{
"NDC": [
{
"NDCCode": "17478-171-30",
"PackageDescription": "30 POUCH in 1 CARTON (17478-171-30) > 1 VIAL, SINGLE-DOSE in 1 POUCH (17478-171-01) > .5 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "17478-0171-30",
"ProductNDC": "17478-171",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Xopenex",
"NonProprietaryName": "Levalbuterol Hydrochloride",
"DosageFormName": "SOLUTION, CONCENTRATE",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20150226",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020837",
"LabelerName": "Akorn",
"SubstanceName": "LEVALBUTEROL HYDROCHLORIDE",
"StrengthNumber": "1.25",
"StrengthUnit": "mg/.5mL",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20150226",
"SamplePackage": "N",
"IndicationAndUsage": "XOPENEX (levalbuterol HCl) Inhalation Solution Concentrate is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease.",
"Description": "XOPENEX Inhalation Solution Concentrate is a sterile, clear, colorless, preservative-free solution of the hydrochloride salt of levalbuterol, the (R)-enantiomer of the drug substance racemic albuterol. Levalbuterol HCl is a relatively selective beta2-adrenergic receptor agonist [see Clinical Pharmacology (12)]. The chemical name for levalbuterol HCl is (R)-α1-[[(1,1-dimethylethyl)amino]methyl]-4-hydroxy-1,3-benzenedimethanol hydrochloride, and its established chemical structure is as follows:. The molecular weight of levalbuterol HCl is 275.8, and its empirical formula is C13H21NO3HCl. It is a white to off-white, crystalline solid, with a melting point of approximately 187°C and solubility of approximately 180 mg/mL in water. Levalbuterol HCl is the USAN modified name for (R)-albuterol HCl in the United States. XOPENEX Inhalation Solution Concentrate is supplied in 0.5 mL unit-dose vials that must be diluted with normal saline before administration by nebulization. Each 0.5 mL unit-dose vial contains 1.25 mg of levalbuterol (as 1.44 mg of levalbuterol HCl), sodium chloride to adjust tonicity, and hydrochloric acid to adjust the pH to 4.0 (3.3 to 4.5)."
},
{
"NDCCode": "17478-081-30",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (17478-081-30) > 30 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "17478-0081-30",
"ProductNDC": "17478-081",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropivacaine Hydrochloride",
"NonProprietaryName": "Ropivacaine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "EPIDURAL; INFILTRATION; PERINEURAL",
"StartMarketingDate": "20160411",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203955",
"LabelerName": "Akorn",
"SubstanceName": "ROPIVACAINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20160411",
"SamplePackage": "N",
"IndicationAndUsage": "Ropivacaine Hydrochloride is indicated for the production of local or regional anesthesia for surgery and for acute pain management. Surgical Anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration. Acute Pain Management: epidural continuous infusion or intermittent bolus, eg, postoperative or labor; local infiltration.",
"Description": "Ropivacaine Hydrochloride Injection contains ropivacaine HCl which is a member of the amino amide class of local anesthetics. Ropivacaine Hydrochloride Injection is a sterile, isotonic solution that contains the enantiomerically pure drug substance, sodium chloride for isotonicity and water for injection. Sodium hydroxide and/or hydrochloric acid may be used for pH adjustment. It is administered parenterally. Ropivacaine HCl is chemically described as S‑(‑)‑1‑propyl‑2',6'‑pipecoloxylidide hydrochloride monohydrate. The drug substance is a white crystalline powder, with the following structural formula:. At 25°C ropivacaine HCl has a solubility of 53.8 mg/mL in water, a distribution ratio between n‑octanol and phosphate buffer at pH 7.4 of 14:1 and a pKa of 8.07 in 0.1 M KCl solution. The pKa of ropivacaine is approximately the same as bupivacaine (8.1) and is similar to that of mepivacaine (7.7). However, ropivacaine has an intermediate degree of lipid solubility compared to bupivacaine and mepivacaine. Ropivacaine Hydrochloride Injection is preservative‑free and is available in a single dose container in 5 mg/mL (0.5%) concentration. The specific gravity of Ropivacaine Hydrochloride Injection solutions range from 1.002 to 1.005 at 25°C."
},
{
"NDCCode": "17478-107-30",
"PackageDescription": "1 VIAL in 1 CARTON (17478-107-30) > 30 mL in 1 VIAL",
"NDC11Code": "17478-0107-30",
"ProductNDC": "17478-107",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levofloxacin",
"NonProprietaryName": "Levofloxacin",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20110701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091644",
"LabelerName": "Akorn",
"SubstanceName": "LEVOFLOXACIN",
"StrengthNumber": "25",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20110701",
"SamplePackage": "N",
"IndicationAndUsage": "Levofloxacin Injection is indicated for the treatment of adults (≥18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed in this section. Levofloxacin Injection is indicated when intravenous administration offers a route of administration advantageous to the patient (e.g., patient cannot tolerate an oral dosage form).",
"Description": "Levofloxacin Injection is a synthetic broad-spectrum antibacterial agent for intravenous administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid hemihydrate. Figure 1: The Chemical Structure of Levofloxacin. The empirical formula is C18H20FN3O4 ½ H2O and the molecular weight is 370.38. Levofloxacin is a light yellowish-white to yellow-white crystal or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin is essentially constant (approximately 100 mg/mL). Levofloxacin is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9. Levofloxacin has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order: Al+3>Cu+2>Zn+2>Mg+2>Ca+2."
},
{
"NDCCode": "17478-114-30",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (17478-114-30) > 30 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "17478-0114-30",
"ProductNDC": "17478-114",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tobramycin",
"NonProprietaryName": "Tobramycin Sulfate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20140916",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205179",
"LabelerName": "Akorn",
"SubstanceName": "TOBRAMYCIN SULFATE",
"StrengthNumber": "40",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-05-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20140916",
"SamplePackage": "N"
},
{
"NDCCode": "17478-190-30",
"PackageDescription": "1 TUBE in 1 CARTON (17478-190-30) > 30 g in 1 TUBE",
"NDC11Code": "17478-0190-30",
"ProductNDC": "17478-190",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine And Prilocaine",
"NonProprietaryName": "Lidocaine And Prilocaine",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20121112",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA019941",
"LabelerName": "Akorn, Inc.",
"SubstanceName": "LIDOCAINE; PRILOCAINE",
"StrengthNumber": "25; 25",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2016-12-09"
},
{
"NDCCode": "17478-207-14",
"PackageDescription": "30 VIAL, SINGLE-USE in 1 CARTON (17478-207-14) > .4 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "17478-0207-14",
"ProductNDC": "17478-207",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ketorolac Tromethamine",
"NonProprietaryName": "Ketorolac Tromethamine",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20140210",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203376",
"LabelerName": "Akorn",
"SubstanceName": "KETOROLAC TROMETHAMINE",
"StrengthNumber": "4.5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-09-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20140210",
"SamplePackage": "N"
},
{
"NDCCode": "17478-544-30",
"PackageDescription": "1 VIAL in 1 CARTON (17478-544-30) / 30 mL in 1 VIAL",
"NDC11Code": "17478-0544-30",
"ProductNDC": "17478-544",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Adenosine",
"NonProprietaryName": "Adenosine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20141002",
"EndMarketingDate": "20240630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090450",
"LabelerName": "Akorn",
"SubstanceName": "ADENOSINE",
"StrengthNumber": "3",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adenosine Receptor Agonist [EPC], Adenosine Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-07-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20141002",
"EndMarketingDatePackage": "20240630",
"SamplePackage": "N",
"IndicationAndUsage": "Adenosine injection, USP is indicated as an adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately.",
"Description": "Adenosine is an endogenous nucleoside and is chemically described as 6-amino-9-beta-D-ribofuranosyl-9-H-purine. Adenosine has the following structural formula. The molecular formula for adenosine is C10 H13 N5 O4 and its molecular weight is 267.24. Adenosine is a white crystalline powder. It is soluble in water and practically insoluble in alcohol. Solubility increases by warming and lowering the pH of the solution. Each Adenosine Injection, USP vial contains a sterile, non-pyrogenic solution of adenosine 3 mg/mL and sodium chloride 9 mg/mL in water for injection, with pH between 4.5 and 7.5."
},
{
"NDCCode": "17478-604-30",
"PackageDescription": "4 POUCH in 1 CARTON (17478-604-30) > 15 VIAL, SINGLE-USE in 1 POUCH (17478-604-01) > .2 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "17478-0604-30",
"ProductNDC": "17478-604",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cosopt Pf",
"NonProprietaryName": "Dorzolamide Hydrochloride And Timolol Maleate",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20140514",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202667",
"LabelerName": "Akorn",
"SubstanceName": "DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE",
"StrengthNumber": "20; 5",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20140514",
"SamplePackage": "N",
"IndicationAndUsage": "COSOPT® PF is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers (failed to achieve target IOP determined after multiple measurements over time). The IOP-lowering of COSOPT® 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 (14.1)].",
"Description": "COSOPT PF (dorzolamide hydrochloride-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: : 1 [α] 25°C (C=1, water) = ~ -17°. , 2 405 nm ."
},
{
"NDCCode": "17478-608-30",
"PackageDescription": "1 VIAL in 1 CARTON (17478-608-30) > 10 mL in 1 VIAL",
"NDC11Code": "17478-0608-30",
"ProductNDC": "17478-608",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bacitracin",
"NonProprietaryName": "Bacitracin",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20171023",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206719",
"LabelerName": "Akorn, Inc.",
"SubstanceName": "BACITRACIN A",
"StrengthNumber": "5000",
"StrengthUnit": "[USP'U]/mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20171023",
"SamplePackage": "N"
},
{
"NDCCode": "17478-609-30",
"PackageDescription": "3 POUCH in 1 CARTON (17478-609-30) > 10 VIAL, SINGLE-USE in 1 POUCH (17478-609-01) > .3 mL in 1 VIAL, SINGLE-USE",
"NDC11Code": "17478-0609-30",
"ProductNDC": "17478-609",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zioptan",
"NonProprietaryName": "Tafluprost",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20141126",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA202514",
"LabelerName": "Akorn",
"SubstanceName": "TAFLUPROST",
"StrengthNumber": ".0045",
"StrengthUnit": "mg/.3mL",
"Pharm_Classes": "Increased Prostaglandin Activity [PE], Prostaglandin Analog [EPC], Prostaglandin Receptor Agonists [MoA], Prostaglandins [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20171126",
"SamplePackage": "N",
"IndicationAndUsage": "ZIOPTAN® (tafluprost ophthalmic solution) 0.0015% is indicated for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.",
"Description": "Tafluprost is a fluorinated analog of prostaglandin F2α. The chemical name for tafluprost is 1-methylethyl (5Z)-7-{(1R, 2R, 3R, 5S)-2-[(1E)-3,3-difluoro-4-phenoxy-1-butenyl}-3,5-dihydroxycyclopentyl]-5-heptenoate. The molecular formula of tafluprost is C25H34F2O5 and its molecular weight is 452.53. Its structural formula is:. Tafluprost is a colorless to light yellow viscous liquid that is practically insoluble in water. ZIOPTAN® (tafluprost ophthalmic solution) 0.0015% is supplied as a sterile solution of tafluprost with a pH range of 5.5 to 6.7 and an Osmolality range of 260 to 300 mOsmo/kg. ZIOPTAN® contains Active: tafluprost 0.015 mg/mL; Inactives: glycerol, sodium dihydrogen phosphate dihydrate, disodium edetate, polysorbate 80, hydrochloric acid and/or sodium hydroxide (to adjust pH) and Water for Injection. ZIOPTAN® does not contain a preservative."
},
{
"NDCCode": "17478-660-30",
"PackageDescription": "4 VIAL, SINGLE-DOSE in 1 CARTON (17478-660-30) > 30 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "17478-0660-30",
"ProductNDC": "17478-660",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acetylcysteine",
"NonProprietaryName": "Acetylcysteine",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20150325",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203173",
"LabelerName": "Akorn",
"SubstanceName": "ACETYLCYSTEINE",
"StrengthNumber": "200",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Antidote [EPC], Antidote for Acetaminophen Overdose [EPC], Decreased Respiratory Secretion Viscosity [PE], Increased Glutathione Concentration [PE], Mucolytic [EPC], Reduction Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20150325",
"SamplePackage": "N",
"IndicationAndUsage": "Acetylcysteine Injection is indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen in patients with acute ingestion or from repeated supratherapeutic ingestion (RSI).",
"Description": "Acetylcysteine injection is an intravenous antidote for the treatment of acetaminophen overdose. Acetylcysteine is the nonproprietary name for the N-acetyl derivative of the naturally occurring amino acid, L-cysteine (N-acetyl-L-cysteine). The compound is a white crystalline powder, which melts in the range of 104° to 110°C and has a very slight odor. The molecular formula of the compound is C5H9NO3S, and its molecular weight is 163.2. Acetylcysteine has the following structural formula:. Acetylcysteine Injection is supplied as a sterile solution in vials containing 20% w/v (200 mg/mL) acetylcysteine. The pH of the solution ranges from 6.0 to 7.5. Acetylcysteine Injection contains the following inactive ingredients: 0.5 mg/mL disodium edetate, sodium hydroxide (used for pH adjustment), and Water for Injection, USP."
},
{
"NDCCode": "17478-711-30",
"PackageDescription": "1 TUBE, WITH APPLICATOR in 1 CARTON (17478-711-30) > 30 mL in 1 TUBE, WITH APPLICATOR",
"NDC11Code": "17478-0711-30",
"ProductNDC": "17478-711",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine",
"NonProprietaryName": "Lidocaine Hydrochloride",
"DosageFormName": "JELLY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20030801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040433",
"LabelerName": "Akorn",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20030801",
"SamplePackage": "N",
"IndicationAndUsage": "Lidocaine HCl 2% Jelly is indicated for prevention and control of pain in procedures involving the male and female urethra, for topical treatment of painful urethritis, and as an anesthetic lubricant for endotracheal intubation (oral and nasal).",
"Description": "Lidocaine HCl 2% Jelly is a sterile aqueous product that contains a local anesthetic agent and is administered topically (see INDICATIONS AND USAGE for specific uses). Lidocaine HCl 2% Jelly contains lidocaine HCl which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the following structural formula:. Its molecular formula is C14H22N2O HCl and its molecular weight is 270.80. Lidocaine HCl 2% Jelly also contains hypromellose, and the resulting mixture maximizes contact with mucosa and provides lubrication for instrumentation. The unused portion should be discarded after initial use. Composition of Lidocaine HCl 2% Jelly 30 mL and 5 mL tubes: Each mL contains 20 mg of lidocaine HCl. The formulation also contains methylparaben, propylparaben, hypromellose, and sodium hydroxide and/or hydrochloric acid to adjust pH to 6.0 to 7.0."
},
{
"NDCCode": "17478-768-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (17478-768-30) ",
"NDC11Code": "17478-0768-30",
"ProductNDC": "17478-768",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aminocaproic Acid",
"NonProprietaryName": "Aminocaproic Acid",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190312",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA015197",
"LabelerName": "Akorn Operating Company LLC",
"SubstanceName": "AMINOCAPROIC ACID",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-10-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190312",
"SamplePackage": "N",
"IndicationAndUsage": "Aminocaproic acid is useful in enhancing hemostasis when fibrinolysis contributes to bleeding. In life-threatening situations, transfusion of appropriate blood products and other emergency measures may be required. Fibrinolytic bleeding may frequently be associated with surgical complications following heart surgery (with or without cardiac bypass procedures) and portacaval shunt; hematological disorders such as amegakaryocytic thrombocytopenia (accompanying aplastic anemia); acute and life-threatening abruptio placentae; hepatic cirrhosis; and neoplastic disease such as carcinoma of the prostate, lung, stomach, and cervix. Urinary fibrinolysis, usually a normal physiological phenomenon, may contribute to excessive urinary tract fibrinolytic bleeding associated with surgical hematuria (following prostatectomy and nephrectomy) or nonsurgical hematuria (accompanying polycystic or neoplastic diseases of the genitourinary system). (See Warnings).",
"Description": "Aminocaproic acid is 6-aminohexanoic acid, which acts as an inhibitor of fibrinolysis. Its chemical structure is. Aminocaproic acid is soluble in water, acid, and alkaline solutions; it is sparingly soluble in methanol and practically insoluble in chloroform. Aminocaproic acid oral solution for oral administration, contains 0.25 g/mL of aminocaproic acid with methylparaben 0.20%, propylparaben 0.05%, edetate disodium 0.30% as preservatives and the following inactive ingredients: sodium saccharin, sorbitol solution, citric acid anhydrous, natural and artificial raspberry flavor and an artificial bitterness modifier. Each aminocaproic acid tablet for oral administration contains either 500 mg or 1000 mg of aminocaproic acid and the following inactive ingredients: povidone, crospovidone, stearic acid, and magnesium stearate."
},
{
"NDCCode": "17478-769-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (17478-769-30) ",
"NDC11Code": "17478-0769-30",
"ProductNDC": "17478-769",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aminocaproic Acid",
"NonProprietaryName": "Aminocaproic Acid",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190312",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA015197",
"LabelerName": "Akorn Operating Company LLC",
"SubstanceName": "AMINOCAPROIC ACID",
"StrengthNumber": "1000",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-10-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190312",
"SamplePackage": "N",
"IndicationAndUsage": "Aminocaproic acid is useful in enhancing hemostasis when fibrinolysis contributes to bleeding. In life-threatening situations, transfusion of appropriate blood products and other emergency measures may be required. Fibrinolytic bleeding may frequently be associated with surgical complications following heart surgery (with or without cardiac bypass procedures) and portacaval shunt; hematological disorders such as amegakaryocytic thrombocytopenia (accompanying aplastic anemia); acute and life-threatening abruptio placentae; hepatic cirrhosis; and neoplastic disease such as carcinoma of the prostate, lung, stomach, and cervix. Urinary fibrinolysis, usually a normal physiological phenomenon, may contribute to excessive urinary tract fibrinolytic bleeding associated with surgical hematuria (following prostatectomy and nephrectomy) or nonsurgical hematuria (accompanying polycystic or neoplastic diseases of the genitourinary system). (See Warnings).",
"Description": "Aminocaproic acid is 6-aminohexanoic acid, which acts as an inhibitor of fibrinolysis. Its chemical structure is. Aminocaproic acid is soluble in water, acid, and alkaline solutions; it is sparingly soluble in methanol and practically insoluble in chloroform. Aminocaproic acid oral solution for oral administration, contains 0.25 g/mL of aminocaproic acid with methylparaben 0.20%, propylparaben 0.05%, edetate disodium 0.30% as preservatives and the following inactive ingredients: sodium saccharin, sorbitol solution, citric acid anhydrous, natural and artificial raspberry flavor and an artificial bitterness modifier. Each aminocaproic acid tablet for oral administration contains either 500 mg or 1000 mg of aminocaproic acid and the following inactive ingredients: povidone, crospovidone, stearic acid, and magnesium stearate."
},
{
"NDCCode": "17478-811-30",
"PackageDescription": "1 TUBE, WITH APPLICATOR in 1 CARTON (17478-811-30) > 30 mL in 1 TUBE, WITH APPLICATOR",
"NDC11Code": "17478-0811-30",
"ProductNDC": "17478-811",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine",
"NonProprietaryName": "Lidocaine Hydrochloride",
"DosageFormName": "JELLY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20030801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040433",
"LabelerName": "Akorn",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2022-05-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20030801",
"SamplePackage": "N"
},
{
"NDCCode": "17478-840-30",
"PackageDescription": "1 TUBE, WITH APPLICATOR in 1 CARTON (17478-840-30) > 30 mL in 1 TUBE, WITH APPLICATOR",
"NDC11Code": "17478-0840-30",
"ProductNDC": "17478-840",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine",
"NonProprietaryName": "Lidocaine Hydrochloride",
"DosageFormName": "JELLY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130801",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040433",
"LabelerName": "Akorn, Inc.",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2021-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20130801",
"SamplePackage": "N"
},
{
"NDCCode": "10370-171-11",
"PackageDescription": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (10370-171-11) ",
"NDC11Code": "10370-0171-11",
"ProductNDC": "10370-171",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Darifenacin Hydrobromide",
"ProprietaryNameSuffix": "Extended-release",
"NonProprietaryName": "Darifenacin Hydrobromide",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20160315",
"EndMarketingDate": "20210228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091190",
"LabelerName": "Par Pharmaceutical, Inc.",
"SubstanceName": "DARIFENACIN HYDROBROMIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-03-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160315",
"EndMarketingDatePackage": "20210228",
"SamplePackage": "N"
},
{
"NDCCode": "10544-171-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (10544-171-30)",
"NDC11Code": "10544-0171-30",
"ProductNDC": "10544-171",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atenolol",
"NonProprietaryName": "Atenolol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20131115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077877",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "ATENOLOL",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Atenolol tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including atenolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (eg, on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Atenolol tablets may be administered with other antihypertensive agents.",
"Description": "Atenolol, a synthetic, beta 1-selective (cardioselective) adrenoreceptor blocking agent, may be chemically described as benzeneacetamide, 4 -[2’-hydroxy-3’-[(1- methylethyl) amino] propoxy]-. The molecular formula is C 14H 22N 2O 3 and its structural formula is:. Atenolol (free base) has a molecular weight of 266. It is a relatively polar hydrophilic compound with a water solubility of 26.5 mg/mL at 37° C and a log partition coefficient (octanol/water) of 0.23. It is freely soluble in 1N HCl (300 mg/mL at 25° C) and less soluble in chloroform (3 mg/mL at 25° C). Atenolol tablets, USP are available as 25, 50 and 100 mg tablets for oral administration. Inactive Ingredients: Colloidal silicon dioxide, corn starch, magnesium carbonate, magnesium stearate, sodium lauryl sulfate, sodium starch glycolate."
},
{
"NDCCode": "10702-171-03",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (10702-171-03) / 30 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "10702-0171-03",
"ProductNDC": "10702-171",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxycodone Hydrochloride",
"NonProprietaryName": "Oxycodone Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20170721",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208593",
"LabelerName": "KVK-Tech, Inc.",
"SubstanceName": "OXYCODONE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170721",
"SamplePackage": "N",
"IndicationAndUsage": "Oxycodone Hydrochloride Oral Solution is indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg/mL) is indicated for use in opioid-tolerant adult patientswho require higher doses of opioids for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration, and persist over the course of therapy [see Warnings and Precautions (5.2)], reserve opioid analgesics, including Oxycodone Hydrochloride Oral Solution, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.",
"Description": "Oxycodone Hydrochloride Oral Solution, USP is an agonist, available as a red solution 5 mg/5 mL (1 mg/mL) and a yellow solution 100 mg/5 mL (20 mg/mL) for oral administration. The chemical name is (5R,9R,13S,14S)-4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride. The molecular weight is 351.82. Its molecular formula is C 18H 21NO 4 HCl, and it has the following chemical structure. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. It is soluble in water and slightly soluble in alcohol. The inactive ingredients in Oxycodone Hydrochloride Oral Solution, USP 5 mg per 5 mL (1 mg/mL) include: FD&C Red #40 powder, glycerin, hydrochloric acid, maltitol syrup, natural/artificial berry flavor, purified water, sodium benzoate, sorbitol, and sucralose powder. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH. The inactive ingredients in Oxycodone Hydrochloride Oral Solution, USP 100 mg per 5 mL (20 mg/ mL) include: D&C Yellow #10, glycerin, hydrochloric acid, maltitol syrup, natural/artificial berry flavor, purified water, sodium benzoate, sorbitol, and sucralose powder. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH."
},
{
"NDCCode": "10812-171-01",
"PackageDescription": "30 mL in 1 BOTTLE, PUMP (10812-171-01) ",
"NDC11Code": "10812-0171-01",
"ProductNDC": "10812-171",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Neutrogena Healthy Skin Enhancer",
"ProprietaryNameSuffix": "Sunscreen Broad Spectrum Spf20 - Neutral To Tan 40",
"NonProprietaryName": "Octinoxate, Octisalate, And Titanium Dioxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130524",
"EndMarketingDate": "20210331",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Johnson & Johnson Consumer Inc.",
"SubstanceName": "OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE",
"StrengthNumber": "70; 30; 51",
"StrengthUnit": "mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2021-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20130524",
"EndMarketingDatePackage": "20210331",
"SamplePackage": "N"
},
{
"NDCCode": "12634-171-59",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (12634-171-59)",
"NDC11Code": "12634-0171-59",
"ProductNDC": "12634-171",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20081120",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075682",
"LabelerName": "Apotheca Inc.",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of Ibuprofentablets and other treatment options before deciding to use Ibuprofen.Use the lowest effective dose for the shortest duration consistent withindividual patient treatment goals (see WARNINGS). IBU tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. IBU tablets are indicated for relief of mild to moderate pain. IBU tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of IBU tablets in children have not been conducted.",
"Description": "IBU tablets contain the active ingredient ibuprofen, which is (±) -2 - ( p - isobutylphenyl) propionic acid. Ibuprofen is a white powde rwith a melting point of 74-77° C and is very slightly soluble in water(<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below:. IBU, a nonsteroidal anti-inflammatory drug (NSAID), is availablein 400 mg, 600 mg, and 800 mg tablets for oral administration.Inactive ingredients: carnauba wax, colloidal silicon dioxide,croscarmellose sodium, hypromellose, magnesium stearate, microcrystallinecellulose, polydextrose, polyethylene glycol, polysorbate,titanium dioxide."
},
{
"NDCCode": "12634-171-71",
"PackageDescription": "30 TABLET in 1 BOTTLE (12634-171-71)",
"NDC11Code": "12634-0171-71",
"ProductNDC": "12634-171",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20081120",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075682",
"LabelerName": "Apotheca Inc.",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of Ibuprofentablets and other treatment options before deciding to use Ibuprofen.Use the lowest effective dose for the shortest duration consistent withindividual patient treatment goals (see WARNINGS). IBU tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. IBU tablets are indicated for relief of mild to moderate pain. IBU tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of IBU tablets in children have not been conducted.",
"Description": "IBU tablets contain the active ingredient ibuprofen, which is (±) -2 - ( p - isobutylphenyl) propionic acid. Ibuprofen is a white powde rwith a melting point of 74-77° C and is very slightly soluble in water(<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below:. IBU, a nonsteroidal anti-inflammatory drug (NSAID), is availablein 400 mg, 600 mg, and 800 mg tablets for oral administration.Inactive ingredients: carnauba wax, colloidal silicon dioxide,croscarmellose sodium, hypromellose, magnesium stearate, microcrystallinecellulose, polydextrose, polyethylene glycol, polysorbate,titanium dioxide."
},
{
"NDCCode": "13668-171-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (13668-171-30) ",
"NDC11Code": "13668-0171-30",
"ProductNDC": "13668-171",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091434",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260228",
"SamplePackage": "N",
"IndicationAndUsage": "Olanzapine is an atypical antipsychotic indicated. As oral formulation for the. Treatment of schizophrenia. ( 1.1). Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. ( 14.1). Adolescents (ages 13 to 17): Efficacy was established in one 6-week trial in patients with schizophrenia ( 14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. ( 1.1). Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. ( 1.2). Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. ( 14.2). Adolescents (ages 13 to 17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder ( 14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. ( 1.2). Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. ( 1.3). Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. ( 1.2). Efficacy was established in two 6-week clinical trials in adults ( 14.2). Maintenance efficacy has not been systematically evaluated. As Olanzapine and Fluoxetine in Combination for the. Treatment of depressive episodes associated with bipolar I disorder. ( 1.5). Efficacy was established with Symbynax (olanzapine and fluoxetine in combination); refer to the product label for Symbyax. Treatment of treatment resistant depression. ( 1.6). Efficacy was established with Symbyax (olanzapine and fluoxetine in combination) in adults; refer to the product label for Symbyax.",
"Description": "Olanzapine is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)- 10H-thieno[2,3- b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine, USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets, USP are intended for oral administration only. Each tablet contains olanzapine equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are crospovidone, magnesium stearate, mannitol and microcrystalline cellulose. For olanzapine tablets, USP: Meets USP Dissolution Test 2. Olanzapine orally disintegrating tablets, USP are intended for oral administration only. Each orally disintegrating tablet contains olanzapine equivalent to 5 mg (16 μmol), 10 mg (32 μmol), 15 mg (48 μmol) or 20 mg (64 μmol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. Olanzapine orally disintegrating tablets, USP also contain the following inactive ingredients: aspartame, crospovidone, magnesium stearate, mannitol and microcrystalline cellulose. For olanzapine orally disintegrating tablets, USP: Meets USP Disintegration Test 2."
},
{
"NDCCode": "14783-171-02",
"PackageDescription": "1 BOTTLE in 1 BOX (14783-171-02) > 30 g in 1 BOTTLE (14783-171-01) ",
"NDC11Code": "14783-0171-02",
"ProductNDC": "14783-171",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Esika Pro Natural Mattifying Foundation Adaptable To Your Skin Tone Spf 20",
"ProprietaryNameSuffix": "Medio1/beige",
"NonProprietaryName": "Octinoxate And Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20181019",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura International LTD",
"SubstanceName": "OCTINOXATE; ZINC OXIDE",
"StrengthNumber": ".05; .042",
"StrengthUnit": "g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20181019",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "16590-171-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (16590-171-30)",
"NDC11Code": "16590-0171-30",
"ProductNDC": "16590-171",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nortriptyline Hydrochloride",
"NonProprietaryName": "Nortriptyline Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19920701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA073554",
"LabelerName": "STAT RX USA LLC",
"SubstanceName": "NORTRIPTYLINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Nortriptyline hydrochloride is indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states.",
"Description": "Nortriptyline hydrochloride is 1-Propanamine, 3-(10,11-dihydro-5H-dibenzo[a,d]cyclohepten-5-ylidene)-N-methyl-, hydrochloride. The structural formula is represented below. C19H21NHCl M.W. 299.84. Nortriptyline Hydrochloride Capsules USP (equivalent to 10 mg, 25 mg, 50 mg and 75 mg Nortriptyline), for oral administration, contain the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, pregelatinized starch and sodium lauryl sulfate. The 10 mg, 25 mg, 50 mg and 75 mg capsule shells contain: gelatin, methylparaben, propylparaben, sodium lauryl sulfate and titanium dioxide. They may also contain: benzyl alcohol, butylparaben, edentate calcium disodium, silicon dioxide or sodium propionate. The 10 mg, 25 mg and 75 mg capsule shells also contain D&C Yellow No. 10 and FD&C Blue No. 1."
},
{
"NDCCode": "16729-171-10",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (16729-171-10)",
"NDC11Code": "16729-0171-10",
"ProductNDC": "16729-171",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amitriptyline Hydrochloride",
"NonProprietaryName": "Amitriptyline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20141205",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202446",
"LabelerName": "Accord Healthcare Inc.",
"SubstanceName": "AMITRIPTYLINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "17224-171-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (17224-171-30) ",
"NDC11Code": "17224-0171-30",
"ProductNDC": "17224-171",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluoxetine",
"NonProprietaryName": "Fluoxetine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20150316",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204597",
"LabelerName": "Calvin Scott & Co., Inc.",
"SubstanceName": "FLUOXETINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2023-03-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150316",
"SamplePackage": "N",
"IndicationAndUsage": "Fluoxetine is indicated for the treatment of. : 1 Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies (14.1)] . , 2 Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2)] . , 3 Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3)] . , 4 Acute treatment of Panic Disorder, with or without agoraphobia [see Clinical Studies (14.4)] . .",
"Description": "Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N-methyl-3-phenyl-3- [(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of C 17H 18F 3NOHCl. Its molecular weight is 345.79. The structural formula is:. Fluoxetine hydrochloride, USP is a white to off-white crystalline powder with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine. The capsules also contain the following inactive ingredients: pregelatinized starch (maize [corn]), colloidal silicon dioxide, gelatin, sodium lauryl sulphate, FD&C Blue #1, FD&C Red #3, and titanium dioxide. In addition 20 mg capsules also contains D&C Yellow #10 and 10 mg capsules also contains FD&C Yellow #6. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution."
},
{
"NDCCode": "24658-171-30",
"PackageDescription": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (24658-171-30) ",
"NDC11Code": "24658-0171-30",
"ProductNDC": "24658-171",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diltiazem Hydrochloride",
"NonProprietaryName": "Diltiazem Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20161101",
"EndMarketingDate": "20200831",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA020401",
"LabelerName": "PuraCap Laboratories LLC",
"SubstanceName": "DILTIAZEM HYDROCHLORIDE",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20161101",
"EndMarketingDatePackage": "20200831",
"SamplePackage": "N",
"IndicationAndUsage": "Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications.",
"Description": "Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5 H)-one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2, 3-dihydro- 2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol and chloroform and has a molecular weight of 450.98. Diltiazem Hydrochloride extended-release capsules contain diltiazem hydrochloride in extended-release beads at doses of 120, 180, 240, 300, 360 and 420 mg. Diltiazem Hydrochloride extended-release capsules also contains: black iron oxide, D&C Red No. 28, ethyl acrylate and methyl methacrylate copolymer dispersion, FD&C Blue No. 1, FD&C Green No. 3, FD&C Red No. 40, gelatin, hypromellose, magnesium stearate, microcrystalline cellulose, polysorbate, povidone, simethicone, sucrose stearate, talc, and titanium dioxide. For oral administration."
},
{
"NDCCode": "30142-171-01",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (30142-171-01) / 30 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "30142-0171-01",
"ProductNDC": "30142-171",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Infants Gas Relief",
"ProprietaryNameSuffix": "Dye Free",
"NonProprietaryName": "Simethicone Antigas",
"DosageFormName": "EMULSION",
"RouteName": "ORAL",
"StartMarketingDate": "20190716",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M002",
"LabelerName": "THE KROGER CO.",
"SubstanceName": "DIMETHICONE, UNSPECIFIED",
"StrengthNumber": "20",
"StrengthUnit": "mg/.3mL",
"Pharm_Classes": "Skin Barrier Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190716",
"SamplePackage": "N",
"IndicationAndUsage": "Relieves the discomfort of infant gas frequently caused by air swallowing or certain formulas or foods."
},
{
"NDCCode": "33261-171-30",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (33261-171-30)",
"NDC11Code": "33261-0171-30",
"ProductNDC": "33261-171",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hydrochloride",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20071018",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077397",
"LabelerName": "Aidarex Pharmaceuticals LLC",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Major Depressive Disorder– Sertraline hydrochloride is indicated for the treatment of major depressive disorder in adults. The efficacy of Sertraline hydrochloride in the treatment of a major depressive episode was established in six to eight week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III category of major depressive disorder (see Clinical Trials under CLINICAL PHARMACOLOGY). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The antidepressant action of sertraline hydrochloride in hospitalized depressed patients has not been adequately studied. The efficacy of sertraline hydrochloride in maintaining an antidepressant response for up to 44 weeks following 8 weeks of open-label acute treatment (52 weeks total) was demonstrated in a placebo-controlled trial. The usefulness of the drug in patients receiving sertraline hydrochloride for extended periods should be reevaluated periodically (see Clinical Trials under CLINICAL PHARMACOLOGY). Obsessive-Compulsive Disorder– Sertraline hydrochloride is indicated for the treatment of obsessions and compulsions in patients with obsessive-compulsive disorder (OCD), as defined in the DSM-III-R; i.e., the obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning. The efficacy of Sertraline hydrochloride was established in 12-week trials with obsessive-compulsive outpatients having diagnoses of obsessive-compulsive disorder as defined according to DSM-III or DSM-III-R criteria (see Clinical Trials under CLINICAL PHARMACOLOGY). Obsessive-compulsive disorder is characterized by recurrent and persistent ideas, thoughts, impulses, or images (obsessions) that are ego-dystonic and/or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable. The efficacy of Sertraline hydrochloride in maintaining a response, in patients with OCD who responded during a 52-week treatment phase while taking Sertraline hydrochloride and were then observed for relapse during a period of up to 28 weeks, was demonstrated in a placebo-controlled trial (see Clinical Trials under CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use Sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Panic Disorder– Sertraline hydrochloride is indicated for the treatment of panic disorder in adults, with or without agoraphobia, as defined in DSM-IV. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks. The efficacy of Sertraline hydrochloride was established in three 10-12 week trials in adult panic disorder patients whose diagnoses corresponded to the DSM-III-R category of panic disorder (see Clinical Trials under CLINICAL PHARMACOLOGY). Panic disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart, or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded, or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes. The efficacy of Sertraline hydrochloride in maintaining a response, in adult patients with panic disorder who responded during a 52-week treatment phase while taking Sertraline hydrochloride and were then observed for relapse during a period of up to 28 weeks, was demonstrated in a placebo-controlled trial (see Clinical Trials under CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use Sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Posttraumatic Stress Disorder (PTSD)– Sertraline hydrochloride (sertraline hydrochloride) is indicated for the treatment of posttraumatic stress disorder in adults. The efficacy of Sertraline hydrochloride in the treatment of PTSD was established in two 12-week placebo-controlled trials of adult outpatients whose diagnosis met criteria for the DSM-III-R category of PTSD (see Clinical Trials under CLINICAL PHARMACOLOGY). PTSD, as defined by DSM-III-R/IV, requires exposure to a traumatic event that involved actual or threatened death or serious injury, or threat to the physical integrity of self or others, and a response which involves intense fear, helplessness, or horror. Symptoms that occur as a result of exposure to the traumatic event include reexperiencing of the event in the form of intrusive thoughts, flashbacks or dreams, and intense psychological distress and physiological reactivity on exposure to cues to the event; avoidance of situations reminiscent of the traumatic event, inability to recall details of the event, and/or numbing of general responsiveness manifested as diminished interest in significant activities, estrangement from others, restricted range of affect, or sense of foreshortened future; and symptoms of autonomic arousal including hypervigilance, exaggerated startle response, sleep disturbance, impaired concentration, and irritability or outbursts of anger. A PTSD diagnosis requires that the symptoms are present for at least a month and that they cause clinically significant distress or impairment in social, occupational, or other important areas of functioning. The efficacy of Sertraline hydrochloride in maintaining a response in adult patients with PTSD for up to 28 weeks following 24 weeks of open-label treatment was demonstrated in a placebo-controlled trial. Nevertheless, the physician who elects to use Sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Premenstrual Dysphoric Disorder (PMDD) – Sertraline hydrochloride is indicated for the treatment of premenstrual dysphoric disorder (PMDD) in adults. The efficacy of sertraline hydrochloride in the treatment of PMDD was established in 2 placebo-controlled trials of female adult outpatients treated for 3 menstrual cycles who met criteria for the DSM-IIIR/IV category of PMDD (see Clinical Trials under CLINICAL PHARMACOLOGY). The essential features of PMDD include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. Other features include decreased interest in activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. Physical symptoms associated with PMDD include breast tenderness, headache, joint and muscle pain, bloating and weight gain. These symptoms occur regularly during the luteal phase and remit within a few days following onset of menses; the disturbance markedly interferes with work or school or with usual social activities and relationships with others. In making the diagnosis, care should be taken to rule out other cyclical mood disorders that may be exacerbated by treatment with an antidepressant. The effectiveness of Sertraline hydrochloride in long-term use, that is, for more than 3 menstrual cycles, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use Sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Social Anxiety Disorder – Sertraline hydrochloride is indicated for the treatment of social anxiety disorder, also known as social phobia in adults. The efficacy of Sertraline hydrochloride in the treatment of social anxiety disorder was established in two placebo-controlled trials of adult outpatients with a diagnosis of social anxiety disorder as defined by DSM-IV criteria (see Clinical Trials under CLINICAL PHARMACOLOGY). Social anxiety disorder, as defined by DSM-IV, is characterized by marked and persistent fear of social or performance situations involving exposure to unfamiliar people or possible scrutiny by others and by fears of acting in a humiliating or embarrassing way. Exposure to the feared social situation almost always provokes anxiety and feared social or performance situations are avoided or else are endured with intense anxiety or distress. In addition, patients recognize that the fear is excessive or unreasonable and the avoidance and anticipatory anxiety of the feared situation is associated with functional impairment or marked distress. The efficacy of Sertraline hydrochloride in maintaining a response in adult patients with social anxiety disorder for up to 24 weeks following 20 weeks of Sertraline hydrochloride treatment was demonstrated in a placebo-controlled trial. Physicians who prescribe Sertraline hydrochloride for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see Clinical Trials under CLINICAL PHARMACOLOGY).",
"Description": "Sertraline hydrochloride is a selective serotonin reuptake inhibitor (SSRI) for oral administration. It has a molecular weight of 342.7. Sertraline hydrochloride has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula. Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol and sparingly soluble in ethanol. Sertraline hydrochloride is supplied for oral administration as scored tablets containing sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, opadry green (titanium dioxide, hypromellose 3cP, hypromellose 6cP, Macrogol/Peg 400, Polysorbate 80, D&C Yellow # 10 Aluminum Lake, and FD&C Blue # 2/Indigo Carmine Aluminum Lake for 25mg tablet), opadry light blue (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, FD&C Blue # 2/Indigo Carmine Aluminum Lake and Polysorbate 80 for 50 mg tablet), opadry yellow (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, Polysorbate 80, Iron Oxide Yellow, Iron oxide Red for 100mg tablet) and sodium starch glycolate."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>17478-171-30</NDCCode>
<PackageDescription>30 POUCH in 1 CARTON (17478-171-30) > 1 VIAL, SINGLE-DOSE in 1 POUCH (17478-171-01) > .5 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>17478-0171-30</NDC11Code>
<ProductNDC>17478-171</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Xopenex</ProprietaryName>
<NonProprietaryName>Levalbuterol Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20150226</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020837</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>LEVALBUTEROL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1.25</StrengthNumber>
<StrengthUnit>mg/.5mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150226</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>XOPENEX (levalbuterol HCl) Inhalation Solution Concentrate is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease.</IndicationAndUsage>
<Description>XOPENEX Inhalation Solution Concentrate is a sterile, clear, colorless, preservative-free solution of the hydrochloride salt of levalbuterol, the (R)-enantiomer of the drug substance racemic albuterol. Levalbuterol HCl is a relatively selective beta2-adrenergic receptor agonist [see Clinical Pharmacology (12)]. The chemical name for levalbuterol HCl is (R)-α1-[[(1,1-dimethylethyl)amino]methyl]-4-hydroxy-1,3-benzenedimethanol hydrochloride, and its established chemical structure is as follows:. The molecular weight of levalbuterol HCl is 275.8, and its empirical formula is C13H21NO3HCl. It is a white to off-white, crystalline solid, with a melting point of approximately 187°C and solubility of approximately 180 mg/mL in water. Levalbuterol HCl is the USAN modified name for (R)-albuterol HCl in the United States. XOPENEX Inhalation Solution Concentrate is supplied in 0.5 mL unit-dose vials that must be diluted with normal saline before administration by nebulization. Each 0.5 mL unit-dose vial contains 1.25 mg of levalbuterol (as 1.44 mg of levalbuterol HCl), sodium chloride to adjust tonicity, and hydrochloric acid to adjust the pH to 4.0 (3.3 to 4.5).</Description>
</NDC>
<NDC>
<NDCCode>17478-081-30</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (17478-081-30) > 30 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>17478-0081-30</NDC11Code>
<ProductNDC>17478-081</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ropivacaine Hydrochloride</ProprietaryName>
<NonProprietaryName>Ropivacaine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>EPIDURAL; INFILTRATION; PERINEURAL</RouteName>
<StartMarketingDate>20160411</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203955</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>ROPIVACAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160411</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ropivacaine Hydrochloride is indicated for the production of local or regional anesthesia for surgery and for acute pain management. Surgical Anesthesia: epidural block for surgery including cesarean section; major nerve block; local infiltration. Acute Pain Management: epidural continuous infusion or intermittent bolus, eg, postoperative or labor; local infiltration.</IndicationAndUsage>
<Description>Ropivacaine Hydrochloride Injection contains ropivacaine HCl which is a member of the amino amide class of local anesthetics. Ropivacaine Hydrochloride Injection is a sterile, isotonic solution that contains the enantiomerically pure drug substance, sodium chloride for isotonicity and water for injection. Sodium hydroxide and/or hydrochloric acid may be used for pH adjustment. It is administered parenterally. Ropivacaine HCl is chemically described as S‑(‑)‑1‑propyl‑2',6'‑pipecoloxylidide hydrochloride monohydrate. The drug substance is a white crystalline powder, with the following structural formula:. At 25°C ropivacaine HCl has a solubility of 53.8 mg/mL in water, a distribution ratio between n‑octanol and phosphate buffer at pH 7.4 of 14:1 and a pKa of 8.07 in 0.1 M KCl solution. The pKa of ropivacaine is approximately the same as bupivacaine (8.1) and is similar to that of mepivacaine (7.7). However, ropivacaine has an intermediate degree of lipid solubility compared to bupivacaine and mepivacaine. Ropivacaine Hydrochloride Injection is preservative‑free and is available in a single dose container in 5 mg/mL (0.5%) concentration. The specific gravity of Ropivacaine Hydrochloride Injection solutions range from 1.002 to 1.005 at 25°C.</Description>
</NDC>
<NDC>
<NDCCode>17478-107-30</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (17478-107-30) > 30 mL in 1 VIAL</PackageDescription>
<NDC11Code>17478-0107-30</NDC11Code>
<ProductNDC>17478-107</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levofloxacin</ProprietaryName>
<NonProprietaryName>Levofloxacin</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20110701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091644</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>LEVOFLOXACIN</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levofloxacin Injection is indicated for the treatment of adults (≥18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed in this section. Levofloxacin Injection is indicated when intravenous administration offers a route of administration advantageous to the patient (e.g., patient cannot tolerate an oral dosage form).</IndicationAndUsage>
<Description>Levofloxacin Injection is a synthetic broad-spectrum antibacterial agent for intravenous administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid hemihydrate. Figure 1: The Chemical Structure of Levofloxacin. The empirical formula is C18H20FN3O4 ½ H2O and the molecular weight is 370.38. Levofloxacin is a light yellowish-white to yellow-white crystal or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin is essentially constant (approximately 100 mg/mL). Levofloxacin is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9. Levofloxacin has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order: Al+3>Cu+2>Zn+2>Mg+2>Ca+2.</Description>
</NDC>
<NDC>
<NDCCode>17478-114-30</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (17478-114-30) > 30 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>17478-0114-30</NDC11Code>
<ProductNDC>17478-114</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tobramycin</ProprietaryName>
<NonProprietaryName>Tobramycin Sulfate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20140916</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205179</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>TOBRAMYCIN SULFATE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-05-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140916</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>17478-190-30</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (17478-190-30) > 30 g in 1 TUBE</PackageDescription>
<NDC11Code>17478-0190-30</NDC11Code>
<ProductNDC>17478-190</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine And Prilocaine</ProprietaryName>
<NonProprietaryName>Lidocaine And Prilocaine</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20121112</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA019941</ApplicationNumber>
<LabelerName>Akorn, Inc.</LabelerName>
<SubstanceName>LIDOCAINE; PRILOCAINE</SubstanceName>
<StrengthNumber>25; 25</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-09</LastUpdate>
</NDC>
<NDC>
<NDCCode>17478-207-14</NDCCode>
<PackageDescription>30 VIAL, SINGLE-USE in 1 CARTON (17478-207-14) > .4 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>17478-0207-14</NDC11Code>
<ProductNDC>17478-207</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ketorolac Tromethamine</ProprietaryName>
<NonProprietaryName>Ketorolac Tromethamine</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20140210</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203376</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>KETOROLAC TROMETHAMINE</SubstanceName>
<StrengthNumber>4.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-09-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>17478-544-30</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (17478-544-30) / 30 mL in 1 VIAL</PackageDescription>
<NDC11Code>17478-0544-30</NDC11Code>
<ProductNDC>17478-544</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Adenosine</ProprietaryName>
<NonProprietaryName>Adenosine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20141002</StartMarketingDate>
<EndMarketingDate>20240630</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090450</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>ADENOSINE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Adenosine Receptor Agonist [EPC], Adenosine Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-07-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20141002</StartMarketingDatePackage>
<EndMarketingDatePackage>20240630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adenosine injection, USP is indicated as an adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately.</IndicationAndUsage>
<Description>Adenosine is an endogenous nucleoside and is chemically described as 6-amino-9-beta-D-ribofuranosyl-9-H-purine. Adenosine has the following structural formula. The molecular formula for adenosine is C10 H13 N5 O4 and its molecular weight is 267.24. Adenosine is a white crystalline powder. It is soluble in water and practically insoluble in alcohol. Solubility increases by warming and lowering the pH of the solution. Each Adenosine Injection, USP vial contains a sterile, non-pyrogenic solution of adenosine 3 mg/mL and sodium chloride 9 mg/mL in water for injection, with pH between 4.5 and 7.5.</Description>
</NDC>
<NDC>
<NDCCode>17478-604-30</NDCCode>
<PackageDescription>4 POUCH in 1 CARTON (17478-604-30) > 15 VIAL, SINGLE-USE in 1 POUCH (17478-604-01) > .2 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>17478-0604-30</NDC11Code>
<ProductNDC>17478-604</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cosopt Pf</ProprietaryName>
<NonProprietaryName>Dorzolamide Hydrochloride And Timolol Maleate</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20140514</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202667</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>20140514</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>COSOPT® PF is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers (failed to achieve target IOP determined after multiple measurements over time). The IOP-lowering of COSOPT® 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 (14.1)].</IndicationAndUsage>
<Description>COSOPT PF (dorzolamide hydrochloride-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: : 1 [α] 25°C (C=1, water) = ~ -17°. , 2 405 nm .</Description>
</NDC>
<NDC>
<NDCCode>17478-608-30</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (17478-608-30) > 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>17478-0608-30</NDC11Code>
<ProductNDC>17478-608</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bacitracin</ProprietaryName>
<NonProprietaryName>Bacitracin</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20171023</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206719</ApplicationNumber>
<LabelerName>Akorn, Inc.</LabelerName>
<SubstanceName>BACITRACIN A</SubstanceName>
<StrengthNumber>5000</StrengthNumber>
<StrengthUnit>[USP'U]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171023</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>17478-609-30</NDCCode>
<PackageDescription>3 POUCH in 1 CARTON (17478-609-30) > 10 VIAL, SINGLE-USE in 1 POUCH (17478-609-01) > .3 mL in 1 VIAL, SINGLE-USE</PackageDescription>
<NDC11Code>17478-0609-30</NDC11Code>
<ProductNDC>17478-609</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zioptan</ProprietaryName>
<NonProprietaryName>Tafluprost</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20141126</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA202514</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>TAFLUPROST</SubstanceName>
<StrengthNumber>.0045</StrengthNumber>
<StrengthUnit>mg/.3mL</StrengthUnit>
<Pharm_Classes>Increased Prostaglandin Activity [PE], Prostaglandin Analog [EPC], Prostaglandin Receptor Agonists [MoA], Prostaglandins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171126</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ZIOPTAN® (tafluprost ophthalmic solution) 0.0015% is indicated for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.</IndicationAndUsage>
<Description>Tafluprost is a fluorinated analog of prostaglandin F2α. The chemical name for tafluprost is 1-methylethyl (5Z)-7-{(1R, 2R, 3R, 5S)-2-[(1E)-3,3-difluoro-4-phenoxy-1-butenyl}-3,5-dihydroxycyclopentyl]-5-heptenoate. The molecular formula of tafluprost is C25H34F2O5 and its molecular weight is 452.53. Its structural formula is:. Tafluprost is a colorless to light yellow viscous liquid that is practically insoluble in water. ZIOPTAN® (tafluprost ophthalmic solution) 0.0015% is supplied as a sterile solution of tafluprost with a pH range of 5.5 to 6.7 and an Osmolality range of 260 to 300 mOsmo/kg. ZIOPTAN® contains Active: tafluprost 0.015 mg/mL; Inactives: glycerol, sodium dihydrogen phosphate dihydrate, disodium edetate, polysorbate 80, hydrochloric acid and/or sodium hydroxide (to adjust pH) and Water for Injection. ZIOPTAN® does not contain a preservative.</Description>
</NDC>
<NDC>
<NDCCode>17478-660-30</NDCCode>
<PackageDescription>4 VIAL, SINGLE-DOSE in 1 CARTON (17478-660-30) > 30 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>17478-0660-30</NDC11Code>
<ProductNDC>17478-660</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acetylcysteine</ProprietaryName>
<NonProprietaryName>Acetylcysteine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20150325</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203173</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>ACETYLCYSTEINE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Antidote [EPC], Antidote for Acetaminophen Overdose [EPC], Decreased Respiratory Secretion Viscosity [PE], Increased Glutathione Concentration [PE], Mucolytic [EPC], Reduction Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150325</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Acetylcysteine Injection is indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen in patients with acute ingestion or from repeated supratherapeutic ingestion (RSI).</IndicationAndUsage>
<Description>Acetylcysteine injection is an intravenous antidote for the treatment of acetaminophen overdose. Acetylcysteine is the nonproprietary name for the N-acetyl derivative of the naturally occurring amino acid, L-cysteine (N-acetyl-L-cysteine). The compound is a white crystalline powder, which melts in the range of 104° to 110°C and has a very slight odor. The molecular formula of the compound is C5H9NO3S, and its molecular weight is 163.2. Acetylcysteine has the following structural formula:. Acetylcysteine Injection is supplied as a sterile solution in vials containing 20% w/v (200 mg/mL) acetylcysteine. The pH of the solution ranges from 6.0 to 7.5. Acetylcysteine Injection contains the following inactive ingredients: 0.5 mg/mL disodium edetate, sodium hydroxide (used for pH adjustment), and Water for Injection, USP.</Description>
</NDC>
<NDC>
<NDCCode>17478-711-30</NDCCode>
<PackageDescription>1 TUBE, WITH APPLICATOR in 1 CARTON (17478-711-30) > 30 mL in 1 TUBE, WITH APPLICATOR</PackageDescription>
<NDC11Code>17478-0711-30</NDC11Code>
<ProductNDC>17478-711</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine</ProprietaryName>
<NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName>
<DosageFormName>JELLY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20030801</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040433</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20030801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lidocaine HCl 2% Jelly is indicated for prevention and control of pain in procedures involving the male and female urethra, for topical treatment of painful urethritis, and as an anesthetic lubricant for endotracheal intubation (oral and nasal).</IndicationAndUsage>
<Description>Lidocaine HCl 2% Jelly is a sterile aqueous product that contains a local anesthetic agent and is administered topically (see INDICATIONS AND USAGE for specific uses). Lidocaine HCl 2% Jelly contains lidocaine HCl which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the following structural formula:. Its molecular formula is C14H22N2O HCl and its molecular weight is 270.80. Lidocaine HCl 2% Jelly also contains hypromellose, and the resulting mixture maximizes contact with mucosa and provides lubrication for instrumentation. The unused portion should be discarded after initial use. Composition of Lidocaine HCl 2% Jelly 30 mL and 5 mL tubes: Each mL contains 20 mg of lidocaine HCl. The formulation also contains methylparaben, propylparaben, hypromellose, and sodium hydroxide and/or hydrochloric acid to adjust pH to 6.0 to 7.0.</Description>
</NDC>
<NDC>
<NDCCode>17478-768-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (17478-768-30) </PackageDescription>
<NDC11Code>17478-0768-30</NDC11Code>
<ProductNDC>17478-768</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aminocaproic Acid</ProprietaryName>
<NonProprietaryName>Aminocaproic Acid</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190312</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA015197</ApplicationNumber>
<LabelerName>Akorn Operating Company LLC</LabelerName>
<SubstanceName>AMINOCAPROIC ACID</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-10-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190312</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aminocaproic acid is useful in enhancing hemostasis when fibrinolysis contributes to bleeding. In life-threatening situations, transfusion of appropriate blood products and other emergency measures may be required. Fibrinolytic bleeding may frequently be associated with surgical complications following heart surgery (with or without cardiac bypass procedures) and portacaval shunt; hematological disorders such as amegakaryocytic thrombocytopenia (accompanying aplastic anemia); acute and life-threatening abruptio placentae; hepatic cirrhosis; and neoplastic disease such as carcinoma of the prostate, lung, stomach, and cervix. Urinary fibrinolysis, usually a normal physiological phenomenon, may contribute to excessive urinary tract fibrinolytic bleeding associated with surgical hematuria (following prostatectomy and nephrectomy) or nonsurgical hematuria (accompanying polycystic or neoplastic diseases of the genitourinary system). (See Warnings).</IndicationAndUsage>
<Description>Aminocaproic acid is 6-aminohexanoic acid, which acts as an inhibitor of fibrinolysis. Its chemical structure is. Aminocaproic acid is soluble in water, acid, and alkaline solutions; it is sparingly soluble in methanol and practically insoluble in chloroform. Aminocaproic acid oral solution for oral administration, contains 0.25 g/mL of aminocaproic acid with methylparaben 0.20%, propylparaben 0.05%, edetate disodium 0.30% as preservatives and the following inactive ingredients: sodium saccharin, sorbitol solution, citric acid anhydrous, natural and artificial raspberry flavor and an artificial bitterness modifier. Each aminocaproic acid tablet for oral administration contains either 500 mg or 1000 mg of aminocaproic acid and the following inactive ingredients: povidone, crospovidone, stearic acid, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>17478-769-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (17478-769-30) </PackageDescription>
<NDC11Code>17478-0769-30</NDC11Code>
<ProductNDC>17478-769</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aminocaproic Acid</ProprietaryName>
<NonProprietaryName>Aminocaproic Acid</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190312</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA015197</ApplicationNumber>
<LabelerName>Akorn Operating Company LLC</LabelerName>
<SubstanceName>AMINOCAPROIC ACID</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-10-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190312</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aminocaproic acid is useful in enhancing hemostasis when fibrinolysis contributes to bleeding. In life-threatening situations, transfusion of appropriate blood products and other emergency measures may be required. Fibrinolytic bleeding may frequently be associated with surgical complications following heart surgery (with or without cardiac bypass procedures) and portacaval shunt; hematological disorders such as amegakaryocytic thrombocytopenia (accompanying aplastic anemia); acute and life-threatening abruptio placentae; hepatic cirrhosis; and neoplastic disease such as carcinoma of the prostate, lung, stomach, and cervix. Urinary fibrinolysis, usually a normal physiological phenomenon, may contribute to excessive urinary tract fibrinolytic bleeding associated with surgical hematuria (following prostatectomy and nephrectomy) or nonsurgical hematuria (accompanying polycystic or neoplastic diseases of the genitourinary system). (See Warnings).</IndicationAndUsage>
<Description>Aminocaproic acid is 6-aminohexanoic acid, which acts as an inhibitor of fibrinolysis. Its chemical structure is. Aminocaproic acid is soluble in water, acid, and alkaline solutions; it is sparingly soluble in methanol and practically insoluble in chloroform. Aminocaproic acid oral solution for oral administration, contains 0.25 g/mL of aminocaproic acid with methylparaben 0.20%, propylparaben 0.05%, edetate disodium 0.30% as preservatives and the following inactive ingredients: sodium saccharin, sorbitol solution, citric acid anhydrous, natural and artificial raspberry flavor and an artificial bitterness modifier. Each aminocaproic acid tablet for oral administration contains either 500 mg or 1000 mg of aminocaproic acid and the following inactive ingredients: povidone, crospovidone, stearic acid, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>17478-811-30</NDCCode>
<PackageDescription>1 TUBE, WITH APPLICATOR in 1 CARTON (17478-811-30) > 30 mL in 1 TUBE, WITH APPLICATOR</PackageDescription>
<NDC11Code>17478-0811-30</NDC11Code>
<ProductNDC>17478-811</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine</ProprietaryName>
<NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName>
<DosageFormName>JELLY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20030801</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040433</ApplicationNumber>
<LabelerName>Akorn</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-05-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20030801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>17478-840-30</NDCCode>
<PackageDescription>1 TUBE, WITH APPLICATOR in 1 CARTON (17478-840-30) > 30 mL in 1 TUBE, WITH APPLICATOR</PackageDescription>
<NDC11Code>17478-0840-30</NDC11Code>
<ProductNDC>17478-840</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine</ProprietaryName>
<NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName>
<DosageFormName>JELLY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130801</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040433</ApplicationNumber>
<LabelerName>Akorn, Inc.</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>10370-171-11</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BOTTLE (10370-171-11) </PackageDescription>
<NDC11Code>10370-0171-11</NDC11Code>
<ProductNDC>10370-171</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Darifenacin Hydrobromide</ProprietaryName>
<ProprietaryNameSuffix>Extended-release</ProprietaryNameSuffix>
<NonProprietaryName>Darifenacin Hydrobromide</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160315</StartMarketingDate>
<EndMarketingDate>20210228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091190</ApplicationNumber>
<LabelerName>Par Pharmaceutical, Inc.</LabelerName>
<SubstanceName>DARIFENACIN HYDROBROMIDE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-03-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160315</StartMarketingDatePackage>
<EndMarketingDatePackage>20210228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>10544-171-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (10544-171-30)</PackageDescription>
<NDC11Code>10544-0171-30</NDC11Code>
<ProductNDC>10544-171</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atenolol</ProprietaryName>
<NonProprietaryName>Atenolol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077877</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>ATENOLOL</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Atenolol tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including atenolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (eg, on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Atenolol tablets may be administered with other antihypertensive agents.</IndicationAndUsage>
<Description>Atenolol, a synthetic, beta 1-selective (cardioselective) adrenoreceptor blocking agent, may be chemically described as benzeneacetamide, 4 -[2’-hydroxy-3’-[(1- methylethyl) amino] propoxy]-. The molecular formula is C 14H 22N 2O 3 and its structural formula is:. Atenolol (free base) has a molecular weight of 266. It is a relatively polar hydrophilic compound with a water solubility of 26.5 mg/mL at 37° C and a log partition coefficient (octanol/water) of 0.23. It is freely soluble in 1N HCl (300 mg/mL at 25° C) and less soluble in chloroform (3 mg/mL at 25° C). Atenolol tablets, USP are available as 25, 50 and 100 mg tablets for oral administration. Inactive Ingredients: Colloidal silicon dioxide, corn starch, magnesium carbonate, magnesium stearate, sodium lauryl sulfate, sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>10702-171-03</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (10702-171-03) / 30 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>10702-0171-03</NDC11Code>
<ProductNDC>10702-171</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxycodone Hydrochloride</ProprietaryName>
<NonProprietaryName>Oxycodone Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170721</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208593</ApplicationNumber>
<LabelerName>KVK-Tech, Inc.</LabelerName>
<SubstanceName>OXYCODONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170721</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxycodone Hydrochloride Oral Solution is indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg/mL) is indicated for use in opioid-tolerant adult patientswho require higher doses of opioids for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration, and persist over the course of therapy [see Warnings and Precautions (5.2)], reserve opioid analgesics, including Oxycodone Hydrochloride Oral Solution, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.</IndicationAndUsage>
<Description>Oxycodone Hydrochloride Oral Solution, USP is an agonist, available as a red solution 5 mg/5 mL (1 mg/mL) and a yellow solution 100 mg/5 mL (20 mg/mL) for oral administration. The chemical name is (5R,9R,13S,14S)-4, 5α-epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride. The molecular weight is 351.82. Its molecular formula is C 18H 21NO 4 HCl, and it has the following chemical structure. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. It is soluble in water and slightly soluble in alcohol. The inactive ingredients in Oxycodone Hydrochloride Oral Solution, USP 5 mg per 5 mL (1 mg/mL) include: FD&C Red #40 powder, glycerin, hydrochloric acid, maltitol syrup, natural/artificial berry flavor, purified water, sodium benzoate, sorbitol, and sucralose powder. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH. The inactive ingredients in Oxycodone Hydrochloride Oral Solution, USP 100 mg per 5 mL (20 mg/ mL) include: D&C Yellow #10, glycerin, hydrochloric acid, maltitol syrup, natural/artificial berry flavor, purified water, sodium benzoate, sorbitol, and sucralose powder. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>10812-171-01</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, PUMP (10812-171-01) </PackageDescription>
<NDC11Code>10812-0171-01</NDC11Code>
<ProductNDC>10812-171</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Neutrogena Healthy Skin Enhancer</ProprietaryName>
<ProprietaryNameSuffix>Sunscreen Broad Spectrum Spf20 - Neutral To Tan 40</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate, Octisalate, And Titanium Dioxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130524</StartMarketingDate>
<EndMarketingDate>20210331</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Johnson & Johnson Consumer Inc.</LabelerName>
<SubstanceName>OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>70; 30; 51</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20130524</StartMarketingDatePackage>
<EndMarketingDatePackage>20210331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>12634-171-59</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (12634-171-59)</PackageDescription>
<NDC11Code>12634-0171-59</NDC11Code>
<ProductNDC>12634-171</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20081120</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075682</ApplicationNumber>
<LabelerName>Apotheca Inc.</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Carefully consider the potential benefits and risks of Ibuprofentablets and other treatment options before deciding to use Ibuprofen.Use the lowest effective dose for the shortest duration consistent withindividual patient treatment goals (see WARNINGS). IBU tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. IBU tablets are indicated for relief of mild to moderate pain. IBU tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of IBU tablets in children have not been conducted.</IndicationAndUsage>
<Description>IBU tablets contain the active ingredient ibuprofen, which is (±) -2 - ( p - isobutylphenyl) propionic acid. Ibuprofen is a white powde rwith a melting point of 74-77° C and is very slightly soluble in water(<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below:. IBU, a nonsteroidal anti-inflammatory drug (NSAID), is availablein 400 mg, 600 mg, and 800 mg tablets for oral administration.Inactive ingredients: carnauba wax, colloidal silicon dioxide,croscarmellose sodium, hypromellose, magnesium stearate, microcrystallinecellulose, polydextrose, polyethylene glycol, polysorbate,titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>12634-171-71</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (12634-171-71)</PackageDescription>
<NDC11Code>12634-0171-71</NDC11Code>
<ProductNDC>12634-171</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20081120</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075682</ApplicationNumber>
<LabelerName>Apotheca Inc.</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Carefully consider the potential benefits and risks of Ibuprofentablets and other treatment options before deciding to use Ibuprofen.Use the lowest effective dose for the shortest duration consistent withindividual patient treatment goals (see WARNINGS). IBU tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. IBU tablets are indicated for relief of mild to moderate pain. IBU tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of IBU tablets in children have not been conducted.</IndicationAndUsage>
<Description>IBU tablets contain the active ingredient ibuprofen, which is (±) -2 - ( p - isobutylphenyl) propionic acid. Ibuprofen is a white powde rwith a melting point of 74-77° C and is very slightly soluble in water(<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below:. IBU, a nonsteroidal anti-inflammatory drug (NSAID), is availablein 400 mg, 600 mg, and 800 mg tablets for oral administration.Inactive ingredients: carnauba wax, colloidal silicon dioxide,croscarmellose sodium, hypromellose, magnesium stearate, microcrystallinecellulose, polydextrose, polyethylene glycol, polysorbate,titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>13668-171-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (13668-171-30) </PackageDescription>
<NDC11Code>13668-0171-30</NDC11Code>
<ProductNDC>13668-171</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091434</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olanzapine is an atypical antipsychotic indicated. As oral formulation for the. Treatment of schizophrenia. ( 1.1). Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. ( 14.1). Adolescents (ages 13 to 17): Efficacy was established in one 6-week trial in patients with schizophrenia ( 14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. ( 1.1). Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. ( 1.2). Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. ( 14.2). Adolescents (ages 13 to 17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder ( 14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. ( 1.2). Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. ( 1.3). Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. ( 1.2). Efficacy was established in two 6-week clinical trials in adults ( 14.2). Maintenance efficacy has not been systematically evaluated. As Olanzapine and Fluoxetine in Combination for the. Treatment of depressive episodes associated with bipolar I disorder. ( 1.5). Efficacy was established with Symbynax (olanzapine and fluoxetine in combination); refer to the product label for Symbyax. Treatment of treatment resistant depression. ( 1.6). Efficacy was established with Symbyax (olanzapine and fluoxetine in combination) in adults; refer to the product label for Symbyax.</IndicationAndUsage>
<Description>Olanzapine is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)- 10H-thieno[2,3- b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44. The chemical structure is. Olanzapine, USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine tablets, USP are intended for oral administration only. Each tablet contains olanzapine equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol). Inactive ingredients are crospovidone, magnesium stearate, mannitol and microcrystalline cellulose. For olanzapine tablets, USP: Meets USP Dissolution Test 2. Olanzapine orally disintegrating tablets, USP are intended for oral administration only. Each orally disintegrating tablet contains olanzapine equivalent to 5 mg (16 μmol), 10 mg (32 μmol), 15 mg (48 μmol) or 20 mg (64 μmol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. Olanzapine orally disintegrating tablets, USP also contain the following inactive ingredients: aspartame, crospovidone, magnesium stearate, mannitol and microcrystalline cellulose. For olanzapine orally disintegrating tablets, USP: Meets USP Disintegration Test 2.</Description>
</NDC>
<NDC>
<NDCCode>14783-171-02</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (14783-171-02) > 30 g in 1 BOTTLE (14783-171-01) </PackageDescription>
<NDC11Code>14783-0171-02</NDC11Code>
<ProductNDC>14783-171</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Esika Pro Natural Mattifying Foundation Adaptable To Your Skin Tone Spf 20</ProprietaryName>
<ProprietaryNameSuffix>Medio1/beige</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate And Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20181019</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura International LTD</LabelerName>
<SubstanceName>OCTINOXATE; ZINC OXIDE</SubstanceName>
<StrengthNumber>.05; .042</StrengthNumber>
<StrengthUnit>g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181019</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>16590-171-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (16590-171-30)</PackageDescription>
<NDC11Code>16590-0171-30</NDC11Code>
<ProductNDC>16590-171</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nortriptyline Hydrochloride</ProprietaryName>
<NonProprietaryName>Nortriptyline Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19920701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA073554</ApplicationNumber>
<LabelerName>STAT RX USA LLC</LabelerName>
<SubstanceName>NORTRIPTYLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Nortriptyline hydrochloride is indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states.</IndicationAndUsage>
<Description>Nortriptyline hydrochloride is 1-Propanamine, 3-(10,11-dihydro-5H-dibenzo[a,d]cyclohepten-5-ylidene)-N-methyl-, hydrochloride. The structural formula is represented below. C19H21NHCl M.W. 299.84. Nortriptyline Hydrochloride Capsules USP (equivalent to 10 mg, 25 mg, 50 mg and 75 mg Nortriptyline), for oral administration, contain the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, pregelatinized starch and sodium lauryl sulfate. The 10 mg, 25 mg, 50 mg and 75 mg capsule shells contain: gelatin, methylparaben, propylparaben, sodium lauryl sulfate and titanium dioxide. They may also contain: benzyl alcohol, butylparaben, edentate calcium disodium, silicon dioxide or sodium propionate. The 10 mg, 25 mg and 75 mg capsule shells also contain D&C Yellow No. 10 and FD&C Blue No. 1.</Description>
</NDC>
<NDC>
<NDCCode>16729-171-10</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (16729-171-10)</PackageDescription>
<NDC11Code>16729-0171-10</NDC11Code>
<ProductNDC>16729-171</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amitriptyline Hydrochloride</ProprietaryName>
<NonProprietaryName>Amitriptyline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141205</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202446</ApplicationNumber>
<LabelerName>Accord Healthcare Inc.</LabelerName>
<SubstanceName>AMITRIPTYLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>17224-171-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (17224-171-30) </PackageDescription>
<NDC11Code>17224-0171-30</NDC11Code>
<ProductNDC>17224-171</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluoxetine</ProprietaryName>
<NonProprietaryName>Fluoxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150316</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204597</ApplicationNumber>
<LabelerName>Calvin Scott & Co., Inc.</LabelerName>
<SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-03-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150316</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluoxetine is indicated for the treatment of. : 1 Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies (14.1)] . , 2 Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2)] . , 3 Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3)] . , 4 Acute treatment of Panic Disorder, with or without agoraphobia [see Clinical Studies (14.4)] . .</IndicationAndUsage>
<Description>Fluoxetine capsules, USP are a selective serotonin reuptake inhibitor for oral administration. It is designated (±)-N-methyl-3-phenyl-3- [(α,α,α-trifluoro-p-tolyl)oxy]propylamine hydrochloride and has the empirical formula of C 17H 18F 3NOHCl. Its molecular weight is 345.79. The structural formula is:. Fluoxetine hydrochloride, USP is a white to off-white crystalline powder with a solubility of 14 mg/mL in water. Each capsule contains fluoxetine hydrochloride equivalent to 10 mg (32.3 μmol), 20 mg (64.7 μmol), or 40 mg (129.3 μmol) of fluoxetine. The capsules also contain the following inactive ingredients: pregelatinized starch (maize [corn]), colloidal silicon dioxide, gelatin, sodium lauryl sulphate, FD&C Blue #1, FD&C Red #3, and titanium dioxide. In addition 20 mg capsules also contains D&C Yellow #10 and 10 mg capsules also contains FD&C Yellow #6. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>24658-171-30</NDCCode>
<PackageDescription>30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (24658-171-30) </PackageDescription>
<NDC11Code>24658-0171-30</NDC11Code>
<ProductNDC>24658-171</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diltiazem Hydrochloride</ProprietaryName>
<NonProprietaryName>Diltiazem Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161101</StartMarketingDate>
<EndMarketingDate>20200831</EndMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA020401</ApplicationNumber>
<LabelerName>PuraCap Laboratories LLC</LabelerName>
<SubstanceName>DILTIAZEM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>180</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA],Calcium Channel Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20161101</StartMarketingDatePackage>
<EndMarketingDatePackage>20200831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications.</IndicationAndUsage>
<Description>Diltiazem hydrochloride is a calcium ion cellular influx inhibitor (slow channel blocker). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5 H)-one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2, 3-dihydro- 2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol and chloroform and has a molecular weight of 450.98. Diltiazem Hydrochloride extended-release capsules contain diltiazem hydrochloride in extended-release beads at doses of 120, 180, 240, 300, 360 and 420 mg. Diltiazem Hydrochloride extended-release capsules also contains: black iron oxide, D&C Red No. 28, ethyl acrylate and methyl methacrylate copolymer dispersion, FD&C Blue No. 1, FD&C Green No. 3, FD&C Red No. 40, gelatin, hypromellose, magnesium stearate, microcrystalline cellulose, polysorbate, povidone, simethicone, sucrose stearate, talc, and titanium dioxide. For oral administration.</Description>
</NDC>
<NDC>
<NDCCode>30142-171-01</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (30142-171-01) / 30 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>30142-0171-01</NDC11Code>
<ProductNDC>30142-171</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Infants Gas Relief</ProprietaryName>
<ProprietaryNameSuffix>Dye Free</ProprietaryNameSuffix>
<NonProprietaryName>Simethicone Antigas</NonProprietaryName>
<DosageFormName>EMULSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190716</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M002</ApplicationNumber>
<LabelerName>THE KROGER CO.</LabelerName>
<SubstanceName>DIMETHICONE, UNSPECIFIED</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/.3mL</StrengthUnit>
<Pharm_Classes>Skin Barrier Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190716</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Relieves the discomfort of infant gas frequently caused by air swallowing or certain formulas or foods.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>33261-171-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (33261-171-30)</PackageDescription>
<NDC11Code>33261-0171-30</NDC11Code>
<ProductNDC>33261-171</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20071018</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077397</ApplicationNumber>
<LabelerName>Aidarex Pharmaceuticals LLC</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Major Depressive Disorder– Sertraline hydrochloride is indicated for the treatment of major depressive disorder in adults. The efficacy of Sertraline hydrochloride in the treatment of a major depressive episode was established in six to eight week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III category of major depressive disorder (see Clinical Trials under CLINICAL PHARMACOLOGY). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The antidepressant action of sertraline hydrochloride in hospitalized depressed patients has not been adequately studied. The efficacy of sertraline hydrochloride in maintaining an antidepressant response for up to 44 weeks following 8 weeks of open-label acute treatment (52 weeks total) was demonstrated in a placebo-controlled trial. The usefulness of the drug in patients receiving sertraline hydrochloride for extended periods should be reevaluated periodically (see Clinical Trials under CLINICAL PHARMACOLOGY). Obsessive-Compulsive Disorder– Sertraline hydrochloride is indicated for the treatment of obsessions and compulsions in patients with obsessive-compulsive disorder (OCD), as defined in the DSM-III-R; i.e., the obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning. The efficacy of Sertraline hydrochloride was established in 12-week trials with obsessive-compulsive outpatients having diagnoses of obsessive-compulsive disorder as defined according to DSM-III or DSM-III-R criteria (see Clinical Trials under CLINICAL PHARMACOLOGY). Obsessive-compulsive disorder is characterized by recurrent and persistent ideas, thoughts, impulses, or images (obsessions) that are ego-dystonic and/or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable. The efficacy of Sertraline hydrochloride in maintaining a response, in patients with OCD who responded during a 52-week treatment phase while taking Sertraline hydrochloride and were then observed for relapse during a period of up to 28 weeks, was demonstrated in a placebo-controlled trial (see Clinical Trials under CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use Sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Panic Disorder– Sertraline hydrochloride is indicated for the treatment of panic disorder in adults, with or without agoraphobia, as defined in DSM-IV. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks. The efficacy of Sertraline hydrochloride was established in three 10-12 week trials in adult panic disorder patients whose diagnoses corresponded to the DSM-III-R category of panic disorder (see Clinical Trials under CLINICAL PHARMACOLOGY). Panic disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart, or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded, or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes. The efficacy of Sertraline hydrochloride in maintaining a response, in adult patients with panic disorder who responded during a 52-week treatment phase while taking Sertraline hydrochloride and were then observed for relapse during a period of up to 28 weeks, was demonstrated in a placebo-controlled trial (see Clinical Trials under CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use Sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Posttraumatic Stress Disorder (PTSD)– Sertraline hydrochloride (sertraline hydrochloride) is indicated for the treatment of posttraumatic stress disorder in adults. The efficacy of Sertraline hydrochloride in the treatment of PTSD was established in two 12-week placebo-controlled trials of adult outpatients whose diagnosis met criteria for the DSM-III-R category of PTSD (see Clinical Trials under CLINICAL PHARMACOLOGY). PTSD, as defined by DSM-III-R/IV, requires exposure to a traumatic event that involved actual or threatened death or serious injury, or threat to the physical integrity of self or others, and a response which involves intense fear, helplessness, or horror. Symptoms that occur as a result of exposure to the traumatic event include reexperiencing of the event in the form of intrusive thoughts, flashbacks or dreams, and intense psychological distress and physiological reactivity on exposure to cues to the event; avoidance of situations reminiscent of the traumatic event, inability to recall details of the event, and/or numbing of general responsiveness manifested as diminished interest in significant activities, estrangement from others, restricted range of affect, or sense of foreshortened future; and symptoms of autonomic arousal including hypervigilance, exaggerated startle response, sleep disturbance, impaired concentration, and irritability or outbursts of anger. A PTSD diagnosis requires that the symptoms are present for at least a month and that they cause clinically significant distress or impairment in social, occupational, or other important areas of functioning. The efficacy of Sertraline hydrochloride in maintaining a response in adult patients with PTSD for up to 28 weeks following 24 weeks of open-label treatment was demonstrated in a placebo-controlled trial. Nevertheless, the physician who elects to use Sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Premenstrual Dysphoric Disorder (PMDD) – Sertraline hydrochloride is indicated for the treatment of premenstrual dysphoric disorder (PMDD) in adults. The efficacy of sertraline hydrochloride in the treatment of PMDD was established in 2 placebo-controlled trials of female adult outpatients treated for 3 menstrual cycles who met criteria for the DSM-IIIR/IV category of PMDD (see Clinical Trials under CLINICAL PHARMACOLOGY). The essential features of PMDD include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. Other features include decreased interest in activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. Physical symptoms associated with PMDD include breast tenderness, headache, joint and muscle pain, bloating and weight gain. These symptoms occur regularly during the luteal phase and remit within a few days following onset of menses; the disturbance markedly interferes with work or school or with usual social activities and relationships with others. In making the diagnosis, care should be taken to rule out other cyclical mood disorders that may be exacerbated by treatment with an antidepressant. The effectiveness of Sertraline hydrochloride in long-term use, that is, for more than 3 menstrual cycles, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use Sertraline hydrochloride for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Social Anxiety Disorder – Sertraline hydrochloride is indicated for the treatment of social anxiety disorder, also known as social phobia in adults. The efficacy of Sertraline hydrochloride in the treatment of social anxiety disorder was established in two placebo-controlled trials of adult outpatients with a diagnosis of social anxiety disorder as defined by DSM-IV criteria (see Clinical Trials under CLINICAL PHARMACOLOGY). Social anxiety disorder, as defined by DSM-IV, is characterized by marked and persistent fear of social or performance situations involving exposure to unfamiliar people or possible scrutiny by others and by fears of acting in a humiliating or embarrassing way. Exposure to the feared social situation almost always provokes anxiety and feared social or performance situations are avoided or else are endured with intense anxiety or distress. In addition, patients recognize that the fear is excessive or unreasonable and the avoidance and anticipatory anxiety of the feared situation is associated with functional impairment or marked distress. The efficacy of Sertraline hydrochloride in maintaining a response in adult patients with social anxiety disorder for up to 24 weeks following 20 weeks of Sertraline hydrochloride treatment was demonstrated in a placebo-controlled trial. Physicians who prescribe Sertraline hydrochloride for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see Clinical Trials under CLINICAL PHARMACOLOGY).</IndicationAndUsage>
<Description>Sertraline hydrochloride is a selective serotonin reuptake inhibitor (SSRI) for oral administration. It has a molecular weight of 342.7. Sertraline hydrochloride has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C17H17NCl2HCl is represented by the following structural formula. Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol and sparingly soluble in ethanol. Sertraline hydrochloride is supplied for oral administration as scored tablets containing sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, opadry green (titanium dioxide, hypromellose 3cP, hypromellose 6cP, Macrogol/Peg 400, Polysorbate 80, D&C Yellow # 10 Aluminum Lake, and FD&C Blue # 2/Indigo Carmine Aluminum Lake for 25mg tablet), opadry light blue (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, FD&C Blue # 2/Indigo Carmine Aluminum Lake and Polysorbate 80 for 50 mg tablet), opadry yellow (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, Polysorbate 80, Iron Oxide Yellow, Iron oxide Red for 100mg tablet) and sodium starch glycolate.</Description>
</NDC>
</NDCList>