RESTful Lookup — Test-Drive (2007 – 2026)

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<NDCList>
  <NDC>
    <NDCCode>50090-0233-0</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (50090-0233-0)  &gt; 15 g in 1 TUBE</PackageDescription>
    <NDC11Code>50090-0233-00</NDC11Code>
    <ProductNDC>50090-0233</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nystatin</ProprietaryName>
    <NonProprietaryName>Nystatin</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20060915</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA062472</ApplicationNumber>
    <LabelerName>A-S Medication Solutions</LabelerName>
    <SubstanceName>NYSTATIN</SubstanceName>
    <StrengthNumber>100000</StrengthNumber>
    <StrengthUnit>[USP'U]/g</StrengthUnit>
    <Pharm_Classes>Polyene Antifungal [EPC], Polyenes [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2022-12-08</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160629</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>15631-0233-0</NDCCode>
    <PackageDescription>100 PELLET in 1 PACKAGE (15631-0233-0) </PackageDescription>
    <NDC11Code>15631-0233-00</NDC11Code>
    <ProductNDC>15631-0233</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Indigo</ProprietaryName>
    <NonProprietaryName>Indigo</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20151002</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
    <SubstanceName>D&amp;C BLUE NO. 6</SubstanceName>
    <StrengthNumber>3</StrengthNumber>
    <StrengthUnit>[hp_X]/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>51927-0233-0</NDCCode>
    <PackageDescription>1 kg in 1 BOTTLE (51927-0233-0) </PackageDescription>
    <NDC11Code>51927-0233-00</NDC11Code>
    <ProductNDC>51927-0233</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Nifedipine</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20220223</StartMarketingDate>
    <EndMarketingDate>20241130</EndMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
    <LabelerName>Professional Compounding Centers of America</LabelerName>
    <SubstanceName>NIFEDIPINE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <StartMarketingDatePackage>23-FEB-22</StartMarketingDatePackage>
    <EndMarketingDatePackage>30-NOV-24</EndMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>60870-0233-0</NDCCode>
    <PackageDescription>1 BAG in 1 DRUM (60870-0233-0)  &gt; 15000 g in 1 BAG</PackageDescription>
    <NDC11Code>60870-0233-00</NDC11Code>
    <ProductNDC>60870-0233</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Nandrolone Decanoate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>19800425</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Aspen Oss B.V.</LabelerName>
    <SubstanceName>NANDROLONE DECANOATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <DEASchedule>CIII</DEASchedule>
    <Status>Unfinished</Status>
    <LastUpdate>2023-01-11</LastUpdate>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>25-APR-80</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>70518-0233-0</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BLISTER PACK (70518-0233-0) </PackageDescription>
    <NDC11Code>70518-0233-00</NDC11Code>
    <ProductNDC>70518-0233</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Topiramate</ProprietaryName>
    <NonProprietaryName>Topiramate</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20170216</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078235</ApplicationNumber>
    <LabelerName>REMEDYREPACK INC.</LabelerName>
    <SubstanceName>TOPIRAMATE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170216</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Topiramate is indicated for: 1   Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older ( 1.1); adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older ( 1.2) , 2   Preventive treatment of migraine in patients 12 years of age and older ( 1.3) .</IndicationAndUsage>
    <Description>Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets, USP are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Topiramate capsules, USP are available as 15 mg, 25 mg and 50 mg sprinkle capsules for oral administration as whole capsules or opened and sprinkled onto soft food. Topiramate, USP is a white to off-white crystalline powder with bitter taste. It is freely soluble in dichloromethane. Topiramate has the molecular formula C 12H 21NO 8S and a molecular weight of 339.36. Topiramate is designated chemically as 2,3:4,5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula:. Each topiramate tablet,USP intended for oral administration contains 25 mg or 50 mg or 100 mg or 200 mg of topiramate. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, talc and titanium dioxide. Each topiramate capsule, USP intended for oral administration contains 15 mg or 25 mg or 50 mg of topiramate. In addition, each capsule contains the following inactive ingredients: cellulose acetate, gelatin, hypromellose, povidone, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide and water. Each capsule is printed with black pharmaceutical ink and contains the following inactive ingredients: shellac, propylene glycol, black iron oxide and potassium hydroxide. Topiramate Capsules, USP meet USP dissolution test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>16590-233-10</NDCCode>
    <PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (16590-233-10)  &gt; 10 mL in 1 BOTTLE, DROPPER</PackageDescription>
    <NDC11Code>16590-0233-10</NDC11Code>
    <ProductNDC>16590-233</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Polymyxin B Sulfate And Trimethoprim</ProprietaryName>
    <NonProprietaryName>Polymyxin B Sulfate And Trimethoprim</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>19980413</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA064211</ApplicationNumber>
    <LabelerName>STAT RX LLC USA</LabelerName>
    <SubstanceName>POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE</SubstanceName>
    <StrengthNumber>10000; 1</StrengthNumber>
    <StrengthUnit>1/mL; mg/mL</StrengthUnit>
    <Pharm_Classes>Polymyxin-class Antibacterial [EPC],Polymyxins [Chemical/Ingredient],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-02-07</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution is indicated in the treatment of surface ocular bacterial infections, including acute bacterial conjunctivitis, and blepharoconjunctivitis, caused by susceptible strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus viridans, Haemophilus influenzae and Pseudomonas aeruginosa.*. *Efficacy for this organism in this organ system was studied in fewer than 10 infections.</IndicationAndUsage>
    <Description>Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution is a sterile antimicrobial solution for topical ophthalmic use. It has a pH of 4.0 to 6.2 and osmolality of 270 to 310 mOsm/kg. Chemical Names: Trimethoprim sulfate, 2,4-diamino-5-(3,4,5-trimethoxybenzyl)pyrimidine sulfate (2:1), is a white, odorless, crystalline powder with a molecular weight of 678.72 and the following structural formula.</Description>
  </NDC>
  <NDC>
    <NDCCode>16729-233-01</NDCCode>
    <PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (16729-233-01) </PackageDescription>
    <NDC11Code>16729-0233-01</NDC11Code>
    <ProductNDC>16729-233</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ropinirole</ProprietaryName>
    <NonProprietaryName>Ropinirole</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20181017</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204022</ApplicationNumber>
    <LabelerName>Accord Healthcare Inc.</LabelerName>
    <SubstanceName>ROPINIROLE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-10-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20181017</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ropinirole tablets are a non-ergoline dopamine agonist indicated for the treatment of Parkinson’s disease (PD) and moderate-to-severe primary Restless Legs Syndrome (RLS). ( 1.1,1.2).</IndicationAndUsage>
    <Description>Ropinirole tablets, USP contains ropinirole, a non-ergoline dopamine agonist, as the hydrochloride salt. The chemical name of ropinirole hydrochloride is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the molecular formula is C 16H 24N 2OHCl. The molecular weight is 296.84 (260.38 as the free base). The structural formula is. Ropinirole hydrochloride is a white to yellow solid with a melting range of 243°C to 250°C and a solubility of 133 mg/mL in water. Each film-coated tablet contains ropinirole hydrochloride equivalent to ropinirole, 0.25, 0.5, 1, 2, 3, 4, or 5 mg. Inactive ingredients consist of: croscarmellose sodium, lactose monohydrate, and magnesium stearate, microcrystalline cellulose. The film coating of the tablet consists of following inactive ingredients. 0.25 mg: hypromellose, polyethylene glycol, polysorbate 80 and titanium dioxide. 0.5 mg: FD&amp;C Blue #2/Indigo carmine aluminum lake, hypromellose, iron oxide red, iron oxide yellow, polyethylene glycol and titanium dioxide. 1 mg: FD&amp;C Blue #2/Indigo carmine aluminum lake, hypromellose, iron oxide yellow, polyethylene glycol and titanium dioxide. 2 mg: hypromellose, iron oxide red, iron oxide yellow, polyethylene glycol and titanium dioxide. 3 mg: carmine, FD&amp;C Blue #2/Indigo carmine aluminum lake, FD&amp;C Yellow No. 6/Sunset yellow FCF aluminum lake, hypromellose, polyethylene glycol and titanium dioxide. 4 mg: hypromellose, iron oxide black, iron oxide red, iron oxide yellow, polyethylene glycol and titanium dioxide. 5 mg: FD&amp;C Blue #2/Indigo carmine aluminum lake, hypromellose, polyethylene glycol, polysorbate 80 and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>42023-233-01</NDCCode>
    <PackageDescription>10 mL in 1 VIAL (42023-233-01) </PackageDescription>
    <NDC11Code>42023-0233-01</NDC11Code>
    <ProductNDC>42023-233</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Corphedra</ProprietaryName>
    <NonProprietaryName>Ephedrine Sulfate</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20190118</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA208943</ApplicationNumber>
    <LabelerName>Par Pharmaceutical, Inc.</LabelerName>
    <SubstanceName>EPHEDRINE SULFATE</SubstanceName>
    <StrengthNumber>500</StrengthNumber>
    <StrengthUnit>mg/10mL</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Increased Norepinephrine Activity [PE], Norepinephrine Releasing Agent [EPC], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-10-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190118</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>CORPHEDRA is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia.</IndicationAndUsage>
    <Description>Ephedrine sulfate is an alpha- and beta-adrenergic agonist and a norepinephrine-releasing agent. CORPHEDRA (ephedrine sulfate injection) is a clear, colorless, sterile solution for intravenous injection. The 1 mL solution contains ephedrine sulfate 50 mg in water for injection as a single-dose product.  The 10 mL solution contains ephedrine sulfate 500 mg and phenol (a preservative) in water for injection as a multi-dose product (50 mg/mL).  The pH range is 4.5 to 7.0.  The drug product must be diluted before intravenous administration. The chemical name of ephedrine sulfate is (1R,2S)-(-)-2-methylamine-1-phenylpropan-1-ol sulfate (2:1) (salt). Its molecular weight is 428.54. The structural formula is. Ephedrine sulfate darkens on exposure to light.  It is freely soluble in water and ethanol, very slightly soluble in chloroform, and practically insoluble in ether.</Description>
  </NDC>
  <NDC>
    <NDCCode>42291-233-60</NDCCode>
    <PackageDescription>60 TABLET, DELAYED RELEASE in 1 BOTTLE (42291-233-60) </PackageDescription>
    <NDC11Code>42291-0233-60</NDC11Code>
    <ProductNDC>42291-233</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Diclofenac Sodium And Misoprostol</ProprietaryName>
    <NonProprietaryName>Diclofenac Sodium And Misoprostol</NonProprietaryName>
    <DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20121214</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA201089</ApplicationNumber>
    <LabelerName>AvKARE</LabelerName>
    <SubstanceName>DICLOFENAC SODIUM; MISOPROSTOL</SubstanceName>
    <StrengthNumber>75; 200</StrengthNumber>
    <StrengthUnit>mg/1; ug/1</StrengthUnit>
    <Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Prostaglandin E1 Analog [EPC], Prostaglandins E, Synthetic [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20121214</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Diclofenac sodium and misoprostol delayed-release tablets are indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications. For a list of factors that may increase the risk of NSAID-induced gastric and duodenal ulcers and their complications [see Warnings and Precautions (5.2) ].</IndicationAndUsage>
    <Description>Diclofenac sodium and misoprostol delayed-release tablets, USP are a combination product containing diclofenac sodium, a nonsteroidal anti-inflammatory drug (NSAID) with analgesic properties, and misoprostol, a gastrointestinal (GI) mucosal protective prostaglandin E 1 analog. Diclofenac sodium and misoprostol delayed-release tablets, USP are white to off-white, round, biconvex tablets, and approximately 11 mm in diameter. Each tablet consists of an enteric-coated core containing 50 mg or 75 mg diclofenac sodium surrounded by an outer mantle containing 0.2 mg misoprostol. Diclofenac sodium is a phenylacetic acid derivative that is a white to off-white, virtually odorless, crystalline powder. Diclofenac sodium is freely soluble in methanol, soluble in ethanol, and practically insoluble in chloroform and in dilute acid. Diclofenac sodium is sparingly soluble in water. Its chemical formula and name are:. C 14H 10Cl 2NO 2Na [M.W. = 318.14] 2-[(2,6-dichlorophenyl) amino] benzeneacetic acid, monosodium salt. Misoprostol is a water-soluble, viscous liquid that contains approximately equal amounts of two diastereomers. Its chemical formula and name are. C 22H 38O 5 [M.W. = 382.54] (±) methyl 11α,16-dihydroxy-16-methyl-9-oxoprost-13E-en-1-oate. Inactive ingredients in diclofenac sodium and misoprostol delayed-release tablets include: colloidal silicon dioxide; crospovidone; hydrogenated castor oil; hypromellose; lactose; magnesium stearate; methacrylic acid copolymer dispersion; microcrystalline cellulose; povidone (polyvidone) K-30; sodium hydroxide; starch (corn); talc; triethyl citrate.</Description>
  </NDC>
  <NDC>
    <NDCCode>42571-233-01</NDCCode>
    <PackageDescription>100 CAPSULE in 1 BOTTLE (42571-233-01) </PackageDescription>
    <NDC11Code>42571-0233-01</NDC11Code>
    <ProductNDC>42571-233</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amoxicillin</ProprietaryName>
    <NonProprietaryName>Amoxicillin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20221101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207471</ApplicationNumber>
    <LabelerName>Micro Labs Limited</LabelerName>
    <SubstanceName>AMOXICILLIN</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-10-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Amoxicillin capsules are a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms. To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin capsules and other antibacterial drugs, amoxicillin capsules should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. ( 1.6).</IndicationAndUsage>
    <Description>Formulations of Amoxicillin capsules, USP contain amoxicillin USP, a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2 S,5 R,6 R)-6-[( R)-(-)-2-amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane­2-carboxylic acid trihydrate. It may be represented structurally as:. The amoxicillin USP molecular formula is C 16H 19N 3O 5S3H 2O, and the molecular weight is 419.45. Each capsule, for oral administration, contains 250 mg or 500 mg amoxicillin as the trihydrate. Inactive ingredients: black iron oxide, gelatin, magnesium stearate, potassium hydroxide, propylene glycol, shellac, strong ammonia, talc, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>42571-233-05</NDCCode>
    <PackageDescription>500 CAPSULE in 1 BOTTLE (42571-233-05) </PackageDescription>
    <NDC11Code>42571-0233-05</NDC11Code>
    <ProductNDC>42571-233</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amoxicillin</ProprietaryName>
    <NonProprietaryName>Amoxicillin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20221101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207471</ApplicationNumber>
    <LabelerName>Micro Labs Limited</LabelerName>
    <SubstanceName>AMOXICILLIN</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-10-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Amoxicillin capsules are a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms. To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin capsules and other antibacterial drugs, amoxicillin capsules should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. ( 1.6).</IndicationAndUsage>
    <Description>Formulations of Amoxicillin capsules, USP contain amoxicillin USP, a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2 S,5 R,6 R)-6-[( R)-(-)-2-amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane­2-carboxylic acid trihydrate. It may be represented structurally as:. The amoxicillin USP molecular formula is C 16H 19N 3O 5S3H 2O, and the molecular weight is 419.45. Each capsule, for oral administration, contains 250 mg or 500 mg amoxicillin as the trihydrate. Inactive ingredients: black iron oxide, gelatin, magnesium stearate, potassium hydroxide, propylene glycol, shellac, strong ammonia, talc, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>42571-233-10</NDCCode>
    <PackageDescription>1000 CAPSULE in 1 BOTTLE (42571-233-10) </PackageDescription>
    <NDC11Code>42571-0233-10</NDC11Code>
    <ProductNDC>42571-233</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amoxicillin</ProprietaryName>
    <NonProprietaryName>Amoxicillin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20221101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207471</ApplicationNumber>
    <LabelerName>Micro Labs Limited</LabelerName>
    <SubstanceName>AMOXICILLIN</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-10-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Amoxicillin capsules are a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms. To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin capsules and other antibacterial drugs, amoxicillin capsules should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. ( 1.6).</IndicationAndUsage>
    <Description>Formulations of Amoxicillin capsules, USP contain amoxicillin USP, a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2 S,5 R,6 R)-6-[( R)-(-)-2-amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane­2-carboxylic acid trihydrate. It may be represented structurally as:. The amoxicillin USP molecular formula is C 16H 19N 3O 5S3H 2O, and the molecular weight is 419.45. Each capsule, for oral administration, contains 250 mg or 500 mg amoxicillin as the trihydrate. Inactive ingredients: black iron oxide, gelatin, magnesium stearate, potassium hydroxide, propylene glycol, shellac, strong ammonia, talc, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>42571-233-30</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BOTTLE (42571-233-30) </PackageDescription>
    <NDC11Code>42571-0233-30</NDC11Code>
    <ProductNDC>42571-233</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amoxicillin</ProprietaryName>
    <NonProprietaryName>Amoxicillin</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20221101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA207471</ApplicationNumber>
    <LabelerName>Micro Labs Limited</LabelerName>
    <SubstanceName>AMOXICILLIN</SubstanceName>
    <StrengthNumber>250</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-10-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Amoxicillin capsules are a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms. To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin capsules and other antibacterial drugs, amoxicillin capsules should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. ( 1.6).</IndicationAndUsage>
    <Description>Formulations of Amoxicillin capsules, USP contain amoxicillin USP, a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2 S,5 R,6 R)-6-[( R)-(-)-2-amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane­2-carboxylic acid trihydrate. It may be represented structurally as:. The amoxicillin USP molecular formula is C 16H 19N 3O 5S3H 2O, and the molecular weight is 419.45. Each capsule, for oral administration, contains 250 mg or 500 mg amoxicillin as the trihydrate. Inactive ingredients: black iron oxide, gelatin, magnesium stearate, potassium hydroxide, propylene glycol, shellac, strong ammonia, talc, and titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>43353-233-79</NDCCode>
    <PackageDescription>2160 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43353-233-79)</PackageDescription>
    <NDC11Code>43353-0233-79</NDC11Code>
    <ProductNDC>43353-233</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Venlafaxine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Venlafaxine Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110601</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA200834</ApplicationNumber>
    <LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
    <SubstanceName>VENLAFAXINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-06-10</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Venlafaxine hydrochloride extended-release capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of: : 1 Major Depressive Disorder (MDD), 2 Social Anxiety Disorder (SAD) , 3 Panic Disorder (PD).</IndicationAndUsage>
    <Description>Venlafaxine hydrochloride extended-release capsule USP is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride USP, a serotonin and norepinephrine reuptake inhibitor (SNRI).Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-­methoxybenzyl] cyclohexanol hydrochloride and has the molecular formula of C17H27NO2HCl. Its molecular weight is 313.86. The structural formula is shown as follows. Venlafaxine hydrochloride USP is a white or almost white crystalline powder, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43.Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride USP equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of ethyl cellulose, hypromellose, sugar spheres, and talc. The empty hard gelatin capsule shells contain iron oxide red, gelatin, titanium dioxide, and sodium lauryl sulphate. In addition, the 37.5 mg empty hard gelatin capsule shells contain iron oxide black. The capsules are printed with edible ink containing black iron oxide and shellac.Meets the USP Dissolution Test - 4.</Description>
  </NDC>
  <NDC>
    <NDCCode>43598-233-11</NDCCode>
    <PackageDescription>1 VIAL, GLASS in 1 CARTON (43598-233-11)  / 5 mL in 1 VIAL, GLASS</PackageDescription>
    <NDC11Code>43598-0233-11</NDC11Code>
    <ProductNDC>43598-233</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Zoledronic Acid</ProprietaryName>
    <NonProprietaryName>Zoledronic Acid</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20230821</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA091186</ApplicationNumber>
    <LabelerName>Dr. Reddy's Laboratories Inc.</LabelerName>
    <SubstanceName>ZOLEDRONIC ACID</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Pharm_Classes>Bisphosphonate [EPC], Diphosphonates [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-05-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230821</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Zoledronic acid injection is a bisphosphonate indicated for the treatment of: 1 Hypercalcemia of malignancy. (1.1), 2 Patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. Prostate cancer should have progressed after treatment with at least one hormonal therapy. (1.2)  .</IndicationAndUsage>
    <Description>Zoledronic acid injection contains zoledronic acid, a bisphosphonic acid which is an inhibitor of osteoclastic bone resorption. Zoledronic acid is designated chemically as (1-Hydroxy-2-imidazol-1-yl-phosphonoethyl) phosphonic acid monohydrate and its structural formula is. Zoledronic acid is white to almost white crystalline solid. Its molecular formula is C5H10N2O7P2  H2O and its molar mass is 290.1 g/mol. Zoledronic acid is sparingly soluble in 0.1N sodium hydroxide solution. The pH of a 0.7% aqueous solution of zoledronic acid is between 1.5 and 2.5. Zoledronic acid injection is available in 5 mL vials as a sterile liquid solution for dilution prior to intravenous infusion. : 1 Each 5 mL solution for dilution prior to intravenous infusion vial contains 4.264 mg zoledronic acid monohydrate, USP corresponding to 4 mg zoledronic acid on an anhydrous basis, 220 mg of mannitol, USP, water for injection, and 24 mg of sodium citrate, USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>49035-233-01</NDCCode>
    <PackageDescription>63 g in 1 BOTTLE (49035-233-01)</PackageDescription>
    <NDC11Code>49035-0233-01</NDC11Code>
    <ProductNDC>49035-233</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Glitter Ritz Iced Berry</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20150415</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>Wal-Mart Stores Inc.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>63</StrengthNumber>
    <StrengthUnit>1/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Hand Sanitizer. 30 ml 1.0 fl.oz.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>49288-0233-3</NDCCode>
    <PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (49288-0233-3)</PackageDescription>
    <NDC11Code>49288-0233-03</NDC11Code>
    <ProductNDC>49288-0233</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Mixture Of Five Standardized Grasses</ProprietaryName>
    <NonProprietaryName>Mixture Of Five Standardized Grasses</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19970613</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103421</ApplicationNumber>
    <LabelerName>Antigen Laboratories, Inc.</LabelerName>
    <SubstanceName>POA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; AGROSTIS GIGANTEA POLLEN; PHLEUM PRATENSE POLLEN; ANTHOXANTHUM ODORATUM POLLEN</SubstanceName>
    <StrengthNumber>20000; 20000; 20000; 20000; 20000</StrengthNumber>
    <StrengthUnit>[BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL</StrengthUnit>
    <Pharm_Classes>Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],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>INDICATIONS AND USAGE     Allergenic extract is indicated for diagnostic testing and treatment (immunotherapy) of patients whose histories indicate allergic symptoms upon natural exposure to grass allergens. Confirmation is determined by skin testing. 10,000 BAU/ml extracts are intended for percutaneous testing. If negative, 100,000 BAU/ml products can be used for percutaneous test. Dilutions made from 10,000 BAU/ml products are indicated for immunotherapy of previously untreated patients. If 10,000 BAU/ml product is tolerated and symptoms persist, dilutions made from 100,000 BAU/ml can be administered. Standardized Grass Pollen extracts labeled in Bioequivalent Allergy Units (BAU/ml) are not interchangeable with grass pollen extracts labeled In Allergy Units (AU/ml) or with non-standardized grass pollen extracts.</IndicationAndUsage>
    <Description>DESCRIPTION     Antigen Laboratories' Standardized Grass Pollen allergenic extracts are sterile and intended for dilution prior to skin testing and/or immunotherapy. The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. Standardized Grass Pollen allergenic extract labeled in BAU/ml is not interchangeable with grass pollen extract labeled in AU/ml or with non-standardized grass pollen extract.     Potency of Standardized Grass Pollen allergenic extract is determined by comparison to a Center for Biologics Evaluation and Research (CBER) approved reference. References are available for pollen extracts of Orchard Grass (Dactylis glomerata), Perennial Rye Grass (Lolium perenne), Timothy Grass (Phleum pratense), Redtop Grass (Agrostis alba), Kentucky (June) Bluegrass (Poa pratensis), Bermuda Grass (Cynodon dactylon), Meadow Fescue Grass (Festuca elatior), and Sweet Vernal Grass (Anthoxanthum odoratum). Quantitative skin testing is used by CBER to establish reference's potency as Bioequivalent Allergy Units (BAU). CBER reference labeled 10,000 BAU/ml produces a sum of erythema diameter of 50 mm with highly puncture reactive subjects at an intradermal dilution of approximately 1:500,000.11,17 CBER references labeled 100,000 BAU/ml produce a SumE=50 mm at an intradermal dilution of 1:5,000,000. Relative potency of Standardized Grass Pollen allergenic extracts to CBER reference is determined by Enzyme-linked Immunosorbent Assay (ELISA).     In addition to relative potency testing of Standardized Grass Pollen extract the following testing is performed:     1. Microscopic examination to confirm identity and purity of source pollens.     2. lsoelectric focusing (IEF) pattern of source material is compared to respective CBER reference extract.     3. lsoelectric focusing pattern of final 100,000 BAU/ml (10,000 BAU/ml Bermuda Grass) product is compared to CBER reference extract.     4. Ninhydrin Protein Analysis.     5. Glycerine Analysis. (A minimum of 50% v/v glycerine for optimal stability during the entire dating period.)     6. Sterility Testing.     7. Animal Safety Testing.     Standardized Grass Pollen allergenic extracts are extracted at 1:10 weight to volume (w/v) ratio of source material to extraction fluid. Bermuda Grass is only available in 10,000 BAU/ml. Standardized Grass Pollen extracts are diluted after extraction to fall in acceptable relative potency range for a 100,000 BAU/ml or 10,000 BAU/ml (Bermuda Grass) product. Standardized Grass Pollen allergenic extracts (except Bermuda) of 10,000 BAU/ml potency are prepared by diluting the 100,000 BAU/ml extract 1:10 with extracting fluid.    Various mixtures of eight Standardized Grass Pollen extracts are available. Mixtures of Standardized Grass Pollen extracts with non-standardized grass pollen extracts are available. Concentrations of Standardized Grass Pollen extracts (BAU/ml) and non-standardized grass pollen extracts (w/v) in a mixture are printed on the last page of this circular, if applicable.     Active Ingredients: Allergens are described by common and scientific name on container label or last page of this circular. Preservative is 50% v/v glycerine. Inactive ingredients are 0.95% sodium chloride, 0.24% sodium bicarbonate and water for injection.</Description>
  </NDC>
  <NDC>
    <NDCCode>49288-0233-4</NDCCode>
    <PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (49288-0233-4)</PackageDescription>
    <NDC11Code>49288-0233-04</NDC11Code>
    <ProductNDC>49288-0233</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Mixture Of Five Standardized Grasses</ProprietaryName>
    <NonProprietaryName>Mixture Of Five Standardized Grasses</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19970613</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103421</ApplicationNumber>
    <LabelerName>Antigen Laboratories, Inc.</LabelerName>
    <SubstanceName>POA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; AGROSTIS GIGANTEA POLLEN; PHLEUM PRATENSE POLLEN; ANTHOXANTHUM ODORATUM POLLEN</SubstanceName>
    <StrengthNumber>20000; 20000; 20000; 20000; 20000</StrengthNumber>
    <StrengthUnit>[BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL</StrengthUnit>
    <Pharm_Classes>Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],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>INDICATIONS AND USAGE     Allergenic extract is indicated for diagnostic testing and treatment (immunotherapy) of patients whose histories indicate allergic symptoms upon natural exposure to grass allergens. Confirmation is determined by skin testing. 10,000 BAU/ml extracts are intended for percutaneous testing. If negative, 100,000 BAU/ml products can be used for percutaneous test. Dilutions made from 10,000 BAU/ml products are indicated for immunotherapy of previously untreated patients. If 10,000 BAU/ml product is tolerated and symptoms persist, dilutions made from 100,000 BAU/ml can be administered. Standardized Grass Pollen extracts labeled in Bioequivalent Allergy Units (BAU/ml) are not interchangeable with grass pollen extracts labeled In Allergy Units (AU/ml) or with non-standardized grass pollen extracts.</IndicationAndUsage>
    <Description>DESCRIPTION     Antigen Laboratories' Standardized Grass Pollen allergenic extracts are sterile and intended for dilution prior to skin testing and/or immunotherapy. The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. Standardized Grass Pollen allergenic extract labeled in BAU/ml is not interchangeable with grass pollen extract labeled in AU/ml or with non-standardized grass pollen extract.     Potency of Standardized Grass Pollen allergenic extract is determined by comparison to a Center for Biologics Evaluation and Research (CBER) approved reference. References are available for pollen extracts of Orchard Grass (Dactylis glomerata), Perennial Rye Grass (Lolium perenne), Timothy Grass (Phleum pratense), Redtop Grass (Agrostis alba), Kentucky (June) Bluegrass (Poa pratensis), Bermuda Grass (Cynodon dactylon), Meadow Fescue Grass (Festuca elatior), and Sweet Vernal Grass (Anthoxanthum odoratum). Quantitative skin testing is used by CBER to establish reference's potency as Bioequivalent Allergy Units (BAU). CBER reference labeled 10,000 BAU/ml produces a sum of erythema diameter of 50 mm with highly puncture reactive subjects at an intradermal dilution of approximately 1:500,000.11,17 CBER references labeled 100,000 BAU/ml produce a SumE=50 mm at an intradermal dilution of 1:5,000,000. Relative potency of Standardized Grass Pollen allergenic extracts to CBER reference is determined by Enzyme-linked Immunosorbent Assay (ELISA).     In addition to relative potency testing of Standardized Grass Pollen extract the following testing is performed:     1. Microscopic examination to confirm identity and purity of source pollens.     2. lsoelectric focusing (IEF) pattern of source material is compared to respective CBER reference extract.     3. lsoelectric focusing pattern of final 100,000 BAU/ml (10,000 BAU/ml Bermuda Grass) product is compared to CBER reference extract.     4. Ninhydrin Protein Analysis.     5. Glycerine Analysis. (A minimum of 50% v/v glycerine for optimal stability during the entire dating period.)     6. Sterility Testing.     7. Animal Safety Testing.     Standardized Grass Pollen allergenic extracts are extracted at 1:10 weight to volume (w/v) ratio of source material to extraction fluid. Bermuda Grass is only available in 10,000 BAU/ml. Standardized Grass Pollen extracts are diluted after extraction to fall in acceptable relative potency range for a 100,000 BAU/ml or 10,000 BAU/ml (Bermuda Grass) product. Standardized Grass Pollen allergenic extracts (except Bermuda) of 10,000 BAU/ml potency are prepared by diluting the 100,000 BAU/ml extract 1:10 with extracting fluid.    Various mixtures of eight Standardized Grass Pollen extracts are available. Mixtures of Standardized Grass Pollen extracts with non-standardized grass pollen extracts are available. Concentrations of Standardized Grass Pollen extracts (BAU/ml) and non-standardized grass pollen extracts (w/v) in a mixture are printed on the last page of this circular, if applicable.     Active Ingredients: Allergens are described by common and scientific name on container label or last page of this circular. Preservative is 50% v/v glycerine. Inactive ingredients are 0.95% sodium chloride, 0.24% sodium bicarbonate and water for injection.</Description>
  </NDC>
  <NDC>
    <NDCCode>49288-0233-5</NDCCode>
    <PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (49288-0233-5)</PackageDescription>
    <NDC11Code>49288-0233-05</NDC11Code>
    <ProductNDC>49288-0233</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Mixture Of Five Standardized Grasses</ProprietaryName>
    <NonProprietaryName>Mixture Of Five Standardized Grasses</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19970613</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA103421</ApplicationNumber>
    <LabelerName>Antigen Laboratories, Inc.</LabelerName>
    <SubstanceName>POA PRATENSIS POLLEN; DACTYLIS GLOMERATA POLLEN; AGROSTIS GIGANTEA POLLEN; PHLEUM PRATENSE POLLEN; ANTHOXANTHUM ODORATUM POLLEN</SubstanceName>
    <StrengthNumber>20000; 20000; 20000; 20000; 20000</StrengthNumber>
    <StrengthUnit>[BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL; [BAU]/mL</StrengthUnit>
    <Pharm_Classes>Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS],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>INDICATIONS AND USAGE     Allergenic extract is indicated for diagnostic testing and treatment (immunotherapy) of patients whose histories indicate allergic symptoms upon natural exposure to grass allergens. Confirmation is determined by skin testing. 10,000 BAU/ml extracts are intended for percutaneous testing. If negative, 100,000 BAU/ml products can be used for percutaneous test. Dilutions made from 10,000 BAU/ml products are indicated for immunotherapy of previously untreated patients. If 10,000 BAU/ml product is tolerated and symptoms persist, dilutions made from 100,000 BAU/ml can be administered. Standardized Grass Pollen extracts labeled in Bioequivalent Allergy Units (BAU/ml) are not interchangeable with grass pollen extracts labeled In Allergy Units (AU/ml) or with non-standardized grass pollen extracts.</IndicationAndUsage>
    <Description>DESCRIPTION     Antigen Laboratories' Standardized Grass Pollen allergenic extracts are sterile and intended for dilution prior to skin testing and/or immunotherapy. The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. Standardized Grass Pollen allergenic extract labeled in BAU/ml is not interchangeable with grass pollen extract labeled in AU/ml or with non-standardized grass pollen extract.     Potency of Standardized Grass Pollen allergenic extract is determined by comparison to a Center for Biologics Evaluation and Research (CBER) approved reference. References are available for pollen extracts of Orchard Grass (Dactylis glomerata), Perennial Rye Grass (Lolium perenne), Timothy Grass (Phleum pratense), Redtop Grass (Agrostis alba), Kentucky (June) Bluegrass (Poa pratensis), Bermuda Grass (Cynodon dactylon), Meadow Fescue Grass (Festuca elatior), and Sweet Vernal Grass (Anthoxanthum odoratum). Quantitative skin testing is used by CBER to establish reference's potency as Bioequivalent Allergy Units (BAU). CBER reference labeled 10,000 BAU/ml produces a sum of erythema diameter of 50 mm with highly puncture reactive subjects at an intradermal dilution of approximately 1:500,000.11,17 CBER references labeled 100,000 BAU/ml produce a SumE=50 mm at an intradermal dilution of 1:5,000,000. Relative potency of Standardized Grass Pollen allergenic extracts to CBER reference is determined by Enzyme-linked Immunosorbent Assay (ELISA).     In addition to relative potency testing of Standardized Grass Pollen extract the following testing is performed:     1. Microscopic examination to confirm identity and purity of source pollens.     2. lsoelectric focusing (IEF) pattern of source material is compared to respective CBER reference extract.     3. lsoelectric focusing pattern of final 100,000 BAU/ml (10,000 BAU/ml Bermuda Grass) product is compared to CBER reference extract.     4. Ninhydrin Protein Analysis.     5. Glycerine Analysis. (A minimum of 50% v/v glycerine for optimal stability during the entire dating period.)     6. Sterility Testing.     7. Animal Safety Testing.     Standardized Grass Pollen allergenic extracts are extracted at 1:10 weight to volume (w/v) ratio of source material to extraction fluid. Bermuda Grass is only available in 10,000 BAU/ml. Standardized Grass Pollen extracts are diluted after extraction to fall in acceptable relative potency range for a 100,000 BAU/ml or 10,000 BAU/ml (Bermuda Grass) product. Standardized Grass Pollen allergenic extracts (except Bermuda) of 10,000 BAU/ml potency are prepared by diluting the 100,000 BAU/ml extract 1:10 with extracting fluid.    Various mixtures of eight Standardized Grass Pollen extracts are available. Mixtures of Standardized Grass Pollen extracts with non-standardized grass pollen extracts are available. Concentrations of Standardized Grass Pollen extracts (BAU/ml) and non-standardized grass pollen extracts (w/v) in a mixture are printed on the last page of this circular, if applicable.     Active Ingredients: Allergens are described by common and scientific name on container label or last page of this circular. Preservative is 50% v/v glycerine. Inactive ingredients are 0.95% sodium chloride, 0.24% sodium bicarbonate and water for injection.</Description>
  </NDC>
  <NDC>
    <NDCCode>49702-233-08</NDCCode>
    <PackageDescription>120 TABLET, FILM COATED in 1 BOTTLE (49702-233-08) </PackageDescription>
    <NDC11Code>49702-0233-08</NDC11Code>
    <ProductNDC>49702-233</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Selzentry</ProprietaryName>
    <NonProprietaryName>Maraviroc</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20161104</StartMarketingDate>
    <EndMarketingDate>20250531</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022128</ApplicationNumber>
    <LabelerName>ViiV Healthcare Company</LabelerName>
    <SubstanceName>MARAVIROC</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>CCR5 Co-receptor Antagonist [EPC], Chemokine Co-receptor 5 Antagonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-06-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20161104</StartMarketingDatePackage>
    <EndMarketingDatePackage>20250531</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>SELZENTRY is indicated in combination with other antiretroviral agents for the treatment of only CCR5‑tropic human immunodeficiency virus type 1 (HIV‑1) infection in adult and pediatric patients weighing at least 2 kg. Limitations of Use: 1 SELZENTRY is not recommended in patients with dual/mixed- or CXCR4-tropic HIV-1 [see Microbiology (12.4)].</IndicationAndUsage>
    <Description>SELZENTRY (maraviroc) is a selective, slowly reversible, small molecule antagonist of the interaction between human CCR5 and HIV-1 gp120. Blocking this interaction prevents CCR5-tropic HIV-1 entry into cells. SELZENTRY film-coated tablets for oral administration contain 25, 75, 150, or 300 mg of maraviroc and the following inactive ingredients: dibasic calcium phosphate (anhydrous), magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The film coat (Opadry II Blue [85G20583]) contains FD&amp;C blue #2 aluminum lake, soya lecithin, polyethylene glycol (macrogol 3350), polyvinyl alcohol, talc, and titanium dioxide. SELZENTRY oral solution contains 20 mg per mL of maraviroc and the following inactive ingredients: citric acid (anhydrous), purified water, sodium benzoate, sodium citrate dihydrate, strawberry flavoring (501440T), and sucralose. Maraviroc is chemically described as 4,4-difluoro-N-{(1S)-3-[exo-3-(3-isopropyl-5-methyl-4H-1,2,4-triazol-4-yl)-8-azabicyclo[3.2.1]oct-8-yl]-1-phenylpropyl}cyclohexanecarboxamide. The molecular formula is C29H41F2N5O and the structural formula is. Maraviroc is a white to pale-colored powder with a molecular weight of 513.67. It is highly soluble across the physiological pH range (pH 1.0 to 7.5).</Description>
  </NDC>
  <NDC>
    <NDCCode>50102-233-11</NDCCode>
    <PackageDescription>1 BLISTER PACK in 1 CARTON (50102-233-11)  / 1 KIT in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>50102-0233-11</NDC11Code>
    <ProductNDC>50102-233</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tri-vylibra</ProprietaryName>
    <NonProprietaryName>Norgestimate And Ethinyl Estradiol</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20160706</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA205441</ApplicationNumber>
    <LabelerName>Afaxys Pharma, LLC</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2024-02-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160706</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tri-VyLibra is combination of norgestimate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. (1.1). Tri-VyLibra is indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Tri-VyLibra should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. (1.2).</IndicationAndUsage>
    <Description>Tri-VyLibra is a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol. Norgestimate is designated as (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime, (17α)-(+)-) and ethinyl estradiol is designated as (19-nor-17α-pregna,1,3,5(10)-trien-20-yne-3,17-diol). Each active white tablet contains 0.180 mg of norgestimate USP and 0.035 mg of ethinyl estradiol USP. Inactive ingredients include croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide. Each active light blue tablet contains 0.215 mg of norgestimate USP and 0.035 mg of ethinyl estradiol USP. Inactive ingredients include croscarmellose sodium, FD&amp;C #2/Indigo carmine aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide. Each active dark blue tablet contains 0.250 mg of norgestimate USP and 0.035 mg of ethinyl estradiol USP. Inactive ingredients include croscarmellose sodium, FD&amp;C #2/Indigo carmine aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide. Each green tablet contains only inert ingredients, as follows: anhydrous lactose, FD&amp;C Blue No. 2 aluminum lake, ferric oxide yellow, magnesium stearate, microcrystalline cellulose, and povidone.</Description>
  </NDC>
  <NDC>
    <NDCCode>50102-233-13</NDCCode>
    <PackageDescription>3 BLISTER PACK in 1 CARTON (50102-233-13)  / 1 KIT in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>50102-0233-13</NDC11Code>
    <ProductNDC>50102-233</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Tri-vylibra</ProprietaryName>
    <NonProprietaryName>Norgestimate And Ethinyl Estradiol</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20160706</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA205441</ApplicationNumber>
    <LabelerName>Afaxys Pharma, LLC</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2024-02-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160706</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Tri-VyLibra is combination of norgestimate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. (1.1). Tri-VyLibra is indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Tri-VyLibra should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control. (1.2).</IndicationAndUsage>
    <Description>Tri-VyLibra is a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol. Norgestimate is designated as (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime, (17α)-(+)-) and ethinyl estradiol is designated as (19-nor-17α-pregna,1,3,5(10)-trien-20-yne-3,17-diol). Each active white tablet contains 0.180 mg of norgestimate USP and 0.035 mg of ethinyl estradiol USP. Inactive ingredients include croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide. Each active light blue tablet contains 0.215 mg of norgestimate USP and 0.035 mg of ethinyl estradiol USP. Inactive ingredients include croscarmellose sodium, FD&amp;C #2/Indigo carmine aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide. Each active dark blue tablet contains 0.250 mg of norgestimate USP and 0.035 mg of ethinyl estradiol USP. Inactive ingredients include croscarmellose sodium, FD&amp;C #2/Indigo carmine aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide. Each green tablet contains only inert ingredients, as follows: anhydrous lactose, FD&amp;C Blue No. 2 aluminum lake, ferric oxide yellow, magnesium stearate, microcrystalline cellulose, and povidone.</Description>
  </NDC>
  <NDC>
    <NDCCode>50383-233-10</NDCCode>
    <PackageDescription>1 BOTTLE, DROPPER in 1 BOX (50383-233-10)  &gt; 10 mL in 1 BOTTLE, DROPPER</PackageDescription>
    <NDC11Code>50383-0233-10</NDC11Code>
    <ProductNDC>50383-233</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dorzolamide Hydrochloride And Timolol Maleate</ProprietaryName>
    <NonProprietaryName>Dorzolamide Hydrochloride And Timolol Maleate</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20081028</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077847</ApplicationNumber>
    <LabelerName>Akorn</LabelerName>
    <SubstanceName>DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE</SubstanceName>
    <StrengthNumber>20; 5</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic beta-Antagonists [MoA], Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20091028</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dorzolamide hydrochloride and timolol maleate ophthalmic solution is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to betablockers (failed to achieve target IOP determined after multiple measurements over time). The IOP-lowering of dorzolamide hydrochloride and timolol maleate ophthalmic solution administered twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol administered twice a day and 2% dorzolamide administered three times a day [see Clinical Studies (14)].</IndicationAndUsage>
    <Description>Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution is the combination of a topical carbonic anhydrase inhibitor and a topical beta-adrenergic receptor blocking agent. Dorzolamide hydrochloride is described chemically as: (4S-trans)-4-(ethylamino)-5,6-dihydro-6-methyl-4H-thieno[2,3-b]thiopyran-2- sulfonamide 7,7-dioxide monohydrochloride. Dorzolamide hydrochloride is optically active. The specific rotation is. Its empirical formula is C10H16N2O4S3HCl and its structural formula is. Dorzolamide hydrochloride has a molecular weight of 360.91. It is a white to off-white, crystalline powder, which is soluble in water and slightly soluble in methanol and ethanol. Timolol maleate is described chemically as: (-)-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 as the levo-isomer. The optical rotation of timolol maleate is. Its molecular formula is C13H24N4O3SC4H4O4 and its structural formula is. Timolol maleate has a molecular weight of 432.50. It is a white, odorless, crystalline powder which is soluble in water, methanol, and alcohol. Timolol maleate is stable at room temperature. Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution is supplied as a sterile, clear, colorless to nearly colorless, isotonic, buffered, slightly viscous, aqueous solution. The pH of the solution is approximately 5.65, and the osmolarity is 242-323 mOsM. Each mL of Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution contains 20 mg dorzolamide (22.26 mg of dorzolamide hydrochloride) and 5 mg timolol (6.83 mg timolol maleate). Inactive ingredients are sodium citrate, hydroxyethyl cellulose, sodium hydroxide, mannitol, and purified water. Benzalkonium chloride 0.0075% is added as a preservative.</Description>
  </NDC>
  <NDC>
    <NDCCode>55150-233-02</NDCCode>
    <PackageDescription>2 SYRINGE, GLASS in 1 CARTON (55150-233-02)  / .8 mL in 1 SYRINGE, GLASS (55150-233-00) </PackageDescription>
    <NDC11Code>55150-0233-02</NDC11Code>
    <ProductNDC>55150-233</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fondaparinux Sodium</ProprietaryName>
    <NonProprietaryName>Fondaparinux Sodium</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20171226</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206918</ApplicationNumber>
    <LabelerName>Eugia US LLC</LabelerName>
    <SubstanceName>FONDAPARINUX SODIUM</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/.8mL</StrengthUnit>
    <Pharm_Classes>Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-02-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20171226</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fondaparinux sodium injection is a Factor Xa inhibitor (anticoagulant) indicated for: 1 Prophylaxis of deep vein thrombosis (DVT) in patients undergoing hip fracture surgery (including extended prophylaxis), hip replacement surgery, knee replacement surgery, or abdominal surgery. (1.1), 2 Treatment of DVT or acute pulmonary embolism (PE) when administered in conjunction with warfarin. (1.2, 1.3).</IndicationAndUsage>
    <Description>Fondaparinux sodium injection, USP is a sterile solution containing fondaparinux sodium. It is a synthetic and specific inhibitor of activated Factor X (Xa). Fondaparinux sodium is methyl O-2-deoxy-6-O-sulfo-2-(sulfoamino)-α-D-glucopyranosyl-(1→4)-O-β-D-glucopyra-nuronosyl-(1→4)-O-2-deoxy-3,6-di-O-sulfo-2-(sulfoamino)-α-D-glucopyranosyl-(1→4)-O-2-O-­sulfo-α-L-idopyranuronosyl-(1→4)-2-deoxy-6-O-sulfo-2-(sulfoamino)-α-D-glucopyranoside, decasodium salt. Fondaparinux sodium USP is a white to almost white, hygroscopic powder. The molecular formula of fondaparinux sodium is C31H43N3Na10O49S8 and its molecular weight is 1728. The structural formula is provided below: Fondaparinux sodium injection, USP is supplied as a sterile, preservative-free injectable solution for subcutaneous use. Each single-dose, prefilled syringe of fondaparinux sodium injection, USP, affixed with an automatic needle protection system, contains 2.5 mg of fondaparinux sodium USP (equivalent to 2.18 mg fondaparinux) in 0.5 mL, 5 mg of fondaparinux sodium USP (equivalent to 4.36 mg fondaparinux) in 0.4 mL, 7.5 mg of fondaparinux sodium USP (equivalent to 6.54 mg fondaparinux) in 0.6 mL, or 10 mg of fondaparinux sodium USP (equivalent to 8.73 mg fondaparinux) in 0.8 mL of an isotonic solution of sodium chloride and water for injection. Also contain hydrochloric acid and sodium hydroxide as pH adjusters. The final drug product is a sterile, clear, colorless to slightly yellow solution, free from visible particles with a pH between 5.0 and 8.0.</Description>
  </NDC>
  <NDC>
    <NDCCode>55150-233-10</NDCCode>
    <PackageDescription>10 SYRINGE, GLASS in 1 CARTON (55150-233-10)  / .8 mL in 1 SYRINGE, GLASS (55150-233-00) </PackageDescription>
    <NDC11Code>55150-0233-10</NDC11Code>
    <ProductNDC>55150-233</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fondaparinux Sodium</ProprietaryName>
    <NonProprietaryName>Fondaparinux Sodium</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20171226</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206918</ApplicationNumber>
    <LabelerName>Eugia US LLC</LabelerName>
    <SubstanceName>FONDAPARINUX SODIUM</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/.8mL</StrengthUnit>
    <Pharm_Classes>Factor Xa Inhibitor [EPC], Factor Xa Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-02-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20171226</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fondaparinux sodium injection is a Factor Xa inhibitor (anticoagulant) indicated for: 1 Prophylaxis of deep vein thrombosis (DVT) in patients undergoing hip fracture surgery (including extended prophylaxis), hip replacement surgery, knee replacement surgery, or abdominal surgery. (1.1), 2 Treatment of DVT or acute pulmonary embolism (PE) when administered in conjunction with warfarin. (1.2, 1.3).</IndicationAndUsage>
    <Description>Fondaparinux sodium injection, USP is a sterile solution containing fondaparinux sodium. It is a synthetic and specific inhibitor of activated Factor X (Xa). Fondaparinux sodium is methyl O-2-deoxy-6-O-sulfo-2-(sulfoamino)-α-D-glucopyranosyl-(1→4)-O-β-D-glucopyra-nuronosyl-(1→4)-O-2-deoxy-3,6-di-O-sulfo-2-(sulfoamino)-α-D-glucopyranosyl-(1→4)-O-2-O-­sulfo-α-L-idopyranuronosyl-(1→4)-2-deoxy-6-O-sulfo-2-(sulfoamino)-α-D-glucopyranoside, decasodium salt. Fondaparinux sodium USP is a white to almost white, hygroscopic powder. The molecular formula of fondaparinux sodium is C31H43N3Na10O49S8 and its molecular weight is 1728. The structural formula is provided below: Fondaparinux sodium injection, USP is supplied as a sterile, preservative-free injectable solution for subcutaneous use. Each single-dose, prefilled syringe of fondaparinux sodium injection, USP, affixed with an automatic needle protection system, contains 2.5 mg of fondaparinux sodium USP (equivalent to 2.18 mg fondaparinux) in 0.5 mL, 5 mg of fondaparinux sodium USP (equivalent to 4.36 mg fondaparinux) in 0.4 mL, 7.5 mg of fondaparinux sodium USP (equivalent to 6.54 mg fondaparinux) in 0.6 mL, or 10 mg of fondaparinux sodium USP (equivalent to 8.73 mg fondaparinux) in 0.8 mL of an isotonic solution of sodium chloride and water for injection. Also contain hydrochloric acid and sodium hydroxide as pH adjusters. The final drug product is a sterile, clear, colorless to slightly yellow solution, free from visible particles with a pH between 5.0 and 8.0.</Description>
  </NDC>
  <NDC>
    <NDCCode>59651-233-01</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (59651-233-01) </PackageDescription>
    <NDC11Code>59651-0233-01</NDC11Code>
    <ProductNDC>59651-233</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Clonidine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Clonidine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210602</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA070886</ApplicationNumber>
    <LabelerName>Aurobindo Pharma Limited</LabelerName>
    <SubstanceName>CLONIDINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>.2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-06-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210602</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Clonidine hydrochloride tablets are indicated in the treatment of hypertension. Clonidine hydrochloride tablets may be employed alone or concomitantly with other antihypertensive agents.</IndicationAndUsage>
    <Description>Clonidine hydrochloride USP is a centrally acting alpha-agonist hypotensive agent available as tablets for oral administration in three dosage strengths: 0.1 mg, 0.2 mg and 0.3 mg. The 0.1 mg tablet is equivalent to 0.087 mg of the free base. The inactive ingredients are corn starch, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80, in addition 0.1 mg and 0.2 mg contains D&amp;C Yellow No. 10, 0.1 mg and 0.3 mg contains FD&amp;C Blue No. 1, and 0.3 mg contains FD&amp;C Blue No. 2.  Clonidine hydrochloride is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2,6-dichlorophenylamino)-2-imidazoline hydrochloride. The following is the structural formula. Clonidine hydrochloride is an odorless, bitter, white or almost white crystalline powder. Soluble in water and ethanol, slightly soluble in chloroform.</Description>
  </NDC>
  <NDC>
    <NDCCode>59651-233-05</NDCCode>
    <PackageDescription>500 TABLET in 1 BOTTLE (59651-233-05) </PackageDescription>
    <NDC11Code>59651-0233-05</NDC11Code>
    <ProductNDC>59651-233</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Clonidine Hydrochloride</ProprietaryName>
    <NonProprietaryName>Clonidine Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20210602</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA070886</ApplicationNumber>
    <LabelerName>Aurobindo Pharma Limited</LabelerName>
    <SubstanceName>CLONIDINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>.2</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-06-10</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210602</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Clonidine hydrochloride tablets are indicated in the treatment of hypertension. Clonidine hydrochloride tablets may be employed alone or concomitantly with other antihypertensive agents.</IndicationAndUsage>
    <Description>Clonidine hydrochloride USP is a centrally acting alpha-agonist hypotensive agent available as tablets for oral administration in three dosage strengths: 0.1 mg, 0.2 mg and 0.3 mg. The 0.1 mg tablet is equivalent to 0.087 mg of the free base. The inactive ingredients are corn starch, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polysorbate 80, in addition 0.1 mg and 0.2 mg contains D&amp;C Yellow No. 10, 0.1 mg and 0.3 mg contains FD&amp;C Blue No. 1, and 0.3 mg contains FD&amp;C Blue No. 2.  Clonidine hydrochloride is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2,6-dichlorophenylamino)-2-imidazoline hydrochloride. The following is the structural formula. Clonidine hydrochloride is an odorless, bitter, white or almost white crystalline powder. Soluble in water and ethanol, slightly soluble in chloroform.</Description>
  </NDC>
  <NDC>
    <NDCCode>61919-233-10</NDCCode>
    <PackageDescription>10 mL in 1 CARTON (61919-233-10) </PackageDescription>
    <NDC11Code>61919-0233-10</NDC11Code>
    <ProductNDC>61919-233</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Polymyxin B Sulfate And Trimethoprim Sulfate</ProprietaryName>
    <NonProprietaryName>Polymyxin B Sulfate And Trimethoprim Sulfate</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20140101</StartMarketingDate>
    <MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
    <ApplicationNumber>NDA050567</ApplicationNumber>
    <LabelerName>DIRECT RX</LabelerName>
    <SubstanceName>POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE</SubstanceName>
    <StrengthNumber>10000; 1</StrengthNumber>
    <StrengthUnit>[USP'U]/mL; mg/mL</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C8 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Polymyxin B sulfate and trimethoprim ophthalmic solution, USP is indicated in the treatment of surface ocular bacterial infections, including acute bacterial conjunctivitis, and blepharoconjunctivitis, caused by susceptible strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus viridans, Haemophilus influenzae and Pseudomonas aeruginosa.*. *Efficacy for this organism in this organ system was studied in fewer than 10 infections.</IndicationAndUsage>
    <Description>Polymyxin B sulfate and trimethoprim ophthalmic solution, USP is a sterile antimicrobial solution for topical ophthalmic use. Chemical Names: Trimethoprim sulfate, 2,4-Diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine sulfate (2:1), is a white, odorless, crystalline powder with a molecular weight of 678.72 and the following structural formula. Polymyxin B sulfate is the sulfate salt of polymyxin B1 and B2 which are produced by the growth of Bacillus polymyxa (Prazmowski) Migula (Fam. Bacillaceae). It has a potency of not less than 6,000 polymyxin B units per mg, calculated on an anhydrous basis. The structural formulae are. Contains: Actives: polymyxin B sulfate 10,000 units/mL; trimethoprim sulfate equivalent to 1 mg/mL. Preservative: benzalkonium chloride 0.04 mg/mL. Inactives: purified water; sodium chloride; and sulfuric acid. May also contain sodium hydroxide for pH adjustment. It has pH of 4.0 to 6.2 and osmolality of 270 to 310 mOsm/kg.</Description>
  </NDC>
  <NDC>
    <NDCCode>62756-233-01</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (62756-233-01)  / 1 INJECTABLE, LIPOSOMAL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>62756-0233-01</NDC11Code>
    <ProductNDC>62756-233</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amphotericin B</ProprietaryName>
    <NonProprietaryName>Amphotericin B</NonProprietaryName>
    <DosageFormName>INJECTABLE, LIPOSOMAL</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20220209</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212514</ApplicationNumber>
    <LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
    <SubstanceName>AMPHOTERICIN B</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Lipid-based Polyene Antifungal [EPC], Polyene Antifungal [EPC], Polyenes [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220209</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Amphotericin B liposome for injection is indicated for the following: 1 Empirical therapy for presumed fungal infection in febrile, neutropenic patients., 2 Treatment of Cryptococcal Meningitis in HIV infected patients (see DESCRIPTION OF CLINICAL STUDIES)., 3 Treatment of patients with Aspergillus species, Candida species and/or Cryptococcus species infections (see above for the treatment of Cryptococcal Meningitis) refractory to amphotericin B deoxycholate, or in patients where renal impairment or unacceptable toxicity precludes the use of amphotericin B deoxycholate., 4 Treatment of visceral leishmaniasis. In immunocompromised patients with visceral leishmaniasis treated with amphotericin B liposome for injection, relapse rates were high following initial clearance of parasites (see DESCRIPTION OF CLINICAL STUDIES).</IndicationAndUsage>
    <Description>Amphotericin B liposome for injection is a sterile, non-pyrogenic lyophilized product for intravenous infusion. Each vial contains amphotericin B, USP 50 milligrams (mg), intercalated into a liposomal membrane consisting of alpha tocopherol approximately 0.64 mg; cholesterol 52 mg; distearoylphosphatidylglycerol, sodium salt 84 mg; hydrogenated soy phosphatidylcholine 213 mg, together with disodium succinate hexahydrate 27 mg; and sucrose 900 mg. Amphotericin B liposome for injection may also contain hydrochloric acid and/or sodium hydroxide as pH adjusters. Following reconstitution with Sterile Water for Injection, the resulting pH of the suspension is between 5.0 to 6.0. Amphotericin B liposome for injection is a true single bilayer liposomal drug delivery system. Liposomes are closed, spherical vesicles created by mixing specific proportions of amphophilic substances such as phospholipids and cholesterol so that they arrange themselves into multiple concentric bilayer membranes when hydrated in aqueous solutions. Single bilayer liposomes are then formed by microemulsification of multilamellar vesicles using a homogenizer. Amphotericin B liposome for injection consists of these unilamellar bilayer liposomes with amphotericin B intercalated within the membrane. Due to the nature and quantity of amphophilic substances used, and the lipophilic moiety in the amphotericin B molecule, the drug is an integral part of the overall structure of the Amphotericin B liposomes. Amphotericin B liposome for injection contains true liposomes that are less than 100 nm in diameter. A schematic depiction of the liposome is presented below. Note: Liposomal encapsulation or incorporation into a lipid complex can substantially affect a drug’s functional properties relative to those of the unencapsulated drug or non-lipid associated drug. In addition, different liposomal or lipid-complex products with a common active ingredient may vary from one another in the chemical composition and physical form of the lipid component. Such differences may affect the functional properties of these drug products. Amphotericin B is a macrocyclic, polyene, antifungal antibiotic produced from a strain of Streptomyces nodosus. Amphotericin B is designated chemically as: [1R-(1R*,3S*,5R*,6R*,9R*,11R*,15S*,16R*,17R*,18S*, 19E,21E,23E,25E,27E,29E,31E,33R*,35S*,36R*,37S*)]-33-[(3-Amino-3,6-dideoxy-ß-D-mannopyranosyl)oxy]-1,3,5,6,9,11,17,37-octahydroxy-15,16,18-trimethyl-13-oxo-14,39-dioxabicyclo-[33.3.1]nonatriaconta-19,21,23,25,27,29,31-heptaene-36-carboxylic acid (CAS No.1397-89-3). Amphotericin B has a molecular formula of C47H73NO17 and a molecular weight of 924.09 g/mol. The structure of amphotericin B is shown below.</Description>
  </NDC>
  <NDC>
    <NDCCode>62756-233-02</NDCCode>
    <PackageDescription>10 CARTON in 1 CARTON (62756-233-02)  / 1 VIAL, SINGLE-DOSE in 1 CARTON / 1 INJECTABLE, LIPOSOMAL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>62756-0233-02</NDC11Code>
    <ProductNDC>62756-233</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Amphotericin B</ProprietaryName>
    <NonProprietaryName>Amphotericin B</NonProprietaryName>
    <DosageFormName>INJECTABLE, LIPOSOMAL</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20220209</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA212514</ApplicationNumber>
    <LabelerName>Sun Pharmaceutical Industries, Inc.</LabelerName>
    <SubstanceName>AMPHOTERICIN B</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Lipid-based Polyene Antifungal [EPC], Polyene Antifungal [EPC], Polyenes [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220209</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Amphotericin B liposome for injection is indicated for the following: 1 Empirical therapy for presumed fungal infection in febrile, neutropenic patients., 2 Treatment of Cryptococcal Meningitis in HIV infected patients (see DESCRIPTION OF CLINICAL STUDIES)., 3 Treatment of patients with Aspergillus species, Candida species and/or Cryptococcus species infections (see above for the treatment of Cryptococcal Meningitis) refractory to amphotericin B deoxycholate, or in patients where renal impairment or unacceptable toxicity precludes the use of amphotericin B deoxycholate., 4 Treatment of visceral leishmaniasis. In immunocompromised patients with visceral leishmaniasis treated with amphotericin B liposome for injection, relapse rates were high following initial clearance of parasites (see DESCRIPTION OF CLINICAL STUDIES).</IndicationAndUsage>
    <Description>Amphotericin B liposome for injection is a sterile, non-pyrogenic lyophilized product for intravenous infusion. Each vial contains amphotericin B, USP 50 milligrams (mg), intercalated into a liposomal membrane consisting of alpha tocopherol approximately 0.64 mg; cholesterol 52 mg; distearoylphosphatidylglycerol, sodium salt 84 mg; hydrogenated soy phosphatidylcholine 213 mg, together with disodium succinate hexahydrate 27 mg; and sucrose 900 mg. Amphotericin B liposome for injection may also contain hydrochloric acid and/or sodium hydroxide as pH adjusters. Following reconstitution with Sterile Water for Injection, the resulting pH of the suspension is between 5.0 to 6.0. Amphotericin B liposome for injection is a true single bilayer liposomal drug delivery system. Liposomes are closed, spherical vesicles created by mixing specific proportions of amphophilic substances such as phospholipids and cholesterol so that they arrange themselves into multiple concentric bilayer membranes when hydrated in aqueous solutions. Single bilayer liposomes are then formed by microemulsification of multilamellar vesicles using a homogenizer. Amphotericin B liposome for injection consists of these unilamellar bilayer liposomes with amphotericin B intercalated within the membrane. Due to the nature and quantity of amphophilic substances used, and the lipophilic moiety in the amphotericin B molecule, the drug is an integral part of the overall structure of the Amphotericin B liposomes. Amphotericin B liposome for injection contains true liposomes that are less than 100 nm in diameter. A schematic depiction of the liposome is presented below. Note: Liposomal encapsulation or incorporation into a lipid complex can substantially affect a drug’s functional properties relative to those of the unencapsulated drug or non-lipid associated drug. In addition, different liposomal or lipid-complex products with a common active ingredient may vary from one another in the chemical composition and physical form of the lipid component. Such differences may affect the functional properties of these drug products. Amphotericin B is a macrocyclic, polyene, antifungal antibiotic produced from a strain of Streptomyces nodosus. Amphotericin B is designated chemically as: [1R-(1R*,3S*,5R*,6R*,9R*,11R*,15S*,16R*,17R*,18S*, 19E,21E,23E,25E,27E,29E,31E,33R*,35S*,36R*,37S*)]-33-[(3-Amino-3,6-dideoxy-ß-D-mannopyranosyl)oxy]-1,3,5,6,9,11,17,37-octahydroxy-15,16,18-trimethyl-13-oxo-14,39-dioxabicyclo-[33.3.1]nonatriaconta-19,21,23,25,27,29,31-heptaene-36-carboxylic acid (CAS No.1397-89-3). Amphotericin B has a molecular formula of C47H73NO17 and a molecular weight of 924.09 g/mol. The structure of amphotericin B is shown below.</Description>
  </NDC>
</NDCList>