{
"NDC": [
{
"NDCCode": "76168-714-20",
"PackageDescription": "2 BOTTLE, DROPPER in 1 CARTON (76168-714-20) > 10 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "76168-0714-20",
"ProductNDC": "76168-714",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cvs Health Lubricant Drops",
"NonProprietaryName": "Propylene Glycol",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20211111",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part349",
"LabelerName": "VELOCITY PHARMA",
"SubstanceName": "PROPYLENE GLYCOL",
"StrengthNumber": ".06",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20211111",
"SamplePackage": "N",
"IndicationAndUsage": "for the temporary relief of burning and irritation due to dryness of the eye. for the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun . for use as a protectant against further irritation or to relieve dryness of the eye. for use as a lubricant to prevent further irritation or to relieve dryness of the eye."
},
{
"NDCCode": "76168-714-10",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (76168-714-10) > 10 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "76168-0714-10",
"ProductNDC": "76168-714",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cvs Health Lubricant Drops",
"NonProprietaryName": "Propylene Glycol",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20211111",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part349",
"LabelerName": "VELOCITY PHARMA",
"SubstanceName": "PROPYLENE GLYCOL",
"StrengthNumber": ".06",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20211111",
"SamplePackage": "N",
"IndicationAndUsage": "for the temporary relief of burning and irritation due to dryness of the eye. for the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun . for use as a protectant against further irritation or to relieve dryness of the eye. for use as a lubricant to prevent further irritation or to relieve dryness of the eye."
},
{
"NDCCode": "76168-064-03",
"PackageDescription": "20 CARTON in 1 BOTTLE (76168-064-03) > 1 TABLET in 1 CARTON",
"NDC11Code": "76168-0064-03",
"ProductNDC": "76168-064",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Menstrual Relief",
"NonProprietaryName": "Acetaminophen,caffeine,pyrilamine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130501",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "Velocity Pharma",
"SubstanceName": "ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE",
"StrengthNumber": "500; 60; 15",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "For the temporary relief of these symptoms associated with menstrual periods: 1 Cramps, 2 Bloating, 3 Water-weight gain, 4 Headache, 5 Backache, 6 Muscle aches, 7 Fatigue."
},
{
"NDCCode": "76168-095-20",
"PackageDescription": "200 CARTON in 1 BOTTLE (76168-095-20) > 1 TABLET, COATED in 1 CARTON",
"NDC11Code": "76168-0095-20",
"ProductNDC": "76168-095",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190327",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091239",
"LabelerName": "Velocity Pharma",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190327",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to:. headache. toothache. backache. menstrual cramps. minor pains of arthritis. muscular aches. the common cold. temporarily reduces fever."
},
{
"NDCCode": "10596-714-20",
"PackageDescription": "1 TUBE in 1 BOX (10596-714-20) / 59 mL in 1 TUBE",
"NDC11Code": "10596-0714-20",
"ProductNDC": "10596-714",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Jergens Natural Glow Face",
"ProprietaryNameSuffix": "Daily Moisturizer For Fair/medium Skin",
"NonProprietaryName": "Avobenzone, Octisalate, Octocrylene",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150220",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Kao USA Inc.",
"SubstanceName": "AVOBENZONE; OCTOCRYLENE; OCTISALATE",
"StrengthNumber": ".74; .65; 2.95",
"StrengthUnit": "g/59mL; g/59mL; g/59mL",
"Status": "Active",
"LastUpdate": "2024-07-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150220",
"SamplePackage": "N",
"IndicationAndUsage": "Use. helps prevent sunburn."
},
{
"NDCCode": "35356-714-20",
"PackageDescription": "20 TABLET, DELAYED RELEASE in 1 BOTTLE (35356-714-20) ",
"NDC11Code": "35356-0714-20",
"ProductNDC": "35356-714",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diclofenac Sodium",
"NonProprietaryName": "Diclofenac Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20080819",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077863",
"LabelerName": "Quality Care Products LLC",
"SubstanceName": "DICLOFENAC SODIUM",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-12-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20130207",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Diclofenac sodium delayed-release tablets, are indicated: 1 For relief of signs and symptoms of osteoarthritis, 2 For relief of signs and symptoms of rheumatoid arthritis, 3 For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis.",
"Description": "Diclofenac sodium delayed-release tablets are a benzene-acetic acid derivative. Diclofenac sodium delayed-release tablets are available as delayed-release tablets of 75 mg for oral administration. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The molecular weight is 318.14. Its molecular formula is C14H10Cl2NNaO2, and it has the following structural formula. The inactive ingredients in Diclofenac sodium delayed-release tablets include: lactose (monohydrate), microcrystalline cellulose, croscarmellose sodium, povidone, talc, magnesium stearate, methacrylic acid copolymer, polyethylene glycol, opadry brown (Titanium dioxide, hypromellose, polyethylene glycol, iron oxide red, iron oxide yellow) and purified water."
},
{
"NDCCode": "42385-714-20",
"PackageDescription": "20 kg in 1 DRUM (42385-714-20) ",
"NDC11Code": "42385-0714-20",
"ProductNDC": "42385-714",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Lamivudine",
"DosageFormName": "POWDER",
"StartMarketingDate": "20170707",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "LAURUS LABS LIMITED",
"SubstanceName": "LAMIVUDINE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2023-12-05",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "07-JUL-17"
},
{
"NDCCode": "58602-714-73",
"PackageDescription": "1 BOTTLE in 1 CARTON (58602-714-73) / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE",
"NDC11Code": "58602-0714-73",
"ProductNDC": "58602-714",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Guaifenesin And Dextromethorphan Hbr",
"NonProprietaryName": "Guaifenesin And Dextromethorphan Hbr",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20170317",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206941",
"LabelerName": "Aurohealth LLC",
"SubstanceName": "GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE",
"StrengthNumber": "600; 30",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2024-10-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170317",
"SamplePackage": "N"
},
{
"NDCCode": "67046-714-20",
"PackageDescription": "20 TABLET in 1 BLISTER PACK (67046-714-20)",
"NDC11Code": "67046-0714-20",
"ProductNDC": "67046-714",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sulfamethoxazole And Trimethoprim",
"NonProprietaryName": "Sulfamethoxazole And Trimethoprim",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090828",
"LabelerName": "Contract Pharmacy Services-PA",
"SubstanceName": "SULFAMETHOXAZOLE; TRIMETHOPRIM",
"StrengthNumber": "800; 160",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Sulfonamide Antimicrobial [EPC],Sulfonamides [CS],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets USP and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy.",
"Description": "Sulfamethoxazole and trimethoprim tablets USP are a synthetic antibacterial combination product available in double strength (DS) tablets, each containing 800 mg sulfamethoxazole USP and 160 mg trimethoprim USP; in tablets, each containing 400 mg sulfamethoxazole USP and 80 mg trimethoprim USP for oral administration. Sulfamethoxazole USP is N1 - (5-methyl-3-isoxazolyl) sulfanilamide; the molecular formula is C10H11N3O3S. It is an almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula. Trimethoprim USP is 2,4-diamino-5-(3,4,5-trimethoxybenzyl)pyrimidine; the molecular formula is C14H18N4O3. It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.3 and the following structural formula. Inactive ingredients:colloidal silicon dioxide, docusate sodium, magnesium stearate, pregelatinized starch, sodium benzoate, sodium starch glycolate and talc."
},
{
"NDCCode": "68016-714-20",
"PackageDescription": "1 BOTTLE in 1 CARTON (68016-714-20) / 20 TABLET in 1 BOTTLE",
"NDC11Code": "68016-0714-20",
"ProductNDC": "68016-714",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Motion Sickness Relief",
"NonProprietaryName": "Meclizine Hcl",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220501",
"EndMarketingDate": "20251130",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M009",
"LabelerName": "Pharmacy Value Alliance, LLC",
"SubstanceName": "MECLIZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiemetic [EPC], Emesis Suppression [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20220501",
"EndMarketingDatePackage": "20251130",
"SamplePackage": "N",
"IndicationAndUsage": "For the prevention and treatment of these symptoms associated with motion sickness nausea vomiting dizziness."
},
{
"NDCCode": "76230-727-09",
"PackageDescription": "1 BOTTLE in 1 PACKAGE (76230-727-09) / 75 mL in 1 BOTTLE",
"NDC11Code": "76230-0727-09",
"ProductNDC": "76230-727",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Everyday Facial Moisturizer And Sunscreen Spf 20",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110609",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "714 Essentials LTD",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": "163.2",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-01-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20171219",
"SamplePackage": "N",
"IndicationAndUsage": "USE: Provides broad spectrum protection against UVA (cause of cancer and aging) and UVB (sunburn) rays. Recommended for all skin types. Its powerful anti-inflammatory and antioxident properties (green tea, algae, and Vitamin E) guard against free radical damage. No ghostly residue. PABA free. Oil free.",
"Description": "Ottilie and Lulu Non-Chemical Sunscreen Smooth Silky Feel Water-Resistant - Dermatologist Tested Allergy Tested - Clinically Tested Not Tested on Animals - Made in the USA Please Visit us at www.ottilieandlulu.com Manufactured exclusively for 714 Essentials LTD. Dba: Ottilie and Lulu'\" NY. NY 10024."
},
{
"NDCCode": "76420-714-20",
"PackageDescription": "20 CAPSULE in 1 BOTTLE (76420-714-20) ",
"NDC11Code": "76420-0714-20",
"ProductNDC": "76420-714",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Celecoxib",
"NonProprietaryName": "Celecoxib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20150312",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200562",
"LabelerName": "Asclemed USA, Inc.",
"SubstanceName": "CELECOXIB",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2024-05-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240510",
"SamplePackage": "N",
"IndicationAndUsage": "Celecoxib capsules are indicated.",
"Description": "Celecoxib capsules are a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib, USP for oral administration. The chemical name is 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. It has the following chemical structure. C 17H 14F 3N 3O 2S M.W. 381.38. Celecoxib, USP is a white to almost white powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib, USP is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range. The inactive ingredients in celecoxib capsules include: black iron oxide, crospovidone, dehydrated alcohol, FD&C Blue No.1, gelatin, lactose monohydrate, magnesium stearate, povidone, shellac, sodium lauryl sulfate, and titanium dioxide. The 50 mg, 200 mg and 400 mg capsules also contain D&C Yellow No. 10. The 50 mg, 100 mg and 200 mg capsules also contain D&C Red No. 28. The 400 mg capsule also contains FD&C Yellow No. 6."
},
{
"NDCCode": "0270-7350-20",
"PackageDescription": "10 BOTTLE, GLASS in 1 BOX (0270-7350-20) / 200 mL in 1 BOTTLE, GLASS",
"NDC11Code": "00270-7350-20",
"ProductNDC": "0270-7350",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Iomeron",
"NonProprietaryName": "Iomeprol Injection",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVASCULAR",
"StartMarketingDate": "20220701",
"MarketingCategoryName": "UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE",
"LabelerName": "BRACCO DIAGNOSTICS INC",
"SubstanceName": "IOMEPROL",
"StrengthNumber": "714",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220701",
"EndMarketingDatePackage": "20270301",
"SamplePackage": "N"
},
{
"NDCCode": "13537-714-02",
"PackageDescription": "1 TUBE in 1 BOX (13537-714-02) > 4 g in 1 TUBE (13537-714-01)",
"NDC11Code": "13537-0714-02",
"ProductNDC": "13537-714",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Esika Pro Hd Color Matte High Definition Color Spf 20",
"ProprietaryNameSuffix": "Rosa Deseo Mate - Pink",
"NonProprietaryName": "Octinoxate",
"DosageFormName": "LIPSTICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20151214",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura Corporation LTD",
"SubstanceName": "OCTINOXATE",
"StrengthNumber": ".068",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "16714-714-01",
"PackageDescription": "30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16714-714-01) ",
"NDC11Code": "16714-0714-01",
"ProductNDC": "16714-714",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Omeprazole",
"NonProprietaryName": "Omeprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20191025",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075576",
"LabelerName": "NorthStar Rx LLC",
"SubstanceName": "OMEPRAZOLE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191025",
"SamplePackage": "N",
"Description": "The active ingredient in omeprazole delayed-release capsules is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is. Omeprazole is a white to off-white powder. Melts between 150°C and 160°C with decomposition. It is soluble in dichloromethane, sparingly soluble in methanol and in alcohol and very slightly soluble in water. Omeprazole is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg or 40 mg of omeprazole in the form of enteric-coated granules with the following inactive ingredients: crospovidone, hypromellose, magnesium stearate, mannitol, meglumine, methacrylic acid copolymer, poloxamer, povidone and triethyl citrate. The capsule shells contains: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, yellow iron oxide, gelatin, silicon dioxide, sodium lauryl sulphate and titanium dioxide. Imprinting ink contains: D&C Yellow No. 10 aluminum lake, FD&C Blue No. 1 aluminum lake, FD&C Blue No. 2 aluminum lake, FD&C Red No. 40 aluminum lake, n-butyl alcohol, pharmaceutical glaze, propylene glycol, SDA-3A alcohol and synthetic black iron oxide. Omeprazole delayed-release capsules meets USP Dissolution Test 2."
},
{
"NDCCode": "21130-714-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (21130-714-01) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE",
"NDC11Code": "21130-0714-01",
"ProductNDC": "21130-714",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Signature Care Esomeprazole Magnesium",
"NonProprietaryName": "Esomeprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200702",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207193",
"LabelerName": "Safeway",
"SubstanceName": "ESOMEPRAZOLE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200702",
"EndMarketingDatePackage": "20250131",
"SamplePackage": "N",
"IndicationAndUsage": "treats frequent heartburn (occurs 2 or more days a week). not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect."
},
{
"NDCCode": "21130-714-03",
"PackageDescription": "3 BOTTLE in 1 CARTON (21130-714-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE",
"NDC11Code": "21130-0714-03",
"ProductNDC": "21130-714",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Signature Care Esomeprazole Magnesium",
"NonProprietaryName": "Esomeprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200702",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207193",
"LabelerName": "Safeway",
"SubstanceName": "ESOMEPRAZOLE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-08-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200702",
"SamplePackage": "N",
"IndicationAndUsage": "treats frequent heartburn (occurs 2 or more days a week). not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect."
},
{
"NDCCode": "41250-714-34",
"PackageDescription": "236 mL in 1 BOTTLE, PLASTIC (41250-714-34) ",
"NDC11Code": "41250-0714-34",
"ProductNDC": "41250-714",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sunscreen",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190702",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Meijer, Inc.",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "30.3; 101; 50.5; 101",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Active",
"LastUpdate": "2026-02-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190702",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protections measures (see Directions), decreases the rist of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "42806-714-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (42806-714-01) ",
"NDC11Code": "42806-0714-01",
"ProductNDC": "42806-714",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benzonatate",
"NonProprietaryName": "Benzonatate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20181221",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206948",
"LabelerName": "Epic Pharma LLC",
"SubstanceName": "BENZONATATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Tracheobronchial Stretch Receptor Activity [PE], Non-narcotic Antitussive [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181221",
"SamplePackage": "N",
"IndicationAndUsage": "Benzonatate capsules, USP are indicated for the symptomatic relief of cough.",
"Description": "Benzonatate capsules, USP, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26- onaoxaoctacosan-28-ylp-(butylamino) benzoate; with a molecular weight of 603.7. Each benzonatate capsules, USP for oral administration contains 100 mg or 200 mg benzonatate, USP. In addition, each capsule contains the following inactive ingredients: D&C Yellow #10, gelatin, glycerin, lecithin, light mineral oil, propylene glycol, purified water, shellac glaze, titanium dioxide, and white edible ink."
},
{
"NDCCode": "42806-714-05",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (42806-714-05) ",
"NDC11Code": "42806-0714-05",
"ProductNDC": "42806-714",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benzonatate",
"NonProprietaryName": "Benzonatate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20181221",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206948",
"LabelerName": "Epic Pharma LLC",
"SubstanceName": "BENZONATATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Tracheobronchial Stretch Receptor Activity [PE], Non-narcotic Antitussive [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181221",
"SamplePackage": "N",
"IndicationAndUsage": "Benzonatate capsules, USP are indicated for the symptomatic relief of cough.",
"Description": "Benzonatate capsules, USP, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26- onaoxaoctacosan-28-ylp-(butylamino) benzoate; with a molecular weight of 603.7. Each benzonatate capsules, USP for oral administration contains 100 mg or 200 mg benzonatate, USP. In addition, each capsule contains the following inactive ingredients: D&C Yellow #10, gelatin, glycerin, lecithin, light mineral oil, propylene glycol, purified water, shellac glaze, titanium dioxide, and white edible ink."
},
{
"NDCCode": "50268-714-15",
"PackageDescription": "50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-714-15) > 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-714-11) ",
"NDC11Code": "50268-0714-15",
"ProductNDC": "50268-714",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Simvastatin",
"NonProprietaryName": "Simvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20141202",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077691",
"LabelerName": "AvPAK",
"SubstanceName": "SIMVASTATIN",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-11-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20141202",
"SamplePackage": "N"
},
{
"NDCCode": "59923-714-02",
"PackageDescription": "1 VIAL in 1 CARTON (59923-714-02) > 2 mL in 1 VIAL",
"NDC11Code": "59923-0714-02",
"ProductNDC": "59923-714",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Irinotecan Hydrochloride",
"NonProprietaryName": "Irinotecan Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20190301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208718",
"LabelerName": "Areva Pharmaceuticals, Inc.",
"SubstanceName": "IRINOTECAN HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Topoisomerase Inhibitor [EPC], Topoisomerase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20190301",
"SamplePackage": "N",
"IndicationAndUsage": ": 1 Irinotecan hydrochloride injection is indicated as a component of first-line therapy in combination with 5-fluorouracil (5-FU) and leucovorin (LV) for patients with metastatic carcinoma of the colon or rectum.",
"Description": "Irinotecan hydrochloride injection, USP is an antineoplastic agent of the topoisomerase I inhibitor class. Irinotecan hydrochloride injection, USP is supplied as a sterile, pale yellow, clear, aqueous solution. Each milliliter of solution contains 20 mg of irinotecan hydrochloride (on the basis of the trihydrate salt), 45 mg of sorbitol, NF, and 0.9 mg of lactic acid, USP. The pH of the solution has been adjusted to 3.5 (range, 3.0 to 3.8) with sodium hydroxide or hydrochloric acid. Irinotecan hydrochloride injection, USP is intended for dilution with 5% Dextrose Injection, USP (D5W), or 0.9% Sodium Chloride Injection, USP, prior to intravenous infusion. The preferred diluent is 5% Dextrose Injection, USP. Irinotecan hydrochloride is a semisynthetic derivative of camptothecin, an alkaloid extract from plants such as Camptotheca acuminata or is chemically synthesized. The chemical name is [1, 4’-bipiperidine]-1’-carboxylic acid (4S) - 4,11-diethyl-3,4,12,14-tetrahydro-4-hydroxy-3,14-dioxo-1 H-pyrano [3’,4’:6,7]indolizino[1,2- b]quinolin-9-yl ester hydrochloride trihydrate. Its empirical formula is C 33H 38N 4O 6HCl.3H 2O and molecular weight is 677.18. It is slightly soluble in water and organic solvents. Its structural formula is as follows:."
},
{
"NDCCode": "61786-714-02",
"PackageDescription": "30 TABLET, FILM COATED in 1 BLISTER PACK (61786-714-02)",
"NDC11Code": "61786-0714-02",
"ProductNDC": "61786-714",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160525",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076133",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-12-04",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "63323-714-14",
"PackageDescription": "1440 mL in 1 BAG (63323-714-14) ",
"NDC11Code": "63323-0714-14",
"ProductNDC": "63323-714",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Perikabiven",
"NonProprietaryName": "Dextrose, Soybean Oil, Electrolytes, Lysine, Phenylalanine, Leucine, Valine, Threonine, Methionine, Isoleucine, Tryptophan, Alanine, Arginine, Glycine, Proline, Histidine, Glutamic Acid, Serine, Aspartic Acid And Tyrosine",
"DosageFormName": "INJECTION, EMULSION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20140825",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA200656",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "DEXTROSE MONOHYDRATE; SOYBEAN OIL; SODIUM ACETATE; POTASSIUM CHLORIDE; SODIUM GLYCEROPHOSPHATE ANHYDROUS; MAGNESIUM SULFATE HEPTAHYDRATE; CALCIUM CHLORIDE; LYSINE HYDROCHLORIDE; PHENYLALANINE; LEUCINE; VALINE; HISTIDINE; THREONINE; METHIONINE; ISOLEUCINE; TRYPTOPHAN; ALANINE; ARGININE; GLYCINE; PROLINE; GLUTAMIC ACID; SERINE; ASPARTIC ACID; TYROSINE",
"StrengthNumber": "7.5; 3.5; 170; 124; 105; 68; 20; 187; 164; 164; 152; 141; 116; 116; 116; 40; 333; 235; 164; 141; 116; 94; 71; 4.8",
"StrengthUnit": "g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Amino Acid [EPC], Amino Acids [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Lipid Emulsion [EPC], Lipids [CS], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2025-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140825",
"SamplePackage": "N",
"IndicationAndUsage": "PERIKABIVEN is indicated as a source of calories, protein, electrolytes and essential fatty acids for adult patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. PERIKABIVEN may be used to prevent essential fatty acid deficiency or treat negative nitrogen balance in adult patients.",
"Description": "PERIKABIVEN is a sterile, hypertonic emulsion, for peripheral or central venous administration, in a Three Chamber Bag. The product contains no added sulfites. Chamber 1 contains Dextrose monohydrate solution for fluid replenishment and caloric supply. Chamber 2 contains the Amino Acid solution with Electrolytes, which comprises essential and nonessential amino acids provided with electrolytes. Chamber 3 contains Intralipid® 20% (a 20% Lipid Injectable Emulsion), prepared for intravenous administration as a source of calories and essential fatty acids. See below for formulations of each chamber and Table 2 for strength, pH, osmolarity, ionic concentration and caloric content of PERIKABIVEN when all the chambers are mixed together. Chamber 1: Contains sterile, hypertonic solution of Dextrose, USP in water for injection with a pH range of 3.5 to 5.5. Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6 H2O) and has the following structure:. Dextrose is derived from corn. Chamber 2: Contains a sterile solution of amino acids and electrolytes in water for injection. In addition, glacial acetic acid has been added to adjust the pH so that the final solution pH is 5.4 to 5.8. The formulas for the individual electrolytes and amino acids are as follows:. Chamber 3: Contains a 20% Lipid Injectable Emulsion (Intralipid® 20%) which is made up of 20% Soybean Oil, 1.2% Egg Yolk Phospholipids, 2.25% Glycerin, and water for injection. In addition, sodium hydroxide has been added to adjust the pH. The final product pH range is 6 to 9. The soybean oil is a refined natural product consisting of a mixture of neutral triglycerides of predominantly unsaturated fatty acids with the following structure:. where are saturated and unsaturated fatty acid residues. The major component fatty acids are linoleic (48 to 58 %), oleic (17 to 30%), palmitic (9 to 13%), linolenic (5 to 11%) and stearic acid (2.5 to 5%). These fatty acids have the following chemical and structural formulas:. Purified egg phosphatides are a mixture of naturally occurring phospholipids which are isolated from the egg yolk. These phospholipids have the following general structure:. contain saturated and unsaturated fatty acids that abound in neutral fats. R3 is primarily either the choline or ethanolamine ester of phosphoric acid. Glycerin is chemically designated C3H8O3 and is a clear colorless, hygroscopic syrupy liquid. It has the following structural formula:. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional oxygen and moisture barrier when necessary. An oxygen absorber is placed between the inner bag and the overpouch. The container is not made with natural rubber latex or polyvinyl chloride (PVC). PERIKABIVEN contains no more than 25 mcg/L of aluminum."
},
{
"NDCCode": "63323-714-19",
"PackageDescription": "1920 mL in 1 BAG (63323-714-19) ",
"NDC11Code": "63323-0714-19",
"ProductNDC": "63323-714",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Perikabiven",
"NonProprietaryName": "Dextrose, Soybean Oil, Electrolytes, Lysine, Phenylalanine, Leucine, Valine, Threonine, Methionine, Isoleucine, Tryptophan, Alanine, Arginine, Glycine, Proline, Histidine, Glutamic Acid, Serine, Aspartic Acid And Tyrosine",
"DosageFormName": "INJECTION, EMULSION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20140825",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA200656",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "DEXTROSE MONOHYDRATE; SOYBEAN OIL; SODIUM ACETATE; POTASSIUM CHLORIDE; SODIUM GLYCEROPHOSPHATE ANHYDROUS; MAGNESIUM SULFATE HEPTAHYDRATE; CALCIUM CHLORIDE; LYSINE HYDROCHLORIDE; PHENYLALANINE; LEUCINE; VALINE; HISTIDINE; THREONINE; METHIONINE; ISOLEUCINE; TRYPTOPHAN; ALANINE; ARGININE; GLYCINE; PROLINE; GLUTAMIC ACID; SERINE; ASPARTIC ACID; TYROSINE",
"StrengthNumber": "7.5; 3.5; 170; 124; 105; 68; 20; 187; 164; 164; 152; 141; 116; 116; 116; 40; 333; 235; 164; 141; 116; 94; 71; 4.8",
"StrengthUnit": "g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Amino Acid [EPC], Amino Acids [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Lipid Emulsion [EPC], Lipids [CS], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2025-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140825",
"SamplePackage": "N",
"IndicationAndUsage": "PERIKABIVEN is indicated as a source of calories, protein, electrolytes and essential fatty acids for adult patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. PERIKABIVEN may be used to prevent essential fatty acid deficiency or treat negative nitrogen balance in adult patients.",
"Description": "PERIKABIVEN is a sterile, hypertonic emulsion, for peripheral or central venous administration, in a Three Chamber Bag. The product contains no added sulfites. Chamber 1 contains Dextrose monohydrate solution for fluid replenishment and caloric supply. Chamber 2 contains the Amino Acid solution with Electrolytes, which comprises essential and nonessential amino acids provided with electrolytes. Chamber 3 contains Intralipid® 20% (a 20% Lipid Injectable Emulsion), prepared for intravenous administration as a source of calories and essential fatty acids. See below for formulations of each chamber and Table 2 for strength, pH, osmolarity, ionic concentration and caloric content of PERIKABIVEN when all the chambers are mixed together. Chamber 1: Contains sterile, hypertonic solution of Dextrose, USP in water for injection with a pH range of 3.5 to 5.5. Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6 H2O) and has the following structure:. Dextrose is derived from corn. Chamber 2: Contains a sterile solution of amino acids and electrolytes in water for injection. In addition, glacial acetic acid has been added to adjust the pH so that the final solution pH is 5.4 to 5.8. The formulas for the individual electrolytes and amino acids are as follows:. Chamber 3: Contains a 20% Lipid Injectable Emulsion (Intralipid® 20%) which is made up of 20% Soybean Oil, 1.2% Egg Yolk Phospholipids, 2.25% Glycerin, and water for injection. In addition, sodium hydroxide has been added to adjust the pH. The final product pH range is 6 to 9. The soybean oil is a refined natural product consisting of a mixture of neutral triglycerides of predominantly unsaturated fatty acids with the following structure:. where are saturated and unsaturated fatty acid residues. The major component fatty acids are linoleic (48 to 58 %), oleic (17 to 30%), palmitic (9 to 13%), linolenic (5 to 11%) and stearic acid (2.5 to 5%). These fatty acids have the following chemical and structural formulas:. Purified egg phosphatides are a mixture of naturally occurring phospholipids which are isolated from the egg yolk. These phospholipids have the following general structure:. contain saturated and unsaturated fatty acids that abound in neutral fats. R3 is primarily either the choline or ethanolamine ester of phosphoric acid. Glycerin is chemically designated C3H8O3 and is a clear colorless, hygroscopic syrupy liquid. It has the following structural formula:. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional oxygen and moisture barrier when necessary. An oxygen absorber is placed between the inner bag and the overpouch. The container is not made with natural rubber latex or polyvinyl chloride (PVC). PERIKABIVEN contains no more than 25 mcg/L of aluminum."
},
{
"NDCCode": "63323-714-24",
"PackageDescription": "2400 mL in 1 BAG (63323-714-24) ",
"NDC11Code": "63323-0714-24",
"ProductNDC": "63323-714",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Perikabiven",
"NonProprietaryName": "Dextrose, Soybean Oil, Electrolytes, Lysine, Phenylalanine, Leucine, Valine, Threonine, Methionine, Isoleucine, Tryptophan, Alanine, Arginine, Glycine, Proline, Histidine, Glutamic Acid, Serine, Aspartic Acid And Tyrosine",
"DosageFormName": "INJECTION, EMULSION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20140825",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA200656",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "ALANINE; ARGININE; ASPARTIC ACID; CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE HYDROCHLORIDE; MAGNESIUM SULFATE HEPTAHYDRATE; METHIONINE; PHENYLALANINE; POTASSIUM CHLORIDE; PROLINE; SERINE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE ANHYDROUS; SOYBEAN OIL; THREONINE; TRYPTOPHAN; TYROSINE; VALINE",
"StrengthNumber": "333; 235; 71; 20; 6.8; 116; 164; 141; 116; 164; 187; 68; 116; 164; 174; 141; 94; 170; 105; 3.5; 116; 40; 4.8; 152",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Amino Acid [EPC], Amino Acids [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Lipid Emulsion [EPC], Lipids [CS], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-02-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20140825",
"SamplePackage": "N"
},
{
"NDCCode": "68040-714-08",
"PackageDescription": "1 BOTTLE, SPRAY in 1 CARTON (68040-714-08) / 10 g in 1 BOTTLE, SPRAY",
"NDC11Code": "68040-0714-08",
"ProductNDC": "68040-714",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sernivo",
"NonProprietaryName": "Betamethasone Dipropionate",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210628",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208079",
"LabelerName": "Primus Pharmaceuticals, Inc.",
"SubstanceName": "BETAMETHASONE DIPROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210628",
"SamplePackage": "N",
"IndicationAndUsage": "SERNIVO Spray is indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older.",
"Description": "SERNIVO Spray contains 0.0643% betamethasone dipropionate (equivalent to 0.05% betamethasone), a synthetic, fluorinated corticosteroid for topical use. The chemical name for betamethasone dipropionate is 9-fluoro-11(β), 17, 21-trihydroxy-16(β)-methylpregna-1,4-diene-3,20-dione-17,21-dipropionate. The empirical formula is C28H37FO7 and the molecular weight is 504.6. The structural formula is shown below. Each gram of SERNIVO Spray contains 0.643 mg of betamethasone dipropionate USP (equivalent to 0.5 mg betamethasone) in a slightly thickened, white to off-white, oil-in-water, non-sterile emulsion with the following inactive ingredients: butylated hydroxytoluene, cetostearyl alcohol, hydroxyethyl cellulose, methylparaben, mineral oil, oleyl alcohol, polyoxyl 20 cetostearyl ether, propylparaben, purified water, and sorbitan monostearate. SERNIVO Spray is co-packaged with a manual spray pump for installation by the pharmacist prior to dispensing to patients."
},
{
"NDCCode": "68040-714-28",
"PackageDescription": "1 BOTTLE, SPRAY in 1 CARTON (68040-714-28) / 120 g in 1 BOTTLE, SPRAY",
"NDC11Code": "68040-0714-28",
"ProductNDC": "68040-714",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sernivo",
"NonProprietaryName": "Betamethasone Dipropionate",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210628",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208079",
"LabelerName": "Primus Pharmaceuticals, Inc.",
"SubstanceName": "BETAMETHASONE DIPROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210628",
"EndMarketingDatePackage": "20280430",
"SamplePackage": "N",
"IndicationAndUsage": "SERNIVO Spray is indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older.",
"Description": "SERNIVO Spray contains 0.0643% betamethasone dipropionate (equivalent to 0.05% betamethasone), a synthetic, fluorinated corticosteroid for topical use. The chemical name for betamethasone dipropionate is 9-fluoro-11(β), 17, 21-trihydroxy-16(β)-methylpregna-1,4-diene-3,20-dione-17,21-dipropionate. The empirical formula is C28H37FO7 and the molecular weight is 504.6. The structural formula is shown below. Each gram of SERNIVO Spray contains 0.643 mg of betamethasone dipropionate USP (equivalent to 0.5 mg betamethasone) in a slightly thickened, white to off-white, oil-in-water, non-sterile emulsion with the following inactive ingredients: butylated hydroxytoluene, cetostearyl alcohol, hydroxyethyl cellulose, methylparaben, mineral oil, oleyl alcohol, polyoxyl 20 cetostearyl ether, propylparaben, purified water, and sorbitan monostearate. SERNIVO Spray is co-packaged with a manual spray pump for installation by the pharmacist prior to dispensing to patients."
},
{
"NDCCode": "68047-714-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (68047-714-01) ",
"NDC11Code": "68047-0714-01",
"ProductNDC": "68047-714",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline Hyclate",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20101115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065287",
"LabelerName": "Larken Laboratories, Inc.",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Active",
"LastUpdate": "2025-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20101115",
"SamplePackage": "N",
"IndicationAndUsage": "Doxycycline Hyclate is indicated for use as an adjunct to scaling and root planing to promote attachment level gain and to reduce pocket depth in patients with adult periodontitis.",
"Description": "Doxycycline hyclate is available as a 20 mg tablet formulation of doxycycline for oral administration. The structural formula of doxycycline hyclate is. with an empirical formula of (C 22H 24N 2O 8HCl) 2C 2H 6OH 2O and a molecular weight of 1025.89. The chemical designation for doxycycline is 4-(dimethylamino)-1, 4, 4a, 5, 5a, 6, 11, 12a–octahydro-3, 5, 10, 12, 12a–octahydro-3, 5, 10, 12, 12a-pentahydroxy-6-methyl-1, 11-dioxo-2-naphthacenecarboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline hyclate is a yellow to light-yellow crystalline powder which is soluble in water."
},
{
"NDCCode": "68047-714-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (68047-714-60) ",
"NDC11Code": "68047-0714-60",
"ProductNDC": "68047-714",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline Hyclate",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20101115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065287",
"LabelerName": "Larken Laboratories, Inc.",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Active",
"LastUpdate": "2025-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20101115",
"SamplePackage": "N",
"IndicationAndUsage": "Doxycycline Hyclate is indicated for use as an adjunct to scaling and root planing to promote attachment level gain and to reduce pocket depth in patients with adult periodontitis.",
"Description": "Doxycycline hyclate is available as a 20 mg tablet formulation of doxycycline for oral administration. The structural formula of doxycycline hyclate is. with an empirical formula of (C 22H 24N 2O 8HCl) 2C 2H 6OH 2O and a molecular weight of 1025.89. The chemical designation for doxycycline is 4-(dimethylamino)-1, 4, 4a, 5, 5a, 6, 11, 12a–octahydro-3, 5, 10, 12, 12a–octahydro-3, 5, 10, 12, 12a-pentahydroxy-6-methyl-1, 11-dioxo-2-naphthacenecarboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline hyclate is a yellow to light-yellow crystalline powder which is soluble in water."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>76168-714-20</NDCCode>
<PackageDescription>2 BOTTLE, DROPPER in 1 CARTON (76168-714-20) > 10 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>76168-0714-20</NDC11Code>
<ProductNDC>76168-714</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cvs Health Lubricant Drops</ProprietaryName>
<NonProprietaryName>Propylene Glycol</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20211111</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part349</ApplicationNumber>
<LabelerName>VELOCITY PHARMA</LabelerName>
<SubstanceName>PROPYLENE GLYCOL</SubstanceName>
<StrengthNumber>.06</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211111</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the temporary relief of burning and irritation due to dryness of the eye. for the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun . for use as a protectant against further irritation or to relieve dryness of the eye. for use as a lubricant to prevent further irritation or to relieve dryness of the eye.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>76168-714-10</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (76168-714-10) > 10 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>76168-0714-10</NDC11Code>
<ProductNDC>76168-714</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cvs Health Lubricant Drops</ProprietaryName>
<NonProprietaryName>Propylene Glycol</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20211111</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part349</ApplicationNumber>
<LabelerName>VELOCITY PHARMA</LabelerName>
<SubstanceName>PROPYLENE GLYCOL</SubstanceName>
<StrengthNumber>.06</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211111</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for the temporary relief of burning and irritation due to dryness of the eye. for the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun . for use as a protectant against further irritation or to relieve dryness of the eye. for use as a lubricant to prevent further irritation or to relieve dryness of the eye.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>76168-064-03</NDCCode>
<PackageDescription>20 CARTON in 1 BOTTLE (76168-064-03) > 1 TABLET in 1 CARTON</PackageDescription>
<NDC11Code>76168-0064-03</NDC11Code>
<ProductNDC>76168-064</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Menstrual Relief</ProprietaryName>
<NonProprietaryName>Acetaminophen,caffeine,pyrilamine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130501</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>Velocity Pharma</LabelerName>
<SubstanceName>ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE</SubstanceName>
<StrengthNumber>500; 60; 15</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For the temporary relief of these symptoms associated with menstrual periods: 1 Cramps, 2 Bloating, 3 Water-weight gain, 4 Headache, 5 Backache, 6 Muscle aches, 7 Fatigue.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>76168-095-20</NDCCode>
<PackageDescription>200 CARTON in 1 BOTTLE (76168-095-20) > 1 TABLET, COATED in 1 CARTON</PackageDescription>
<NDC11Code>76168-0095-20</NDC11Code>
<ProductNDC>76168-095</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190327</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091239</ApplicationNumber>
<LabelerName>Velocity Pharma</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190327</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pains due to:. headache. toothache. backache. menstrual cramps. minor pains of arthritis. muscular aches. the common cold. temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10596-714-20</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (10596-714-20) / 59 mL in 1 TUBE</PackageDescription>
<NDC11Code>10596-0714-20</NDC11Code>
<ProductNDC>10596-714</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Jergens Natural Glow Face</ProprietaryName>
<ProprietaryNameSuffix>Daily Moisturizer For Fair/medium Skin</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Octisalate, Octocrylene</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150220</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Kao USA Inc.</LabelerName>
<SubstanceName>AVOBENZONE; OCTOCRYLENE; OCTISALATE</SubstanceName>
<StrengthNumber>.74; .65; 2.95</StrengthNumber>
<StrengthUnit>g/59mL; g/59mL; g/59mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-07-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150220</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Use. helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>35356-714-20</NDCCode>
<PackageDescription>20 TABLET, DELAYED RELEASE in 1 BOTTLE (35356-714-20) </PackageDescription>
<NDC11Code>35356-0714-20</NDC11Code>
<ProductNDC>35356-714</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diclofenac Sodium</ProprietaryName>
<NonProprietaryName>Diclofenac Sodium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080819</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077863</ApplicationNumber>
<LabelerName>Quality Care Products LLC</LabelerName>
<SubstanceName>DICLOFENAC SODIUM</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130207</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Diclofenac sodium delayed-release tablets, are indicated: 1 For relief of signs and symptoms of osteoarthritis, 2 For relief of signs and symptoms of rheumatoid arthritis, 3 For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis.</IndicationAndUsage>
<Description>Diclofenac sodium delayed-release tablets are a benzene-acetic acid derivative. Diclofenac sodium delayed-release tablets are available as delayed-release tablets of 75 mg for oral administration. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The molecular weight is 318.14. Its molecular formula is C14H10Cl2NNaO2, and it has the following structural formula. The inactive ingredients in Diclofenac sodium delayed-release tablets include: lactose (monohydrate), microcrystalline cellulose, croscarmellose sodium, povidone, talc, magnesium stearate, methacrylic acid copolymer, polyethylene glycol, opadry brown (Titanium dioxide, hypromellose, polyethylene glycol, iron oxide red, iron oxide yellow) and purified water.</Description>
</NDC>
<NDC>
<NDCCode>42385-714-20</NDCCode>
<PackageDescription>20 kg in 1 DRUM (42385-714-20) </PackageDescription>
<NDC11Code>42385-0714-20</NDC11Code>
<ProductNDC>42385-714</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Lamivudine</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20170707</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>LAURUS LABS LIMITED</LabelerName>
<SubstanceName>LAMIVUDINE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2023-12-05</LastUpdate>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>07-JUL-17</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>58602-714-73</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (58602-714-73) / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE</PackageDescription>
<NDC11Code>58602-0714-73</NDC11Code>
<ProductNDC>58602-714</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Guaifenesin And Dextromethorphan Hbr</ProprietaryName>
<NonProprietaryName>Guaifenesin And Dextromethorphan Hbr</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170317</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206941</ApplicationNumber>
<LabelerName>Aurohealth LLC</LabelerName>
<SubstanceName>GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE</SubstanceName>
<StrengthNumber>600; 30</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170317</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>67046-714-20</NDCCode>
<PackageDescription>20 TABLET in 1 BLISTER PACK (67046-714-20)</PackageDescription>
<NDC11Code>67046-0714-20</NDC11Code>
<ProductNDC>67046-714</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sulfamethoxazole And Trimethoprim</ProprietaryName>
<NonProprietaryName>Sulfamethoxazole And Trimethoprim</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110114</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090828</ApplicationNumber>
<LabelerName>Contract Pharmacy Services-PA</LabelerName>
<SubstanceName>SULFAMETHOXAZOLE; TRIMETHOPRIM</SubstanceName>
<StrengthNumber>800; 160</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Sulfonamide Antimicrobial [EPC],Sulfonamides [CS],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets USP and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy.</IndicationAndUsage>
<Description>Sulfamethoxazole and trimethoprim tablets USP are a synthetic antibacterial combination product available in double strength (DS) tablets, each containing 800 mg sulfamethoxazole USP and 160 mg trimethoprim USP; in tablets, each containing 400 mg sulfamethoxazole USP and 80 mg trimethoprim USP for oral administration. Sulfamethoxazole USP is N1 - (5-methyl-3-isoxazolyl) sulfanilamide; the molecular formula is C10H11N3O3S. It is an almost white, odorless, tasteless compound with a molecular weight of 253.28 and the following structural formula. Trimethoprim USP is 2,4-diamino-5-(3,4,5-trimethoxybenzyl)pyrimidine; the molecular formula is C14H18N4O3. It is a white to light yellow, odorless, bitter compound with a molecular weight of 290.3 and the following structural formula. Inactive ingredients:colloidal silicon dioxide, docusate sodium, magnesium stearate, pregelatinized starch, sodium benzoate, sodium starch glycolate and talc.</Description>
</NDC>
<NDC>
<NDCCode>68016-714-20</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (68016-714-20) / 20 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>68016-0714-20</NDC11Code>
<ProductNDC>68016-714</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Motion Sickness Relief</ProprietaryName>
<NonProprietaryName>Meclizine Hcl</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220501</StartMarketingDate>
<EndMarketingDate>20251130</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M009</ApplicationNumber>
<LabelerName>Pharmacy Value Alliance, LLC</LabelerName>
<SubstanceName>MECLIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiemetic [EPC], Emesis Suppression [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20220501</StartMarketingDatePackage>
<EndMarketingDatePackage>20251130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the prevention and treatment of these symptoms associated with motion sickness nausea vomiting dizziness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>76230-727-09</NDCCode>
<PackageDescription>1 BOTTLE in 1 PACKAGE (76230-727-09) / 75 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>76230-0727-09</NDC11Code>
<ProductNDC>76230-727</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Everyday Facial Moisturizer And Sunscreen Spf 20</ProprietaryName>
<NonProprietaryName>Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110609</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>714 Essentials LTD</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
<StrengthNumber>163.2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USE: Provides broad spectrum protection against UVA (cause of cancer and aging) and UVB (sunburn) rays. Recommended for all skin types. Its powerful anti-inflammatory and antioxident properties (green tea, algae, and Vitamin E) guard against free radical damage. No ghostly residue. PABA free. Oil free.</IndicationAndUsage>
<Description>Ottilie and Lulu Non-Chemical Sunscreen Smooth Silky Feel Water-Resistant - Dermatologist Tested Allergy Tested - Clinically Tested Not Tested on Animals - Made in the USA Please Visit us at www.ottilieandlulu.com Manufactured exclusively for 714 Essentials LTD. Dba: Ottilie and Lulu'" NY. NY 10024.</Description>
</NDC>
<NDC>
<NDCCode>76420-714-20</NDCCode>
<PackageDescription>20 CAPSULE in 1 BOTTLE (76420-714-20) </PackageDescription>
<NDC11Code>76420-0714-20</NDC11Code>
<ProductNDC>76420-714</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Celecoxib</ProprietaryName>
<NonProprietaryName>Celecoxib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150312</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200562</ApplicationNumber>
<LabelerName>Asclemed USA, Inc.</LabelerName>
<SubstanceName>CELECOXIB</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-05-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240510</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Celecoxib capsules are indicated.</IndicationAndUsage>
<Description>Celecoxib capsules are a nonsteroidal anti-inflammatory drug, available as capsules containing 50 mg, 100 mg, 200 mg and 400 mg celecoxib, USP for oral administration. The chemical name is 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. It has the following chemical structure. C 17H 14F 3N 3O 2S M.W. 381.38. Celecoxib, USP is a white to almost white powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib, USP is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range. The inactive ingredients in celecoxib capsules include: black iron oxide, crospovidone, dehydrated alcohol, FD&C Blue No.1, gelatin, lactose monohydrate, magnesium stearate, povidone, shellac, sodium lauryl sulfate, and titanium dioxide. The 50 mg, 200 mg and 400 mg capsules also contain D&C Yellow No. 10. The 50 mg, 100 mg and 200 mg capsules also contain D&C Red No. 28. The 400 mg capsule also contains FD&C Yellow No. 6.</Description>
</NDC>
<NDC>
<NDCCode>0270-7350-20</NDCCode>
<PackageDescription>10 BOTTLE, GLASS in 1 BOX (0270-7350-20) / 200 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>00270-7350-20</NDC11Code>
<ProductNDC>0270-7350</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Iomeron</ProprietaryName>
<NonProprietaryName>Iomeprol Injection</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVASCULAR</RouteName>
<StartMarketingDate>20220701</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE</MarketingCategoryName>
<LabelerName>BRACCO DIAGNOSTICS INC</LabelerName>
<SubstanceName>IOMEPROL</SubstanceName>
<StrengthNumber>714</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220701</StartMarketingDatePackage>
<EndMarketingDatePackage>20270301</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>13537-714-02</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (13537-714-02) > 4 g in 1 TUBE (13537-714-01)</PackageDescription>
<NDC11Code>13537-0714-02</NDC11Code>
<ProductNDC>13537-714</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Esika Pro Hd Color Matte High Definition Color Spf 20</ProprietaryName>
<ProprietaryNameSuffix>Rosa Deseo Mate - Pink</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate</NonProprietaryName>
<DosageFormName>LIPSTICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20151214</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura Corporation LTD</LabelerName>
<SubstanceName>OCTINOXATE</SubstanceName>
<StrengthNumber>.068</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>16714-714-01</NDCCode>
<PackageDescription>30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (16714-714-01) </PackageDescription>
<NDC11Code>16714-0714-01</NDC11Code>
<ProductNDC>16714-714</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Omeprazole</ProprietaryName>
<NonProprietaryName>Omeprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191025</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075576</ApplicationNumber>
<LabelerName>NorthStar Rx LLC</LabelerName>
<SubstanceName>OMEPRAZOLE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191025</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>The active ingredient in omeprazole delayed-release capsules is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3, 5-dimethyl-2-pyridinyl) methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C17H19N3O3S, with a molecular weight of 345.42. The structural formula is. Omeprazole is a white to off-white powder. Melts between 150°C and 160°C with decomposition. It is soluble in dichloromethane, sparingly soluble in methanol and in alcohol and very slightly soluble in water. Omeprazole is supplied as delayed-release capsules for oral administration. Each delayed-release capsule contains either 10 mg, 20 mg or 40 mg of omeprazole in the form of enteric-coated granules with the following inactive ingredients: crospovidone, hypromellose, magnesium stearate, mannitol, meglumine, methacrylic acid copolymer, poloxamer, povidone and triethyl citrate. The capsule shells contains: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, yellow iron oxide, gelatin, silicon dioxide, sodium lauryl sulphate and titanium dioxide. Imprinting ink contains: D&C Yellow No. 10 aluminum lake, FD&C Blue No. 1 aluminum lake, FD&C Blue No. 2 aluminum lake, FD&C Red No. 40 aluminum lake, n-butyl alcohol, pharmaceutical glaze, propylene glycol, SDA-3A alcohol and synthetic black iron oxide. Omeprazole delayed-release capsules meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>21130-714-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (21130-714-01) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE</PackageDescription>
<NDC11Code>21130-0714-01</NDC11Code>
<ProductNDC>21130-714</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Signature Care Esomeprazole Magnesium</ProprietaryName>
<NonProprietaryName>Esomeprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200702</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207193</ApplicationNumber>
<LabelerName>Safeway</LabelerName>
<SubstanceName>ESOMEPRAZOLE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200702</StartMarketingDatePackage>
<EndMarketingDatePackage>20250131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>treats frequent heartburn (occurs 2 or more days a week). not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>21130-714-03</NDCCode>
<PackageDescription>3 BOTTLE in 1 CARTON (21130-714-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE</PackageDescription>
<NDC11Code>21130-0714-03</NDC11Code>
<ProductNDC>21130-714</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Signature Care Esomeprazole Magnesium</ProprietaryName>
<NonProprietaryName>Esomeprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200702</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207193</ApplicationNumber>
<LabelerName>Safeway</LabelerName>
<SubstanceName>ESOMEPRAZOLE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200702</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>treats frequent heartburn (occurs 2 or more days a week). not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>41250-714-34</NDCCode>
<PackageDescription>236 mL in 1 BOTTLE, PLASTIC (41250-714-34) </PackageDescription>
<NDC11Code>41250-0714-34</NDC11Code>
<ProductNDC>41250-714</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sunscreen</ProprietaryName>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190702</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Meijer, Inc.</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>30.3; 101; 50.5; 101</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-02-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190702</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protections measures (see Directions), decreases the rist of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>42806-714-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (42806-714-01) </PackageDescription>
<NDC11Code>42806-0714-01</NDC11Code>
<ProductNDC>42806-714</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benzonatate</ProprietaryName>
<NonProprietaryName>Benzonatate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181221</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206948</ApplicationNumber>
<LabelerName>Epic Pharma LLC</LabelerName>
<SubstanceName>BENZONATATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Tracheobronchial Stretch Receptor Activity [PE], Non-narcotic Antitussive [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Benzonatate capsules, USP are indicated for the symptomatic relief of cough.</IndicationAndUsage>
<Description>Benzonatate capsules, USP, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26- onaoxaoctacosan-28-ylp-(butylamino) benzoate; with a molecular weight of 603.7. Each benzonatate capsules, USP for oral administration contains 100 mg or 200 mg benzonatate, USP. In addition, each capsule contains the following inactive ingredients: D&C Yellow #10, gelatin, glycerin, lecithin, light mineral oil, propylene glycol, purified water, shellac glaze, titanium dioxide, and white edible ink.</Description>
</NDC>
<NDC>
<NDCCode>42806-714-05</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE (42806-714-05) </PackageDescription>
<NDC11Code>42806-0714-05</NDC11Code>
<ProductNDC>42806-714</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benzonatate</ProprietaryName>
<NonProprietaryName>Benzonatate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181221</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206948</ApplicationNumber>
<LabelerName>Epic Pharma LLC</LabelerName>
<SubstanceName>BENZONATATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Tracheobronchial Stretch Receptor Activity [PE], Non-narcotic Antitussive [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Benzonatate capsules, USP are indicated for the symptomatic relief of cough.</IndicationAndUsage>
<Description>Benzonatate capsules, USP, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26- onaoxaoctacosan-28-ylp-(butylamino) benzoate; with a molecular weight of 603.7. Each benzonatate capsules, USP for oral administration contains 100 mg or 200 mg benzonatate, USP. In addition, each capsule contains the following inactive ingredients: D&C Yellow #10, gelatin, glycerin, lecithin, light mineral oil, propylene glycol, purified water, shellac glaze, titanium dioxide, and white edible ink.</Description>
</NDC>
<NDC>
<NDCCode>50268-714-15</NDCCode>
<PackageDescription>50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-714-15) > 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-714-11) </PackageDescription>
<NDC11Code>50268-0714-15</NDC11Code>
<ProductNDC>50268-714</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Simvastatin</ProprietaryName>
<NonProprietaryName>Simvastatin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141202</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077691</ApplicationNumber>
<LabelerName>AvPAK</LabelerName>
<SubstanceName>SIMVASTATIN</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-11-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>59923-714-02</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (59923-714-02) > 2 mL in 1 VIAL</PackageDescription>
<NDC11Code>59923-0714-02</NDC11Code>
<ProductNDC>59923-714</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Irinotecan Hydrochloride</ProprietaryName>
<NonProprietaryName>Irinotecan Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20190301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208718</ApplicationNumber>
<LabelerName>Areva Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>IRINOTECAN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Topoisomerase Inhibitor [EPC], Topoisomerase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>: 1 Irinotecan hydrochloride injection is indicated as a component of first-line therapy in combination with 5-fluorouracil (5-FU) and leucovorin (LV) for patients with metastatic carcinoma of the colon or rectum.</IndicationAndUsage>
<Description>Irinotecan hydrochloride injection, USP is an antineoplastic agent of the topoisomerase I inhibitor class. Irinotecan hydrochloride injection, USP is supplied as a sterile, pale yellow, clear, aqueous solution. Each milliliter of solution contains 20 mg of irinotecan hydrochloride (on the basis of the trihydrate salt), 45 mg of sorbitol, NF, and 0.9 mg of lactic acid, USP. The pH of the solution has been adjusted to 3.5 (range, 3.0 to 3.8) with sodium hydroxide or hydrochloric acid. Irinotecan hydrochloride injection, USP is intended for dilution with 5% Dextrose Injection, USP (D5W), or 0.9% Sodium Chloride Injection, USP, prior to intravenous infusion. The preferred diluent is 5% Dextrose Injection, USP. Irinotecan hydrochloride is a semisynthetic derivative of camptothecin, an alkaloid extract from plants such as Camptotheca acuminata or is chemically synthesized. The chemical name is [1, 4’-bipiperidine]-1’-carboxylic acid (4S) - 4,11-diethyl-3,4,12,14-tetrahydro-4-hydroxy-3,14-dioxo-1 H-pyrano [3’,4’:6,7]indolizino[1,2- b]quinolin-9-yl ester hydrochloride trihydrate. Its empirical formula is C 33H 38N 4O 6HCl.3H 2O and molecular weight is 677.18. It is slightly soluble in water and organic solvents. Its structural formula is as follows:.</Description>
</NDC>
<NDC>
<NDCCode>61786-714-02</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BLISTER PACK (61786-714-02)</PackageDescription>
<NDC11Code>61786-0714-02</NDC11Code>
<ProductNDC>61786-714</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160525</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076133</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-12-04</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>63323-714-14</NDCCode>
<PackageDescription>1440 mL in 1 BAG (63323-714-14) </PackageDescription>
<NDC11Code>63323-0714-14</NDC11Code>
<ProductNDC>63323-714</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Perikabiven</ProprietaryName>
<NonProprietaryName>Dextrose, Soybean Oil, Electrolytes, Lysine, Phenylalanine, Leucine, Valine, Threonine, Methionine, Isoleucine, Tryptophan, Alanine, Arginine, Glycine, Proline, Histidine, Glutamic Acid, Serine, Aspartic Acid And Tyrosine</NonProprietaryName>
<DosageFormName>INJECTION, EMULSION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20140825</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA200656</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>DEXTROSE MONOHYDRATE; SOYBEAN OIL; SODIUM ACETATE; POTASSIUM CHLORIDE; SODIUM GLYCEROPHOSPHATE ANHYDROUS; MAGNESIUM SULFATE HEPTAHYDRATE; CALCIUM CHLORIDE; LYSINE HYDROCHLORIDE; PHENYLALANINE; LEUCINE; VALINE; HISTIDINE; THREONINE; METHIONINE; ISOLEUCINE; TRYPTOPHAN; ALANINE; ARGININE; GLYCINE; PROLINE; GLUTAMIC ACID; SERINE; ASPARTIC ACID; TYROSINE</SubstanceName>
<StrengthNumber>7.5; 3.5; 170; 124; 105; 68; 20; 187; 164; 164; 152; 141; 116; 116; 116; 40; 333; 235; 164; 141; 116; 94; 71; 4.8</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Amino Acid [EPC], Amino Acids [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Lipid Emulsion [EPC], Lipids [CS], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140825</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PERIKABIVEN is indicated as a source of calories, protein, electrolytes and essential fatty acids for adult patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. PERIKABIVEN may be used to prevent essential fatty acid deficiency or treat negative nitrogen balance in adult patients.</IndicationAndUsage>
<Description>PERIKABIVEN is a sterile, hypertonic emulsion, for peripheral or central venous administration, in a Three Chamber Bag. The product contains no added sulfites. Chamber 1 contains Dextrose monohydrate solution for fluid replenishment and caloric supply. Chamber 2 contains the Amino Acid solution with Electrolytes, which comprises essential and nonessential amino acids provided with electrolytes. Chamber 3 contains Intralipid® 20% (a 20% Lipid Injectable Emulsion), prepared for intravenous administration as a source of calories and essential fatty acids. See below for formulations of each chamber and Table 2 for strength, pH, osmolarity, ionic concentration and caloric content of PERIKABIVEN when all the chambers are mixed together. Chamber 1: Contains sterile, hypertonic solution of Dextrose, USP in water for injection with a pH range of 3.5 to 5.5. Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6 H2O) and has the following structure:. Dextrose is derived from corn. Chamber 2: Contains a sterile solution of amino acids and electrolytes in water for injection. In addition, glacial acetic acid has been added to adjust the pH so that the final solution pH is 5.4 to 5.8. The formulas for the individual electrolytes and amino acids are as follows:. Chamber 3: Contains a 20% Lipid Injectable Emulsion (Intralipid® 20%) which is made up of 20% Soybean Oil, 1.2% Egg Yolk Phospholipids, 2.25% Glycerin, and water for injection. In addition, sodium hydroxide has been added to adjust the pH. The final product pH range is 6 to 9. The soybean oil is a refined natural product consisting of a mixture of neutral triglycerides of predominantly unsaturated fatty acids with the following structure:. where are saturated and unsaturated fatty acid residues. The major component fatty acids are linoleic (48 to 58 %), oleic (17 to 30%), palmitic (9 to 13%), linolenic (5 to 11%) and stearic acid (2.5 to 5%). These fatty acids have the following chemical and structural formulas:. Purified egg phosphatides are a mixture of naturally occurring phospholipids which are isolated from the egg yolk. These phospholipids have the following general structure:. contain saturated and unsaturated fatty acids that abound in neutral fats. R3 is primarily either the choline or ethanolamine ester of phosphoric acid. Glycerin is chemically designated C3H8O3 and is a clear colorless, hygroscopic syrupy liquid. It has the following structural formula:. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional oxygen and moisture barrier when necessary. An oxygen absorber is placed between the inner bag and the overpouch. The container is not made with natural rubber latex or polyvinyl chloride (PVC). PERIKABIVEN contains no more than 25 mcg/L of aluminum.</Description>
</NDC>
<NDC>
<NDCCode>63323-714-19</NDCCode>
<PackageDescription>1920 mL in 1 BAG (63323-714-19) </PackageDescription>
<NDC11Code>63323-0714-19</NDC11Code>
<ProductNDC>63323-714</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Perikabiven</ProprietaryName>
<NonProprietaryName>Dextrose, Soybean Oil, Electrolytes, Lysine, Phenylalanine, Leucine, Valine, Threonine, Methionine, Isoleucine, Tryptophan, Alanine, Arginine, Glycine, Proline, Histidine, Glutamic Acid, Serine, Aspartic Acid And Tyrosine</NonProprietaryName>
<DosageFormName>INJECTION, EMULSION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20140825</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA200656</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>DEXTROSE MONOHYDRATE; SOYBEAN OIL; SODIUM ACETATE; POTASSIUM CHLORIDE; SODIUM GLYCEROPHOSPHATE ANHYDROUS; MAGNESIUM SULFATE HEPTAHYDRATE; CALCIUM CHLORIDE; LYSINE HYDROCHLORIDE; PHENYLALANINE; LEUCINE; VALINE; HISTIDINE; THREONINE; METHIONINE; ISOLEUCINE; TRYPTOPHAN; ALANINE; ARGININE; GLYCINE; PROLINE; GLUTAMIC ACID; SERINE; ASPARTIC ACID; TYROSINE</SubstanceName>
<StrengthNumber>7.5; 3.5; 170; 124; 105; 68; 20; 187; 164; 164; 152; 141; 116; 116; 116; 40; 333; 235; 164; 141; 116; 94; 71; 4.8</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Amino Acid [EPC], Amino Acids [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Lipid Emulsion [EPC], Lipids [CS], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140825</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PERIKABIVEN is indicated as a source of calories, protein, electrolytes and essential fatty acids for adult patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. PERIKABIVEN may be used to prevent essential fatty acid deficiency or treat negative nitrogen balance in adult patients.</IndicationAndUsage>
<Description>PERIKABIVEN is a sterile, hypertonic emulsion, for peripheral or central venous administration, in a Three Chamber Bag. The product contains no added sulfites. Chamber 1 contains Dextrose monohydrate solution for fluid replenishment and caloric supply. Chamber 2 contains the Amino Acid solution with Electrolytes, which comprises essential and nonessential amino acids provided with electrolytes. Chamber 3 contains Intralipid® 20% (a 20% Lipid Injectable Emulsion), prepared for intravenous administration as a source of calories and essential fatty acids. See below for formulations of each chamber and Table 2 for strength, pH, osmolarity, ionic concentration and caloric content of PERIKABIVEN when all the chambers are mixed together. Chamber 1: Contains sterile, hypertonic solution of Dextrose, USP in water for injection with a pH range of 3.5 to 5.5. Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6 H2O) and has the following structure:. Dextrose is derived from corn. Chamber 2: Contains a sterile solution of amino acids and electrolytes in water for injection. In addition, glacial acetic acid has been added to adjust the pH so that the final solution pH is 5.4 to 5.8. The formulas for the individual electrolytes and amino acids are as follows:. Chamber 3: Contains a 20% Lipid Injectable Emulsion (Intralipid® 20%) which is made up of 20% Soybean Oil, 1.2% Egg Yolk Phospholipids, 2.25% Glycerin, and water for injection. In addition, sodium hydroxide has been added to adjust the pH. The final product pH range is 6 to 9. The soybean oil is a refined natural product consisting of a mixture of neutral triglycerides of predominantly unsaturated fatty acids with the following structure:. where are saturated and unsaturated fatty acid residues. The major component fatty acids are linoleic (48 to 58 %), oleic (17 to 30%), palmitic (9 to 13%), linolenic (5 to 11%) and stearic acid (2.5 to 5%). These fatty acids have the following chemical and structural formulas:. Purified egg phosphatides are a mixture of naturally occurring phospholipids which are isolated from the egg yolk. These phospholipids have the following general structure:. contain saturated and unsaturated fatty acids that abound in neutral fats. R3 is primarily either the choline or ethanolamine ester of phosphoric acid. Glycerin is chemically designated C3H8O3 and is a clear colorless, hygroscopic syrupy liquid. It has the following structural formula:. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional oxygen and moisture barrier when necessary. An oxygen absorber is placed between the inner bag and the overpouch. The container is not made with natural rubber latex or polyvinyl chloride (PVC). PERIKABIVEN contains no more than 25 mcg/L of aluminum.</Description>
</NDC>
<NDC>
<NDCCode>63323-714-24</NDCCode>
<PackageDescription>2400 mL in 1 BAG (63323-714-24) </PackageDescription>
<NDC11Code>63323-0714-24</NDC11Code>
<ProductNDC>63323-714</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Perikabiven</ProprietaryName>
<NonProprietaryName>Dextrose, Soybean Oil, Electrolytes, Lysine, Phenylalanine, Leucine, Valine, Threonine, Methionine, Isoleucine, Tryptophan, Alanine, Arginine, Glycine, Proline, Histidine, Glutamic Acid, Serine, Aspartic Acid And Tyrosine</NonProprietaryName>
<DosageFormName>INJECTION, EMULSION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20140825</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA200656</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>ALANINE; ARGININE; ASPARTIC ACID; CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; GLUTAMIC ACID; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE HYDROCHLORIDE; MAGNESIUM SULFATE HEPTAHYDRATE; METHIONINE; PHENYLALANINE; POTASSIUM CHLORIDE; PROLINE; SERINE; SODIUM ACETATE; SODIUM GLYCEROPHOSPHATE ANHYDROUS; SOYBEAN OIL; THREONINE; TRYPTOPHAN; TYROSINE; VALINE</SubstanceName>
<StrengthNumber>333; 235; 71; 20; 6.8; 116; 164; 141; 116; 164; 187; 68; 116; 164; 174; 141; 94; 170; 105; 3.5; 116; 40; 4.8; 152</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Amino Acid [EPC], Amino Acids [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Lipid Emulsion [EPC], Lipids [CS], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-02-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140825</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68040-714-08</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 CARTON (68040-714-08) / 10 g in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>68040-0714-08</NDC11Code>
<ProductNDC>68040-714</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sernivo</ProprietaryName>
<NonProprietaryName>Betamethasone Dipropionate</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210628</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208079</ApplicationNumber>
<LabelerName>Primus Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>BETAMETHASONE DIPROPIONATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210628</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SERNIVO Spray is indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older.</IndicationAndUsage>
<Description>SERNIVO Spray contains 0.0643% betamethasone dipropionate (equivalent to 0.05% betamethasone), a synthetic, fluorinated corticosteroid for topical use. The chemical name for betamethasone dipropionate is 9-fluoro-11(β), 17, 21-trihydroxy-16(β)-methylpregna-1,4-diene-3,20-dione-17,21-dipropionate. The empirical formula is C28H37FO7 and the molecular weight is 504.6. The structural formula is shown below. Each gram of SERNIVO Spray contains 0.643 mg of betamethasone dipropionate USP (equivalent to 0.5 mg betamethasone) in a slightly thickened, white to off-white, oil-in-water, non-sterile emulsion with the following inactive ingredients: butylated hydroxytoluene, cetostearyl alcohol, hydroxyethyl cellulose, methylparaben, mineral oil, oleyl alcohol, polyoxyl 20 cetostearyl ether, propylparaben, purified water, and sorbitan monostearate. SERNIVO Spray is co-packaged with a manual spray pump for installation by the pharmacist prior to dispensing to patients.</Description>
</NDC>
<NDC>
<NDCCode>68040-714-28</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 CARTON (68040-714-28) / 120 g in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>68040-0714-28</NDC11Code>
<ProductNDC>68040-714</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sernivo</ProprietaryName>
<NonProprietaryName>Betamethasone Dipropionate</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210628</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208079</ApplicationNumber>
<LabelerName>Primus Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>BETAMETHASONE DIPROPIONATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210628</StartMarketingDatePackage>
<EndMarketingDatePackage>20280430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SERNIVO Spray is indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older.</IndicationAndUsage>
<Description>SERNIVO Spray contains 0.0643% betamethasone dipropionate (equivalent to 0.05% betamethasone), a synthetic, fluorinated corticosteroid for topical use. The chemical name for betamethasone dipropionate is 9-fluoro-11(β), 17, 21-trihydroxy-16(β)-methylpregna-1,4-diene-3,20-dione-17,21-dipropionate. The empirical formula is C28H37FO7 and the molecular weight is 504.6. The structural formula is shown below. Each gram of SERNIVO Spray contains 0.643 mg of betamethasone dipropionate USP (equivalent to 0.5 mg betamethasone) in a slightly thickened, white to off-white, oil-in-water, non-sterile emulsion with the following inactive ingredients: butylated hydroxytoluene, cetostearyl alcohol, hydroxyethyl cellulose, methylparaben, mineral oil, oleyl alcohol, polyoxyl 20 cetostearyl ether, propylparaben, purified water, and sorbitan monostearate. SERNIVO Spray is co-packaged with a manual spray pump for installation by the pharmacist prior to dispensing to patients.</Description>
</NDC>
<NDC>
<NDCCode>68047-714-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (68047-714-01) </PackageDescription>
<NDC11Code>68047-0714-01</NDC11Code>
<ProductNDC>68047-714</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline Hyclate</ProprietaryName>
<NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065287</ApplicationNumber>
<LabelerName>Larken Laboratories, Inc.</LabelerName>
<SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxycycline Hyclate is indicated for use as an adjunct to scaling and root planing to promote attachment level gain and to reduce pocket depth in patients with adult periodontitis.</IndicationAndUsage>
<Description>Doxycycline hyclate is available as a 20 mg tablet formulation of doxycycline for oral administration. The structural formula of doxycycline hyclate is. with an empirical formula of (C 22H 24N 2O 8HCl) 2C 2H 6OH 2O and a molecular weight of 1025.89. The chemical designation for doxycycline is 4-(dimethylamino)-1, 4, 4a, 5, 5a, 6, 11, 12a–octahydro-3, 5, 10, 12, 12a–octahydro-3, 5, 10, 12, 12a-pentahydroxy-6-methyl-1, 11-dioxo-2-naphthacenecarboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline hyclate is a yellow to light-yellow crystalline powder which is soluble in water.</Description>
</NDC>
<NDC>
<NDCCode>68047-714-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (68047-714-60) </PackageDescription>
<NDC11Code>68047-0714-60</NDC11Code>
<ProductNDC>68047-714</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline Hyclate</ProprietaryName>
<NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065287</ApplicationNumber>
<LabelerName>Larken Laboratories, Inc.</LabelerName>
<SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Doxycycline Hyclate is indicated for use as an adjunct to scaling and root planing to promote attachment level gain and to reduce pocket depth in patients with adult periodontitis.</IndicationAndUsage>
<Description>Doxycycline hyclate is available as a 20 mg tablet formulation of doxycycline for oral administration. The structural formula of doxycycline hyclate is. with an empirical formula of (C 22H 24N 2O 8HCl) 2C 2H 6OH 2O and a molecular weight of 1025.89. The chemical designation for doxycycline is 4-(dimethylamino)-1, 4, 4a, 5, 5a, 6, 11, 12a–octahydro-3, 5, 10, 12, 12a–octahydro-3, 5, 10, 12, 12a-pentahydroxy-6-methyl-1, 11-dioxo-2-naphthacenecarboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline hyclate is a yellow to light-yellow crystalline powder which is soluble in water.</Description>
</NDC>
</NDCList>