{
"NDC": [
{
"NDCCode": "64893-440-08",
"PackageDescription": "237 mL in 1 BOTTLE (64893-440-08) ",
"NDC11Code": "64893-0440-08",
"ProductNDC": "64893-440",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Smileguard Strawberry Shortcake Bubblegum",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "MOUTHWASH",
"RouteName": "ORAL",
"StartMarketingDate": "20111209",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part355",
"LabelerName": "Dr. Fresh LLC",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": ".2",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2021-07-27",
"PackageNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20111209",
"SamplePackage": "N"
},
{
"NDCCode": "64893-100-08",
"PackageDescription": "236 mL in 1 BOTTLE (64893-100-08) ",
"NDC11Code": "64893-0100-08",
"ProductNDC": "64893-100",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Infectiguard Fast Acting Antiseptic Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20091230",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Dr. Fresh, Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "62",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20091230",
"SamplePackage": "N"
},
{
"NDCCode": "64893-200-08",
"PackageDescription": "236 mL in 1 BOTTLE (64893-200-08) ",
"NDC11Code": "64893-0200-08",
"ProductNDC": "64893-200",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Infectiguard Fast Acting Antiseptic Hand Sanitizer With Moisturizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20091230",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Dr. Fresh, Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "62",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180723",
"SamplePackage": "N"
},
{
"NDCCode": "64893-441-08",
"PackageDescription": "237 mL in 1 BOTTLE (64893-441-08) ",
"NDC11Code": "64893-0441-08",
"ProductNDC": "64893-441",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Smileguard Spider Sense Spider-man Bubblegum",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "MOUTHWASH",
"RouteName": "ORAL",
"StartMarketingDate": "20111209",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part355",
"LabelerName": "Dr. Fresh LLC",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": ".2",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2021-07-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20111209",
"SamplePackage": "N"
},
{
"NDCCode": "37000-440-08",
"PackageDescription": "236 mL in 1 BOTTLE, PLASTIC (37000-440-08) ",
"NDC11Code": "37000-0440-08",
"ProductNDC": "37000-440",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pepto-bismol",
"ProprietaryNameSuffix": "Ultra",
"NonProprietaryName": "Bismuth Subsalicylate",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20180301",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M008",
"LabelerName": "The Procter & Gamble Manufacturing Company",
"SubstanceName": "BISMUTH SUBSALICYLATE",
"StrengthNumber": "525",
"StrengthUnit": "mg/15mL",
"Status": "Active",
"LastUpdate": "2026-03-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20180301",
"SamplePackage": "N",
"IndicationAndUsage": "relieves: 1 travelers' diarrhea, 2 diarrhea, 3 upset stomach due to overindulgence in food and drink, including:, 4 heartburn, 5 indigestion, 6 nausea, 7 gas, 8 belching, 9 fullness."
},
{
"NDCCode": "62756-440-08",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (62756-440-08)",
"NDC11Code": "62756-0440-08",
"ProductNDC": "62756-440",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Donepezil Hydrochloride",
"NonProprietaryName": "Donepezil Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090493",
"LabelerName": "Sun Pharmaceutical Industries Limited",
"SubstanceName": "DONEPEZIL HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-02-17"
},
{
"NDCCode": "71919-440-08",
"PackageDescription": "30 mL in 1 VIAL, GLASS (71919-440-08) ",
"NDC11Code": "71919-0440-08",
"ProductNDC": "71919-440",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Manganum Aceticum",
"NonProprietaryName": "Manganese Acetate Tetrahydrate",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20100401",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "MANGANESE ACETATE TETRAHYDRATE",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/mL",
"Pharm_Classes": "Magnetic Resonance Contrast Activity [MoA], Paramagnetic Contrast Agent [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-03-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20100401",
"SamplePackage": "N"
},
{
"NDCCode": "75582-440-08",
"PackageDescription": "2011 mL in 1 BOTTLE, PUMP (75582-440-08) ",
"NDC11Code": "75582-0440-08",
"ProductNDC": "75582-440",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200730",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Lustrous Metal Coatings, Inc.",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2023-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20200730",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "64893-802-00",
"PackageDescription": "1 TUBE in 1 POUCH (64893-802-00) > 28 g in 1 TUBE",
"NDC11Code": "64893-0802-00",
"ProductNDC": "64893-802",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Firefly Pediatric",
"NonProprietaryName": "Sodium Monofluorophosphate",
"DosageFormName": "PASTE",
"RouteName": "DENTAL",
"StartMarketingDate": "20110817",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part355",
"LabelerName": "Dr. Fresh, LLC",
"SubstanceName": "SODIUM MONOFLUOROPHOSPHATE",
"StrengthNumber": ".1",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20110817",
"SamplePackage": "N",
"IndicationAndUsage": "Use: Helps prevent against cavities.",
"Description": "DR.Fresh. USA - Dr.Fresh Inc., CA - Dr.Fresh Inc. Buena Park,CA 90620 USA Ontario,Canada L7C2T4. U.K. - Dr.Fresh UK LTD. \"FireFly\" and related. Winchester House, London, trademark are owned by. NW1 5RA Dr.Fresh Inc., U.S.A."
},
{
"NDCCode": "29300-440-19",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (29300-440-19) ",
"NDC11Code": "29300-0440-19",
"ProductNDC": "29300-440",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pregabalin",
"NonProprietaryName": "Pregabalin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20260803",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219593",
"LabelerName": "Unichem Pharmaceuticals (USA), Inc.",
"SubstanceName": "PREGABALIN",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2026-08-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260803",
"SamplePackage": "N",
"IndicationAndUsage": "Pregabalin capsules are indicated for. Management of neuropathic pain associated with diabetic peripheral neuropathy. Management of postherpetic neuralgia. Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older. Management of fibromyalgia. Management of neuropathic pain associated with spinal cord injury.",
"Description": "Pregabalin, USP is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin, USP is a white or almost white powder with a pKa1 of 4.4 and a pKa2 of 10.1. It is sparingly soluble in water, very slightly soluble to practically insoluble in methanol, acetonitrile and practically insoluble in heptane. The log of the partition coefficient is – 1.0. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with hydroxypropyl cellulose, mannitol, pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin, sodium lauryl sulfate, and titanium dioxide. In addition, the 25 mg,50 mg and 300 mg capsule shells contains FD & C Yellow# 6.The 100 mg, 150 mg, 200 mg and 225 mg capsule shells contains FD & C Blue 1.The imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol and shellac."
},
{
"NDCCode": "41167-1092-8",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (41167-1092-8) > 9 LOZENGE in 1 BLISTER PACK",
"NDC11Code": "41167-1092-08",
"ProductNDC": "41167-1092",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rolaids Heartburn Soothers",
"NonProprietaryName": "Calcium Carbonate And Magnesium Hydroxide",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL",
"StartMarketingDate": "20190201",
"EndMarketingDate": "20210513",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part331",
"LabelerName": "Chattem, Inc.",
"SubstanceName": "CALCIUM CARBONATE; MAGNESIUM HYDROXIDE",
"StrengthNumber": "440; 90",
"StrengthUnit": "mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2021-05-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190201",
"EndMarketingDatePackage": "20210513",
"SamplePackage": "N"
},
{
"NDCCode": "42627-440-01",
"PackageDescription": "1 TUBE in 1 CARTON (42627-440-01) / 50 mL in 1 TUBE",
"NDC11Code": "42627-0440-01",
"ProductNDC": "42627-440",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Illusion Hyaluronic Skin Tint Oil Free Sunscreen Broad Spectrum Vanilla",
"ProprietaryNameSuffix": "Spf 15",
"NonProprietaryName": "Octonoxate, Octisalate, Titanium Dioxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210630",
"EndMarketingDate": "20230818",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "M020",
"LabelerName": "Kingdon Animalia, LLC DBA Hourglass Cosmetics",
"SubstanceName": "OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE",
"StrengthNumber": "7; 4; 4",
"StrengthUnit": "g/100mL; g/100mL; g/100mL",
"Status": "Deprecated",
"LastUpdate": "2023-08-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20210630",
"EndMarketingDatePackage": "20230818",
"SamplePackage": "N"
},
{
"NDCCode": "50268-440-15",
"PackageDescription": "50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-440-15) / 1 TABLET in 1 BLISTER PACK (50268-440-11) ",
"NDC11Code": "50268-0440-15",
"ProductNDC": "50268-440",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Irbesartan",
"NonProprietaryName": "Irbesartan",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230808",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202910",
"LabelerName": "AvPAK",
"SubstanceName": "IRBESARTAN",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230808",
"SamplePackage": "N",
"IndicationAndUsage": "1.1 Hypertension Irbesartan tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular (CV) events, primarily strokes and myocardial infarction. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention. Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Irbesartan tablets may be used alone or in combination with other antihypertensive agents. 1.2 Nephropathy in Type 2 Diabetic Patients Irbesartan tablets are indicated for the treatment of diabetic nephropathy in patients with type 2 diabetes and hypertension, an elevated serum creatinine, and proteinuria (>300 mg/day). In this population, irbesartan reduces the rate of progression of nephropathy as measured by the occurrence of doubling of serum creatinine or end-stage renal disease (need for dialysis or renal transplantation) [see Clinical Studies (14.2)].",
"Description": "Irbesartan USP is an angiotensin II receptor (AT1 subtype) antagonist. Irbesartan USP is a non-peptide compound, chemically described as a 2-butyl-3-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]-1,3-diazaspiro[4.4]non-1-en-4-one. Its empirical formula is C 25H 28N 6O, and the structural formula: Irbesartan USP is a white to off-white crystalline powder with a molecular weight of 428.5. It is a nonpolar compound with a partition coefficient (octanol/water) of 10.1 at pH of 7.4. Irbesartan is slightly soluble in alcohol and methylene chloride and practically insoluble in water. Irbesartan is available for oral administration in unscored tablets containing 75 mg, 150 mg, or 300 mg of Irbesartan USP. Inactive ingredients include: calcium stearate, carboxy methyl cellulose calcium, colloidal silicon dioxide, microcrystalline cellulose and povidone."
},
{
"NDCCode": "50563-440-01",
"PackageDescription": "1 KIT in 1 KIT (50563-440-01) * 20 APPLICATOR in 1 PACKET (50563-439-01) > 6 mL in 1 APPLICATOR * 20 APPLICATOR in 1 PACKET (50563-438-01) > 6 mL in 1 APPLICATOR * 20 APPLICATOR in 1 PACKET (50563-437-01) > 6 mL in 1 APPLICATOR",
"NDC11Code": "50563-0440-01",
"ProductNDC": "50563-440",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Beauty Concepts Antibacterial Hand Wipes Vanilla Sugar Peppermint Winter Berry 3 Pack Special Offer",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "KIT",
"StartMarketingDate": "20210630",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "ENCHANTE ACCESSORIES INC.",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20210630",
"SamplePackage": "N"
},
{
"NDCCode": "51407-440-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (51407-440-30) ",
"NDC11Code": "51407-0440-30",
"ProductNDC": "51407-440",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tamoxifen Citrate",
"NonProprietaryName": "Tamoxifen Citrate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20030220",
"EndMarketingDate": "20250731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075797",
"LabelerName": "Golden State Medical Supply, Inc.",
"SubstanceName": "TAMOXIFEN CITRATE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Estrogen Agonist/Antagonist [EPC], Selective Estrogen Receptor Modulators [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20210802",
"EndMarketingDatePackage": "20250731",
"SamplePackage": "N",
"IndicationAndUsage": "Tamoxifen citrate tablets are effective in the treatment of metastatic breast cancer in women and men. In premenopausal women with metastatic breast cancer, tamoxifen is an alternative to oophorectomy or ovarian irradiation. Available evidence indicates that patients whose tumors are estrogen receptor positive are more likely to benefit from tamoxifen therapy.",
"Description": "Tamoxifen citrate tablets USP, a nonsteroidal antiestrogen, are for oral administration. Each tablet contains 10 mg or 20 mg tamoxifen (equivalent to 15.2 mg or 30.4 mg, respectively, of tamoxifen citrate, USP). Each tablet contains the following inactive ingredients: croscarmellose sodium, hypromellose, lactose (monohydrate), magnesium stearate, polyethylene glycol 400, povidone, corn starch, and titanium dioxide. Chemically, tamoxifen is the trans-isomer of a triphenylethylene derivative. The chemical name is (Z)2-[4-(1,2-diphenyl-1-butenyl)phenoxy]- N, N-dimethylethanamine 2-hydroxy-1,2,3- propanetricarboxylate (1:1). The structural formula, empirical formula, and molecular weight are as follows:. Tamoxifen citrate has a pKa' of 8.85, the equilibrium solubility in water at 37°C is 0.5 mg/mL and in 0.02 N HCl at 37°C, it is 0.2 mg/mL."
},
{
"NDCCode": "55570-440-11",
"PackageDescription": "50 kg in 1 DRUM (55570-440-11) ",
"NDC11Code": "55570-0440-11",
"ProductNDC": "55570-440",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Sodium Phosphate Dibasic Dihydrate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20081205",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Jost Chemical Co.",
"SubstanceName": "SODIUM PHOSPHATE DIBASIC DIHYDRATE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2026-04-22",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "05-DEC-08"
},
{
"NDCCode": "55570-440-12",
"PackageDescription": "25 kg in 1 BOX (55570-440-12) ",
"NDC11Code": "55570-0440-12",
"ProductNDC": "55570-440",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Sodium Phosphate Dibasic Dihydrate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20081205",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Jost Chemical Co.",
"SubstanceName": "SODIUM PHOSPHATE DIBASIC DIHYDRATE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2026-04-22",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "05-DEC-08"
},
{
"NDCCode": "55910-440-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (55910-440-01) / 100 TABLET, COATED in 1 BOTTLE",
"NDC11Code": "55910-0440-01",
"ProductNDC": "55910-440",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Extra Strength Headache Relief",
"NonProprietaryName": "Acetaminophen, Aspirin, And Caffeine",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210501",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Dollar General",
"SubstanceName": "ACETAMINOPHEN; ASPIRIN; CAFFEINE",
"StrengthNumber": "250; 250; 65",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]",
"Status": "Active",
"LastUpdate": "2025-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210501",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieves minor aches and pains due to: headache a cold arthritis muscular aches toothache premenstrual & menstrual cramps."
},
{
"NDCCode": "57962-007-12",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (57962-007-12) / 108 mL in 1 BOTTLE, GLASS",
"NDC11Code": "57962-0007-12",
"ProductNDC": "57962-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Imbruvica",
"NonProprietaryName": "Ibrutinib",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20220824",
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"ApplicationNumber": "NDA217003",
"LabelerName": "Pharmacyclics LLC",
"SubstanceName": "IBRUTINIB",
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"StrengthUnit": "mg/mL",
"Pharm_Classes": "Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-08",
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"IndicationAndUsage": "IMBRUVICA is a kinase inhibitor indicated for the treatment of: 1 Adult patients with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) (1.1)., 2 Adult patients with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion (1.2)., 3 Adult patients with Waldenström’s macroglobulinemia (WM) (1.3). , 4 Adult and pediatric patients age 1 year and older with chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy (1.4).",
"Description": "Ibrutinib is a kinase inhibitor. It is a white to off-white solid with the empirical formula C25H24N6O2 and a molecular weight 440.50. Ibrutinib is freely soluble in dimethyl sulfoxide, soluble in methanol and practically insoluble in water. The chemical name for ibrutinib is 1-[(3R)-3-[4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl]-1-piperidinyl]-2-propen-1-one and has the following structure. IMBRUVICA (ibrutinib) is available as immediate-release oral capsules, immediate-release oral tablets, and immediate-release oral suspension. IMBRUVICA (ibrutinib) capsules for oral use are available in the following dosage strengths: 70 mg and 140 mg. Each capsule contains ibrutinib (active ingredient) and the following inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate. The capsule shell contains gelatin, titanium dioxide, yellow iron oxide (70 mg capsule only), and black ink. IMBRUVICA (ibrutinib) tablets for oral use are available in the following dosage strengths: 140 mg, 280 mg, and 420 mg. Each tablet contains ibrutinib (active ingredient) and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate. The film coating for each tablet contains ferrosoferric oxide (140 mg, 280 mg, and 420 mg tablets), polyvinyl alcohol, polyethylene glycol, red iron oxide (280 mg tablets), talc, titanium dioxide, and yellow iron oxide (140 mg and 420 mg tablets). IMBRUVICA (ibrutinib) oral suspension contains 70 mg/mL ibrutinib (active ingredient) and the following inactive ingredients: benzyl alcohol, citric acid monohydrate, disodium hydrogen phosphate, hypromellose, microcrystalline cellulose and carboxymethylcellulose sodium, purified water and sucralose."
},
{
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"ProductNDC": "57962-014",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Imbruvica",
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"ApplicationNumber": "NDA210563",
"LabelerName": "Pharmacyclics LLC",
"SubstanceName": "IBRUTINIB",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-08",
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"IndicationAndUsage": "IMBRUVICA is a kinase inhibitor indicated for the treatment of: 1 Adult patients with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) (1.1)., 2 Adult patients with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion (1.2)., 3 Adult patients with Waldenström’s macroglobulinemia (WM) (1.3). , 4 Adult and pediatric patients age 1 year and older with chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy (1.4).",
"Description": "Ibrutinib is a kinase inhibitor. It is a white to off-white solid with the empirical formula C25H24N6O2 and a molecular weight 440.50. Ibrutinib is freely soluble in dimethyl sulfoxide, soluble in methanol and practically insoluble in water. The chemical name for ibrutinib is 1-[(3R)-3-[4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl]-1-piperidinyl]-2-propen-1-one and has the following structure. IMBRUVICA (ibrutinib) is available as immediate-release oral capsules, immediate-release oral tablets, and immediate-release oral suspension. IMBRUVICA (ibrutinib) capsules for oral use are available in the following dosage strengths: 70 mg and 140 mg. Each capsule contains ibrutinib (active ingredient) and the following inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate. The capsule shell contains gelatin, titanium dioxide, yellow iron oxide (70 mg capsule only), and black ink. IMBRUVICA (ibrutinib) tablets for oral use are available in the following dosage strengths: 140 mg, 280 mg, and 420 mg. Each tablet contains ibrutinib (active ingredient) and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate. The film coating for each tablet contains ferrosoferric oxide (140 mg, 280 mg, and 420 mg tablets), polyvinyl alcohol, polyethylene glycol, red iron oxide (280 mg tablets), talc, titanium dioxide, and yellow iron oxide (140 mg and 420 mg tablets). IMBRUVICA (ibrutinib) oral suspension contains 70 mg/mL ibrutinib (active ingredient) and the following inactive ingredients: benzyl alcohol, citric acid monohydrate, disodium hydrogen phosphate, hypromellose, microcrystalline cellulose and carboxymethylcellulose sodium, purified water and sucralose."
},
{
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"PackageDescription": "28 CAPSULE in 1 BOTTLE, PLASTIC (57962-070-28) ",
"NDC11Code": "57962-0070-28",
"ProductNDC": "57962-070",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Imbruvica",
"NonProprietaryName": "Ibrutinib",
"DosageFormName": "CAPSULE",
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"StartMarketingDate": "20171220",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205552",
"LabelerName": "Pharmacyclics LLC",
"SubstanceName": "IBRUTINIB",
"StrengthNumber": "70",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "IMBRUVICA is a kinase inhibitor indicated for the treatment of: 1 Adult patients with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) (1.1)., 2 Adult patients with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion (1.2)., 3 Adult patients with Waldenström’s macroglobulinemia (WM) (1.3). , 4 Adult and pediatric patients age 1 year and older with chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy (1.4).",
"Description": "Ibrutinib is a kinase inhibitor. It is a white to off-white solid with the empirical formula C25H24N6O2 and a molecular weight 440.50. Ibrutinib is freely soluble in dimethyl sulfoxide, soluble in methanol and practically insoluble in water. The chemical name for ibrutinib is 1-[(3R)-3-[4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl]-1-piperidinyl]-2-propen-1-one and has the following structure. IMBRUVICA (ibrutinib) is available as immediate-release oral capsules, immediate-release oral tablets, and immediate-release oral suspension. IMBRUVICA (ibrutinib) capsules for oral use are available in the following dosage strengths: 70 mg and 140 mg. Each capsule contains ibrutinib (active ingredient) and the following inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate. The capsule shell contains gelatin, titanium dioxide, yellow iron oxide (70 mg capsule only), and black ink. IMBRUVICA (ibrutinib) tablets for oral use are available in the following dosage strengths: 140 mg, 280 mg, and 420 mg. Each tablet contains ibrutinib (active ingredient) and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate. The film coating for each tablet contains ferrosoferric oxide (140 mg, 280 mg, and 420 mg tablets), polyvinyl alcohol, polyethylene glycol, red iron oxide (280 mg tablets), talc, titanium dioxide, and yellow iron oxide (140 mg and 420 mg tablets). IMBRUVICA (ibrutinib) oral suspension contains 70 mg/mL ibrutinib (active ingredient) and the following inactive ingredients: benzyl alcohol, citric acid monohydrate, disodium hydrogen phosphate, hypromellose, microcrystalline cellulose and carboxymethylcellulose sodium, purified water and sucralose."
},
{
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"PackageDescription": "90 CAPSULE in 1 BOTTLE, PLASTIC (57962-140-09) ",
"NDC11Code": "57962-0140-09",
"ProductNDC": "57962-140",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Imbruvica",
"NonProprietaryName": "Ibrutinib",
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"RouteName": "ORAL",
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"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205552",
"LabelerName": "Pharmacyclics LLC",
"SubstanceName": "IBRUTINIB",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-08",
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"IndicationAndUsage": "IMBRUVICA is a kinase inhibitor indicated for the treatment of: 1 Adult patients with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) (1.1)., 2 Adult patients with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion (1.2)., 3 Adult patients with Waldenström’s macroglobulinemia (WM) (1.3). , 4 Adult and pediatric patients age 1 year and older with chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy (1.4).",
"Description": "Ibrutinib is a kinase inhibitor. It is a white to off-white solid with the empirical formula C25H24N6O2 and a molecular weight 440.50. Ibrutinib is freely soluble in dimethyl sulfoxide, soluble in methanol and practically insoluble in water. The chemical name for ibrutinib is 1-[(3R)-3-[4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl]-1-piperidinyl]-2-propen-1-one and has the following structure. IMBRUVICA (ibrutinib) is available as immediate-release oral capsules, immediate-release oral tablets, and immediate-release oral suspension. IMBRUVICA (ibrutinib) capsules for oral use are available in the following dosage strengths: 70 mg and 140 mg. Each capsule contains ibrutinib (active ingredient) and the following inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate. The capsule shell contains gelatin, titanium dioxide, yellow iron oxide (70 mg capsule only), and black ink. IMBRUVICA (ibrutinib) tablets for oral use are available in the following dosage strengths: 140 mg, 280 mg, and 420 mg. Each tablet contains ibrutinib (active ingredient) and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate. The film coating for each tablet contains ferrosoferric oxide (140 mg, 280 mg, and 420 mg tablets), polyvinyl alcohol, polyethylene glycol, red iron oxide (280 mg tablets), talc, titanium dioxide, and yellow iron oxide (140 mg and 420 mg tablets). IMBRUVICA (ibrutinib) oral suspension contains 70 mg/mL ibrutinib (active ingredient) and the following inactive ingredients: benzyl alcohol, citric acid monohydrate, disodium hydrogen phosphate, hypromellose, microcrystalline cellulose and carboxymethylcellulose sodium, purified water and sucralose."
},
{
"NDCCode": "57962-140-12",
"PackageDescription": "120 CAPSULE in 1 BOTTLE, PLASTIC (57962-140-12) ",
"NDC11Code": "57962-0140-12",
"ProductNDC": "57962-140",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Imbruvica",
"NonProprietaryName": "Ibrutinib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20131113",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205552",
"LabelerName": "Pharmacyclics LLC",
"SubstanceName": "IBRUTINIB",
"StrengthNumber": "140",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"IndicationAndUsage": "IMBRUVICA is a kinase inhibitor indicated for the treatment of: 1 Adult patients with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) (1.1)., 2 Adult patients with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion (1.2)., 3 Adult patients with Waldenström’s macroglobulinemia (WM) (1.3). , 4 Adult and pediatric patients age 1 year and older with chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy (1.4).",
"Description": "Ibrutinib is a kinase inhibitor. It is a white to off-white solid with the empirical formula C25H24N6O2 and a molecular weight 440.50. Ibrutinib is freely soluble in dimethyl sulfoxide, soluble in methanol and practically insoluble in water. The chemical name for ibrutinib is 1-[(3R)-3-[4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl]-1-piperidinyl]-2-propen-1-one and has the following structure. IMBRUVICA (ibrutinib) is available as immediate-release oral capsules, immediate-release oral tablets, and immediate-release oral suspension. IMBRUVICA (ibrutinib) capsules for oral use are available in the following dosage strengths: 70 mg and 140 mg. Each capsule contains ibrutinib (active ingredient) and the following inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate. The capsule shell contains gelatin, titanium dioxide, yellow iron oxide (70 mg capsule only), and black ink. IMBRUVICA (ibrutinib) tablets for oral use are available in the following dosage strengths: 140 mg, 280 mg, and 420 mg. Each tablet contains ibrutinib (active ingredient) and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate. The film coating for each tablet contains ferrosoferric oxide (140 mg, 280 mg, and 420 mg tablets), polyvinyl alcohol, polyethylene glycol, red iron oxide (280 mg tablets), talc, titanium dioxide, and yellow iron oxide (140 mg and 420 mg tablets). IMBRUVICA (ibrutinib) oral suspension contains 70 mg/mL ibrutinib (active ingredient) and the following inactive ingredients: benzyl alcohol, citric acid monohydrate, disodium hydrogen phosphate, hypromellose, microcrystalline cellulose and carboxymethylcellulose sodium, purified water and sucralose."
},
{
"NDCCode": "57962-280-28",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (57962-280-28) / 28 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "57962-0280-28",
"ProductNDC": "57962-280",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Imbruvica",
"NonProprietaryName": "Ibrutinib",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180216",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210563",
"LabelerName": "Pharmacyclics LLC",
"SubstanceName": "IBRUTINIB",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-08",
"PackageNdcExcludeFlag": "N",
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"IndicationAndUsage": "IMBRUVICA is a kinase inhibitor indicated for the treatment of: 1 Adult patients with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) (1.1)., 2 Adult patients with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion (1.2)., 3 Adult patients with Waldenström’s macroglobulinemia (WM) (1.3). , 4 Adult and pediatric patients age 1 year and older with chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy (1.4).",
"Description": "Ibrutinib is a kinase inhibitor. It is a white to off-white solid with the empirical formula C25H24N6O2 and a molecular weight 440.50. Ibrutinib is freely soluble in dimethyl sulfoxide, soluble in methanol and practically insoluble in water. The chemical name for ibrutinib is 1-[(3R)-3-[4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl]-1-piperidinyl]-2-propen-1-one and has the following structure. IMBRUVICA (ibrutinib) is available as immediate-release oral capsules, immediate-release oral tablets, and immediate-release oral suspension. IMBRUVICA (ibrutinib) capsules for oral use are available in the following dosage strengths: 70 mg and 140 mg. Each capsule contains ibrutinib (active ingredient) and the following inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate. The capsule shell contains gelatin, titanium dioxide, yellow iron oxide (70 mg capsule only), and black ink. IMBRUVICA (ibrutinib) tablets for oral use are available in the following dosage strengths: 140 mg, 280 mg, and 420 mg. Each tablet contains ibrutinib (active ingredient) and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate. The film coating for each tablet contains ferrosoferric oxide (140 mg, 280 mg, and 420 mg tablets), polyvinyl alcohol, polyethylene glycol, red iron oxide (280 mg tablets), talc, titanium dioxide, and yellow iron oxide (140 mg and 420 mg tablets). IMBRUVICA (ibrutinib) oral suspension contains 70 mg/mL ibrutinib (active ingredient) and the following inactive ingredients: benzyl alcohol, citric acid monohydrate, disodium hydrogen phosphate, hypromellose, microcrystalline cellulose and carboxymethylcellulose sodium, purified water and sucralose."
},
{
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"PackageDescription": "1 BLISTER PACK in 1 CARTON (57962-420-28) / 28 TABLET, FILM COATED in 1 BLISTER PACK",
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"ProductNDC": "57962-420",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Imbruvica",
"NonProprietaryName": "Ibrutinib",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180216",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210563",
"LabelerName": "Pharmacyclics LLC",
"SubstanceName": "IBRUTINIB",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-08",
"PackageNdcExcludeFlag": "N",
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"IndicationAndUsage": "IMBRUVICA is a kinase inhibitor indicated for the treatment of: 1 Adult patients with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) (1.1)., 2 Adult patients with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion (1.2)., 3 Adult patients with Waldenström’s macroglobulinemia (WM) (1.3). , 4 Adult and pediatric patients age 1 year and older with chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy (1.4).",
"Description": "Ibrutinib is a kinase inhibitor. It is a white to off-white solid with the empirical formula C25H24N6O2 and a molecular weight 440.50. Ibrutinib is freely soluble in dimethyl sulfoxide, soluble in methanol and practically insoluble in water. The chemical name for ibrutinib is 1-[(3R)-3-[4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl]-1-piperidinyl]-2-propen-1-one and has the following structure. IMBRUVICA (ibrutinib) is available as immediate-release oral capsules, immediate-release oral tablets, and immediate-release oral suspension. IMBRUVICA (ibrutinib) capsules for oral use are available in the following dosage strengths: 70 mg and 140 mg. Each capsule contains ibrutinib (active ingredient) and the following inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate. The capsule shell contains gelatin, titanium dioxide, yellow iron oxide (70 mg capsule only), and black ink. IMBRUVICA (ibrutinib) tablets for oral use are available in the following dosage strengths: 140 mg, 280 mg, and 420 mg. Each tablet contains ibrutinib (active ingredient) and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate. The film coating for each tablet contains ferrosoferric oxide (140 mg, 280 mg, and 420 mg tablets), polyvinyl alcohol, polyethylene glycol, red iron oxide (280 mg tablets), talc, titanium dioxide, and yellow iron oxide (140 mg and 420 mg tablets). IMBRUVICA (ibrutinib) oral suspension contains 70 mg/mL ibrutinib (active ingredient) and the following inactive ingredients: benzyl alcohol, citric acid monohydrate, disodium hydrogen phosphate, hypromellose, microcrystalline cellulose and carboxymethylcellulose sodium, purified water and sucralose."
},
{
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"ProductNDC": "58411-505",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Shiseido Synchro Skin Self-refreshing Foundation 440 Amber",
"NonProprietaryName": "Octinoxate And Titanium Dioxide",
"DosageFormName": "EMULSION",
"RouteName": "TOPICAL",
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"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
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"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE",
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"StrengthUnit": "g/30mL; g/30mL",
"Status": "Active",
"LastUpdate": "2026-01-08",
"PackageNdcExcludeFlag": "N",
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"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190901",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun ."
},
{
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"PackageDescription": "25 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-440-01) > 30 TABLET in 1 BLISTER PACK",
"NDC11Code": "63739-0440-01",
"ProductNDC": "63739-440",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acetaminophen",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090301",
"EndMarketingDate": "20210731",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "McKesson Packaging Services Business Unit of McKesson Corporation",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "325",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2021-08-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20090430",
"EndMarketingDatePackage": "20210731",
"SamplePackage": "N"
},
{
"NDCCode": "63776-440-11",
"PackageDescription": ".5 mL in 1 AMPULE (63776-440-11) ",
"NDC11Code": "63776-0440-11",
"ProductNDC": "63776-440",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pollens Early",
"NonProprietaryName": "Adrenal, Apis, Early Season Allersode (ash, Beech, Birch, Cottonwood, Elm, Hickory, Maple, Red Oak, Sycamore, Walnut, Willow), Ethanol, Fumaria, Gallic Acid, Hepar Sulph Calc, Histamine, Interleukin-12 Human, Interferon Gamma-1a, Kali Carb, Lymph Node, Manganese, Pinus Sylvestre, Piper Nigrum, Prunus Spinosa, Quercetin, Rutin, Salsolinol, Silicea, Spleen, Sulphricum Acidum, Thymus, Tilia Tomentosa",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20120724",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "ACER SACCHARUM POLLEN; APIS MELLIFERA; BETULA NIGRA POLLEN; BLACK PEPPER; BOS TAURUS ADRENAL GLAND; BOS TAURUS LYMPH VESSEL; BOS TAURUS SPLEEN; BOS TAURUS THYMUS; CALCIUM SULFIDE; CARYA ALBA POLLEN; FAGUS GRANDIFOLIA POLLEN; FRAXINUS AMERICANA POLLEN; FUMARIA OFFICINALIS FLOWERING TOP; GALLIC ACID; HISTAMINE; INTERFERON GAMMA-1A; INTERLEUKIN-12 HUMAN; JUGLANS NIGRA POLLEN; MANGANESE; PINUS SYLVESTRIS SPROUT; PLATANUS RACEMOSA POLLEN; POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN; POTASSIUM CARBONATE; PRUNUS SPINOSA FLOWER BUD; QUERCETIN; QUERCUS RUBRA POLLEN; RUTIN; SALIX REPENS POLLEN; SALSOLINOL; SILICON DIOXIDE; SULFURIC ACID; SUS SCROFA ADRENAL GLAND; SUS SCROFA LYMPH VESSEL; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; TILIA TOMENTOSA BUD; ULMUS AMERICANA POLLEN",
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"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [hp_X]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
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"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20180301",
"SamplePackage": "N",
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},
{
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}
]
}
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<NDC>
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</NDC>
<NDC>
<NDCCode>71919-440-08</NDCCode>
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200730</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Lustrous Metal Coatings, Inc.</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200730</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>64893-802-00</NDCCode>
<PackageDescription>1 TUBE in 1 POUCH (64893-802-00) > 28 g in 1 TUBE</PackageDescription>
<NDC11Code>64893-0802-00</NDC11Code>
<ProductNDC>64893-802</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Firefly Pediatric</ProprietaryName>
<NonProprietaryName>Sodium Monofluorophosphate</NonProprietaryName>
<DosageFormName>PASTE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20110817</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part355</ApplicationNumber>
<LabelerName>Dr. Fresh, LLC</LabelerName>
<SubstanceName>SODIUM MONOFLUOROPHOSPHATE</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110817</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Use: Helps prevent against cavities.</IndicationAndUsage>
<Description>DR.Fresh. USA - Dr.Fresh Inc., CA - Dr.Fresh Inc. Buena Park,CA 90620 USA Ontario,Canada L7C2T4. U.K. - Dr.Fresh UK LTD. "FireFly" and related. Winchester House, London, trademark are owned by. NW1 5RA Dr.Fresh Inc., U.S.A.</Description>
</NDC>
<NDC>
<NDCCode>29300-440-19</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE (29300-440-19) </PackageDescription>
<NDC11Code>29300-0440-19</NDC11Code>
<ProductNDC>29300-440</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pregabalin</ProprietaryName>
<NonProprietaryName>Pregabalin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260803</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219593</ApplicationNumber>
<LabelerName>Unichem Pharmaceuticals (USA), Inc.</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-08-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260803</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pregabalin capsules are indicated for. Management of neuropathic pain associated with diabetic peripheral neuropathy. Management of postherpetic neuralgia. Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older. Management of fibromyalgia. Management of neuropathic pain associated with spinal cord injury.</IndicationAndUsage>
<Description>Pregabalin, USP is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is. Pregabalin, USP is a white or almost white powder with a pKa1 of 4.4 and a pKa2 of 10.1. It is sparingly soluble in water, very slightly soluble to practically insoluble in methanol, acetonitrile and practically insoluble in heptane. The log of the partition coefficient is – 1.0. Pregabalin capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with hydroxypropyl cellulose, mannitol, pregelatinized starch and talc as inactive ingredients. The capsule shells contain gelatin, sodium lauryl sulfate, and titanium dioxide. In addition, the 25 mg,50 mg and 300 mg capsule shells contains FD & C Yellow# 6.The 100 mg, 150 mg, 200 mg and 225 mg capsule shells contains FD & C Blue 1.The imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol and shellac.</Description>
</NDC>
<NDC>
<NDCCode>41167-1092-8</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (41167-1092-8) > 9 LOZENGE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>41167-1092-08</NDC11Code>
<ProductNDC>41167-1092</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Rolaids Heartburn Soothers</ProprietaryName>
<NonProprietaryName>Calcium Carbonate And Magnesium Hydroxide</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190201</StartMarketingDate>
<EndMarketingDate>20210513</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part331</ApplicationNumber>
<LabelerName>Chattem, Inc.</LabelerName>
<SubstanceName>CALCIUM CARBONATE; MAGNESIUM HYDROXIDE</SubstanceName>
<StrengthNumber>440; 90</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-05-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190201</StartMarketingDatePackage>
<EndMarketingDatePackage>20210513</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>42627-440-01</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (42627-440-01) / 50 mL in 1 TUBE</PackageDescription>
<NDC11Code>42627-0440-01</NDC11Code>
<ProductNDC>42627-440</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Illusion Hyaluronic Skin Tint Oil Free Sunscreen Broad Spectrum Vanilla</ProprietaryName>
<ProprietaryNameSuffix>Spf 15</ProprietaryNameSuffix>
<NonProprietaryName>Octonoxate, Octisalate, Titanium Dioxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210630</StartMarketingDate>
<EndMarketingDate>20230818</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Kingdon Animalia, LLC DBA Hourglass Cosmetics</LabelerName>
<SubstanceName>OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>7; 4; 4</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-08-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20210630</StartMarketingDatePackage>
<EndMarketingDatePackage>20230818</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50268-440-15</NDCCode>
<PackageDescription>50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-440-15) / 1 TABLET in 1 BLISTER PACK (50268-440-11) </PackageDescription>
<NDC11Code>50268-0440-15</NDC11Code>
<ProductNDC>50268-440</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Irbesartan</ProprietaryName>
<NonProprietaryName>Irbesartan</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230808</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202910</ApplicationNumber>
<LabelerName>AvPAK</LabelerName>
<SubstanceName>IRBESARTAN</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230808</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>1.1 Hypertension Irbesartan tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular (CV) events, primarily strokes and myocardial infarction. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention. Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Irbesartan tablets may be used alone or in combination with other antihypertensive agents. 1.2 Nephropathy in Type 2 Diabetic Patients Irbesartan tablets are indicated for the treatment of diabetic nephropathy in patients with type 2 diabetes and hypertension, an elevated serum creatinine, and proteinuria (>300 mg/day). In this population, irbesartan reduces the rate of progression of nephropathy as measured by the occurrence of doubling of serum creatinine or end-stage renal disease (need for dialysis or renal transplantation) [see Clinical Studies (14.2)].</IndicationAndUsage>
<Description>Irbesartan USP is an angiotensin II receptor (AT1 subtype) antagonist. Irbesartan USP is a non-peptide compound, chemically described as a 2-butyl-3-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]-1,3-diazaspiro[4.4]non-1-en-4-one. Its empirical formula is C 25H 28N 6O, and the structural formula: Irbesartan USP is a white to off-white crystalline powder with a molecular weight of 428.5. It is a nonpolar compound with a partition coefficient (octanol/water) of 10.1 at pH of 7.4. Irbesartan is slightly soluble in alcohol and methylene chloride and practically insoluble in water. Irbesartan is available for oral administration in unscored tablets containing 75 mg, 150 mg, or 300 mg of Irbesartan USP. Inactive ingredients include: calcium stearate, carboxy methyl cellulose calcium, colloidal silicon dioxide, microcrystalline cellulose and povidone.</Description>
</NDC>
<NDC>
<NDCCode>50563-440-01</NDCCode>
<PackageDescription>1 KIT in 1 KIT (50563-440-01) * 20 APPLICATOR in 1 PACKET (50563-439-01) > 6 mL in 1 APPLICATOR * 20 APPLICATOR in 1 PACKET (50563-438-01) > 6 mL in 1 APPLICATOR * 20 APPLICATOR in 1 PACKET (50563-437-01) > 6 mL in 1 APPLICATOR</PackageDescription>
<NDC11Code>50563-0440-01</NDC11Code>
<ProductNDC>50563-440</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Beauty Concepts Antibacterial Hand Wipes Vanilla Sugar Peppermint Winter Berry 3 Pack Special Offer</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20210630</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>ENCHANTE ACCESSORIES INC.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210630</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>51407-440-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (51407-440-30) </PackageDescription>
<NDC11Code>51407-0440-30</NDC11Code>
<ProductNDC>51407-440</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tamoxifen Citrate</ProprietaryName>
<NonProprietaryName>Tamoxifen Citrate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030220</StartMarketingDate>
<EndMarketingDate>20250731</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075797</ApplicationNumber>
<LabelerName>Golden State Medical Supply, Inc.</LabelerName>
<SubstanceName>TAMOXIFEN CITRATE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Estrogen Agonist/Antagonist [EPC], Selective Estrogen Receptor Modulators [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20210802</StartMarketingDatePackage>
<EndMarketingDatePackage>20250731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tamoxifen citrate tablets are effective in the treatment of metastatic breast cancer in women and men. In premenopausal women with metastatic breast cancer, tamoxifen is an alternative to oophorectomy or ovarian irradiation. Available evidence indicates that patients whose tumors are estrogen receptor positive are more likely to benefit from tamoxifen therapy.</IndicationAndUsage>
<Description>Tamoxifen citrate tablets USP, a nonsteroidal antiestrogen, are for oral administration. Each tablet contains 10 mg or 20 mg tamoxifen (equivalent to 15.2 mg or 30.4 mg, respectively, of tamoxifen citrate, USP). Each tablet contains the following inactive ingredients: croscarmellose sodium, hypromellose, lactose (monohydrate), magnesium stearate, polyethylene glycol 400, povidone, corn starch, and titanium dioxide. Chemically, tamoxifen is the trans-isomer of a triphenylethylene derivative. The chemical name is (Z)2-[4-(1,2-diphenyl-1-butenyl)phenoxy]- N, N-dimethylethanamine 2-hydroxy-1,2,3- propanetricarboxylate (1:1). The structural formula, empirical formula, and molecular weight are as follows:. Tamoxifen citrate has a pKa' of 8.85, the equilibrium solubility in water at 37°C is 0.5 mg/mL and in 0.02 N HCl at 37°C, it is 0.2 mg/mL.</Description>
</NDC>
<NDC>
<NDCCode>55570-440-11</NDCCode>
<PackageDescription>50 kg in 1 DRUM (55570-440-11) </PackageDescription>
<NDC11Code>55570-0440-11</NDC11Code>
<ProductNDC>55570-440</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Sodium Phosphate Dibasic Dihydrate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20081205</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Jost Chemical Co.</LabelerName>
<SubstanceName>SODIUM PHOSPHATE DIBASIC DIHYDRATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-04-22</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>05-DEC-08</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>55570-440-12</NDCCode>
<PackageDescription>25 kg in 1 BOX (55570-440-12) </PackageDescription>
<NDC11Code>55570-0440-12</NDC11Code>
<ProductNDC>55570-440</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Sodium Phosphate Dibasic Dihydrate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20081205</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Jost Chemical Co.</LabelerName>
<SubstanceName>SODIUM PHOSPHATE DIBASIC DIHYDRATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-04-22</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>05-DEC-08</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>55910-440-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (55910-440-01) / 100 TABLET, COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>55910-0440-01</NDC11Code>
<ProductNDC>55910-440</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Extra Strength Headache Relief</ProprietaryName>
<NonProprietaryName>Acetaminophen, Aspirin, And Caffeine</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210501</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>Dollar General</LabelerName>
<SubstanceName>ACETAMINOPHEN; ASPIRIN; CAFFEINE</SubstanceName>
<StrengthNumber>250; 250; 65</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves minor aches and pains due to: headache a cold arthritis muscular aches toothache premenstrual & menstrual cramps.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57962-007-12</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (57962-007-12) / 108 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>57962-0007-12</NDC11Code>
<ProductNDC>57962-007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Imbruvica</ProprietaryName>
<NonProprietaryName>Ibrutinib</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220824</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA217003</ApplicationNumber>
<LabelerName>Pharmacyclics LLC</LabelerName>
<SubstanceName>IBRUTINIB</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220824</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>IMBRUVICA is a kinase inhibitor indicated for the treatment of: 1 Adult patients with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) (1.1)., 2 Adult patients with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion (1.2)., 3 Adult patients with Waldenström’s macroglobulinemia (WM) (1.3). , 4 Adult and pediatric patients age 1 year and older with chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy (1.4).</IndicationAndUsage>
<Description>Ibrutinib is a kinase inhibitor. It is a white to off-white solid with the empirical formula C25H24N6O2 and a molecular weight 440.50. Ibrutinib is freely soluble in dimethyl sulfoxide, soluble in methanol and practically insoluble in water. The chemical name for ibrutinib is 1-[(3R)-3-[4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl]-1-piperidinyl]-2-propen-1-one and has the following structure. IMBRUVICA (ibrutinib) is available as immediate-release oral capsules, immediate-release oral tablets, and immediate-release oral suspension. IMBRUVICA (ibrutinib) capsules for oral use are available in the following dosage strengths: 70 mg and 140 mg. Each capsule contains ibrutinib (active ingredient) and the following inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate. The capsule shell contains gelatin, titanium dioxide, yellow iron oxide (70 mg capsule only), and black ink. IMBRUVICA (ibrutinib) tablets for oral use are available in the following dosage strengths: 140 mg, 280 mg, and 420 mg. Each tablet contains ibrutinib (active ingredient) and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate. The film coating for each tablet contains ferrosoferric oxide (140 mg, 280 mg, and 420 mg tablets), polyvinyl alcohol, polyethylene glycol, red iron oxide (280 mg tablets), talc, titanium dioxide, and yellow iron oxide (140 mg and 420 mg tablets). IMBRUVICA (ibrutinib) oral suspension contains 70 mg/mL ibrutinib (active ingredient) and the following inactive ingredients: benzyl alcohol, citric acid monohydrate, disodium hydrogen phosphate, hypromellose, microcrystalline cellulose and carboxymethylcellulose sodium, purified water and sucralose.</Description>
</NDC>
<NDC>
<NDCCode>57962-014-28</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (57962-014-28) / 28 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>57962-0014-28</NDC11Code>
<ProductNDC>57962-014</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Imbruvica</ProprietaryName>
<NonProprietaryName>Ibrutinib</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180216</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA210563</ApplicationNumber>
<LabelerName>Pharmacyclics LLC</LabelerName>
<SubstanceName>IBRUTINIB</SubstanceName>
<StrengthNumber>140</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180216</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>IMBRUVICA is a kinase inhibitor indicated for the treatment of: 1 Adult patients with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) (1.1)., 2 Adult patients with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion (1.2)., 3 Adult patients with Waldenström’s macroglobulinemia (WM) (1.3). , 4 Adult and pediatric patients age 1 year and older with chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy (1.4).</IndicationAndUsage>
<Description>Ibrutinib is a kinase inhibitor. It is a white to off-white solid with the empirical formula C25H24N6O2 and a molecular weight 440.50. Ibrutinib is freely soluble in dimethyl sulfoxide, soluble in methanol and practically insoluble in water. The chemical name for ibrutinib is 1-[(3R)-3-[4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl]-1-piperidinyl]-2-propen-1-one and has the following structure. IMBRUVICA (ibrutinib) is available as immediate-release oral capsules, immediate-release oral tablets, and immediate-release oral suspension. IMBRUVICA (ibrutinib) capsules for oral use are available in the following dosage strengths: 70 mg and 140 mg. Each capsule contains ibrutinib (active ingredient) and the following inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate. The capsule shell contains gelatin, titanium dioxide, yellow iron oxide (70 mg capsule only), and black ink. IMBRUVICA (ibrutinib) tablets for oral use are available in the following dosage strengths: 140 mg, 280 mg, and 420 mg. Each tablet contains ibrutinib (active ingredient) and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate. The film coating for each tablet contains ferrosoferric oxide (140 mg, 280 mg, and 420 mg tablets), polyvinyl alcohol, polyethylene glycol, red iron oxide (280 mg tablets), talc, titanium dioxide, and yellow iron oxide (140 mg and 420 mg tablets). IMBRUVICA (ibrutinib) oral suspension contains 70 mg/mL ibrutinib (active ingredient) and the following inactive ingredients: benzyl alcohol, citric acid monohydrate, disodium hydrogen phosphate, hypromellose, microcrystalline cellulose and carboxymethylcellulose sodium, purified water and sucralose.</Description>
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<Description>Ibrutinib is a kinase inhibitor. It is a white to off-white solid with the empirical formula C25H24N6O2 and a molecular weight 440.50. Ibrutinib is freely soluble in dimethyl sulfoxide, soluble in methanol and practically insoluble in water. The chemical name for ibrutinib is 1-[(3R)-3-[4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl]-1-piperidinyl]-2-propen-1-one and has the following structure. IMBRUVICA (ibrutinib) is available as immediate-release oral capsules, immediate-release oral tablets, and immediate-release oral suspension. IMBRUVICA (ibrutinib) capsules for oral use are available in the following dosage strengths: 70 mg and 140 mg. Each capsule contains ibrutinib (active ingredient) and the following inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate. The capsule shell contains gelatin, titanium dioxide, yellow iron oxide (70 mg capsule only), and black ink. IMBRUVICA (ibrutinib) tablets for oral use are available in the following dosage strengths: 140 mg, 280 mg, and 420 mg. Each tablet contains ibrutinib (active ingredient) and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate. The film coating for each tablet contains ferrosoferric oxide (140 mg, 280 mg, and 420 mg tablets), polyvinyl alcohol, polyethylene glycol, red iron oxide (280 mg tablets), talc, titanium dioxide, and yellow iron oxide (140 mg and 420 mg tablets). IMBRUVICA (ibrutinib) oral suspension contains 70 mg/mL ibrutinib (active ingredient) and the following inactive ingredients: benzyl alcohol, citric acid monohydrate, disodium hydrogen phosphate, hypromellose, microcrystalline cellulose and carboxymethylcellulose sodium, purified water and sucralose.</Description>
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<Description>Ibrutinib is a kinase inhibitor. It is a white to off-white solid with the empirical formula C25H24N6O2 and a molecular weight 440.50. Ibrutinib is freely soluble in dimethyl sulfoxide, soluble in methanol and practically insoluble in water. The chemical name for ibrutinib is 1-[(3R)-3-[4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl]-1-piperidinyl]-2-propen-1-one and has the following structure. IMBRUVICA (ibrutinib) is available as immediate-release oral capsules, immediate-release oral tablets, and immediate-release oral suspension. IMBRUVICA (ibrutinib) capsules for oral use are available in the following dosage strengths: 70 mg and 140 mg. Each capsule contains ibrutinib (active ingredient) and the following inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate. The capsule shell contains gelatin, titanium dioxide, yellow iron oxide (70 mg capsule only), and black ink. IMBRUVICA (ibrutinib) tablets for oral use are available in the following dosage strengths: 140 mg, 280 mg, and 420 mg. Each tablet contains ibrutinib (active ingredient) and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate. The film coating for each tablet contains ferrosoferric oxide (140 mg, 280 mg, and 420 mg tablets), polyvinyl alcohol, polyethylene glycol, red iron oxide (280 mg tablets), talc, titanium dioxide, and yellow iron oxide (140 mg and 420 mg tablets). IMBRUVICA (ibrutinib) oral suspension contains 70 mg/mL ibrutinib (active ingredient) and the following inactive ingredients: benzyl alcohol, citric acid monohydrate, disodium hydrogen phosphate, hypromellose, microcrystalline cellulose and carboxymethylcellulose sodium, purified water and sucralose.</Description>
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<IndicationAndUsage>IMBRUVICA is a kinase inhibitor indicated for the treatment of: 1 Adult patients with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) (1.1)., 2 Adult patients with chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion (1.2)., 3 Adult patients with Waldenström’s macroglobulinemia (WM) (1.3). , 4 Adult and pediatric patients age 1 year and older with chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy (1.4).</IndicationAndUsage>
<Description>Ibrutinib is a kinase inhibitor. It is a white to off-white solid with the empirical formula C25H24N6O2 and a molecular weight 440.50. Ibrutinib is freely soluble in dimethyl sulfoxide, soluble in methanol and practically insoluble in water. The chemical name for ibrutinib is 1-[(3R)-3-[4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl]-1-piperidinyl]-2-propen-1-one and has the following structure. IMBRUVICA (ibrutinib) is available as immediate-release oral capsules, immediate-release oral tablets, and immediate-release oral suspension. IMBRUVICA (ibrutinib) capsules for oral use are available in the following dosage strengths: 70 mg and 140 mg. Each capsule contains ibrutinib (active ingredient) and the following inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate. The capsule shell contains gelatin, titanium dioxide, yellow iron oxide (70 mg capsule only), and black ink. IMBRUVICA (ibrutinib) tablets for oral use are available in the following dosage strengths: 140 mg, 280 mg, and 420 mg. Each tablet contains ibrutinib (active ingredient) and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate. The film coating for each tablet contains ferrosoferric oxide (140 mg, 280 mg, and 420 mg tablets), polyvinyl alcohol, polyethylene glycol, red iron oxide (280 mg tablets), talc, titanium dioxide, and yellow iron oxide (140 mg and 420 mg tablets). IMBRUVICA (ibrutinib) oral suspension contains 70 mg/mL ibrutinib (active ingredient) and the following inactive ingredients: benzyl alcohol, citric acid monohydrate, disodium hydrogen phosphate, hypromellose, microcrystalline cellulose and carboxymethylcellulose sodium, purified water and sucralose.</Description>
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<Description>Ibrutinib is a kinase inhibitor. It is a white to off-white solid with the empirical formula C25H24N6O2 and a molecular weight 440.50. Ibrutinib is freely soluble in dimethyl sulfoxide, soluble in methanol and practically insoluble in water. The chemical name for ibrutinib is 1-[(3R)-3-[4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl]-1-piperidinyl]-2-propen-1-one and has the following structure. IMBRUVICA (ibrutinib) is available as immediate-release oral capsules, immediate-release oral tablets, and immediate-release oral suspension. IMBRUVICA (ibrutinib) capsules for oral use are available in the following dosage strengths: 70 mg and 140 mg. Each capsule contains ibrutinib (active ingredient) and the following inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate. The capsule shell contains gelatin, titanium dioxide, yellow iron oxide (70 mg capsule only), and black ink. IMBRUVICA (ibrutinib) tablets for oral use are available in the following dosage strengths: 140 mg, 280 mg, and 420 mg. Each tablet contains ibrutinib (active ingredient) and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate. The film coating for each tablet contains ferrosoferric oxide (140 mg, 280 mg, and 420 mg tablets), polyvinyl alcohol, polyethylene glycol, red iron oxide (280 mg tablets), talc, titanium dioxide, and yellow iron oxide (140 mg and 420 mg tablets). IMBRUVICA (ibrutinib) oral suspension contains 70 mg/mL ibrutinib (active ingredient) and the following inactive ingredients: benzyl alcohol, citric acid monohydrate, disodium hydrogen phosphate, hypromellose, microcrystalline cellulose and carboxymethylcellulose sodium, purified water and sucralose.</Description>
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<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Standardized Insect Venom Allergenic Extract [EPC], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary support of symptoms related to seasonal spring sensitivities.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63776-440-14</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE (63776-440-14) </PackageDescription>
<NDC11Code>63776-0440-14</NDC11Code>
<ProductNDC>63776-440</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pollens Early</ProprietaryName>
<NonProprietaryName>Adrenal, Apis, Early Season Allersode (ash, Beech, Birch, Cottonwood, Elm, Hickory, Maple, Red Oak, Sycamore, Walnut, Willow), Ethanol, Fumaria, Gallic Acid, Hepar Sulph Calc, Histamine, Interleukin-12 Human, Interferon Gamma-1a, Kali Carb, Lymph Node, Manganese, Pinus Sylvestre, Piper Nigrum, Prunus Spinosa, Quercetin, Rutin, Salsolinol, Silicea, Spleen, Sulphricum Acidum, Thymus, Tilia Tomentosa</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120724</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>ACER SACCHARUM POLLEN; APIS MELLIFERA; BETULA NIGRA POLLEN; BLACK PEPPER; BOS TAURUS ADRENAL GLAND; BOS TAURUS LYMPH VESSEL; BOS TAURUS SPLEEN; BOS TAURUS THYMUS; CALCIUM SULFIDE; CARYA ALBA POLLEN; FAGUS GRANDIFOLIA POLLEN; FRAXINUS AMERICANA POLLEN; FUMARIA OFFICINALIS FLOWERING TOP; GALLIC ACID; HISTAMINE; INTERFERON GAMMA-1A; INTERLEUKIN-12 HUMAN; JUGLANS NIGRA POLLEN; MANGANESE; PINUS SYLVESTRIS SPROUT; PLATANUS RACEMOSA POLLEN; POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN; POTASSIUM CARBONATE; PRUNUS SPINOSA FLOWER BUD; QUERCETIN; QUERCUS RUBRA POLLEN; RUTIN; SALIX REPENS POLLEN; SALSOLINOL; SILICON DIOXIDE; SULFURIC ACID; SUS SCROFA ADRENAL GLAND; SUS SCROFA LYMPH VESSEL; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; TILIA TOMENTOSA BUD; ULMUS AMERICANA POLLEN</SubstanceName>
<StrengthNumber>200; 30; 200; 30; 200; 200; 200; 200; 30; 200; 200; 200; 30; 200; 200; 200; 200; 200; 12; 30; 200; 200; 30; 30; 200; 200; 200; 200; 200; 200; 30; 200; 200; 200; 200; 30; 200</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [hp_X]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Standardized Insect Venom Allergenic Extract [EPC], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary support of symptoms related to seasonal spring sensitivities.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63776-440-15</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE (63776-440-15) </PackageDescription>
<NDC11Code>63776-0440-15</NDC11Code>
<ProductNDC>63776-440</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pollens Early</ProprietaryName>
<NonProprietaryName>Adrenal, Apis, Early Season Allersode (ash, Beech, Birch, Cottonwood, Elm, Hickory, Maple, Red Oak, Sycamore, Walnut, Willow), Ethanol, Fumaria, Gallic Acid, Hepar Sulph Calc, Histamine, Interleukin-12 Human, Interferon Gamma-1a, Kali Carb, Lymph Node, Manganese, Pinus Sylvestre, Piper Nigrum, Prunus Spinosa, Quercetin, Rutin, Salsolinol, Silicea, Spleen, Sulphricum Acidum, Thymus, Tilia Tomentosa</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120724</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>ACER SACCHARUM POLLEN; APIS MELLIFERA; BETULA NIGRA POLLEN; BLACK PEPPER; BOS TAURUS ADRENAL GLAND; BOS TAURUS LYMPH VESSEL; BOS TAURUS SPLEEN; BOS TAURUS THYMUS; CALCIUM SULFIDE; CARYA ALBA POLLEN; FAGUS GRANDIFOLIA POLLEN; FRAXINUS AMERICANA POLLEN; FUMARIA OFFICINALIS FLOWERING TOP; GALLIC ACID; HISTAMINE; INTERFERON GAMMA-1A; INTERLEUKIN-12 HUMAN; JUGLANS NIGRA POLLEN; MANGANESE; PINUS SYLVESTRIS SPROUT; PLATANUS RACEMOSA POLLEN; POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN; POTASSIUM CARBONATE; PRUNUS SPINOSA FLOWER BUD; QUERCETIN; QUERCUS RUBRA POLLEN; RUTIN; SALIX REPENS POLLEN; SALSOLINOL; SILICON DIOXIDE; SULFURIC ACID; SUS SCROFA ADRENAL GLAND; SUS SCROFA LYMPH VESSEL; SUS SCROFA SPLEEN; SUS SCROFA THYMUS; TILIA TOMENTOSA BUD; ULMUS AMERICANA POLLEN</SubstanceName>
<StrengthNumber>200; 30; 200; 30; 200; 200; 200; 200; 30; 200; 200; 200; 30; 200; 200; 200; 200; 200; 12; 30; 200; 200; 30; 30; 200; 200; 200; 200; 200; 200; 30; 200; 200; 200; 200; 30; 200</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [hp_X]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Pollen [CS], Standardized Insect Venom Allergenic Extract [EPC], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary support of symptoms related to seasonal spring sensitivities.</IndicationAndUsage>
</NDC>
</NDCList>