{
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"ProprietaryName": "Mucinex Fast-max Kickstart Severe Cold And Flu And Mucinex Fast-max Recharge Nighttime Cold And Flu",
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"IndicationAndUsage": "Uses. Day:. ■ temporarily relieves these common cold and flu symptoms: ■ cough ■ nasal congestion ■ minor aches and pains ■ sore throat ■ headache ■ stuffy nose ■ sinus congestion and pressure ■ temporarily reduces fever ■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive. Night. ■ temporarily relieves these common cold and flu symptoms: ■ cough ■ minor aches and pains ■ sore throat ■ headache ■ runny nose ■ sneezing ■ itching of the nose or throat ■ itchy, watery eyes due to hay fever ■ temporarily reduces fever ■ controls cough to help you get to sleep."
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{
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"PackageDescription": "1 KIT in 1 CARTON (72854-139-26) * 180 mL in 1 BOTTLE (72854-138-66) * 180 mL in 1 BOTTLE (72854-140-66) ",
"NDC11Code": "72854-0139-26",
"ProductNDC": "72854-139",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mucinex Fast Max Liquid Cold And Flu Kickstart And Mucinex Nightshift Kickstart",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hci, Triprolidine Hci",
"DosageFormName": "KIT",
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"MarketingCategoryName": "OTC MONOGRAPH DRUG",
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"LabelerName": "Reckitt Benckiser LLC",
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"IndicationAndUsage": "KICKSTART SEVERE COLD & FLU. temporarily relieves these common cold and flu symptoms. ■ cough. ■ nasal congestion. ■ minor aches and pains. ■ sore throat ■ headache. ■ stuffy nose. ■ sinus congestion and pressure ■ temporarily reduces fever ■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive. NIGHT TIME SEVERE COLD & FLU. temporarily relieves these common cold and flu symptoms. ■ cough. ■ nasal congestion. ■ minor aches and pains. ■ sore throat ■ headache. ■ sinus congestion and pressure. ■ runny nose. ■ sneezing. ■ itching of the nose or throat. ■ itchy, watery eyes due to hay fever ■ temporarily reduces fever ■ controls cough to help you get to sleep."
},
{
"NDCCode": "72854-142-26",
"PackageDescription": "2 BOTTLE in 1 CARTON (72854-142-26) / 1 KIT in 1 BOTTLE * 180 mL in 1 BOTTLE (63824-019-66) * 1 BOTTLE in 1 CARTON (72854-141-66) / 180 mL in 1 BOTTLE",
"NDC11Code": "72854-0142-26",
"ProductNDC": "72854-142",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mucinex Fast-max Dm Max And Mucinex Fast-max Nighttime Dm Max Value Pack",
"NonProprietaryName": "Dextromethorphan Hbr, Guaifenesin And Triprolidine Hcl",
"DosageFormName": "KIT",
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"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Reckitt Benckiser LLC",
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"StartMarketingDatePackage": "20260701",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. Day: ■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive ■ temporarily relieves: ■ cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants ■ the intensity of coughing ■ the impulse to cough to help you get to sleep. Night. ■ temporarily relieves: ■ cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants ■ the intensity of coughing ■ the impulse to cough to help you get to sleep ■ runny nose ■ sneezing ■ itching of the nose or throat ■ itchy, watery eyes due to hay fever."
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{
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"PackageDescription": "1 KIT in 1 CARTON (72854-154-26) * 180 mL in 1 BOTTLE (63824-504-66) * 180 mL in 1 BOTTLE (63824-548-66) ",
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"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mucinex Fast-max Cold And Flu And Mucinex Nighttime Cold And Flu",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride, And Triprolidine Hydrochloride",
"DosageFormName": "KIT",
"StartMarketingDate": "20250601",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Reckitt Benckiser LLC",
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"LastUpdate": "2026-05-15",
"PackageNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20250601",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these common cold and flu symptoms: coughnasal congestionminor aches and painssore throatheadachestuffy nosesinus congestion and pressure. temporarily reduces fever. helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive."
},
{
"NDCCode": "72854-160-26",
"PackageDescription": "1 KIT in 1 CARTON (72854-160-26) * 180 LIQUID in 1 BOTTLE (72854-159-66) * 180 mL in 1 BOTTLE (72854-143-66) ",
"NDC11Code": "72854-0160-26",
"ProductNDC": "72854-160",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mucinex Fast-max Kickstart Severe Congestion And Cough And Mucinex Fast-max Nighttime Cold And Flu",
"NonProprietaryName": "Dextromethorphan Hydrobromide, Guaifenesin, Acetaminophen,triprolidine Hydrochloride",
"DosageFormName": "KIT",
"StartMarketingDate": "20250402",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Reckitt Benckiser LLC",
"Status": "Active",
"LastUpdate": "2026-05-20",
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"StartMarketingDatePackage": "20250402",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. ■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive ■ temporarily relieves: ■ cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants ■ the intensity of coughing ■ the impulse to cough to help you get to sleep. ■ temporarily relieves these common cold and flu symptoms: ■ cough ■ minor aches and pains ■ sore throat ■ headache ■ runny nose ■ sneezing ■ itching of the nose or throat ■ itchy, watery eyes due to hay fever ■ temporarily reduces fever ■ controls cough to help you get to sleep."
},
{
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"NDC11Code": "72854-0165-26",
"ProductNDC": "72854-165",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mucinex Fast-max Dm Max And Mucinex Nighttime Cold And Flu",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, And Triprolidine Hydrochloride",
"DosageFormName": "KIT",
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"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Reckitt Benckiser LLC",
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"StartMarketingDatePackage": "20250601",
"SamplePackage": "N",
"IndicationAndUsage": "helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily relieves:. cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the intensity of coughing the impulse to cough to help you get to sleep."
},
{
"NDCCode": "72854-166-26",
"PackageDescription": "1 KIT in 1 CARTON (72854-166-26) * 180 mL in 1 BOTTLE (63824-540-66) * 180 mL in 1 BOTTLE (63824-503-66) ",
"NDC11Code": "72854-0166-26",
"ProductNDC": "72854-166",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mucinex Fast-max Severe Congestion And Cough And Mucinex Nighttime Cold And Flu",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride, And Triprolidine Hydrochloride",
"DosageFormName": "KIT",
"StartMarketingDate": "20250601",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Reckitt Benckiser LLC",
"Status": "Active",
"LastUpdate": "2026-05-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20250601",
"SamplePackage": "N",
"IndicationAndUsage": "Mucinex Fast-Max Severe Congestion & Cough ■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive ■ temporarily relieves: ■ cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants ■ the intensity of coughing ■ nasal congestion due to a cold ■ temporarily helps you cough less. Mucinex Nighttime Cold & Flu ■ temporarily relieves these common cold and flu symptoms: ■ cough ■ nasal congestion ■minor aches and pains ■ sore throat ■headache ■ sinus congestion and pressure ■runny nose ■ sneezing ■ itching of the nose or throat ■ itchy, watery eyes due to hay fever ■ temporarily reduces fever ■ controls cough to help you get to sleep."
},
{
"NDCCode": "0869-0338-26",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (0869-0338-26) / 188 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "00869-0338-26",
"ProductNDC": "0869-0338",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Daily Moisturizer",
"NonProprietaryName": "Avobenzone, Octinoxate, Octisalate",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170806",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Vi-Jon, LLC",
"SubstanceName": "AVOBENZONE; OCTINOXATE; OCTISALATE",
"StrengthNumber": "30; 75; 20",
"StrengthUnit": "mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-02-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20170806",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions). decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "24385-188-26",
"PackageDescription": "1 BOTTLE in 1 CARTON (24385-188-26) > 120 mL in 1 BOTTLE",
"NDC11Code": "24385-0188-26",
"ProductNDC": "24385-188",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Good Neighbor Pharmacy All Day Allergy",
"NonProprietaryName": "Cetirizine Hydrochloride",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20080422",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090254",
"LabelerName": "Amerisource Bergen",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/5mL",
"Status": "Deprecated",
"LastUpdate": "2017-12-07"
},
{
"NDCCode": "49035-338-26",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (49035-338-26) / 188 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "49035-0338-26",
"ProductNDC": "49035-338",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Naturally Beaming",
"NonProprietaryName": "Avobenzone, Octinoxate, Octisalate",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100117",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Wal-Mart",
"SubstanceName": "AVOBENZONE; OCTINOXATE; OCTISALATE",
"StrengthNumber": "30; 75; 20",
"StrengthUnit": "mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2025-06-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20100117",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun ."
},
{
"NDCCode": "56136-188-01",
"PackageDescription": "10 PATCH in 1 PACKAGE (56136-188-01) / .26 g in 1 PATCH",
"NDC11Code": "56136-0188-01",
"ProductNDC": "56136-188",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Blemish Dots - Charcoal (10 Patches)",
"NonProprietaryName": "Salicylic Acid 0.5%",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240714",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M006",
"LabelerName": "Ganzhou Olivee Cosmetic Co., Ltd.",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": ".5",
"StrengthUnit": "g/100g",
"Status": "Active",
"LastUpdate": "2024-07-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240714",
"SamplePackage": "N",
"IndicationAndUsage": "soothe and help diminish the redness and irritation of blemished skin and a sorbs excess oil for faster healing."
},
{
"NDCCode": "70436-186-24",
"PackageDescription": "2 BOX in 1 KIT (70436-186-24) / 1 KIT in 1 BOX * 1 BLISTER PACK in 1 BOX (70436-187-25) / 11 TABLET, FILM COATED in 1 BLISTER PACK * 3 BLISTER PACK in 1 BOX (70436-188-26) / 14 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "70436-0186-24",
"ProductNDC": "70436-186",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Varenicline",
"NonProprietaryName": "Varenicline",
"DosageFormName": "KIT",
"StartMarketingDate": "20240730",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217115",
"LabelerName": "Slate Run Pharmaceuticals",
"Status": "Deprecated",
"LastUpdate": "2025-09-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20240730",
"SamplePackage": "N",
"IndicationAndUsage": "Varenicline tablets are indicated for use as an aid to smoking cessation treatment.",
"Description": "Varenicline tablets contain varenicline (as the tartrate salt), which is a partial nicotinic agonist selective for α4β2 nicotinic acetylcholine receptor subtypes. Varenicline, as the tartrate salt, is a powder which is a white to slightly yellow to light pink solid with the following chemical name: 7,8,9,10-tetrahydro-6,10-methano- 6H-pyrazino[2,3- h][3]benzazepine tartrate, (2R,3R)-2,3-dihydroxybutanedioate (1:1). It is slightly soluble in methanol and soluble in water. Varenicline tartrate has a molecular weight of 361.35 Daltons, and a molecular formula of C13H13N3 C4H6O6. The chemical structure is. Varenicline tablets are supplied for oral administration in two strengths: a 0.5 mg dark brown colored, capsule shaped, biconvex, film coated tablet, debossed with “V0.5” on one side and plain on other side and a 1 mg brick red colored, capsule shaped, biconvex, film coated tablet, debossed with “V1.0” on one side and plain on other side. Each 0.5 mg varenicline tablet contains 0.855 mg of varenicline tartrate equivalent to 0.5 mg of varenicline free base; each 1 mg varenicline tablet contains 1.710 mg of varenicline tartrate equivalent to 1 mg of varenicline free base. The following inactive ingredients are included in the tablets: ascorbic acid, microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate. The tablets are film-coated with a coating material containing hypromellose, hydroxypropyl cellulose, titanium dioxide, talc, iron oxide red, iron oxide black and iron oxide yellow."
},
{
"NDCCode": "72288-338-26",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (72288-338-26) > 188 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "72288-0338-26",
"ProductNDC": "72288-338",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Daily Moisturizer",
"NonProprietaryName": "Octinoxate, Octisalate",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180426",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Amazon.com Services LLC",
"SubstanceName": "AVOBENZONE; OCTINOXATE; OCTISALATE",
"StrengthNumber": "30; 75; 20",
"StrengthUnit": "mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2024-09-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20180426",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions). decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "0008-1030-06",
"PackageDescription": "1 CARTON in 1 KIT (0008-1030-06) / 1 BOTTLE, GLASS in 1 CARTON (0008-1030-04) / 60 mL in 1 BOTTLE, GLASS",
"NDC11Code": "00008-1030-06",
"ProductNDC": "0008-1030",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rapamune",
"NonProprietaryName": "Sirolimus",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "19990901",
"EndMarketingDate": "20250131",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021083",
"LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
"SubstanceName": "SIROLIMUS",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19990901",
"EndMarketingDatePackage": "20250131",
"SamplePackage": "N",
"IndicationAndUsage": "Rapamune is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants:oPatients at low- to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended 2–4 months after transplantation (1.1). oPatients at high-immunologic risk: Use in combination with CsA and corticosteroids for the first 12 months following transplantation (1.1). Safety and efficacy of CsA withdrawal has not been established in high risk patients (1.1, 1.2, 14.3). . Rapamune is an mTOR inhibitor indicated for the treatment of patients with lymphangioleiomyomatosis (1.3).",
"Description": "Rapamune (sirolimus) is an mTOR inhibitor immunosuppressive agent. Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus. The chemical name of sirolimus (also known as rapamycin) is (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34, 34a-hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclohentriacontine-1,5,11,28,29 (4H,6H,31H)-pentone. Its molecular formula is C51H79NO13 and its molecular weight is 914.2. The structural formula of sirolimus is illustrated as follows. Sirolimus is a white to off-white powder and is insoluble in water, but freely soluble in benzyl alcohol, chloroform, acetone, and acetonitrile. Rapamune is available for administration as an oral solution containing 1 mg/mL sirolimus. Rapamune is also available as a tan, triangular-shaped tablet containing 0.5 mg sirolimus, as a white, triangular-shaped tablet containing 1 mg sirolimus, and as a yellow-to-beige triangular-shaped tablet containing 2 mg sirolimus. The inactive ingredients in Rapamune Oral Solution are Phosal 50 PG® (phosphatidylcholine, propylene glycol, mono- and di-glycerides, ethanol, soy fatty acids, and ascorbyl palmitate) and polysorbate 80. Rapamune Oral Solution contains 1.5% – 2.5% ethanol. The inactive ingredients in Rapamune Tablets include sucrose, lactose, polyethylene glycol 8000, calcium sulfate, microcrystalline cellulose, pharmaceutical glaze, talc, titanium dioxide, magnesium stearate, povidone, poloxamer 188, polyethylene glycol 20,000, glyceryl monooleate, carnauba wax, dl-alpha tocopherol, and other ingredients. The 0.5 mg and 2 mg dosage strengths also contain yellow iron (ferric) oxide and brown iron (ferric) oxide."
},
{
"NDCCode": "0008-1040-05",
"PackageDescription": "100 TABLET, SUGAR COATED in 1 BOTTLE (0008-1040-05) ",
"NDC11Code": "00008-1040-05",
"ProductNDC": "0008-1040",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rapamune",
"NonProprietaryName": "Sirolimus",
"DosageFormName": "TABLET, SUGAR COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20100301",
"EndMarketingDate": "20250228",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021110",
"LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
"SubstanceName": "SIROLIMUS",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-12-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20100301",
"EndMarketingDatePackage": "20241130",
"SamplePackage": "N",
"IndicationAndUsage": "Rapamune is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants:oPatients at low- to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended 2–4 months after transplantation (1.1). oPatients at high-immunologic risk: Use in combination with CsA and corticosteroids for the first 12 months following transplantation (1.1). Safety and efficacy of CsA withdrawal has not been established in high risk patients (1.1, 1.2, 14.3). . Rapamune is an mTOR inhibitor indicated for the treatment of patients with lymphangioleiomyomatosis (1.3).",
"Description": "Rapamune (sirolimus) is an mTOR inhibitor immunosuppressive agent. Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus. The chemical name of sirolimus (also known as rapamycin) is (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34, 34a-hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclohentriacontine-1,5,11,28,29 (4H,6H,31H)-pentone. Its molecular formula is C51H79NO13 and its molecular weight is 914.2. The structural formula of sirolimus is illustrated as follows. Sirolimus is a white to off-white powder and is insoluble in water, but freely soluble in benzyl alcohol, chloroform, acetone, and acetonitrile. Rapamune is available for administration as an oral solution containing 1 mg/mL sirolimus. Rapamune is also available as a tan, triangular-shaped tablet containing 0.5 mg sirolimus, as a white, triangular-shaped tablet containing 1 mg sirolimus, and as a yellow-to-beige triangular-shaped tablet containing 2 mg sirolimus. The inactive ingredients in Rapamune Oral Solution are Phosal 50 PG® (phosphatidylcholine, propylene glycol, mono- and di-glycerides, ethanol, soy fatty acids, and ascorbyl palmitate) and polysorbate 80. Rapamune Oral Solution contains 1.5% – 2.5% ethanol. The inactive ingredients in Rapamune Tablets include sucrose, lactose, polyethylene glycol 8000, calcium sulfate, microcrystalline cellulose, pharmaceutical glaze, talc, titanium dioxide, magnesium stearate, povidone, poloxamer 188, polyethylene glycol 20,000, glyceryl monooleate, carnauba wax, dl-alpha tocopherol, and other ingredients. The 0.5 mg and 2 mg dosage strengths also contain yellow iron (ferric) oxide and brown iron (ferric) oxide."
},
{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rapamune",
"NonProprietaryName": "Sirolimus",
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"RouteName": "ORAL",
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"EndMarketingDate": "20250228",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021110",
"LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
"SubstanceName": "SIROLIMUS",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
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"IndicationAndUsage": "Rapamune is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants:oPatients at low- to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended 2–4 months after transplantation (1.1). oPatients at high-immunologic risk: Use in combination with CsA and corticosteroids for the first 12 months following transplantation (1.1). Safety and efficacy of CsA withdrawal has not been established in high risk patients (1.1, 1.2, 14.3). . Rapamune is an mTOR inhibitor indicated for the treatment of patients with lymphangioleiomyomatosis (1.3).",
"Description": "Rapamune (sirolimus) is an mTOR inhibitor immunosuppressive agent. Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus. The chemical name of sirolimus (also known as rapamycin) is (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34, 34a-hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclohentriacontine-1,5,11,28,29 (4H,6H,31H)-pentone. Its molecular formula is C51H79NO13 and its molecular weight is 914.2. The structural formula of sirolimus is illustrated as follows. Sirolimus is a white to off-white powder and is insoluble in water, but freely soluble in benzyl alcohol, chloroform, acetone, and acetonitrile. Rapamune is available for administration as an oral solution containing 1 mg/mL sirolimus. Rapamune is also available as a tan, triangular-shaped tablet containing 0.5 mg sirolimus, as a white, triangular-shaped tablet containing 1 mg sirolimus, and as a yellow-to-beige triangular-shaped tablet containing 2 mg sirolimus. The inactive ingredients in Rapamune Oral Solution are Phosal 50 PG® (phosphatidylcholine, propylene glycol, mono- and di-glycerides, ethanol, soy fatty acids, and ascorbyl palmitate) and polysorbate 80. Rapamune Oral Solution contains 1.5% – 2.5% ethanol. The inactive ingredients in Rapamune Tablets include sucrose, lactose, polyethylene glycol 8000, calcium sulfate, microcrystalline cellulose, pharmaceutical glaze, talc, titanium dioxide, magnesium stearate, povidone, poloxamer 188, polyethylene glycol 20,000, glyceryl monooleate, carnauba wax, dl-alpha tocopherol, and other ingredients. The 0.5 mg and 2 mg dosage strengths also contain yellow iron (ferric) oxide and brown iron (ferric) oxide."
},
{
"NDCCode": "0008-1041-05",
"PackageDescription": "100 TABLET, SUGAR COATED in 1 BOTTLE (0008-1041-05) ",
"NDC11Code": "00008-1041-05",
"ProductNDC": "0008-1041",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rapamune",
"NonProprietaryName": "Sirolimus",
"DosageFormName": "TABLET, SUGAR COATED",
"RouteName": "ORAL",
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"EndMarketingDate": "20251231",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021110",
"LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
"SubstanceName": "SIROLIMUS",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
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"LastUpdate": "2026-01-01",
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"IndicationAndUsage": "Rapamune is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants:oPatients at low- to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended 2–4 months after transplantation (1.1). oPatients at high-immunologic risk: Use in combination with CsA and corticosteroids for the first 12 months following transplantation (1.1). Safety and efficacy of CsA withdrawal has not been established in high risk patients (1.1, 1.2, 14.3). . Rapamune is an mTOR inhibitor indicated for the treatment of patients with lymphangioleiomyomatosis (1.3).",
"Description": "Rapamune (sirolimus) is an mTOR inhibitor immunosuppressive agent. Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus. The chemical name of sirolimus (also known as rapamycin) is (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34, 34a-hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclohentriacontine-1,5,11,28,29 (4H,6H,31H)-pentone. Its molecular formula is C51H79NO13 and its molecular weight is 914.2. The structural formula of sirolimus is illustrated as follows. Sirolimus is a white to off-white powder and is insoluble in water, but freely soluble in benzyl alcohol, chloroform, acetone, and acetonitrile. Rapamune is available for administration as an oral solution containing 1 mg/mL sirolimus. Rapamune is also available as a tan, triangular-shaped tablet containing 0.5 mg sirolimus, as a white, triangular-shaped tablet containing 1 mg sirolimus, and as a yellow-to-beige triangular-shaped tablet containing 2 mg sirolimus. The inactive ingredients in Rapamune Oral Solution are Phosal 50 PG® (phosphatidylcholine, propylene glycol, mono- and di-glycerides, ethanol, soy fatty acids, and ascorbyl palmitate) and polysorbate 80. Rapamune Oral Solution contains 1.5% – 2.5% ethanol. The inactive ingredients in Rapamune Tablets include sucrose, lactose, polyethylene glycol 8000, calcium sulfate, microcrystalline cellulose, pharmaceutical glaze, talc, titanium dioxide, magnesium stearate, povidone, poloxamer 188, polyethylene glycol 20,000, glyceryl monooleate, carnauba wax, dl-alpha tocopherol, and other ingredients. The 0.5 mg and 2 mg dosage strengths also contain yellow iron (ferric) oxide and brown iron (ferric) oxide."
},
{
"NDCCode": "0008-1041-10",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (0008-1041-10) / 1 TABLET, SUGAR COATED in 1 BLISTER PACK",
"NDC11Code": "00008-1041-10",
"ProductNDC": "0008-1041",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rapamune",
"NonProprietaryName": "Sirolimus",
"DosageFormName": "TABLET, SUGAR COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20010701",
"EndMarketingDate": "20251231",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021110",
"LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
"SubstanceName": "SIROLIMUS",
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"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
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"IndicationAndUsage": "Rapamune is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants:oPatients at low- to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended 2–4 months after transplantation (1.1). oPatients at high-immunologic risk: Use in combination with CsA and corticosteroids for the first 12 months following transplantation (1.1). Safety and efficacy of CsA withdrawal has not been established in high risk patients (1.1, 1.2, 14.3). . Rapamune is an mTOR inhibitor indicated for the treatment of patients with lymphangioleiomyomatosis (1.3).",
"Description": "Rapamune (sirolimus) is an mTOR inhibitor immunosuppressive agent. Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus. The chemical name of sirolimus (also known as rapamycin) is (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34, 34a-hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclohentriacontine-1,5,11,28,29 (4H,6H,31H)-pentone. Its molecular formula is C51H79NO13 and its molecular weight is 914.2. The structural formula of sirolimus is illustrated as follows. Sirolimus is a white to off-white powder and is insoluble in water, but freely soluble in benzyl alcohol, chloroform, acetone, and acetonitrile. Rapamune is available for administration as an oral solution containing 1 mg/mL sirolimus. Rapamune is also available as a tan, triangular-shaped tablet containing 0.5 mg sirolimus, as a white, triangular-shaped tablet containing 1 mg sirolimus, and as a yellow-to-beige triangular-shaped tablet containing 2 mg sirolimus. The inactive ingredients in Rapamune Oral Solution are Phosal 50 PG® (phosphatidylcholine, propylene glycol, mono- and di-glycerides, ethanol, soy fatty acids, and ascorbyl palmitate) and polysorbate 80. Rapamune Oral Solution contains 1.5% – 2.5% ethanol. The inactive ingredients in Rapamune Tablets include sucrose, lactose, polyethylene glycol 8000, calcium sulfate, microcrystalline cellulose, pharmaceutical glaze, talc, titanium dioxide, magnesium stearate, povidone, poloxamer 188, polyethylene glycol 20,000, glyceryl monooleate, carnauba wax, dl-alpha tocopherol, and other ingredients. The 0.5 mg and 2 mg dosage strengths also contain yellow iron (ferric) oxide and brown iron (ferric) oxide."
},
{
"NDCCode": "0008-1042-05",
"PackageDescription": "100 TABLET, SUGAR COATED in 1 BOTTLE (0008-1042-05) ",
"NDC11Code": "00008-1042-05",
"ProductNDC": "0008-1042",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Rapamune",
"NonProprietaryName": "Sirolimus",
"DosageFormName": "TABLET, SUGAR COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20010701",
"EndMarketingDate": "20251031",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021110",
"LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
"SubstanceName": "SIROLIMUS",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20010701",
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"IndicationAndUsage": "Rapamune is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants:oPatients at low- to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended 2–4 months after transplantation (1.1). oPatients at high-immunologic risk: Use in combination with CsA and corticosteroids for the first 12 months following transplantation (1.1). Safety and efficacy of CsA withdrawal has not been established in high risk patients (1.1, 1.2, 14.3). . Rapamune is an mTOR inhibitor indicated for the treatment of patients with lymphangioleiomyomatosis (1.3).",
"Description": "Rapamune (sirolimus) is an mTOR inhibitor immunosuppressive agent. Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus. The chemical name of sirolimus (also known as rapamycin) is (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34, 34a-hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclohentriacontine-1,5,11,28,29 (4H,6H,31H)-pentone. Its molecular formula is C51H79NO13 and its molecular weight is 914.2. The structural formula of sirolimus is illustrated as follows. Sirolimus is a white to off-white powder and is insoluble in water, but freely soluble in benzyl alcohol, chloroform, acetone, and acetonitrile. Rapamune is available for administration as an oral solution containing 1 mg/mL sirolimus. Rapamune is also available as a tan, triangular-shaped tablet containing 0.5 mg sirolimus, as a white, triangular-shaped tablet containing 1 mg sirolimus, and as a yellow-to-beige triangular-shaped tablet containing 2 mg sirolimus. The inactive ingredients in Rapamune Oral Solution are Phosal 50 PG® (phosphatidylcholine, propylene glycol, mono- and di-glycerides, ethanol, soy fatty acids, and ascorbyl palmitate) and polysorbate 80. Rapamune Oral Solution contains 1.5% – 2.5% ethanol. The inactive ingredients in Rapamune Tablets include sucrose, lactose, polyethylene glycol 8000, calcium sulfate, microcrystalline cellulose, pharmaceutical glaze, talc, titanium dioxide, magnesium stearate, povidone, poloxamer 188, polyethylene glycol 20,000, glyceryl monooleate, carnauba wax, dl-alpha tocopherol, and other ingredients. The 0.5 mg and 2 mg dosage strengths also contain yellow iron (ferric) oxide and brown iron (ferric) oxide."
},
{
"NDCCode": "0121-0947-94",
"PackageDescription": "3 TRAY in 1 CASE (0121-0947-94) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0947-05) ",
"NDC11Code": "00121-0947-94",
"ProductNDC": "0121-0947",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbamazepine",
"NonProprietaryName": "Carbamazepine",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20211007",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076729",
"LabelerName": "PAI Holdings, LLC",
"SubstanceName": "CARBAMAZEPINE",
"StrengthNumber": "100",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]",
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"PackageNdcExcludeFlag": "N",
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"IndicationAndUsage": "Carbamazepine is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types: 1 Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvement than those with other types., 2 Generalized tonic-clonic seizures (grand mal)., 3 Mixed seizure patterns which include the above, or other partial or generalized seizures. Absence seizures (petit mal) do not appear to be controlled by carbamazepine (see PRECAUTIONS, General). .",
"Description": "Carbamazepine USP, is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as a suspension of 100 mg/5 mL (teaspoon). Its chemical name is 5H-dibenz[b,f]azepine-5-carboxamide, and its structural formula is. C 15H 12N 2O. Carbamazepine USP is a white to off-white powder, practically insoluble in water and soluble in alcohol and in acetone. Its molecular weight is 236.27. Carbamazepine Oral Suspension USP, 100 mg/5 mL – citric acid monohydrate, FD&C yellow no. 6, orange flavor, poloxamer 188, potassium sorbate, propylene glycol, purified water, sorbitol solution, sucrose and xanthan gum."
},
{
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"StartMarketingDate": "20211007",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076729",
"LabelerName": "PAI Holdings, LLC",
"SubstanceName": "CARBAMAZEPINE",
"StrengthNumber": "200",
"StrengthUnit": "mg/10mL",
"Pharm_Classes": "Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]",
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"LastUpdate": "2024-11-26",
"PackageNdcExcludeFlag": "N",
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"IndicationAndUsage": "Carbamazepine is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types: 1 Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvement than those with other types., 2 Generalized tonic-clonic seizures (grand mal)., 3 Mixed seizure patterns which include the above, or other partial or generalized seizures. Absence seizures (petit mal) do not appear to be controlled by carbamazepine (see PRECAUTIONS, General). .",
"Description": "Carbamazepine USP, is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as a suspension of 100 mg/5 mL (teaspoon). Its chemical name is 5H-dibenz[b,f]azepine-5-carboxamide, and its structural formula is. C 15H 12N 2O. Carbamazepine USP is a white to off-white powder, practically insoluble in water and soluble in alcohol and in acetone. Its molecular weight is 236.27. Carbamazepine Oral Suspension USP, 100 mg/5 mL – citric acid monohydrate, FD&C yellow no. 6, orange flavor, poloxamer 188, potassium sorbate, propylene glycol, purified water, sorbitol solution, sucrose and xanthan gum."
},
{
"NDCCode": "0904-7248-04",
"PackageDescription": "30 BLISTER PACK in 1 CARTON (0904-7248-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "00904-7248-04",
"ProductNDC": "0904-7248",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sirolimus",
"NonProprietaryName": "Sirolimus",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210313",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214753",
"LabelerName": "Major Pharmaceuticals",
"SubstanceName": "SIROLIMUS",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-11-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220621",
"SamplePackage": "N",
"IndicationAndUsage": " Sirolimus tablet is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants: o Patients at low-to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended 2-4 months after transplantation (1.1). o Patients at high-immunologic risk: Use in combination with CsA and corticosteroids for the first 12 months following transplantation (1.1). Safety and efficacy of CsA withdrawal has not been established in high risk patients (1.1, 1.2, 14.3). Sirolimus tablet is an mTOR inhibitor indicated for the treatment of patients with lymphangioleiomyomatosis (1.3).",
"Description": "Sirolimus is an mTOR inhibitor immunosuppressive agent. Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus. The chemical name of sirolimus (also known as rapamycin) is (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)9,10,12,13,14,21,22,23,24,25,26,27,32,33,34, 34a-hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy3H-pyrido[2,1-c][1,4] oxaazacyclohentriacontine-1,5,11,28,29 (4H,6H,31H)-pentone. Its molecular formula is C51H79NO13 and its molecular weight is 914.2. The structural formula of sirolimus is illustrated as follows. Sirolimus is a white to off-white powder and is insoluble in water, but freely soluble in benzyl alcohol, chloroform, acetone, and acetonitrile. Sirolimus tablets are also available as a tan, round-shaped tablet containing 0.5 mg sirolimus, as a white, round-shaped tablet containing 1 mg sirolimus, and as a yellow-to-beige round-shaped tablet containing 2 mg sirolimus. The inactive ingredients in sirolimus tablets include edetate disodium, poloxamer 188, sucrose, Hypromellose, vitamin E, microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, glyceryl behenate.The 0.5 mg strength also contains polyethylene glycol and the 1 mg and the 2 mg contains polyvinyl alcohol, talc, titanium dioxide, sodium lauryl sulphate, glyceryl monocaprylocaprate, yellow iron oxide, black iron oxide, red iron oxide. Also 2 mg additionally contains FD & C Yellow # 6 and lake pigment D & C Yellow # 10."
},
{
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"PackageDescription": "188 L in 1 CYLINDER (11054-010-11)",
"NDC11Code": "11054-0010-11",
"ProductNDC": "11054-010",
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<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride, And Triprolidine Hydrochloride</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20250601</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Reckitt Benckiser LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-05-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these common cold and flu symptoms: coughnasal congestionminor aches and painssore throatheadachestuffy nosesinus congestion and pressure. temporarily reduces fever. helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72854-160-26</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (72854-160-26) * 180 LIQUID in 1 BOTTLE (72854-159-66) * 180 mL in 1 BOTTLE (72854-143-66) </PackageDescription>
<NDC11Code>72854-0160-26</NDC11Code>
<ProductNDC>72854-160</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mucinex Fast-max Kickstart Severe Congestion And Cough And Mucinex Fast-max Nighttime Cold And Flu</ProprietaryName>
<NonProprietaryName>Dextromethorphan Hydrobromide, Guaifenesin, Acetaminophen,triprolidine Hydrochloride</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20250402</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Reckitt Benckiser LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-05-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250402</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. ■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive ■ temporarily relieves: ■ cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants ■ the intensity of coughing ■ the impulse to cough to help you get to sleep. ■ temporarily relieves these common cold and flu symptoms: ■ cough ■ minor aches and pains ■ sore throat ■ headache ■ runny nose ■ sneezing ■ itching of the nose or throat ■ itchy, watery eyes due to hay fever ■ temporarily reduces fever ■ controls cough to help you get to sleep.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72854-165-26</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (72854-165-26) * 180 mL in 1 BOTTLE (63824-503-66) * 180 mL in 1 BOTTLE (63824-019-66) </PackageDescription>
<NDC11Code>72854-0165-26</NDC11Code>
<ProductNDC>72854-165</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mucinex Fast-max Dm Max And Mucinex Nighttime Cold And Flu</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, And Triprolidine Hydrochloride</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20250601</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Reckitt Benckiser LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-05-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily relieves:. cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the intensity of coughing the impulse to cough to help you get to sleep.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72854-166-26</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (72854-166-26) * 180 mL in 1 BOTTLE (63824-540-66) * 180 mL in 1 BOTTLE (63824-503-66) </PackageDescription>
<NDC11Code>72854-0166-26</NDC11Code>
<ProductNDC>72854-166</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mucinex Fast-max Severe Congestion And Cough And Mucinex Nighttime Cold And Flu</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride, And Triprolidine Hydrochloride</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20250601</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Reckitt Benckiser LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-05-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mucinex Fast-Max Severe Congestion & Cough ■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive ■ temporarily relieves: ■ cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants ■ the intensity of coughing ■ nasal congestion due to a cold ■ temporarily helps you cough less. Mucinex Nighttime Cold & Flu ■ temporarily relieves these common cold and flu symptoms: ■ cough ■ nasal congestion ■minor aches and pains ■ sore throat ■headache ■ sinus congestion and pressure ■runny nose ■ sneezing ■ itching of the nose or throat ■ itchy, watery eyes due to hay fever ■ temporarily reduces fever ■ controls cough to help you get to sleep.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0869-0338-26</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (0869-0338-26) / 188 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>00869-0338-26</NDC11Code>
<ProductNDC>0869-0338</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Daily Moisturizer</ProprietaryName>
<NonProprietaryName>Avobenzone, Octinoxate, Octisalate</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170806</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Vi-Jon, LLC</LabelerName>
<SubstanceName>AVOBENZONE; OCTINOXATE; OCTISALATE</SubstanceName>
<StrengthNumber>30; 75; 20</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-02-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170806</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions). decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>24385-188-26</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (24385-188-26) > 120 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>24385-0188-26</NDC11Code>
<ProductNDC>24385-188</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Good Neighbor Pharmacy All Day Allergy</ProprietaryName>
<NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080422</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090254</ApplicationNumber>
<LabelerName>Amerisource Bergen</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-12-07</LastUpdate>
</NDC>
<NDC>
<NDCCode>49035-338-26</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (49035-338-26) / 188 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>49035-0338-26</NDC11Code>
<ProductNDC>49035-338</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Naturally Beaming</ProprietaryName>
<NonProprietaryName>Avobenzone, Octinoxate, Octisalate</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100117</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Wal-Mart</LabelerName>
<SubstanceName>AVOBENZONE; OCTINOXATE; OCTISALATE</SubstanceName>
<StrengthNumber>30; 75; 20</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-06-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100117</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>56136-188-01</NDCCode>
<PackageDescription>10 PATCH in 1 PACKAGE (56136-188-01) / .26 g in 1 PATCH</PackageDescription>
<NDC11Code>56136-0188-01</NDC11Code>
<ProductNDC>56136-188</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Blemish Dots - Charcoal (10 Patches)</ProprietaryName>
<NonProprietaryName>Salicylic Acid 0.5%</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240714</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M006</ApplicationNumber>
<LabelerName>Ganzhou Olivee Cosmetic Co., Ltd.</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-07-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240714</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>soothe and help diminish the redness and irritation of blemished skin and a sorbs excess oil for faster healing.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>70436-186-24</NDCCode>
<PackageDescription>2 BOX in 1 KIT (70436-186-24) / 1 KIT in 1 BOX * 1 BLISTER PACK in 1 BOX (70436-187-25) / 11 TABLET, FILM COATED in 1 BLISTER PACK * 3 BLISTER PACK in 1 BOX (70436-188-26) / 14 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>70436-0186-24</NDC11Code>
<ProductNDC>70436-186</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Varenicline</ProprietaryName>
<NonProprietaryName>Varenicline</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20240730</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217115</ApplicationNumber>
<LabelerName>Slate Run Pharmaceuticals</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2025-09-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240730</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Varenicline tablets are indicated for use as an aid to smoking cessation treatment.</IndicationAndUsage>
<Description>Varenicline tablets contain varenicline (as the tartrate salt), which is a partial nicotinic agonist selective for α4β2 nicotinic acetylcholine receptor subtypes. Varenicline, as the tartrate salt, is a powder which is a white to slightly yellow to light pink solid with the following chemical name: 7,8,9,10-tetrahydro-6,10-methano- 6H-pyrazino[2,3- h][3]benzazepine tartrate, (2R,3R)-2,3-dihydroxybutanedioate (1:1). It is slightly soluble in methanol and soluble in water. Varenicline tartrate has a molecular weight of 361.35 Daltons, and a molecular formula of C13H13N3 C4H6O6. The chemical structure is. Varenicline tablets are supplied for oral administration in two strengths: a 0.5 mg dark brown colored, capsule shaped, biconvex, film coated tablet, debossed with “V0.5” on one side and plain on other side and a 1 mg brick red colored, capsule shaped, biconvex, film coated tablet, debossed with “V1.0” on one side and plain on other side. Each 0.5 mg varenicline tablet contains 0.855 mg of varenicline tartrate equivalent to 0.5 mg of varenicline free base; each 1 mg varenicline tablet contains 1.710 mg of varenicline tartrate equivalent to 1 mg of varenicline free base. The following inactive ingredients are included in the tablets: ascorbic acid, microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate. The tablets are film-coated with a coating material containing hypromellose, hydroxypropyl cellulose, titanium dioxide, talc, iron oxide red, iron oxide black and iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>72288-338-26</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (72288-338-26) > 188 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>72288-0338-26</NDC11Code>
<ProductNDC>72288-338</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Daily Moisturizer</ProprietaryName>
<NonProprietaryName>Octinoxate, Octisalate</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180426</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Amazon.com Services LLC</LabelerName>
<SubstanceName>AVOBENZONE; OCTINOXATE; OCTISALATE</SubstanceName>
<StrengthNumber>30; 75; 20</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-09-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180426</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions). decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0008-1030-06</NDCCode>
<PackageDescription>1 CARTON in 1 KIT (0008-1030-06) / 1 BOTTLE, GLASS in 1 CARTON (0008-1030-04) / 60 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>00008-1030-06</NDC11Code>
<ProductNDC>0008-1030</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rapamune</ProprietaryName>
<NonProprietaryName>Sirolimus</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19990901</StartMarketingDate>
<EndMarketingDate>20250131</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021083</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>SIROLIMUS</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19990901</StartMarketingDatePackage>
<EndMarketingDatePackage>20250131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rapamune is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants:oPatients at low- to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended 2–4 months after transplantation (1.1). oPatients at high-immunologic risk: Use in combination with CsA and corticosteroids for the first 12 months following transplantation (1.1). Safety and efficacy of CsA withdrawal has not been established in high risk patients (1.1, 1.2, 14.3). . Rapamune is an mTOR inhibitor indicated for the treatment of patients with lymphangioleiomyomatosis (1.3).</IndicationAndUsage>
<Description>Rapamune (sirolimus) is an mTOR inhibitor immunosuppressive agent. Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus. The chemical name of sirolimus (also known as rapamycin) is (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34, 34a-hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclohentriacontine-1,5,11,28,29 (4H,6H,31H)-pentone. Its molecular formula is C51H79NO13 and its molecular weight is 914.2. The structural formula of sirolimus is illustrated as follows. Sirolimus is a white to off-white powder and is insoluble in water, but freely soluble in benzyl alcohol, chloroform, acetone, and acetonitrile. Rapamune is available for administration as an oral solution containing 1 mg/mL sirolimus. Rapamune is also available as a tan, triangular-shaped tablet containing 0.5 mg sirolimus, as a white, triangular-shaped tablet containing 1 mg sirolimus, and as a yellow-to-beige triangular-shaped tablet containing 2 mg sirolimus. The inactive ingredients in Rapamune Oral Solution are Phosal 50 PG® (phosphatidylcholine, propylene glycol, mono- and di-glycerides, ethanol, soy fatty acids, and ascorbyl palmitate) and polysorbate 80. Rapamune Oral Solution contains 1.5% – 2.5% ethanol. The inactive ingredients in Rapamune Tablets include sucrose, lactose, polyethylene glycol 8000, calcium sulfate, microcrystalline cellulose, pharmaceutical glaze, talc, titanium dioxide, magnesium stearate, povidone, poloxamer 188, polyethylene glycol 20,000, glyceryl monooleate, carnauba wax, dl-alpha tocopherol, and other ingredients. The 0.5 mg and 2 mg dosage strengths also contain yellow iron (ferric) oxide and brown iron (ferric) oxide.</Description>
</NDC>
<NDC>
<NDCCode>0008-1040-05</NDCCode>
<PackageDescription>100 TABLET, SUGAR COATED in 1 BOTTLE (0008-1040-05) </PackageDescription>
<NDC11Code>00008-1040-05</NDC11Code>
<ProductNDC>0008-1040</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rapamune</ProprietaryName>
<NonProprietaryName>Sirolimus</NonProprietaryName>
<DosageFormName>TABLET, SUGAR COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100301</StartMarketingDate>
<EndMarketingDate>20250228</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021110</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>SIROLIMUS</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20100301</StartMarketingDatePackage>
<EndMarketingDatePackage>20241130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rapamune is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants:oPatients at low- to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended 2–4 months after transplantation (1.1). oPatients at high-immunologic risk: Use in combination with CsA and corticosteroids for the first 12 months following transplantation (1.1). Safety and efficacy of CsA withdrawal has not been established in high risk patients (1.1, 1.2, 14.3). . Rapamune is an mTOR inhibitor indicated for the treatment of patients with lymphangioleiomyomatosis (1.3).</IndicationAndUsage>
<Description>Rapamune (sirolimus) is an mTOR inhibitor immunosuppressive agent. Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus. The chemical name of sirolimus (also known as rapamycin) is (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34, 34a-hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclohentriacontine-1,5,11,28,29 (4H,6H,31H)-pentone. Its molecular formula is C51H79NO13 and its molecular weight is 914.2. The structural formula of sirolimus is illustrated as follows. Sirolimus is a white to off-white powder and is insoluble in water, but freely soluble in benzyl alcohol, chloroform, acetone, and acetonitrile. Rapamune is available for administration as an oral solution containing 1 mg/mL sirolimus. Rapamune is also available as a tan, triangular-shaped tablet containing 0.5 mg sirolimus, as a white, triangular-shaped tablet containing 1 mg sirolimus, and as a yellow-to-beige triangular-shaped tablet containing 2 mg sirolimus. The inactive ingredients in Rapamune Oral Solution are Phosal 50 PG® (phosphatidylcholine, propylene glycol, mono- and di-glycerides, ethanol, soy fatty acids, and ascorbyl palmitate) and polysorbate 80. Rapamune Oral Solution contains 1.5% – 2.5% ethanol. The inactive ingredients in Rapamune Tablets include sucrose, lactose, polyethylene glycol 8000, calcium sulfate, microcrystalline cellulose, pharmaceutical glaze, talc, titanium dioxide, magnesium stearate, povidone, poloxamer 188, polyethylene glycol 20,000, glyceryl monooleate, carnauba wax, dl-alpha tocopherol, and other ingredients. The 0.5 mg and 2 mg dosage strengths also contain yellow iron (ferric) oxide and brown iron (ferric) oxide.</Description>
</NDC>
<NDC>
<NDCCode>0008-1040-10</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (0008-1040-10) / 1 TABLET, SUGAR COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00008-1040-10</NDC11Code>
<ProductNDC>0008-1040</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Rapamune</ProprietaryName>
<NonProprietaryName>Sirolimus</NonProprietaryName>
<DosageFormName>TABLET, SUGAR COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100301</StartMarketingDate>
<EndMarketingDate>20250228</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021110</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
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<Description>Rapamune (sirolimus) is an mTOR inhibitor immunosuppressive agent. Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus. The chemical name of sirolimus (also known as rapamycin) is (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34, 34a-hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclohentriacontine-1,5,11,28,29 (4H,6H,31H)-pentone. Its molecular formula is C51H79NO13 and its molecular weight is 914.2. The structural formula of sirolimus is illustrated as follows. Sirolimus is a white to off-white powder and is insoluble in water, but freely soluble in benzyl alcohol, chloroform, acetone, and acetonitrile. Rapamune is available for administration as an oral solution containing 1 mg/mL sirolimus. Rapamune is also available as a tan, triangular-shaped tablet containing 0.5 mg sirolimus, as a white, triangular-shaped tablet containing 1 mg sirolimus, and as a yellow-to-beige triangular-shaped tablet containing 2 mg sirolimus. The inactive ingredients in Rapamune Oral Solution are Phosal 50 PG® (phosphatidylcholine, propylene glycol, mono- and di-glycerides, ethanol, soy fatty acids, and ascorbyl palmitate) and polysorbate 80. Rapamune Oral Solution contains 1.5% – 2.5% ethanol. The inactive ingredients in Rapamune Tablets include sucrose, lactose, polyethylene glycol 8000, calcium sulfate, microcrystalline cellulose, pharmaceutical glaze, talc, titanium dioxide, magnesium stearate, povidone, poloxamer 188, polyethylene glycol 20,000, glyceryl monooleate, carnauba wax, dl-alpha tocopherol, and other ingredients. The 0.5 mg and 2 mg dosage strengths also contain yellow iron (ferric) oxide and brown iron (ferric) oxide.</Description>
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<Description>Rapamune (sirolimus) is an mTOR inhibitor immunosuppressive agent. Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus. The chemical name of sirolimus (also known as rapamycin) is (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34, 34a-hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclohentriacontine-1,5,11,28,29 (4H,6H,31H)-pentone. Its molecular formula is C51H79NO13 and its molecular weight is 914.2. The structural formula of sirolimus is illustrated as follows. Sirolimus is a white to off-white powder and is insoluble in water, but freely soluble in benzyl alcohol, chloroform, acetone, and acetonitrile. Rapamune is available for administration as an oral solution containing 1 mg/mL sirolimus. Rapamune is also available as a tan, triangular-shaped tablet containing 0.5 mg sirolimus, as a white, triangular-shaped tablet containing 1 mg sirolimus, and as a yellow-to-beige triangular-shaped tablet containing 2 mg sirolimus. The inactive ingredients in Rapamune Oral Solution are Phosal 50 PG® (phosphatidylcholine, propylene glycol, mono- and di-glycerides, ethanol, soy fatty acids, and ascorbyl palmitate) and polysorbate 80. Rapamune Oral Solution contains 1.5% – 2.5% ethanol. The inactive ingredients in Rapamune Tablets include sucrose, lactose, polyethylene glycol 8000, calcium sulfate, microcrystalline cellulose, pharmaceutical glaze, talc, titanium dioxide, magnesium stearate, povidone, poloxamer 188, polyethylene glycol 20,000, glyceryl monooleate, carnauba wax, dl-alpha tocopherol, and other ingredients. The 0.5 mg and 2 mg dosage strengths also contain yellow iron (ferric) oxide and brown iron (ferric) oxide.</Description>
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<Description>Rapamune (sirolimus) is an mTOR inhibitor immunosuppressive agent. Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus. The chemical name of sirolimus (also known as rapamycin) is (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34, 34a-hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclohentriacontine-1,5,11,28,29 (4H,6H,31H)-pentone. Its molecular formula is C51H79NO13 and its molecular weight is 914.2. The structural formula of sirolimus is illustrated as follows. Sirolimus is a white to off-white powder and is insoluble in water, but freely soluble in benzyl alcohol, chloroform, acetone, and acetonitrile. Rapamune is available for administration as an oral solution containing 1 mg/mL sirolimus. Rapamune is also available as a tan, triangular-shaped tablet containing 0.5 mg sirolimus, as a white, triangular-shaped tablet containing 1 mg sirolimus, and as a yellow-to-beige triangular-shaped tablet containing 2 mg sirolimus. The inactive ingredients in Rapamune Oral Solution are Phosal 50 PG® (phosphatidylcholine, propylene glycol, mono- and di-glycerides, ethanol, soy fatty acids, and ascorbyl palmitate) and polysorbate 80. Rapamune Oral Solution contains 1.5% – 2.5% ethanol. The inactive ingredients in Rapamune Tablets include sucrose, lactose, polyethylene glycol 8000, calcium sulfate, microcrystalline cellulose, pharmaceutical glaze, talc, titanium dioxide, magnesium stearate, povidone, poloxamer 188, polyethylene glycol 20,000, glyceryl monooleate, carnauba wax, dl-alpha tocopherol, and other ingredients. The 0.5 mg and 2 mg dosage strengths also contain yellow iron (ferric) oxide and brown iron (ferric) oxide.</Description>
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<Description>Rapamune (sirolimus) is an mTOR inhibitor immunosuppressive agent. Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus. The chemical name of sirolimus (also known as rapamycin) is (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34, 34a-hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy-3H-pyrido[2,1-c][1,4] oxaazacyclohentriacontine-1,5,11,28,29 (4H,6H,31H)-pentone. Its molecular formula is C51H79NO13 and its molecular weight is 914.2. The structural formula of sirolimus is illustrated as follows. Sirolimus is a white to off-white powder and is insoluble in water, but freely soluble in benzyl alcohol, chloroform, acetone, and acetonitrile. Rapamune is available for administration as an oral solution containing 1 mg/mL sirolimus. Rapamune is also available as a tan, triangular-shaped tablet containing 0.5 mg sirolimus, as a white, triangular-shaped tablet containing 1 mg sirolimus, and as a yellow-to-beige triangular-shaped tablet containing 2 mg sirolimus. The inactive ingredients in Rapamune Oral Solution are Phosal 50 PG® (phosphatidylcholine, propylene glycol, mono- and di-glycerides, ethanol, soy fatty acids, and ascorbyl palmitate) and polysorbate 80. Rapamune Oral Solution contains 1.5% – 2.5% ethanol. The inactive ingredients in Rapamune Tablets include sucrose, lactose, polyethylene glycol 8000, calcium sulfate, microcrystalline cellulose, pharmaceutical glaze, talc, titanium dioxide, magnesium stearate, povidone, poloxamer 188, polyethylene glycol 20,000, glyceryl monooleate, carnauba wax, dl-alpha tocopherol, and other ingredients. The 0.5 mg and 2 mg dosage strengths also contain yellow iron (ferric) oxide and brown iron (ferric) oxide.</Description>
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<Description>Carbamazepine USP, is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as a suspension of 100 mg/5 mL (teaspoon). Its chemical name is 5H-dibenz[b,f]azepine-5-carboxamide, and its structural formula is. C 15H 12N 2O. Carbamazepine USP is a white to off-white powder, practically insoluble in water and soluble in alcohol and in acetone. Its molecular weight is 236.27. Carbamazepine Oral Suspension USP, 100 mg/5 mL – citric acid monohydrate, FD&C yellow no. 6, orange flavor, poloxamer 188, potassium sorbate, propylene glycol, purified water, sorbitol solution, sucrose and xanthan gum.</Description>
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<Description>Carbamazepine USP, is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as a suspension of 100 mg/5 mL (teaspoon). Its chemical name is 5H-dibenz[b,f]azepine-5-carboxamide, and its structural formula is. C 15H 12N 2O. Carbamazepine USP is a white to off-white powder, practically insoluble in water and soluble in alcohol and in acetone. Its molecular weight is 236.27. Carbamazepine Oral Suspension USP, 100 mg/5 mL – citric acid monohydrate, FD&C yellow no. 6, orange flavor, poloxamer 188, potassium sorbate, propylene glycol, purified water, sorbitol solution, sucrose and xanthan gum.</Description>
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<IndicationAndUsage> Sirolimus tablet is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants: o Patients at low-to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended 2-4 months after transplantation (1.1). o Patients at high-immunologic risk: Use in combination with CsA and corticosteroids for the first 12 months following transplantation (1.1). Safety and efficacy of CsA withdrawal has not been established in high risk patients (1.1, 1.2, 14.3). Sirolimus tablet is an mTOR inhibitor indicated for the treatment of patients with lymphangioleiomyomatosis (1.3).</IndicationAndUsage>
<Description>Sirolimus is an mTOR inhibitor immunosuppressive agent. Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus. The chemical name of sirolimus (also known as rapamycin) is (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)9,10,12,13,14,21,22,23,24,25,26,27,32,33,34, 34a-hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy3H-pyrido[2,1-c][1,4] oxaazacyclohentriacontine-1,5,11,28,29 (4H,6H,31H)-pentone. Its molecular formula is C51H79NO13 and its molecular weight is 914.2. The structural formula of sirolimus is illustrated as follows. Sirolimus is a white to off-white powder and is insoluble in water, but freely soluble in benzyl alcohol, chloroform, acetone, and acetonitrile. Sirolimus tablets are also available as a tan, round-shaped tablet containing 0.5 mg sirolimus, as a white, round-shaped tablet containing 1 mg sirolimus, and as a yellow-to-beige round-shaped tablet containing 2 mg sirolimus. The inactive ingredients in sirolimus tablets include edetate disodium, poloxamer 188, sucrose, Hypromellose, vitamin E, microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, glyceryl behenate.The 0.5 mg strength also contains polyethylene glycol and the 1 mg and the 2 mg contains polyvinyl alcohol, talc, titanium dioxide, sodium lauryl sulphate, glyceryl monocaprylocaprate, yellow iron oxide, black iron oxide, red iron oxide. Also 2 mg additionally contains FD & C Yellow # 6 and lake pigment D & C Yellow # 10.</Description>
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<LastUpdate>2026-05-13</LastUpdate>
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<IndicationAndUsage>Sirolimus tablets are an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants: 1 Patients at low- to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended 2 to 4 months after transplantation (1.1)., 2 Patients at high-immunologic risk: Use in combination with CsA and corticosteroids for the first 12 months following transplantation (1.1). Safety and efficacy of CsA withdrawal has not been established in high risk patients (1.1, 1.2, 14.3)., 3 Sirolimus tablets are an mTOR inhibitor indicated for the treatment of patients with lymphangioleiomyomatosis (1.3) .</IndicationAndUsage>
<Description>Sirolimus is an mTOR inhibitor immunosuppressive agent. Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus. The chemical name of sirolimus (also known as rapamycin) is (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34,34a-hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy-3H-pyrido[2,1-c] [1,4] oxaazacyclohentriacontine-1,5,11,28,29 (4H,6H,31H)-pentone. Its molecular formula is C51H79NO13 and its molecular weight is 914.2. The structural formula of sirolimus is illustrated as follows. Sirolimus is a white to off-white powder and is freely soluble in chloroform, acetone, and acetonitrile, insoluble in water. Sirolimus tablets are available as a grey to greenish grey colored film-coated, round shaped beveled edge standard convex tablet containing 0.5 mg sirolimus; as a white to off-white colored film-coated, round shaped beveled edge standard convex tablet containing 1 mg sirolimus; and as a yellow to orange yellow colored film-coated, round shaped beveled edge standard convex tablet containing 2 mg sirolimus. Sirolimus tablets, 2 mg contains FD&C yellow No. 6 as a color additive. The inactive ingredients in sirolimus tablets include: croscarmellose sodium, dl-alpha tocopherol, edetate disodium, glyceryl behenate, hypromellose, lactose monohydrate, microcrystalline cellulose, poloxamer 188, polyethylene glycol, sucrose and titanium dioxide. Additionally, the 0.5 mg dosage strength also contains: iron oxide black, iron oxide yellow and iron oxide red and the 2 mg dosage strength also contains: D&C yellow #10, FD&C yellow #6 and FD&C blue #2.</Description>
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<IndicationAndUsage>Sirolimus tablets are an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants: 1 Patients at low- to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended 2 to 4 months after transplantation (1.1)., 2 Patients at high-immunologic risk: Use in combination with CsA and corticosteroids for the first 12 months following transplantation (1.1). Safety and efficacy of CsA withdrawal has not been established in high risk patients (1.1, 1.2, 14.3)., 3 Sirolimus tablets are an mTOR inhibitor indicated for the treatment of patients with lymphangioleiomyomatosis (1.3) .</IndicationAndUsage>
<Description>Sirolimus is an mTOR inhibitor immunosuppressive agent. Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus. The chemical name of sirolimus (also known as rapamycin) is (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34,34a-hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy-3H-pyrido[2,1-c] [1,4] oxaazacyclohentriacontine-1,5,11,28,29 (4H,6H,31H)-pentone. Its molecular formula is C51H79NO13 and its molecular weight is 914.2. The structural formula of sirolimus is illustrated as follows. Sirolimus is a white to off-white powder and is freely soluble in chloroform, acetone, and acetonitrile, insoluble in water. Sirolimus tablets are available as a grey to greenish grey colored film-coated, round shaped beveled edge standard convex tablet containing 0.5 mg sirolimus; as a white to off-white colored film-coated, round shaped beveled edge standard convex tablet containing 1 mg sirolimus; and as a yellow to orange yellow colored film-coated, round shaped beveled edge standard convex tablet containing 2 mg sirolimus. Sirolimus tablets, 2 mg contains FD&C yellow No. 6 as a color additive. The inactive ingredients in sirolimus tablets include: croscarmellose sodium, dl-alpha tocopherol, edetate disodium, glyceryl behenate, hypromellose, lactose monohydrate, microcrystalline cellulose, poloxamer 188, polyethylene glycol, sucrose and titanium dioxide. Additionally, the 0.5 mg dosage strength also contains: iron oxide black, iron oxide yellow and iron oxide red and the 2 mg dosage strength also contains: D&C yellow #10, FD&C yellow #6 and FD&C blue #2.</Description>
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<IndicationAndUsage>Sirolimus tablets are an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants: 1 Patients at low- to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended 2 to 4 months after transplantation (1.1)., 2 Patients at high-immunologic risk: Use in combination with CsA and corticosteroids for the first 12 months following transplantation (1.1). Safety and efficacy of CsA withdrawal has not been established in high risk patients (1.1, 1.2, 14.3)., 3 Sirolimus tablets are an mTOR inhibitor indicated for the treatment of patients with lymphangioleiomyomatosis (1.3) .</IndicationAndUsage>
<Description>Sirolimus is an mTOR inhibitor immunosuppressive agent. Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus. The chemical name of sirolimus (also known as rapamycin) is (3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34,34a-hexadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylethyl]-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy-3H-pyrido[2,1-c] [1,4] oxaazacyclohentriacontine-1,5,11,28,29 (4H,6H,31H)-pentone. Its molecular formula is C51H79NO13 and its molecular weight is 914.2. The structural formula of sirolimus is illustrated as follows. Sirolimus is a white to off-white powder and is freely soluble in chloroform, acetone, and acetonitrile, insoluble in water. Sirolimus tablets are available as a grey to greenish grey colored film-coated, round shaped beveled edge standard convex tablet containing 0.5 mg sirolimus; as a white to off-white colored film-coated, round shaped beveled edge standard convex tablet containing 1 mg sirolimus; and as a yellow to orange yellow colored film-coated, round shaped beveled edge standard convex tablet containing 2 mg sirolimus. Sirolimus tablets, 2 mg contains FD&C yellow No. 6 as a color additive. The inactive ingredients in sirolimus tablets include: croscarmellose sodium, dl-alpha tocopherol, edetate disodium, glyceryl behenate, hypromellose, lactose monohydrate, microcrystalline cellulose, poloxamer 188, polyethylene glycol, sucrose and titanium dioxide. Additionally, the 0.5 mg dosage strength also contains: iron oxide black, iron oxide yellow and iron oxide red and the 2 mg dosage strength also contains: D&C yellow #10, FD&C yellow #6 and FD&C blue #2.</Description>
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<IndicationAndUsage>ENSPRYNG is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.</IndicationAndUsage>
<Description>Satralizumab-mwge is a recombinant humanized anti-human interleukin 6 (IL-6) receptor monoclonal antibody based on a human IgG2 framework. Each light chain and heavy chain consists of 214 and 443 amino acids, respectively. Satralizumab-mwge is a glycoprotein with an approximate molecular weight of 143 kDa and is produced by recombinant DNA technology in Chinese hamster ovary cells. The binding of satralizumab-mwge to the IL-6 receptor is pH-sensitive. ENSPRYNG (satralizumab-mwge) injection for subcutaneous administration is supplied as a sterile, clear, colorless to slightly yellow solution with no preservative with an approximate pH of 6. ENSPRYNG is supplied in a single-dose 1.0 mL prefilled syringe with a needle safety device or a single-dose 1.0 mL autoinjector that contains a prefilled syringe. Each prefilled syringe or autoinjector delivers 1 mL of solution containing 120 mg satralizumab-mwge, L-arginine (26.1 mg), L-aspartic acid (pH adjustment), L-histidine (3.1 mg), poloxamer 188 (0.5 mg), and Water for Injection, USP.</Description>
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<IndicationAndUsage>ENSPRYNG is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.</IndicationAndUsage>
<Description>Satralizumab-mwge is a recombinant humanized anti-human interleukin 6 (IL-6) receptor monoclonal antibody based on a human IgG2 framework. Each light chain and heavy chain consists of 214 and 443 amino acids, respectively. Satralizumab-mwge is a glycoprotein with an approximate molecular weight of 143 kDa and is produced by recombinant DNA technology in Chinese hamster ovary cells. The binding of satralizumab-mwge to the IL-6 receptor is pH-sensitive. ENSPRYNG (satralizumab-mwge) injection for subcutaneous administration is supplied as a sterile, clear, colorless to slightly yellow solution with no preservative with an approximate pH of 6. ENSPRYNG is supplied in a single-dose 1.0 mL prefilled syringe with a needle safety device or a single-dose 1.0 mL autoinjector that contains a prefilled syringe. Each prefilled syringe or autoinjector delivers 1 mL of solution containing 120 mg satralizumab-mwge, L-arginine (26.1 mg), L-aspartic acid (pH adjustment), L-histidine (3.1 mg), poloxamer 188 (0.5 mg), and Water for Injection, USP.</Description>
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<IndicationAndUsage>ENSPRYNG is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.</IndicationAndUsage>
<Description>Satralizumab-mwge is a recombinant humanized anti-human interleukin 6 (IL-6) receptor monoclonal antibody based on a human IgG2 framework. Each light chain and heavy chain consists of 214 and 443 amino acids, respectively. Satralizumab-mwge is a glycoprotein with an approximate molecular weight of 143 kDa and is produced by recombinant DNA technology in Chinese hamster ovary cells. The binding of satralizumab-mwge to the IL-6 receptor is pH-sensitive. ENSPRYNG (satralizumab-mwge) injection for subcutaneous administration is supplied as a sterile, clear, colorless to slightly yellow solution with no preservative with an approximate pH of 6. ENSPRYNG is supplied in a single-dose 1.0 mL prefilled syringe with a needle safety device or a single-dose 1.0 mL autoinjector that contains a prefilled syringe. Each prefilled syringe or autoinjector delivers 1 mL of solution containing 120 mg satralizumab-mwge, L-arginine (26.1 mg), L-aspartic acid (pH adjustment), L-histidine (3.1 mg), poloxamer 188 (0.5 mg), and Water for Injection, USP.</Description>
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<IndicationAndUsage>ENSPRYNG is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.</IndicationAndUsage>
<Description>Satralizumab-mwge is a recombinant humanized anti-human interleukin 6 (IL-6) receptor monoclonal antibody based on a human IgG2 framework. Each light chain and heavy chain consists of 214 and 443 amino acids, respectively. Satralizumab-mwge is a glycoprotein with an approximate molecular weight of 143 kDa and is produced by recombinant DNA technology in Chinese hamster ovary cells. The binding of satralizumab-mwge to the IL-6 receptor is pH-sensitive. ENSPRYNG (satralizumab-mwge) injection for subcutaneous administration is supplied as a sterile, clear, colorless to slightly yellow solution with no preservative with an approximate pH of 6. ENSPRYNG is supplied in a single-dose 1.0 mL prefilled syringe with a needle safety device or a single-dose 1.0 mL autoinjector that contains a prefilled syringe. Each prefilled syringe or autoinjector delivers 1 mL of solution containing 120 mg satralizumab-mwge, L-arginine (26.1 mg), L-aspartic acid (pH adjustment), L-histidine (3.1 mg), poloxamer 188 (0.5 mg), and Water for Injection, USP.</Description>
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