{
"NDC": [
{
"NDCCode": "71610-219-04",
"PackageDescription": "4 TABLET, COATED in 1 BOTTLE, PLASTIC (71610-219-04) ",
"NDC11Code": "71610-0219-04",
"ProductNDC": "71610-219",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bisacodyl",
"NonProprietaryName": "Bisacodyl",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20181201",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "BISACODYL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Stimulant Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190110",
"SamplePackage": "N",
"IndicationAndUsage": "for temporary relief of occasional constipation and irregularity. this product generally produces bowel movement in 6 to 12 hours."
},
{
"NDCCode": "71610-219-02",
"PackageDescription": "2 TABLET, COATED in 1 BOTTLE, PLASTIC (71610-219-02) ",
"NDC11Code": "71610-0219-02",
"ProductNDC": "71610-219",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bisacodyl",
"NonProprietaryName": "Bisacodyl",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20181201",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "BISACODYL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Stimulant Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190228",
"SamplePackage": "N",
"IndicationAndUsage": "for temporary relief of occasional constipation and irregularity. this product generally produces bowel movement in 6 to 12 hours."
},
{
"NDCCode": "71610-219-03",
"PackageDescription": "3 TABLET, COATED in 1 BOTTLE, PLASTIC (71610-219-03) ",
"NDC11Code": "71610-0219-03",
"ProductNDC": "71610-219",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bisacodyl",
"NonProprietaryName": "Bisacodyl",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20181201",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "BISACODYL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Stimulant Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190121",
"SamplePackage": "N",
"IndicationAndUsage": "for temporary relief of occasional constipation and irregularity. this product generally produces bowel movement in 6 to 12 hours."
},
{
"NDCCode": "71610-219-08",
"PackageDescription": "8 TABLET, COATED in 1 BOTTLE, PLASTIC (71610-219-08) ",
"NDC11Code": "71610-0219-08",
"ProductNDC": "71610-219",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bisacodyl",
"NonProprietaryName": "Bisacodyl",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20181201",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "BISACODYL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Stimulant Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190221",
"SamplePackage": "N",
"IndicationAndUsage": "for temporary relief of occasional constipation and irregularity. this product generally produces bowel movement in 6 to 12 hours."
},
{
"NDCCode": "71610-219-20",
"PackageDescription": "20 TABLET, COATED in 1 BOTTLE, PLASTIC (71610-219-20) ",
"NDC11Code": "71610-0219-20",
"ProductNDC": "71610-219",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bisacodyl",
"NonProprietaryName": "Bisacodyl",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20181201",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part334",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "BISACODYL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Stimulant Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190606",
"SamplePackage": "N",
"IndicationAndUsage": "for temporary relief of occasional constipation and irregularity. this product generally produces bowel movement in 6 to 12 hours."
},
{
"NDCCode": "11673-219-04",
"PackageDescription": "40 CAPSULE, LIQUID FILLED in 1 BOTTLE (11673-219-04) ",
"NDC11Code": "11673-0219-04",
"ProductNDC": "11673-219",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cetirizine",
"NonProprietaryName": "Cetirizine",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20171206",
"EndMarketingDate": "20211130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207235",
"LabelerName": "TARGET CORPORATION",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2021-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20171206",
"EndMarketingDatePackage": "20211130",
"SamplePackage": "N"
},
{
"NDCCode": "43353-219-04",
"PackageDescription": "4 CAPSULE in 1 BOTTLE, PLASTIC (43353-219-04)",
"NDC11Code": "43353-0219-04",
"ProductNDC": "43353-219",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ergocalciferol",
"NonProprietaryName": "Ergocalciferol",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20111115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040833",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "ERGOCALCIFEROL",
"StrengthNumber": "1.25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Ergocalciferols [CS], Provitamin D2 Compound [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-06-10",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"IndicationAndUsage": "Ergocalciferol Capsules, USP are indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia.",
"Description": "Ergocalciferol Capsules, USP is a synthetic calcium regulator for oral administration. Ergocalciferol is a white, colorless crystal, insoluble in water, soluble in organic solvents, and slightly soluble in vegetable oils. It is affected by air and by light. Ergosterol or provitamin D2 is found in plants and yeast and has no antirachitic activity. There are more than 10 substances belonging to a group of steroid compounds, classified as having vitamin D or antirachitic activity. One USP Unit of vitamin D2 is equivalent to one International Unit (IU), and 1 mcg of vitamin D2 is equal to 40 IU. Each softgel capsule, for oral administration, contains Ergocalciferol, USP 1.25 mg (equivalent to 50,000 USP units of Vitamin D), in an edible vegetable oil. Ergocalciferol, also called vitamin D2 ,is 9, 10-secoergosta-5, 7,10(19),22-tetraen-3-ol,(3β,5Z,7E,22E)-; (C28H44O) with a molecular weight of 396.65, and has the following structural formula:. Inactive Ingredients: D&C Yellow #10, FD&C Blue #1, Gelatin, Glycerin, Purified Water, Refined Soybean Oil."
},
{
"NDCCode": "51009-219-04",
"PackageDescription": "1 TUBE in 1 CARTON (51009-219-04) / 113 g in 1 TUBE",
"NDC11Code": "51009-0219-04",
"ProductNDC": "51009-219",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Toms Whole Care Cinnamon Clove",
"ProprietaryNameSuffix": "Fights Cavities Whitening Fresh Breath Helps Fight Tartar",
"NonProprietaryName": "Sodium Monofluorophosphate",
"DosageFormName": "PASTE, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20160712",
"EndMarketingDate": "20280331",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M021",
"LabelerName": "Tom's of Maine, Inc.",
"SubstanceName": "SODIUM MONOFLUOROPHOSPHATE",
"StrengthNumber": "1.4",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2026-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20181115",
"EndMarketingDatePackage": "20280331",
"SamplePackage": "N",
"IndicationAndUsage": "helps protect against cavities."
},
{
"NDCCode": "54162-219-04",
"PackageDescription": "113 g in 1 TUBE (54162-219-04)",
"NDC11Code": "54162-0219-04",
"ProductNDC": "54162-219",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Calmodrox",
"NonProprietaryName": "Menthol, Zinc Oxide",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150122",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "Geritrex Corp",
"SubstanceName": "MENTHOL; ZINC OXIDE",
"StrengthNumber": ".44; 20",
"StrengthUnit": "g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Cleanse skin gently with mild skin cleanser. Pet dry or allow to air dry. Apply a thin layer of Calmodrox Ointment to reddened or irritated skin 2-4 times daily or after each incontinent episode or diaper change to promote comfort and long lasting protection."
},
{
"NDCCode": "54473-219-04",
"PackageDescription": "4.25 g in 1 APPLICATOR (54473-219-04) ",
"NDC11Code": "54473-0219-04",
"ProductNDC": "54473-219",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sun Shades Lip Balm",
"ProprietaryNameSuffix": "Vanilla Bean",
"NonProprietaryName": "Avobenzone 2.5%, Octinoxate 6%, Oxybenzone 3%",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130201",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Melaleuca Inc.",
"SubstanceName": "AVOBENZONE; OCTINOXATE; OXYBENZONE",
"StrengthNumber": ".1175; .282; .141",
"StrengthUnit": "g/4.25g; g/4.25g; g/4.25g",
"Status": "Active",
"LastUpdate": "2026-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180101",
"SamplePackage": "N",
"IndicationAndUsage": "■ helps prevent sunburn ■ if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "63545-219-04",
"PackageDescription": "10000 PELLET in 1 BOTTLE, GLASS (63545-219-04) ",
"NDC11Code": "63545-0219-04",
"ProductNDC": "63545-219",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Arsenicum Sulphuratum Flavum",
"NonProprietaryName": "Arsenicum Sulphuratum Flavum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210330",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, Inc.",
"SubstanceName": "ARSENIC TRISULFIDE",
"StrengthNumber": "500",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2021-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210330",
"SamplePackage": "N"
},
{
"NDCCode": "64220-219-04",
"PackageDescription": "50 kg in 1 CANISTER (64220-219-04) ",
"NDC11Code": "64220-0219-04",
"ProductNDC": "64220-219",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "D-2,3-diaminopropionic Acid Hydrochloride",
"DosageFormName": "POWDER",
"StartMarketingDate": "20230801",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD.",
"SubstanceName": "2,3-DIAMINOPROPIONIC ACID HYDROCHLORIDE, (-)-",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2023-08-11",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "01-AUG-23"
},
{
"NDCCode": "66780-219-04",
"PackageDescription": "4 TRAY in 1 CARTON (66780-219-04) > 1 KIT in 1 TRAY * .65 mL in 1 VIAL * .65 mL in 1 SYRINGE, GLASS (66780-221-01)",
"NDC11Code": "66780-0219-04",
"ProductNDC": "66780-219",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bydureon",
"NonProprietaryName": "Exenatide",
"DosageFormName": "KIT",
"StartMarketingDate": "20120127",
"EndMarketingDate": "20180131",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022200",
"LabelerName": "Amylin Pharmaceuticals, LLC",
"Status": "Deprecated",
"LastUpdate": "2018-02-01",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "67777-219-04",
"PackageDescription": "72 TUBE in 1 CASE (67777-219-04) > 14.17 g in 1 TUBE",
"NDC11Code": "67777-0219-04",
"ProductNDC": "67777-219",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bacitracin",
"NonProprietaryName": "Bacitracin",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20091201",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333B",
"LabelerName": "Dynarex Corporation",
"SubstanceName": "BACITRACIN",
"StrengthNumber": "500",
"StrengthUnit": "[iU]/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Ask a doctor before use: 1 in case of deep or puncture wounds, 2 animal bites, 3 serious burns."
},
{
"NDCCode": "70281-219-04",
"PackageDescription": "89 g in 1 CONTAINER (70281-219-04) ",
"NDC11Code": "70281-0219-04",
"ProductNDC": "70281-219",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Op Protect And Nourish Spf 30 Sunscreen",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170915",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "SolSkyn Personal Care LLC",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "3; 15; 5; 7",
"StrengthUnit": "g/100g; g/100g; g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2020-08-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20170915",
"SamplePackage": "N",
"IndicationAndUsage": " Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "76045-219-24",
"PackageDescription": "24 SYRINGE in 1 CARTON (76045-219-24) / 2 mL in 1 SYRINGE (76045-219-04) ",
"NDC11Code": "76045-0219-24",
"ProductNDC": "76045-219",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sugammadex",
"NonProprietaryName": "Sugammadex",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20260728",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219448",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "SUGAMMADEX SODIUM",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "gamma-Cyclodextrins [CS]",
"Status": "Active",
"LastUpdate": "2026-08-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260728",
"SamplePackage": "N",
"IndicationAndUsage": "Sugammadex Injection is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adult and pediatric patients aged 2 years and older undergoing surgery. Additional pediatric use information is approved for Merck Sharp & Dohme LLC's BRIDION® (sugammadex) injection. However, due to Merck Sharp & Dohme LLC's marketing exclusivity rights, this drug product is not labeled with that information.",
"Description": "Sugammadex Injection, for intravenous use, contains sugammadex sodium, a modified gamma cyclodextrin chemically designated as 6A,6B,6C,6D,6E,6F,6G,6H-Octakis-S-(2-carboxyethyl)-6A,6B,6C,6D,6E,6F,6G,6H-octathio-γ-cyclodextrin sodium salt (1:8) with a molecular weight of 2178.01. The structural formula is:. Sugammadex Injection is supplied as a sterile, non-pyrogenic aqueous solution that is clear, colorless to slightly yellow-brown for intravenous injection only. Each mL contains 100 mg sugammadex, which is equivalent to 108.8 mg sugammadex sodium. The aqueous solution is adjusted to a pH of between 7 and 8 with hydrochloric acid and/or sodium hydroxide. The osmolality of the product is between 300 and 500 mOsmol/kg. Sugammadex Injection may contain up to 7 mg/mL of the mono OH-derivative of sugammadex [see Clinical Pharmacology (12.2)]. This derivative is chemically designated as 6A,6B,6C,6D,6E,6F,6G-Heptakis-S-(2-carboxyethyl)-6A,6B,6C,6D,6E,6F,6G-heptathio-γ-cyclodextrin sodium salt (1:7) with a molecular weight of 2067.90. The structural formula is:."
},
{
"NDCCode": "71610-012-04",
"PackageDescription": "4000 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-012-04) ",
"NDC11Code": "71610-0012-04",
"ProductNDC": "71610-012",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nifedipine",
"NonProprietaryName": "Nifedipine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20001204",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075269",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "NIFEDIPINE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]",
"Status": "Active",
"LastUpdate": "2024-04-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240402",
"SamplePackage": "N",
"IndicationAndUsage": "Nifedipine extended-release tablets are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.",
"Description": "Nifedipine extended-release tablets are an extended-release tablet dosage form of the calcium channel blocker nifedipine. Nifedipine is 3,5-pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(2 -nitrophenyl)-, dimethyl ester. The molecular formula is C 17H 18N 2O 6and has the structural formula:. Nifedipine is a yellow crystalline substance, practically insoluble in water but soluble in ethanol. It has a molecular weight of 346.3. Nifedipine extended-release tablets contain 60 mg of nifedipine for once-a-day oral administration. In addition, each tablet contains the following inactive ingredients: ethylcellulose, ferric oxide yellow, hydroxyethyl cellulose, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyacrylic dispersion (copolymer of ethyl acrylate and methyl methacrylate), polyethylene glycol, silicon dioxide, sodium lauryl sulfate, talc, and titanium dioxide. Nifedipine extended-release tablets meet USP Dissolution Test 4."
},
{
"NDCCode": "71610-213-04",
"PackageDescription": "4 TABLET, FILM COATED in 1 BOTTLE (71610-213-04) ",
"NDC11Code": "71610-0213-04",
"ProductNDC": "71610-213",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tadalafil",
"NonProprietaryName": "Tadalafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180927",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021368",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "TADALAFIL",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-06-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20181228",
"SamplePackage": "N",
"IndicationAndUsage": "Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: : 1 erectile dysfunction (ED) (1.1) , 2 the signs and symptoms of benign prostatic hyperplasia (BPH) (1.2) , 3 ED and the signs and symptoms of BPH (ED/BPH) (1.3) .",
"Description": "Tadalafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C22H19N3O4 representing a molecular weight of 389.41. The structural formula is:. The chemical designation is pyrazino[1´,2´:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. Tadalafil is available as almond-shaped tablets for oral administration. Each tablet contains 2.5, 5, 10, or 20 mg of tadalafil and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, talc, titanium dioxide, and triacetin."
},
{
"NDCCode": "71610-237-04",
"PackageDescription": "4 TABLET, FILM COATED in 1 BOTTLE (71610-237-04) ",
"NDC11Code": "71610-0237-04",
"ProductNDC": "71610-237",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sildenafil",
"NonProprietaryName": "Sildenafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180529",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077342",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "SILDENAFIL CITRATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190208",
"SamplePackage": "N",
"IndicationAndUsage": "Sildenafil tablets are indicated for the treatment of erectile dysfunction.",
"Description": "Sildenafil tablets USP, an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil citrate, USP is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1 H-pyrazolo[4,3- d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate and has the following structural formula:. C 22H 30N 6O 4SC 6H 8O 7 M.W. 666.7. Sildenafil citrate, USP is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water. Sildenafil citrate, USP is formulated as white to off-white, film-coated, modified oval-shaped, convex tablets equivalent to 25 mg, 50 mg and 100 mg of sildenafil for oral administration. In addition to the active ingredient, sildenafil citrate, USP, each tablet contains the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol – part. hydrolyzed, talc, and titanium dioxide."
},
{
"NDCCode": "71610-240-04",
"PackageDescription": "4 CAPSULE in 1 BOTTLE (71610-240-04) ",
"NDC11Code": "71610-0240-04",
"ProductNDC": "71610-240",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ergocalciferol",
"NonProprietaryName": "Ergocalciferol",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20090520",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040833",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "ERGOCALCIFEROL",
"StrengthNumber": "1.25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Ergocalciferols [CS], Provitamin D2 Compound [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190215",
"SamplePackage": "N",
"IndicationAndUsage": "Ergocalciferol Capsules, USP are indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia.",
"Description": "Ergocalciferol Capsules, USP is a synthetic calcium regulator for oral administration. Ergocalciferol is a white, colorless crystal, insoluble in water, soluble in organic solvents, and slightly soluble in vegetable oils. It is affected by air and by light. Ergosterol or provitamin D 2 is found in plants and yeast and has no antirachitic activity. There are more than 10 substances belonging to a group of steroid compounds, classified as having vitamin D or antirachitic activity. One USP Unit of vitamin D 2 is equivalent to one International Unit (IU), and 1 mcg of vitamin D 2 is equal to 40 IU. Each softgel capsule, for oral administration, contains Ergocalciferol, USP 1.25 mg (equivalent to 50,000 USP units of Vitamin D), in an edible vegetable oil. Ergocalciferol, also called vitamin D 2, is 9, 10-secoergosta - 5, 7, 10 (19), 22-tetraen-3-ol , (3β, 5 Z, 7 E, 22 E) -; (C 28H 44O) with a molecular weight of 396.65, and has the following structural formula:. Inactive Ingredients : D&C Yellow No. 10, FD&C Blue No. 1, Gelatin, Glycerin, Purified Water, Refined Soybean Oil."
},
{
"NDCCode": "71610-256-04",
"PackageDescription": "4 TABLET, FILM COATED in 1 BOTTLE (71610-256-04) ",
"NDC11Code": "71610-0256-04",
"ProductNDC": "71610-256",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sildenafil",
"NonProprietaryName": "Sildenafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180529",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077342",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "SILDENAFIL CITRATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190329",
"SamplePackage": "N",
"IndicationAndUsage": "Sildenafil tablets are indicated for the treatment of erectile dysfunction.",
"Description": "Sildenafil tablets USP, an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil citrate, USP is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1 H-pyrazolo[4,3- d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate and has the following structural formula:. C 22H 30N 6O 4SC 6H 8O 7 M.W. 666.7. Sildenafil citrate, USP is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water. Sildenafil citrate, USP is formulated as white to off-white, film-coated, modified oval-shaped, convex tablets equivalent to 25 mg, 50 mg and 100 mg of sildenafil for oral administration. In addition to the active ingredient, sildenafil citrate, USP, each tablet contains the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol – part. hydrolyzed, talc, and titanium dioxide."
},
{
"NDCCode": "71610-271-04",
"PackageDescription": "4 TABLET, FILM COATED in 1 BOTTLE (71610-271-04) ",
"NDC11Code": "71610-0271-04",
"ProductNDC": "71610-271",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sildenafil",
"NonProprietaryName": "Sildenafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180529",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077342",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "SILDENAFIL CITRATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-05-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190501",
"SamplePackage": "N",
"IndicationAndUsage": "Sildenafil tablets are indicated for the treatment of erectile dysfunction.",
"Description": "Sildenafil tablets USP, an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil citrate, USP is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1 H-pyrazolo[4,3- d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate and has the following structural formula:. C 22H 30N 6O 4SC 6H 8O 7 M.W. 666.7. Sildenafil citrate, USP is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water. Sildenafil citrate, USP is formulated as white to off-white, film-coated, modified oval-shaped, convex tablets equivalent to 25 mg, 50 mg and 100 mg of sildenafil for oral administration. In addition to the active ingredient, sildenafil citrate, USP, each tablet contains the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol – part. hydrolyzed, talc, and titanium dioxide."
},
{
"NDCCode": "71610-303-04",
"PackageDescription": "4 TABLET in 1 BOTTLE (71610-303-04) ",
"NDC11Code": "71610-0303-04",
"ProductNDC": "71610-303",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tadalafil",
"NonProprietaryName": "Tadalafil",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190326",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211839",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "TADALAFIL",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190710",
"SamplePackage": "N",
"IndicationAndUsage": "Tadalafil tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: 1 erectile dysfunction (ED) (1.1), 2 the signs and symptoms of benign prostatic hyperplasia (BPH) (1.2), 3 ED and the signs and symptoms of BPH (ED/BPH) (1.3).",
"Description": "Tadalafil USP is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C22H19N3O4 representing a molecular weight of 389.40. The structural formula is. The chemical designation is pyrazino[1′,2′:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)- 2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-1,3. It is a crystalline solid that is practically insoluble in water, freely soluble in dimethylsulfoxide and slightly soluble in methylene chloride. Tadalafil tablets USP are available as oval shaped, biconvex beveled edge, film coated tablets for oral administration. Each tablet contains 2.5, 5, 10, or 20 mg of tadalafil USP and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, Opadry® II Yellow, and sodium lauryl sulfate. The color coating material contains following ingredients."
},
{
"NDCCode": "71610-310-04",
"PackageDescription": "4 TABLET in 1 BOTTLE (71610-310-04) ",
"NDC11Code": "71610-0310-04",
"ProductNDC": "71610-310",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vardenafil Hydrochloride",
"NonProprietaryName": "Vardenafil Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209057",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "VARDENAFIL HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190802",
"SamplePackage": "N",
"IndicationAndUsage": "Vardenafil hydrochloride tablets are indicated for the treatment of erectile dysfunction.",
"Description": "Vardenafil hydrochloride tablets (vardenafil hydrochloride) are administered orally for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Vardenafil HCl is designated chemically as piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1- f][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-, monohydrochloride and has the following structural formula:. Vardenafil HCl is a nearly colorless, solid substance with a molecular weight of 579.1 g/mol and a solubility of 0.11 mg/mL in water. Vardenafil hydrochloride tablets are formulated as orange, round, tablets embossed with \"2.5\", \"5\", \"10\" or \"20\" on one side corresponding to 2.5 mg, 5 mg, 10 mg, and 20 mg of vardenafil, respectively. In addition to the active ingredient, vardenafil HCl, each tablet contains microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate, aspartame, titanium dioxide, ferric oxide red, and ferric oxide yellow."
},
{
"NDCCode": "71610-325-04",
"PackageDescription": "4 TABLET, FILM COATED in 1 BOTTLE (71610-325-04) ",
"NDC11Code": "71610-0325-04",
"ProductNDC": "71610-325",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tadalafil",
"NonProprietaryName": "Tadalafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190326",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208934",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "TADALAFIL",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190813",
"SamplePackage": "N",
"IndicationAndUsage": "Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: 1 erectile dysfunction (ED) (1.1), 2 the signs and symptoms of benign prostatic hyperplasia (BPH) (1.2), 3 ED and the signs and symptoms of BPH (ED/BPH) (1.3).",
"Description": "Tadalafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the molecular formula C22H19N3O4 representing a molecular weight of 389.41. The structural formula is. The chemical designation is pyrazino[1’,2’:1,6]pyrido[3,4-b]indole-1,4-dione,6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-,(6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. Tadalafil tablets, USP are available as round shaped (2.5 mg) and oval shaped (5 mg, 10 mg, and 20 mg) tablets for oral administration. Each tadalafil tablet, USP contains 2.5 mg, 5 mg, 10 mg, or 20 mg of tadalafil, USP and the following inactive ingredients: colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, poloxamer, polyethylene glycol, talc, titanium dioxide, and yellow iron oxide."
},
{
"NDCCode": "71610-353-04",
"PackageDescription": "4 TABLET, FILM COATED in 1 BOTTLE (71610-353-04) ",
"NDC11Code": "71610-0353-04",
"ProductNDC": "71610-353",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tadalafil",
"NonProprietaryName": "Tadalafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20181009",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090141",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "TADALAFIL",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20191018",
"SamplePackage": "N",
"IndicationAndUsage": "Tadalafil tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: 1 erectile dysfunction (ED) ( 1.1) , 2 the signs and symptoms of benign prostatic hyperplasia (BPH) ( 1.2) , 3 ED and the signs and symptoms of BPH (ED/BPH) ( 1.3) .",
"Description": "Tadalafil, USP is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). The structural formula is. C 22H 19N 3O 4 M.W. 389.41. The chemical designation is (6R,12aR)-2,3,6,7,12,12a-hexahydro-2-methyl-6-(3,4-methylenedioxyphenyl)-pyrazino-[2',1':6,1]pyrido[3,4-b]indole-1,4-dione. It is a white to off-white crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. Tadalafil, USP is available as round or oval-shaped, film-coated tablets for oral administration. Each tablet contains 2.5, 5, 10, or 20 mg of tadalafil, USP and the following inactive ingredients: croscarmellose sodium, iron oxide yellow, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol – part. hydrolyzed, povidone, sodium lauryl sulfate, sodium starch glycolate, sodium stearyl fumarate, talc, and titanium dioxide."
},
{
"NDCCode": "71610-453-04",
"PackageDescription": "4 TABLET in 1 BOTTLE (71610-453-04) ",
"NDC11Code": "71610-0453-04",
"ProductNDC": "71610-453",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Stimulant Laxative Enteric Coated",
"NonProprietaryName": "Bisacodyl",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20000101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "BISACODYL",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Stimulant Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2025-01-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200731",
"SamplePackage": "N",
"IndicationAndUsage": "relieves occasional constipation and irregularity."
},
{
"NDCCode": "71610-473-04",
"PackageDescription": "4000 TABLET in 1 BOTTLE (71610-473-04) ",
"NDC11Code": "71610-0473-04",
"ProductNDC": "71610-473",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Plaquenil",
"NonProprietaryName": "Hydroxychloroquine Sulfate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130628",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA009768",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "HYDROXYCHLOROQUINE SULFATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antimalarial [EPC], Antirheumatic Agent [EPC]",
"Status": "Active",
"LastUpdate": "2024-04-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240403",
"SamplePackage": "N",
"IndicationAndUsage": "PLAQUENIL is an antimalarial and antirheumatic indicated for the: Treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium malariae, Plasmodium ovale, and Plasmodium vivax in adult and pediatric patients. (1.1) Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported in adult and pediatric patients (1.1) Treatment of rheumatoid arthritis in adults. (1.2) Treatment of systemic lupus erythematosus in adults. (1.3) Treatment of chronic discoid lupus erythematosus in adults. (1.4)Limitations of Use (1.1): PLAQUENIL is not recommended for the: Treatment of complicated malaria. Treatment of chloroquine or hydroxychloroquine-resistant strains of Plasmodium species. Treatment of malaria acquired in geographic areas where chloroquine resistance occurs or when the Plasmodium species has not been identified. Prophylaxis of malaria in geographic areas where chloroquine resistance occurs. Prevention of relapses of P. vivax or P. ovale because it is not active against the hypnozoite liver stage forms of these parasites. For radical cure of P. vivax and P. ovale infections, concomitant therapy with an 8-aminoquinoline drug is necessary.",
"Description": "PLAQUENIL (hydroxychloroquine sulfate) is an antimalarial and antirheumatic drug, chemically described as 2-[[4-[(7-Chloro-4- quinolyl) amino]pentyl] ethylamino]ethanol sulfate (1:1) with the molecular formula C 18H 26ClN 3OH 2SO 4. The molecular weight of hydroxychloroquine sulfate is 433.95. Its structural formula is:. Hydroxychloroquine sulfate is a white or off-white crystalline powder, freely soluble in water; practically soluble in alcohol, chloroform, and ether. PLAQUENIL (hydroxychloroquine sulfate) tablets for oral administration contain 200 mg hydroxychloroquine sulfate (equivalent to 155 mg of hydroxychloroquine) and the following inactive ingredients: black iron oxide, carnauba wax, corn starch, dibasic calcium phosphate, hydroxypropyl methylcellulose, magnesium stearate, polyethylene glycol 400, polysorbate 80, titanium dioxide."
},
{
"NDCCode": "71610-477-04",
"PackageDescription": "4 TABLET, FILM COATED in 1 BOTTLE (71610-477-04) ",
"NDC11Code": "71610-0477-04",
"ProductNDC": "71610-477",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vardenafil",
"NonProprietaryName": "Vardenafil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20181101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208960",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "VARDENAFIL HYDROCHLORIDE TRIHYDRATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2021-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201023",
"SamplePackage": "N",
"IndicationAndUsage": "Vardenafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction. (1).",
"Description": "Vardenafil hydrochloride tablets are administered orally for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Vardenafil hydrochloride is designated chemically as piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1-f][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-, monohydrochloride and has the following structural formula. Vardenafil hydrochloride trihydrate, USP is white or slightly brown or yellow powder. It is slightly soluble in water, freely soluble in anhydrous ethanol, practically insoluble in heptane. Each tablet contains active ingredient vardenafil 2.5 mg (equivalent to 2.963 mg vardenafil hydrochloride trihydrate) or 5 mg (equivalent to 5.926 mg vardenafil hydrochloride trihydrate) or 10 mg (equivalent to 11.852 mg vardenafil hydrochloride trihydrate) or 20 mg (equivalent to 23.705 mg vardenafil hydrochloride trihydrate) and inactive ingredients: colloidal silicon dioxide, hypromellose, iron oxide red (5 mg, 10 mg and 20 mg), iron oxide yellow (5 mg, 10 mg and 20 mg), microcrystalline cellulose, polyethylene glycol, pregelatinized starch (corn-zea mays), sodium stearyl fumarate, titanium dioxide."
},
{
"NDCCode": "71610-508-04",
"PackageDescription": "4 TABLET in 1 BOTTLE (71610-508-04) ",
"NDC11Code": "71610-0508-04",
"ProductNDC": "71610-508",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vardenafil Hydrochloride",
"NonProprietaryName": "Vardenafil Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20181101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209057",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "VARDENAFIL HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2021-01-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20201221",
"SamplePackage": "N",
"IndicationAndUsage": "Vardenafil hydrochloride tablets are indicated for the treatment of erectile dysfunction.",
"Description": "Vardenafil hydrochloride tablets (vardenafil hydrochloride) are administered orally for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Vardenafil HCl is designated chemically as piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1- f][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-, monohydrochloride and has the following structural formula:. Vardenafil HCl is a nearly colorless, solid substance with a molecular weight of 579.1 g/mol and a solubility of 0.11 mg/mL in water. Vardenafil hydrochloride tablets are formulated as orange, round, tablets embossed with \"2.5\", \"5\", \"10\" or \"20\" on one side corresponding to 2.5 mg, 5 mg, 10 mg, and 20 mg of vardenafil, respectively. In addition to the active ingredient, vardenafil HCl, each tablet contains microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate, aspartame, titanium dioxide, ferric oxide red, and ferric oxide yellow."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>71610-219-04</NDCCode>
<PackageDescription>4 TABLET, COATED in 1 BOTTLE, PLASTIC (71610-219-04) </PackageDescription>
<NDC11Code>71610-0219-04</NDC11Code>
<ProductNDC>71610-219</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bisacodyl</ProprietaryName>
<NonProprietaryName>Bisacodyl</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>BISACODYL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Stimulant Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190110</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for temporary relief of occasional constipation and irregularity. this product generally produces bowel movement in 6 to 12 hours.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71610-219-02</NDCCode>
<PackageDescription>2 TABLET, COATED in 1 BOTTLE, PLASTIC (71610-219-02) </PackageDescription>
<NDC11Code>71610-0219-02</NDC11Code>
<ProductNDC>71610-219</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bisacodyl</ProprietaryName>
<NonProprietaryName>Bisacodyl</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>BISACODYL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Stimulant Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for temporary relief of occasional constipation and irregularity. this product generally produces bowel movement in 6 to 12 hours.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71610-219-03</NDCCode>
<PackageDescription>3 TABLET, COATED in 1 BOTTLE, PLASTIC (71610-219-03) </PackageDescription>
<NDC11Code>71610-0219-03</NDC11Code>
<ProductNDC>71610-219</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bisacodyl</ProprietaryName>
<NonProprietaryName>Bisacodyl</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>BISACODYL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Stimulant Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190121</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for temporary relief of occasional constipation and irregularity. this product generally produces bowel movement in 6 to 12 hours.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71610-219-08</NDCCode>
<PackageDescription>8 TABLET, COATED in 1 BOTTLE, PLASTIC (71610-219-08) </PackageDescription>
<NDC11Code>71610-0219-08</NDC11Code>
<ProductNDC>71610-219</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bisacodyl</ProprietaryName>
<NonProprietaryName>Bisacodyl</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>BISACODYL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Stimulant Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for temporary relief of occasional constipation and irregularity. this product generally produces bowel movement in 6 to 12 hours.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71610-219-20</NDCCode>
<PackageDescription>20 TABLET, COATED in 1 BOTTLE, PLASTIC (71610-219-20) </PackageDescription>
<NDC11Code>71610-0219-20</NDC11Code>
<ProductNDC>71610-219</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bisacodyl</ProprietaryName>
<NonProprietaryName>Bisacodyl</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part334</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>BISACODYL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Stimulant Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190606</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for temporary relief of occasional constipation and irregularity. this product generally produces bowel movement in 6 to 12 hours.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>11673-219-04</NDCCode>
<PackageDescription>40 CAPSULE, LIQUID FILLED in 1 BOTTLE (11673-219-04) </PackageDescription>
<NDC11Code>11673-0219-04</NDC11Code>
<ProductNDC>11673-219</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cetirizine</ProprietaryName>
<NonProprietaryName>Cetirizine</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171206</StartMarketingDate>
<EndMarketingDate>20211130</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207235</ApplicationNumber>
<LabelerName>TARGET CORPORATION</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20171206</StartMarketingDatePackage>
<EndMarketingDatePackage>20211130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>43353-219-04</NDCCode>
<PackageDescription>4 CAPSULE in 1 BOTTLE, PLASTIC (43353-219-04)</PackageDescription>
<NDC11Code>43353-0219-04</NDC11Code>
<ProductNDC>43353-219</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ergocalciferol</ProprietaryName>
<NonProprietaryName>Ergocalciferol</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040833</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>ERGOCALCIFEROL</SubstanceName>
<StrengthNumber>1.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Ergocalciferols [CS], Provitamin D2 Compound [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-10</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Ergocalciferol Capsules, USP are indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia.</IndicationAndUsage>
<Description>Ergocalciferol Capsules, USP is a synthetic calcium regulator for oral administration. Ergocalciferol is a white, colorless crystal, insoluble in water, soluble in organic solvents, and slightly soluble in vegetable oils. It is affected by air and by light. Ergosterol or provitamin D2 is found in plants and yeast and has no antirachitic activity. There are more than 10 substances belonging to a group of steroid compounds, classified as having vitamin D or antirachitic activity. One USP Unit of vitamin D2 is equivalent to one International Unit (IU), and 1 mcg of vitamin D2 is equal to 40 IU. Each softgel capsule, for oral administration, contains Ergocalciferol, USP 1.25 mg (equivalent to 50,000 USP units of Vitamin D), in an edible vegetable oil. Ergocalciferol, also called vitamin D2 ,is 9, 10-secoergosta-5, 7,10(19),22-tetraen-3-ol,(3β,5Z,7E,22E)-; (C28H44O) with a molecular weight of 396.65, and has the following structural formula:. Inactive Ingredients: D&C Yellow #10, FD&C Blue #1, Gelatin, Glycerin, Purified Water, Refined Soybean Oil.</Description>
</NDC>
<NDC>
<NDCCode>51009-219-04</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (51009-219-04) / 113 g in 1 TUBE</PackageDescription>
<NDC11Code>51009-0219-04</NDC11Code>
<ProductNDC>51009-219</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Toms Whole Care Cinnamon Clove</ProprietaryName>
<ProprietaryNameSuffix>Fights Cavities Whitening Fresh Breath Helps Fight Tartar</ProprietaryNameSuffix>
<NonProprietaryName>Sodium Monofluorophosphate</NonProprietaryName>
<DosageFormName>PASTE, DENTIFRICE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20160712</StartMarketingDate>
<EndMarketingDate>20280331</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M021</ApplicationNumber>
<LabelerName>Tom's of Maine, Inc.</LabelerName>
<SubstanceName>SODIUM MONOFLUOROPHOSPHATE</SubstanceName>
<StrengthNumber>1.4</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-06-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20181115</StartMarketingDatePackage>
<EndMarketingDatePackage>20280331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps protect against cavities.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>54162-219-04</NDCCode>
<PackageDescription>113 g in 1 TUBE (54162-219-04)</PackageDescription>
<NDC11Code>54162-0219-04</NDC11Code>
<ProductNDC>54162-219</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Calmodrox</ProprietaryName>
<NonProprietaryName>Menthol, Zinc Oxide</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150122</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>Geritrex Corp</LabelerName>
<SubstanceName>MENTHOL; ZINC OXIDE</SubstanceName>
<StrengthNumber>.44; 20</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Cleanse skin gently with mild skin cleanser. Pet dry or allow to air dry. Apply a thin layer of Calmodrox Ointment to reddened or irritated skin 2-4 times daily or after each incontinent episode or diaper change to promote comfort and long lasting protection.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>54473-219-04</NDCCode>
<PackageDescription>4.25 g in 1 APPLICATOR (54473-219-04) </PackageDescription>
<NDC11Code>54473-0219-04</NDC11Code>
<ProductNDC>54473-219</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sun Shades Lip Balm</ProprietaryName>
<ProprietaryNameSuffix>Vanilla Bean</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone 2.5%, Octinoxate 6%, Oxybenzone 3%</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Melaleuca Inc.</LabelerName>
<SubstanceName>AVOBENZONE; OCTINOXATE; OXYBENZONE</SubstanceName>
<StrengthNumber>.1175; .282; .141</StrengthNumber>
<StrengthUnit>g/4.25g; g/4.25g; g/4.25g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>■ helps prevent sunburn ■ if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63545-219-04</NDCCode>
<PackageDescription>10000 PELLET in 1 BOTTLE, GLASS (63545-219-04) </PackageDescription>
<NDC11Code>63545-0219-04</NDC11Code>
<ProductNDC>63545-219</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Arsenicum Sulphuratum Flavum</ProprietaryName>
<NonProprietaryName>Arsenicum Sulphuratum Flavum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210330</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, Inc.</LabelerName>
<SubstanceName>ARSENIC TRISULFIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2021-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>64220-219-04</NDCCode>
<PackageDescription>50 kg in 1 CANISTER (64220-219-04) </PackageDescription>
<NDC11Code>64220-0219-04</NDC11Code>
<ProductNDC>64220-219</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>D-2,3-diaminopropionic Acid Hydrochloride</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20230801</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD.</LabelerName>
<SubstanceName>2,3-DIAMINOPROPIONIC ACID HYDROCHLORIDE, (-)-</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2023-08-11</LastUpdate>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>01-AUG-23</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>66780-219-04</NDCCode>
<PackageDescription>4 TRAY in 1 CARTON (66780-219-04) > 1 KIT in 1 TRAY * .65 mL in 1 VIAL * .65 mL in 1 SYRINGE, GLASS (66780-221-01)</PackageDescription>
<NDC11Code>66780-0219-04</NDC11Code>
<ProductNDC>66780-219</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bydureon</ProprietaryName>
<NonProprietaryName>Exenatide</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20120127</StartMarketingDate>
<EndMarketingDate>20180131</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022200</ApplicationNumber>
<LabelerName>Amylin Pharmaceuticals, LLC</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2018-02-01</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>67777-219-04</NDCCode>
<PackageDescription>72 TUBE in 1 CASE (67777-219-04) > 14.17 g in 1 TUBE</PackageDescription>
<NDC11Code>67777-0219-04</NDC11Code>
<ProductNDC>67777-219</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bacitracin</ProprietaryName>
<NonProprietaryName>Bacitracin</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20091201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333B</ApplicationNumber>
<LabelerName>Dynarex Corporation</LabelerName>
<SubstanceName>BACITRACIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>[iU]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Ask a doctor before use: 1 in case of deep or puncture wounds, 2 animal bites, 3 serious burns.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70281-219-04</NDCCode>
<PackageDescription>89 g in 1 CONTAINER (70281-219-04) </PackageDescription>
<NDC11Code>70281-0219-04</NDC11Code>
<ProductNDC>70281-219</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Op Protect And Nourish Spf 30 Sunscreen</ProprietaryName>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170915</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>SolSkyn Personal Care LLC</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>3; 15; 5; 7</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-08-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>76045-219-24</NDCCode>
<PackageDescription>24 SYRINGE in 1 CARTON (76045-219-24) / 2 mL in 1 SYRINGE (76045-219-04) </PackageDescription>
<NDC11Code>76045-0219-24</NDC11Code>
<ProductNDC>76045-219</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sugammadex</ProprietaryName>
<NonProprietaryName>Sugammadex</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20260728</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219448</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>SUGAMMADEX SODIUM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>gamma-Cyclodextrins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260728</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sugammadex Injection is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adult and pediatric patients aged 2 years and older undergoing surgery. Additional pediatric use information is approved for Merck Sharp & Dohme LLC's BRIDION® (sugammadex) injection. However, due to Merck Sharp & Dohme LLC's marketing exclusivity rights, this drug product is not labeled with that information.</IndicationAndUsage>
<Description>Sugammadex Injection, for intravenous use, contains sugammadex sodium, a modified gamma cyclodextrin chemically designated as 6A,6B,6C,6D,6E,6F,6G,6H-Octakis-S-(2-carboxyethyl)-6A,6B,6C,6D,6E,6F,6G,6H-octathio-γ-cyclodextrin sodium salt (1:8) with a molecular weight of 2178.01. The structural formula is:. Sugammadex Injection is supplied as a sterile, non-pyrogenic aqueous solution that is clear, colorless to slightly yellow-brown for intravenous injection only. Each mL contains 100 mg sugammadex, which is equivalent to 108.8 mg sugammadex sodium. The aqueous solution is adjusted to a pH of between 7 and 8 with hydrochloric acid and/or sodium hydroxide. The osmolality of the product is between 300 and 500 mOsmol/kg. Sugammadex Injection may contain up to 7 mg/mL of the mono OH-derivative of sugammadex [see Clinical Pharmacology (12.2)]. This derivative is chemically designated as 6A,6B,6C,6D,6E,6F,6G-Heptakis-S-(2-carboxyethyl)-6A,6B,6C,6D,6E,6F,6G-heptathio-γ-cyclodextrin sodium salt (1:7) with a molecular weight of 2067.90. The structural formula is:.</Description>
</NDC>
<NDC>
<NDCCode>71610-012-04</NDCCode>
<PackageDescription>4000 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-012-04) </PackageDescription>
<NDC11Code>71610-0012-04</NDC11Code>
<ProductNDC>71610-012</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nifedipine</ProprietaryName>
<NonProprietaryName>Nifedipine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20001204</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075269</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>NIFEDIPINE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-04-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240402</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nifedipine extended-release tablets are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents.</IndicationAndUsage>
<Description>Nifedipine extended-release tablets are an extended-release tablet dosage form of the calcium channel blocker nifedipine. Nifedipine is 3,5-pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(2 -nitrophenyl)-, dimethyl ester. The molecular formula is C 17H 18N 2O 6and has the structural formula:. Nifedipine is a yellow crystalline substance, practically insoluble in water but soluble in ethanol. It has a molecular weight of 346.3. Nifedipine extended-release tablets contain 60 mg of nifedipine for once-a-day oral administration. In addition, each tablet contains the following inactive ingredients: ethylcellulose, ferric oxide yellow, hydroxyethyl cellulose, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyacrylic dispersion (copolymer of ethyl acrylate and methyl methacrylate), polyethylene glycol, silicon dioxide, sodium lauryl sulfate, talc, and titanium dioxide. Nifedipine extended-release tablets meet USP Dissolution Test 4.</Description>
</NDC>
<NDC>
<NDCCode>71610-213-04</NDCCode>
<PackageDescription>4 TABLET, FILM COATED in 1 BOTTLE (71610-213-04) </PackageDescription>
<NDC11Code>71610-0213-04</NDC11Code>
<ProductNDC>71610-213</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tadalafil</ProprietaryName>
<NonProprietaryName>Tadalafil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180927</StartMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021368</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>TADALAFIL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: : 1 erectile dysfunction (ED) (1.1) , 2 the signs and symptoms of benign prostatic hyperplasia (BPH) (1.2) , 3 ED and the signs and symptoms of BPH (ED/BPH) (1.3) .</IndicationAndUsage>
<Description>Tadalafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C22H19N3O4 representing a molecular weight of 389.41. The structural formula is:. The chemical designation is pyrazino[1´,2´:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. Tadalafil is available as almond-shaped tablets for oral administration. Each tablet contains 2.5, 5, 10, or 20 mg of tadalafil and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, talc, titanium dioxide, and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>71610-237-04</NDCCode>
<PackageDescription>4 TABLET, FILM COATED in 1 BOTTLE (71610-237-04) </PackageDescription>
<NDC11Code>71610-0237-04</NDC11Code>
<ProductNDC>71610-237</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sildenafil</ProprietaryName>
<NonProprietaryName>Sildenafil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180529</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077342</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>SILDENAFIL CITRATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190208</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sildenafil tablets are indicated for the treatment of erectile dysfunction.</IndicationAndUsage>
<Description>Sildenafil tablets USP, an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil citrate, USP is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1 H-pyrazolo[4,3- d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate and has the following structural formula:. C 22H 30N 6O 4SC 6H 8O 7 M.W. 666.7. Sildenafil citrate, USP is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water. Sildenafil citrate, USP is formulated as white to off-white, film-coated, modified oval-shaped, convex tablets equivalent to 25 mg, 50 mg and 100 mg of sildenafil for oral administration. In addition to the active ingredient, sildenafil citrate, USP, each tablet contains the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol – part. hydrolyzed, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>71610-240-04</NDCCode>
<PackageDescription>4 CAPSULE in 1 BOTTLE (71610-240-04) </PackageDescription>
<NDC11Code>71610-0240-04</NDC11Code>
<ProductNDC>71610-240</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ergocalciferol</ProprietaryName>
<NonProprietaryName>Ergocalciferol</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090520</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040833</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>ERGOCALCIFEROL</SubstanceName>
<StrengthNumber>1.25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Ergocalciferols [CS], Provitamin D2 Compound [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ergocalciferol Capsules, USP are indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia.</IndicationAndUsage>
<Description>Ergocalciferol Capsules, USP is a synthetic calcium regulator for oral administration. Ergocalciferol is a white, colorless crystal, insoluble in water, soluble in organic solvents, and slightly soluble in vegetable oils. It is affected by air and by light. Ergosterol or provitamin D 2 is found in plants and yeast and has no antirachitic activity. There are more than 10 substances belonging to a group of steroid compounds, classified as having vitamin D or antirachitic activity. One USP Unit of vitamin D 2 is equivalent to one International Unit (IU), and 1 mcg of vitamin D 2 is equal to 40 IU. Each softgel capsule, for oral administration, contains Ergocalciferol, USP 1.25 mg (equivalent to 50,000 USP units of Vitamin D), in an edible vegetable oil. Ergocalciferol, also called vitamin D 2, is 9, 10-secoergosta - 5, 7, 10 (19), 22-tetraen-3-ol , (3β, 5 Z, 7 E, 22 E) -; (C 28H 44O) with a molecular weight of 396.65, and has the following structural formula:. Inactive Ingredients : D&C Yellow No. 10, FD&C Blue No. 1, Gelatin, Glycerin, Purified Water, Refined Soybean Oil.</Description>
</NDC>
<NDC>
<NDCCode>71610-256-04</NDCCode>
<PackageDescription>4 TABLET, FILM COATED in 1 BOTTLE (71610-256-04) </PackageDescription>
<NDC11Code>71610-0256-04</NDC11Code>
<ProductNDC>71610-256</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sildenafil</ProprietaryName>
<NonProprietaryName>Sildenafil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180529</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077342</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>SILDENAFIL CITRATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190329</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sildenafil tablets are indicated for the treatment of erectile dysfunction.</IndicationAndUsage>
<Description>Sildenafil tablets USP, an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil citrate, USP is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1 H-pyrazolo[4,3- d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate and has the following structural formula:. C 22H 30N 6O 4SC 6H 8O 7 M.W. 666.7. Sildenafil citrate, USP is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water. Sildenafil citrate, USP is formulated as white to off-white, film-coated, modified oval-shaped, convex tablets equivalent to 25 mg, 50 mg and 100 mg of sildenafil for oral administration. In addition to the active ingredient, sildenafil citrate, USP, each tablet contains the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol – part. hydrolyzed, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>71610-271-04</NDCCode>
<PackageDescription>4 TABLET, FILM COATED in 1 BOTTLE (71610-271-04) </PackageDescription>
<NDC11Code>71610-0271-04</NDC11Code>
<ProductNDC>71610-271</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sildenafil</ProprietaryName>
<NonProprietaryName>Sildenafil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180529</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077342</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>SILDENAFIL CITRATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sildenafil tablets are indicated for the treatment of erectile dysfunction.</IndicationAndUsage>
<Description>Sildenafil tablets USP, an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil citrate, USP is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1 H-pyrazolo[4,3- d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate and has the following structural formula:. C 22H 30N 6O 4SC 6H 8O 7 M.W. 666.7. Sildenafil citrate, USP is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water. Sildenafil citrate, USP is formulated as white to off-white, film-coated, modified oval-shaped, convex tablets equivalent to 25 mg, 50 mg and 100 mg of sildenafil for oral administration. In addition to the active ingredient, sildenafil citrate, USP, each tablet contains the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol – part. hydrolyzed, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>71610-303-04</NDCCode>
<PackageDescription>4 TABLET in 1 BOTTLE (71610-303-04) </PackageDescription>
<NDC11Code>71610-0303-04</NDC11Code>
<ProductNDC>71610-303</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tadalafil</ProprietaryName>
<NonProprietaryName>Tadalafil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190326</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211839</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>TADALAFIL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190710</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tadalafil tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: 1 erectile dysfunction (ED) (1.1), 2 the signs and symptoms of benign prostatic hyperplasia (BPH) (1.2), 3 ED and the signs and symptoms of BPH (ED/BPH) (1.3).</IndicationAndUsage>
<Description>Tadalafil USP is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the empirical formula C22H19N3O4 representing a molecular weight of 389.40. The structural formula is. The chemical designation is pyrazino[1′,2′:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)- 2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-1,3. It is a crystalline solid that is practically insoluble in water, freely soluble in dimethylsulfoxide and slightly soluble in methylene chloride. Tadalafil tablets USP are available as oval shaped, biconvex beveled edge, film coated tablets for oral administration. Each tablet contains 2.5, 5, 10, or 20 mg of tadalafil USP and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, Opadry® II Yellow, and sodium lauryl sulfate. The color coating material contains following ingredients.</Description>
</NDC>
<NDC>
<NDCCode>71610-310-04</NDCCode>
<PackageDescription>4 TABLET in 1 BOTTLE (71610-310-04) </PackageDescription>
<NDC11Code>71610-0310-04</NDC11Code>
<ProductNDC>71610-310</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vardenafil Hydrochloride</ProprietaryName>
<NonProprietaryName>Vardenafil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190131</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209057</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>VARDENAFIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190802</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vardenafil hydrochloride tablets are indicated for the treatment of erectile dysfunction.</IndicationAndUsage>
<Description>Vardenafil hydrochloride tablets (vardenafil hydrochloride) are administered orally for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Vardenafil HCl is designated chemically as piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1- f][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-, monohydrochloride and has the following structural formula:. Vardenafil HCl is a nearly colorless, solid substance with a molecular weight of 579.1 g/mol and a solubility of 0.11 mg/mL in water. Vardenafil hydrochloride tablets are formulated as orange, round, tablets embossed with "2.5", "5", "10" or "20" on one side corresponding to 2.5 mg, 5 mg, 10 mg, and 20 mg of vardenafil, respectively. In addition to the active ingredient, vardenafil HCl, each tablet contains microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate, aspartame, titanium dioxide, ferric oxide red, and ferric oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>71610-325-04</NDCCode>
<PackageDescription>4 TABLET, FILM COATED in 1 BOTTLE (71610-325-04) </PackageDescription>
<NDC11Code>71610-0325-04</NDC11Code>
<ProductNDC>71610-325</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tadalafil</ProprietaryName>
<NonProprietaryName>Tadalafil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190326</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208934</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>TADALAFIL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190813</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: 1 erectile dysfunction (ED) (1.1), 2 the signs and symptoms of benign prostatic hyperplasia (BPH) (1.2), 3 ED and the signs and symptoms of BPH (ED/BPH) (1.3).</IndicationAndUsage>
<Description>Tadalafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil has the molecular formula C22H19N3O4 representing a molecular weight of 389.41. The structural formula is. The chemical designation is pyrazino[1’,2’:1,6]pyrido[3,4-b]indole-1,4-dione,6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-,(6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. Tadalafil tablets, USP are available as round shaped (2.5 mg) and oval shaped (5 mg, 10 mg, and 20 mg) tablets for oral administration. Each tadalafil tablet, USP contains 2.5 mg, 5 mg, 10 mg, or 20 mg of tadalafil, USP and the following inactive ingredients: colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, poloxamer, polyethylene glycol, talc, titanium dioxide, and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>71610-353-04</NDCCode>
<PackageDescription>4 TABLET, FILM COATED in 1 BOTTLE (71610-353-04) </PackageDescription>
<NDC11Code>71610-0353-04</NDC11Code>
<ProductNDC>71610-353</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tadalafil</ProprietaryName>
<NonProprietaryName>Tadalafil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181009</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090141</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>TADALAFIL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191018</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tadalafil tablets are a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: 1 erectile dysfunction (ED) ( 1.1) , 2 the signs and symptoms of benign prostatic hyperplasia (BPH) ( 1.2) , 3 ED and the signs and symptoms of BPH (ED/BPH) ( 1.3) .</IndicationAndUsage>
<Description>Tadalafil, USP is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). The structural formula is. C 22H 19N 3O 4 M.W. 389.41. The chemical designation is (6R,12aR)-2,3,6,7,12,12a-hexahydro-2-methyl-6-(3,4-methylenedioxyphenyl)-pyrazino-[2',1':6,1]pyrido[3,4-b]indole-1,4-dione. It is a white to off-white crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. Tadalafil, USP is available as round or oval-shaped, film-coated tablets for oral administration. Each tablet contains 2.5, 5, 10, or 20 mg of tadalafil, USP and the following inactive ingredients: croscarmellose sodium, iron oxide yellow, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol – part. hydrolyzed, povidone, sodium lauryl sulfate, sodium starch glycolate, sodium stearyl fumarate, talc, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>71610-453-04</NDCCode>
<PackageDescription>4 TABLET in 1 BOTTLE (71610-453-04) </PackageDescription>
<NDC11Code>71610-0453-04</NDC11Code>
<ProductNDC>71610-453</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Stimulant Laxative Enteric Coated</ProprietaryName>
<NonProprietaryName>Bisacodyl</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20000101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>BISACODYL</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Stimulant Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200731</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves occasional constipation and irregularity.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71610-473-04</NDCCode>
<PackageDescription>4000 TABLET in 1 BOTTLE (71610-473-04) </PackageDescription>
<NDC11Code>71610-0473-04</NDC11Code>
<ProductNDC>71610-473</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Plaquenil</ProprietaryName>
<NonProprietaryName>Hydroxychloroquine Sulfate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130628</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA009768</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>HYDROXYCHLOROQUINE SULFATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antimalarial [EPC], Antirheumatic Agent [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-04-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240403</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PLAQUENIL is an antimalarial and antirheumatic indicated for the: Treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium malariae, Plasmodium ovale, and Plasmodium vivax in adult and pediatric patients. (1.1) Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported in adult and pediatric patients (1.1) Treatment of rheumatoid arthritis in adults. (1.2) Treatment of systemic lupus erythematosus in adults. (1.3) Treatment of chronic discoid lupus erythematosus in adults. (1.4)Limitations of Use (1.1): PLAQUENIL is not recommended for the: Treatment of complicated malaria. Treatment of chloroquine or hydroxychloroquine-resistant strains of Plasmodium species. Treatment of malaria acquired in geographic areas where chloroquine resistance occurs or when the Plasmodium species has not been identified. Prophylaxis of malaria in geographic areas where chloroquine resistance occurs. Prevention of relapses of P. vivax or P. ovale because it is not active against the hypnozoite liver stage forms of these parasites. For radical cure of P. vivax and P. ovale infections, concomitant therapy with an 8-aminoquinoline drug is necessary.</IndicationAndUsage>
<Description>PLAQUENIL (hydroxychloroquine sulfate) is an antimalarial and antirheumatic drug, chemically described as 2-[[4-[(7-Chloro-4- quinolyl) amino]pentyl] ethylamino]ethanol sulfate (1:1) with the molecular formula C 18H 26ClN 3OH 2SO 4. The molecular weight of hydroxychloroquine sulfate is 433.95. Its structural formula is:. Hydroxychloroquine sulfate is a white or off-white crystalline powder, freely soluble in water; practically soluble in alcohol, chloroform, and ether. PLAQUENIL (hydroxychloroquine sulfate) tablets for oral administration contain 200 mg hydroxychloroquine sulfate (equivalent to 155 mg of hydroxychloroquine) and the following inactive ingredients: black iron oxide, carnauba wax, corn starch, dibasic calcium phosphate, hydroxypropyl methylcellulose, magnesium stearate, polyethylene glycol 400, polysorbate 80, titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>71610-477-04</NDCCode>
<PackageDescription>4 TABLET, FILM COATED in 1 BOTTLE (71610-477-04) </PackageDescription>
<NDC11Code>71610-0477-04</NDC11Code>
<ProductNDC>71610-477</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vardenafil</ProprietaryName>
<NonProprietaryName>Vardenafil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208960</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>VARDENAFIL HYDROCHLORIDE TRIHYDRATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201023</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vardenafil is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction. (1).</IndicationAndUsage>
<Description>Vardenafil hydrochloride tablets are administered orally for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Vardenafil hydrochloride is designated chemically as piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1-f][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-, monohydrochloride and has the following structural formula. Vardenafil hydrochloride trihydrate, USP is white or slightly brown or yellow powder. It is slightly soluble in water, freely soluble in anhydrous ethanol, practically insoluble in heptane. Each tablet contains active ingredient vardenafil 2.5 mg (equivalent to 2.963 mg vardenafil hydrochloride trihydrate) or 5 mg (equivalent to 5.926 mg vardenafil hydrochloride trihydrate) or 10 mg (equivalent to 11.852 mg vardenafil hydrochloride trihydrate) or 20 mg (equivalent to 23.705 mg vardenafil hydrochloride trihydrate) and inactive ingredients: colloidal silicon dioxide, hypromellose, iron oxide red (5 mg, 10 mg and 20 mg), iron oxide yellow (5 mg, 10 mg and 20 mg), microcrystalline cellulose, polyethylene glycol, pregelatinized starch (corn-zea mays), sodium stearyl fumarate, titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>71610-508-04</NDCCode>
<PackageDescription>4 TABLET in 1 BOTTLE (71610-508-04) </PackageDescription>
<NDC11Code>71610-0508-04</NDC11Code>
<ProductNDC>71610-508</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vardenafil Hydrochloride</ProprietaryName>
<NonProprietaryName>Vardenafil Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209057</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>VARDENAFIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-01-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vardenafil hydrochloride tablets are indicated for the treatment of erectile dysfunction.</IndicationAndUsage>
<Description>Vardenafil hydrochloride tablets (vardenafil hydrochloride) are administered orally for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Vardenafil HCl is designated chemically as piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1- f][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-, monohydrochloride and has the following structural formula:. Vardenafil HCl is a nearly colorless, solid substance with a molecular weight of 579.1 g/mol and a solubility of 0.11 mg/mL in water. Vardenafil hydrochloride tablets are formulated as orange, round, tablets embossed with "2.5", "5", "10" or "20" on one side corresponding to 2.5 mg, 5 mg, 10 mg, and 20 mg of vardenafil, respectively. In addition to the active ingredient, vardenafil HCl, each tablet contains microcrystalline cellulose, crospovidone, colloidal silicon dioxide, magnesium stearate, aspartame, titanium dioxide, ferric oxide red, and ferric oxide yellow.</Description>
</NDC>
</NDCList>