RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <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>36987-2280-2</NDCCode>
    <PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (36987-2280-2)</PackageDescription>
    <NDC11Code>36987-2280-02</NDC11Code>
    <ProductNDC>36987-2280</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Canadian Blue Grass</ProprietaryName>
    <NonProprietaryName>Canadian Blue Grass</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19720829</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA102192</ApplicationNumber>
    <LabelerName>Nelco Laboratories, Inc.</LabelerName>
    <SubstanceName>POA COMPRESSA POLLEN</SubstanceName>
    <StrengthNumber>10000</StrengthNumber>
    <StrengthUnit>[PNU]/mL</StrengthUnit>
    <Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [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>37662-2280-2</NDCCode>
    <PackageDescription>1200 PELLET in 1 BOTTLE, GLASS (37662-2280-2) </PackageDescription>
    <NDC11Code>37662-2280-02</NDC11Code>
    <ProductNDC>37662-2280</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Staphysagria</ProprietaryName>
    <NonProprietaryName>Staphysagria</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230109</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Hahnemann Laboratories, INC.</LabelerName>
    <SubstanceName>DELPHINIUM STAPHISAGRIA SEED</SubstanceName>
    <StrengthNumber>12</StrengthNumber>
    <StrengthUnit>[hp_C]/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2023-01-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230109</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>55714-2280-2</NDCCode>
    <PackageDescription>59.14 mL in 1 BOTTLE, GLASS (55714-2280-2)</PackageDescription>
    <NDC11Code>55714-2280-02</NDC11Code>
    <ProductNDC>55714-2280</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Eye Care</ProprietaryName>
    <NonProprietaryName>Aconitum Nap., Allium Cepa, Arsenicum Alb., Bryonia, Calendula, Chelidonium Majus, Cineraria, Euphrasia, Graphites, Lycopodium, Merc. Corros., Nux Vom., Phosphorus, Phytolacca, Picricum Ac., Pulsatilla, Rhus Toxicodendron, Sulphur, Echinacea</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110301</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Newton Laboratories, Inc.</LabelerName>
    <SubstanceName>ACONITUM NAPELLUS; ONION; ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; CHELIDONIUM MAJUS; JACOBAEA MARITIMA; EUPHRASIA STRICTA; GRAPHITE; LYCOPODIUM CLAVATUM SPORE; MERCURIC CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; TRINITROPHENOL; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SULFUR; ECHINACEA, UNSPECIFIED</SubstanceName>
    <StrengthNumber>15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3</StrengthNumber>
    <StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-13</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>61577-2280-2</NDCCode>
    <PackageDescription>58.7 g in 1 JAR (61577-2280-2) </PackageDescription>
    <NDC11Code>61577-2280-02</NDC11Code>
    <ProductNDC>61577-2280</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sore No More</ProprietaryName>
    <NonProprietaryName>Menthol Camphor</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20161025</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M017</ApplicationNumber>
    <LabelerName>SOMBRA COSMETICS INC.</LabelerName>
    <SubstanceName>MENTHOL; CAMPHOR (SYNTHETIC)</SubstanceName>
    <StrengthNumber>.03; .03</StrengthNumber>
    <StrengthUnit>g/g; g/g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-03-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20161025</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Temporarily relieves minor aches, pains, inflammation and sor muscles associated with stiffness, arthritis, and injuries.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>64942-2280-2</NDCCode>
    <PackageDescription>2 CONTAINER in 1 CONTAINER (64942-2280-2)  / 76 g in 1 CONTAINER (64942-2280-1) </PackageDescription>
    <NDC11Code>64942-2280-02</NDC11Code>
    <ProductNDC>64942-2280</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Degree</ProprietaryName>
    <NonProprietaryName>Advanced Adventure 72h Antiperspirant Deodorant</NonProprietaryName>
    <DosageFormName>STICK</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20240701</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M019</ApplicationNumber>
    <LabelerName>Conopco Inc. d/b/a/ Unilever</LabelerName>
    <SubstanceName>ALUMINUM SESQUICHLOROHYDRATE</SubstanceName>
    <StrengthNumber>16</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-07-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240701</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>reduces underarm wetness.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>71335-2280-2</NDCCode>
    <PackageDescription>500 CAPSULE in 1 BOTTLE (71335-2280-2) </PackageDescription>
    <NDC11Code>71335-2280-02</NDC11Code>
    <ProductNDC>71335-2280</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Gabapentin</ProprietaryName>
    <NonProprietaryName>Gabapentin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20180514</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206943</ApplicationNumber>
    <LabelerName>Bryant Ranch Prepack</LabelerName>
    <SubstanceName>GABAPENTIN</SubstanceName>
    <StrengthNumber>300</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-04-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240403</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Gabapentin Capsules, USP are indicated for: : 1 Management of postherpetic neuralgia in adults , 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.</IndicationAndUsage>
    <Description>The active ingredient in Gabapentin Capsules USP is gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Each Gabapentin capsule contains 100 mg, 300 mg, or 400 mg of gabapentin and the following inactive ingredients: Pregelatinized Maize starch, talc, gelatin, titanium dioxide, yellow iron oxide (300 mg and 400 mg only), and red iron oxide (300 mg and 400 mg only), black iron oxide (300 mg and 400 mg only). Ingredients of Imprinting Ink( Black SW-9049) are Black Iron Oxide NF(E 172), Butyl Alcohol NF, Dehydrated Alcohol USP, Isopropyl Alcohol USP, Potassium Hydroxide NF, Propylene Glycol USP, Shellac NF, and Strong Ammonia Solution NF.</Description>
  </NDC>
  <NDC>
    <NDCCode>72162-2280-2</NDCCode>
    <PackageDescription>144 PACKET in 1 CARTON (72162-2280-2)  / .9 g in 1 PACKET</PackageDescription>
    <NDC11Code>72162-2280-02</NDC11Code>
    <ProductNDC>72162-2280</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Bacitracin</ProprietaryName>
    <NonProprietaryName>Bacitracin</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20110620</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M004</ApplicationNumber>
    <LabelerName>Bryant Ranch Prepack</LabelerName>
    <SubstanceName>BACITRACIN</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>[USP'U]/g</StrengthUnit>
    <Pharm_Classes>Decreased Cell Wall Synthesis &amp; Repair [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240906</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>first aid to help prevent infection in: : 1 minor cuts , 2 scrapes , 3 burns.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>60219-1362-2</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (60219-1362-2)  / 10 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>60219-1362-02</NDC11Code>
    <ProductNDC>60219-1362</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Loteprednol Etabonate</ProprietaryName>
    <NonProprietaryName>Loteprednol Etabonate</NonProprietaryName>
    <DosageFormName>SUSPENSION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20250522</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217484</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>LOTEPREDNOL ETABONATE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-05-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250522</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Loteprednol etabonate ophthalmic suspension is indicated for the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation. Loteprednol etabonate ophthalmic suspension is less effective than prednisolone acetate 1% in two 28-day controlled clinical studies in acute anterior uveitis, where 72% of patients treated with loteprednol etabonate ophthalmic suspension experienced resolution of anterior chamber cells, compared to 87% of patients treated with prednisolone acetate 1%. The incidence of patients with clinically significant increases in IOP (≥ 10 mmHg) was 1% with loteprednol etabonate ophthalmic suspension and 6% with prednisolone acetate 1%. Loteprednol etabonate ophthalmic suspension should not be used in patients who require a more potent corticosteroid for this indication. Loteprednol etabonate ophthalmic suspension is also indicated for the treatment of post-operative inflammation following ocular surgery.</IndicationAndUsage>
    <Description>Loteprednol etabonate ophthalmic suspension contains a sterile, topical anti-inflammatory corticosteroid for ophthalmic use. Loteprednol etabonate is a white to off-white crystalline powder. Loteprednol etabonate is represented by the following structural formula. Molecular formula: C24H31ClO7                                Molecular weight: 466.95 g/mol. Chemical name: chloromethyl 17α-[(ethoxycarbonyl)oxy]-11β-hydroxy-3-oxoandrosta-1,4-diene-17β-carboxylate. Each mL contains. ACTIVE: Loteprednol Etabonate, 5 mg (0.5%). INACTIVES: Edetate Disodium, Glycerin, Povidone, Tyloxapol and Water for Injection. Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust the pH to 3.5 to 6.0. The suspension is essentially isotonic with a tonicity of 250 to 310 mOsmol/kg. PRESERVATIVE ADDED: Benzalkonium Chloride, 0.01%.</Description>
  </NDC>
  <NDC>
    <NDCCode>60219-1467-2</NDCCode>
    <PackageDescription>25 VIAL in 1 CARTON (60219-1467-2)  / 1 mL in 1 VIAL</PackageDescription>
    <NDC11Code>60219-1467-02</NDC11Code>
    <ProductNDC>60219-1467</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Medroxyprogesterone Acetate</ProprietaryName>
    <NonProprietaryName>Medroxyprogesterone Acetate</NonProprietaryName>
    <DosageFormName>INJECTION, SUSPENSION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20250610</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA210227</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>MEDROXYPROGESTERONE ACETATE</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Progesterone Congeners [CS], Progestin [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250610</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Medroxyprogesterone acetate injectable suspension is indicated for use by females of reproductive potential to prevent pregnancy. Limitations of Use. The use of medroxyprogesterone acetate injectable suspension is not recommended as a long-term (i.e., longer than 2 years) birth control method unless other options are considered inadequate [see Dosage and Administration (2.1) and Warnings and Precautions (5.1)].</IndicationAndUsage>
    <Description>Medroxyprogesterone acetate injectable suspension, USP contains medroxyprogesterone acetate, USP a derivative of progesterone, as its active ingredient. Medroxyprogesterone acetate, USP is active by the parenteral and oral routes of administration. It is a white to off-white; odorless crystalline powder that is stable in air and that melts between 205°C and 209°C. It is freely soluble in chloroform, soluble in acetone and dioxane, sparingly soluble in alcohol and methanol, slightly soluble in ether, and insoluble in water. The chemical name for medroxyprogesterone acetate, USP is pregn-4-ene-3, 20-dione,17-(acetyloxy)-6-methyl-, (6α)-17- Hydroxy-6α-methylpregn-4-ene-3,20-dione acetate. The structural formula is as follows. Medroxyprogesterone acetate injectable suspension, USP for intramuscular (IM) injection is available in vials containing 1 mL of medroxyprogesterone acetate, USP sterile aqueous suspension 150 mg/mL. For medroxyprogesterone acetate injectable suspension, USP vials, each mL of sterile aqueous suspension contains. Medroxyprogesterone acetate, USP              150 mg. Polyethylene glycol 3350                                28.9 mg. Polysorbate 80                                                2.41 mg. Sodium chloride                                              8.68 mg. Methylparaben                                               1.37 mg. Propylparaben                                                0.150 mg. Water for injection                                          quantity sufficient. When necessary, pH is adjusted with sodium hydroxide or hydrochloric acid, or both.</Description>
  </NDC>
  <NDC>
    <NDCCode>60219-1504-2</NDCCode>
    <PackageDescription>100 mL in 1 BOTTLE (60219-1504-2) </PackageDescription>
    <NDC11Code>60219-1504-02</NDC11Code>
    <ProductNDC>60219-1504</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Erythromycin Ethylsuccinate</ProprietaryName>
    <NonProprietaryName>Erythromycin</NonProprietaryName>
    <DosageFormName>SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20231202</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA211204</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>ERYTHROMYCIN ETHYLSUCCINATE</SubstanceName>
    <StrengthNumber>400</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Decreased Sebaceous Gland Activity [PE], Macrolide Antimicrobial [EPC], Macrolide [EPC], Macrolides [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-04-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231202</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin ethylsuccinate for oral suspension and other antibacterial drugs, erythromycin ethylsuccinate for oral suspension 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. Erythromycin ethylsuccinate for oral suspension is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below:. Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes, Streptococcus pneumoniae, or Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information.). Lower-respiratory tract infections of mild to moderate severity caused by Streptococcus pneumoniae or Streptococcus pyogenes. Listeriosis caused by Listeria monocytogenes. Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals. Respiratory tract infections due to Mycoplasma pneumoniae. Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment). Diphtheria: Infections due to Corynebacterium diphtheriae, as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers. Erythrasma: In the treatment of infections due to Corynebacterium minutissimum. Intestinal amebiasis caused by Entamoeba histolytica (oral erythromycins only). Extraenteric amebiasis requires treatment with other agents. Acute Pelvic Inflammatory Disease Caused by Neisseria gonorrhoeae: As an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeae in female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months. Syphilis Caused by Treponema pallidum: Erythromycin is an alternate choice of treatment for primary syphilis in penicillin-allergic patients. In primary syphilis, spinal fluid examinations should be done before treatment and as part of follow-up after therapy. Erythromycins are indicated for the treatment of the following infections caused by Chlamydia trachomatis: Conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum. Legionnaires' Disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease. Prophylaxis. Prevention of Initial Attacks of Rheumatic Fever. Penicillin is considered by the American Heart Association to be the drug of choice in the prevention of initial attacks of rheumatic fever (treatment of Streptococcus pyogenes infections of the upper respiratory tract, e.g., tonsillitis or pharyngitis). Erythromycin is indicated for the treatment of penicillin-allergic patients.4 The therapeutic dose should be administered for 10 days. Prevention of Recurrent Attacks of Rheumatic Fever. Penicillin or sulfonamides are considered by the American Heart Association to be the drugs of choice in the prevention of recurrent attacks of rheumatic fever. In patients who are allergic to penicillin and sulfonamides, oral erythromycin is recommended by the American Heart Association in the long-term prophylaxis of Streptococcal pharyngitis (for the prevention of recurrent attacks of rheumatic fever).4.</IndicationAndUsage>
    <Description>Erythromycin, USP is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. The base, the stearate salt, and the esters are poorly soluble in water. Erythromycin ethylsuccinate, USP is an ester of erythromycin, USP suitable for oral administration. Erythromycin ethylsuccinate, USP is known chemically as erythromycin 2'-(ethyl succinate). The molecular formula is C43H75NO16 and the molecular weight is 862.05 g/mol. The structural formula is. Erythromycin ethylsuccinate for oral suspension, USP, 200 mg/5 mL when reconstituted with water, forms a suspension containing erythromycin ethylsuccinate, USP equivalent to 200 mg erythromycin per 5 mL (teaspoonful) or 100 mg per 2.5 mL (dropperful) with an appealing fruit flavor. Erythromycin ethylsuccinate for oral suspension, USP, 400 mg/5 mL when reconstituted with water, forms a suspension containing erythromycin ethylsuccinate, USP equivalent to 400 mg of erythromycin per 5 mL (teaspoonful) with an appealing banana flavor. These products are intended primarily for pediatric use but can also be used in adults. Inactive Ingredients. Erythromycin ethylsuccinate for oral suspension, USP, 200 mg/5 mL contains caramel flavor, mixed fruit flavor, polysorbate 80, sodium citrate dihydrate, sucrose, and xanthan gum. Erythromycin ethylsuccinate for oral suspension, USP 400 mg/5 mL contains banana flavor, caramel flavor, polysorbate 80, sodium citrate dihydrate, sucrose, and xanthan gum.</Description>
  </NDC>
  <NDC>
    <NDCCode>60219-1595-2</NDCCode>
    <PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (60219-1595-2)  / 225 mL in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>60219-1595-02</NDC11Code>
    <ProductNDC>60219-1595</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Mycophenolate Mofetil</ProprietaryName>
    <NonProprietaryName>Mycophenolate Mofetil</NonProprietaryName>
    <DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20240321</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214871</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>MYCOPHENOLATE MOFETIL</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Antimetabolite Immunosuppressant [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-09-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240321</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Mycophenolate mofetil for oral suspension is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see Clinical Studies (14.1)], heart [see Clinical Studies (14.2)] or liver transplants [see Clinical Studies (14.3)], in combination with other immunosuppressants.</IndicationAndUsage>
    <Description>Mycophenolate mofetil, USP is an antimetabolite immunosuppressant. It is the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH) inhibitor. The chemical name for mycophenolate mofetil, USP (MMF) is 2-morpholinoethyl (E)-6-(4-hydroxy-6­-methoxy-7-methyl-3-oxo-5-phthalanyl)-4-methyl-4-hexenoate. It has an empirical formula of C23H31NO7, a molecular weight of 433.49, and the following structural formula. MMF is a white to off-white crystalline powder. It is slightly soluble in water (43 mcg/mL at pH 7.4); the solubility increases in acidic medium (4.27 mg/mL at pH 3.6). It is freely soluble in acetone, soluble in methanol, and sparingly soluble in ethanol. The apparent partition coefficient in 1-octanol/water (pH 7.4) buffer solution is 238. The pKa values for MMF are 5.6 for the morpholino group and 8.5 for the phenolic group. Mycophenolate mofetil is available for oral administration as a powder for oral suspension which, when reconstituted, contains 200 mg/mL of mycophenolate mofetil, USP. Inactive ingredients in mycophenolate mofetil for oral suspension, USP include anhydrous citric acid, aspartame, colloidal silicon dioxide, methylparaben, natural and artificial mixed fruit flavor, sodium citrate, sorbitol, soybean lecithin, and xanthan gum.</Description>
  </NDC>
  <NDC>
    <NDCCode>60219-1706-3</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 CARTON (60219-1706-3)  / 10 TABLET in 1 BLISTER PACK (60219-1706-2) </PackageDescription>
    <NDC11Code>60219-1706-03</NDC11Code>
    <ProductNDC>60219-1706</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Prednisone</ProprietaryName>
    <NonProprietaryName>Prednisone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210804</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213385</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>PREDNISONE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210804</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>1. Endocrine Disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance). Congenital adrenal hyperplasia. Nonsuppurative thyroiditis. Hypercalcemia associated with cancer. 2. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:. Psoriatic arthritis. Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). Ankylosing spondylitis. Acute and subacute bursitis. Acute non-specific tenosynovitis. Acute gouty arthritis. Post-traumatic osteoarthritis. Synovitis of osteoarthritis. Epicondylitis. 3. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of:. Systemic lupus erythematosus. Acute rheumatic carditis. 4. Dermatologic Diseases. Pemphigus. Bullous dermatitis herpetiformis. Severe erythema multiforme (Stevens-Johnson syndrome). Exfoliative dermatitis. Mycosis fungoides. Severe psoriasis. Severe seborrheic dermatitis. 5. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: Seasonal or perennial allergic rhinitis. Serum sickness. Bronchial asthma. Contact dermatitis. Atopic dermatitis. Drug hypersensitivity reactions. 6. Ophthalmic Diseases. Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:. Allergic conjunctivitis. Keratitis. Allergic corneal marginal ulcers. Herpes zoster ophthalmicus. Iritis and iridocyclitis. Chorioretinitis. Anterior segment inflammation. Diffuse posterior uveitis and choroiditis. Optic neuritis. Sympathetic ophthalmia. 7. Respiratory Diseases. Symptomatic sarcoidosis. Loeffler’s syndrome not manageable by other means. Berylliosis. Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy. Aspiration pneumonitis. 8. Hematologic Disorders. Idiopathic thrombocytopenic purpura in adults. Secondary thrombocytopenia in adults. Acquired (autoimmune) hemolytic anemia. Erythroblastopenia (RBC anemia). Congenital (erythroid) hypoplastic anemia. 9. Neoplastic Diseases. For palliative management of:. Leukemias and lymphomas in adults. Acute leukemia of childhood. 10. Edematous States. To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 11. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in:. Ulcerative colitis. Regional enteritis. 12. Miscellaneous. Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate anti-tuberculous chemotherapy. Trichinosis with neurologic or myocardial involvement.</IndicationAndUsage>
    <Description>Prednisone, USP is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, that are readily absorbed from the gastrointestinal tract. The chemical formula for prednisone is C21H26O5. Chemically, it is 17,21-dihydroxypregna-1,4-diene- 3,11,20-trione and has the following structure. Prednisone, USP is a white or practically white, crystalline powder and has a molecular weight of 358.4 g/mol. It melts at about 234°C. Prednisone, USP is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. Prednisone tablets, USP contain 1 mg or 5 mg of prednisone, USP. The inactive ingredients for prednisone tablets, USP include: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate type A and stearic acid. Meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>60219-1707-3</NDCCode>
    <PackageDescription>10 BLISTER PACK in 1 CARTON (60219-1707-3)  / 10 TABLET in 1 BLISTER PACK (60219-1707-2) </PackageDescription>
    <NDC11Code>60219-1707-03</NDC11Code>
    <ProductNDC>60219-1707</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Prednisone</ProprietaryName>
    <NonProprietaryName>Prednisone</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20200624</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA213386</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>PREDNISONE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200624</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Prednisone tablets are indicated in the following conditions. 1. Endocrine DisordersPrimary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance) Congenital adrenal hyperplasiaHypercalcemia associated with cancerNonsuppurative thyroiditis2. Rheumatic DisordersAs adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Psoriatic arthritisRheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)Ankylosing spondylitisAcute and subacute bursitisAcute nonspecific tenosynovitisAcute gouty arthritisPost-traumatic osteoarthritisSynovitis of osteoarthritisEpicondylitis3. Collagen DiseasesDuring an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosusSystemic dermatomyositis (polymyositis)Acute rheumatic carditis4. Dermatologic DiseasesPemphigus Bullous dermatitis herpetiformisSevere erythema multiforme (Stevens-Johnson syndrome)Exfoliative dermatitisMycosis fungoidesSevere psoriasisSevere seborrheic dermatitis5. Allergic StatesControl of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: Seasonal or perennial allergic rhinitisBronchial asthmaContact dermatitisAtopic dermatitisSerum sicknessDrug hypersensitivity reactions6. Ophthalmic DiseasesSevere acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: Allergic corneal marginal ulcers Herpes zoster ophthalmicusAnterior segment inflammationDiffuse posterior uveitis and choroiditisSympathetic ophthalmiaAllergic conjunctivitisKeratitisChorioretinitisOptic neuritisIritis and iridocyclitis7. Respiratory DiseasesSymptomatic sarcoidosis Loeffler’s syndrome not manageable by other meansBerylliosisFulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapyAspiration pneumonitis8. Hematologic DisordersIdiopathic thrombocytopenic purpura in adults Secondary thrombocytopenia in adultsAcquired (autoimmune) hemolytic anemiaErythroblastopenia (RBC anemia)Congenital (erythroid) hypoplastic anemia9. Neoplastic DiseasesFor palliative management of: Leukemias and lymphomas in adultsAcute leukemia of childhood10. Edematous StatesTo induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus11. Gastrointestinal DiseasesTo tide the patient over a critical period of the disease in: Ulcerative colitisRegional enteritis12. Nervous SystemAcute exacerbations of multiple sclerosis13. MiscellaneousTuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapyTrichinosis with neurologic or myocardial involvement.</IndicationAndUsage>
    <Description>Prednisone tablets, USP contain prednisone, USP which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisone, USP is a white to practically white, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, in chloroform, in dioxane, and in methanol. The chemical name for prednisone is 17,21-dihydroxypregna-1,4-diene-3,11,20-trione. Its molecular formula is C21H26O5 and its molecular weight is 358.4 g/mole. The structural formula is represented below. Prednisone tablets, USP are available in 2 strengths: 10 mg and 20 mg. Inactive Ingredients: Lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch and sodium starch glycolate type A. Meets USP Dissolution Test 2. ACTIONS. Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are primarily used for their potent anti-inflammatory effects in disorders of many organ systems. Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body's immune responses to diverse stimuli.</Description>
  </NDC>
  <NDC>
    <NDCCode>60219-1714-2</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (60219-1714-2) </PackageDescription>
    <NDC11Code>60219-1714-02</NDC11Code>
    <ProductNDC>60219-1714</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lenalidomide</ProprietaryName>
    <NonProprietaryName>Lenalidomide</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250212</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216213</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>LENALIDOMIDE</SubstanceName>
    <StrengthNumber>2.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Thalidomide Analog [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250212</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lenalidomide is a thalidomide analogue indicated for the treatment of adult patients with: : 1 Multiple myeloma (MM), in combination with dexamethasone. (1.1), 2 MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT). (1.1), 3 Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities. (1.2) .</IndicationAndUsage>
    <Description>Lenalidomide capsules contains lenalidomide dimethyl sulphoxide, a thalidomide analogue, is an immunomodulatory agent with antiangiogenic and antineoplastic properties. The chemical name of lenalidomide dimethyl sulphoxide is 3-(4-amino-1-oxoisoindolin-2-yl) piperidine-2,6-dione dimethyl sulphoxide and it has the following chemical structure. The molecular formula for lenalidomide dimethyl sulphoxide is C13H13N3O3.&amp;frac12; (C2H6OS), and the gram molecular weight is 298.33 g/mol. Lenalidomide dimethyl sulphoxide is an off-white to brown color powder. It is soluble in dimethyl sulfoxide, N,N-Dimethyl formamide and practically insoluble in water. Lenalidomide dimethyl sulphoxide contains one chiral center, hence a pair of stereoisomer is possible, and is produced as a racemic in nature. Lenalidomide is available in 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg and 25 mg capsules for oral administration. Each capsule contains lenalidomide dimethyl sulphoxide as the active ingredient and the following inactive ingredients: croscarmellose sodium, lactose anhydrous, microcrystalline cellulose and magnesium stearate. The 5 mg and 25 mg capsule shell contains gelatin and titanium dioxide. The 2.5 mg and 10 mg capsule shell contains FD&amp;C blue #1, gelatin, ferric oxide red, ferric oxide yellow and titanium dioxide. The 15 mg capsule shell contains FD&amp;C blue #1, gelatin and titanium dioxide. The 20 mg capsule shell contains FD&amp;C blue #1, gelatin, ferric oxide red, ferric oxide yellow and titanium dioxide. Each capsule is imprinted with black pharmaceutical ink which contains ferrosoferric oxide, potassium hydroxide, propylene glycol, purified water and shellac.</Description>
  </NDC>
  <NDC>
    <NDCCode>60219-1715-2</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (60219-1715-2) </PackageDescription>
    <NDC11Code>60219-1715-02</NDC11Code>
    <ProductNDC>60219-1715</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lenalidomide</ProprietaryName>
    <NonProprietaryName>Lenalidomide</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250212</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216213</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>LENALIDOMIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Thalidomide Analog [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250212</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lenalidomide is a thalidomide analogue indicated for the treatment of adult patients with: : 1 Multiple myeloma (MM), in combination with dexamethasone. (1.1), 2 MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT). (1.1), 3 Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities. (1.2) .</IndicationAndUsage>
    <Description>Lenalidomide capsules contains lenalidomide dimethyl sulphoxide, a thalidomide analogue, is an immunomodulatory agent with antiangiogenic and antineoplastic properties. The chemical name of lenalidomide dimethyl sulphoxide is 3-(4-amino-1-oxoisoindolin-2-yl) piperidine-2,6-dione dimethyl sulphoxide and it has the following chemical structure. The molecular formula for lenalidomide dimethyl sulphoxide is C13H13N3O3.&amp;frac12; (C2H6OS), and the gram molecular weight is 298.33 g/mol. Lenalidomide dimethyl sulphoxide is an off-white to brown color powder. It is soluble in dimethyl sulfoxide, N,N-Dimethyl formamide and practically insoluble in water. Lenalidomide dimethyl sulphoxide contains one chiral center, hence a pair of stereoisomer is possible, and is produced as a racemic in nature. Lenalidomide is available in 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg and 25 mg capsules for oral administration. Each capsule contains lenalidomide dimethyl sulphoxide as the active ingredient and the following inactive ingredients: croscarmellose sodium, lactose anhydrous, microcrystalline cellulose and magnesium stearate. The 5 mg and 25 mg capsule shell contains gelatin and titanium dioxide. The 2.5 mg and 10 mg capsule shell contains FD&amp;C blue #1, gelatin, ferric oxide red, ferric oxide yellow and titanium dioxide. The 15 mg capsule shell contains FD&amp;C blue #1, gelatin and titanium dioxide. The 20 mg capsule shell contains FD&amp;C blue #1, gelatin, ferric oxide red, ferric oxide yellow and titanium dioxide. Each capsule is imprinted with black pharmaceutical ink which contains ferrosoferric oxide, potassium hydroxide, propylene glycol, purified water and shellac.</Description>
  </NDC>
  <NDC>
    <NDCCode>60219-1716-2</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (60219-1716-2) </PackageDescription>
    <NDC11Code>60219-1716-02</NDC11Code>
    <ProductNDC>60219-1716</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lenalidomide</ProprietaryName>
    <NonProprietaryName>Lenalidomide</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250212</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216213</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>LENALIDOMIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Thalidomide Analog [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250212</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lenalidomide is a thalidomide analogue indicated for the treatment of adult patients with: : 1 Multiple myeloma (MM), in combination with dexamethasone. (1.1), 2 MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT). (1.1), 3 Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities. (1.2) .</IndicationAndUsage>
    <Description>Lenalidomide capsules contains lenalidomide dimethyl sulphoxide, a thalidomide analogue, is an immunomodulatory agent with antiangiogenic and antineoplastic properties. The chemical name of lenalidomide dimethyl sulphoxide is 3-(4-amino-1-oxoisoindolin-2-yl) piperidine-2,6-dione dimethyl sulphoxide and it has the following chemical structure. The molecular formula for lenalidomide dimethyl sulphoxide is C13H13N3O3.&amp;frac12; (C2H6OS), and the gram molecular weight is 298.33 g/mol. Lenalidomide dimethyl sulphoxide is an off-white to brown color powder. It is soluble in dimethyl sulfoxide, N,N-Dimethyl formamide and practically insoluble in water. Lenalidomide dimethyl sulphoxide contains one chiral center, hence a pair of stereoisomer is possible, and is produced as a racemic in nature. Lenalidomide is available in 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg and 25 mg capsules for oral administration. Each capsule contains lenalidomide dimethyl sulphoxide as the active ingredient and the following inactive ingredients: croscarmellose sodium, lactose anhydrous, microcrystalline cellulose and magnesium stearate. The 5 mg and 25 mg capsule shell contains gelatin and titanium dioxide. The 2.5 mg and 10 mg capsule shell contains FD&amp;C blue #1, gelatin, ferric oxide red, ferric oxide yellow and titanium dioxide. The 15 mg capsule shell contains FD&amp;C blue #1, gelatin and titanium dioxide. The 20 mg capsule shell contains FD&amp;C blue #1, gelatin, ferric oxide red, ferric oxide yellow and titanium dioxide. Each capsule is imprinted with black pharmaceutical ink which contains ferrosoferric oxide, potassium hydroxide, propylene glycol, purified water and shellac.</Description>
  </NDC>
  <NDC>
    <NDCCode>60219-1717-2</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (60219-1717-2) </PackageDescription>
    <NDC11Code>60219-1717-02</NDC11Code>
    <ProductNDC>60219-1717</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lenalidomide</ProprietaryName>
    <NonProprietaryName>Lenalidomide</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250212</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216213</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>LENALIDOMIDE</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Thalidomide Analog [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250212</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lenalidomide is a thalidomide analogue indicated for the treatment of adult patients with: : 1 Multiple myeloma (MM), in combination with dexamethasone. (1.1), 2 MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT). (1.1), 3 Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities. (1.2) .</IndicationAndUsage>
    <Description>Lenalidomide capsules contains lenalidomide dimethyl sulphoxide, a thalidomide analogue, is an immunomodulatory agent with antiangiogenic and antineoplastic properties. The chemical name of lenalidomide dimethyl sulphoxide is 3-(4-amino-1-oxoisoindolin-2-yl) piperidine-2,6-dione dimethyl sulphoxide and it has the following chemical structure. The molecular formula for lenalidomide dimethyl sulphoxide is C13H13N3O3.&amp;frac12; (C2H6OS), and the gram molecular weight is 298.33 g/mol. Lenalidomide dimethyl sulphoxide is an off-white to brown color powder. It is soluble in dimethyl sulfoxide, N,N-Dimethyl formamide and practically insoluble in water. Lenalidomide dimethyl sulphoxide contains one chiral center, hence a pair of stereoisomer is possible, and is produced as a racemic in nature. Lenalidomide is available in 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg and 25 mg capsules for oral administration. Each capsule contains lenalidomide dimethyl sulphoxide as the active ingredient and the following inactive ingredients: croscarmellose sodium, lactose anhydrous, microcrystalline cellulose and magnesium stearate. The 5 mg and 25 mg capsule shell contains gelatin and titanium dioxide. The 2.5 mg and 10 mg capsule shell contains FD&amp;C blue #1, gelatin, ferric oxide red, ferric oxide yellow and titanium dioxide. The 15 mg capsule shell contains FD&amp;C blue #1, gelatin and titanium dioxide. The 20 mg capsule shell contains FD&amp;C blue #1, gelatin, ferric oxide red, ferric oxide yellow and titanium dioxide. Each capsule is imprinted with black pharmaceutical ink which contains ferrosoferric oxide, potassium hydroxide, propylene glycol, purified water and shellac.</Description>
  </NDC>
  <NDC>
    <NDCCode>60219-1718-2</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (60219-1718-2) </PackageDescription>
    <NDC11Code>60219-1718-02</NDC11Code>
    <ProductNDC>60219-1718</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lenalidomide</ProprietaryName>
    <NonProprietaryName>Lenalidomide</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250212</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216213</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>LENALIDOMIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Thalidomide Analog [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250212</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lenalidomide is a thalidomide analogue indicated for the treatment of adult patients with: : 1 Multiple myeloma (MM), in combination with dexamethasone. (1.1), 2 MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT). (1.1), 3 Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities. (1.2) .</IndicationAndUsage>
    <Description>Lenalidomide capsules contains lenalidomide dimethyl sulphoxide, a thalidomide analogue, is an immunomodulatory agent with antiangiogenic and antineoplastic properties. The chemical name of lenalidomide dimethyl sulphoxide is 3-(4-amino-1-oxoisoindolin-2-yl) piperidine-2,6-dione dimethyl sulphoxide and it has the following chemical structure. The molecular formula for lenalidomide dimethyl sulphoxide is C13H13N3O3.&amp;frac12; (C2H6OS), and the gram molecular weight is 298.33 g/mol. Lenalidomide dimethyl sulphoxide is an off-white to brown color powder. It is soluble in dimethyl sulfoxide, N,N-Dimethyl formamide and practically insoluble in water. Lenalidomide dimethyl sulphoxide contains one chiral center, hence a pair of stereoisomer is possible, and is produced as a racemic in nature. Lenalidomide is available in 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg and 25 mg capsules for oral administration. Each capsule contains lenalidomide dimethyl sulphoxide as the active ingredient and the following inactive ingredients: croscarmellose sodium, lactose anhydrous, microcrystalline cellulose and magnesium stearate. The 5 mg and 25 mg capsule shell contains gelatin and titanium dioxide. The 2.5 mg and 10 mg capsule shell contains FD&amp;C blue #1, gelatin, ferric oxide red, ferric oxide yellow and titanium dioxide. The 15 mg capsule shell contains FD&amp;C blue #1, gelatin and titanium dioxide. The 20 mg capsule shell contains FD&amp;C blue #1, gelatin, ferric oxide red, ferric oxide yellow and titanium dioxide. Each capsule is imprinted with black pharmaceutical ink which contains ferrosoferric oxide, potassium hydroxide, propylene glycol, purified water and shellac.</Description>
  </NDC>
  <NDC>
    <NDCCode>60219-1719-2</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (60219-1719-2) </PackageDescription>
    <NDC11Code>60219-1719-02</NDC11Code>
    <ProductNDC>60219-1719</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lenalidomide</ProprietaryName>
    <NonProprietaryName>Lenalidomide</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250212</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216213</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>LENALIDOMIDE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Thalidomide Analog [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250212</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lenalidomide is a thalidomide analogue indicated for the treatment of adult patients with: : 1 Multiple myeloma (MM), in combination with dexamethasone. (1.1), 2 MM, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT). (1.1), 3 Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities. (1.2) .</IndicationAndUsage>
    <Description>Lenalidomide capsules contains lenalidomide dimethyl sulphoxide, a thalidomide analogue, is an immunomodulatory agent with antiangiogenic and antineoplastic properties. The chemical name of lenalidomide dimethyl sulphoxide is 3-(4-amino-1-oxoisoindolin-2-yl) piperidine-2,6-dione dimethyl sulphoxide and it has the following chemical structure. The molecular formula for lenalidomide dimethyl sulphoxide is C13H13N3O3.&amp;frac12; (C2H6OS), and the gram molecular weight is 298.33 g/mol. Lenalidomide dimethyl sulphoxide is an off-white to brown color powder. It is soluble in dimethyl sulfoxide, N,N-Dimethyl formamide and practically insoluble in water. Lenalidomide dimethyl sulphoxide contains one chiral center, hence a pair of stereoisomer is possible, and is produced as a racemic in nature. Lenalidomide is available in 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg and 25 mg capsules for oral administration. Each capsule contains lenalidomide dimethyl sulphoxide as the active ingredient and the following inactive ingredients: croscarmellose sodium, lactose anhydrous, microcrystalline cellulose and magnesium stearate. The 5 mg and 25 mg capsule shell contains gelatin and titanium dioxide. The 2.5 mg and 10 mg capsule shell contains FD&amp;C blue #1, gelatin, ferric oxide red, ferric oxide yellow and titanium dioxide. The 15 mg capsule shell contains FD&amp;C blue #1, gelatin and titanium dioxide. The 20 mg capsule shell contains FD&amp;C blue #1, gelatin, ferric oxide red, ferric oxide yellow and titanium dioxide. Each capsule is imprinted with black pharmaceutical ink which contains ferrosoferric oxide, potassium hydroxide, propylene glycol, purified water and shellac.</Description>
  </NDC>
  <NDC>
    <NDCCode>60219-1748-2</NDCCode>
    <PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (60219-1748-2)  / 2 mL in 1 BOTTLE, DROPPER</PackageDescription>
    <NDC11Code>60219-1748-02</NDC11Code>
    <ProductNDC>60219-1748</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Atropine</ProprietaryName>
    <NonProprietaryName>Atropine Sulfate</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20220719</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA214752</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>ATROPINE SULFATE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220719</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Atropine sulfate ophthalmic solution, 1% is indicated in adults and pediatric patients aged three (3) months and older for:.</IndicationAndUsage>
    <Description>Atropine Sulfate Ophthalmic Solution USP, 1% contains atropine, an anticholinergic, in a sterile colorless, clear solution for topical ophthalmic use. The active ingredient is represented by the chemical structure. Chemical Name: Benzeneacetic acid, α-(hydroxymethyl)-, 8-methyl-8-azabicyclo-[3.2.1]oct-3-yl ester, endo –(±), sulfate (2:1) (salt), monohydrate. Molecular Formula: (C17H23NO3)2  H2SO4  H2O. Molecular Weight: 694.83 g/mol. Each mL of atropine sulfate ophthalmic solution USP, 1% contains:. Active: atropine sulfate, USP 10 mg equivalent to 8.3 mg of atropine. Inactives: benzalkonium chloride 0.1 mg (0.01%), dibasic sodium phosphate, edetate disodium, hypromellose (2910), monobasic sodium phosphate, hydrochloric acid and/or sodium hydroxide may be added to adjust pH (3.5 to 6.0) and water for injection USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>60219-2054-3</NDCCode>
    <PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (60219-2054-3)  / 2.5 mL in 1 BOTTLE, DROPPER</PackageDescription>
    <NDC11Code>60219-2054-03</NDC11Code>
    <ProductNDC>60219-2054</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Timolol Maleate</ProprietaryName>
    <NonProprietaryName>Timolol Maleate</NonProprietaryName>
    <DosageFormName>SOLUTION, GEL FORMING / DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20240527</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216343</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>TIMOLOL MALEATE</SubstanceName>
    <StrengthNumber>2.5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240527</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Timolol maleate ophthalmic gel forming solution is indicated for the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.</IndicationAndUsage>
    <Description>Timolol maleate ophthalmic gel forming solution, 0.25% and 0.5% is a non-selective beta-adrenergic receptor inhibitor. Its chemical name is (-)-1-(tert-butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol maleate possesses an asymmetric carbon atom in its structure and is provided at the levo-isomer. The nominal optical rotation of timolol maleate is. Its molecular formula is C13H24N4O3S·C4H4O4 and its structural formula is. Timolol maleate, USP has a molecular weight of 432.5 g/mol. Timolol maleate, USP is a white or almost white crystalline powder which is soluble in water, sparingly soluble in ethanol, slightly soluble in chloroform and practically insoluble in ether. Timolol maleate ophthalmic gel forming solution is a colorless to nearly colorless, slightly opalescent, and slightly viscous, is supplied as a sterile, isotonic, buffered, aqueous topical ophthalmic solution of timolol maleate in two dosage strengths: 0.25% and 0.5%. Timolol maleate gel forming solution has a pH between 6.5 to 7.5 and an osmolality between 260 mOsmol/kg to 310 mOsmol/kg. Active:. Each mL of timolol maleate ophthalmic gel forming solution 0.25% contains 2.5 mg of timolol (3.4 mg of timolol maleate). Each mL of timolol maleate ophthalmic gel forming solution 0.5% contains 5 mg of timolol (6.8 mg of timolol maleate). Preservative. Benzododecinium bromide, 0.12 mg (0.012%). Inactives. Xanthan gum, tromethamine, boric acid, mannitol, polysorbate-80, and water for injection. Xanthan gum is a purified high molecular weight polysaccharide gum produced from the fermentation by bacterium Xanthomonas campestris. An aqueous solution of xanthan gum, in the presence of tear protein (lysozyme), forms a gel. Upon contact with the precorneal tear film, timolol maleate ophthalmic gel forming solution forms a gel that is subsequently removed by the flow of tears.</Description>
  </NDC>
  <NDC>
    <NDCCode>60219-2055-3</NDCCode>
    <PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (60219-2055-3)  / 2.5 mL in 1 BOTTLE, DROPPER</PackageDescription>
    <NDC11Code>60219-2055-03</NDC11Code>
    <ProductNDC>60219-2055</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Timolol Maleate</ProprietaryName>
    <NonProprietaryName>Timolol Maleate</NonProprietaryName>
    <DosageFormName>SOLUTION, GEL FORMING / DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20240527</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA216343</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>TIMOLOL MALEATE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240527</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Timolol maleate ophthalmic gel forming solution is indicated for the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.</IndicationAndUsage>
    <Description>Timolol maleate ophthalmic gel forming solution, 0.25% and 0.5% is a non-selective beta-adrenergic receptor inhibitor. Its chemical name is (-)-1-(tert-butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol maleate possesses an asymmetric carbon atom in its structure and is provided at the levo-isomer. The nominal optical rotation of timolol maleate is. Its molecular formula is C13H24N4O3S·C4H4O4 and its structural formula is. Timolol maleate, USP has a molecular weight of 432.5 g/mol. Timolol maleate, USP is a white or almost white crystalline powder which is soluble in water, sparingly soluble in ethanol, slightly soluble in chloroform and practically insoluble in ether. Timolol maleate ophthalmic gel forming solution is a colorless to nearly colorless, slightly opalescent, and slightly viscous, is supplied as a sterile, isotonic, buffered, aqueous topical ophthalmic solution of timolol maleate in two dosage strengths: 0.25% and 0.5%. Timolol maleate gel forming solution has a pH between 6.5 to 7.5 and an osmolality between 260 mOsmol/kg to 310 mOsmol/kg. Active:. Each mL of timolol maleate ophthalmic gel forming solution 0.25% contains 2.5 mg of timolol (3.4 mg of timolol maleate). Each mL of timolol maleate ophthalmic gel forming solution 0.5% contains 5 mg of timolol (6.8 mg of timolol maleate). Preservative. Benzododecinium bromide, 0.12 mg (0.012%). Inactives. Xanthan gum, tromethamine, boric acid, mannitol, polysorbate-80, and water for injection. Xanthan gum is a purified high molecular weight polysaccharide gum produced from the fermentation by bacterium Xanthomonas campestris. An aqueous solution of xanthan gum, in the presence of tear protein (lysozyme), forms a gel. Upon contact with the precorneal tear film, timolol maleate ophthalmic gel forming solution forms a gel that is subsequently removed by the flow of tears.</Description>
  </NDC>
  <NDC>
    <NDCCode>60219-2104-7</NDCCode>
    <PackageDescription>2 VIAL in 1 CARTON (60219-2104-7)  / .1 mL in 1 VIAL (60219-2104-1) </PackageDescription>
    <NDC11Code>60219-2104-07</NDC11Code>
    <ProductNDC>60219-2104</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Naloxone Hydrochloride</ProprietaryName>
    <NonProprietaryName>Naloxone</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>NASAL</RouteName>
    <StartMarketingDate>20240424</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217992</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>NALOXONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>mg/.1mL</StrengthUnit>
    <Pharm_Classes>Opioid Antagonist [EPC], Opioid Antagonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240424</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>to “revive” someone during an overdose from many prescription pain medications or street drugs such as heroin. this medicine can save a life.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>60219-2149-1</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (60219-2149-1)  / 2.5 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>60219-2149-01</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>20261231</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>60219-2149-2</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (60219-2149-2)  / 7.5 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>60219-2149-02</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>20261231</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>60219-2281-2</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>60219-2366-2</NDCCode>
    <PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (60219-2366-2)  / 2.5 mL in 1 BOTTLE, DROPPER</PackageDescription>
    <NDC11Code>60219-2366-02</NDC11Code>
    <ProductNDC>60219-2366</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pilocarpine Hydrochloride Ophthalmic</ProprietaryName>
    <NonProprietaryName>Pilocarpine Hydrochloride</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20250501</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217733</ApplicationNumber>
    <LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
    <SubstanceName>PILOCARPINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>12.5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Cholinergic Agonists [MoA], Cholinergic Muscarinic Agonists [MoA], Cholinergic Receptor Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-09-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250501</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pilocarpine hydrochloride ophthalmic solution is indicated for the treatment of presbyopia in adults.</IndicationAndUsage>
    <Description>Pilocarpine hydrochloride ophthalmic solution USP, 1.25% is a cholinergic muscarinic receptor agonist prepared as an isotonic, clear, colorless, sterile ophthalmic solution containing 1.25% of pilocarpine hydrochloride, USP. The chemical name for pilocarpine hydrochloride, USP is (3S,4R)-3-ethyl-4-[(1-methyl-1H-imidazol-5-yl)methyl]-oxolan-2-one hydrochloride. Its molecular weight is 244.72 g/mol and its molecular formula is C11H16N2O2 · HCl. Its structural formula is. Pilocarpine hydrochloride, USP is a white or almost white, crystalline powder or colorless crystals hygroscopic. It is very soluble in water and freely soluble in alcohol, slightly soluble in chloroform and insoluble in ether. Each mL of Pilocarpine Hydrochloride Ophthalmic Solution, USP contains. Active: Pilocarpine hydrochloride USP, 1.25% (12.5 mg) equivalent to 1.06% (10.6 mg) pilocarpine free-base. Preservative: Benzalkonium chloride, 0.0075%. Inactives: Boric acid, sodium citrate dihydrate, sodium chloride, water for injection and may also include hydrochloric acid and/or sodium hydroxide for pH adjustment to between 3.5 and 5.5, if necessary.</Description>
  </NDC>
  <NDC>
    <NDCCode>0456-2280-30</NDCCode>
    <PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0456-2280-30) </PackageDescription>
    <NDC11Code>00456-2280-30</NDC11Code>
    <ProductNDC>0456-2280</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fetzima</ProprietaryName>
    <NonProprietaryName>Levomilnacipran Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20130725</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA204168</ApplicationNumber>
    <LabelerName>Allergan, Inc.</LabelerName>
    <SubstanceName>LEVOMILNACIPRAN HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20130725</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>FETZIMA® is indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)]. Limitation of Use: FETZIMA is not approved for the management of fibromyalgia. The efficacy and safety of FETZIMA for the management of fibromyalgia have not been established.</IndicationAndUsage>
    <Description>FETZIMA contains levomilnacipran, a selective serotonin and norepinephrine reuptake inhibitor (SNRI), in the form of hydrochloride salt with the chemical name of levomilnacipran hydrochloride is (1S,2R)-2-(aminomethyl)-N,N-diethyl-1-phenylcyclopropanecarboxamide hydrochloride. Its empirical formula is C15H22N2O∙HCl and its molecular weight is 282.8 g/mol. Levomilnacipran (Initial US approval: 2013) is the 1S,2R-enantiomer of milnacipran. The chemical structure of levomilnacipran hydrochloride is. FETZIMA extended-release capsules are intended for oral administration. Each FETZIMA capsule contains 23.0, 45.9, 91.8, or 137.8 mg of levomilnacipran hydrochloride equivalent to 20, 40, 80, or 120 mg of levomilnacipran, respectively. Inactive ingredients include ethylcellulose, hypromellose, povidone, sugar spheres, talc, titanium dioxide, and triethyl citrate. Inactive ingredients also include black iron oxide, red iron oxide (80 mg and 120 mg capsules only), shellac glaze, and yellow iron oxide (20 mg and 40 mg capsules only).</Description>
  </NDC>
</NDCList>