{
"NDC": [
{
"NDCCode": "84756-278-05",
"PackageDescription": "100 mL in 1 BOTTLE (84756-278-05) ",
"NDC11Code": "84756-0278-05",
"ProductNDC": "84756-278",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Trstay Intensive Strength Hair Tonic",
"NonProprietaryName": "Trstay Intensive Strength Hair Tonic",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241104",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M032",
"LabelerName": "Yiwu Luoxin E� Commerce Co Ltd",
"SubstanceName": "MINOXIDIL",
"StrengthNumber": "5",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20241104",
"SamplePackage": "N",
"IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
},
{
"NDCCode": "84756-278-01",
"PackageDescription": "5 mL in 1 BOTTLE (84756-278-01) ",
"NDC11Code": "84756-0278-01",
"ProductNDC": "84756-278",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Trstay Intensive Strength Hair Tonic",
"NonProprietaryName": "Trstay Intensive Strength Hair Tonic",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241104",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M032",
"LabelerName": "Yiwu Luoxin E� Commerce Co Ltd",
"SubstanceName": "MINOXIDIL",
"StrengthNumber": "5",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20241104",
"SamplePackage": "N",
"IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
},
{
"NDCCode": "84756-278-02",
"PackageDescription": "15 mL in 1 BOTTLE (84756-278-02) ",
"NDC11Code": "84756-0278-02",
"ProductNDC": "84756-278",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Trstay Intensive Strength Hair Tonic",
"NonProprietaryName": "Trstay Intensive Strength Hair Tonic",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241104",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M032",
"LabelerName": "Yiwu Luoxin E� Commerce Co Ltd",
"SubstanceName": "MINOXIDIL",
"StrengthNumber": "5",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20241104",
"SamplePackage": "N",
"IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
},
{
"NDCCode": "84756-278-03",
"PackageDescription": "30 mL in 1 BOTTLE (84756-278-03) ",
"NDC11Code": "84756-0278-03",
"ProductNDC": "84756-278",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Trstay Intensive Strength Hair Tonic",
"NonProprietaryName": "Trstay Intensive Strength Hair Tonic",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241104",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M032",
"LabelerName": "Yiwu Luoxin E� Commerce Co Ltd",
"SubstanceName": "MINOXIDIL",
"StrengthNumber": "5",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20241104",
"SamplePackage": "N",
"IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
},
{
"NDCCode": "84756-278-04",
"PackageDescription": "50 mL in 1 BOTTLE (84756-278-04) ",
"NDC11Code": "84756-0278-04",
"ProductNDC": "84756-278",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Trstay Intensive Strength Hair Tonic",
"NonProprietaryName": "Trstay Intensive Strength Hair Tonic",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241104",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M032",
"LabelerName": "Yiwu Luoxin E� Commerce Co Ltd",
"SubstanceName": "MINOXIDIL",
"StrengthNumber": "5",
"StrengthUnit": "g/100mL",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20241104",
"SamplePackage": "N",
"IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
},
{
"NDCCode": "10631-278-05",
"PackageDescription": "140 g in 1 BOTTLE, PLASTIC (10631-278-05)",
"NDC11Code": "10631-0278-05",
"ProductNDC": "10631-278",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Desquam-x Wash",
"NonProprietaryName": "Benzoyl Peroxide",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110426",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333D",
"LabelerName": "Ranbaxy Laboratories Inc.",
"SubstanceName": "BENZOYL PEROXIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2018-03-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "31722-278-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (31722-278-05)",
"NDC11Code": "31722-0278-05",
"ProductNDC": "31722-278",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
"NonProprietaryName": "Topiramate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079162",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Topiramate is indicated for: 1 Monotherapy epilepsy: Initial monotherapy in patients ≥ 2 years of age with partial onset or primary generalized tonic-clonic seizures (1.1)., 2 Adjunctive therapy epilepsy: Adjunctive therapy for adults and pediatric patients (2 to 16 years of age) with partial onset seizures or primary generalized tonic-clonic seizures, and in patients ≥2 years of age with seizures associated with Lennox-Gastaut syndrome (LGS) (1.2).",
"Description": "Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets, USP are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Topiramate, USP is a white crystalline powder with a bitter taste. Topiramate is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate is designated chemically as 2, 3:4, 5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate tablets contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pre-gelatinized starch (maize), sodium starch glycolate, magnesium stearate, opadry white (titanium dioxide, hypromellose 3cp, hypromellose 6cp, PEG 400, polysorbate 80) for 25 mg tablets, opadry yellow (titanium dioxide, hypromellose 3cp, hypromellose 6cp, PEG 400, polysorbate 80, iron oxide yellow) for 50 mg tablets, opadry yellow (hypromellose 3cp, hypromellose 6cp, titanium dioxide, PEG 400, iron oxide yellow, polysorbate 80, iron oxide red) for 100 mg tablets and, opadry pink (titanium dioxide, hypromellose 6cp, PEG 400,iron oxide red) for 200 mg tablets."
},
{
"NDCCode": "51021-278-01",
"PackageDescription": "1 KIT in 1 CARTON (51021-278-01) * 150 mL in 1 BOTTLE, PLASTIC (51021-150-05) * 100 POUCH in 1 BOX (67777-121-14) > .55 mL in 1 POUCH",
"NDC11Code": "51021-0278-01",
"ProductNDC": "51021-278",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vopac Mds - Anti-inflammatory Management Kit With Metered Dose Bottle",
"NonProprietaryName": "Diclofenac Sodium And Isopropyl Alcohol",
"DosageFormName": "KIT",
"StartMarketingDate": "20160401",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203399",
"LabelerName": "Sircle Laboratories, LLC",
"Status": "Deprecated",
"LastUpdate": "2018-02-15",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "54340-278-05",
"PackageDescription": "904 g in 1 CELLO PACK (54340-278-05) ",
"NDC11Code": "54340-0278-05",
"ProductNDC": "54340-278",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dial Antibacterial Bar",
"NonProprietaryName": "Dial White Antibacterial Bar Soap",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170701",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Henkel Corporation",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".1",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20170701",
"SamplePackage": "N"
},
{
"NDCCode": "59651-278-05",
"PackageDescription": "500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (59651-278-05) ",
"NDC11Code": "59651-0278-05",
"ProductNDC": "59651-278",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propafenone Hydrochloride",
"NonProprietaryName": "Propafenone Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20230221",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213096",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "PROPAFENONE HYDROCHLORIDE",
"StrengthNumber": "425",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230221",
"SamplePackage": "N",
"IndicationAndUsage": "Propafenone hydrochloride extended-release capsules are indicated to prolong the time to recurrence of symptomatic atrial fibrillation (AF) in patients with episodic (most likely paroxysmal or persistent) AF who do not have structural heart disease. Usage Considerations: 1 The use of propafenone hydrochloride extended-release capsules in patients with permanent AF or in patients exclusively with atrial flutter or paroxysmal supraventricular tachycardia (PSVT) has not been evaluated. Do not use propafenone hydrochloride extended-release capsules to control ventricular rate during AF., 2 Some patients with atrial flutter treated with propafenone have developed 1:1 conduction, producing an increase in ventricular rate. Concomitant treatment with drugs that increase the functional atrioventricular (AV) nodal refractory period is recommended., 3 The effect of propafenone on mortality has not been determined [see Boxed Warning].",
"Description": "Propafenone hydrochloride is an antiarrhythmic drug supplied in extended-release capsules of 225 mg, 325 mg, and 425 mg for oral administration. Chemically, propafenone hydrochloride is 2’-[2-hydroxy-3-(propylamino)-propoxy]-3- phenylpropiophenone hydrochloride, with a molecular weight of 377.92. The molecular formula is C21H27NO3HCl. Propafenone hydrochloride has some structural similarities to beta-blocking agents. The structural formula of propafenone hydrochloride is given below. Propafenone hydrochloride, USP occurs as white or almost white powder or colorless crystals. It is soluble in methanol and hot water, slightly soluble in 96% ethanol and cold water. Propafenone hydrochloride extended-release capsules USP are filled with 2 mm white to off white round biconvex microtablets containing propafenone and the following inactive ingredients: gelatin, hypromellose, magnesium stearate, polyethylene glycol, red iron oxide, shellac, sodium lauryl sulphate and titanium dioxide."
},
{
"NDCCode": "60429-278-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60429-278-05) ",
"NDC11Code": "60429-0278-05",
"ProductNDC": "60429-278",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Labetalol Hydrochloride",
"NonProprietaryName": "Labetalol Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130416",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075133",
"LabelerName": "Golden State Medical Supply, Inc.",
"SubstanceName": "LABETALOL HYDROCHLORIDE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2020-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20130416",
"SamplePackage": "N"
},
{
"NDCCode": "62559-278-05",
"PackageDescription": "500 TABLET in 1 BOTTLE (62559-278-05) ",
"NDC11Code": "62559-0278-05",
"ProductNDC": "62559-278",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nebivolol",
"NonProprietaryName": "Nebivolol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210917",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203659",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "NEBIVOLOL HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211115",
"SamplePackage": "N",
"IndicationAndUsage": "Nebivolol Tablets are a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1).",
"Description": "The chemical name for the active ingredient in nebivolol tablets is (1RS,1'RS)-1,1'-[(2RS,2'SR)-bis(6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl)]- 2,2'-iminodiethanol hydrochloride. Nebivolol is a racemate composed of d-Nebivolol and l-Nebivolol with the stereochemical designations of [SRRR]-nebivolol and [RSSS]-nebivolol, respectively. Nebivolol's molecular formula is (C22H25F2NO4HCl) with the following structural formula. Nebivolol hydrochloride is a white to almost white powder that is soluble in methanol, dimethylsulfoxide, and N,N-dimethylformamide, sparingly soluble in ethanol, propylene glycol, and polyethylene glycol, and very slightly soluble in hexane, dichloromethane, and methylbenzene. Nebivolol tablets for oral administration contain nebivolol hydrochloride equivalent to 2.5, 5, 10, and 20 mg of nebivolol base. In addition, nebivolol tablets contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, polysorbate 80, and sodium lauryl sulfate."
},
{
"NDCCode": "68428-278-05",
"PackageDescription": "150 PELLET in 1 VIAL, GLASS (68428-278-05) ",
"NDC11Code": "68428-0278-05",
"ProductNDC": "68428-278",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Calcarea Phosphorica",
"NonProprietaryName": "Tribasic Calcium Phosphate",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100203",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "TRIBASIC CALCIUM PHOSPHATE",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-08-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20100203",
"SamplePackage": "N"
},
{
"NDCCode": "23155-141-05",
"PackageDescription": "500 TABLET, DELAYED RELEASE in 1 BOTTLE (23155-141-05) ",
"NDC11Code": "23155-0141-05",
"ProductNDC": "23155-141",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline Hyclate",
"ProprietaryNameSuffix": "Delayed Release",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130430",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200856",
"LabelerName": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Active",
"LastUpdate": "2025-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130430",
"SamplePackage": "N",
"IndicationAndUsage": "Doxycycline hyclate delayed-release tablets are a tetracycline-class drug indicated for: Rickettsial infections (1.1) Sexually transmitted infections (1.2) Respiratory tract infections (1.3) Specific bacterial infections (1.4) Ophthalmic infections (1.5) Anthrax, including inhalational anthrax (post-exposure) (1.6) Alternative treatment for selected infections when penicillin is contraindicated (1.7) Adjunctive therapy in acute intestinal amebiasis and severe acne (1.8) Prophylaxis of malaria (1.9). UsageTo reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate delayed-release tablets, should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1.10).",
"Description": "Doxycycline hyclate delayed-release tablets, USP, contain specially coated pellets of doxycycline hyclate, a tetracycline class drug synthetically derived from oxytetracycline, in a delayed-release formulation for oral administration. The structural formula for doxycycline hyclate is. with a molecular formula of C22H24N2O8, HCl, ½ C2H6O, ½ H2O and a molecular weight of 512.9. The chemical name for doxycycline hyclate is [4S(4aR,5S,5aR,6R,12aS)]-4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-deoxonaphthacene-2-carboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline hyclate is a yellow crystalline powder soluble in water and in solutions of alkali hydroxides and carbonates. Doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each tablet contains doxycycline 75 mg, 100 mg, 150 mg or 200 mg (equivalent to doxycycline hyclate 86.6 mg, 115.4 mg, 173.1 mg or 230.8 mg). Inactive ingredients in the tablet formulation are: lactose monohydrate, microcrystalline cellulose; sodium lauryl sulfate, sodium chloride, hypromellose phthalate, hypromellose, triethyl citrate, anhydrous lactose, crospovidone, stearic acid, magnesium stearate. The tablets also contain opadry 03K29121 clear, which contains: hypromellose and triacetin. Each doxycycline hyclate delayed-release tablets 75 mg tablet contains 4.8 mg (0.208 mEq) of sodium, each doxycycline hyclate delayed-release tablets 100 mg tablet contains 6.4 mg (0.278 mEq) of sodium, each doxycycline hyclate delayed-release tablets 150 mg tablet contains 9.6 mg (0.417 mEq) of sodium, and each doxycycline hyclate delayed-release tablets 200 mg tablet contains 12.8 mg (0.556 mEq) of sodium. USP dissolution test pending."
},
{
"NDCCode": "23155-142-05",
"PackageDescription": "500 TABLET, DELAYED RELEASE in 1 BOTTLE (23155-142-05) ",
"NDC11Code": "23155-0142-05",
"ProductNDC": "23155-142",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline Hyclate",
"ProprietaryNameSuffix": "Delayed Release",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20130430",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200856",
"LabelerName": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Active",
"LastUpdate": "2025-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130430",
"SamplePackage": "N",
"IndicationAndUsage": "Doxycycline hyclate delayed-release tablets are a tetracycline-class drug indicated for: Rickettsial infections (1.1) Sexually transmitted infections (1.2) Respiratory tract infections (1.3) Specific bacterial infections (1.4) Ophthalmic infections (1.5) Anthrax, including inhalational anthrax (post-exposure) (1.6) Alternative treatment for selected infections when penicillin is contraindicated (1.7) Adjunctive therapy in acute intestinal amebiasis and severe acne (1.8) Prophylaxis of malaria (1.9). UsageTo reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate delayed-release tablets, should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1.10).",
"Description": "Doxycycline hyclate delayed-release tablets, USP, contain specially coated pellets of doxycycline hyclate, a tetracycline class drug synthetically derived from oxytetracycline, in a delayed-release formulation for oral administration. The structural formula for doxycycline hyclate is. with a molecular formula of C22H24N2O8, HCl, ½ C2H6O, ½ H2O and a molecular weight of 512.9. The chemical name for doxycycline hyclate is [4S(4aR,5S,5aR,6R,12aS)]-4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-deoxonaphthacene-2-carboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline hyclate is a yellow crystalline powder soluble in water and in solutions of alkali hydroxides and carbonates. Doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each tablet contains doxycycline 75 mg, 100 mg, 150 mg or 200 mg (equivalent to doxycycline hyclate 86.6 mg, 115.4 mg, 173.1 mg or 230.8 mg). Inactive ingredients in the tablet formulation are: lactose monohydrate, microcrystalline cellulose; sodium lauryl sulfate, sodium chloride, hypromellose phthalate, hypromellose, triethyl citrate, anhydrous lactose, crospovidone, stearic acid, magnesium stearate. The tablets also contain opadry 03K29121 clear, which contains: hypromellose and triacetin. Each doxycycline hyclate delayed-release tablets 75 mg tablet contains 4.8 mg (0.208 mEq) of sodium, each doxycycline hyclate delayed-release tablets 100 mg tablet contains 6.4 mg (0.278 mEq) of sodium, each doxycycline hyclate delayed-release tablets 150 mg tablet contains 9.6 mg (0.417 mEq) of sodium, and each doxycycline hyclate delayed-release tablets 200 mg tablet contains 12.8 mg (0.556 mEq) of sodium. USP dissolution test pending."
},
{
"NDCCode": "42571-278-37",
"PackageDescription": "10 kg in 1 DRUM (42571-278-37) ",
"NDC11Code": "42571-0278-37",
"ProductNDC": "42571-278",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Telmisartan",
"DosageFormName": "POWDER",
"StartMarketingDate": "20130921",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Micro Labs Limited",
"SubstanceName": "TELMISARTAN",
"StrengthNumber": "10",
"StrengthUnit": "kg/10kg",
"Status": "Unfinished",
"LastUpdate": "2023-12-05",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "21-SEP-13"
},
{
"NDCCode": "43975-278-10",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43975-278-10) ",
"NDC11Code": "43975-0278-10",
"ProductNDC": "43975-278",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate",
"NonProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200316",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205401",
"LabelerName": "ANI Pharmaceuticals, Inc.",
"SubstanceName": "AMPHETAMINE SULFATE; AMPHETAMINE DL-ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE",
"StrengthNumber": "2.5; 2.5; 2.5; 2.5",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-05-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200316",
"SamplePackage": "N",
"IndicationAndUsage": "Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules, a CNS stimulant, is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older. (1). Limitations of Use. The use of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage. (5.5, 8.4).",
"Description": "Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules contain mixed salts of a single-entity amphetamine, a CNS stimulant. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules contain equal amounts (by weight) of four salts: dextroamphetamine sulfate, amphetamine sulfate, dextroamphetamine saccharate and amphetamine (D,L)-aspartate monohydrate. This results in a 3.1:1 mixture of dextro- to levo- amphetamine base equivalent. The 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg strength extended release capsules are for oral administration. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules contain drug-containing beads, which prolong the release of amphetamine compared to the dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate (immediate-release) tablet formulation. Inactive Ingredients and ColorsThe inactive ingredients in dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules include: hard gelatin capsules, glyceryl monostearate, hypromellose, methacrylic acid copolymer dispersion, microcrystalline cellulose, polysorbate 80, talc, titanium dioxide, triacetin, triethyl citrate, and yellow iron oxide. The hard gelatin capsules contain: gelatin, titanium dioxide and FD&C red #40. The 5 mg, 10 mg, and 15 mg capsules also contain FD&C green #3 and D&C yellow #10. The printing on the capsules uses edible inks containing: shellac, potassium hydroxide and black iron oxide."
},
{
"NDCCode": "46581-210-06",
"PackageDescription": "1 POUCH in 1 BOX (46581-210-06) / 6 PATCH in 1 POUCH",
"NDC11Code": "46581-0210-06",
"ProductNDC": "46581-210",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Salonpas",
"NonProprietaryName": "Camphor, Menthol, Methyl Salicylate",
"DosageFormName": "PATCH",
"RouteName": "PERCUTANEOUS; TOPICAL; TRANSDERMAL",
"StartMarketingDate": "20160517",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Hisamitsu Pharmaceutical Co., Inc.",
"SubstanceName": "CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE",
"StrengthNumber": "86.24; 166.92; 278.2",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Status": "Active",
"LastUpdate": "2024-12-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160517",
"SamplePackage": "N",
"IndicationAndUsage": "For temporary relief of minor aches and pains of muscles and joints associated with: 1 arthritis, 2 simple backache, 3 strains, 4 bruises, 5 sprains."
},
{
"NDCCode": "46708-278-10",
"PackageDescription": "100 CAPSULE, DELAYED RELEASE in 1 CARTON (46708-278-10) ",
"NDC11Code": "46708-0278-10",
"ProductNDC": "46708-278",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine Hydrochloride",
"NonProprietaryName": "Duloxetine",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20140609",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202949",
"LabelerName": "Alembic Pharmaceuticals Limited",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-05-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140609",
"SamplePackage": "N",
"IndicationAndUsage": "Duloxetine delayed-release capsules are indicated for the treatment of: : 1 Major depressive disorder in adults , 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older , 3 Diabetic peripheral neuropathic pain in adults , 4 Fibromyalgia in adults , 5 Chronic musculoskeletal pain in adults.",
"Description": "Duloxetine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydochloride USP is a white to off-white powder, which is freely soluble in methanol and slightly soluble in water. Each capsule contains enteric-coated pellets of 20, 30 and 60 mg of duloxetine (equivalent to 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include sugar spheres, hypromellose, talc, sucrose, hypromellose phthalate, triethyl citrate, FD&C Blue No. 2, titanium dioxide, gelatin, sodium lauryl sulfate. The 20 and 60 mg capsules also contain iron oxide yellow. Ink contains following ingredients. 20 mg: shellac, black iron oxide, potassium hydroxide, propylene glycol and strong ammonia solution. 30 mg: shellac, titanium dioxide, yellow iron oxide, FD&C Blue No. 2 Aluminum Lake, propylene glycol and strong ammonia solution 60 mg: shellac, potassium hydroxide, titanium dioxide, propylene glycol and strong ammonia solution."
},
{
"NDCCode": "46708-278-30",
"PackageDescription": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-278-30) ",
"NDC11Code": "46708-0278-30",
"ProductNDC": "46708-278",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine Hydrochloride",
"NonProprietaryName": "Duloxetine",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20140609",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202949",
"LabelerName": "Alembic Pharmaceuticals Limited",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140609",
"SamplePackage": "N",
"IndicationAndUsage": "Duloxetine delayed-release capsules are indicated for the treatment of: : 1 Major depressive disorder in adults , 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older , 3 Diabetic peripheral neuropathic pain in adults , 4 Fibromyalgia in adults , 5 Chronic musculoskeletal pain in adults.",
"Description": "Duloxetine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydochloride USP is a white to off-white powder, which is freely soluble in methanol and slightly soluble in water. Each capsule contains enteric-coated pellets of 20, 30 and 60 mg of duloxetine (equivalent to 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include ascorbic acid, FD&C Blue No. 2, gelatin, hypromellose, hypromellose phthalate, talc, titanium dioxide, triethyl citrate, sodium lauryl sulfate, sucrose and sugar spheres. The 20 and 60 mg capsules also contain iron oxide yellow. Ink contains following ingredients. 20 mg: black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. 30 mg: FD&C Blue No. 2 Aluminum Lake, propylene glycol, shellac, strong ammonia solution, titanium dioxide and yellow iron oxide. 60 mg: potassium hydroxide, propylene glycol, shellac, strong ammonia solution and titanium dioxide."
},
{
"NDCCode": "46708-278-60",
"PackageDescription": "60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-278-60) ",
"NDC11Code": "46708-0278-60",
"ProductNDC": "46708-278",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine Hydrochloride",
"NonProprietaryName": "Duloxetine",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20140609",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202949",
"LabelerName": "Alembic Pharmaceuticals Limited",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140609",
"SamplePackage": "N",
"IndicationAndUsage": "Duloxetine delayed-release capsules are indicated for the treatment of: : 1 Major depressive disorder in adults , 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older , 3 Diabetic peripheral neuropathic pain in adults , 4 Fibromyalgia in adults , 5 Chronic musculoskeletal pain in adults.",
"Description": "Duloxetine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydochloride USP is a white to off-white powder, which is freely soluble in methanol and slightly soluble in water. Each capsule contains enteric-coated pellets of 20, 30 and 60 mg of duloxetine (equivalent to 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include ascorbic acid, FD&C Blue No. 2, gelatin, hypromellose, hypromellose phthalate, talc, titanium dioxide, triethyl citrate, sodium lauryl sulfate, sucrose and sugar spheres. The 20 and 60 mg capsules also contain iron oxide yellow. Ink contains following ingredients. 20 mg: black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. 30 mg: FD&C Blue No. 2 Aluminum Lake, propylene glycol, shellac, strong ammonia solution, titanium dioxide and yellow iron oxide. 60 mg: potassium hydroxide, propylene glycol, shellac, strong ammonia solution and titanium dioxide."
},
{
"NDCCode": "46708-278-90",
"PackageDescription": "90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-278-90) ",
"NDC11Code": "46708-0278-90",
"ProductNDC": "46708-278",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine Hydrochloride",
"NonProprietaryName": "Duloxetine",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20140609",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202949",
"LabelerName": "Alembic Pharmaceuticals Limited",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140609",
"SamplePackage": "N",
"IndicationAndUsage": "Duloxetine delayed-release capsules are indicated for the treatment of: : 1 Major depressive disorder in adults , 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older , 3 Diabetic peripheral neuropathic pain in adults , 4 Fibromyalgia in adults , 5 Chronic musculoskeletal pain in adults.",
"Description": "Duloxetine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydochloride USP is a white to off-white powder, which is freely soluble in methanol and slightly soluble in water. Each capsule contains enteric-coated pellets of 20, 30 and 60 mg of duloxetine (equivalent to 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include ascorbic acid, FD&C Blue No. 2, gelatin, hypromellose, hypromellose phthalate, talc, titanium dioxide, triethyl citrate, sodium lauryl sulfate, sucrose and sugar spheres. The 20 and 60 mg capsules also contain iron oxide yellow. Ink contains following ingredients. 20 mg: black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. 30 mg: FD&C Blue No. 2 Aluminum Lake, propylene glycol, shellac, strong ammonia solution, titanium dioxide and yellow iron oxide. 60 mg: potassium hydroxide, propylene glycol, shellac, strong ammonia solution and titanium dioxide."
},
{
"NDCCode": "46708-278-91",
"PackageDescription": "1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-278-91) ",
"NDC11Code": "46708-0278-91",
"ProductNDC": "46708-278",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duloxetine Hydrochloride",
"NonProprietaryName": "Duloxetine",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20140609",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202949",
"LabelerName": "Alembic Pharmaceuticals Limited",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260409",
"SamplePackage": "N",
"IndicationAndUsage": "Duloxetine delayed-release capsules are indicated for the treatment of: : 1 Major depressive disorder in adults , 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older , 3 Diabetic peripheral neuropathic pain in adults , 4 Fibromyalgia in adults , 5 Chronic musculoskeletal pain in adults.",
"Description": "Duloxetine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydochloride USP is a white to off-white powder, which is freely soluble in methanol and slightly soluble in water. Each capsule contains enteric-coated pellets of 20, 30 and 60 mg of duloxetine (equivalent to 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include ascorbic acid, FD&C Blue No. 2, gelatin, hypromellose, hypromellose phthalate, talc, titanium dioxide, triethyl citrate, sodium lauryl sulfate, sucrose and sugar spheres. The 20 and 60 mg capsules also contain iron oxide yellow. Ink contains following ingredients. 20 mg: black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. 30 mg: FD&C Blue No. 2 Aluminum Lake, propylene glycol, shellac, strong ammonia solution, titanium dioxide and yellow iron oxide. 60 mg: potassium hydroxide, propylene glycol, shellac, strong ammonia solution and titanium dioxide."
},
{
"NDCCode": "49281-016-50",
"PackageDescription": "10 SYRINGE, GLASS in 1 PACKAGE (49281-016-50) / .5 mL in 1 SYRINGE, GLASS (49281-016-88) ",
"NDC11Code": "49281-0016-50",
"ProductNDC": "49281-016",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Fluzone Hd Tiv Sh 2026",
"NonProprietaryName": "Influenza A Virus A/switzerland/6849/2025 Ivr-278 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/singapore/gp20238/2024 Ivr-277 (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20260220",
"EndMarketingDate": "20261231",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103914",
"LabelerName": "Sanofi Vaccines US Inc.",
"SubstanceName": "INFLUENZA A VIRUS A/SWITZERLAND/6849/2025 IVR-278 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/SINGAPORE/GP20238/2024 IVR-277 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED)",
"StrengthNumber": "60; 60; 60",
"StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL",
"Status": "Active",
"LastUpdate": "2026-05-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20260220",
"EndMarketingDatePackage": "20261231",
"SamplePackage": "N",
"IndicationAndUsage": "Fluzone® High-Dose Southern Hemisphere is a vaccine indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B virus contained in the vaccine. Fluzone High-Dose Southern Hemisphere is approved for use in persons 65 years of age and older.",
"Description": "Fluzone High-Dose Southern Hemisphere (Influenza Vaccine) for intramuscular use is an inactivated influenza vaccine, prepared from influenza viruses propagated in embryonated chicken eggs. The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. Influenza virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. The virus is then chemically disrupted using a non-ionic surfactant, octylphenol ethoxylate (Triton® X-100), producing a \"split virus\". The split virus containing hemagglutinin (HA) antigen is further purified and then suspended in sodium phosphate-buffered isotonic sodium chloride solution. The Fluzone High-Dose Southern Hemisphere process uses an additional concentration factor after the ultrafiltration step to obtain a higher HA antigen concentration. The purified split virus from the three strains included in the vaccine are produced separately and then combined to make the trivalent formulation. Fluzone High-Dose Southern Hemisphere is an injectable suspension and is a colorless opalescent liquid. Neither antibiotics nor preservative are used in the manufacture of Fluzone High-Dose Southern Hemisphere. The Fluzone High-Dose Southern Hemisphere prefilled syringe presentation is not made with natural rubber latex. Fluzone High-Dose Southern Hemisphere is standardized according to United States Public Health Service requirements and is formulated to contain HA of each of the following three influenza strains recommended for the 2026 influenza season: A/Switzerland/6849/2025 IVR-278 (A/Missouri/11/2025 pdm09-like virus) (H1N1), A/Singapore/GP20238/2024 IVR-277 (H3N2), and B/Michigan/01/2021 (a B/Austria/1359417/2021-like virus, B Victoria lineage). The amounts of HA and other ingredients per dose of vaccine are listed in Table 2."
},
{
"NDCCode": "49281-315-15",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 PACKAGE (49281-315-15) / 5 mL in 1 VIAL, MULTI-DOSE (49281-315-78) ",
"NDC11Code": "49281-0315-15",
"ProductNDC": "49281-315",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Fluzone Tiv Sh 2026",
"NonProprietaryName": "Influenza A Virus A/switzerland/6849/2025 Ivr-278 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/singapore/gp20238/2024 Ivr-277 (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20260220",
"EndMarketingDate": "20261231",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103914",
"LabelerName": "Sanofi Vaccines US Inc.",
"SubstanceName": "INFLUENZA A VIRUS A/SWITZERLAND/6849/2025 IVR-278 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/SINGAPORE/GP20238/2024 IVR-277 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED)",
"StrengthNumber": "15; 15; 15",
"StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL",
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"LastUpdate": "2026-05-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"EndMarketingDatePackage": "20261231",
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"IndicationAndUsage": "Fluzone® Southern Hemisphere is a vaccine indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B virus contained in the vaccine. Fluzone Southern Hemisphere is approved for use in persons 6 months of age and older.",
"Description": "Fluzone Southern Hemisphere (Influenza Vaccine) for intramuscular use is an inactivated influenza vaccine, prepared from influenza viruses propagated in embryonated chicken eggs. The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. Influenza virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. The virus is then chemically disrupted using a non-ionic surfactant, octylphenol ethoxylate (Triton® X-100), producing a \"split virus\". The split virus containing hemagglutinin (HA) antigen is further purified and then suspended in sodium phosphate-buffered isotonic sodium chloride solution. The purified split virus from the three strains included in the vaccine are produced separately and then combined to make the trivalent formulation. Fluzone Southern Hemisphere is an injectable suspension and is clear and slightly opalescent in color. Antibiotics are not used in the manufacture of Fluzone Southern Hemisphere. No presentation of Fluzone Southern Hemisphere is made with natural rubber latex. Fluzone Southern Hemisphere is standardized according to United States Public Health Service requirements and is formulated to contain HA of each of the following three influenza strains recommended for the 2026-Southern Hemisphere influenza season: A/Switzerland/6849/2025 IVR-278 (A/Missouri/11/2025 pdm09-like virus) (H1N1), A/Singapore/GP20238/2024 IVR-277 (H3N2), and B/Michigan/01/2021 (a B/Austria/1359417/2021-like virus, B Victoria lineage). The amounts of HA and other ingredients per dose of vaccine are listed in Table 9. The 0.5 mL single-dose, pre-filled syringe presentation is manufactured and formulated without thimerosal or any other preservative. The 5 mL multi-dose vial presentation contains thimerosal, a mercury derivative, added as a preservative. Each 0.5 mL dose from the multi-dose vial contains 25 mcg mercury. Each 0.25 mL dose from the multi-dose vial contains 12.5 mcg mercury."
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{
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"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20260220",
"EndMarketingDate": "20261231",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103914",
"LabelerName": "Sanofi Vaccines US Inc.",
"SubstanceName": "INFLUENZA A VIRUS A/SWITZERLAND/6849/2025 IVR-278 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/SINGAPORE/GP20238/2024 IVR-277 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED)",
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"StrengthUnit": "ug/.5mL; ug/.5mL; ug/.5mL",
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"SamplePackage": "N",
"IndicationAndUsage": "Fluzone® Southern Hemisphere is a vaccine indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B virus contained in the vaccine. Fluzone Southern Hemisphere is approved for use in persons 6 months of age and older.",
"Description": "Fluzone Southern Hemisphere (Influenza Vaccine) for intramuscular use is an inactivated influenza vaccine, prepared from influenza viruses propagated in embryonated chicken eggs. The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. Influenza virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. The virus is then chemically disrupted using a non-ionic surfactant, octylphenol ethoxylate (Triton® X-100), producing a \"split virus\". The split virus containing hemagglutinin (HA) antigen is further purified and then suspended in sodium phosphate-buffered isotonic sodium chloride solution. The purified split virus from the three strains included in the vaccine are produced separately and then combined to make the trivalent formulation. Fluzone Southern Hemisphere is an injectable suspension and is clear and slightly opalescent in color. Antibiotics are not used in the manufacture of Fluzone Southern Hemisphere. No presentation of Fluzone Southern Hemisphere is made with natural rubber latex. Fluzone Southern Hemisphere is standardized according to United States Public Health Service requirements and is formulated to contain HA of each of the following three influenza strains recommended for the 2026-Southern Hemisphere influenza season: A/Switzerland/6849/2025 IVR-278 (A/Missouri/11/2025 pdm09-like virus) (H1N1), A/Singapore/GP20238/2024 IVR-277 (H3N2), and B/Michigan/01/2021 (a B/Austria/1359417/2021-like virus, B Victoria lineage). The amounts of HA and other ingredients per dose of vaccine are listed in Table 9. The 0.5 mL single-dose, pre-filled syringe presentation is manufactured and formulated without thimerosal or any other preservative. The 5 mL multi-dose vial presentation contains thimerosal, a mercury derivative, added as a preservative. Each 0.5 mL dose from the multi-dose vial contains 25 mcg mercury. Each 0.25 mL dose from the multi-dose vial contains 12.5 mcg mercury."
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{
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"Description": "Duloxetine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride USP is a white to off-white powder, which is freely soluble in methanol and slightly soluble in water. Each capsule contains enteric-coated pellets of 20, 30 and 60 mg of duloxetine (equivalent to 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include ascorbic acid, FD&C Blue No. 2, gelatin, hypromellose, hypromellose phthalate, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide and triethyl citrate. The 20 and 60 mg capsules also contain iron oxide yellow. Ink contains following ingredients. 20 mg: black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. 30 mg: FD&C Blue No. 2 Aluminum Lake, propylene glycol, shellac, strong ammonia solution, titanium dioxide and yellow iron oxide. 60 mg: potassium hydroxide, propylene glycol, shellac, strong ammonia solution and titanium dioxide."
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{
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{
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{
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"ProductNDC": "62332-278",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"LabelerName": "Alembic Pharmaceuticals Inc.",
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"PackageNdcExcludeFlag": "N",
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}
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<Status>Deprecated</Status>
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<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
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<ProductNDC>10631-278</ProductNDC>
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<ProprietaryName>Desquam-x Wash</ProprietaryName>
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<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
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<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-03-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
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<NDC>
<NDCCode>31722-278-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (31722-278-05)</PackageDescription>
<NDC11Code>31722-0278-05</NDC11Code>
<ProductNDC>31722-278</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Topiramate</ProprietaryName>
<NonProprietaryName>Topiramate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079162</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>TOPIRAMATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Topiramate is indicated for: 1 Monotherapy epilepsy: Initial monotherapy in patients ≥ 2 years of age with partial onset or primary generalized tonic-clonic seizures (1.1)., 2 Adjunctive therapy epilepsy: Adjunctive therapy for adults and pediatric patients (2 to 16 years of age) with partial onset seizures or primary generalized tonic-clonic seizures, and in patients ≥2 years of age with seizures associated with Lennox-Gastaut syndrome (LGS) (1.2).</IndicationAndUsage>
<Description>Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets, USP are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. Topiramate, USP is a white crystalline powder with a bitter taste. Topiramate is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.36. Topiramate is designated chemically as 2, 3:4, 5-Di-O-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula. Topiramate tablets contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pre-gelatinized starch (maize), sodium starch glycolate, magnesium stearate, opadry white (titanium dioxide, hypromellose 3cp, hypromellose 6cp, PEG 400, polysorbate 80) for 25 mg tablets, opadry yellow (titanium dioxide, hypromellose 3cp, hypromellose 6cp, PEG 400, polysorbate 80, iron oxide yellow) for 50 mg tablets, opadry yellow (hypromellose 3cp, hypromellose 6cp, titanium dioxide, PEG 400, iron oxide yellow, polysorbate 80, iron oxide red) for 100 mg tablets and, opadry pink (titanium dioxide, hypromellose 6cp, PEG 400,iron oxide red) for 200 mg tablets.</Description>
</NDC>
<NDC>
<NDCCode>51021-278-01</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (51021-278-01) * 150 mL in 1 BOTTLE, PLASTIC (51021-150-05) * 100 POUCH in 1 BOX (67777-121-14) > .55 mL in 1 POUCH</PackageDescription>
<NDC11Code>51021-0278-01</NDC11Code>
<ProductNDC>51021-278</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vopac Mds - Anti-inflammatory Management Kit With Metered Dose Bottle</ProprietaryName>
<NonProprietaryName>Diclofenac Sodium And Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20160401</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203399</ApplicationNumber>
<LabelerName>Sircle Laboratories, LLC</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2018-02-15</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>54340-278-05</NDCCode>
<PackageDescription>904 g in 1 CELLO PACK (54340-278-05) </PackageDescription>
<NDC11Code>54340-0278-05</NDC11Code>
<ProductNDC>54340-278</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dial Antibacterial Bar</ProprietaryName>
<NonProprietaryName>Dial White Antibacterial Bar Soap</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170701</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Henkel Corporation</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>59651-278-05</NDCCode>
<PackageDescription>500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (59651-278-05) </PackageDescription>
<NDC11Code>59651-0278-05</NDC11Code>
<ProductNDC>59651-278</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propafenone Hydrochloride</ProprietaryName>
<NonProprietaryName>Propafenone Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230221</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213096</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>PROPAFENONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>425</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Propafenone hydrochloride extended-release capsules are indicated to prolong the time to recurrence of symptomatic atrial fibrillation (AF) in patients with episodic (most likely paroxysmal or persistent) AF who do not have structural heart disease. Usage Considerations: 1 The use of propafenone hydrochloride extended-release capsules in patients with permanent AF or in patients exclusively with atrial flutter or paroxysmal supraventricular tachycardia (PSVT) has not been evaluated. Do not use propafenone hydrochloride extended-release capsules to control ventricular rate during AF., 2 Some patients with atrial flutter treated with propafenone have developed 1:1 conduction, producing an increase in ventricular rate. Concomitant treatment with drugs that increase the functional atrioventricular (AV) nodal refractory period is recommended., 3 The effect of propafenone on mortality has not been determined [see Boxed Warning].</IndicationAndUsage>
<Description>Propafenone hydrochloride is an antiarrhythmic drug supplied in extended-release capsules of 225 mg, 325 mg, and 425 mg for oral administration. Chemically, propafenone hydrochloride is 2’-[2-hydroxy-3-(propylamino)-propoxy]-3- phenylpropiophenone hydrochloride, with a molecular weight of 377.92. The molecular formula is C21H27NO3HCl. Propafenone hydrochloride has some structural similarities to beta-blocking agents. The structural formula of propafenone hydrochloride is given below. Propafenone hydrochloride, USP occurs as white or almost white powder or colorless crystals. It is soluble in methanol and hot water, slightly soluble in 96% ethanol and cold water. Propafenone hydrochloride extended-release capsules USP are filled with 2 mm white to off white round biconvex microtablets containing propafenone and the following inactive ingredients: gelatin, hypromellose, magnesium stearate, polyethylene glycol, red iron oxide, shellac, sodium lauryl sulphate and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>60429-278-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60429-278-05) </PackageDescription>
<NDC11Code>60429-0278-05</NDC11Code>
<ProductNDC>60429-278</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Labetalol Hydrochloride</ProprietaryName>
<NonProprietaryName>Labetalol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130416</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075133</ApplicationNumber>
<LabelerName>Golden State Medical Supply, Inc.</LabelerName>
<SubstanceName>LABETALOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130416</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62559-278-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (62559-278-05) </PackageDescription>
<NDC11Code>62559-0278-05</NDC11Code>
<ProductNDC>62559-278</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nebivolol</ProprietaryName>
<NonProprietaryName>Nebivolol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210917</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203659</ApplicationNumber>
<LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>NEBIVOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nebivolol Tablets are a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1).</IndicationAndUsage>
<Description>The chemical name for the active ingredient in nebivolol tablets is (1RS,1'RS)-1,1'-[(2RS,2'SR)-bis(6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl)]- 2,2'-iminodiethanol hydrochloride. Nebivolol is a racemate composed of d-Nebivolol and l-Nebivolol with the stereochemical designations of [SRRR]-nebivolol and [RSSS]-nebivolol, respectively. Nebivolol's molecular formula is (C22H25F2NO4HCl) with the following structural formula. Nebivolol hydrochloride is a white to almost white powder that is soluble in methanol, dimethylsulfoxide, and N,N-dimethylformamide, sparingly soluble in ethanol, propylene glycol, and polyethylene glycol, and very slightly soluble in hexane, dichloromethane, and methylbenzene. Nebivolol tablets for oral administration contain nebivolol hydrochloride equivalent to 2.5, 5, 10, and 20 mg of nebivolol base. In addition, nebivolol tablets contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, polysorbate 80, and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
<NDCCode>68428-278-05</NDCCode>
<PackageDescription>150 PELLET in 1 VIAL, GLASS (68428-278-05) </PackageDescription>
<NDC11Code>68428-0278-05</NDC11Code>
<ProductNDC>68428-278</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Calcarea Phosphorica</ProprietaryName>
<NonProprietaryName>Tribasic Calcium Phosphate</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100203</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>TRIBASIC CALCIUM PHOSPHATE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-08-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>23155-141-05</NDCCode>
<PackageDescription>500 TABLET, DELAYED RELEASE in 1 BOTTLE (23155-141-05) </PackageDescription>
<NDC11Code>23155-0141-05</NDC11Code>
<ProductNDC>23155-141</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline Hyclate</ProprietaryName>
<ProprietaryNameSuffix>Delayed Release</ProprietaryNameSuffix>
<NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130430</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200856</ApplicationNumber>
<LabelerName>Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.</LabelerName>
<SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxycycline hyclate delayed-release tablets are a tetracycline-class drug indicated for: Rickettsial infections (1.1) Sexually transmitted infections (1.2) Respiratory tract infections (1.3) Specific bacterial infections (1.4) Ophthalmic infections (1.5) Anthrax, including inhalational anthrax (post-exposure) (1.6) Alternative treatment for selected infections when penicillin is contraindicated (1.7) Adjunctive therapy in acute intestinal amebiasis and severe acne (1.8) Prophylaxis of malaria (1.9). UsageTo reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate delayed-release tablets, should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1.10).</IndicationAndUsage>
<Description>Doxycycline hyclate delayed-release tablets, USP, contain specially coated pellets of doxycycline hyclate, a tetracycline class drug synthetically derived from oxytetracycline, in a delayed-release formulation for oral administration. The structural formula for doxycycline hyclate is. with a molecular formula of C22H24N2O8, HCl, ½ C2H6O, ½ H2O and a molecular weight of 512.9. The chemical name for doxycycline hyclate is [4S(4aR,5S,5aR,6R,12aS)]-4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-deoxonaphthacene-2-carboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline hyclate is a yellow crystalline powder soluble in water and in solutions of alkali hydroxides and carbonates. Doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each tablet contains doxycycline 75 mg, 100 mg, 150 mg or 200 mg (equivalent to doxycycline hyclate 86.6 mg, 115.4 mg, 173.1 mg or 230.8 mg). Inactive ingredients in the tablet formulation are: lactose monohydrate, microcrystalline cellulose; sodium lauryl sulfate, sodium chloride, hypromellose phthalate, hypromellose, triethyl citrate, anhydrous lactose, crospovidone, stearic acid, magnesium stearate. The tablets also contain opadry 03K29121 clear, which contains: hypromellose and triacetin. Each doxycycline hyclate delayed-release tablets 75 mg tablet contains 4.8 mg (0.208 mEq) of sodium, each doxycycline hyclate delayed-release tablets 100 mg tablet contains 6.4 mg (0.278 mEq) of sodium, each doxycycline hyclate delayed-release tablets 150 mg tablet contains 9.6 mg (0.417 mEq) of sodium, and each doxycycline hyclate delayed-release tablets 200 mg tablet contains 12.8 mg (0.556 mEq) of sodium. USP dissolution test pending.</Description>
</NDC>
<NDC>
<NDCCode>23155-142-05</NDCCode>
<PackageDescription>500 TABLET, DELAYED RELEASE in 1 BOTTLE (23155-142-05) </PackageDescription>
<NDC11Code>23155-0142-05</NDC11Code>
<ProductNDC>23155-142</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline Hyclate</ProprietaryName>
<ProprietaryNameSuffix>Delayed Release</ProprietaryNameSuffix>
<NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130430</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200856</ApplicationNumber>
<LabelerName>Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.</LabelerName>
<SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130430</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxycycline hyclate delayed-release tablets are a tetracycline-class drug indicated for: Rickettsial infections (1.1) Sexually transmitted infections (1.2) Respiratory tract infections (1.3) Specific bacterial infections (1.4) Ophthalmic infections (1.5) Anthrax, including inhalational anthrax (post-exposure) (1.6) Alternative treatment for selected infections when penicillin is contraindicated (1.7) Adjunctive therapy in acute intestinal amebiasis and severe acne (1.8) Prophylaxis of malaria (1.9). UsageTo reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate delayed-release tablets, should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (1.10).</IndicationAndUsage>
<Description>Doxycycline hyclate delayed-release tablets, USP, contain specially coated pellets of doxycycline hyclate, a tetracycline class drug synthetically derived from oxytetracycline, in a delayed-release formulation for oral administration. The structural formula for doxycycline hyclate is. with a molecular formula of C22H24N2O8, HCl, ½ C2H6O, ½ H2O and a molecular weight of 512.9. The chemical name for doxycycline hyclate is [4S(4aR,5S,5aR,6R,12aS)]-4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-deoxonaphthacene-2-carboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline hyclate is a yellow crystalline powder soluble in water and in solutions of alkali hydroxides and carbonates. Doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each tablet contains doxycycline 75 mg, 100 mg, 150 mg or 200 mg (equivalent to doxycycline hyclate 86.6 mg, 115.4 mg, 173.1 mg or 230.8 mg). Inactive ingredients in the tablet formulation are: lactose monohydrate, microcrystalline cellulose; sodium lauryl sulfate, sodium chloride, hypromellose phthalate, hypromellose, triethyl citrate, anhydrous lactose, crospovidone, stearic acid, magnesium stearate. The tablets also contain opadry 03K29121 clear, which contains: hypromellose and triacetin. Each doxycycline hyclate delayed-release tablets 75 mg tablet contains 4.8 mg (0.208 mEq) of sodium, each doxycycline hyclate delayed-release tablets 100 mg tablet contains 6.4 mg (0.278 mEq) of sodium, each doxycycline hyclate delayed-release tablets 150 mg tablet contains 9.6 mg (0.417 mEq) of sodium, and each doxycycline hyclate delayed-release tablets 200 mg tablet contains 12.8 mg (0.556 mEq) of sodium. USP dissolution test pending.</Description>
</NDC>
<NDC>
<NDCCode>42571-278-37</NDCCode>
<PackageDescription>10 kg in 1 DRUM (42571-278-37) </PackageDescription>
<NDC11Code>42571-0278-37</NDC11Code>
<ProductNDC>42571-278</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Telmisartan</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20130921</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Micro Labs Limited</LabelerName>
<SubstanceName>TELMISARTAN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>kg/10kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2023-12-05</LastUpdate>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>21-SEP-13</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>43975-278-10</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43975-278-10) </PackageDescription>
<NDC11Code>43975-0278-10</NDC11Code>
<ProductNDC>43975-278</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate</ProprietaryName>
<NonProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200316</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205401</ApplicationNumber>
<LabelerName>ANI Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>AMPHETAMINE SULFATE; AMPHETAMINE DL-ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE</SubstanceName>
<StrengthNumber>2.5; 2.5; 2.5; 2.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-05-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200316</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules, a CNS stimulant, is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older. (1). Limitations of Use. The use of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage. (5.5, 8.4).</IndicationAndUsage>
<Description>Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules contain mixed salts of a single-entity amphetamine, a CNS stimulant. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules contain equal amounts (by weight) of four salts: dextroamphetamine sulfate, amphetamine sulfate, dextroamphetamine saccharate and amphetamine (D,L)-aspartate monohydrate. This results in a 3.1:1 mixture of dextro- to levo- amphetamine base equivalent. The 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg strength extended release capsules are for oral administration. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules contain drug-containing beads, which prolong the release of amphetamine compared to the dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate (immediate-release) tablet formulation. Inactive Ingredients and ColorsThe inactive ingredients in dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate extended-release capsules include: hard gelatin capsules, glyceryl monostearate, hypromellose, methacrylic acid copolymer dispersion, microcrystalline cellulose, polysorbate 80, talc, titanium dioxide, triacetin, triethyl citrate, and yellow iron oxide. The hard gelatin capsules contain: gelatin, titanium dioxide and FD&C red #40. The 5 mg, 10 mg, and 15 mg capsules also contain FD&C green #3 and D&C yellow #10. The printing on the capsules uses edible inks containing: shellac, potassium hydroxide and black iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>46581-210-06</NDCCode>
<PackageDescription>1 POUCH in 1 BOX (46581-210-06) / 6 PATCH in 1 POUCH</PackageDescription>
<NDC11Code>46581-0210-06</NDC11Code>
<ProductNDC>46581-210</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Salonpas</ProprietaryName>
<NonProprietaryName>Camphor, Menthol, Methyl Salicylate</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>PERCUTANEOUS; TOPICAL; TRANSDERMAL</RouteName>
<StartMarketingDate>20160517</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>Hisamitsu Pharmaceutical Co., Inc.</LabelerName>
<SubstanceName>CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE</SubstanceName>
<StrengthNumber>86.24; 166.92; 278.2</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-12-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160517</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For temporary relief of minor aches and pains of muscles and joints associated with: 1 arthritis, 2 simple backache, 3 strains, 4 bruises, 5 sprains.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>46708-278-10</NDCCode>
<PackageDescription>100 CAPSULE, DELAYED RELEASE in 1 CARTON (46708-278-10) </PackageDescription>
<NDC11Code>46708-0278-10</NDC11Code>
<ProductNDC>46708-278</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine Hydrochloride</ProprietaryName>
<NonProprietaryName>Duloxetine</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140609</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202949</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-05-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140609</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Duloxetine delayed-release capsules are indicated for the treatment of: : 1 Major depressive disorder in adults , 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older , 3 Diabetic peripheral neuropathic pain in adults , 4 Fibromyalgia in adults , 5 Chronic musculoskeletal pain in adults.</IndicationAndUsage>
<Description>Duloxetine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydochloride USP is a white to off-white powder, which is freely soluble in methanol and slightly soluble in water. Each capsule contains enteric-coated pellets of 20, 30 and 60 mg of duloxetine (equivalent to 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include sugar spheres, hypromellose, talc, sucrose, hypromellose phthalate, triethyl citrate, FD&C Blue No. 2, titanium dioxide, gelatin, sodium lauryl sulfate. The 20 and 60 mg capsules also contain iron oxide yellow. Ink contains following ingredients. 20 mg: shellac, black iron oxide, potassium hydroxide, propylene glycol and strong ammonia solution. 30 mg: shellac, titanium dioxide, yellow iron oxide, FD&C Blue No. 2 Aluminum Lake, propylene glycol and strong ammonia solution 60 mg: shellac, potassium hydroxide, titanium dioxide, propylene glycol and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>46708-278-30</NDCCode>
<PackageDescription>30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-278-30) </PackageDescription>
<NDC11Code>46708-0278-30</NDC11Code>
<ProductNDC>46708-278</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine Hydrochloride</ProprietaryName>
<NonProprietaryName>Duloxetine</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140609</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202949</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140609</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Duloxetine delayed-release capsules are indicated for the treatment of: : 1 Major depressive disorder in adults , 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older , 3 Diabetic peripheral neuropathic pain in adults , 4 Fibromyalgia in adults , 5 Chronic musculoskeletal pain in adults.</IndicationAndUsage>
<Description>Duloxetine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydochloride USP is a white to off-white powder, which is freely soluble in methanol and slightly soluble in water. Each capsule contains enteric-coated pellets of 20, 30 and 60 mg of duloxetine (equivalent to 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include ascorbic acid, FD&C Blue No. 2, gelatin, hypromellose, hypromellose phthalate, talc, titanium dioxide, triethyl citrate, sodium lauryl sulfate, sucrose and sugar spheres. The 20 and 60 mg capsules also contain iron oxide yellow. Ink contains following ingredients. 20 mg: black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. 30 mg: FD&C Blue No. 2 Aluminum Lake, propylene glycol, shellac, strong ammonia solution, titanium dioxide and yellow iron oxide. 60 mg: potassium hydroxide, propylene glycol, shellac, strong ammonia solution and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>46708-278-60</NDCCode>
<PackageDescription>60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-278-60) </PackageDescription>
<NDC11Code>46708-0278-60</NDC11Code>
<ProductNDC>46708-278</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine Hydrochloride</ProprietaryName>
<NonProprietaryName>Duloxetine</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140609</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202949</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140609</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Duloxetine delayed-release capsules are indicated for the treatment of: : 1 Major depressive disorder in adults , 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older , 3 Diabetic peripheral neuropathic pain in adults , 4 Fibromyalgia in adults , 5 Chronic musculoskeletal pain in adults.</IndicationAndUsage>
<Description>Duloxetine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydochloride USP is a white to off-white powder, which is freely soluble in methanol and slightly soluble in water. Each capsule contains enteric-coated pellets of 20, 30 and 60 mg of duloxetine (equivalent to 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include ascorbic acid, FD&C Blue No. 2, gelatin, hypromellose, hypromellose phthalate, talc, titanium dioxide, triethyl citrate, sodium lauryl sulfate, sucrose and sugar spheres. The 20 and 60 mg capsules also contain iron oxide yellow. Ink contains following ingredients. 20 mg: black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. 30 mg: FD&C Blue No. 2 Aluminum Lake, propylene glycol, shellac, strong ammonia solution, titanium dioxide and yellow iron oxide. 60 mg: potassium hydroxide, propylene glycol, shellac, strong ammonia solution and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>46708-278-90</NDCCode>
<PackageDescription>90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-278-90) </PackageDescription>
<NDC11Code>46708-0278-90</NDC11Code>
<ProductNDC>46708-278</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine Hydrochloride</ProprietaryName>
<NonProprietaryName>Duloxetine</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140609</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202949</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140609</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Duloxetine delayed-release capsules are indicated for the treatment of: : 1 Major depressive disorder in adults , 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older , 3 Diabetic peripheral neuropathic pain in adults , 4 Fibromyalgia in adults , 5 Chronic musculoskeletal pain in adults.</IndicationAndUsage>
<Description>Duloxetine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydochloride USP is a white to off-white powder, which is freely soluble in methanol and slightly soluble in water. Each capsule contains enteric-coated pellets of 20, 30 and 60 mg of duloxetine (equivalent to 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include ascorbic acid, FD&C Blue No. 2, gelatin, hypromellose, hypromellose phthalate, talc, titanium dioxide, triethyl citrate, sodium lauryl sulfate, sucrose and sugar spheres. The 20 and 60 mg capsules also contain iron oxide yellow. Ink contains following ingredients. 20 mg: black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. 30 mg: FD&C Blue No. 2 Aluminum Lake, propylene glycol, shellac, strong ammonia solution, titanium dioxide and yellow iron oxide. 60 mg: potassium hydroxide, propylene glycol, shellac, strong ammonia solution and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>46708-278-91</NDCCode>
<PackageDescription>1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-278-91) </PackageDescription>
<NDC11Code>46708-0278-91</NDC11Code>
<ProductNDC>46708-278</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine Hydrochloride</ProprietaryName>
<NonProprietaryName>Duloxetine</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140609</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202949</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Limited</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260409</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Duloxetine delayed-release capsules are indicated for the treatment of: : 1 Major depressive disorder in adults , 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older , 3 Diabetic peripheral neuropathic pain in adults , 4 Fibromyalgia in adults , 5 Chronic musculoskeletal pain in adults.</IndicationAndUsage>
<Description>Duloxetine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydochloride USP is a white to off-white powder, which is freely soluble in methanol and slightly soluble in water. Each capsule contains enteric-coated pellets of 20, 30 and 60 mg of duloxetine (equivalent to 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include ascorbic acid, FD&C Blue No. 2, gelatin, hypromellose, hypromellose phthalate, talc, titanium dioxide, triethyl citrate, sodium lauryl sulfate, sucrose and sugar spheres. The 20 and 60 mg capsules also contain iron oxide yellow. Ink contains following ingredients. 20 mg: black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. 30 mg: FD&C Blue No. 2 Aluminum Lake, propylene glycol, shellac, strong ammonia solution, titanium dioxide and yellow iron oxide. 60 mg: potassium hydroxide, propylene glycol, shellac, strong ammonia solution and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>49281-016-50</NDCCode>
<PackageDescription>10 SYRINGE, GLASS in 1 PACKAGE (49281-016-50) / .5 mL in 1 SYRINGE, GLASS (49281-016-88) </PackageDescription>
<NDC11Code>49281-0016-50</NDC11Code>
<ProductNDC>49281-016</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Fluzone Hd Tiv Sh 2026</ProprietaryName>
<NonProprietaryName>Influenza A Virus A/switzerland/6849/2025 Ivr-278 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/singapore/gp20238/2024 Ivr-277 (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20260220</StartMarketingDate>
<EndMarketingDate>20261231</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103914</ApplicationNumber>
<LabelerName>Sanofi Vaccines US Inc.</LabelerName>
<SubstanceName>INFLUENZA A VIRUS A/SWITZERLAND/6849/2025 IVR-278 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/SINGAPORE/GP20238/2024 IVR-277 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
<StrengthNumber>60; 60; 60</StrengthNumber>
<StrengthUnit>ug/.5mL; ug/.5mL; ug/.5mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-05-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20260220</StartMarketingDatePackage>
<EndMarketingDatePackage>20261231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluzone® High-Dose Southern Hemisphere is a vaccine indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B virus contained in the vaccine. Fluzone High-Dose Southern Hemisphere is approved for use in persons 65 years of age and older.</IndicationAndUsage>
<Description>Fluzone High-Dose Southern Hemisphere (Influenza Vaccine) for intramuscular use is an inactivated influenza vaccine, prepared from influenza viruses propagated in embryonated chicken eggs. The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. Influenza virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. The virus is then chemically disrupted using a non-ionic surfactant, octylphenol ethoxylate (Triton® X-100), producing a "split virus". The split virus containing hemagglutinin (HA) antigen is further purified and then suspended in sodium phosphate-buffered isotonic sodium chloride solution. The Fluzone High-Dose Southern Hemisphere process uses an additional concentration factor after the ultrafiltration step to obtain a higher HA antigen concentration. The purified split virus from the three strains included in the vaccine are produced separately and then combined to make the trivalent formulation. Fluzone High-Dose Southern Hemisphere is an injectable suspension and is a colorless opalescent liquid. Neither antibiotics nor preservative are used in the manufacture of Fluzone High-Dose Southern Hemisphere. The Fluzone High-Dose Southern Hemisphere prefilled syringe presentation is not made with natural rubber latex. Fluzone High-Dose Southern Hemisphere is standardized according to United States Public Health Service requirements and is formulated to contain HA of each of the following three influenza strains recommended for the 2026 influenza season: A/Switzerland/6849/2025 IVR-278 (A/Missouri/11/2025 pdm09-like virus) (H1N1), A/Singapore/GP20238/2024 IVR-277 (H3N2), and B/Michigan/01/2021 (a B/Austria/1359417/2021-like virus, B Victoria lineage). The amounts of HA and other ingredients per dose of vaccine are listed in Table 2.</Description>
</NDC>
<NDC>
<NDCCode>49281-315-15</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 PACKAGE (49281-315-15) / 5 mL in 1 VIAL, MULTI-DOSE (49281-315-78) </PackageDescription>
<NDC11Code>49281-0315-15</NDC11Code>
<ProductNDC>49281-315</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Fluzone Tiv Sh 2026</ProprietaryName>
<NonProprietaryName>Influenza A Virus A/switzerland/6849/2025 Ivr-278 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/singapore/gp20238/2024 Ivr-277 (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20260220</StartMarketingDate>
<EndMarketingDate>20261231</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103914</ApplicationNumber>
<LabelerName>Sanofi Vaccines US Inc.</LabelerName>
<SubstanceName>INFLUENZA A VIRUS A/SWITZERLAND/6849/2025 IVR-278 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/SINGAPORE/GP20238/2024 IVR-277 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
<StrengthNumber>15; 15; 15</StrengthNumber>
<StrengthUnit>ug/.5mL; ug/.5mL; ug/.5mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-05-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20260220</StartMarketingDatePackage>
<EndMarketingDatePackage>20261231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluzone® Southern Hemisphere is a vaccine indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B virus contained in the vaccine. Fluzone Southern Hemisphere is approved for use in persons 6 months of age and older.</IndicationAndUsage>
<Description>Fluzone Southern Hemisphere (Influenza Vaccine) for intramuscular use is an inactivated influenza vaccine, prepared from influenza viruses propagated in embryonated chicken eggs. The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. Influenza virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. The virus is then chemically disrupted using a non-ionic surfactant, octylphenol ethoxylate (Triton® X-100), producing a "split virus". The split virus containing hemagglutinin (HA) antigen is further purified and then suspended in sodium phosphate-buffered isotonic sodium chloride solution. The purified split virus from the three strains included in the vaccine are produced separately and then combined to make the trivalent formulation. Fluzone Southern Hemisphere is an injectable suspension and is clear and slightly opalescent in color. Antibiotics are not used in the manufacture of Fluzone Southern Hemisphere. No presentation of Fluzone Southern Hemisphere is made with natural rubber latex. Fluzone Southern Hemisphere is standardized according to United States Public Health Service requirements and is formulated to contain HA of each of the following three influenza strains recommended for the 2026-Southern Hemisphere influenza season: A/Switzerland/6849/2025 IVR-278 (A/Missouri/11/2025 pdm09-like virus) (H1N1), A/Singapore/GP20238/2024 IVR-277 (H3N2), and B/Michigan/01/2021 (a B/Austria/1359417/2021-like virus, B Victoria lineage). The amounts of HA and other ingredients per dose of vaccine are listed in Table 9. The 0.5 mL single-dose, pre-filled syringe presentation is manufactured and formulated without thimerosal or any other preservative. The 5 mL multi-dose vial presentation contains thimerosal, a mercury derivative, added as a preservative. Each 0.5 mL dose from the multi-dose vial contains 25 mcg mercury. Each 0.25 mL dose from the multi-dose vial contains 12.5 mcg mercury.</Description>
</NDC>
<NDC>
<NDCCode>49281-626-50</NDCCode>
<PackageDescription>10 SYRINGE, GLASS in 1 PACKAGE (49281-626-50) / .5 mL in 1 SYRINGE, GLASS (49281-626-88) </PackageDescription>
<NDC11Code>49281-0626-50</NDC11Code>
<ProductNDC>49281-626</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Fluzone Tiv Sh 2026</ProprietaryName>
<NonProprietaryName>Influenza A Virus A/switzerland/6849/2025 Ivr-278 (h1n1) Antigen (formaldehyde Inactivated), Influenza A Virus A/singapore/gp20238/2024 Ivr-277 (h3n2) Antigen (formaldehyde Inactivated), And Influenza B Virus B/michigan/01/2021 Antigen (formaldehyde Inactivated)</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20260220</StartMarketingDate>
<EndMarketingDate>20261231</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103914</ApplicationNumber>
<LabelerName>Sanofi Vaccines US Inc.</LabelerName>
<SubstanceName>INFLUENZA A VIRUS A/SWITZERLAND/6849/2025 IVR-278 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA A VIRUS A/SINGAPORE/GP20238/2024 IVR-277 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED); INFLUENZA B VIRUS B/MICHIGAN/01/2021 ANTIGEN (FORMALDEHYDE INACTIVATED)</SubstanceName>
<StrengthNumber>15; 15; 15</StrengthNumber>
<StrengthUnit>ug/.5mL; ug/.5mL; ug/.5mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-05-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20260220</StartMarketingDatePackage>
<EndMarketingDatePackage>20261231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluzone® Southern Hemisphere is a vaccine indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B virus contained in the vaccine. Fluzone Southern Hemisphere is approved for use in persons 6 months of age and older.</IndicationAndUsage>
<Description>Fluzone Southern Hemisphere (Influenza Vaccine) for intramuscular use is an inactivated influenza vaccine, prepared from influenza viruses propagated in embryonated chicken eggs. The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. Influenza virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. The virus is then chemically disrupted using a non-ionic surfactant, octylphenol ethoxylate (Triton® X-100), producing a "split virus". The split virus containing hemagglutinin (HA) antigen is further purified and then suspended in sodium phosphate-buffered isotonic sodium chloride solution. The purified split virus from the three strains included in the vaccine are produced separately and then combined to make the trivalent formulation. Fluzone Southern Hemisphere is an injectable suspension and is clear and slightly opalescent in color. Antibiotics are not used in the manufacture of Fluzone Southern Hemisphere. No presentation of Fluzone Southern Hemisphere is made with natural rubber latex. Fluzone Southern Hemisphere is standardized according to United States Public Health Service requirements and is formulated to contain HA of each of the following three influenza strains recommended for the 2026-Southern Hemisphere influenza season: A/Switzerland/6849/2025 IVR-278 (A/Missouri/11/2025 pdm09-like virus) (H1N1), A/Singapore/GP20238/2024 IVR-277 (H3N2), and B/Michigan/01/2021 (a B/Austria/1359417/2021-like virus, B Victoria lineage). The amounts of HA and other ingredients per dose of vaccine are listed in Table 9. The 0.5 mL single-dose, pre-filled syringe presentation is manufactured and formulated without thimerosal or any other preservative. The 5 mL multi-dose vial presentation contains thimerosal, a mercury derivative, added as a preservative. Each 0.5 mL dose from the multi-dose vial contains 25 mcg mercury. Each 0.25 mL dose from the multi-dose vial contains 12.5 mcg mercury.</Description>
</NDC>
<NDC>
<NDCCode>62332-278-30</NDCCode>
<PackageDescription>30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (62332-278-30) </PackageDescription>
<NDC11Code>62332-0278-30</NDC11Code>
<ProductNDC>62332-278</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine Hydrochloride</ProprietaryName>
<NonProprietaryName>Duloxetine</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260409</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202949</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260409</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Duloxetine delayed-release capsules are indicated for the treatment of: : 1 Major depressive disorder in adults , 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older , 3 Diabetic peripheral neuropathic pain in adults , 4 Fibromyalgia in adults and pediatric patients 13 years of age and older, 5 Chronic musculoskeletal pain in adults.</IndicationAndUsage>
<Description>Duloxetine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride USP is a white to off-white powder, which is freely soluble in methanol and slightly soluble in water. Each capsule contains enteric-coated pellets of 20, 30 and 60 mg of duloxetine (equivalent to 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include ascorbic acid, FD&C Blue No. 2, gelatin, hypromellose, hypromellose phthalate, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide and triethyl citrate. The 20 and 60 mg capsules also contain iron oxide yellow. Ink contains following ingredients. 20 mg: black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. 30 mg: FD&C Blue No. 2 Aluminum Lake, propylene glycol, shellac, strong ammonia solution, titanium dioxide and yellow iron oxide. 60 mg: potassium hydroxide, propylene glycol, shellac, strong ammonia solution and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>62332-278-60</NDCCode>
<PackageDescription>60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (62332-278-60) </PackageDescription>
<NDC11Code>62332-0278-60</NDC11Code>
<ProductNDC>62332-278</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine Hydrochloride</ProprietaryName>
<NonProprietaryName>Duloxetine</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260409</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202949</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260409</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Duloxetine delayed-release capsules are indicated for the treatment of: : 1 Major depressive disorder in adults , 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older , 3 Diabetic peripheral neuropathic pain in adults , 4 Fibromyalgia in adults and pediatric patients 13 years of age and older, 5 Chronic musculoskeletal pain in adults.</IndicationAndUsage>
<Description>Duloxetine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride USP is a white to off-white powder, which is freely soluble in methanol and slightly soluble in water. Each capsule contains enteric-coated pellets of 20, 30 and 60 mg of duloxetine (equivalent to 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include ascorbic acid, FD&C Blue No. 2, gelatin, hypromellose, hypromellose phthalate, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide and triethyl citrate. The 20 and 60 mg capsules also contain iron oxide yellow. Ink contains following ingredients. 20 mg: black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. 30 mg: FD&C Blue No. 2 Aluminum Lake, propylene glycol, shellac, strong ammonia solution, titanium dioxide and yellow iron oxide. 60 mg: potassium hydroxide, propylene glycol, shellac, strong ammonia solution and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>62332-278-90</NDCCode>
<PackageDescription>90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (62332-278-90) </PackageDescription>
<NDC11Code>62332-0278-90</NDC11Code>
<ProductNDC>62332-278</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine Hydrochloride</ProprietaryName>
<NonProprietaryName>Duloxetine</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260409</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202949</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260409</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Duloxetine delayed-release capsules are indicated for the treatment of: : 1 Major depressive disorder in adults , 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older , 3 Diabetic peripheral neuropathic pain in adults , 4 Fibromyalgia in adults and pediatric patients 13 years of age and older, 5 Chronic musculoskeletal pain in adults.</IndicationAndUsage>
<Description>Duloxetine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride USP is a white to off-white powder, which is freely soluble in methanol and slightly soluble in water. Each capsule contains enteric-coated pellets of 20, 30 and 60 mg of duloxetine (equivalent to 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include ascorbic acid, FD&C Blue No. 2, gelatin, hypromellose, hypromellose phthalate, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide and triethyl citrate. The 20 and 60 mg capsules also contain iron oxide yellow. Ink contains following ingredients. 20 mg: black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. 30 mg: FD&C Blue No. 2 Aluminum Lake, propylene glycol, shellac, strong ammonia solution, titanium dioxide and yellow iron oxide. 60 mg: potassium hydroxide, propylene glycol, shellac, strong ammonia solution and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>62332-278-91</NDCCode>
<PackageDescription>1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (62332-278-91) </PackageDescription>
<NDC11Code>62332-0278-91</NDC11Code>
<ProductNDC>62332-278</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duloxetine Hydrochloride</ProprietaryName>
<NonProprietaryName>Duloxetine</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260409</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202949</ApplicationNumber>
<LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260409</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Duloxetine delayed-release capsules are indicated for the treatment of: : 1 Major depressive disorder in adults , 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older , 3 Diabetic peripheral neuropathic pain in adults , 4 Fibromyalgia in adults and pediatric patients 13 years of age and older, 5 Chronic musculoskeletal pain in adults.</IndicationAndUsage>
<Description>Duloxetine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-(S)-N-methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C18H19NOSHCl, which corresponds to a molecular weight of 333.88. The structural formula is. Duloxetine hydrochloride USP is a white to off-white powder, which is freely soluble in methanol and slightly soluble in water. Each capsule contains enteric-coated pellets of 20, 30 and 60 mg of duloxetine (equivalent to 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include ascorbic acid, FD&C Blue No. 2, gelatin, hypromellose, hypromellose phthalate, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide and triethyl citrate. The 20 and 60 mg capsules also contain iron oxide yellow. Ink contains following ingredients. 20 mg: black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. 30 mg: FD&C Blue No. 2 Aluminum Lake, propylene glycol, shellac, strong ammonia solution, titanium dioxide and yellow iron oxide. 60 mg: potassium hydroxide, propylene glycol, shellac, strong ammonia solution and titanium dioxide.</Description>
</NDC>
</NDCList>