{
"NDC": [
{
"NDCCode": "75839-530-55",
"PackageDescription": "50 g in 1 CONTAINER (75839-530-55)",
"NDC11Code": "75839-0530-55",
"ProductNDC": "75839-530",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Quinacrine Dihydrochloride",
"DosageFormName": "POWDER",
"StartMarketingDate": "20190710",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Attix Pharmaceuticals",
"SubstanceName": "QUINACRINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "g/25g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "71052-530-55",
"PackageDescription": "50 g in 1 CONTAINER (71052-530-55)",
"NDC11Code": "71052-0530-55",
"ProductNDC": "71052-530",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Quinacrine Dihydrochloride",
"DosageFormName": "POWDER",
"StartMarketingDate": "20190725",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "DARMERICA, LLC",
"SubstanceName": "QUINACRINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "g/25g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20211231"
},
{
"NDCCode": "75839-530-05",
"PackageDescription": "500 g in 1 CONTAINER (75839-530-05)",
"NDC11Code": "75839-0530-05",
"ProductNDC": "75839-530",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Quinacrine Dihydrochloride",
"DosageFormName": "POWDER",
"StartMarketingDate": "20190710",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Attix Pharmaceuticals",
"SubstanceName": "QUINACRINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "g/25g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "75839-530-25",
"PackageDescription": "25 g in 1 CONTAINER (75839-530-25)",
"NDC11Code": "75839-0530-25",
"ProductNDC": "75839-530",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Quinacrine Dihydrochloride",
"DosageFormName": "POWDER",
"StartMarketingDate": "20190710",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Attix Pharmaceuticals",
"SubstanceName": "QUINACRINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "g/25g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "75839-038-55",
"PackageDescription": "50 g in 1 CONTAINER (75839-038-55)",
"NDC11Code": "75839-0038-55",
"ProductNDC": "75839-038",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Hyaluronic Acid Sodium Salt",
"DosageFormName": "POWDER",
"StartMarketingDate": "20130411",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Attix Pharmaceuticals",
"SubstanceName": "HYALURONATE SODIUM",
"StrengthNumber": "50",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "75839-054-55",
"PackageDescription": "500 g in 1 CONTAINER (75839-054-55)",
"NDC11Code": "75839-0054-55",
"ProductNDC": "75839-054",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Pimobendan",
"DosageFormName": "POWDER",
"StartMarketingDate": "20130411",
"MarketingCategoryName": "BULK INGREDIENT FOR ANIMAL DRUG COMPOUNDING",
"LabelerName": "Attix Pharmaceuticals",
"SubstanceName": "PIMOBENDAN",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "75839-057-55",
"PackageDescription": "5000 g in 1 CONTAINER (75839-057-55)",
"NDC11Code": "75839-0057-55",
"ProductNDC": "75839-057",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Sildenafil Citrate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20130411",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Attix Pharmaceuticals",
"SubstanceName": "SILDENAFIL CITRATE",
"StrengthNumber": "50",
"StrengthUnit": "g/50g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "59310-530-08",
"PackageDescription": "1 POUCH in 1 CARTON (59310-530-08) / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER",
"NDC11Code": "59310-0530-08",
"ProductNDC": "59310-530",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Airduo Digihaler",
"NonProprietaryName": "Fluticasone Propionate And Salmeterol",
"DosageFormName": "POWDER, METERED",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20200915",
"EndMarketingDate": "20250731",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208799",
"LabelerName": "Teva Respiratory, LLC",
"SubstanceName": "FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE",
"StrengthNumber": "232; 14",
"StrengthUnit": "ug/1; ug/1",
"Pharm_Classes": "Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200915",
"EndMarketingDatePackage": "20250731",
"SamplePackage": "Y",
"IndicationAndUsage": "AirDuo® Digihaler® is indicated for the treatment of asthma in adult and pediatric patients aged 12 years and older. AirDuo Digihaler should be used for patients not adequately controlled on a long term asthma control medication such as an inhaled corticosteroid or whose disease warrants initiation of treatment with both an inhaled corticosteroid and long acting beta2-adrenergic agonist (LABA). Limitations of Use:. AirDuo Digihaler is not indicated for the relief of acute bronchospasm.",
"Description": "AirDuo Digihaler 55/14 mcg, AirDuo Digihaler 113/14 mcg and AirDuo Digihaler 232/14 mcg are combinations of fluticasone propionate and salmeterol. Fluticasone Propionate. One active component of AirDuo Digihaler is fluticasone propionate, a corticosteroid having the chemical name S-(fluoromethyl) 6α,9-difluoro-11ß,17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17ß-carbothioate, 17-propionate, and the following chemical structure. Fluticasone propionate is a white powder with a molecular weight of 500.6, and the empirical formula is C25H31F3O5S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. Salmeterol Xinafoate. The other active component of AirDuo Digihaler is salmeterol xinafoate, a beta2–adrenergic bronchodilator. Salmeterol xinafoate is the racemic form of the 1‑hydroxy‑2‑naphthoic acid salt of salmeterol. It has the chemical name 4-hydroxy-α -[[[6-(4-phenylbutoxy)hexyl]amino]methyl]-1,3-benzenedimethanol, 1-hydroxy-2-naphthalenecarboxylate and the following chemical structure. Salmeterol xinafoate is a white powder with a molecular weight of 603.8, and the empirical formula is C25H37NO4C11H8O3. It is freely soluble in methanol; slightly soluble in ethanol, chloroform, and isopropanol; and sparingly soluble in water. AirDuo Digihaler. AirDuo Digihaler is a multidose dry powder inhaler (MDPI) with an electronic module, for oral inhalation only. It contains fluticasone propionate, salmeterol xinafoate, and lactose monohydrate (which may contain milk proteins). The opening of the mouthpiece cover meters 5.5 mg of the formulation from the device reservoir, which contains 55 mcg, 113 mcg, or 232 mcg of fluticasone propionate, and 14 mcg of salmeterol base (equivalent to 20.3 mcg of salmeterol xinafoate). Patient inhalation through the mouthpiece causes the deagglomeration and aerosolization of the drug particles as the formulation moves through the cyclone component of the device. This is followed by dispersion into the airstream. Under standardized in vitro test conditions, the AirDuo Digihaler inhaler delivers 49 mcg, 100 mcg, or 202 mcg of fluticasone propionate and 12.75 mcg of salmeterol base (equivalent to 18.5 mcg of salmeterol xinafoate), with lactose from the mouthpiece when tested at a flow rate of 85 L/min for 1.4 seconds. The amount of drug delivered to the lung will depend on patient factors such as inspiratory flow profiles. In adult subjects (N=50, aged 18 to 45 years) with asthma, mean peak inspiratory flow (PIF) through the MDPI was 108.28 L/min (range: 70.37 to 129.24 L/min). In adolescent subjects (N=50, aged 12 to 17 years) with asthma, mean peak inspiratory flow (PIF) through the MDPI was 106.72 L/min (range: 73.64 to 125.51 L/min). AirDuo Digihaler includes a QR code (on the top of the inhaler), and contains a built-in electronic module which automatically detects, records and stores data on inhaler events, including peak inspiratory flow rate (L/min). AirDuo Digihaler may pair with and transmit data to the mobile App where inhaler events are categorized."
},
{
"NDCCode": "72789-530-30",
"PackageDescription": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-530-30) ",
"NDC11Code": "72789-0530-30",
"ProductNDC": "72789-530",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Minocycline Hydrochloride",
"NonProprietaryName": "Minocycline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20160930",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204453",
"LabelerName": "PD-Rx Pharmaceuticals, Inc.",
"SubstanceName": "MINOCYCLINE HYDROCHLORIDE",
"StrengthNumber": "135",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Active",
"LastUpdate": "2026-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250910",
"SamplePackage": "N",
"IndicationAndUsage": "Minocycline hydrochloride extended-release tablets is indicated to treat inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. Limitations of Use: 1 Minocycline hydrochloride extended-release tablets did not demonstrate any effect on non-inflammatory acne lesions., 2 This formulation of minocycline has not been evaluated in the treatment of infections [see Clinical Studies ( 14)]. , 3 To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, use minocycline hydrochloride extended-release tablets only as indicated [see Warnings and Precautions ( 5.12)]. .",
"Description": "Minocycline hydrochloride, a semi synthetic derivative of tetracycline, is [4 S-(4α,4aα,5aα, 12aα)]-4,7–Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. The structural formula is represented below. C 23H 27N 3O 7HCl M. W. 493.95. Minocycline hydrochloride extended-release tablets, USP for oral administration contain minocycline hydrochloride USP equivalent to 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg, and 135 mg of minocycline. In addition, 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg, and 135 mg tablets contain the following inactive ingredients: lactose monohydrate, hypromellose type 2910, hypromellose type 2208, colloidal silicon dioxide, magnesium stearate, titanium dioxide and triacetin. The 45 mg tablets also contain iron oxide black. The 65 mg tablets also contain FD&C blue #1/brilliant blue FCF aluminium lake. polyethylene glycol 3350, FD&C blue #2/indigo carmine aluminum lake and D&C yellow #10 aluminum lake. The 55 mg tablets also contain macrogol, FD&C RED #40. The 80 mg tablets also contain macrogol, FD&C blue #2, FD&C red #40, FD&C yellow #6. The 90 mg tablets also contain iron oxide yellow and polyethylene glycol 3350. The 105 mg tablets also D&C red #27, macrogol, FD&C blue #1. The 115 mg tablets also contain D&C yellow #10 aluminum lake, FD&C blue #1/brilliant blue FCF aluminium lake and FD&C blue #2/indigo carmine aluminum lake. The 135 mg tablets also contain polyethylene glycol 3350 and iron oxide red. The USP Dissolution Test is pending."
},
{
"NDCCode": "0006-3516-59",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 TRAY (0006-3516-59) / 100 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00006-3516-59",
"ProductNDC": "0006-3516",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Primaxin",
"ProprietaryNameSuffix": "Iv",
"NonProprietaryName": "Imipenem And Cilastatin Sodium",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19851126",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050587",
"LabelerName": "Merck Sharp & Dohme LLC",
"SubstanceName": "IMIPENEM; CILASTATIN SODIUM",
"StrengthNumber": "500; 500",
"StrengthUnit": "mg/100mL; mg/100mL",
"Pharm_Classes": "Carbapenems [CS], Dipeptidase Inhibitors [MoA], Penem Antibacterial [EPC], Renal Dehydropeptidase Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19851126",
"SamplePackage": "N",
"IndicationAndUsage": "PRIMAXIN for intravenous use is a combination of imipenem, a penem antibacterial, and cilastatin, a renal dehydropeptidase inhibitor, indicated for the treatment of the following serious infections caused by designated susceptible bacteria: 1 Lower respiratory tract infections. (1.1), 2 Urinary tract infections. (1.2), 3 Intra-abdominal infections. (1.3), 4 Gynecologic infections. (1.4), 5 Bacterial septicemia. (1.5), 6 Bone and joint infections. (1.6), 7 Skin and skin structure infections. (1.7), 8 Endocarditis. (1.8).",
"Description": "PRIMAXIN (imipenem and cilastatin) for Injection is a sterile formulation of imipenem, a penem antibacterial, and cilastatin, a renal dehydropeptidase inhibitor with sodium bicarbonate added as a buffer. PRIMAXIN is an antibacterial drug for intravenous administration. Imipenem (N-formimidoylthienamycin monohydrate) is a crystalline derivative of thienamycin, which is produced by Streptomyces cattleya. Its chemical name is (5R,6S)-3-[[2-(formimidoylamino)ethyl]thio]-6-[(R)-1-hydroxyethyl]-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid monohydrate. It is an off-white, nonhygroscopic crystalline compound with a molecular weight of 317.37. It is sparingly soluble in water and slightly soluble in methanol. Its empirical formula is C12H17N3O4S∙H2O, and its structural formula is. Cilastatin sodium is the sodium salt of a derivatized heptenoic acid. Its chemical name is sodium (Z)-7[[(R)-2-amino-2-carboxyethyl]thio]-2-[(S)-2,2-dimethylcyclopropanecarboxamido]-2-heptenoate. It is an off-white to yellowish-white, hygroscopic, amorphous compound with a molecular weight of 380.43. It is very soluble in water and in methanol. Its empirical formula is C16H25N2O5SNa, and its structural formula is. Each single-dose vial of PRIMAXIN contains 500 mg imipenem (equivalent to 530 mg imipenem monohydrate), 500 mg cilastatin (equivalent to 531 mg cilastatin sodium), and 20 mg sodium bicarbonate (used as a buffer). PRIMAXIN is buffered to provide solutions in the pH range of 6.5 to 8.5. There is no significant change in pH when solutions are prepared and used as directed [see How Supplied/Storage and Handling (16.1)]. PRIMAXIN 500 contains 37.5 mg of sodium (1.6 mEq). Solutions of PRIMAXIN range from colorless to yellow. Variations of color within this range do not affect the potency of the product."
},
{
"NDCCode": "0008-1123-12",
"PackageDescription": "1 POUCH in 1 CARTON (0008-1123-12) / 2 BLISTER PACK in 1 POUCH / 15 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "00008-1123-12",
"ProductNDC": "0008-1123",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Duavee",
"NonProprietaryName": "Conjugated Estrogens/bazedoxifene",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20131003",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022247",
"LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
"SubstanceName": "ESTROGENS, CONJUGATED; BAZEDOXIFENE ACETATE",
"StrengthNumber": ".45; 20",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Estrogen Agonist/Antagonist [EPC], Estrogen Receptor Agonists [MoA], Estrogen [EPC], Estrogens, Conjugated (USP) [CS], Selective Estrogen Receptor Modulators [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20131003",
"SamplePackage": "N",
"IndicationAndUsage": "DUAVEE is indicated in women with a uterus for.",
"Description": "DUAVEE (conjugated estrogens/bazedoxifene), contains conjugated estrogens with bazedoxifene, an estrogen agonist/antagonist. Conjugated estrogens are purified from pregnant mares' urine and consist of the sodium salts of water-soluble estrogen sulfates blended to represent the average composition of material derived from pregnant mares' urine. Conjugated estrogens are a mixture of sodium estrone sulfate and sodium equilin sulfate, and also contain as concomitant components, sodium sulfate conjugates, 17α-dihydroequilin, 17α-estradiol, and 17β-dihydroequilin. Bazedoxifene is supplied as the acetate salt (bazedoxifene acetate) and has the chemical name 1H-Indol-5-ol, 1-[[4-[2-(hexahydro-1H-azepin-1-yl) ethoxy]phenyl]methyl]-2-(4-hydroxyphenyl)-3-methyl-, monoacetate. The empirical formula is C30H34N2O3 ∙ C2H4O2, and the molecular weight is 530.65. Bazedoxifene acetate is a white to tan powder. The aqueous solubility of bazedoxifene is pH-dependent. Solubility is higher at lower pH. The solubility of bazedoxifene acetate in unbuffered sterile water was measured to be 923 microgramsA/mL at pH 5.4. The following represents the chemical structure of bazedoxifene acetate:. DUAVEE is available for oral administration as tablets containing 0.45 mg of conjugated estrogens with 20 mg of bazedoxifene (equivalent to 22.6 mg of bazedoxifene acetate). Each tablet of DUAVEE contains the following inactive ingredients: calcium phosphate tribasic, hydroxypropyl cellulose, microcrystalline cellulose, powdered cellulose, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, sucrose, ascorbic acid, sucrose palmitic acid ester, hydroxyethylcellulose, titanium dioxide, red iron oxide, yellow iron oxide, black iron oxide, povidone, polydextrose, maltitol, poloxamer 188, propylene glycol, and isopropyl alcohol."
},
{
"NDCCode": "0069-0135-01",
"PackageDescription": "120 TABLET, FILM COATED in 1 BOTTLE (0069-0135-01) ",
"NDC11Code": "00069-0135-01",
"ProductNDC": "0069-0135",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bosulif",
"NonProprietaryName": "Bosutinib",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120904",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA203341",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "BOSUTINIB MONOHYDRATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Kinase Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120904",
"SamplePackage": "N",
"IndicationAndUsage": "BOSULIF is indicated for the treatment of: 1 Adult and pediatric patients 1 year of age and older with chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML), newly-diagnosed or resistant or intolerant to prior therapy [see Clinical Studies (14.1, 14.2, 14.3)]., 2 Adult patients with accelerated phase (AP), or blast phase (BP) Ph+ CML with resistance or intolerance to prior therapy [see Clinical Studies (14.2)].",
"Description": "BOSULIF contains bosutinib, a kinase inhibitor. Bosutinib is present as a monohydrate with a chemical name of 3-Quinolinecarbonitrile, 4-[(2,4-dichloro-5-methoxyphenyl)amino]-6-methoxy-7-[3-(4-methyl-1-piperazinyl) propoxy]-, hydrate (1:1). Its chemical formula is C26H29Cl2N5O3∙H2O (monohydrate); its molecular weight is 548.46 (monohydrate), equivalent to 530.46 (anhydrous). Bosutinib monohydrate has the following chemical structure:. Bosutinib monohydrate is a white to yellowish-tan powder. Bosutinib monohydrate has a pH dependent solubility across the physiological pH range. At or below pH 5, bosutinib monohydrate behaves as a highly soluble compound. Above pH 5, the solubility of bosutinib monohydrate reduces rapidly. BOSULIF® (bosutinib) tablets are supplied for oral administration in 3 strengths: 100 mg, 400 mg and 500 mg. Each strength reflects the equivalent amount of bosutinib content (on anhydrous basis). The tablets contain the following inactive ingredients: croscarmellose sodium, iron oxide red (for 400 mg, and 500 mg tablet) and iron oxide yellow (for 100 mg, and 400 mg tablet), magnesium stearate, microcrystalline cellulose, poloxamer, polyethylene glycol, polyvinyl alcohol, povidone, talc and titanium dioxide. BOSULIF® (bosutinib) capsules are supplied for oral administration in 2 strengths: 50 mg and 100 mg. Each strength reflects the equivalent amount of bosutinib (on anhydrous basis). The capsules contain the following inactive ingredients: croscarmellose sodium, gelatin, magnesium stearate, mannitol, microcrystalline cellulose, poloxamer, povidone, red iron oxide, titanium dioxide, yellow iron oxide. The printing ink contains black iron oxide, potassium hydroxide, propylene glycol, shellac, strong ammonia solution."
},
{
"NDCCode": "0069-0136-01",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0069-0136-01) ",
"NDC11Code": "00069-0136-01",
"ProductNDC": "0069-0136",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bosulif",
"NonProprietaryName": "Bosutinib",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120904",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA203341",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "BOSUTINIB MONOHYDRATE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Kinase Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120904",
"SamplePackage": "N",
"IndicationAndUsage": "BOSULIF is indicated for the treatment of: 1 Adult and pediatric patients 1 year of age and older with chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML), newly-diagnosed or resistant or intolerant to prior therapy [see Clinical Studies (14.1, 14.2, 14.3)]., 2 Adult patients with accelerated phase (AP), or blast phase (BP) Ph+ CML with resistance or intolerance to prior therapy [see Clinical Studies (14.2)].",
"Description": "BOSULIF contains bosutinib, a kinase inhibitor. Bosutinib is present as a monohydrate with a chemical name of 3-Quinolinecarbonitrile, 4-[(2,4-dichloro-5-methoxyphenyl)amino]-6-methoxy-7-[3-(4-methyl-1-piperazinyl) propoxy]-, hydrate (1:1). Its chemical formula is C26H29Cl2N5O3∙H2O (monohydrate); its molecular weight is 548.46 (monohydrate), equivalent to 530.46 (anhydrous). Bosutinib monohydrate has the following chemical structure:. Bosutinib monohydrate is a white to yellowish-tan powder. Bosutinib monohydrate has a pH dependent solubility across the physiological pH range. At or below pH 5, bosutinib monohydrate behaves as a highly soluble compound. Above pH 5, the solubility of bosutinib monohydrate reduces rapidly. BOSULIF® (bosutinib) tablets are supplied for oral administration in 3 strengths: 100 mg, 400 mg and 500 mg. Each strength reflects the equivalent amount of bosutinib content (on anhydrous basis). The tablets contain the following inactive ingredients: croscarmellose sodium, iron oxide red (for 400 mg, and 500 mg tablet) and iron oxide yellow (for 100 mg, and 400 mg tablet), magnesium stearate, microcrystalline cellulose, poloxamer, polyethylene glycol, polyvinyl alcohol, povidone, talc and titanium dioxide. BOSULIF® (bosutinib) capsules are supplied for oral administration in 2 strengths: 50 mg and 100 mg. Each strength reflects the equivalent amount of bosutinib (on anhydrous basis). The capsules contain the following inactive ingredients: croscarmellose sodium, gelatin, magnesium stearate, mannitol, microcrystalline cellulose, poloxamer, povidone, red iron oxide, titanium dioxide, yellow iron oxide. The printing ink contains black iron oxide, potassium hydroxide, propylene glycol, shellac, strong ammonia solution."
},
{
"NDCCode": "0069-0193-01",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0069-0193-01) ",
"NDC11Code": "00069-0193-01",
"ProductNDC": "0069-0193",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bosulif",
"NonProprietaryName": "Bosutinib",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20171218",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA203341",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "BOSUTINIB MONOHYDRATE",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Kinase Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20171218",
"SamplePackage": "N",
"IndicationAndUsage": "BOSULIF is indicated for the treatment of: 1 Adult and pediatric patients 1 year of age and older with chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML), newly-diagnosed or resistant or intolerant to prior therapy [see Clinical Studies (14.1, 14.2, 14.3)]., 2 Adult patients with accelerated phase (AP), or blast phase (BP) Ph+ CML with resistance or intolerance to prior therapy [see Clinical Studies (14.2)].",
"Description": "BOSULIF contains bosutinib, a kinase inhibitor. Bosutinib is present as a monohydrate with a chemical name of 3-Quinolinecarbonitrile, 4-[(2,4-dichloro-5-methoxyphenyl)amino]-6-methoxy-7-[3-(4-methyl-1-piperazinyl) propoxy]-, hydrate (1:1). Its chemical formula is C26H29Cl2N5O3∙H2O (monohydrate); its molecular weight is 548.46 (monohydrate), equivalent to 530.46 (anhydrous). Bosutinib monohydrate has the following chemical structure:. Bosutinib monohydrate is a white to yellowish-tan powder. Bosutinib monohydrate has a pH dependent solubility across the physiological pH range. At or below pH 5, bosutinib monohydrate behaves as a highly soluble compound. Above pH 5, the solubility of bosutinib monohydrate reduces rapidly. BOSULIF® (bosutinib) tablets are supplied for oral administration in 3 strengths: 100 mg, 400 mg and 500 mg. Each strength reflects the equivalent amount of bosutinib content (on anhydrous basis). The tablets contain the following inactive ingredients: croscarmellose sodium, iron oxide red (for 400 mg, and 500 mg tablet) and iron oxide yellow (for 100 mg, and 400 mg tablet), magnesium stearate, microcrystalline cellulose, poloxamer, polyethylene glycol, polyvinyl alcohol, povidone, talc and titanium dioxide. BOSULIF® (bosutinib) capsules are supplied for oral administration in 2 strengths: 50 mg and 100 mg. Each strength reflects the equivalent amount of bosutinib (on anhydrous basis). The capsules contain the following inactive ingredients: croscarmellose sodium, gelatin, magnesium stearate, mannitol, microcrystalline cellulose, poloxamer, povidone, red iron oxide, titanium dioxide, yellow iron oxide. The printing ink contains black iron oxide, potassium hydroxide, propylene glycol, shellac, strong ammonia solution."
},
{
"NDCCode": "0069-0504-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (0069-0504-30) ",
"NDC11Code": "00069-0504-30",
"ProductNDC": "0069-0504",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bosulif",
"NonProprietaryName": "Bosutinib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20240102",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA217729",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "BOSUTINIB MONOHYDRATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Kinase Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240102",
"SamplePackage": "N",
"IndicationAndUsage": "BOSULIF is indicated for the treatment of: 1 Adult and pediatric patients 1 year of age and older with chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML), newly-diagnosed or resistant or intolerant to prior therapy [see Clinical Studies (14.1, 14.2, 14.3)]., 2 Adult patients with accelerated phase (AP), or blast phase (BP) Ph+ CML with resistance or intolerance to prior therapy [see Clinical Studies (14.2)].",
"Description": "BOSULIF contains bosutinib, a kinase inhibitor. Bosutinib is present as a monohydrate with a chemical name of 3-Quinolinecarbonitrile, 4-[(2,4-dichloro-5-methoxyphenyl)amino]-6-methoxy-7-[3-(4-methyl-1-piperazinyl) propoxy]-, hydrate (1:1). Its chemical formula is C26H29Cl2N5O3∙H2O (monohydrate); its molecular weight is 548.46 (monohydrate), equivalent to 530.46 (anhydrous). Bosutinib monohydrate has the following chemical structure:. Bosutinib monohydrate is a white to yellowish-tan powder. Bosutinib monohydrate has a pH dependent solubility across the physiological pH range. At or below pH 5, bosutinib monohydrate behaves as a highly soluble compound. Above pH 5, the solubility of bosutinib monohydrate reduces rapidly. BOSULIF® (bosutinib) tablets are supplied for oral administration in 3 strengths: 100 mg, 400 mg and 500 mg. Each strength reflects the equivalent amount of bosutinib content (on anhydrous basis). The tablets contain the following inactive ingredients: croscarmellose sodium, iron oxide red (for 400 mg, and 500 mg tablet) and iron oxide yellow (for 100 mg, and 400 mg tablet), magnesium stearate, microcrystalline cellulose, poloxamer, polyethylene glycol, polyvinyl alcohol, povidone, talc and titanium dioxide. BOSULIF® (bosutinib) capsules are supplied for oral administration in 2 strengths: 50 mg and 100 mg. Each strength reflects the equivalent amount of bosutinib (on anhydrous basis). The capsules contain the following inactive ingredients: croscarmellose sodium, gelatin, magnesium stearate, mannitol, microcrystalline cellulose, poloxamer, povidone, red iron oxide, titanium dioxide, yellow iron oxide. The printing ink contains black iron oxide, potassium hydroxide, propylene glycol, shellac, strong ammonia solution."
},
{
"NDCCode": "0069-1014-15",
"PackageDescription": "150 CAPSULE in 1 BOTTLE (0069-1014-15) ",
"NDC11Code": "00069-1014-15",
"ProductNDC": "0069-1014",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bosulif",
"NonProprietaryName": "Bosutinib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20240102",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA217729",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "BOSUTINIB MONOHYDRATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Kinase Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240102",
"SamplePackage": "N",
"IndicationAndUsage": "BOSULIF is indicated for the treatment of: 1 Adult and pediatric patients 1 year of age and older with chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML), newly-diagnosed or resistant or intolerant to prior therapy [see Clinical Studies (14.1, 14.2, 14.3)]., 2 Adult patients with accelerated phase (AP), or blast phase (BP) Ph+ CML with resistance or intolerance to prior therapy [see Clinical Studies (14.2)].",
"Description": "BOSULIF contains bosutinib, a kinase inhibitor. Bosutinib is present as a monohydrate with a chemical name of 3-Quinolinecarbonitrile, 4-[(2,4-dichloro-5-methoxyphenyl)amino]-6-methoxy-7-[3-(4-methyl-1-piperazinyl) propoxy]-, hydrate (1:1). Its chemical formula is C26H29Cl2N5O3∙H2O (monohydrate); its molecular weight is 548.46 (monohydrate), equivalent to 530.46 (anhydrous). Bosutinib monohydrate has the following chemical structure:. Bosutinib monohydrate is a white to yellowish-tan powder. Bosutinib monohydrate has a pH dependent solubility across the physiological pH range. At or below pH 5, bosutinib monohydrate behaves as a highly soluble compound. Above pH 5, the solubility of bosutinib monohydrate reduces rapidly. BOSULIF® (bosutinib) tablets are supplied for oral administration in 3 strengths: 100 mg, 400 mg and 500 mg. Each strength reflects the equivalent amount of bosutinib content (on anhydrous basis). The tablets contain the following inactive ingredients: croscarmellose sodium, iron oxide red (for 400 mg, and 500 mg tablet) and iron oxide yellow (for 100 mg, and 400 mg tablet), magnesium stearate, microcrystalline cellulose, poloxamer, polyethylene glycol, polyvinyl alcohol, povidone, talc and titanium dioxide. BOSULIF® (bosutinib) capsules are supplied for oral administration in 2 strengths: 50 mg and 100 mg. Each strength reflects the equivalent amount of bosutinib (on anhydrous basis). The capsules contain the following inactive ingredients: croscarmellose sodium, gelatin, magnesium stearate, mannitol, microcrystalline cellulose, poloxamer, povidone, red iron oxide, titanium dioxide, yellow iron oxide. The printing ink contains black iron oxide, potassium hydroxide, propylene glycol, shellac, strong ammonia solution."
},
{
"NDCCode": "0143-9295-01",
"PackageDescription": "1 VIAL in 1 BOX (0143-9295-01) / 1 mL in 1 VIAL",
"NDC11Code": "00143-9295-01",
"ProductNDC": "0143-9295",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Haloperidol Decanoate",
"NonProprietaryName": "Haloperidol Decanoate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "19981001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075305",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "HALOPERIDOL DECANOATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Typical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19981001",
"SamplePackage": "N",
"IndicationAndUsage": "Haloperidol Decanoate Injection is indicated for the treatment of patients with schizophrenia who require prolonged parenteral antipsychotic therapy.",
"Description": "Haloperidol decanoate is the decanoate ester of the butyrophenone, haloperidol. It has a markedly extended duration of effect. It is available in sesame oil in sterile form for intramuscular (IM) injection. The structural formula of haloperidol decanoate, 4-[4-(p-chlorophenyl)-4-hydroxypiperidino]-4’-fluorobutyrophenone decanoate, is. Molecular Formula: C31H41ClFNO3 M.W. 530.13. Haloperidol decanoate is almost insoluble in water (0.01 mg/mL), but is soluble in most organic solvents. Each mL of Haloperidol Decanoate Injection, 100 mg/mL, contains 141.04 mg haloperidol decanoate, equivalent to 100 mg haloperidol, in a sesame oil vehicle, with 1.2% (w/v) benzyl alcohol as a preservative."
},
{
"NDCCode": "0143-9296-01",
"PackageDescription": "1 VIAL in 1 BOX (0143-9296-01) / 5 mL in 1 VIAL",
"NDC11Code": "00143-9296-01",
"ProductNDC": "0143-9296",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Haloperidol Decanoate",
"NonProprietaryName": "Haloperidol Decanoate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "19981001",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075305",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "HALOPERIDOL DECANOATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Typical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2025-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19981001",
"SamplePackage": "N",
"IndicationAndUsage": "Haloperidol Decanoate Injection is indicated for the treatment of patients with schizophrenia who require prolonged parenteral antipsychotic therapy.",
"Description": "Haloperidol decanoate is the decanoate ester of the butyrophenone, haloperidol. It has a markedly extended duration of effect. It is available in sesame oil in sterile form for intramuscular (IM) injection. The structural formula of haloperidol decanoate, 4-[4-(p-chlorophenyl)-4-hydroxypiperidino]-4’-fluorobutyrophenone decanoate, is. Molecular Formula: C31H41ClFNO3 M.W. 530.13. Haloperidol decanoate is almost insoluble in water (0.01 mg/mL), but is soluble in most organic solvents. Each mL of Haloperidol Decanoate Injection, 100 mg/mL, contains 141.04 mg haloperidol decanoate, equivalent to 100 mg haloperidol, in a sesame oil vehicle, with 1.2% (w/v) benzyl alcohol as a preservative."
},
{
"NDCCode": "0395-0055-16",
"PackageDescription": "473 mL in 1 BOTTLE, PLASTIC (0395-0055-16)",
"NDC11Code": "00395-0055-16",
"ProductNDC": "0395-0055",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Humco Aluminum Acetate (burrow)",
"NonProprietaryName": "Aluminum Acetate",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "19980325",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "Humco Holding Group, Inc.",
"SubstanceName": "ALUMINUM ACETATE",
"StrengthNumber": "530",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2017-08-29"
},
{
"NDCCode": "0409-4164-03",
"PackageDescription": "12 POUCH in 1 CASE (0409-4164-03) > 1 BAG in 1 POUCH > 500 mL in 1 BAG",
"NDC11Code": "00409-4164-03",
"ProductNDC": "0409-4164",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aminosyn Ii",
"NonProprietaryName": "Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Aspartic Acid, Glutamic Acid, Histidine, Proline, Serine, N-acetyl-tyrosine, And Glycine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20050901",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019438",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; HISTIDINE; PROLINE; SERINE; N-ACETYLTYROSINE; GLYCINE",
"StrengthNumber": "660; 1000; 1050; 172; 298; 400; 200; 500; 993; 1018; 700; 738; 300; 722; 530; 270; 500",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Amino Acid [EPC],Amino Acids [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-04-18",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0409-4164-05",
"PackageDescription": "6 POUCH in 1 CASE (0409-4164-05) > 1 BAG in 1 POUCH > 1000 mL in 1 BAG",
"NDC11Code": "00409-4164-05",
"ProductNDC": "0409-4164",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aminosyn Ii",
"NonProprietaryName": "Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Aspartic Acid, Glutamic Acid, Histidine, Proline, Serine, N-acetyl-tyrosine, And Glycine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20050901",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019438",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; HISTIDINE; PROLINE; SERINE; N-ACETYLTYROSINE; GLYCINE",
"StrengthNumber": "660; 1000; 1050; 172; 298; 400; 200; 500; 993; 1018; 700; 738; 300; 722; 530; 270; 500",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Amino Acid [EPC],Amino Acids [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-04-18",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0409-7121-07",
"PackageDescription": "6 POUCH in 1 CASE (0409-7121-07) > 1 BAG in 1 POUCH > 2000 mL in 1 BAG",
"NDC11Code": "00409-7121-07",
"ProductNDC": "0409-7121",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aminosyn Ii",
"NonProprietaryName": "Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Aspartic Acid, Glutamic Acid, Histidine, Proline, Serine, N-acetyltyrosine, And Glycine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19911219",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020015",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; HISTIDINE; PROLINE; SERINE; N-ACETYLTYROSINE; GLYCINE",
"StrengthNumber": "660; 1000; 1050; 172; 298; 400; 200; 500; 993; 1018; 700; 738; 300; 722; 530; 270; 500",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Amino Acid [EPC],Amino Acids [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-04-18",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "0409-7172-17",
"PackageDescription": "6 POUCH in 1 CASE (0409-7172-17) > 1 BAG in 1 POUCH > 2000 mL in 1 BAG",
"NDC11Code": "00409-7172-17",
"ProductNDC": "0409-7172",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aminosyn Ii",
"NonProprietaryName": "Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Aspartic Acid, Glutamic Acid, Histidine, Proline, Serine, N-acetyltyrosine, And Glycine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19911219",
"EndMarketingDate": "20201201",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020015",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; HISTIDINE; PROLINE; SERINE; N-ACETYLTYROSINE; GLYCINE",
"StrengthNumber": "660; 1000; 1050; 172; 298; 400; 200; 500; 993; 1018; 700; 738; 300; 722; 530; 270; 500",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Amino Acid [EPC],Amino Acids [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-12-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19911219",
"EndMarketingDatePackage": "20201201",
"SamplePackage": "N"
},
{
"NDCCode": "0480-3777-58",
"PackageDescription": "1 BOTTLE in 1 CARTON (0480-3777-58) / 25 mL in 1 BOTTLE",
"NDC11Code": "00480-3777-58",
"ProductNDC": "0480-3777",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Glycerol Phenylbutyrate",
"NonProprietaryName": "Glycerol Phenylbutyrate",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20260416",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA218738",
"LabelerName": "Teva Pharmaceuticals, Inc.",
"SubstanceName": "GLYCEROL PHENYLBUTYRATE",
"StrengthNumber": "1.1",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Ammonium Ion Binding Activity [MoA], Nitrogen Binding Agent [EPC]",
"Status": "Active",
"LastUpdate": "2026-04-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260416",
"SamplePackage": "N",
"IndicationAndUsage": "Glycerol phenylbutyrate oral liquid is indicated for use as a nitrogen-binding agent for chronic management of patients with urea cycle disorders (UCDs) who cannot be managed by dietary protein restriction and/or amino acid supplementation alone. Glycerol phenylbutyrate oral liquid must be used with dietary protein restriction and, in some cases, dietary supplements (e.g., essential amino acids, arginine, citrulline, protein-free calorie supplements). Limitations of Use: 1 Glycerol phenylbutyrate oral liquid is not indicated for the treatment of acute hyperammonemia in patients with UCDs because more rapidly acting interventions are essential to reduce plasma ammonia levels., 2 The safety and efficacy of glycerol phenylbutyrate oral liquid for the treatment of N-acetylglutamate synthase (NAGS) deficiency has not been established.",
"Description": "Glycerol phenylbutyrate oral liquid is a clear, colorless to pale yellow oral liquid. It is insoluble in water and most organic solvents, and it is soluble in dimethylsulfoxide (DMSO) and greater than 65% acetonitrile. Glycerol phenylbutyrate is a nitrogen-binding agent. It is a triglyceride containing 3 molecules of PBA linked to a glycerol backbone, the chemical name of which is benzenebutanoic acid, 1', 1' ' –(1,2,3-propanetriyl) ester with a molecular weight of 530.65. It has a molecular formula of C33H38O6. The structural formula is."
},
{
"NDCCode": "0548-9701-00",
"PackageDescription": "1 VIAL in 1 CARTON (0548-9701-00) > 1 mL in 1 VIAL",
"NDC11Code": "00548-9701-00",
"ProductNDC": "0548-9701",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vasopressin",
"NonProprietaryName": "Vasopressin",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220822",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211857",
"LabelerName": "Amphastar Pharmaceuticals, Inc.",
"SubstanceName": "VASOPRESSIN",
"StrengthNumber": "20",
"StrengthUnit": "[USP'U]/mL",
"Pharm_Classes": "Decreased Diuresis [PE], Vasoconstriction [PE], Vasopressins [CS]",
"Status": "Active",
"LastUpdate": "2022-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220831",
"SamplePackage": "N",
"IndicationAndUsage": "Vasopressin Injection, USP is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines.",
"Description": "Vasopressin is a polypeptide hormone. Vasopressin Injection, USP is a sterile, aqueous solution of synthetic arginine vasopressin for intravenous administration. The 1 mL solution contains vasopressin 20 units/mL, chlorobutanol, NF 0.5% as a preservative, and Water for Injection, USP adjusted with acetic acid to pH 3.4-3.6. The chemical name of vasopressin is Cyclo (1-6) L-Cysteinyl-L-Tyrosyl-L-Phenylalanyl-LGlutaminyl-L-Asparaginyl-L-Cysteinyl-L-Prolyl-L-Arginyl-L-Glycinamide. It is a white to off-white amorphous powder, freely soluble in water. The structural formula is. Molecular Formula: C46H65N15O12S2 Molecular Weight: 1084.23. One mg is equivalent to 530 units."
},
{
"NDCCode": "0990-7172-17",
"PackageDescription": "6 POUCH in 1 CASE (0990-7172-17) / 1 BAG in 1 POUCH / 2000 mL in 1 BAG",
"NDC11Code": "00990-7172-17",
"ProductNDC": "0990-7172",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aminosyn Ii",
"NonProprietaryName": "Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Aspartic Acid, Glutamic Acid, Histidine, Proline, Serine, N-acetyltyrosine, And Glycine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20191101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020015",
"LabelerName": "ICU Medical Inc.",
"SubstanceName": "ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; HISTIDINE; PROLINE; SERINE; ACETYL L-TYROSINE; GLYCINE",
"StrengthNumber": "660; 1000; 1050; 172; 298; 400; 200; 500; 993; 1018; 700; 738; 300; 722; 530; 270; 500",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Amino Acid [EPC], Amino Acids [CS]",
"Status": "Active",
"LastUpdate": "2026-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191101",
"SamplePackage": "N",
"IndicationAndUsage": "Aminosyn II, Sulfite-Free, (an amino acid injection) infused with dextrose by peripheral vein infusion is indicated as a source of nitrogen in the nutritional support of patients with adequate stores of body fat, in whom, for short periods of time, oral nutrition cannot be tolerated, is undesirable, or inadequate. SUPPLEMENTAL ELECTROLYTES, IN ACCORDANCE WITH THE PRESCRIPTION OF THE ATTENDING PHYSICIAN, MUST BE ADDED TO AMINOSYN II SOLUTIONS WITHOUT ELECTROLYTES. Aminosyn II can be administered peripherally with dilute (5 to 10%) dextrose solution and I.V. fat emulsion as a source of nutritional support. This form of nutritional support can help to preserve protein and reduce catabolism in stress conditions where oral intake is inadequate. Aminosyn II is also indicated for central vein infusion to prevent or reverse negative nitrogen balance in patients where the alimentary tract, by the oral, gastrostomy or jejunostomy route cannot or should not be used and gastrointestinal absorption of protein is impaired.",
"Description": "Aminosyn II, Sulfite-Free, (an amino acid injection) is a sterile, nonpyrogenic solution for intravenous infusion. Aminosyn II is oxygen sensitive. The Pharmacy Bulk Package is a sterile dosage form which contains multiple single doses for use only in a pharmacy bulk admixture program. The formulations are described below. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. The formulas for the individual amino acids are as follows. The Pharmacy Bulk Package is designed for use with manual, gravity flow operations and automated compounding devices for preparing sterile parenteral nutrient admixtures; it contains no bacteriostat. Multiple single doses may be dispensed during continual aliquoting operations. Withdrawal of container contents should be promptly completed within 4 hours after initial closure puncture."
},
{
"NDCCode": "10056-530-06",
"PackageDescription": "1 TUBE in 1 BOX (10056-530-06) / 191 g in 1 TUBE",
"NDC11Code": "10056-0530-06",
"ProductNDC": "10056-530",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Glister Multi-action Fluoride",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "PASTE, DENTIFRICE",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110411",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M021",
"LabelerName": "Access Business Group, LLC",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": "2.1",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2025-11-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110411",
"SamplePackage": "N",
"IndicationAndUsage": "Aids in the prevention of dental cavities."
},
{
"NDCCode": "10056-530-65",
"PackageDescription": "1 TUBE in 1 BOX (10056-530-65) / 65 g in 1 TUBE",
"NDC11Code": "10056-0530-65",
"ProductNDC": "10056-530",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Glister Multi-action Fluoride",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "PASTE, DENTIFRICE",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110411",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M021",
"LabelerName": "Access Business Group, LLC",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": "2.1",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2025-11-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110411",
"SamplePackage": "N",
"IndicationAndUsage": "Aids in the prevention of dental cavities."
},
{
"NDCCode": "10893-530-04",
"PackageDescription": "118.3 mL in 1 BOTTLE (10893-530-04) ",
"NDC11Code": "10893-0530-04",
"ProductNDC": "10893-530",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Naturasil Mite B Gone",
"NonProprietaryName": "Sulfur",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240201",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Nature's Innovation, Inc.",
"SubstanceName": "SULFUR",
"StrengthNumber": "1",
"StrengthUnit": "[hp_X]/118.3mL",
"Status": "Active",
"LastUpdate": "2024-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240201",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: Symptomatic treatment of mite infections."
},
{
"NDCCode": "10893-530-08",
"PackageDescription": "1 BOTTLE in 1 BOX (10893-530-08) / 236.6 mL in 1 BOTTLE",
"NDC11Code": "10893-0530-08",
"ProductNDC": "10893-530",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Naturasil Mite B Gone",
"NonProprietaryName": "Sulfur",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240201",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Nature's Innovation, Inc.",
"SubstanceName": "SULFUR",
"StrengthNumber": "1",
"StrengthUnit": "[hp_X]/118.3mL",
"Status": "Active",
"LastUpdate": "2024-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240201",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: Symptomatic treatment of mite infections."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>75839-530-55</NDCCode>
<PackageDescription>50 g in 1 CONTAINER (75839-530-55)</PackageDescription>
<NDC11Code>75839-0530-55</NDC11Code>
<ProductNDC>75839-530</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Quinacrine Dihydrochloride</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20190710</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Attix Pharmaceuticals</LabelerName>
<SubstanceName>QUINACRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>g/25g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>71052-530-55</NDCCode>
<PackageDescription>50 g in 1 CONTAINER (71052-530-55)</PackageDescription>
<NDC11Code>71052-0530-55</NDC11Code>
<ProductNDC>71052-530</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Quinacrine Dihydrochloride</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20190725</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>DARMERICA, LLC</LabelerName>
<SubstanceName>QUINACRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>g/25g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>75839-530-05</NDCCode>
<PackageDescription>500 g in 1 CONTAINER (75839-530-05)</PackageDescription>
<NDC11Code>75839-0530-05</NDC11Code>
<ProductNDC>75839-530</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Quinacrine Dihydrochloride</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20190710</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Attix Pharmaceuticals</LabelerName>
<SubstanceName>QUINACRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>g/25g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>75839-530-25</NDCCode>
<PackageDescription>25 g in 1 CONTAINER (75839-530-25)</PackageDescription>
<NDC11Code>75839-0530-25</NDC11Code>
<ProductNDC>75839-530</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Quinacrine Dihydrochloride</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20190710</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Attix Pharmaceuticals</LabelerName>
<SubstanceName>QUINACRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>g/25g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>75839-038-55</NDCCode>
<PackageDescription>50 g in 1 CONTAINER (75839-038-55)</PackageDescription>
<NDC11Code>75839-0038-55</NDC11Code>
<ProductNDC>75839-038</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Hyaluronic Acid Sodium Salt</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20130411</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Attix Pharmaceuticals</LabelerName>
<SubstanceName>HYALURONATE SODIUM</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>75839-054-55</NDCCode>
<PackageDescription>500 g in 1 CONTAINER (75839-054-55)</PackageDescription>
<NDC11Code>75839-0054-55</NDC11Code>
<ProductNDC>75839-054</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Pimobendan</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20130411</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR ANIMAL DRUG COMPOUNDING</MarketingCategoryName>
<LabelerName>Attix Pharmaceuticals</LabelerName>
<SubstanceName>PIMOBENDAN</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>75839-057-55</NDCCode>
<PackageDescription>5000 g in 1 CONTAINER (75839-057-55)</PackageDescription>
<NDC11Code>75839-0057-55</NDC11Code>
<ProductNDC>75839-057</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Sildenafil Citrate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20130411</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Attix Pharmaceuticals</LabelerName>
<SubstanceName>SILDENAFIL CITRATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>g/50g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>59310-530-08</NDCCode>
<PackageDescription>1 POUCH in 1 CARTON (59310-530-08) / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER</PackageDescription>
<NDC11Code>59310-0530-08</NDC11Code>
<ProductNDC>59310-530</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Airduo Digihaler</ProprietaryName>
<NonProprietaryName>Fluticasone Propionate And Salmeterol</NonProprietaryName>
<DosageFormName>POWDER, METERED</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20200915</StartMarketingDate>
<EndMarketingDate>20250731</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208799</ApplicationNumber>
<LabelerName>Teva Respiratory, LLC</LabelerName>
<SubstanceName>FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE</SubstanceName>
<StrengthNumber>232; 14</StrengthNumber>
<StrengthUnit>ug/1; ug/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200915</StartMarketingDatePackage>
<EndMarketingDatePackage>20250731</EndMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>AirDuo® Digihaler® is indicated for the treatment of asthma in adult and pediatric patients aged 12 years and older. AirDuo Digihaler should be used for patients not adequately controlled on a long term asthma control medication such as an inhaled corticosteroid or whose disease warrants initiation of treatment with both an inhaled corticosteroid and long acting beta2-adrenergic agonist (LABA). Limitations of Use:. AirDuo Digihaler is not indicated for the relief of acute bronchospasm.</IndicationAndUsage>
<Description>AirDuo Digihaler 55/14 mcg, AirDuo Digihaler 113/14 mcg and AirDuo Digihaler 232/14 mcg are combinations of fluticasone propionate and salmeterol. Fluticasone Propionate. One active component of AirDuo Digihaler is fluticasone propionate, a corticosteroid having the chemical name S-(fluoromethyl) 6α,9-difluoro-11ß,17-dihydroxy-16α-methyl-3-oxoandrosta-1,4-diene-17ß-carbothioate, 17-propionate, and the following chemical structure. Fluticasone propionate is a white powder with a molecular weight of 500.6, and the empirical formula is C25H31F3O5S. It is practically insoluble in water, freely soluble in dimethyl sulfoxide and dimethylformamide, and slightly soluble in methanol and 95% ethanol. Salmeterol Xinafoate. The other active component of AirDuo Digihaler is salmeterol xinafoate, a beta2–adrenergic bronchodilator. Salmeterol xinafoate is the racemic form of the 1‑hydroxy‑2‑naphthoic acid salt of salmeterol. It has the chemical name 4-hydroxy-α -[[[6-(4-phenylbutoxy)hexyl]amino]methyl]-1,3-benzenedimethanol, 1-hydroxy-2-naphthalenecarboxylate and the following chemical structure. Salmeterol xinafoate is a white powder with a molecular weight of 603.8, and the empirical formula is C25H37NO4C11H8O3. It is freely soluble in methanol; slightly soluble in ethanol, chloroform, and isopropanol; and sparingly soluble in water. AirDuo Digihaler. AirDuo Digihaler is a multidose dry powder inhaler (MDPI) with an electronic module, for oral inhalation only. It contains fluticasone propionate, salmeterol xinafoate, and lactose monohydrate (which may contain milk proteins). The opening of the mouthpiece cover meters 5.5 mg of the formulation from the device reservoir, which contains 55 mcg, 113 mcg, or 232 mcg of fluticasone propionate, and 14 mcg of salmeterol base (equivalent to 20.3 mcg of salmeterol xinafoate). Patient inhalation through the mouthpiece causes the deagglomeration and aerosolization of the drug particles as the formulation moves through the cyclone component of the device. This is followed by dispersion into the airstream. Under standardized in vitro test conditions, the AirDuo Digihaler inhaler delivers 49 mcg, 100 mcg, or 202 mcg of fluticasone propionate and 12.75 mcg of salmeterol base (equivalent to 18.5 mcg of salmeterol xinafoate), with lactose from the mouthpiece when tested at a flow rate of 85 L/min for 1.4 seconds. The amount of drug delivered to the lung will depend on patient factors such as inspiratory flow profiles. In adult subjects (N=50, aged 18 to 45 years) with asthma, mean peak inspiratory flow (PIF) through the MDPI was 108.28 L/min (range: 70.37 to 129.24 L/min). In adolescent subjects (N=50, aged 12 to 17 years) with asthma, mean peak inspiratory flow (PIF) through the MDPI was 106.72 L/min (range: 73.64 to 125.51 L/min). AirDuo Digihaler includes a QR code (on the top of the inhaler), and contains a built-in electronic module which automatically detects, records and stores data on inhaler events, including peak inspiratory flow rate (L/min). AirDuo Digihaler may pair with and transmit data to the mobile App where inhaler events are categorized.</Description>
</NDC>
<NDC>
<NDCCode>72789-530-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-530-30) </PackageDescription>
<NDC11Code>72789-0530-30</NDC11Code>
<ProductNDC>72789-530</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Minocycline Hydrochloride</ProprietaryName>
<NonProprietaryName>Minocycline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204453</ApplicationNumber>
<LabelerName>PD-Rx Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>MINOCYCLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>135</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250910</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Minocycline hydrochloride extended-release tablets is indicated to treat inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. Limitations of Use: 1 Minocycline hydrochloride extended-release tablets did not demonstrate any effect on non-inflammatory acne lesions., 2 This formulation of minocycline has not been evaluated in the treatment of infections [see Clinical Studies ( 14)]. , 3 To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, use minocycline hydrochloride extended-release tablets only as indicated [see Warnings and Precautions ( 5.12)]. .</IndicationAndUsage>
<Description>Minocycline hydrochloride, a semi synthetic derivative of tetracycline, is [4 S-(4α,4aα,5aα, 12aα)]-4,7–Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. The structural formula is represented below. C 23H 27N 3O 7HCl M. W. 493.95. Minocycline hydrochloride extended-release tablets, USP for oral administration contain minocycline hydrochloride USP equivalent to 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg, and 135 mg of minocycline. In addition, 45 mg, 55 mg, 65 mg, 80 mg, 90 mg, 105 mg, 115 mg, and 135 mg tablets contain the following inactive ingredients: lactose monohydrate, hypromellose type 2910, hypromellose type 2208, colloidal silicon dioxide, magnesium stearate, titanium dioxide and triacetin. The 45 mg tablets also contain iron oxide black. The 65 mg tablets also contain FD&C blue #1/brilliant blue FCF aluminium lake. polyethylene glycol 3350, FD&C blue #2/indigo carmine aluminum lake and D&C yellow #10 aluminum lake. The 55 mg tablets also contain macrogol, FD&C RED #40. The 80 mg tablets also contain macrogol, FD&C blue #2, FD&C red #40, FD&C yellow #6. The 90 mg tablets also contain iron oxide yellow and polyethylene glycol 3350. The 105 mg tablets also D&C red #27, macrogol, FD&C blue #1. The 115 mg tablets also contain D&C yellow #10 aluminum lake, FD&C blue #1/brilliant blue FCF aluminium lake and FD&C blue #2/indigo carmine aluminum lake. The 135 mg tablets also contain polyethylene glycol 3350 and iron oxide red. The USP Dissolution Test is pending.</Description>
</NDC>
<NDC>
<NDCCode>0006-3516-59</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 TRAY (0006-3516-59) / 100 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00006-3516-59</NDC11Code>
<ProductNDC>0006-3516</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Primaxin</ProprietaryName>
<ProprietaryNameSuffix>Iv</ProprietaryNameSuffix>
<NonProprietaryName>Imipenem And Cilastatin Sodium</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19851126</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050587</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme LLC</LabelerName>
<SubstanceName>IMIPENEM; CILASTATIN SODIUM</SubstanceName>
<StrengthNumber>500; 500</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Carbapenems [CS], Dipeptidase Inhibitors [MoA], Penem Antibacterial [EPC], Renal Dehydropeptidase Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19851126</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PRIMAXIN for intravenous use is a combination of imipenem, a penem antibacterial, and cilastatin, a renal dehydropeptidase inhibitor, indicated for the treatment of the following serious infections caused by designated susceptible bacteria: 1 Lower respiratory tract infections. (1.1), 2 Urinary tract infections. (1.2), 3 Intra-abdominal infections. (1.3), 4 Gynecologic infections. (1.4), 5 Bacterial septicemia. (1.5), 6 Bone and joint infections. (1.6), 7 Skin and skin structure infections. (1.7), 8 Endocarditis. (1.8).</IndicationAndUsage>
<Description>PRIMAXIN (imipenem and cilastatin) for Injection is a sterile formulation of imipenem, a penem antibacterial, and cilastatin, a renal dehydropeptidase inhibitor with sodium bicarbonate added as a buffer. PRIMAXIN is an antibacterial drug for intravenous administration. Imipenem (N-formimidoylthienamycin monohydrate) is a crystalline derivative of thienamycin, which is produced by Streptomyces cattleya. Its chemical name is (5R,6S)-3-[[2-(formimidoylamino)ethyl]thio]-6-[(R)-1-hydroxyethyl]-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid monohydrate. It is an off-white, nonhygroscopic crystalline compound with a molecular weight of 317.37. It is sparingly soluble in water and slightly soluble in methanol. Its empirical formula is C12H17N3O4S∙H2O, and its structural formula is. Cilastatin sodium is the sodium salt of a derivatized heptenoic acid. Its chemical name is sodium (Z)-7[[(R)-2-amino-2-carboxyethyl]thio]-2-[(S)-2,2-dimethylcyclopropanecarboxamido]-2-heptenoate. It is an off-white to yellowish-white, hygroscopic, amorphous compound with a molecular weight of 380.43. It is very soluble in water and in methanol. Its empirical formula is C16H25N2O5SNa, and its structural formula is. Each single-dose vial of PRIMAXIN contains 500 mg imipenem (equivalent to 530 mg imipenem monohydrate), 500 mg cilastatin (equivalent to 531 mg cilastatin sodium), and 20 mg sodium bicarbonate (used as a buffer). PRIMAXIN is buffered to provide solutions in the pH range of 6.5 to 8.5. There is no significant change in pH when solutions are prepared and used as directed [see How Supplied/Storage and Handling (16.1)]. PRIMAXIN 500 contains 37.5 mg of sodium (1.6 mEq). Solutions of PRIMAXIN range from colorless to yellow. Variations of color within this range do not affect the potency of the product.</Description>
</NDC>
<NDC>
<NDCCode>0008-1123-12</NDCCode>
<PackageDescription>1 POUCH in 1 CARTON (0008-1123-12) / 2 BLISTER PACK in 1 POUCH / 15 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00008-1123-12</NDC11Code>
<ProductNDC>0008-1123</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Duavee</ProprietaryName>
<NonProprietaryName>Conjugated Estrogens/bazedoxifene</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131003</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022247</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>ESTROGENS, CONJUGATED; BAZEDOXIFENE ACETATE</SubstanceName>
<StrengthNumber>.45; 20</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Estrogen Agonist/Antagonist [EPC], Estrogen Receptor Agonists [MoA], Estrogen [EPC], Estrogens, Conjugated (USP) [CS], Selective Estrogen Receptor Modulators [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131003</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DUAVEE is indicated in women with a uterus for.</IndicationAndUsage>
<Description>DUAVEE (conjugated estrogens/bazedoxifene), contains conjugated estrogens with bazedoxifene, an estrogen agonist/antagonist. Conjugated estrogens are purified from pregnant mares' urine and consist of the sodium salts of water-soluble estrogen sulfates blended to represent the average composition of material derived from pregnant mares' urine. Conjugated estrogens are a mixture of sodium estrone sulfate and sodium equilin sulfate, and also contain as concomitant components, sodium sulfate conjugates, 17α-dihydroequilin, 17α-estradiol, and 17β-dihydroequilin. Bazedoxifene is supplied as the acetate salt (bazedoxifene acetate) and has the chemical name 1H-Indol-5-ol, 1-[[4-[2-(hexahydro-1H-azepin-1-yl) ethoxy]phenyl]methyl]-2-(4-hydroxyphenyl)-3-methyl-, monoacetate. The empirical formula is C30H34N2O3 ∙ C2H4O2, and the molecular weight is 530.65. Bazedoxifene acetate is a white to tan powder. The aqueous solubility of bazedoxifene is pH-dependent. Solubility is higher at lower pH. The solubility of bazedoxifene acetate in unbuffered sterile water was measured to be 923 microgramsA/mL at pH 5.4. The following represents the chemical structure of bazedoxifene acetate:. DUAVEE is available for oral administration as tablets containing 0.45 mg of conjugated estrogens with 20 mg of bazedoxifene (equivalent to 22.6 mg of bazedoxifene acetate). Each tablet of DUAVEE contains the following inactive ingredients: calcium phosphate tribasic, hydroxypropyl cellulose, microcrystalline cellulose, powdered cellulose, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, sucrose, ascorbic acid, sucrose palmitic acid ester, hydroxyethylcellulose, titanium dioxide, red iron oxide, yellow iron oxide, black iron oxide, povidone, polydextrose, maltitol, poloxamer 188, propylene glycol, and isopropyl alcohol.</Description>
</NDC>
<NDC>
<NDCCode>0069-0135-01</NDCCode>
<PackageDescription>120 TABLET, FILM COATED in 1 BOTTLE (0069-0135-01) </PackageDescription>
<NDC11Code>00069-0135-01</NDC11Code>
<ProductNDC>0069-0135</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bosulif</ProprietaryName>
<NonProprietaryName>Bosutinib</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120904</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA203341</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<SubstanceName>BOSUTINIB MONOHYDRATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Kinase Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120904</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BOSULIF is indicated for the treatment of: 1 Adult and pediatric patients 1 year of age and older with chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML), newly-diagnosed or resistant or intolerant to prior therapy [see Clinical Studies (14.1, 14.2, 14.3)]., 2 Adult patients with accelerated phase (AP), or blast phase (BP) Ph+ CML with resistance or intolerance to prior therapy [see Clinical Studies (14.2)].</IndicationAndUsage>
<Description>BOSULIF contains bosutinib, a kinase inhibitor. Bosutinib is present as a monohydrate with a chemical name of 3-Quinolinecarbonitrile, 4-[(2,4-dichloro-5-methoxyphenyl)amino]-6-methoxy-7-[3-(4-methyl-1-piperazinyl) propoxy]-, hydrate (1:1). Its chemical formula is C26H29Cl2N5O3∙H2O (monohydrate); its molecular weight is 548.46 (monohydrate), equivalent to 530.46 (anhydrous). Bosutinib monohydrate has the following chemical structure:. Bosutinib monohydrate is a white to yellowish-tan powder. Bosutinib monohydrate has a pH dependent solubility across the physiological pH range. At or below pH 5, bosutinib monohydrate behaves as a highly soluble compound. Above pH 5, the solubility of bosutinib monohydrate reduces rapidly. BOSULIF® (bosutinib) tablets are supplied for oral administration in 3 strengths: 100 mg, 400 mg and 500 mg. Each strength reflects the equivalent amount of bosutinib content (on anhydrous basis). The tablets contain the following inactive ingredients: croscarmellose sodium, iron oxide red (for 400 mg, and 500 mg tablet) and iron oxide yellow (for 100 mg, and 400 mg tablet), magnesium stearate, microcrystalline cellulose, poloxamer, polyethylene glycol, polyvinyl alcohol, povidone, talc and titanium dioxide. BOSULIF® (bosutinib) capsules are supplied for oral administration in 2 strengths: 50 mg and 100 mg. Each strength reflects the equivalent amount of bosutinib (on anhydrous basis). The capsules contain the following inactive ingredients: croscarmellose sodium, gelatin, magnesium stearate, mannitol, microcrystalline cellulose, poloxamer, povidone, red iron oxide, titanium dioxide, yellow iron oxide. The printing ink contains black iron oxide, potassium hydroxide, propylene glycol, shellac, strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>0069-0136-01</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (0069-0136-01) </PackageDescription>
<NDC11Code>00069-0136-01</NDC11Code>
<ProductNDC>0069-0136</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bosulif</ProprietaryName>
<NonProprietaryName>Bosutinib</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120904</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA203341</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<SubstanceName>BOSUTINIB MONOHYDRATE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Kinase Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120904</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BOSULIF is indicated for the treatment of: 1 Adult and pediatric patients 1 year of age and older with chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML), newly-diagnosed or resistant or intolerant to prior therapy [see Clinical Studies (14.1, 14.2, 14.3)]., 2 Adult patients with accelerated phase (AP), or blast phase (BP) Ph+ CML with resistance or intolerance to prior therapy [see Clinical Studies (14.2)].</IndicationAndUsage>
<Description>BOSULIF contains bosutinib, a kinase inhibitor. Bosutinib is present as a monohydrate with a chemical name of 3-Quinolinecarbonitrile, 4-[(2,4-dichloro-5-methoxyphenyl)amino]-6-methoxy-7-[3-(4-methyl-1-piperazinyl) propoxy]-, hydrate (1:1). Its chemical formula is C26H29Cl2N5O3∙H2O (monohydrate); its molecular weight is 548.46 (monohydrate), equivalent to 530.46 (anhydrous). Bosutinib monohydrate has the following chemical structure:. Bosutinib monohydrate is a white to yellowish-tan powder. Bosutinib monohydrate has a pH dependent solubility across the physiological pH range. At or below pH 5, bosutinib monohydrate behaves as a highly soluble compound. Above pH 5, the solubility of bosutinib monohydrate reduces rapidly. BOSULIF® (bosutinib) tablets are supplied for oral administration in 3 strengths: 100 mg, 400 mg and 500 mg. Each strength reflects the equivalent amount of bosutinib content (on anhydrous basis). The tablets contain the following inactive ingredients: croscarmellose sodium, iron oxide red (for 400 mg, and 500 mg tablet) and iron oxide yellow (for 100 mg, and 400 mg tablet), magnesium stearate, microcrystalline cellulose, poloxamer, polyethylene glycol, polyvinyl alcohol, povidone, talc and titanium dioxide. BOSULIF® (bosutinib) capsules are supplied for oral administration in 2 strengths: 50 mg and 100 mg. Each strength reflects the equivalent amount of bosutinib (on anhydrous basis). The capsules contain the following inactive ingredients: croscarmellose sodium, gelatin, magnesium stearate, mannitol, microcrystalline cellulose, poloxamer, povidone, red iron oxide, titanium dioxide, yellow iron oxide. The printing ink contains black iron oxide, potassium hydroxide, propylene glycol, shellac, strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>0069-0193-01</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (0069-0193-01) </PackageDescription>
<NDC11Code>00069-0193-01</NDC11Code>
<ProductNDC>0069-0193</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bosulif</ProprietaryName>
<NonProprietaryName>Bosutinib</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171218</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA203341</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<SubstanceName>BOSUTINIB MONOHYDRATE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Kinase Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171218</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BOSULIF is indicated for the treatment of: 1 Adult and pediatric patients 1 year of age and older with chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML), newly-diagnosed or resistant or intolerant to prior therapy [see Clinical Studies (14.1, 14.2, 14.3)]., 2 Adult patients with accelerated phase (AP), or blast phase (BP) Ph+ CML with resistance or intolerance to prior therapy [see Clinical Studies (14.2)].</IndicationAndUsage>
<Description>BOSULIF contains bosutinib, a kinase inhibitor. Bosutinib is present as a monohydrate with a chemical name of 3-Quinolinecarbonitrile, 4-[(2,4-dichloro-5-methoxyphenyl)amino]-6-methoxy-7-[3-(4-methyl-1-piperazinyl) propoxy]-, hydrate (1:1). Its chemical formula is C26H29Cl2N5O3∙H2O (monohydrate); its molecular weight is 548.46 (monohydrate), equivalent to 530.46 (anhydrous). Bosutinib monohydrate has the following chemical structure:. Bosutinib monohydrate is a white to yellowish-tan powder. Bosutinib monohydrate has a pH dependent solubility across the physiological pH range. At or below pH 5, bosutinib monohydrate behaves as a highly soluble compound. Above pH 5, the solubility of bosutinib monohydrate reduces rapidly. BOSULIF® (bosutinib) tablets are supplied for oral administration in 3 strengths: 100 mg, 400 mg and 500 mg. Each strength reflects the equivalent amount of bosutinib content (on anhydrous basis). The tablets contain the following inactive ingredients: croscarmellose sodium, iron oxide red (for 400 mg, and 500 mg tablet) and iron oxide yellow (for 100 mg, and 400 mg tablet), magnesium stearate, microcrystalline cellulose, poloxamer, polyethylene glycol, polyvinyl alcohol, povidone, talc and titanium dioxide. BOSULIF® (bosutinib) capsules are supplied for oral administration in 2 strengths: 50 mg and 100 mg. Each strength reflects the equivalent amount of bosutinib (on anhydrous basis). The capsules contain the following inactive ingredients: croscarmellose sodium, gelatin, magnesium stearate, mannitol, microcrystalline cellulose, poloxamer, povidone, red iron oxide, titanium dioxide, yellow iron oxide. The printing ink contains black iron oxide, potassium hydroxide, propylene glycol, shellac, strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>0069-0504-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (0069-0504-30) </PackageDescription>
<NDC11Code>00069-0504-30</NDC11Code>
<ProductNDC>0069-0504</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bosulif</ProprietaryName>
<NonProprietaryName>Bosutinib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240102</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA217729</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<SubstanceName>BOSUTINIB MONOHYDRATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Kinase Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BOSULIF is indicated for the treatment of: 1 Adult and pediatric patients 1 year of age and older with chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML), newly-diagnosed or resistant or intolerant to prior therapy [see Clinical Studies (14.1, 14.2, 14.3)]., 2 Adult patients with accelerated phase (AP), or blast phase (BP) Ph+ CML with resistance or intolerance to prior therapy [see Clinical Studies (14.2)].</IndicationAndUsage>
<Description>BOSULIF contains bosutinib, a kinase inhibitor. Bosutinib is present as a monohydrate with a chemical name of 3-Quinolinecarbonitrile, 4-[(2,4-dichloro-5-methoxyphenyl)amino]-6-methoxy-7-[3-(4-methyl-1-piperazinyl) propoxy]-, hydrate (1:1). Its chemical formula is C26H29Cl2N5O3∙H2O (monohydrate); its molecular weight is 548.46 (monohydrate), equivalent to 530.46 (anhydrous). Bosutinib monohydrate has the following chemical structure:. Bosutinib monohydrate is a white to yellowish-tan powder. Bosutinib monohydrate has a pH dependent solubility across the physiological pH range. At or below pH 5, bosutinib monohydrate behaves as a highly soluble compound. Above pH 5, the solubility of bosutinib monohydrate reduces rapidly. BOSULIF® (bosutinib) tablets are supplied for oral administration in 3 strengths: 100 mg, 400 mg and 500 mg. Each strength reflects the equivalent amount of bosutinib content (on anhydrous basis). The tablets contain the following inactive ingredients: croscarmellose sodium, iron oxide red (for 400 mg, and 500 mg tablet) and iron oxide yellow (for 100 mg, and 400 mg tablet), magnesium stearate, microcrystalline cellulose, poloxamer, polyethylene glycol, polyvinyl alcohol, povidone, talc and titanium dioxide. BOSULIF® (bosutinib) capsules are supplied for oral administration in 2 strengths: 50 mg and 100 mg. Each strength reflects the equivalent amount of bosutinib (on anhydrous basis). The capsules contain the following inactive ingredients: croscarmellose sodium, gelatin, magnesium stearate, mannitol, microcrystalline cellulose, poloxamer, povidone, red iron oxide, titanium dioxide, yellow iron oxide. The printing ink contains black iron oxide, potassium hydroxide, propylene glycol, shellac, strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>0069-1014-15</NDCCode>
<PackageDescription>150 CAPSULE in 1 BOTTLE (0069-1014-15) </PackageDescription>
<NDC11Code>00069-1014-15</NDC11Code>
<ProductNDC>0069-1014</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bosulif</ProprietaryName>
<NonProprietaryName>Bosutinib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240102</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA217729</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<SubstanceName>BOSUTINIB MONOHYDRATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Kinase Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BOSULIF is indicated for the treatment of: 1 Adult and pediatric patients 1 year of age and older with chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML), newly-diagnosed or resistant or intolerant to prior therapy [see Clinical Studies (14.1, 14.2, 14.3)]., 2 Adult patients with accelerated phase (AP), or blast phase (BP) Ph+ CML with resistance or intolerance to prior therapy [see Clinical Studies (14.2)].</IndicationAndUsage>
<Description>BOSULIF contains bosutinib, a kinase inhibitor. Bosutinib is present as a monohydrate with a chemical name of 3-Quinolinecarbonitrile, 4-[(2,4-dichloro-5-methoxyphenyl)amino]-6-methoxy-7-[3-(4-methyl-1-piperazinyl) propoxy]-, hydrate (1:1). Its chemical formula is C26H29Cl2N5O3∙H2O (monohydrate); its molecular weight is 548.46 (monohydrate), equivalent to 530.46 (anhydrous). Bosutinib monohydrate has the following chemical structure:. Bosutinib monohydrate is a white to yellowish-tan powder. Bosutinib monohydrate has a pH dependent solubility across the physiological pH range. At or below pH 5, bosutinib monohydrate behaves as a highly soluble compound. Above pH 5, the solubility of bosutinib monohydrate reduces rapidly. BOSULIF® (bosutinib) tablets are supplied for oral administration in 3 strengths: 100 mg, 400 mg and 500 mg. Each strength reflects the equivalent amount of bosutinib content (on anhydrous basis). The tablets contain the following inactive ingredients: croscarmellose sodium, iron oxide red (for 400 mg, and 500 mg tablet) and iron oxide yellow (for 100 mg, and 400 mg tablet), magnesium stearate, microcrystalline cellulose, poloxamer, polyethylene glycol, polyvinyl alcohol, povidone, talc and titanium dioxide. BOSULIF® (bosutinib) capsules are supplied for oral administration in 2 strengths: 50 mg and 100 mg. Each strength reflects the equivalent amount of bosutinib (on anhydrous basis). The capsules contain the following inactive ingredients: croscarmellose sodium, gelatin, magnesium stearate, mannitol, microcrystalline cellulose, poloxamer, povidone, red iron oxide, titanium dioxide, yellow iron oxide. The printing ink contains black iron oxide, potassium hydroxide, propylene glycol, shellac, strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>0143-9295-01</NDCCode>
<PackageDescription>1 VIAL in 1 BOX (0143-9295-01) / 1 mL in 1 VIAL</PackageDescription>
<NDC11Code>00143-9295-01</NDC11Code>
<ProductNDC>0143-9295</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Haloperidol Decanoate</ProprietaryName>
<NonProprietaryName>Haloperidol Decanoate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>19981001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075305</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>HALOPERIDOL DECANOATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Typical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19981001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Haloperidol Decanoate Injection is indicated for the treatment of patients with schizophrenia who require prolonged parenteral antipsychotic therapy.</IndicationAndUsage>
<Description>Haloperidol decanoate is the decanoate ester of the butyrophenone, haloperidol. It has a markedly extended duration of effect. It is available in sesame oil in sterile form for intramuscular (IM) injection. The structural formula of haloperidol decanoate, 4-[4-(p-chlorophenyl)-4-hydroxypiperidino]-4’-fluorobutyrophenone decanoate, is. Molecular Formula: C31H41ClFNO3 M.W. 530.13. Haloperidol decanoate is almost insoluble in water (0.01 mg/mL), but is soluble in most organic solvents. Each mL of Haloperidol Decanoate Injection, 100 mg/mL, contains 141.04 mg haloperidol decanoate, equivalent to 100 mg haloperidol, in a sesame oil vehicle, with 1.2% (w/v) benzyl alcohol as a preservative.</Description>
</NDC>
<NDC>
<NDCCode>0143-9296-01</NDCCode>
<PackageDescription>1 VIAL in 1 BOX (0143-9296-01) / 5 mL in 1 VIAL</PackageDescription>
<NDC11Code>00143-9296-01</NDC11Code>
<ProductNDC>0143-9296</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Haloperidol Decanoate</ProprietaryName>
<NonProprietaryName>Haloperidol Decanoate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>19981001</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075305</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>HALOPERIDOL DECANOATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Typical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19981001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Haloperidol Decanoate Injection is indicated for the treatment of patients with schizophrenia who require prolonged parenteral antipsychotic therapy.</IndicationAndUsage>
<Description>Haloperidol decanoate is the decanoate ester of the butyrophenone, haloperidol. It has a markedly extended duration of effect. It is available in sesame oil in sterile form for intramuscular (IM) injection. The structural formula of haloperidol decanoate, 4-[4-(p-chlorophenyl)-4-hydroxypiperidino]-4’-fluorobutyrophenone decanoate, is. Molecular Formula: C31H41ClFNO3 M.W. 530.13. Haloperidol decanoate is almost insoluble in water (0.01 mg/mL), but is soluble in most organic solvents. Each mL of Haloperidol Decanoate Injection, 100 mg/mL, contains 141.04 mg haloperidol decanoate, equivalent to 100 mg haloperidol, in a sesame oil vehicle, with 1.2% (w/v) benzyl alcohol as a preservative.</Description>
</NDC>
<NDC>
<NDCCode>0395-0055-16</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE, PLASTIC (0395-0055-16)</PackageDescription>
<NDC11Code>00395-0055-16</NDC11Code>
<ProductNDC>0395-0055</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Humco Aluminum Acetate (burrow)</ProprietaryName>
<NonProprietaryName>Aluminum Acetate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19980325</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>Humco Holding Group, Inc.</LabelerName>
<SubstanceName>ALUMINUM ACETATE</SubstanceName>
<StrengthNumber>530</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-08-29</LastUpdate>
</NDC>
<NDC>
<NDCCode>0409-4164-03</NDCCode>
<PackageDescription>12 POUCH in 1 CASE (0409-4164-03) > 1 BAG in 1 POUCH > 500 mL in 1 BAG</PackageDescription>
<NDC11Code>00409-4164-03</NDC11Code>
<ProductNDC>0409-4164</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aminosyn Ii</ProprietaryName>
<NonProprietaryName>Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Aspartic Acid, Glutamic Acid, Histidine, Proline, Serine, N-acetyl-tyrosine, And Glycine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20050901</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019438</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; HISTIDINE; PROLINE; SERINE; N-ACETYLTYROSINE; GLYCINE</SubstanceName>
<StrengthNumber>660; 1000; 1050; 172; 298; 400; 200; 500; 993; 1018; 700; 738; 300; 722; 530; 270; 500</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Amino Acid [EPC],Amino Acids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-04-18</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0409-4164-05</NDCCode>
<PackageDescription>6 POUCH in 1 CASE (0409-4164-05) > 1 BAG in 1 POUCH > 1000 mL in 1 BAG</PackageDescription>
<NDC11Code>00409-4164-05</NDC11Code>
<ProductNDC>0409-4164</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aminosyn Ii</ProprietaryName>
<NonProprietaryName>Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Aspartic Acid, Glutamic Acid, Histidine, Proline, Serine, N-acetyl-tyrosine, And Glycine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20050901</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019438</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; HISTIDINE; PROLINE; SERINE; N-ACETYLTYROSINE; GLYCINE</SubstanceName>
<StrengthNumber>660; 1000; 1050; 172; 298; 400; 200; 500; 993; 1018; 700; 738; 300; 722; 530; 270; 500</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Amino Acid [EPC],Amino Acids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-04-18</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0409-7121-07</NDCCode>
<PackageDescription>6 POUCH in 1 CASE (0409-7121-07) > 1 BAG in 1 POUCH > 2000 mL in 1 BAG</PackageDescription>
<NDC11Code>00409-7121-07</NDC11Code>
<ProductNDC>0409-7121</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aminosyn Ii</ProprietaryName>
<NonProprietaryName>Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Aspartic Acid, Glutamic Acid, Histidine, Proline, Serine, N-acetyltyrosine, And Glycine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19911219</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020015</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; HISTIDINE; PROLINE; SERINE; N-ACETYLTYROSINE; GLYCINE</SubstanceName>
<StrengthNumber>660; 1000; 1050; 172; 298; 400; 200; 500; 993; 1018; 700; 738; 300; 722; 530; 270; 500</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Amino Acid [EPC],Amino Acids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-04-18</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0409-7172-17</NDCCode>
<PackageDescription>6 POUCH in 1 CASE (0409-7172-17) > 1 BAG in 1 POUCH > 2000 mL in 1 BAG</PackageDescription>
<NDC11Code>00409-7172-17</NDC11Code>
<ProductNDC>0409-7172</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aminosyn Ii</ProprietaryName>
<NonProprietaryName>Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Aspartic Acid, Glutamic Acid, Histidine, Proline, Serine, N-acetyltyrosine, And Glycine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19911219</StartMarketingDate>
<EndMarketingDate>20201201</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020015</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; HISTIDINE; PROLINE; SERINE; N-ACETYLTYROSINE; GLYCINE</SubstanceName>
<StrengthNumber>660; 1000; 1050; 172; 298; 400; 200; 500; 993; 1018; 700; 738; 300; 722; 530; 270; 500</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Amino Acid [EPC],Amino Acids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-12-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19911219</StartMarketingDatePackage>
<EndMarketingDatePackage>20201201</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0480-3777-58</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0480-3777-58) / 25 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>00480-3777-58</NDC11Code>
<ProductNDC>0480-3777</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Glycerol Phenylbutyrate</ProprietaryName>
<NonProprietaryName>Glycerol Phenylbutyrate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260416</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA218738</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>GLYCEROL PHENYLBUTYRATE</SubstanceName>
<StrengthNumber>1.1</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Ammonium Ion Binding Activity [MoA], Nitrogen Binding Agent [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260416</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Glycerol phenylbutyrate oral liquid is indicated for use as a nitrogen-binding agent for chronic management of patients with urea cycle disorders (UCDs) who cannot be managed by dietary protein restriction and/or amino acid supplementation alone. Glycerol phenylbutyrate oral liquid must be used with dietary protein restriction and, in some cases, dietary supplements (e.g., essential amino acids, arginine, citrulline, protein-free calorie supplements). Limitations of Use: 1 Glycerol phenylbutyrate oral liquid is not indicated for the treatment of acute hyperammonemia in patients with UCDs because more rapidly acting interventions are essential to reduce plasma ammonia levels., 2 The safety and efficacy of glycerol phenylbutyrate oral liquid for the treatment of N-acetylglutamate synthase (NAGS) deficiency has not been established.</IndicationAndUsage>
<Description>Glycerol phenylbutyrate oral liquid is a clear, colorless to pale yellow oral liquid. It is insoluble in water and most organic solvents, and it is soluble in dimethylsulfoxide (DMSO) and greater than 65% acetonitrile. Glycerol phenylbutyrate is a nitrogen-binding agent. It is a triglyceride containing 3 molecules of PBA linked to a glycerol backbone, the chemical name of which is benzenebutanoic acid, 1', 1' ' –(1,2,3-propanetriyl) ester with a molecular weight of 530.65. It has a molecular formula of C33H38O6. The structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>0548-9701-00</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (0548-9701-00) > 1 mL in 1 VIAL</PackageDescription>
<NDC11Code>00548-9701-00</NDC11Code>
<ProductNDC>0548-9701</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vasopressin</ProprietaryName>
<NonProprietaryName>Vasopressin</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20220822</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211857</ApplicationNumber>
<LabelerName>Amphastar Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>VASOPRESSIN</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>[USP'U]/mL</StrengthUnit>
<Pharm_Classes>Decreased Diuresis [PE], Vasoconstriction [PE], Vasopressins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220831</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Vasopressin Injection, USP is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines.</IndicationAndUsage>
<Description>Vasopressin is a polypeptide hormone. Vasopressin Injection, USP is a sterile, aqueous solution of synthetic arginine vasopressin for intravenous administration. The 1 mL solution contains vasopressin 20 units/mL, chlorobutanol, NF 0.5% as a preservative, and Water for Injection, USP adjusted with acetic acid to pH 3.4-3.6. The chemical name of vasopressin is Cyclo (1-6) L-Cysteinyl-L-Tyrosyl-L-Phenylalanyl-LGlutaminyl-L-Asparaginyl-L-Cysteinyl-L-Prolyl-L-Arginyl-L-Glycinamide. It is a white to off-white amorphous powder, freely soluble in water. The structural formula is. Molecular Formula: C46H65N15O12S2 Molecular Weight: 1084.23. One mg is equivalent to 530 units.</Description>
</NDC>
<NDC>
<NDCCode>0990-7172-17</NDCCode>
<PackageDescription>6 POUCH in 1 CASE (0990-7172-17) / 1 BAG in 1 POUCH / 2000 mL in 1 BAG</PackageDescription>
<NDC11Code>00990-7172-17</NDC11Code>
<ProductNDC>0990-7172</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aminosyn Ii</ProprietaryName>
<NonProprietaryName>Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Aspartic Acid, Glutamic Acid, Histidine, Proline, Serine, N-acetyltyrosine, And Glycine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20191101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020015</ApplicationNumber>
<LabelerName>ICU Medical Inc.</LabelerName>
<SubstanceName>ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ALANINE; ARGININE; ASPARTIC ACID; GLUTAMIC ACID; HISTIDINE; PROLINE; SERINE; ACETYL L-TYROSINE; GLYCINE</SubstanceName>
<StrengthNumber>660; 1000; 1050; 172; 298; 400; 200; 500; 993; 1018; 700; 738; 300; 722; 530; 270; 500</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Amino Acid [EPC], Amino Acids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aminosyn II, Sulfite-Free, (an amino acid injection) infused with dextrose by peripheral vein infusion is indicated as a source of nitrogen in the nutritional support of patients with adequate stores of body fat, in whom, for short periods of time, oral nutrition cannot be tolerated, is undesirable, or inadequate. SUPPLEMENTAL ELECTROLYTES, IN ACCORDANCE WITH THE PRESCRIPTION OF THE ATTENDING PHYSICIAN, MUST BE ADDED TO AMINOSYN II SOLUTIONS WITHOUT ELECTROLYTES. Aminosyn II can be administered peripherally with dilute (5 to 10%) dextrose solution and I.V. fat emulsion as a source of nutritional support. This form of nutritional support can help to preserve protein and reduce catabolism in stress conditions where oral intake is inadequate. Aminosyn II is also indicated for central vein infusion to prevent or reverse negative nitrogen balance in patients where the alimentary tract, by the oral, gastrostomy or jejunostomy route cannot or should not be used and gastrointestinal absorption of protein is impaired.</IndicationAndUsage>
<Description>Aminosyn II, Sulfite-Free, (an amino acid injection) is a sterile, nonpyrogenic solution for intravenous infusion. Aminosyn II is oxygen sensitive. The Pharmacy Bulk Package is a sterile dosage form which contains multiple single doses for use only in a pharmacy bulk admixture program. The formulations are described below. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. The formulas for the individual amino acids are as follows. The Pharmacy Bulk Package is designed for use with manual, gravity flow operations and automated compounding devices for preparing sterile parenteral nutrient admixtures; it contains no bacteriostat. Multiple single doses may be dispensed during continual aliquoting operations. Withdrawal of container contents should be promptly completed within 4 hours after initial closure puncture.</Description>
</NDC>
<NDC>
<NDCCode>10056-530-06</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (10056-530-06) / 191 g in 1 TUBE</PackageDescription>
<NDC11Code>10056-0530-06</NDC11Code>
<ProductNDC>10056-530</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Glister Multi-action Fluoride</ProprietaryName>
<NonProprietaryName>Sodium Fluoride</NonProprietaryName>
<DosageFormName>PASTE, DENTIFRICE</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110411</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M021</ApplicationNumber>
<LabelerName>Access Business Group, LLC</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>2.1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-11-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110411</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aids in the prevention of dental cavities.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10056-530-65</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (10056-530-65) / 65 g in 1 TUBE</PackageDescription>
<NDC11Code>10056-0530-65</NDC11Code>
<ProductNDC>10056-530</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Glister Multi-action Fluoride</ProprietaryName>
<NonProprietaryName>Sodium Fluoride</NonProprietaryName>
<DosageFormName>PASTE, DENTIFRICE</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110411</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M021</ApplicationNumber>
<LabelerName>Access Business Group, LLC</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>2.1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-11-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110411</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aids in the prevention of dental cavities.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10893-530-04</NDCCode>
<PackageDescription>118.3 mL in 1 BOTTLE (10893-530-04) </PackageDescription>
<NDC11Code>10893-0530-04</NDC11Code>
<ProductNDC>10893-530</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Naturasil Mite B Gone</ProprietaryName>
<NonProprietaryName>Sulfur</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240201</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Nature's Innovation, Inc.</LabelerName>
<SubstanceName>SULFUR</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_X]/118.3mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: Symptomatic treatment of mite infections.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10893-530-08</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (10893-530-08) / 236.6 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>10893-0530-08</NDC11Code>
<ProductNDC>10893-530</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Naturasil Mite B Gone</ProprietaryName>
<NonProprietaryName>Sulfur</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240201</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Nature's Innovation, Inc.</LabelerName>
<SubstanceName>SULFUR</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_X]/118.3mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: Symptomatic treatment of mite infections.</IndicationAndUsage>
</NDC>
</NDCList>