{
"NDC": [
{
"NDCCode": "55154-0748-8",
"PackageDescription": "2052 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (55154-0748-8)",
"NDC11Code": "55154-0748-08",
"ProductNDC": "55154-0748",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aspirin",
"NonProprietaryName": "Aspirin",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20110523",
"EndMarketingDate": "20180731",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Cardinal Health",
"SubstanceName": "ASPIRIN",
"StrengthNumber": "81",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2018-07-31",
"ProductNdcExcludeFlag": "N"
},
{
"NDCCode": "55154-0748-9",
"PackageDescription": "6 BLISTER PACK in 1 CARTON (55154-0748-9) > 5 TABLET in 1 BLISTER PACK",
"NDC11Code": "55154-0748-09",
"ProductNDC": "55154-0748",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aspirin",
"NonProprietaryName": "Aspirin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110523",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Cardinal Health",
"SubstanceName": "ASPIRIN",
"StrengthNumber": "81",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2014-04-22"
},
{
"NDCCode": "58232-0748-8",
"PackageDescription": "227 g in 1 TUBE (58232-0748-8)",
"NDC11Code": "58232-0748-08",
"ProductNDC": "58232-0748",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lubriderm",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Oxybenzone And Octocrylene",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100330",
"EndMarketingDate": "20160701",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc.",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE; OCTOCRYLENE",
"StrengthNumber": "30; 60; 50; 50; 35.5",
"StrengthUnit": "mg/g; mg/g; mg/g; mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "68788-0748-8",
"PackageDescription": "28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-0748-8) ",
"NDC11Code": "68788-0748-08",
"ProductNDC": "68788-0748",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amitriptyline Hydrochloride",
"NonProprietaryName": "Amitriptyline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110609",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040218",
"LabelerName": "Preferred Pharmaceuticals, Inc.",
"SubstanceName": "AMITRIPTYLINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-05-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20110609",
"SamplePackage": "N"
},
{
"NDCCode": "43598-748-11",
"PackageDescription": "1 BOTTLE in 1 CARTON (43598-748-11) / 5 mL in 1 BOTTLE",
"NDC11Code": "43598-0748-11",
"ProductNDC": "43598-748",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Timolol Maleate Ophthalmic Gel Forming Solution 0.5%",
"NonProprietaryName": "Timolol Maleate Ophthalmic Gel Forming Solution 0.5%",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20221115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215733",
"LabelerName": "Dr. Reddy's Laboratories, Inc.",
"SubstanceName": "TIMOLOL MALEATE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-06-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20221115",
"SamplePackage": "N",
"IndicationAndUsage": "Timolol maleate ophthalmic gel forming solution is indicated in the treatment of elevatedintraocular pressure in patients with ocular hypertension or open-angle glaucoma.",
"Description": "Timolol maleate ophthalmic gel forming solution is a non-selective beta adrenergic receptor blocking agent. Its chemical name is (-)-1-(tert-butylamino)-3-[(4 morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol maleate possesses an asymmetric carbon atom in its structure and is provided as the levo-isomer. The optical rotation of timolol maleate is. 25°. [α] in 1.0N HCl (C = 5%) = -12.2° (-11.7° to -12.5°). 405 nm. Its molecular formula is C13H24N4O3SC4H4O4 and its structural formula is. Timolol maleate, USP has a molecular weight of 432.49. It is a white to practically white powder, which is soluble in water, methanol, and ethanol. Timolol maleate ophthalmic gel forming solution is supplied as a sterile, isotonic, buffered, aqueous solution of timolol maleate in two dosage strengths. The pH of the solution is 6.5 to 7.5, and the osmolality is 260-330 mOsmol/kg. Each mL of timolol maleate ophthalmic gel forming solution 0.25% contains 2.5 mg of timolol (3.4 mg of timolol maleate USP). Each mL of timolol maleate ophthalmic gel forming solution 0.5% contains 5 mg of timolol (6.8 mg of timolol maleate USP). Inactive ingredients: gellan gum, tromethamine, mannitol and water for injection. Preservative: benzododecinium bromide 0.012%. The gel forming solution contains a purified anionic heteropolysaccharide derived from gellan gum. An aqueous solution of gellan gum, in the presence of a cation, has the ability to gel. Upon contact with the precorneal tear film, timolol maleate ophthalmic gel forming solution forms a gel that is subsequently removed by the flow of tears."
},
{
"NDCCode": "53808-0748-1",
"PackageDescription": "30 TABLET in 1 BLISTER PACK (53808-0748-1)",
"NDC11Code": "53808-0748-01",
"ProductNDC": "53808-0748",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Paroxetine",
"NonProprietaryName": "Paroxetine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075356",
"LabelerName": "State of Florida DOH Central Pharmacy",
"SubstanceName": "PAROXETINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"Description": "Paroxetine hydrochloride is an orally administered psychotropic drug. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)-trans-4R-(4'-fluorophenyl)-3S-[(3',4'-methylenedioxyphenoxy) methyl] piperidine hydrochloride anhydrous and has the empirical formula of C19H20FNO3HCl. The molecular weight is 365.8 (anhydrous) (329.4 as free base). The structural formula of paroxetine hydrochloride is. Paroxetine hydrochloride is an odorless, off-white powder, having a melting point range of 116° to 120°C and a solubility of 5.4 mg/mL in water. Each film-coated tablet, for oral administration, contains paroxetine hydrochloride equivalent to paroxetine as follows: 10 mg; 20 mg; 30 mg; 40 mg. Inactive ingredients consist of anhydrous lactose, hydroxypropyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, sodium starch glycolate and titanium dioxide. Paroxetine tablets USP comply with USP Related Impurities Test 1."
},
{
"NDCCode": "55700-748-05",
"PackageDescription": "5 POUCH in 1 CARTON (55700-748-05) / 1 PATCH in 1 POUCH / 72 h in 1 PATCH",
"NDC11Code": "55700-0748-05",
"ProductNDC": "55700-748",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fentanyl",
"NonProprietaryName": "Fentanyl",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20190517",
"EndMarketingDate": "20260228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077449",
"LabelerName": "Quality Care Products, LLC",
"SubstanceName": "FENTANYL",
"StrengthNumber": "50",
"StrengthUnit": "ug/h",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2026-03-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190517",
"EndMarketingDatePackage": "20260228",
"SamplePackage": "N",
"IndicationAndUsage": "Fentanyl transdermal system is indicated for the management of pain in opioid-tolerant patients, severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Patients considered opioid-tolerant are those who are taking, for one week or longer, at least 60 mg morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. Limitations of Use: 1 Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release/long-acting opioid formulations [see Warnings and Precautions ( 5.1)] , reserve fentanyl transdermal system for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. , 2 Fentanyl transdermal system is not indicated as an as-needed (prn) analgesic.",
"Description": "Fentanyl transdermal system contains fentanyl, an opioid agonist, for transdermal administration. The amount of fentanyl released from each system per hour is proportional to the surface area (25 mcg/hour per 10.5 cm 2). The composition per unit area of all transdermal system sizes is identical. * Nominal delivery rate per hour. ** Nominal delivery rate is 12.5 mcg/hour. The molecular weight of fentanyl base is 336.5 g/mol, and the empirical formula is C 22H 28N 2O. The n-octanol: water partition coefficient is 860:1. The pKa is 8.4. The chemical name is N-phenyl-N-(1-(2-phenylethyl)-4-piperidinyl) propanamide. The structural formula is. Fentanyl transdermal system is a rectangular transparent unit comprising a release liner and two functional layers. Proceeding from the outer surface toward the surface adhering to skin, these layers are. 1) a backing layer of polyethylene terephalate film; 2) a drug-in-adhesive layer. Before use, a release liner covering the drug-in-adhesive layer is removed and discarded."
},
{
"NDCCode": "60429-748-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (60429-748-01) ",
"NDC11Code": "60429-0748-01",
"ProductNDC": "60429-748",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sotalol Hydrochloride",
"NonProprietaryName": "Sotalol Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20020926",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076140",
"LabelerName": "Golden State Medical Supply, Inc.",
"SubstanceName": "SOTALOL HYDROCHLORIDE",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], Antiarrhythmic [EPC], Cardiac Rhythm Alteration [PE]",
"Status": "Active",
"LastUpdate": "2025-08-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20030201",
"SamplePackage": "N",
"Description": "Sotalol hydrochloride/Sotalol hydrochloride AF tablets, USP contains sotalol hydrochloride, an antiarrhythmic drug with Class II (beta-adrenoreceptor blocking) and Class III (cardiac action potential duration prolongation) properties. Sotalol hydrochloride tablets, USP are supplied as a white to off-white, capsule-shaped, scored tablet for oral administration. Sotalol hydrochloride AF is supplied as a white to off-white, capsule-shaped, scored tablet for oral administration. Sotalol hydrochloride is a white, crystalline solid with a molecular weight of 308.8 g/mol. It is hydrophilic, soluble in water, propylene glycol and ethanol, but is only slightly soluble in chloroform. Chemically, sotalol hydrochloride is d,l- N-[4-[1-hydroxy-2-[(1-methylethyl) amino]ethyl]phenyl]methane-sulfonamide monohydrochloride. The molecular formula is C 12H 20N 2O 3S∙HCl and is represented by the following structural formula:. Each Sotalol Hydrochloride tablet, USP/Sotalol Hydrochloride AF tablets, USP for oral administration, contains 80 mg, 120 mg, 160 mg or 240 mg of sotalol hydrochloride. In addition, each tablet also contains the following inactive ingredients: magnesium stearate and microcrystalline cellulose."
},
{
"NDCCode": "60760-748-07",
"PackageDescription": "7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-748-07) ",
"NDC11Code": "60760-0748-07",
"ProductNDC": "60760-748",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tivicay",
"NonProprietaryName": "Dolutegravir Sodium",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130813",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204790",
"LabelerName": "ST. MARY'S MEDICAL PARK PHARMACY",
"SubstanceName": "DOLUTEGRAVIR SODIUM",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HIV Integrase Inhibitors [MoA], Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC], Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260116",
"SamplePackage": "N",
"IndicationAndUsage": "TIVICAY and TIVICAY PD are indicated in combination with other antiretroviral agents for the treatment of HIV‑1 infection in adults (treatment-naïve or -experienced) and in pediatric patients (treatment-naïve or -experienced but integrase strand transfer inhibitor [INSTI]-naïve) aged at least 4 weeks and weighing at least 3 kg [see Microbiology ( 12.4)]. TIVICAY is indicated in combination with rilpivirine as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies/ mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure or known substitutions associated with resistance to either antiretroviral agent.",
"Description": "TIVICAY contains dolutegravir, as dolutegravir sodium, an HIV INSTI. The chemical name of dolutegravir sodium is sodium (4 R,12a S)-9-{[(2,4-difluorophenyl)methyl]carbamoyl}-4-methyl-6,8-dioxo-3,4,6,8,12,12a-hexahydro-2 H-pyrido[1',2':4,5]pyrazino[2,1- b][1,3]oxazin-7-olate. The empirical formula is C 20H 18F 2N 3NaO 5,and the molecular weight is 441.36 g/mol. It has the following structural formula:. Dolutegravir sodium is a white to light yellow powder and is slightly soluble in water. Each film-coated tablet of TIVICAY for oral administration contains 10.5, 26.3, or 52.6 mg of dolutegravir sodium, which is equivalent to 10, 25, or 50 mg dolutegravir free acid, respectively, and the following inactive ingredients: D-mannitol, microcrystalline cellulose, povidone K29/32, sodium starch glycolate, and sodium stearyl fumarate. The tablet film‑coating contains the inactive ingredients iron oxide yellow (25-mg and 50-mg tablets only), macrogol/PEG, polyvinyl alcohol-part hydrolyzed, talc, and titanium dioxide. Each TIVICAY PD tablet for oral suspension contains 5.26 mg of dolutegravir sodium, which is equivalent to 5 mg dolutegravir free acid, and the following inactive ingredients: calcium sulfate dihydrate, crospovidone, mannitol, microcrystalline cellulose, povidone K29/32, silicified microcrystalline cellulose, sodium starch glycolate, strawberry cream flavor, sucralose, and sodium stearyl fumarate. The tablet film-coating contains hypromellose, polyethylene glycol, and titanium dioxide."
},
{
"NDCCode": "66302-748-04",
"PackageDescription": "1 BLISTER PACK in 1 KIT (66302-748-04) / 4 BLISTER PACK in 1 BLISTER PACK / 4 INHALANT in 1 BLISTER PACK",
"NDC11Code": "66302-0748-04",
"ProductNDC": "66302-748",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tyvaso Dpi",
"NonProprietaryName": "Treprostinil",
"DosageFormName": "INHALANT",
"RouteName": "ORAL",
"StartMarketingDate": "20220523",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA214324",
"LabelerName": "United Therapeutics Corporation",
"SubstanceName": "TREPROSTINIL",
"StrengthNumber": "48",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Prostacycline Vasodilator [EPC], Prostaglandins I [CS], Vasodilation [PE]",
"Status": "Active",
"LastUpdate": "2025-11-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220523",
"SamplePackage": "N",
"IndicationAndUsage": "Tyvaso DPI is a prostacyclin mimetic indicated for the treatment of: 1 Pulmonary arterial hypertension (PAH; WHO Group 1) to improve exercise ability. Studies with Tyvaso establishing effectiveness predominately included patients with NYHA Functional Class III symptoms and etiologies of idiopathic or heritable PAH (56%) or PAH associated with connective tissue diseases (33%). (1.1), 2 Pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability. The study with Tyvaso establishing effectiveness predominately included patients with etiologies of idiopathic interstitial pneumonia (IIP) (45%) inclusive of idiopathic pulmonary fibrosis (IPF), combined pulmonary fibrosis and emphysema (CPFE) (25%), and WHO Group 3 connective tissue disease (22%). (1.2).",
"Description": "Tyvaso DPI consists of single-dose plastic cartridges filled with a white powder containing 1% of treprostinil, a prostacyclin mimetic, which is intended for administration by oral inhalation using the Tyvaso DPI Inhaler only. Treprostinil is adsorbed onto carrier particles consisting of fumaryl diketopiperazine (FDKP). Each cartridge contains 16 mcg, 32 mcg, 48 mcg, 64 mcg, or 80 mcg of treprostinil with approximate fill weights of 1.6 mg, 3.2 mg, 4.8 mg, 6.4 mg, or 8.0 mg of Tyvaso DPI, respectively. Treprostinil is (1R,2R,3aS,9aS)-[[2,3,3a,4,9,9a-hexahydro-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-1H-benz[f]inden-5-yl]oxy]acetic acid. Treprostinil has a molecular weight of 390.52 and a molecular formula of C23H34O5. The structural formula of treprostinil is."
},
{
"NDCCode": "67877-748-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (67877-748-01) ",
"NDC11Code": "67877-0748-01",
"ProductNDC": "67877-748",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sirolimus",
"NonProprietaryName": "Sirolimus",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210313",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214753",
"LabelerName": "Ascend Laboratories, LLC",
"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": "Active",
"LastUpdate": "2025-10-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210313",
"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."
},
{
"NDCCode": "67877-748-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (67877-748-05) ",
"NDC11Code": "67877-0748-05",
"ProductNDC": "67877-748",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sirolimus",
"NonProprietaryName": "Sirolimus",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210313",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214753",
"LabelerName": "Ascend Laboratories, LLC",
"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": "Active",
"LastUpdate": "2025-10-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210313",
"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."
},
{
"NDCCode": "67877-748-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (67877-748-30) ",
"NDC11Code": "67877-0748-30",
"ProductNDC": "67877-748",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sirolimus",
"NonProprietaryName": "Sirolimus",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210313",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214753",
"LabelerName": "Ascend Laboratories, LLC",
"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": "Active",
"LastUpdate": "2025-10-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210313",
"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."
},
{
"NDCCode": "67877-748-38",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (67877-748-38) / 10 TABLET, FILM COATED in 1 BLISTER PACK (67877-748-33) ",
"NDC11Code": "67877-0748-38",
"ProductNDC": "67877-748",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sirolimus",
"NonProprietaryName": "Sirolimus",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20210313",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214753",
"LabelerName": "Ascend Laboratories, LLC",
"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": "Active",
"LastUpdate": "2025-10-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210313",
"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."
},
{
"NDCCode": "68308-748-08",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (68308-748-08) / 8 INSERT in 1 BLISTER PACK",
"NDC11Code": "68308-0748-08",
"ProductNDC": "68308-748",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Imvexxy",
"NonProprietaryName": "Estradiol",
"DosageFormName": "INSERT",
"RouteName": "VAGINAL",
"StartMarketingDate": "20231215",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208564",
"LabelerName": "Mayne Pharma",
"SubstanceName": "ESTRADIOL",
"StrengthNumber": "10",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250110",
"SamplePackage": "N",
"IndicationAndUsage": "IMVEXXY is an estrogen indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. (1).",
"Description": "IMVEXXY (estradiol vaginal inserts) are small, light pink, tear-shaped, vaginal inserts for manual placement into the vagina. Inserts contain 4 mcg or 10 mcg of estradiol, an estrogen. Each insert is imprinted in white ink on one side with \"04\" or \"10\" corresponding to the insert's dosage strength. IMVEXXY vaginal inserts are used intravaginally. When the insert comes in contact with the vaginal mucosa, estradiol is released into the vagina. Estradiol is chemically described as estra-1,3,5 (10)-triene-3,17β-diol. The chemical formula is C18H24O2 with a molecular weight of 272.38. The structural formula is. IMVEXXY (estradiol vaginal inserts) contain the following inactive ingredients: ammonium hydroxide, ethanol, ethyl acetate, ethylene glycol palmitostearate, FD&C Red #40, gelatin, glycerin, isopropyl alcohol, lecithin, medium chain triglycerides, polyethylene glycol, polyethylene glycol stearates, polyvinyl acetate phthalate, propylene glycol, purified water, sorbitol-sorbitan solution, and titanium dioxide. FDA approved acceptance criteria for assay, organic impurities, and dissolution tolerances differ from the USP test."
},
{
"NDCCode": "55154-0103-8",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 BAG (55154-0103-8) > 20 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "55154-0103-08",
"ProductNDC": "55154-0103",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Chloride",
"NonProprietaryName": "Sodium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20050228",
"EndMarketingDate": "20191130",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018803",
"LabelerName": "Cardinal Health",
"SubstanceName": "SODIUM CHLORIDE",
"StrengthNumber": "9",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-12-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20050228",
"EndMarketingDatePackage": "20191130",
"SamplePackage": "N"
},
{
"NDCCode": "55154-0119-8",
"PackageDescription": "1 VIAL in 1 BAG (55154-0119-8) > 50 mL in 1 VIAL",
"NDC11Code": "55154-0119-08",
"ProductNDC": "55154-0119",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Bicarbonate",
"NonProprietaryName": "Sodium Bicarbonate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19850418",
"EndMarketingDate": "20190731",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Cardinal Health",
"SubstanceName": "SODIUM BICARBONATE",
"StrengthNumber": "84",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2019-08-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19850418",
"EndMarketingDatePackage": "20190731",
"SamplePackage": "N"
},
{
"NDCCode": "55154-0120-8",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 BAG (55154-0120-8) > 1 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "55154-0120-08",
"ProductNDC": "55154-0120",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ketorolac Tromethamine",
"NonProprietaryName": "Ketorolac Tromethamine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20110727",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074802",
"LabelerName": "Cardinal Health",
"SubstanceName": "KETOROLAC TROMETHAMINE",
"StrengthNumber": "30",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-11-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20110727",
"EndMarketingDatePackage": "20191031",
"SamplePackage": "N"
},
{
"NDCCode": "55154-0124-8",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 BAG (55154-0124-8) > 20 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "55154-0124-08",
"ProductNDC": "55154-0124",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine Hydrochloride",
"NonProprietaryName": "Lidocaine Hydrochloride Anhydrous",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INFILTRATION",
"StartMarketingDate": "20100330",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088299",
"LabelerName": "Cardinal Health",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2019-12-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20100330",
"EndMarketingDatePackage": "20191130",
"SamplePackage": "N"
},
{
"NDCCode": "55154-0127-8",
"PackageDescription": "1 VIAL in 1 BAG (55154-0127-8) > 10 mL in 1 VIAL",
"NDC11Code": "55154-0127-08",
"ProductNDC": "55154-0127",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sterile Water",
"NonProprietaryName": "Water",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS",
"StartMarketingDate": "20110915",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018801",
"LabelerName": "Cardinal Health",
"SubstanceName": "WATER",
"StrengthNumber": "1",
"StrengthUnit": "mL/mL",
"Status": "Deprecated",
"LastUpdate": "2019-06-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20110915",
"EndMarketingDatePackage": "20190531",
"SamplePackage": "N"
},
{
"NDCCode": "55154-0132-8",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 BAG (55154-0132-8) > 20 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "55154-0132-08",
"ProductNDC": "55154-0132",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine Hydrochloride And Epinephrine",
"NonProprietaryName": "Lidocaine Hydrochloride Anhydrous And Epinephrine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INFILTRATION",
"StartMarketingDate": "20100405",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA089644",
"LabelerName": "Cardinal Health",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE; EPINEPHRINE",
"StrengthNumber": "10; 10",
"StrengthUnit": "mg/mL; ug/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-11-21",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "55154-0147-8",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 BAG (55154-0147-8) > 30 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "55154-0147-08",
"ProductNDC": "55154-0147",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine Hydrochloride",
"NonProprietaryName": "Lidocaine Hydrochloride Anhydrous",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL",
"StartMarketingDate": "20100330",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088329",
"LabelerName": "Cardinal Health",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2019-02-06",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "55154-0149-8",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 BAG (55154-0149-8) > 2 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "55154-0149-08",
"ProductNDC": "55154-0149",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ketorolac Tromethamine",
"NonProprietaryName": "Ketorolac Tromethamine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20110727",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074802",
"LabelerName": "Cardinal Health",
"SubstanceName": "KETOROLAC TROMETHAMINE",
"StrengthNumber": "60",
"StrengthUnit": "mg/2mL",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20110727",
"EndMarketingDatePackage": "20190831",
"SamplePackage": "N"
},
{
"NDCCode": "55154-0155-8",
"PackageDescription": "1 PACKET in 1 BAG (55154-0155-8) > .9 g in 1 PACKET",
"NDC11Code": "55154-0155-08",
"ProductNDC": "55154-0155",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bacitracin Zinc",
"NonProprietaryName": "Bacitracin Zinc",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110602",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333B",
"LabelerName": "Cardinal Health",
"SubstanceName": "BACITRACIN ZINC",
"StrengthNumber": "500",
"StrengthUnit": "[USP'U]/g",
"Status": "Deprecated",
"LastUpdate": "2017-12-27",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "55154-0218-8",
"PackageDescription": "2200 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55154-0218-8) ",
"NDC11Code": "55154-0218-08",
"ProductNDC": "55154-0218",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Premarin",
"NonProprietaryName": "Conjugated Estrogens",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20060101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA004782",
"LabelerName": "Cardinal Health",
"SubstanceName": "ESTROGENS, CONJUGATED",
"StrengthNumber": ".45",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-01-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "55154-0219-8",
"PackageDescription": "1400 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55154-0219-8) ",
"NDC11Code": "55154-0219-08",
"ProductNDC": "55154-0219",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Premarin",
"NonProprietaryName": "Conjugated Estrogens",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20060101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA004782",
"LabelerName": "Cardinal Health",
"SubstanceName": "ESTROGENS, CONJUGATED",
"StrengthNumber": ".9",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-01-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "55154-0256-8",
"PackageDescription": "2520 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55154-0256-8) ",
"NDC11Code": "55154-0256-08",
"ProductNDC": "55154-0256",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trintellix",
"NonProprietaryName": "Vortioxetine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20131002",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204447",
"LabelerName": "Cardinal Health 107, LLC",
"SubstanceName": "VORTIOXETINE HYDROBROMIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-02-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20131002",
"SamplePackage": "N",
"IndicationAndUsage": "TRINTELLIX is indicated for the treatment of major depressive disorder (MDD) in adults.",
"Description": "TRINTELLIX is an immediate-release tablet for oral administration that contains the beta (β) polymorph of vortioxetine hydrobromide (HBr), an antidepressant. Vortioxetine HBr is known chemically as 1-[2-(2,4-Dimethyl-phenylsulfanyl)-phenyl]-piperazine, hydrobromide. The empirical formula is C18 H22 N2 S, HBr with a molecular weight of 379.36 g/mol. The structural formula is. Vortioxetine HBr is a white to very slightly beige powder that is slightly soluble in water. Each TRINTELLIX tablet contains 6.355 mg, 12.71 mg or 25.42 mg of vortioxetine HBr equivalent to 5 mg, 10 mg, or 20 mg of vortioxetine, respectively. The inactive ingredients in TRINTELLIX tablets include mannitol, microcrystalline cellulose, hydroxypropyl cellulose, sodium starch glycolate, magnesium stearate and film coating which consists of hypromellose, titanium dioxide, polyethylene glycol 400, iron oxide red (5 mg and 20 mg) and iron oxide yellow (10 mg)."
},
{
"NDCCode": "55154-0257-8",
"PackageDescription": "2430 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55154-0257-8) ",
"NDC11Code": "55154-0257-08",
"ProductNDC": "55154-0257",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Trintellix",
"NonProprietaryName": "Vortioxetine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20131002",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204447",
"LabelerName": "Cardinal Health 107, LLC",
"SubstanceName": "VORTIOXETINE HYDROBROMIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-02-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20131002",
"SamplePackage": "N",
"IndicationAndUsage": "TRINTELLIX is indicated for the treatment of major depressive disorder (MDD) in adults.",
"Description": "TRINTELLIX is an immediate-release tablet for oral administration that contains the beta (β) polymorph of vortioxetine hydrobromide (HBr), an antidepressant. Vortioxetine HBr is known chemically as 1-[2-(2,4-Dimethyl-phenylsulfanyl)-phenyl]-piperazine, hydrobromide. The empirical formula is C18 H22 N2 S, HBr with a molecular weight of 379.36 g/mol. The structural formula is. Vortioxetine HBr is a white to very slightly beige powder that is slightly soluble in water. Each TRINTELLIX tablet contains 6.355 mg, 12.71 mg or 25.42 mg of vortioxetine HBr equivalent to 5 mg, 10 mg, or 20 mg of vortioxetine, respectively. The inactive ingredients in TRINTELLIX tablets include mannitol, microcrystalline cellulose, hydroxypropyl cellulose, sodium starch glycolate, magnesium stearate and film coating which consists of hypromellose, titanium dioxide, polyethylene glycol 400, iron oxide red (5 mg and 20 mg) and iron oxide yellow (10 mg)."
},
{
"NDCCode": "55154-0328-8",
"PackageDescription": "10 BLISTER PACK in 1 BAG (55154-0328-8) > 1 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "55154-0328-08",
"ProductNDC": "55154-0328",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ondansetron",
"NonProprietaryName": "Ondansetron",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070625",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077851",
"LabelerName": "Cardinal Health",
"SubstanceName": "ONDANSETRON HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-03-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "55154-0375-8",
"PackageDescription": "1 VIAL in 1 BAG (55154-0375-8) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL",
"NDC11Code": "55154-0375-08",
"ProductNDC": "55154-0375",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ceftriaxone",
"NonProprietaryName": "Ceftriaxone",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20090722",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065465",
"LabelerName": "Cardinal Health",
"SubstanceName": "CEFTRIAXONE SODIUM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-12-20",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20171231"
}
]
}
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<NDCList>
<NDC>
<NDCCode>55154-0748-8</NDCCode>
<PackageDescription>2052 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (55154-0748-8)</PackageDescription>
<NDC11Code>55154-0748-08</NDC11Code>
<ProductNDC>55154-0748</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aspirin</ProprietaryName>
<NonProprietaryName>Aspirin</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110523</StartMarketingDate>
<EndMarketingDate>20180731</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>ASPIRIN</SubstanceName>
<StrengthNumber>81</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-07-31</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
</NDC>
<NDC>
<NDCCode>55154-0748-9</NDCCode>
<PackageDescription>6 BLISTER PACK in 1 CARTON (55154-0748-9) > 5 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>55154-0748-09</NDC11Code>
<ProductNDC>55154-0748</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aspirin</ProprietaryName>
<NonProprietaryName>Aspirin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110523</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>ASPIRIN</SubstanceName>
<StrengthNumber>81</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-04-22</LastUpdate>
</NDC>
<NDC>
<NDCCode>58232-0748-8</NDCCode>
<PackageDescription>227 g in 1 TUBE (58232-0748-8)</PackageDescription>
<NDC11Code>58232-0748-08</NDC11Code>
<ProductNDC>58232-0748</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lubriderm</ProprietaryName>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Oxybenzone And Octocrylene</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100330</StartMarketingDate>
<EndMarketingDate>20160701</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc.</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OXYBENZONE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>30; 60; 50; 50; 35.5</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g; mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>68788-0748-8</NDCCode>
<PackageDescription>28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-0748-8) </PackageDescription>
<NDC11Code>68788-0748-08</NDC11Code>
<ProductNDC>68788-0748</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amitriptyline Hydrochloride</ProprietaryName>
<NonProprietaryName>Amitriptyline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110609</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040218</ApplicationNumber>
<LabelerName>Preferred Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>AMITRIPTYLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-05-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110609</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>43598-748-11</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (43598-748-11) / 5 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>43598-0748-11</NDC11Code>
<ProductNDC>43598-748</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Timolol Maleate Ophthalmic Gel Forming Solution 0.5%</ProprietaryName>
<NonProprietaryName>Timolol Maleate Ophthalmic Gel Forming Solution 0.5%</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20221115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215733</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories, Inc.</LabelerName>
<SubstanceName>TIMOLOL MALEATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Timolol maleate ophthalmic gel forming solution is indicated in the treatment of elevatedintraocular pressure in patients with ocular hypertension or open-angle glaucoma.</IndicationAndUsage>
<Description>Timolol maleate ophthalmic gel forming solution is a non-selective beta adrenergic receptor blocking agent. Its chemical name is (-)-1-(tert-butylamino)-3-[(4 morpholino-1,2,5-thiadiazol-3-yl)oxy]-2-propanol maleate (1:1) (salt). Timolol maleate possesses an asymmetric carbon atom in its structure and is provided as the levo-isomer. The optical rotation of timolol maleate is. 25°. [α] in 1.0N HCl (C = 5%) = -12.2° (-11.7° to -12.5°). 405 nm. Its molecular formula is C13H24N4O3SC4H4O4 and its structural formula is. Timolol maleate, USP has a molecular weight of 432.49. It is a white to practically white powder, which is soluble in water, methanol, and ethanol. Timolol maleate ophthalmic gel forming solution is supplied as a sterile, isotonic, buffered, aqueous solution of timolol maleate in two dosage strengths. The pH of the solution is 6.5 to 7.5, and the osmolality is 260-330 mOsmol/kg. Each mL of timolol maleate ophthalmic gel forming solution 0.25% contains 2.5 mg of timolol (3.4 mg of timolol maleate USP). Each mL of timolol maleate ophthalmic gel forming solution 0.5% contains 5 mg of timolol (6.8 mg of timolol maleate USP). Inactive ingredients: gellan gum, tromethamine, mannitol and water for injection. Preservative: benzododecinium bromide 0.012%. The gel forming solution contains a purified anionic heteropolysaccharide derived from gellan gum. An aqueous solution of gellan gum, in the presence of a cation, has the ability to gel. Upon contact with the precorneal tear film, timolol maleate ophthalmic gel forming solution forms a gel that is subsequently removed by the flow of tears.</Description>
</NDC>
<NDC>
<NDCCode>53808-0748-1</NDCCode>
<PackageDescription>30 TABLET in 1 BLISTER PACK (53808-0748-1)</PackageDescription>
<NDC11Code>53808-0748-01</NDC11Code>
<ProductNDC>53808-0748</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Paroxetine</ProprietaryName>
<NonProprietaryName>Paroxetine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075356</ApplicationNumber>
<LabelerName>State of Florida DOH Central Pharmacy</LabelerName>
<SubstanceName>PAROXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<Description>Paroxetine hydrochloride is an orally administered psychotropic drug. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)-trans-4R-(4'-fluorophenyl)-3S-[(3',4'-methylenedioxyphenoxy) methyl] piperidine hydrochloride anhydrous and has the empirical formula of C19H20FNO3HCl. The molecular weight is 365.8 (anhydrous) (329.4 as free base). The structural formula of paroxetine hydrochloride is. Paroxetine hydrochloride is an odorless, off-white powder, having a melting point range of 116° to 120°C and a solubility of 5.4 mg/mL in water. Each film-coated tablet, for oral administration, contains paroxetine hydrochloride equivalent to paroxetine as follows: 10 mg; 20 mg; 30 mg; 40 mg. Inactive ingredients consist of anhydrous lactose, hydroxypropyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, sodium starch glycolate and titanium dioxide. Paroxetine tablets USP comply with USP Related Impurities Test 1.</Description>
</NDC>
<NDC>
<NDCCode>55700-748-05</NDCCode>
<PackageDescription>5 POUCH in 1 CARTON (55700-748-05) / 1 PATCH in 1 POUCH / 72 h in 1 PATCH</PackageDescription>
<NDC11Code>55700-0748-05</NDC11Code>
<ProductNDC>55700-748</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fentanyl</ProprietaryName>
<NonProprietaryName>Fentanyl</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20190517</StartMarketingDate>
<EndMarketingDate>20260228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077449</ApplicationNumber>
<LabelerName>Quality Care Products, LLC</LabelerName>
<SubstanceName>FENTANYL</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>ug/h</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2026-03-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190517</StartMarketingDatePackage>
<EndMarketingDatePackage>20260228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fentanyl transdermal system is indicated for the management of pain in opioid-tolerant patients, severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Patients considered opioid-tolerant are those who are taking, for one week or longer, at least 60 mg morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid. Limitations of Use: 1 Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release/long-acting opioid formulations [see Warnings and Precautions ( 5.1)] , reserve fentanyl transdermal system for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. , 2 Fentanyl transdermal system is not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
<Description>Fentanyl transdermal system contains fentanyl, an opioid agonist, for transdermal administration. The amount of fentanyl released from each system per hour is proportional to the surface area (25 mcg/hour per 10.5 cm 2). The composition per unit area of all transdermal system sizes is identical. * Nominal delivery rate per hour. ** Nominal delivery rate is 12.5 mcg/hour. The molecular weight of fentanyl base is 336.5 g/mol, and the empirical formula is C 22H 28N 2O. The n-octanol: water partition coefficient is 860:1. The pKa is 8.4. The chemical name is N-phenyl-N-(1-(2-phenylethyl)-4-piperidinyl) propanamide. The structural formula is. Fentanyl transdermal system is a rectangular transparent unit comprising a release liner and two functional layers. Proceeding from the outer surface toward the surface adhering to skin, these layers are. 1) a backing layer of polyethylene terephalate film; 2) a drug-in-adhesive layer. Before use, a release liner covering the drug-in-adhesive layer is removed and discarded.</Description>
</NDC>
<NDC>
<NDCCode>60429-748-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (60429-748-01) </PackageDescription>
<NDC11Code>60429-0748-01</NDC11Code>
<ProductNDC>60429-748</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sotalol Hydrochloride</ProprietaryName>
<NonProprietaryName>Sotalol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020926</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076140</ApplicationNumber>
<LabelerName>Golden State Medical Supply, Inc.</LabelerName>
<SubstanceName>SOTALOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], Antiarrhythmic [EPC], Cardiac Rhythm Alteration [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20030201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Sotalol hydrochloride/Sotalol hydrochloride AF tablets, USP contains sotalol hydrochloride, an antiarrhythmic drug with Class II (beta-adrenoreceptor blocking) and Class III (cardiac action potential duration prolongation) properties. Sotalol hydrochloride tablets, USP are supplied as a white to off-white, capsule-shaped, scored tablet for oral administration. Sotalol hydrochloride AF is supplied as a white to off-white, capsule-shaped, scored tablet for oral administration. Sotalol hydrochloride is a white, crystalline solid with a molecular weight of 308.8 g/mol. It is hydrophilic, soluble in water, propylene glycol and ethanol, but is only slightly soluble in chloroform. Chemically, sotalol hydrochloride is d,l- N-[4-[1-hydroxy-2-[(1-methylethyl) amino]ethyl]phenyl]methane-sulfonamide monohydrochloride. The molecular formula is C 12H 20N 2O 3S∙HCl and is represented by the following structural formula:. Each Sotalol Hydrochloride tablet, USP/Sotalol Hydrochloride AF tablets, USP for oral administration, contains 80 mg, 120 mg, 160 mg or 240 mg of sotalol hydrochloride. In addition, each tablet also contains the following inactive ingredients: magnesium stearate and microcrystalline cellulose.</Description>
</NDC>
<NDC>
<NDCCode>60760-748-07</NDCCode>
<PackageDescription>7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-748-07) </PackageDescription>
<NDC11Code>60760-0748-07</NDC11Code>
<ProductNDC>60760-748</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tivicay</ProprietaryName>
<NonProprietaryName>Dolutegravir Sodium</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130813</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204790</ApplicationNumber>
<LabelerName>ST. MARY'S MEDICAL PARK PHARMACY</LabelerName>
<SubstanceName>DOLUTEGRAVIR SODIUM</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HIV Integrase Inhibitors [MoA], Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC], Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260116</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TIVICAY and TIVICAY PD are indicated in combination with other antiretroviral agents for the treatment of HIV‑1 infection in adults (treatment-naïve or -experienced) and in pediatric patients (treatment-naïve or -experienced but integrase strand transfer inhibitor [INSTI]-naïve) aged at least 4 weeks and weighing at least 3 kg [see Microbiology ( 12.4)]. TIVICAY is indicated in combination with rilpivirine as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies/ mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure or known substitutions associated with resistance to either antiretroviral agent.</IndicationAndUsage>
<Description>TIVICAY contains dolutegravir, as dolutegravir sodium, an HIV INSTI. The chemical name of dolutegravir sodium is sodium (4 R,12a S)-9-{[(2,4-difluorophenyl)methyl]carbamoyl}-4-methyl-6,8-dioxo-3,4,6,8,12,12a-hexahydro-2 H-pyrido[1',2':4,5]pyrazino[2,1- b][1,3]oxazin-7-olate. The empirical formula is C 20H 18F 2N 3NaO 5,and the molecular weight is 441.36 g/mol. It has the following structural formula:. Dolutegravir sodium is a white to light yellow powder and is slightly soluble in water. Each film-coated tablet of TIVICAY for oral administration contains 10.5, 26.3, or 52.6 mg of dolutegravir sodium, which is equivalent to 10, 25, or 50 mg dolutegravir free acid, respectively, and the following inactive ingredients: D-mannitol, microcrystalline cellulose, povidone K29/32, sodium starch glycolate, and sodium stearyl fumarate. The tablet film‑coating contains the inactive ingredients iron oxide yellow (25-mg and 50-mg tablets only), macrogol/PEG, polyvinyl alcohol-part hydrolyzed, talc, and titanium dioxide. Each TIVICAY PD tablet for oral suspension contains 5.26 mg of dolutegravir sodium, which is equivalent to 5 mg dolutegravir free acid, and the following inactive ingredients: calcium sulfate dihydrate, crospovidone, mannitol, microcrystalline cellulose, povidone K29/32, silicified microcrystalline cellulose, sodium starch glycolate, strawberry cream flavor, sucralose, and sodium stearyl fumarate. The tablet film-coating contains hypromellose, polyethylene glycol, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>66302-748-04</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 KIT (66302-748-04) / 4 BLISTER PACK in 1 BLISTER PACK / 4 INHALANT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>66302-0748-04</NDC11Code>
<ProductNDC>66302-748</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tyvaso Dpi</ProprietaryName>
<NonProprietaryName>Treprostinil</NonProprietaryName>
<DosageFormName>INHALANT</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220523</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA214324</ApplicationNumber>
<LabelerName>United Therapeutics Corporation</LabelerName>
<SubstanceName>TREPROSTINIL</SubstanceName>
<StrengthNumber>48</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Prostacycline Vasodilator [EPC], Prostaglandins I [CS], Vasodilation [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220523</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tyvaso DPI is a prostacyclin mimetic indicated for the treatment of: 1 Pulmonary arterial hypertension (PAH; WHO Group 1) to improve exercise ability. Studies with Tyvaso establishing effectiveness predominately included patients with NYHA Functional Class III symptoms and etiologies of idiopathic or heritable PAH (56%) or PAH associated with connective tissue diseases (33%). (1.1), 2 Pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability. The study with Tyvaso establishing effectiveness predominately included patients with etiologies of idiopathic interstitial pneumonia (IIP) (45%) inclusive of idiopathic pulmonary fibrosis (IPF), combined pulmonary fibrosis and emphysema (CPFE) (25%), and WHO Group 3 connective tissue disease (22%). (1.2).</IndicationAndUsage>
<Description>Tyvaso DPI consists of single-dose plastic cartridges filled with a white powder containing 1% of treprostinil, a prostacyclin mimetic, which is intended for administration by oral inhalation using the Tyvaso DPI Inhaler only. Treprostinil is adsorbed onto carrier particles consisting of fumaryl diketopiperazine (FDKP). Each cartridge contains 16 mcg, 32 mcg, 48 mcg, 64 mcg, or 80 mcg of treprostinil with approximate fill weights of 1.6 mg, 3.2 mg, 4.8 mg, 6.4 mg, or 8.0 mg of Tyvaso DPI, respectively. Treprostinil is (1R,2R,3aS,9aS)-[[2,3,3a,4,9,9a-hexahydro-2-hydroxy-1-[(3S)-3-hydroxyoctyl]-1H-benz[f]inden-5-yl]oxy]acetic acid. Treprostinil has a molecular weight of 390.52 and a molecular formula of C23H34O5. The structural formula of treprostinil is.</Description>
</NDC>
<NDC>
<NDCCode>67877-748-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (67877-748-01) </PackageDescription>
<NDC11Code>67877-0748-01</NDC11Code>
<ProductNDC>67877-748</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sirolimus</ProprietaryName>
<NonProprietaryName>Sirolimus</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210313</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214753</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>SIROLIMUS</SubstanceName>
<StrengthNumber>2</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>Active</Status>
<LastUpdate>2025-10-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210313</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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>
</NDC>
<NDC>
<NDCCode>67877-748-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (67877-748-05) </PackageDescription>
<NDC11Code>67877-0748-05</NDC11Code>
<ProductNDC>67877-748</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sirolimus</ProprietaryName>
<NonProprietaryName>Sirolimus</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210313</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214753</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>SIROLIMUS</SubstanceName>
<StrengthNumber>2</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>Active</Status>
<LastUpdate>2025-10-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210313</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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>
</NDC>
<NDC>
<NDCCode>67877-748-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (67877-748-30) </PackageDescription>
<NDC11Code>67877-0748-30</NDC11Code>
<ProductNDC>67877-748</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sirolimus</ProprietaryName>
<NonProprietaryName>Sirolimus</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210313</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214753</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>SIROLIMUS</SubstanceName>
<StrengthNumber>2</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>Active</Status>
<LastUpdate>2025-10-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210313</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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>
</NDC>
<NDC>
<NDCCode>67877-748-38</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (67877-748-38) / 10 TABLET, FILM COATED in 1 BLISTER PACK (67877-748-33) </PackageDescription>
<NDC11Code>67877-0748-38</NDC11Code>
<ProductNDC>67877-748</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sirolimus</ProprietaryName>
<NonProprietaryName>Sirolimus</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210313</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214753</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>SIROLIMUS</SubstanceName>
<StrengthNumber>2</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>Active</Status>
<LastUpdate>2025-10-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210313</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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>
</NDC>
<NDC>
<NDCCode>68308-748-08</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (68308-748-08) / 8 INSERT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>68308-0748-08</NDC11Code>
<ProductNDC>68308-748</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Imvexxy</ProprietaryName>
<NonProprietaryName>Estradiol</NonProprietaryName>
<DosageFormName>INSERT</DosageFormName>
<RouteName>VAGINAL</RouteName>
<StartMarketingDate>20231215</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208564</ApplicationNumber>
<LabelerName>Mayne Pharma</LabelerName>
<SubstanceName>ESTRADIOL</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250110</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>IMVEXXY is an estrogen indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. (1).</IndicationAndUsage>
<Description>IMVEXXY (estradiol vaginal inserts) are small, light pink, tear-shaped, vaginal inserts for manual placement into the vagina. Inserts contain 4 mcg or 10 mcg of estradiol, an estrogen. Each insert is imprinted in white ink on one side with "04" or "10" corresponding to the insert's dosage strength. IMVEXXY vaginal inserts are used intravaginally. When the insert comes in contact with the vaginal mucosa, estradiol is released into the vagina. Estradiol is chemically described as estra-1,3,5 (10)-triene-3,17β-diol. The chemical formula is C18H24O2 with a molecular weight of 272.38. The structural formula is. IMVEXXY (estradiol vaginal inserts) contain the following inactive ingredients: ammonium hydroxide, ethanol, ethyl acetate, ethylene glycol palmitostearate, FD&C Red #40, gelatin, glycerin, isopropyl alcohol, lecithin, medium chain triglycerides, polyethylene glycol, polyethylene glycol stearates, polyvinyl acetate phthalate, propylene glycol, purified water, sorbitol-sorbitan solution, and titanium dioxide. FDA approved acceptance criteria for assay, organic impurities, and dissolution tolerances differ from the USP test.</Description>
</NDC>
<NDC>
<NDCCode>55154-0103-8</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 BAG (55154-0103-8) > 20 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>55154-0103-08</NDC11Code>
<ProductNDC>55154-0103</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Chloride</ProprietaryName>
<NonProprietaryName>Sodium Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20050228</StartMarketingDate>
<EndMarketingDate>20191130</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018803</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>SODIUM CHLORIDE</SubstanceName>
<StrengthNumber>9</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-12-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20050228</StartMarketingDatePackage>
<EndMarketingDatePackage>20191130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>55154-0119-8</NDCCode>
<PackageDescription>1 VIAL in 1 BAG (55154-0119-8) > 50 mL in 1 VIAL</PackageDescription>
<NDC11Code>55154-0119-08</NDC11Code>
<ProductNDC>55154-0119</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Bicarbonate</ProprietaryName>
<NonProprietaryName>Sodium Bicarbonate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19850418</StartMarketingDate>
<EndMarketingDate>20190731</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>SODIUM BICARBONATE</SubstanceName>
<StrengthNumber>84</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-08-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19850418</StartMarketingDatePackage>
<EndMarketingDatePackage>20190731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>55154-0120-8</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 BAG (55154-0120-8) > 1 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>55154-0120-08</NDC11Code>
<ProductNDC>55154-0120</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ketorolac Tromethamine</ProprietaryName>
<NonProprietaryName>Ketorolac Tromethamine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20110727</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074802</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>KETOROLAC TROMETHAMINE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-11-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110727</StartMarketingDatePackage>
<EndMarketingDatePackage>20191031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>55154-0124-8</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 BAG (55154-0124-8) > 20 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>55154-0124-08</NDC11Code>
<ProductNDC>55154-0124</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine Hydrochloride</ProprietaryName>
<NonProprietaryName>Lidocaine Hydrochloride Anhydrous</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INFILTRATION</RouteName>
<StartMarketingDate>20100330</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088299</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-12-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100330</StartMarketingDatePackage>
<EndMarketingDatePackage>20191130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>55154-0127-8</NDCCode>
<PackageDescription>1 VIAL in 1 BAG (55154-0127-8) > 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>55154-0127-08</NDC11Code>
<ProductNDC>55154-0127</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sterile Water</ProprietaryName>
<NonProprietaryName>Water</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20110915</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018801</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>WATER</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-06-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110915</StartMarketingDatePackage>
<EndMarketingDatePackage>20190531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>55154-0132-8</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 BAG (55154-0132-8) > 20 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>55154-0132-08</NDC11Code>
<ProductNDC>55154-0132</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine Hydrochloride And Epinephrine</ProprietaryName>
<NonProprietaryName>Lidocaine Hydrochloride Anhydrous And Epinephrine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INFILTRATION</RouteName>
<StartMarketingDate>20100405</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA089644</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE; EPINEPHRINE</SubstanceName>
<StrengthNumber>10; 10</StrengthNumber>
<StrengthUnit>mg/mL; ug/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-11-21</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>55154-0147-8</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 BAG (55154-0147-8) > 30 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>55154-0147-08</NDC11Code>
<ProductNDC>55154-0147</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine Hydrochloride</ProprietaryName>
<NonProprietaryName>Lidocaine Hydrochloride Anhydrous</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL</RouteName>
<StartMarketingDate>20100330</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088329</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-02-06</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>55154-0149-8</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 BAG (55154-0149-8) > 2 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>55154-0149-08</NDC11Code>
<ProductNDC>55154-0149</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ketorolac Tromethamine</ProprietaryName>
<NonProprietaryName>Ketorolac Tromethamine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20110727</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074802</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>KETOROLAC TROMETHAMINE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/2mL</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110727</StartMarketingDatePackage>
<EndMarketingDatePackage>20190831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>55154-0155-8</NDCCode>
<PackageDescription>1 PACKET in 1 BAG (55154-0155-8) > .9 g in 1 PACKET</PackageDescription>
<NDC11Code>55154-0155-08</NDC11Code>
<ProductNDC>55154-0155</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bacitracin Zinc</ProprietaryName>
<NonProprietaryName>Bacitracin Zinc</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110602</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333B</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>BACITRACIN ZINC</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>[USP'U]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-12-27</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>55154-0218-8</NDCCode>
<PackageDescription>2200 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55154-0218-8) </PackageDescription>
<NDC11Code>55154-0218-08</NDC11Code>
<ProductNDC>55154-0218</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Premarin</ProprietaryName>
<NonProprietaryName>Conjugated Estrogens</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA004782</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>ESTROGENS, CONJUGATED</SubstanceName>
<StrengthNumber>.45</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-01-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>55154-0219-8</NDCCode>
<PackageDescription>1400 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55154-0219-8) </PackageDescription>
<NDC11Code>55154-0219-08</NDC11Code>
<ProductNDC>55154-0219</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Premarin</ProprietaryName>
<NonProprietaryName>Conjugated Estrogens</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA004782</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>ESTROGENS, CONJUGATED</SubstanceName>
<StrengthNumber>.9</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Estrogen [EPC],Estrogen Receptor Agonists [MoA],Estrogens, Conjugated (USP) [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-01-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>55154-0256-8</NDCCode>
<PackageDescription>2520 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55154-0256-8) </PackageDescription>
<NDC11Code>55154-0256-08</NDC11Code>
<ProductNDC>55154-0256</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Trintellix</ProprietaryName>
<NonProprietaryName>Vortioxetine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131002</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204447</ApplicationNumber>
<LabelerName>Cardinal Health 107, LLC</LabelerName>
<SubstanceName>VORTIOXETINE HYDROBROMIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-02-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131002</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TRINTELLIX is indicated for the treatment of major depressive disorder (MDD) in adults.</IndicationAndUsage>
<Description>TRINTELLIX is an immediate-release tablet for oral administration that contains the beta (β) polymorph of vortioxetine hydrobromide (HBr), an antidepressant. Vortioxetine HBr is known chemically as 1-[2-(2,4-Dimethyl-phenylsulfanyl)-phenyl]-piperazine, hydrobromide. The empirical formula is C18 H22 N2 S, HBr with a molecular weight of 379.36 g/mol. The structural formula is. Vortioxetine HBr is a white to very slightly beige powder that is slightly soluble in water. Each TRINTELLIX tablet contains 6.355 mg, 12.71 mg or 25.42 mg of vortioxetine HBr equivalent to 5 mg, 10 mg, or 20 mg of vortioxetine, respectively. The inactive ingredients in TRINTELLIX tablets include mannitol, microcrystalline cellulose, hydroxypropyl cellulose, sodium starch glycolate, magnesium stearate and film coating which consists of hypromellose, titanium dioxide, polyethylene glycol 400, iron oxide red (5 mg and 20 mg) and iron oxide yellow (10 mg).</Description>
</NDC>
<NDC>
<NDCCode>55154-0257-8</NDCCode>
<PackageDescription>2430 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55154-0257-8) </PackageDescription>
<NDC11Code>55154-0257-08</NDC11Code>
<ProductNDC>55154-0257</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Trintellix</ProprietaryName>
<NonProprietaryName>Vortioxetine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131002</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204447</ApplicationNumber>
<LabelerName>Cardinal Health 107, LLC</LabelerName>
<SubstanceName>VORTIOXETINE HYDROBROMIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-02-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131002</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TRINTELLIX is indicated for the treatment of major depressive disorder (MDD) in adults.</IndicationAndUsage>
<Description>TRINTELLIX is an immediate-release tablet for oral administration that contains the beta (β) polymorph of vortioxetine hydrobromide (HBr), an antidepressant. Vortioxetine HBr is known chemically as 1-[2-(2,4-Dimethyl-phenylsulfanyl)-phenyl]-piperazine, hydrobromide. The empirical formula is C18 H22 N2 S, HBr with a molecular weight of 379.36 g/mol. The structural formula is. Vortioxetine HBr is a white to very slightly beige powder that is slightly soluble in water. Each TRINTELLIX tablet contains 6.355 mg, 12.71 mg or 25.42 mg of vortioxetine HBr equivalent to 5 mg, 10 mg, or 20 mg of vortioxetine, respectively. The inactive ingredients in TRINTELLIX tablets include mannitol, microcrystalline cellulose, hydroxypropyl cellulose, sodium starch glycolate, magnesium stearate and film coating which consists of hypromellose, titanium dioxide, polyethylene glycol 400, iron oxide red (5 mg and 20 mg) and iron oxide yellow (10 mg).</Description>
</NDC>
<NDC>
<NDCCode>55154-0328-8</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 BAG (55154-0328-8) > 1 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>55154-0328-08</NDC11Code>
<ProductNDC>55154-0328</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ondansetron</ProprietaryName>
<NonProprietaryName>Ondansetron</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070625</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077851</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>ONDANSETRON HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-03-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>55154-0375-8</NDCCode>
<PackageDescription>1 VIAL in 1 BAG (55154-0375-8) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL</PackageDescription>
<NDC11Code>55154-0375-08</NDC11Code>
<ProductNDC>55154-0375</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ceftriaxone</ProprietaryName>
<NonProprietaryName>Ceftriaxone</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20090722</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065465</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>CEFTRIAXONE SODIUM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-12-20</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
</NDCList>