolved with addition of one molar equivalent of alkali. Azathioprine, USP is stable in solution at neutral or acid pH but hydrolysis to mercaptopurine occurs in excess sodium hydroxide (0.1N), especially on warming. Conversion to mercaptopurine also occurs in the presence of sulfhydryl compounds such as cysteine, glutathione and hydrogen sulfide.</Description>
  </NDC>
  <NDC>
    <NDCCode>60219-1100-1</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (60219-1100-1) </PackageDescription>
    <NDC11Code>60219-1100-01</NDC11Code>
    <ProductNDC>60219-1100</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxycycline Hyclate</ProprietaryName>
    <NonProprietaryName>Doxycycline</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160628</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207289</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160628</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate capsules and other antibacterial drugs, doxycycline hyclate capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Treatment: Doxycycline is indicated for the treatment of the following infections: : 1 Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae. , 2 Respiratory tract infections caused by Mycoplasma pneumoniae. , 3 Lymphogranuloma venereum caused by Chlamydia trachomatis. , 4 Psittacosis (ornithosis) caused by Chlamydophila psittaci. , 5 Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence. , 6 Inclusion conjunctivitis caused by Chlamydia trachomatis. , 7 Uncomplicated urethral, endocervical, or rectal infections in adults caused by Chlamydia trachomatis. , 8 Nongonococcal urethritis caused by Ureaplasma urealyticum. , 9 Relapsing fever due to Borrelia recurrentis. .</IndicationAndUsage>
    <Description>Doxycycline hyclate, USP is an antibacterial drug synthetically derived from oxytetracycline for oral administration. The structural formula of doxycycline monohydrate is. with a molecular formula of C22H24N2O8H2O and a molecular weight of 462.46 g/mol. The chemical designation for doxycycline is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrate. The molecular formula for doxycycline hydrochloride hemiethanolate hemihydrate is (C22H24N2O8HCl)2C2H6OH2O and the molecular weight is 1025.89 g/mol. Doxycycline, USP is a light-yellow crystalline powder. Doxycycline hyclate, USP is soluble in water. Doxycycline, USP has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline, USP will not degrade into an epianhydro form. Inert ingredients in the capsule formulations are: magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. The hard gelatin capsule shells contains: FD&amp;C Blue 1, gelatin, sodium lauryl sulfate and titanium dioxide. The printing ink contains: black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
  </NDC>
  <NDC>
    <NDCCode>60219-1100-3</NDCCode>
    <PackageDescription>20 CAPSULE in 1 BOTTLE (60219-1100-3) </PackageDescription>
    <NDC11Code>60219-1100-03</NDC11Code>
    <ProductNDC>60219-1100</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Doxycycline Hyclate</ProprietaryName>
    <NonProprietaryName>Doxycycline</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160628</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207289</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-10-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160628</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate capsules and other antibacterial drugs, doxycycline hyclate capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Treatment: Doxycycline is indicated for the treatment of the following infections: : 1 Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae. , 2 Respiratory tract infections caused by Mycoplasma pneumoniae. , 3 Lymphogranuloma venereum caused by Chlamydia trachomatis. , 4 Psittacosis (ornithosis) caused by Chlamydophila psittaci. , 5 Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence. , 6 Inclusion conjunctivitis caused by Chlamydia trachomatis. , 7 Uncomplicated urethral, endocervical, or rectal infections in adults caused by Chlamydia trachomatis. , 8 Nongonococcal urethritis caused by Ureaplasma urealyticum. , 9 Relapsing fever due to Borrelia recurrentis. .</IndicationAndUsage>
    <Description>Doxycycline hyclate, USP is an antibacterial drug synthetically derived from oxytetracycline for oral administration. The structural formula of doxycycline monohydrate is. with a molecular formula of C22H24N2O8H2O and a molecular weight of 462.46 g/mol. The chemical designation for doxycycline is 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrate. The molecular formula for doxycycline hydrochloride hemiethanolate hemihydrate is (C22H24N2O8HCl)2C2H6OH2O and the molecular weight is 1025.89 g/mol. Doxycycline, USP is a light-yellow crystalline powder. Doxycycline hyclate, USP is soluble in water. Doxycycline, USP has a high degree of lipoid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline, USP will not degrade into an epianhydro form. Inert ingredients in the capsule formulations are: magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. The hard gelatin capsule shells contains: FD&amp;C Blue 1, gelatin, sodium lauryl sulfate and titanium dioxide. The printing ink contains: black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
  </NDC>
  <NDC>
    <NDCCode>60219-1144-6</NDCCode>
    <PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (60219-1144-6)  / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>60219-1144-06</NDC11Code>
    <ProductNDC>60219-1144</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Darunavir</ProprietaryName>
    <NonProprietaryName>Darunavir</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20231209</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212493</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>DARUNAVIR</SubstanceName>
    <StrengthNumber>600</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], HIV Protease Inhibitors [MoA], Protease Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-03-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231209</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Darunavir, co-administered with ritonavir (darunavir/ritonavir), in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection in adult and pediatric patients 3 years of age and older [see Use in Specific Populations (8.4) and Clinical Studies (14)].</IndicationAndUsage>
    <Description>Darunavir is an inhibitor of the human immunodeficiency virus (HIV-1) protease. It has the following chemical name: [(1S,2R)-3-[[(4-aminophenyl)sulfonyl](2-methylpropyl)amino]-2-hydroxy-1-(phenylmethyl)propyl]carbamic acid (3R,3aS,6aR)-hexahydrofuro[2,3-b]furan-3-yl ester. Its molecular formula is C27H37N3O7S and its molecular weight is 547.66 g/mol. Darunavir has the following structural formula. Darunavir is a white to creamish solid. It is freely soluble in ethyl acetate and in dichloromethane; practically insoluble in water. Each darunavir tablet contains 600 mg or 800 mg of darunavir. It also contains the inactive ingredients: colloidal silicon dioxide, crospovidone Type A, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose and sodium starch glycolate Type A. The 600 mg tablet film-coating, OPADRY-II Orange, contains FD&amp;C Yellow No. 6, polyethylene glycol 3350, polyvinyl alcohol-partially hydrolyzed, talc, and titanium dioxide. The 800 mg tablet film-coating, OPADRY-II Brown, contains ferric oxide red, polyethylene glycol 3350, polyvinyl alcohol-partially hydrolyzed, talc, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>60219-1145-3</NDCCode>
    <PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (60219-1145-3)  / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>60219-1145-03</NDC11Code>
    <ProductNDC>60219-1145</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Darunavir</ProprietaryName>
    <NonProprietaryName>Darunavir</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20231209</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212493</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>DARUNAVIR</SubstanceName>
    <StrengthNumber>800</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], HIV Protease Inhibitors [MoA], Protease Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-03-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231209</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Darunavir, co-administered with ritonavir (darunavir/ritonavir), in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection in adult and pediatric patients 3 years of age and older [see Use in Specific Populations (8.4) and Clinical Studies (14)].</IndicationAndUsage>
    <Description>Darunavir is an inhibitor of the human immunodeficiency virus (HIV-1) protease. It has the following chemical name: [(1S,2R)-3-[[(4-aminophenyl)sulfonyl](2-methylpropyl)amino]-2-hydroxy-1-(phenylmethyl)propyl]carbamic acid (3R,3aS,6aR)-hexahydrofuro[2,3-b]furan-3-yl ester. Its molecular formula is C27H37N3O7S and its molecular weight is 547.66 g/mol. Darunavir has the following structural formula. Darunavir is a white to creamish solid. It is freely soluble in ethyl acetate and in dichloromethane; practically insoluble in water. Each darunavir tablet contains 600 mg or 800 mg of darunavir. It also contains the inactive ingredients: colloidal silicon dioxide, crospovidone Type A, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose and sodium starch glycolate Type A. The 600 mg tablet film-coating, OPADRY-II Orange, contains FD&amp;C Yellow No. 6, polyethylene glycol 3350, polyvinyl alcohol-partially hydrolyzed, talc, and titanium dioxide. The 800 mg tablet film-coating, OPADRY-II Brown, contains ferric oxide red, polyethylene glycol 3350, polyvinyl alcohol-partially hydrolyzed, talc, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>60219-1155-1</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE (60219-1155-1) </PackageDescription>
    <NDC11Code>60219-1155-01</NDC11Code>
    <ProductNDC>60219-1155</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ezetimibe And Simvastatin</ProprietaryName>
    <NonProprietaryName>Ezetimibe And Simvastatin</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20171121</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208831</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>EZETIMIBE; SIMVASTATIN</SubstanceName>
    <StrengthNumber>10; 10</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-12-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20171121</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ezetimibe and Simvastatin Tablets. Ezetimibe and simvastatin tablets are a combination of simvastatin and ezetimibe indicated: 1 As an adjunct to diet to reduce elevated low density lipoprotein cholesterol (LDL-C): .</IndicationAndUsage>
    <Description>Ezetimibe and simvastatin tablets contain ezetimibe USP, a dietary cholesterol absorption inhibitor, and simvastatin USP, an HMG-CoA reductase inhibitor. The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C24H21F2NO3 and its molecular weight is 409.4 g/mol. Ezetimibe, USP is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Its structural formula is. Simvastatin, USP an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form, which is an inhibitor of HMG-CoA reductase. Simvastatin, USP is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The molecular formula of simvastatin is C25H38O5 and its molecular weight is 418.57 g/mol. Simvastatin, USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water and freely soluble in chloroform, methanol and ethanol. Its structural formula is. Ezetimibe and simvastatin is available for oral use as tablets containing 10 mg of ezetimibe, USP and 10 mg of simvastatin, USP (ezetimibe and simvastatin 10/10), 20 mg of simvastatin, USP (ezetimibe and simvastatin 10/20), 40 mg of simvastatin, USP (ezetimibe and simvastatin 10/40), or 80 mg of simvastatin, USP (ezetimibe and simvastatin 10/80). Each tablet contains the following inactive ingredients: butylated hydroxyanisole, citric acid monohydrate, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and propyl gallate.</Description>
  </NDC>
  <NDC>
    <NDCCode>60219-1155-9</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (60219-1155-9) </PackageDescription>
    <NDC11Code>60219-1155-09</NDC11Code>
    <ProductNDC>60219-1155</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ezetimibe And Simvastatin</ProprietaryName>
    <NonProprietaryName>Ezetimibe And Simvastatin</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20171121</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208831</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>EZETIMIBE; SIMVASTATIN</SubstanceName>
    <StrengthNumber>10; 10</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-12-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20171121</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ezetimibe and Simvastatin Tablets. Ezetimibe and simvastatin tablets are a combination of simvastatin and ezetimibe indicated: 1 As an adjunct to diet to reduce elevated low density lipoprotein cholesterol (LDL-C): .</IndicationAndUsage>
    <Description>Ezetimibe and simvastatin tablets contain ezetimibe USP, a dietary cholesterol absorption inhibitor, and simvastatin USP, an HMG-CoA reductase inhibitor. The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C24H21F2NO3 and its molecular weight is 409.4 g/mol. Ezetimibe, USP is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Its structural formula is. Simvastatin, USP an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form, which is an inhibitor of HMG-CoA reductase. Simvastatin, USP is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The molecular formula of simvastatin is C25H38O5 and its molecular weight is 418.57 g/mol. Simvastatin, USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water and freely soluble in chloroform, methanol and ethanol. Its structural formula is. Ezetimibe and simvastatin is available for oral use as tablets containing 10 mg of ezetimibe, USP and 10 mg of simvastatin, USP (ezetimibe and simvastatin 10/10), 20 mg of simvastatin, USP (ezetimibe and simvastatin 10/20), 40 mg of simvastatin, USP (ezetimibe and simvastatin 10/40), or 80 mg of simvastatin, USP (ezetimibe and simvastatin 10/80). Each tablet contains the following inactive ingredients: butylated hydroxyanisole, citric acid monohydrate, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and propyl gallate.</Description>
  </NDC>
  <NDC>
    <NDCCode>60219-1156-1</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE (60219-1156-1) </PackageDescription>
    <NDC11Code>60219-1156-01</NDC11Code>
    <ProductNDC>60219-1156</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ezetimibe And Simvastatin</ProprietaryName>
    <NonProprietaryName>Ezetimibe And Simvastatin</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20171121</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208831</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>EZETIMIBE; SIMVASTATIN</SubstanceName>
    <StrengthNumber>10; 20</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-12-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20171121</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ezetimibe and Simvastatin Tablets. Ezetimibe and simvastatin tablets are a combination of simvastatin and ezetimibe indicated: 1 As an adjunct to diet to reduce elevated low density lipoprotein cholesterol (LDL-C): .</IndicationAndUsage>
    <Description>Ezetimibe and simvastatin tablets contain ezetimibe USP, a dietary cholesterol absorption inhibitor, and simvastatin USP, an HMG-CoA reductase inhibitor. The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C24H21F2NO3 and its molecular weight is 409.4 g/mol. Ezetimibe, USP is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Its structural formula is. Simvastatin, USP an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form, which is an inhibitor of HMG-CoA reductase. Simvastatin, USP is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The molecular formula of simvastatin is C25H38O5 and its molecular weight is 418.57 g/mol. Simvastatin, USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water and freely soluble in chloroform, methanol and ethanol. Its structural formula is. Ezetimibe and simvastatin is available for oral use as tablets containing 10 mg of ezetimibe, USP and 10 mg of simvastatin, USP (ezetimibe and simvastatin 10/10), 20 mg of simvastatin, USP (ezetimibe and simvastatin 10/20), 40 mg of simvastatin, USP (ezetimibe and simvastatin 10/40), or 80 mg of simvastatin, USP (ezetimibe and simvastatin 10/80). Each tablet contains the following inactive ingredients: butylated hydroxyanisole, citric acid monohydrate, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and propyl gallate.</Description>
  </NDC>
  <NDC>
    <NDCCode>60219-1156-9</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (60219-1156-9) </PackageDescription>
    <NDC11Code>60219-1156-09</NDC11Code>
    <ProductNDC>60219-1156</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ezetimibe And Simvastatin</ProprietaryName>
    <NonProprietaryName>Ezetimibe And Simvastatin</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20171121</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208831</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>EZETIMIBE; SIMVASTATIN</SubstanceName>
    <StrengthNumber>10; 20</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-12-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20171121</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ezetimibe and Simvastatin Tablets. Ezetimibe and simvastatin tablets are a combination of simvastatin and ezetimibe indicated: 1 As an adjunct to diet to reduce elevated low density lipoprotein cholesterol (LDL-C): .</IndicationAndUsage>
    <Description>Ezetimibe and simvastatin tablets contain ezetimibe USP, a dietary cholesterol absorption inhibitor, and simvastatin USP, an HMG-CoA reductase inhibitor. The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C24H21F2NO3 and its molecular weight is 409.4 g/mol. Ezetimibe, USP is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Its structural formula is. Simvastatin, USP an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form, which is an inhibitor of HMG-CoA reductase. Simvastatin, USP is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The molecular formula of simvastatin is C25H38O5 and its molecular weight is 418.57 g/mol. Simvastatin, USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water and freely soluble in chloroform, methanol and ethanol. Its structural formula is. Ezetimibe and simvastatin is available for oral use as tablets containing 10 mg of ezetimibe, USP and 10 mg of simvastatin, USP (ezetimibe and simvastatin 10/10), 20 mg of simvastatin, USP (ezetimibe and simvastatin 10/20), 40 mg of simvastatin, USP (ezetimibe and simvastatin 10/40), or 80 mg of simvastatin, USP (ezetimibe and simvastatin 10/80). Each tablet contains the following inactive ingredients: butylated hydroxyanisole, citric acid monohydrate, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and propyl gallate.</Description>
  </NDC>
  <NDC>
    <NDCCode>60219-1157-1</NDCCode>
    <PackageDescription>1000 TABLET in 1 BOTTLE (60219-1157-1) </PackageDescription>
    <NDC11Code>60219-1157-01</NDC11Code>
    <ProductNDC>60219-1157</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ezetimibe And Simvastatin</ProprietaryName>
    <NonProprietaryName>Ezetimibe And Simvastatin</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20171121</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA208831</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>EZETIMIBE; SIMVASTATIN</SubstanceName>
    <StrengthNumber>10; 40</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-12-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20171121</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ezetimibe and Simvastatin Tablets. Ezetimibe and simvastatin tablets are a combination of simvastatin and ezetimibe indicated: 1 As an adjunct to diet to reduce elevated low density lipoprotein cholesterol (LDL-C): .</IndicationAndUsage>
    <Description>Ezetimibe and simvastatin tablets contain ezetimibe USP, a dietary cholesterol absorption inhibitor, and simvastatin USP, an HMG-CoA reductase inhibitor. The chemical name of ezetimibe is 1-(4-fluorophenyl)-3(R)-[3-(4-fluorophenyl)-3(S)-hydroxypropyl]-4(S)(4-hydroxyphenyl)-2-azetidinone. The molecular formula is C24H21F2NO3 and its molecular weight is 409.4 g/mol. Ezetimibe, USP is a white, crystalline powder that is freely to very soluble in ethanol, methanol, and acetone and practically insoluble in water. Its structural formula is. Simvastatin, USP an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form, which is an inhibitor of HMG-CoA reductase. Simvastatin, USP is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S*,4S*),-8aβ]]. The molecular formula of simvastatin is C25H38O5 and its molecular weight is 418.57 g/mol. Simvastatin, USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water and freely soluble in chloroform, methanol and ethanol. Its structural formula is. Ezetimibe and simvastatin is available for oral use as tablets containing 10 mg of ezetimibe, USP and 10 mg of simvastatin, USP (ezetimibe and simvastatin 10/10), 20 mg of simvastatin, USP (ezetimibe and simvastatin 10/20), 40 mg of simvastatin, USP (ezetimibe and simvastatin 10/40), or 80 mg of simvastatin, USP (ezetimibe and simvastatin 10/80). Each tablet contains the following inactive ingredients: butylated hydroxyanisole, citric acid monohydrate, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and propyl gallate.</Description>
  </NDC>
</NDCList>