{
"NDC": [
{
"NDCCode": "65923-564-20",
"PackageDescription": "20 PATCH in 1 PACKAGE (65923-564-20) / 1 g in 1 PATCH",
"NDC11Code": "65923-0564-20",
"ProductNDC": "65923-564",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Coralite Pain Relief",
"NonProprietaryName": "Camphor, Menthol, Methyl Salicylate",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160412",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "United Exchange Corp.",
"SubstanceName": "CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE",
"StrengthNumber": "1.2; 5.7; 6.3",
"StrengthUnit": "g/100g; g/100g; g/100g",
"Status": "Active",
"LastUpdate": "2025-10-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180412",
"SamplePackage": "N",
"IndicationAndUsage": "Directions. adults and children 12 years of age and over: 1 clean and dry affected area, 2 remove patch from film, 3 apply to affected area not more than 3 to 4 times daily, 4 do not wear patch for more than 4 hours, 5 children under 12 years of age: consult a doctor."
},
{
"NDCCode": "52125-564-01",
"PackageDescription": "20 mL in 1 VIAL, SINGLE-DOSE (52125-564-01)",
"NDC11Code": "52125-0564-01",
"ProductNDC": "52125-564",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Chloride",
"NonProprietaryName": "Sodium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20130501",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018803",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "SODIUM CHLORIDE",
"StrengthNumber": "9",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2017-01-10"
},
{
"NDCCode": "52125-564-03",
"PackageDescription": "20 mL in 1 VIAL, SINGLE-DOSE (52125-564-03)",
"NDC11Code": "52125-0564-03",
"ProductNDC": "52125-564",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Chloride",
"NonProprietaryName": "Sodium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20131202",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018803",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "SODIUM CHLORIDE",
"StrengthNumber": "9",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2017-01-10"
},
{
"NDCCode": "60760-564-20",
"PackageDescription": "20 TABLET in 1 BOTTLE, PLASTIC (60760-564-20) ",
"NDC11Code": "60760-0564-20",
"ProductNDC": "60760-564",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Naproxen",
"NonProprietaryName": "Naproxen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220622",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212517",
"LabelerName": "St. Mary's Medical Park Pharmacy",
"SubstanceName": "NAPROXEN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220622",
"SamplePackage": "N",
"IndicationAndUsage": "Naproxen Tablets are indicated for: the relief of the signs and symptoms of: : 1 rheumatoid arthritis, 2 osteoarthritis, 3 ankylosing spondylitis, 4 polyarticular juvenile idiopathic arthritis, 5 tendonitis, 6 bursitis , 7 acute gout.",
"Description": "Naproxen tablets, USP are nonsteroidal anti-inflammatory drugs and available as follows: Naproxen tablets, USP are available as light yellow round shaped tablets containing 250 mg naproxen, light yellow capsule shaped tablets containing 375 mg naproxen, and light yellow oblong shaped tablets containing 500 mg naproxen for oral administration. Naproxen is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical name for naproxen is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen has a molecular weight of 230.26 and a molecular formula of C 14H 14O 3. It has the following structural formula:. Naproxen is white or almost white crystalline powder. It is insoluble in water, soluble in chloroform, dehydrated ethanol and methanol. Sparingly soluble in ether. The octanol/water partition coefficient of Naproxen at pH < 2.18 is 3.18. Each naproxen tablet, USP contains the following inactive ingredients: croscarmellose sodium, yellow iron oxide, povidone and magnesium stearate."
},
{
"NDCCode": "65219-564-20",
"PackageDescription": "1 VIAL in 1 CARTON (65219-564-20) / 10 mL in 1 VIAL",
"NDC11Code": "65219-0564-20",
"ProductNDC": "65219-564",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mitomycin",
"NonProprietaryName": "Mitomycin",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20230115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA215687",
"LabelerName": "Fresenius Kabi USA, LLC",
"SubstanceName": "MITOMYCIN",
"StrengthNumber": "5",
"StrengthUnit": "mg/10mL",
"Pharm_Classes": "Alkylating Activity [MoA], Alkylating Drug [EPC]",
"Status": "Active",
"LastUpdate": "2023-01-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230115",
"SamplePackage": "N",
"IndicationAndUsage": "Mitomycin for Injection, USP is not recommended as single-agent, primary therapy. It has been shown to be useful in the therapy of disseminated adenocarcinoma of the stomach or pancreas in proven combinations with other approved chemotherapeutic agents and as palliative treatment when other modalities have failed. Mitomycin is not recommended to replace appropriate surgery and/or radiotherapy.",
"Description": "Mitomycin (also known as mitomycin and/or mitomycin-C) is an antibiotic isolated from the broth of Streptomyces caespitosus which has been shown to have antitumor activity. The compound is heat stable, has a high melting point, and is freely soluble in organic solvents. Mitomycin for Injection, USP is a sterile dry mixture of mitomycin and mannitol, which when reconstituted with Sterile Water for Injection provides a solution for intravenous administration. Each Single-Dose vial contains either mitomycin 5 mg and mannitol 10 mg or mitomycin 20 mg and mannitol 40 mg. Each mL of reconstituted solution will contain 0.5 mg mitomycin and have a pH between 6.0 and 8.0. Mitomycin is a blue-violet crystalline powder with the molecular formula of C15H18N4O5, and a molecular weight of 334.33. Its chemical name is 7-amino-9α-methoxymitosane and it has the following structural formula;."
},
{
"NDCCode": "67457-564-20",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (67457-564-20) / 20 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "67457-0564-20",
"ProductNDC": "67457-564",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Baclofen",
"NonProprietaryName": "Baclofen",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRATHECAL",
"StartMarketingDate": "20181221",
"EndMarketingDate": "20250831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209592",
"LabelerName": "Mylan Institutional LLC",
"SubstanceName": "BACLOFEN",
"StrengthNumber": "40",
"StrengthUnit": "mg/20mL",
"Pharm_Classes": "GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-09-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20181221",
"EndMarketingDatePackage": "20250831",
"SamplePackage": "N",
"IndicationAndUsage": "Baclofen injection (intrathecal) is indicated for use in the management of severe spasticity. Patients should first respond to a screening dose of intrathecal baclofen prior to consideration for long term infusion via an implantable pump. For spasticity of spinal cord origin, chronic infusion of baclofen injection (intrathecal) via an implantable pump should be reserved for patients unresponsive to oral baclofen therapy, or those who experience intolerable CNS side effects at effective doses. Patients with spasticity due to traumatic brain injury should wait at least one year after the injury before consideration of long term intrathecal baclofen therapy. Baclofen injection (intrathecal) is intended for use by the intrathecal route in single bolus test doses (via spinal catheter or lumbar puncture) and, for chronic use, only in implantable pumps approved by the FDA specifically for the administration of baclofen injection (intrathecal) into the intrathecal space. Spasticity of Spinal Cord Origin: Evidence supporting the efficacy of baclofen injection (intrathecal) was obtained in randomized, controlled investigations that compared the effects of either a single intrathecal dose or a three day intrathecal infusion of baclofen injection (intrathecal) to placebo in patients with severe spasticity and spasms due to either spinal cord trauma or multiple sclerosis. Baclofen injection (intrathecal) was superior to placebo on both principal outcome measures employed: change from baseline in the Ashworth rating of spasticity and the frequency of spasms. Spasticity of Cerebral Origin: The efficacy of baclofen injection (intrathecal) was investigated in three controlled clinical trials; two enrolled patients with cerebral palsy and one enrolled patients with spasticity due to previous brain injury. The first study, a randomized controlled cross-over trial of 51 patients with cerebral palsy, provided strong, statistically significant results; baclofen injection (intrathecal) was superior to placebo in reducing spasticity as measured by the Ashworth Scale. A second cross-over study was conducted in 11 patients with spasticity arising from brain injury. Despite the small sample size, the study yielded a nearly significant test statistic (p=0.066) and provided directionally favorable results. The last study, however, did not provide data that could be reliably analyzed. Baclofen injection (intrathecal) therapy may be considered an alternative to destructive neurosurgical procedures. Prior to implantation of a device for chronic intrathecal infusion of baclofen injection (intrathecal), patients must show a response to baclofen injection (intrathecal) in a screening trial (see Dosage and Administration).",
"Description": "Baclofen injection, USP (intrathecal) is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl) butanoic acid, and its structural formula is. Baclofen, USP is a white to off white, crystalline powder, with a molecular weight of 213.66. It is slightly soluble in water, very slightly soluble in methanol, and insoluble in chloroform. Baclofen injection, USP (intrathecal) is a sterile, clear, colorless, pyrogen-free, isotonic solution free of antioxidants, preservatives or other potentially neurotoxic additives indicated only for intrathecal administration. The drug is stable in solution at 37°C and compatible with CSF. Each milliliter of baclofen injection, USP (intrathecal) contains baclofen USP, 500 mcg or 2,000 mcg and sodium chloride 9 mg in Water for Injection; pH range is 5.0 to 7.5. Each vial is intended for SINGLE DOSE ONLY. Discard any unused portion. DO NOT AUTOCLAVE."
},
{
"NDCCode": "69842-564-20",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (69842-564-20) > 20 LOZENGE in 1 BOTTLE, PLASTIC",
"NDC11Code": "69842-0564-20",
"ProductNDC": "69842-564",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nicotine",
"NonProprietaryName": "Nicotine Polacrilex",
"DosageFormName": "LOZENGE",
"RouteName": "ORAL",
"StartMarketingDate": "20200529",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207868",
"LabelerName": "CVS Pharmacy",
"SubstanceName": "NICOTINE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]",
"Status": "Active",
"LastUpdate": "2022-11-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200529",
"SamplePackage": "N",
"IndicationAndUsage": "reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking."
},
{
"NDCCode": "65923-003-20",
"PackageDescription": "1 TUBE in 1 CARTON (65923-003-20) / 20 g in 1 TUBE",
"NDC11Code": "65923-0003-20",
"ProductNDC": "65923-003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Family Care Hemorrhoidal",
"NonProprietaryName": "Mineral Oil",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20141124",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M015",
"LabelerName": "United Exchange Corp",
"SubstanceName": "MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "140; 749; 2.5",
"StrengthUnit": "mg/100g; mg/100g; mg/100g",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20141124",
"SamplePackage": "N",
"IndicationAndUsage": "Directions: 1 adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or a soft cloth before applying ointment, 2 when first opening tube, peel back foil seal, 3 apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement, 4 intrarectal use: remove cover from applicator, attach applicator to tube, lubricate applicator well and gently insert applicator into the rectum, 5 thoroughly cleanse applicator after each use and replace cover, 6 also apply ointment to external area, 7 regular use provides continual therapy for relief of symptoms, 8 children under 12 years of age: ask a doctor ."
},
{
"NDCCode": "65923-009-20",
"PackageDescription": "1 TUBE in 1 CARTON (65923-009-20) > 20 g in 1 TUBE",
"NDC11Code": "65923-0009-20",
"ProductNDC": "65923-009",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Family Care Hemorrhoidal",
"NonProprietaryName": "Mineral Oil, Petrolatum, Phenylephrine Hcl, Shark Liver Oil",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120301",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part346",
"LabelerName": "UNITED EXCHANGE CORP.",
"SubstanceName": "MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; SHARK LIVER OIL",
"StrengthNumber": "140; 719; 2.5; 30",
"StrengthUnit": "mg/g; mg/g; mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Directions: 1 children under 12 years of age: ask a doctor , 2 adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe , 3 gently dry by patting or blotting with a tissue or a soft cloth before applying , 4 when first opening tube, remove foil seal , 5 for intrarectal use: remove protective cover form applicator and attach to tube , 6 lubricate applicator well, then gently insert applicator into the rectum , 7 thoroughly clean applicator and replace protective cover after each use , 8 apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement , 9 also apply ointment to external area."
},
{
"NDCCode": "65923-136-25",
"PackageDescription": "20 mg in 1 POUCH (65923-136-25)",
"NDC11Code": "65923-0136-25",
"ProductNDC": "65923-136",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nu Pore Acne",
"NonProprietaryName": "Salicyilc Acid",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20131204",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333D",
"LabelerName": "United Exchange Corp.",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": ".05",
"StrengthUnit": "mg/100mg",
"Status": "Deprecated",
"LastUpdate": "2017-07-11"
},
{
"NDCCode": "65923-156-20",
"PackageDescription": "20 PATCH in 1 PACKAGE (65923-156-20) > 1 g in 1 PATCH",
"NDC11Code": "65923-0156-20",
"ProductNDC": "65923-156",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Coralite Pain Relief",
"NonProprietaryName": "Dl-camphor, L-menthol, Methylsalicylate",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140326",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "United Exchange Corp.",
"SubstanceName": "CAMPHOR (SYNTHETIC); LEVOMENTHOL; METHYL SALICYLATE",
"StrengthNumber": "1.2; 5.7; 6.3",
"StrengthUnit": "g/100g; g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2018-04-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20160418",
"SamplePackage": "N"
},
{
"NDCCode": "65923-344-20",
"PackageDescription": "200 POUCH in 1 BOX (65923-344-20) > 4.5 g in 1 POUCH",
"NDC11Code": "65923-0344-20",
"ProductNDC": "65923-344",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Uec Medical Sterile Alcohol Wipes",
"NonProprietaryName": "Ispropyl Alcohol",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160219",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "United Exchange Corp.",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2019-10-31",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "65923-385-20",
"PackageDescription": "20 PATCH in 1 BOX (65923-385-20) > 2 g in 1 PATCH",
"NDC11Code": "65923-0385-20",
"ProductNDC": "65923-385",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Family Care Pain Relief",
"NonProprietaryName": "Dl-camphor, L-menthol, Methylsalicylate",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20131126",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "United Exchange Corp.",
"SubstanceName": "CAMPHOR (SYNTHETIC); LEVOMENTHOL; METHYL SALICYLATE",
"StrengthNumber": "1.2; 5.7; 6.3",
"StrengthUnit": "g/100g; g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Directions. Aduts and children 12 years of age and over: 1 clean and dry affected area, 2 remove patch from film, 3 apply to affected area no more than 3 to 4 times daily for 7 days, 4 remove patch from skin after at most 8 hours of application."
},
{
"NDCCode": "65923-390-20",
"PackageDescription": "20 PACKET in 1 BOX (65923-390-20) > .9 g in 1 PACKET",
"NDC11Code": "65923-0390-20",
"ProductNDC": "65923-390",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Uec Medical First Aid Antibiotic",
"NonProprietaryName": "Bacitracin Zinc",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160404",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333B",
"LabelerName": "United Exchange Corp.",
"SubstanceName": "BACITRACIN ZINC",
"StrengthNumber": "500",
"StrengthUnit": "[iU]/g",
"Pharm_Classes": "Decreased Cell Wall Synthesis & Repair [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20160404",
"SamplePackage": "N",
"IndicationAndUsage": "Directions: 1 clean the affected area, 2 apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily, 3 may be covered with a sterile bandage."
},
{
"NDCCode": "65923-391-20",
"PackageDescription": "20 PACKET in 1 BOX (65923-391-20) > .5 g in 1 PACKET",
"NDC11Code": "65923-0391-20",
"ProductNDC": "65923-391",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Uec Medical First Aid Antibiotic",
"NonProprietaryName": "Bacitracin Zinc, Neomycin Sulfate, And Polymyxin B Sulfate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160404",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333B",
"LabelerName": "United Exchange Corp.",
"SubstanceName": "BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE",
"StrengthNumber": "400; 3.5; 5000",
"StrengthUnit": "[iU]/g; mg/g; [iU]/g",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20160404",
"SamplePackage": "N",
"IndicationAndUsage": "Directions: 1 clean the affected area, 2 apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily, 3 may be covered with a sterile bandage."
},
{
"NDCCode": "65923-391-21",
"PackageDescription": "20 PACKET in 1 BOX (65923-391-21) > .9 g in 1 PACKET",
"NDC11Code": "65923-0391-21",
"ProductNDC": "65923-391",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Uec Medical First Aid Antibiotic",
"NonProprietaryName": "Bacitracin Zinc, Neomycin Sulfate, And Polymyxin B Sulfate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160404",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333B",
"LabelerName": "United Exchange Corp.",
"SubstanceName": "BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE",
"StrengthNumber": "400; 3.5; 5000",
"StrengthUnit": "[iU]/g; mg/g; [iU]/g",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20160404",
"SamplePackage": "N",
"IndicationAndUsage": "Directions: 1 clean the affected area, 2 apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily, 3 may be covered with a sterile bandage."
},
{
"NDCCode": "65923-393-20",
"PackageDescription": "20 PACKET in 1 BOX (65923-393-20) > .9 g in 1 PACKET",
"NDC11Code": "65923-0393-20",
"ProductNDC": "65923-393",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Uec Medical Anti-itch",
"NonProprietaryName": "Hydrocortisone",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160404",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "United Exchange Corp.",
"SubstanceName": "HYDROCORTISONE",
"StrengthNumber": "1",
"StrengthUnit": "g/100g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20160404",
"SamplePackage": "N",
"IndicationAndUsage": "Directions: 1 for itching of skin irritation, inflammation, and rashes:, 2 adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily, 3 children under 2 years: Ask a doctor, 4 for external anal and genital itching, adults:, 5 when practical, clean the affected area with mild soap and water and rinse thoroughly, 6 gently dry by patting or blotting with toilet tissues or a soft cloth before applying, 7 apply to affected area not more than 3 to 4 times daily, 8 children under 12 years of age: Ask a doctor."
},
{
"NDCCode": "65923-803-20",
"PackageDescription": "20 PATCH in 1 BOX (65923-803-20) > 2 g in 1 PATCH",
"NDC11Code": "65923-0803-20",
"ProductNDC": "65923-803",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Family Care Pain Relief",
"NonProprietaryName": "Dl-camphor,l-menthol,methyl Salicylate",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110920",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "United Exchange Corporation",
"SubstanceName": "CAMPHOR (SYNTHETIC); LEVOMENTHOL; METHYL SALICYLATE",
"StrengthNumber": "1.2; 5.7; 6.3",
"StrengthUnit": "g/100g; g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2015-11-18"
},
{
"NDCCode": "65923-010-11",
"PackageDescription": "1 TUBE in 1 CARTON (65923-010-11) > 11.9 g in 1 TUBE",
"NDC11Code": "65923-0010-11",
"ProductNDC": "65923-010",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Iodent Maximum Strength Oral Analgesic",
"NonProprietaryName": "Benzocaine",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130531",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part356",
"LabelerName": "United Exchange Corp",
"SubstanceName": "BENZOCAINE",
"StrengthNumber": "20",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2021-12-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20160712",
"SamplePackage": "N"
},
{
"NDCCode": "65923-119-01",
"PackageDescription": ".02 g in 1 TUBE (65923-119-01) ",
"NDC11Code": "65923-0119-01",
"ProductNDC": "65923-119",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Family Care Pain Relief",
"NonProprietaryName": "Menthol",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20181030",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "United Exchange Corporation",
"SubstanceName": "MENTHOL",
"StrengthNumber": "20",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20181030",
"SamplePackage": "N",
"IndicationAndUsage": "Directions: 1 adults and children 12 years of age and older:, 2 clean and dry affected area, 3 apply generously to affected area, 4 massage into painful area until thoroughly absorbed into skin, 5 repeat as necessary, but not more than 4 times daily, 6 children under 12 years of age: consult a doctor."
},
{
"NDCCode": "0078-0684-15",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0078-0684-15) ",
"NDC11Code": "00078-0684-15",
"ProductNDC": "0078-0684",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promacta",
"NonProprietaryName": "Eltrombopag Olamine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160822",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022291",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"SubstanceName": "ELTROMBOPAG OLAMINE",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], Increased Megakaryocyte Maturation [PE], Increased Platelet Production [PE], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Thrombopoietin Receptor Agonist [EPC], Thrombopoietin Receptor Agonists [MoA], UGT1A1 Inhibitors [MoA], UGT1A3 Inhibitors [MoA], UGT1A4 Inhibitors [MoA], UGT1A6 Inhibitors [MoA], UGT1A9 Inhibitors [MoA], UGT2B15 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160822",
"SamplePackage": "N",
"IndicationAndUsage": "PROMACTA is a thrombopoietin receptor agonist indicated: 1 for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. PROMACTA should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. (1.1), 2 for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. PROMACTA should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy. (1.2), 3 in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia. (1.3), 4 for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. (1.3).",
"Description": "PROMACTA (eltrombopag) tablets contain eltrombopag olamine, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag olamine is a biphenyl hydrazone. The chemical name for eltrombopag olamine is 3'-{(2Z)-2-[1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]hydrazino}-2'-hydroxy-3-biphenylcarboxylic acid - 2-aminoethanol (1:2). It has the molecular formula C25H22N4O4 2(C2H7NO). The molecular weight is 564.65 g/mol for eltrombopag olamine and 442.5 g/mol for eltrombopag free acid. Eltrombopag olamine has the following structural formula. Eltrombopag olamine is practically insoluble in aqueous buffer across a pH range of 1 to 7.4, and is sparingly soluble in water. PROMACTA (eltrombopag) tablets contain eltrombopag olamine in the amount equivalent to 12.5 mg, 25 mg, 50 mg, or 75 mg of eltrombopag free acid. The inactive ingredients of PROMACTA tablets are. Tablet Core: magnesium stearate, mannitol, microcrystalline cellulose, povidone, and sodium starch glycolate.Coating: FD&C Blue No. 2 aluminum lake (50-mg tablet), FD&C Yellow No. 6 aluminum lake (25-mg tablet), hypromellose, Iron Oxide Black and Iron Oxide Red (75-mg tablet), polyethylene glycol 400, polysorbate 80 (12.5-mg tablet), or titanium dioxide. PROMACTA (eltrombopag) for oral suspension packets contain a reddish-brown to yellow powder which produces a reddish-brown suspension when reconstituted with water. Each packet delivers eltrombopag olamine equivalent to 12.5 mg or 25 mg of eltrombopag free acid. The inactive ingredients of PROMACTA for oral suspension are mannitol, sucralose, and xanthan gum."
},
{
"NDCCode": "0078-0685-15",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0078-0685-15) ",
"NDC11Code": "00078-0685-15",
"ProductNDC": "0078-0685",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promacta",
"NonProprietaryName": "Eltrombopag Olamine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160524",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022291",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"SubstanceName": "ELTROMBOPAG OLAMINE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], Increased Megakaryocyte Maturation [PE], Increased Platelet Production [PE], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Thrombopoietin Receptor Agonist [EPC], Thrombopoietin Receptor Agonists [MoA], UGT1A1 Inhibitors [MoA], UGT1A3 Inhibitors [MoA], UGT1A4 Inhibitors [MoA], UGT1A6 Inhibitors [MoA], UGT1A9 Inhibitors [MoA], UGT2B15 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160524",
"SamplePackage": "N",
"IndicationAndUsage": "PROMACTA is a thrombopoietin receptor agonist indicated: 1 for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. PROMACTA should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. (1.1), 2 for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. PROMACTA should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy. (1.2), 3 in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia. (1.3), 4 for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. (1.3).",
"Description": "PROMACTA (eltrombopag) tablets contain eltrombopag olamine, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag olamine is a biphenyl hydrazone. The chemical name for eltrombopag olamine is 3'-{(2Z)-2-[1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]hydrazino}-2'-hydroxy-3-biphenylcarboxylic acid - 2-aminoethanol (1:2). It has the molecular formula C25H22N4O4 2(C2H7NO). The molecular weight is 564.65 g/mol for eltrombopag olamine and 442.5 g/mol for eltrombopag free acid. Eltrombopag olamine has the following structural formula. Eltrombopag olamine is practically insoluble in aqueous buffer across a pH range of 1 to 7.4, and is sparingly soluble in water. PROMACTA (eltrombopag) tablets contain eltrombopag olamine in the amount equivalent to 12.5 mg, 25 mg, 50 mg, or 75 mg of eltrombopag free acid. The inactive ingredients of PROMACTA tablets are. Tablet Core: magnesium stearate, mannitol, microcrystalline cellulose, povidone, and sodium starch glycolate.Coating: FD&C Blue No. 2 aluminum lake (50-mg tablet), FD&C Yellow No. 6 aluminum lake (25-mg tablet), hypromellose, Iron Oxide Black and Iron Oxide Red (75-mg tablet), polyethylene glycol 400, polysorbate 80 (12.5-mg tablet), or titanium dioxide. PROMACTA (eltrombopag) for oral suspension packets contain a reddish-brown to yellow powder which produces a reddish-brown suspension when reconstituted with water. Each packet delivers eltrombopag olamine equivalent to 12.5 mg or 25 mg of eltrombopag free acid. The inactive ingredients of PROMACTA for oral suspension are mannitol, sucralose, and xanthan gum."
},
{
"NDCCode": "0078-0686-15",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0078-0686-15) ",
"NDC11Code": "00078-0686-15",
"ProductNDC": "0078-0686",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promacta",
"NonProprietaryName": "Eltrombopag Olamine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160407",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022291",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"SubstanceName": "ELTROMBOPAG OLAMINE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], Increased Megakaryocyte Maturation [PE], Increased Platelet Production [PE], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Thrombopoietin Receptor Agonist [EPC], Thrombopoietin Receptor Agonists [MoA], UGT1A1 Inhibitors [MoA], UGT1A3 Inhibitors [MoA], UGT1A4 Inhibitors [MoA], UGT1A6 Inhibitors [MoA], UGT1A9 Inhibitors [MoA], UGT2B15 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160407",
"SamplePackage": "N",
"IndicationAndUsage": "PROMACTA is a thrombopoietin receptor agonist indicated: 1 for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. PROMACTA should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. (1.1), 2 for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. PROMACTA should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy. (1.2), 3 in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia. (1.3), 4 for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. (1.3).",
"Description": "PROMACTA (eltrombopag) tablets contain eltrombopag olamine, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag olamine is a biphenyl hydrazone. The chemical name for eltrombopag olamine is 3'-{(2Z)-2-[1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]hydrazino}-2'-hydroxy-3-biphenylcarboxylic acid - 2-aminoethanol (1:2). It has the molecular formula C25H22N4O4 2(C2H7NO). The molecular weight is 564.65 g/mol for eltrombopag olamine and 442.5 g/mol for eltrombopag free acid. Eltrombopag olamine has the following structural formula. Eltrombopag olamine is practically insoluble in aqueous buffer across a pH range of 1 to 7.4, and is sparingly soluble in water. PROMACTA (eltrombopag) tablets contain eltrombopag olamine in the amount equivalent to 12.5 mg, 25 mg, 50 mg, or 75 mg of eltrombopag free acid. The inactive ingredients of PROMACTA tablets are. Tablet Core: magnesium stearate, mannitol, microcrystalline cellulose, povidone, and sodium starch glycolate.Coating: FD&C Blue No. 2 aluminum lake (50-mg tablet), FD&C Yellow No. 6 aluminum lake (25-mg tablet), hypromellose, Iron Oxide Black and Iron Oxide Red (75-mg tablet), polyethylene glycol 400, polysorbate 80 (12.5-mg tablet), or titanium dioxide. PROMACTA (eltrombopag) for oral suspension packets contain a reddish-brown to yellow powder which produces a reddish-brown suspension when reconstituted with water. Each packet delivers eltrombopag olamine equivalent to 12.5 mg or 25 mg of eltrombopag free acid. The inactive ingredients of PROMACTA for oral suspension are mannitol, sucralose, and xanthan gum."
},
{
"NDCCode": "0078-0686-55",
"PackageDescription": "14 TABLET, FILM COATED in 1 BOTTLE (0078-0686-55) ",
"NDC11Code": "00078-0686-55",
"ProductNDC": "0078-0686",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promacta",
"NonProprietaryName": "Eltrombopag Olamine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160407",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022291",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"SubstanceName": "ELTROMBOPAG OLAMINE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], Increased Megakaryocyte Maturation [PE], Increased Platelet Production [PE], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Thrombopoietin Receptor Agonist [EPC], Thrombopoietin Receptor Agonists [MoA], UGT1A1 Inhibitors [MoA], UGT1A3 Inhibitors [MoA], UGT1A4 Inhibitors [MoA], UGT1A6 Inhibitors [MoA], UGT1A9 Inhibitors [MoA], UGT2B15 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200121",
"SamplePackage": "N",
"IndicationAndUsage": "PROMACTA is a thrombopoietin receptor agonist indicated: 1 for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. PROMACTA should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. (1.1), 2 for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. PROMACTA should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy. (1.2), 3 in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia. (1.3), 4 for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. (1.3).",
"Description": "PROMACTA (eltrombopag) tablets contain eltrombopag olamine, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag olamine is a biphenyl hydrazone. The chemical name for eltrombopag olamine is 3'-{(2Z)-2-[1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]hydrazino}-2'-hydroxy-3-biphenylcarboxylic acid - 2-aminoethanol (1:2). It has the molecular formula C25H22N4O4 2(C2H7NO). The molecular weight is 564.65 g/mol for eltrombopag olamine and 442.5 g/mol for eltrombopag free acid. Eltrombopag olamine has the following structural formula. Eltrombopag olamine is practically insoluble in aqueous buffer across a pH range of 1 to 7.4, and is sparingly soluble in water. PROMACTA (eltrombopag) tablets contain eltrombopag olamine in the amount equivalent to 12.5 mg, 25 mg, 50 mg, or 75 mg of eltrombopag free acid. The inactive ingredients of PROMACTA tablets are. Tablet Core: magnesium stearate, mannitol, microcrystalline cellulose, povidone, and sodium starch glycolate.Coating: FD&C Blue No. 2 aluminum lake (50-mg tablet), FD&C Yellow No. 6 aluminum lake (25-mg tablet), hypromellose, Iron Oxide Black and Iron Oxide Red (75-mg tablet), polyethylene glycol 400, polysorbate 80 (12.5-mg tablet), or titanium dioxide. PROMACTA (eltrombopag) for oral suspension packets contain a reddish-brown to yellow powder which produces a reddish-brown suspension when reconstituted with water. Each packet delivers eltrombopag olamine equivalent to 12.5 mg or 25 mg of eltrombopag free acid. The inactive ingredients of PROMACTA for oral suspension are mannitol, sucralose, and xanthan gum."
},
{
"NDCCode": "0078-0687-15",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (0078-0687-15) ",
"NDC11Code": "00078-0687-15",
"ProductNDC": "0078-0687",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promacta",
"NonProprietaryName": "Eltrombopag Olamine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160401",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022291",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"SubstanceName": "ELTROMBOPAG OLAMINE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], Increased Megakaryocyte Maturation [PE], Increased Platelet Production [PE], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Thrombopoietin Receptor Agonist [EPC], Thrombopoietin Receptor Agonists [MoA], UGT1A1 Inhibitors [MoA], UGT1A3 Inhibitors [MoA], UGT1A4 Inhibitors [MoA], UGT1A6 Inhibitors [MoA], UGT1A9 Inhibitors [MoA], UGT2B15 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160401",
"SamplePackage": "N",
"IndicationAndUsage": "PROMACTA is a thrombopoietin receptor agonist indicated: 1 for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. PROMACTA should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. (1.1), 2 for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. PROMACTA should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy. (1.2), 3 in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia. (1.3), 4 for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. (1.3).",
"Description": "PROMACTA (eltrombopag) tablets contain eltrombopag olamine, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag olamine is a biphenyl hydrazone. The chemical name for eltrombopag olamine is 3'-{(2Z)-2-[1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]hydrazino}-2'-hydroxy-3-biphenylcarboxylic acid - 2-aminoethanol (1:2). It has the molecular formula C25H22N4O4 2(C2H7NO). The molecular weight is 564.65 g/mol for eltrombopag olamine and 442.5 g/mol for eltrombopag free acid. Eltrombopag olamine has the following structural formula. Eltrombopag olamine is practically insoluble in aqueous buffer across a pH range of 1 to 7.4, and is sparingly soluble in water. PROMACTA (eltrombopag) tablets contain eltrombopag olamine in the amount equivalent to 12.5 mg, 25 mg, 50 mg, or 75 mg of eltrombopag free acid. The inactive ingredients of PROMACTA tablets are. Tablet Core: magnesium stearate, mannitol, microcrystalline cellulose, povidone, and sodium starch glycolate.Coating: FD&C Blue No. 2 aluminum lake (50-mg tablet), FD&C Yellow No. 6 aluminum lake (25-mg tablet), hypromellose, Iron Oxide Black and Iron Oxide Red (75-mg tablet), polyethylene glycol 400, polysorbate 80 (12.5-mg tablet), or titanium dioxide. PROMACTA (eltrombopag) for oral suspension packets contain a reddish-brown to yellow powder which produces a reddish-brown suspension when reconstituted with water. Each packet delivers eltrombopag olamine equivalent to 12.5 mg or 25 mg of eltrombopag free acid. The inactive ingredients of PROMACTA for oral suspension are mannitol, sucralose, and xanthan gum."
},
{
"NDCCode": "0078-0697-61",
"PackageDescription": "1 CARTON in 1 KIT (0078-0697-61) / 30 PACKET in 1 CARTON (0078-0697-23) / 1 POWDER, FOR SUSPENSION in 1 PACKET (0078-0697-19) ",
"NDC11Code": "00078-0697-61",
"ProductNDC": "0078-0697",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promacta",
"NonProprietaryName": "Eltrombopag Olamine",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20180927",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207027",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"SubstanceName": "ELTROMBOPAG OLAMINE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], Increased Megakaryocyte Maturation [PE], Increased Platelet Production [PE], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Thrombopoietin Receptor Agonist [EPC], Thrombopoietin Receptor Agonists [MoA], UGT1A1 Inhibitors [MoA], UGT1A3 Inhibitors [MoA], UGT1A4 Inhibitors [MoA], UGT1A6 Inhibitors [MoA], UGT1A9 Inhibitors [MoA], UGT2B15 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200327",
"SamplePackage": "N",
"IndicationAndUsage": "PROMACTA is a thrombopoietin receptor agonist indicated: 1 for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. PROMACTA should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. (1.1), 2 for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. PROMACTA should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy. (1.2), 3 in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia. (1.3), 4 for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. (1.3).",
"Description": "PROMACTA (eltrombopag) tablets contain eltrombopag olamine, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag olamine is a biphenyl hydrazone. The chemical name for eltrombopag olamine is 3'-{(2Z)-2-[1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]hydrazino}-2'-hydroxy-3-biphenylcarboxylic acid - 2-aminoethanol (1:2). It has the molecular formula C25H22N4O4 2(C2H7NO). The molecular weight is 564.65 g/mol for eltrombopag olamine and 442.5 g/mol for eltrombopag free acid. Eltrombopag olamine has the following structural formula. Eltrombopag olamine is practically insoluble in aqueous buffer across a pH range of 1 to 7.4, and is sparingly soluble in water. PROMACTA (eltrombopag) tablets contain eltrombopag olamine in the amount equivalent to 12.5 mg, 25 mg, 50 mg, or 75 mg of eltrombopag free acid. The inactive ingredients of PROMACTA tablets are. Tablet Core: magnesium stearate, mannitol, microcrystalline cellulose, povidone, and sodium starch glycolate.Coating: FD&C Blue No. 2 aluminum lake (50-mg tablet), FD&C Yellow No. 6 aluminum lake (25-mg tablet), hypromellose, Iron Oxide Black and Iron Oxide Red (75-mg tablet), polyethylene glycol 400, polysorbate 80 (12.5-mg tablet), or titanium dioxide. PROMACTA (eltrombopag) for oral suspension packets contain a reddish-brown to yellow powder which produces a reddish-brown suspension when reconstituted with water. Each packet delivers eltrombopag olamine equivalent to 12.5 mg or 25 mg of eltrombopag free acid. The inactive ingredients of PROMACTA for oral suspension are mannitol, sucralose, and xanthan gum."
},
{
"NDCCode": "0078-0972-61",
"PackageDescription": "1 CARTON in 1 KIT (0078-0972-61) / 30 PACKET in 1 CARTON (0078-0972-23) / 1 POWDER, FOR SUSPENSION in 1 PACKET (0078-0972-19) ",
"NDC11Code": "00078-0972-61",
"ProductNDC": "0078-0972",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Promacta",
"NonProprietaryName": "Eltrombopag Olamine",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20180927",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207027",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"SubstanceName": "ELTROMBOPAG OLAMINE",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Breast Cancer Resistance Protein Inhibitors [MoA], Increased Megakaryocyte Maturation [PE], Increased Platelet Production [PE], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Thrombopoietin Receptor Agonist [EPC], Thrombopoietin Receptor Agonists [MoA], UGT1A1 Inhibitors [MoA], UGT1A3 Inhibitors [MoA], UGT1A4 Inhibitors [MoA], UGT1A6 Inhibitors [MoA], UGT1A9 Inhibitors [MoA], UGT2B15 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180927",
"SamplePackage": "N",
"IndicationAndUsage": "PROMACTA is a thrombopoietin receptor agonist indicated: 1 for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. PROMACTA should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. (1.1), 2 for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. PROMACTA should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy. (1.2), 3 in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia. (1.3), 4 for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. (1.3).",
"Description": "PROMACTA (eltrombopag) tablets contain eltrombopag olamine, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag olamine is a biphenyl hydrazone. The chemical name for eltrombopag olamine is 3'-{(2Z)-2-[1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]hydrazino}-2'-hydroxy-3-biphenylcarboxylic acid - 2-aminoethanol (1:2). It has the molecular formula C25H22N4O4 2(C2H7NO). The molecular weight is 564.65 g/mol for eltrombopag olamine and 442.5 g/mol for eltrombopag free acid. Eltrombopag olamine has the following structural formula. Eltrombopag olamine is practically insoluble in aqueous buffer across a pH range of 1 to 7.4, and is sparingly soluble in water. PROMACTA (eltrombopag) tablets contain eltrombopag olamine in the amount equivalent to 12.5 mg, 25 mg, 50 mg, or 75 mg of eltrombopag free acid. The inactive ingredients of PROMACTA tablets are. Tablet Core: magnesium stearate, mannitol, microcrystalline cellulose, povidone, and sodium starch glycolate.Coating: FD&C Blue No. 2 aluminum lake (50-mg tablet), FD&C Yellow No. 6 aluminum lake (25-mg tablet), hypromellose, Iron Oxide Black and Iron Oxide Red (75-mg tablet), polyethylene glycol 400, polysorbate 80 (12.5-mg tablet), or titanium dioxide. PROMACTA (eltrombopag) for oral suspension packets contain a reddish-brown to yellow powder which produces a reddish-brown suspension when reconstituted with water. Each packet delivers eltrombopag olamine equivalent to 12.5 mg or 25 mg of eltrombopag free acid. The inactive ingredients of PROMACTA for oral suspension are mannitol, sucralose, and xanthan gum."
},
{
"NDCCode": "10544-564-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (10544-564-30)",
"NDC11Code": "10544-0564-30",
"ProductNDC": "10544-564",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisinopril And Hydrochlorothiazide",
"NonProprietaryName": "Lisinopril And Hydrochlorothiazide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100504",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077912",
"LabelerName": "Blenheim Pharmacal, Inc.",
"SubstanceName": "LISINOPRIL; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "20; 12.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Lisinopril and hydrochlorothiazide tablets are indicated for the treatment of hypertension. These fixed-dose combinations are not indicated for initial therapy (see DOSAGE AND ADMINISTRATION). In using lisinopril and hydrochlorothiazide tablets, consideration should be given to the fact that an angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that lisinopril does not have a similar risk. (See WARNINGS.). In considering use of lisinopril and hydrochlorothiazide tablets, it should be noted that Black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to non-Blacks. (See WARNINGS, Head and Neck Angioedema.).",
"Description": "Lisinopril and hydrochlorothiazide tablets combines an angiotensin converting enzyme inhibitor, lisinopril, and a diuretic, hydrochlorothiazide. Lisinopril, a synthetic peptide derivative, is an oral long-acting angiotensin converting enzyme inhibitor. It is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21H31N3O52H2O and its structural formula is. Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.52. It is soluble in water, sparingly soluble in methanol, and practically insoluble in ethanol. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide is a white, or practically white, crystalline powder with a molecular weight of 297.73, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Lisinopril and hydrochlorothiazide tablets are available for oral use in three tablet combinations of lisinopril with hydrochlorothiazide: lisinopril and hydrochlorothiazide tablets 10 mg/12.5 mg, containing 10 mg lisinopril and 12.5 mg hydrochlorothiazide, lisinopril and hydrochlorothiazide tablets 20 mg/12.5 mg, containing 20 mg lisinopril and 12.5 mg hydrochlorothiazide and lisinopril and hydrochlorothiazide tablets 20 mg/25 mg, containing 20 mg lisinopril and 25 mg hydrochlorothiazide. Inactive ingredients are dibasic calcium phosphate, magnesium stearate, mannitol, pregelatinized starch and starch. Lisinopril and hydrochlorothiazide tablets 10 mg/12.5 mg also contains FD&C Blue No. 2 Aluminum Lake. Lisinopril and hydrochlorothiazide tablets 20 mg/12.5 mg also contains yellow iron oxide and lisinopril and hydrochlorothiazide tablets 20 mg/25 mg also contain red iron oxide."
},
{
"NDCCode": "16714-564-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (16714-564-01) ",
"NDC11Code": "16714-0564-01",
"ProductNDC": "16714-564",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexmethylphenidate Hydrochloride",
"NonProprietaryName": "Dexmethylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20220121",
"EndMarketingDate": "20250731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206734",
"LabelerName": "Northstar Rx LLC",
"SubstanceName": "DEXMETHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2025-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20220121",
"EndMarketingDatePackage": "20250731",
"SamplePackage": "N",
"IndicationAndUsage": "Dexmethylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [ see Clinical Studies ( 14)].",
"Description": "Dexmethylphenidate hydrochloride extended-release capsules contain dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the d- threoenantiomer of racemic methylphenidate hydrochloride. Dexmethylphenidate hydrochloride extended-release capsules are an extended-release formulation of dexmethylphenidate with a bi-modal release profile. Each bead-filled dexmethylphenidate hydrochloride extended-release capsule contains half the dose as immediate-release beads and half as enteric-coated, delayed-release beads, thus providing an immediate release of dexmethylphenidate and a delayed release of dexmethylphenidate. Dexmethylphenidate hydrochloride extended-release capsules are intended for oral administration and are available as 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, and 40 mg extended-release capsules. Chemically, dexmethylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, (R,R’)-(+)-. Its molecular formula is C 14H 19NO 2HCl. Its structural formula is:. Note* = asymmetric carbon center. Dexmethylphenidate hydrochloride is a white to off-white powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Inactive ingredients: ammonio methacrylate copolymer (Type B), black iron oxide, D&C Red No. 28 (15 mg, and 40 mg strengths), FD&C Blue No. 1 (15 mg, and 40 mg strengths), FD&C Blue No. 2 (5 mg, 25 mg, and 35 mg strengths), gelatin, hypromellose, methacrylic acid and methyl methacrylate copolymer (1:1), methacrylic acid and methyl methacrylate copolymer (1:2), polyethylene glycol, propylene glycol, shellac, sugar spheres, talc, titanium dioxide, triethyl citrate, and yellow iron oxide (10 mg, 15 mg, 30 mg, 35 mg, and 40 mg strengths)."
},
{
"NDCCode": "43598-599-60",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (43598-599-60) ",
"NDC11Code": "43598-0599-60",
"ProductNDC": "43598-599",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dasatinib",
"NonProprietaryName": "Dasatinib",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20250303",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213383",
"LabelerName": "Dr.Reddys Laboratories Inc",
"SubstanceName": "DASATINIB",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-03-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250303",
"SamplePackage": "N",
"IndicationAndUsage": "Dasatinib tablets are indicated for the treatment of adult patients with. newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. Dasatinib tablets are indicated for the treatment of pediatric patients 1 year of age and older with Ph+ CML in chronic phase. newly diagnosed Ph+ ALL in combination with chemotherapy.",
"Description": "Dasatinib is a kinase inhibitor. The chemical name for dasatinib (S)-propylene glycol is N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide S-1, 2-Propanediol. The molecular formula is C22H26ClN7O2S C3H8O2, which corresponds to a formula weight of 564.11 ((S)-Propylene Glycol). The free base has a molecular weight of 488.01. Dasatinib (S)-propylene glycol has the following chemical structure:. Dasatinib (S)-propylene glycol is a white to brown colored powder. The drug substance is freely soluble in dimethyl formamide & N-methyl-2-pyrrolodine while practically insoluble in dichloromethane, methanol, ethanol, acetone, n-heptane, n-hexane, tertrahydrofuran, toluene, ethyl acetate, petroleum ether, (S)-propylene glycol and water. Dasatinib tablets are white to off-white, round/oval, film-coated tablets containing dasatinib (S)-propylene glycol, with the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, hydrogenated castor oil, magnesium stearate and microcrystalline cellulose. The tablet coating consists of hypromellose, titanium dioxide, and triacetin."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>65923-564-20</NDCCode>
<PackageDescription>20 PATCH in 1 PACKAGE (65923-564-20) / 1 g in 1 PATCH</PackageDescription>
<NDC11Code>65923-0564-20</NDC11Code>
<ProductNDC>65923-564</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Coralite Pain Relief</ProprietaryName>
<NonProprietaryName>Camphor, Menthol, Methyl Salicylate</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160412</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>United Exchange Corp.</LabelerName>
<SubstanceName>CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE</SubstanceName>
<StrengthNumber>1.2; 5.7; 6.3</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-10-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180412</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Directions. adults and children 12 years of age and over: 1 clean and dry affected area, 2 remove patch from film, 3 apply to affected area not more than 3 to 4 times daily, 4 do not wear patch for more than 4 hours, 5 children under 12 years of age: consult a doctor.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>52125-564-01</NDCCode>
<PackageDescription>20 mL in 1 VIAL, SINGLE-DOSE (52125-564-01)</PackageDescription>
<NDC11Code>52125-0564-01</NDC11Code>
<ProductNDC>52125-564</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Chloride</ProprietaryName>
<NonProprietaryName>Sodium Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20130501</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018803</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>SODIUM CHLORIDE</SubstanceName>
<StrengthNumber>9</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-01-10</LastUpdate>
</NDC>
<NDC>
<NDCCode>52125-564-03</NDCCode>
<PackageDescription>20 mL in 1 VIAL, SINGLE-DOSE (52125-564-03)</PackageDescription>
<NDC11Code>52125-0564-03</NDC11Code>
<ProductNDC>52125-564</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Chloride</ProprietaryName>
<NonProprietaryName>Sodium Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20131202</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018803</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>SODIUM CHLORIDE</SubstanceName>
<StrengthNumber>9</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-01-10</LastUpdate>
</NDC>
<NDC>
<NDCCode>60760-564-20</NDCCode>
<PackageDescription>20 TABLET in 1 BOTTLE, PLASTIC (60760-564-20) </PackageDescription>
<NDC11Code>60760-0564-20</NDC11Code>
<ProductNDC>60760-564</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Naproxen</ProprietaryName>
<NonProprietaryName>Naproxen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220622</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212517</ApplicationNumber>
<LabelerName>St. Mary's Medical Park Pharmacy</LabelerName>
<SubstanceName>NAPROXEN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220622</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Naproxen Tablets are indicated for: the relief of the signs and symptoms of: : 1 rheumatoid arthritis, 2 osteoarthritis, 3 ankylosing spondylitis, 4 polyarticular juvenile idiopathic arthritis, 5 tendonitis, 6 bursitis , 7 acute gout.</IndicationAndUsage>
<Description>Naproxen tablets, USP are nonsteroidal anti-inflammatory drugs and available as follows: Naproxen tablets, USP are available as light yellow round shaped tablets containing 250 mg naproxen, light yellow capsule shaped tablets containing 375 mg naproxen, and light yellow oblong shaped tablets containing 500 mg naproxen for oral administration. Naproxen is a propionic acid derivative related to the arylacetic acid group of nonsteroidal anti-inflammatory drugs. The chemical name for naproxen is (S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen has a molecular weight of 230.26 and a molecular formula of C 14H 14O 3. It has the following structural formula:. Naproxen is white or almost white crystalline powder. It is insoluble in water, soluble in chloroform, dehydrated ethanol and methanol. Sparingly soluble in ether. The octanol/water partition coefficient of Naproxen at pH < 2.18 is 3.18. Each naproxen tablet, USP contains the following inactive ingredients: croscarmellose sodium, yellow iron oxide, povidone and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>65219-564-20</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (65219-564-20) / 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>65219-0564-20</NDC11Code>
<ProductNDC>65219-564</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mitomycin</ProprietaryName>
<NonProprietaryName>Mitomycin</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20230115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA215687</ApplicationNumber>
<LabelerName>Fresenius Kabi USA, LLC</LabelerName>
<SubstanceName>MITOMYCIN</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/10mL</StrengthUnit>
<Pharm_Classes>Alkylating Activity [MoA], Alkylating Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mitomycin for Injection, USP is not recommended as single-agent, primary therapy. It has been shown to be useful in the therapy of disseminated adenocarcinoma of the stomach or pancreas in proven combinations with other approved chemotherapeutic agents and as palliative treatment when other modalities have failed. Mitomycin is not recommended to replace appropriate surgery and/or radiotherapy.</IndicationAndUsage>
<Description>Mitomycin (also known as mitomycin and/or mitomycin-C) is an antibiotic isolated from the broth of Streptomyces caespitosus which has been shown to have antitumor activity. The compound is heat stable, has a high melting point, and is freely soluble in organic solvents. Mitomycin for Injection, USP is a sterile dry mixture of mitomycin and mannitol, which when reconstituted with Sterile Water for Injection provides a solution for intravenous administration. Each Single-Dose vial contains either mitomycin 5 mg and mannitol 10 mg or mitomycin 20 mg and mannitol 40 mg. Each mL of reconstituted solution will contain 0.5 mg mitomycin and have a pH between 6.0 and 8.0. Mitomycin is a blue-violet crystalline powder with the molecular formula of C15H18N4O5, and a molecular weight of 334.33. Its chemical name is 7-amino-9α-methoxymitosane and it has the following structural formula;.</Description>
</NDC>
<NDC>
<NDCCode>67457-564-20</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (67457-564-20) / 20 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>67457-0564-20</NDC11Code>
<ProductNDC>67457-564</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Baclofen</ProprietaryName>
<NonProprietaryName>Baclofen</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRATHECAL</RouteName>
<StartMarketingDate>20181221</StartMarketingDate>
<EndMarketingDate>20250831</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209592</ApplicationNumber>
<LabelerName>Mylan Institutional LLC</LabelerName>
<SubstanceName>BACLOFEN</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/20mL</StrengthUnit>
<Pharm_Classes>GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-09-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20181221</StartMarketingDatePackage>
<EndMarketingDatePackage>20250831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Baclofen injection (intrathecal) is indicated for use in the management of severe spasticity. Patients should first respond to a screening dose of intrathecal baclofen prior to consideration for long term infusion via an implantable pump. For spasticity of spinal cord origin, chronic infusion of baclofen injection (intrathecal) via an implantable pump should be reserved for patients unresponsive to oral baclofen therapy, or those who experience intolerable CNS side effects at effective doses. Patients with spasticity due to traumatic brain injury should wait at least one year after the injury before consideration of long term intrathecal baclofen therapy. Baclofen injection (intrathecal) is intended for use by the intrathecal route in single bolus test doses (via spinal catheter or lumbar puncture) and, for chronic use, only in implantable pumps approved by the FDA specifically for the administration of baclofen injection (intrathecal) into the intrathecal space. Spasticity of Spinal Cord Origin: Evidence supporting the efficacy of baclofen injection (intrathecal) was obtained in randomized, controlled investigations that compared the effects of either a single intrathecal dose or a three day intrathecal infusion of baclofen injection (intrathecal) to placebo in patients with severe spasticity and spasms due to either spinal cord trauma or multiple sclerosis. Baclofen injection (intrathecal) was superior to placebo on both principal outcome measures employed: change from baseline in the Ashworth rating of spasticity and the frequency of spasms. Spasticity of Cerebral Origin: The efficacy of baclofen injection (intrathecal) was investigated in three controlled clinical trials; two enrolled patients with cerebral palsy and one enrolled patients with spasticity due to previous brain injury. The first study, a randomized controlled cross-over trial of 51 patients with cerebral palsy, provided strong, statistically significant results; baclofen injection (intrathecal) was superior to placebo in reducing spasticity as measured by the Ashworth Scale. A second cross-over study was conducted in 11 patients with spasticity arising from brain injury. Despite the small sample size, the study yielded a nearly significant test statistic (p=0.066) and provided directionally favorable results. The last study, however, did not provide data that could be reliably analyzed. Baclofen injection (intrathecal) therapy may be considered an alternative to destructive neurosurgical procedures. Prior to implantation of a device for chronic intrathecal infusion of baclofen injection (intrathecal), patients must show a response to baclofen injection (intrathecal) in a screening trial (see Dosage and Administration).</IndicationAndUsage>
<Description>Baclofen injection, USP (intrathecal) is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl) butanoic acid, and its structural formula is. Baclofen, USP is a white to off white, crystalline powder, with a molecular weight of 213.66. It is slightly soluble in water, very slightly soluble in methanol, and insoluble in chloroform. Baclofen injection, USP (intrathecal) is a sterile, clear, colorless, pyrogen-free, isotonic solution free of antioxidants, preservatives or other potentially neurotoxic additives indicated only for intrathecal administration. The drug is stable in solution at 37°C and compatible with CSF. Each milliliter of baclofen injection, USP (intrathecal) contains baclofen USP, 500 mcg or 2,000 mcg and sodium chloride 9 mg in Water for Injection; pH range is 5.0 to 7.5. Each vial is intended for SINGLE DOSE ONLY. Discard any unused portion. DO NOT AUTOCLAVE.</Description>
</NDC>
<NDC>
<NDCCode>69842-564-20</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (69842-564-20) > 20 LOZENGE in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>69842-0564-20</NDC11Code>
<ProductNDC>69842-564</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nicotine</ProprietaryName>
<NonProprietaryName>Nicotine Polacrilex</NonProprietaryName>
<DosageFormName>LOZENGE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200529</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207868</ApplicationNumber>
<LabelerName>CVS Pharmacy</LabelerName>
<SubstanceName>NICOTINE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-11-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200529</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>65923-003-20</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (65923-003-20) / 20 g in 1 TUBE</PackageDescription>
<NDC11Code>65923-0003-20</NDC11Code>
<ProductNDC>65923-003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Family Care Hemorrhoidal</ProprietaryName>
<NonProprietaryName>Mineral Oil</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20141124</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M015</ApplicationNumber>
<LabelerName>United Exchange Corp</LabelerName>
<SubstanceName>MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>140; 749; 2.5</StrengthNumber>
<StrengthUnit>mg/100g; mg/100g; mg/100g</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141124</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Directions: 1 adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or a soft cloth before applying ointment, 2 when first opening tube, peel back foil seal, 3 apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement, 4 intrarectal use: remove cover from applicator, attach applicator to tube, lubricate applicator well and gently insert applicator into the rectum, 5 thoroughly cleanse applicator after each use and replace cover, 6 also apply ointment to external area, 7 regular use provides continual therapy for relief of symptoms, 8 children under 12 years of age: ask a doctor .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>65923-009-20</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (65923-009-20) > 20 g in 1 TUBE</PackageDescription>
<NDC11Code>65923-0009-20</NDC11Code>
<ProductNDC>65923-009</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Family Care Hemorrhoidal</ProprietaryName>
<NonProprietaryName>Mineral Oil, Petrolatum, Phenylephrine Hcl, Shark Liver Oil</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120301</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part346</ApplicationNumber>
<LabelerName>UNITED EXCHANGE CORP.</LabelerName>
<SubstanceName>MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; SHARK LIVER OIL</SubstanceName>
<StrengthNumber>140; 719; 2.5; 30</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Directions: 1 children under 12 years of age: ask a doctor , 2 adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe , 3 gently dry by patting or blotting with a tissue or a soft cloth before applying , 4 when first opening tube, remove foil seal , 5 for intrarectal use: remove protective cover form applicator and attach to tube , 6 lubricate applicator well, then gently insert applicator into the rectum , 7 thoroughly clean applicator and replace protective cover after each use , 8 apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement , 9 also apply ointment to external area.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>65923-136-25</NDCCode>
<PackageDescription>20 mg in 1 POUCH (65923-136-25)</PackageDescription>
<NDC11Code>65923-0136-25</NDC11Code>
<ProductNDC>65923-136</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nu Pore Acne</ProprietaryName>
<NonProprietaryName>Salicyilc Acid</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20131204</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333D</ApplicationNumber>
<LabelerName>United Exchange Corp.</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>mg/100mg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-07-11</LastUpdate>
</NDC>
<NDC>
<NDCCode>65923-156-20</NDCCode>
<PackageDescription>20 PATCH in 1 PACKAGE (65923-156-20) > 1 g in 1 PATCH</PackageDescription>
<NDC11Code>65923-0156-20</NDC11Code>
<ProductNDC>65923-156</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Coralite Pain Relief</ProprietaryName>
<NonProprietaryName>Dl-camphor, L-menthol, Methylsalicylate</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140326</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>United Exchange Corp.</LabelerName>
<SubstanceName>CAMPHOR (SYNTHETIC); LEVOMENTHOL; METHYL SALICYLATE</SubstanceName>
<StrengthNumber>1.2; 5.7; 6.3</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-04-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160418</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>65923-344-20</NDCCode>
<PackageDescription>200 POUCH in 1 BOX (65923-344-20) > 4.5 g in 1 POUCH</PackageDescription>
<NDC11Code>65923-0344-20</NDC11Code>
<ProductNDC>65923-344</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Uec Medical Sterile Alcohol Wipes</ProprietaryName>
<NonProprietaryName>Ispropyl Alcohol</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160219</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>United Exchange Corp.</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-10-31</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>65923-385-20</NDCCode>
<PackageDescription>20 PATCH in 1 BOX (65923-385-20) > 2 g in 1 PATCH</PackageDescription>
<NDC11Code>65923-0385-20</NDC11Code>
<ProductNDC>65923-385</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Family Care Pain Relief</ProprietaryName>
<NonProprietaryName>Dl-camphor, L-menthol, Methylsalicylate</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20131126</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>United Exchange Corp.</LabelerName>
<SubstanceName>CAMPHOR (SYNTHETIC); LEVOMENTHOL; METHYL SALICYLATE</SubstanceName>
<StrengthNumber>1.2; 5.7; 6.3</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Directions. Aduts and children 12 years of age and over: 1 clean and dry affected area, 2 remove patch from film, 3 apply to affected area no more than 3 to 4 times daily for 7 days, 4 remove patch from skin after at most 8 hours of application.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>65923-390-20</NDCCode>
<PackageDescription>20 PACKET in 1 BOX (65923-390-20) > .9 g in 1 PACKET</PackageDescription>
<NDC11Code>65923-0390-20</NDC11Code>
<ProductNDC>65923-390</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Uec Medical First Aid Antibiotic</ProprietaryName>
<NonProprietaryName>Bacitracin Zinc</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160404</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333B</ApplicationNumber>
<LabelerName>United Exchange Corp.</LabelerName>
<SubstanceName>BACITRACIN ZINC</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>[iU]/g</StrengthUnit>
<Pharm_Classes>Decreased Cell Wall Synthesis & Repair [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160404</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Directions: 1 clean the affected area, 2 apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily, 3 may be covered with a sterile bandage.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>65923-391-20</NDCCode>
<PackageDescription>20 PACKET in 1 BOX (65923-391-20) > .5 g in 1 PACKET</PackageDescription>
<NDC11Code>65923-0391-20</NDC11Code>
<ProductNDC>65923-391</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Uec Medical First Aid Antibiotic</ProprietaryName>
<NonProprietaryName>Bacitracin Zinc, Neomycin Sulfate, And Polymyxin B Sulfate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160404</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333B</ApplicationNumber>
<LabelerName>United Exchange Corp.</LabelerName>
<SubstanceName>BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE</SubstanceName>
<StrengthNumber>400; 3.5; 5000</StrengthNumber>
<StrengthUnit>[iU]/g; mg/g; [iU]/g</StrengthUnit>
<Pharm_Classes>Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160404</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Directions: 1 clean the affected area, 2 apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily, 3 may be covered with a sterile bandage.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>65923-391-21</NDCCode>
<PackageDescription>20 PACKET in 1 BOX (65923-391-21) > .9 g in 1 PACKET</PackageDescription>
<NDC11Code>65923-0391-21</NDC11Code>
<ProductNDC>65923-391</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Uec Medical First Aid Antibiotic</ProprietaryName>
<NonProprietaryName>Bacitracin Zinc, Neomycin Sulfate, And Polymyxin B Sulfate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160404</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333B</ApplicationNumber>
<LabelerName>United Exchange Corp.</LabelerName>
<SubstanceName>BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE</SubstanceName>
<StrengthNumber>400; 3.5; 5000</StrengthNumber>
<StrengthUnit>[iU]/g; mg/g; [iU]/g</StrengthUnit>
<Pharm_Classes>Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160404</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Directions: 1 clean the affected area, 2 apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily, 3 may be covered with a sterile bandage.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>65923-393-20</NDCCode>
<PackageDescription>20 PACKET in 1 BOX (65923-393-20) > .9 g in 1 PACKET</PackageDescription>
<NDC11Code>65923-0393-20</NDC11Code>
<ProductNDC>65923-393</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Uec Medical Anti-itch</ProprietaryName>
<NonProprietaryName>Hydrocortisone</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160404</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>United Exchange Corp.</LabelerName>
<SubstanceName>HYDROCORTISONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160404</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Directions: 1 for itching of skin irritation, inflammation, and rashes:, 2 adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily, 3 children under 2 years: Ask a doctor, 4 for external anal and genital itching, adults:, 5 when practical, clean the affected area with mild soap and water and rinse thoroughly, 6 gently dry by patting or blotting with toilet tissues or a soft cloth before applying, 7 apply to affected area not more than 3 to 4 times daily, 8 children under 12 years of age: Ask a doctor.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>65923-803-20</NDCCode>
<PackageDescription>20 PATCH in 1 BOX (65923-803-20) > 2 g in 1 PATCH</PackageDescription>
<NDC11Code>65923-0803-20</NDC11Code>
<ProductNDC>65923-803</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Family Care Pain Relief</ProprietaryName>
<NonProprietaryName>Dl-camphor,l-menthol,methyl Salicylate</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110920</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>United Exchange Corporation</LabelerName>
<SubstanceName>CAMPHOR (SYNTHETIC); LEVOMENTHOL; METHYL SALICYLATE</SubstanceName>
<StrengthNumber>1.2; 5.7; 6.3</StrengthNumber>
<StrengthUnit>g/100g; g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2015-11-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>65923-010-11</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (65923-010-11) > 11.9 g in 1 TUBE</PackageDescription>
<NDC11Code>65923-0010-11</NDC11Code>
<ProductNDC>65923-010</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Iodent Maximum Strength Oral Analgesic</ProprietaryName>
<NonProprietaryName>Benzocaine</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130531</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part356</ApplicationNumber>
<LabelerName>United Exchange Corp</LabelerName>
<SubstanceName>BENZOCAINE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-12-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160712</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>65923-119-01</NDCCode>
<PackageDescription>.02 g in 1 TUBE (65923-119-01) </PackageDescription>
<NDC11Code>65923-0119-01</NDC11Code>
<ProductNDC>65923-119</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Family Care Pain Relief</ProprietaryName>
<NonProprietaryName>Menthol</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20181030</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>United Exchange Corporation</LabelerName>
<SubstanceName>MENTHOL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181030</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Directions: 1 adults and children 12 years of age and older:, 2 clean and dry affected area, 3 apply generously to affected area, 4 massage into painful area until thoroughly absorbed into skin, 5 repeat as necessary, but not more than 4 times daily, 6 children under 12 years of age: consult a doctor.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0078-0684-15</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (0078-0684-15) </PackageDescription>
<NDC11Code>00078-0684-15</NDC11Code>
<ProductNDC>0078-0684</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promacta</ProprietaryName>
<NonProprietaryName>Eltrombopag Olamine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160822</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022291</ApplicationNumber>
<LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
<SubstanceName>ELTROMBOPAG OLAMINE</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Increased Megakaryocyte Maturation [PE], Increased Platelet Production [PE], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Thrombopoietin Receptor Agonist [EPC], Thrombopoietin Receptor Agonists [MoA], UGT1A1 Inhibitors [MoA], UGT1A3 Inhibitors [MoA], UGT1A4 Inhibitors [MoA], UGT1A6 Inhibitors [MoA], UGT1A9 Inhibitors [MoA], UGT2B15 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160822</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PROMACTA is a thrombopoietin receptor agonist indicated: 1 for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. PROMACTA should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. (1.1), 2 for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. PROMACTA should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy. (1.2), 3 in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia. (1.3), 4 for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. (1.3).</IndicationAndUsage>
<Description>PROMACTA (eltrombopag) tablets contain eltrombopag olamine, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag olamine is a biphenyl hydrazone. The chemical name for eltrombopag olamine is 3'-{(2Z)-2-[1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]hydrazino}-2'-hydroxy-3-biphenylcarboxylic acid - 2-aminoethanol (1:2). It has the molecular formula C25H22N4O4 2(C2H7NO). The molecular weight is 564.65 g/mol for eltrombopag olamine and 442.5 g/mol for eltrombopag free acid. Eltrombopag olamine has the following structural formula. Eltrombopag olamine is practically insoluble in aqueous buffer across a pH range of 1 to 7.4, and is sparingly soluble in water. PROMACTA (eltrombopag) tablets contain eltrombopag olamine in the amount equivalent to 12.5 mg, 25 mg, 50 mg, or 75 mg of eltrombopag free acid. The inactive ingredients of PROMACTA tablets are. Tablet Core: magnesium stearate, mannitol, microcrystalline cellulose, povidone, and sodium starch glycolate.Coating: FD&C Blue No. 2 aluminum lake (50-mg tablet), FD&C Yellow No. 6 aluminum lake (25-mg tablet), hypromellose, Iron Oxide Black and Iron Oxide Red (75-mg tablet), polyethylene glycol 400, polysorbate 80 (12.5-mg tablet), or titanium dioxide. PROMACTA (eltrombopag) for oral suspension packets contain a reddish-brown to yellow powder which produces a reddish-brown suspension when reconstituted with water. Each packet delivers eltrombopag olamine equivalent to 12.5 mg or 25 mg of eltrombopag free acid. The inactive ingredients of PROMACTA for oral suspension are mannitol, sucralose, and xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>0078-0685-15</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (0078-0685-15) </PackageDescription>
<NDC11Code>00078-0685-15</NDC11Code>
<ProductNDC>0078-0685</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promacta</ProprietaryName>
<NonProprietaryName>Eltrombopag Olamine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160524</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022291</ApplicationNumber>
<LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
<SubstanceName>ELTROMBOPAG OLAMINE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Increased Megakaryocyte Maturation [PE], Increased Platelet Production [PE], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Thrombopoietin Receptor Agonist [EPC], Thrombopoietin Receptor Agonists [MoA], UGT1A1 Inhibitors [MoA], UGT1A3 Inhibitors [MoA], UGT1A4 Inhibitors [MoA], UGT1A6 Inhibitors [MoA], UGT1A9 Inhibitors [MoA], UGT2B15 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160524</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PROMACTA is a thrombopoietin receptor agonist indicated: 1 for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. PROMACTA should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. (1.1), 2 for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. PROMACTA should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy. (1.2), 3 in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia. (1.3), 4 for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. (1.3).</IndicationAndUsage>
<Description>PROMACTA (eltrombopag) tablets contain eltrombopag olamine, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag olamine is a biphenyl hydrazone. The chemical name for eltrombopag olamine is 3'-{(2Z)-2-[1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]hydrazino}-2'-hydroxy-3-biphenylcarboxylic acid - 2-aminoethanol (1:2). It has the molecular formula C25H22N4O4 2(C2H7NO). The molecular weight is 564.65 g/mol for eltrombopag olamine and 442.5 g/mol for eltrombopag free acid. Eltrombopag olamine has the following structural formula. Eltrombopag olamine is practically insoluble in aqueous buffer across a pH range of 1 to 7.4, and is sparingly soluble in water. PROMACTA (eltrombopag) tablets contain eltrombopag olamine in the amount equivalent to 12.5 mg, 25 mg, 50 mg, or 75 mg of eltrombopag free acid. The inactive ingredients of PROMACTA tablets are. Tablet Core: magnesium stearate, mannitol, microcrystalline cellulose, povidone, and sodium starch glycolate.Coating: FD&C Blue No. 2 aluminum lake (50-mg tablet), FD&C Yellow No. 6 aluminum lake (25-mg tablet), hypromellose, Iron Oxide Black and Iron Oxide Red (75-mg tablet), polyethylene glycol 400, polysorbate 80 (12.5-mg tablet), or titanium dioxide. PROMACTA (eltrombopag) for oral suspension packets contain a reddish-brown to yellow powder which produces a reddish-brown suspension when reconstituted with water. Each packet delivers eltrombopag olamine equivalent to 12.5 mg or 25 mg of eltrombopag free acid. The inactive ingredients of PROMACTA for oral suspension are mannitol, sucralose, and xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>0078-0686-15</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (0078-0686-15) </PackageDescription>
<NDC11Code>00078-0686-15</NDC11Code>
<ProductNDC>0078-0686</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promacta</ProprietaryName>
<NonProprietaryName>Eltrombopag Olamine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160407</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022291</ApplicationNumber>
<LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
<SubstanceName>ELTROMBOPAG OLAMINE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Increased Megakaryocyte Maturation [PE], Increased Platelet Production [PE], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Thrombopoietin Receptor Agonist [EPC], Thrombopoietin Receptor Agonists [MoA], UGT1A1 Inhibitors [MoA], UGT1A3 Inhibitors [MoA], UGT1A4 Inhibitors [MoA], UGT1A6 Inhibitors [MoA], UGT1A9 Inhibitors [MoA], UGT2B15 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160407</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PROMACTA is a thrombopoietin receptor agonist indicated: 1 for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. PROMACTA should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. (1.1), 2 for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. PROMACTA should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy. (1.2), 3 in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia. (1.3), 4 for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. (1.3).</IndicationAndUsage>
<Description>PROMACTA (eltrombopag) tablets contain eltrombopag olamine, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag olamine is a biphenyl hydrazone. The chemical name for eltrombopag olamine is 3'-{(2Z)-2-[1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]hydrazino}-2'-hydroxy-3-biphenylcarboxylic acid - 2-aminoethanol (1:2). It has the molecular formula C25H22N4O4 2(C2H7NO). The molecular weight is 564.65 g/mol for eltrombopag olamine and 442.5 g/mol for eltrombopag free acid. Eltrombopag olamine has the following structural formula. Eltrombopag olamine is practically insoluble in aqueous buffer across a pH range of 1 to 7.4, and is sparingly soluble in water. PROMACTA (eltrombopag) tablets contain eltrombopag olamine in the amount equivalent to 12.5 mg, 25 mg, 50 mg, or 75 mg of eltrombopag free acid. The inactive ingredients of PROMACTA tablets are. Tablet Core: magnesium stearate, mannitol, microcrystalline cellulose, povidone, and sodium starch glycolate.Coating: FD&C Blue No. 2 aluminum lake (50-mg tablet), FD&C Yellow No. 6 aluminum lake (25-mg tablet), hypromellose, Iron Oxide Black and Iron Oxide Red (75-mg tablet), polyethylene glycol 400, polysorbate 80 (12.5-mg tablet), or titanium dioxide. PROMACTA (eltrombopag) for oral suspension packets contain a reddish-brown to yellow powder which produces a reddish-brown suspension when reconstituted with water. Each packet delivers eltrombopag olamine equivalent to 12.5 mg or 25 mg of eltrombopag free acid. The inactive ingredients of PROMACTA for oral suspension are mannitol, sucralose, and xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>0078-0686-55</NDCCode>
<PackageDescription>14 TABLET, FILM COATED in 1 BOTTLE (0078-0686-55) </PackageDescription>
<NDC11Code>00078-0686-55</NDC11Code>
<ProductNDC>0078-0686</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promacta</ProprietaryName>
<NonProprietaryName>Eltrombopag Olamine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160407</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022291</ApplicationNumber>
<LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
<SubstanceName>ELTROMBOPAG OLAMINE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Increased Megakaryocyte Maturation [PE], Increased Platelet Production [PE], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Thrombopoietin Receptor Agonist [EPC], Thrombopoietin Receptor Agonists [MoA], UGT1A1 Inhibitors [MoA], UGT1A3 Inhibitors [MoA], UGT1A4 Inhibitors [MoA], UGT1A6 Inhibitors [MoA], UGT1A9 Inhibitors [MoA], UGT2B15 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200121</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PROMACTA is a thrombopoietin receptor agonist indicated: 1 for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. PROMACTA should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. (1.1), 2 for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. PROMACTA should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy. (1.2), 3 in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia. (1.3), 4 for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. (1.3).</IndicationAndUsage>
<Description>PROMACTA (eltrombopag) tablets contain eltrombopag olamine, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag olamine is a biphenyl hydrazone. The chemical name for eltrombopag olamine is 3'-{(2Z)-2-[1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]hydrazino}-2'-hydroxy-3-biphenylcarboxylic acid - 2-aminoethanol (1:2). It has the molecular formula C25H22N4O4 2(C2H7NO). The molecular weight is 564.65 g/mol for eltrombopag olamine and 442.5 g/mol for eltrombopag free acid. Eltrombopag olamine has the following structural formula. Eltrombopag olamine is practically insoluble in aqueous buffer across a pH range of 1 to 7.4, and is sparingly soluble in water. PROMACTA (eltrombopag) tablets contain eltrombopag olamine in the amount equivalent to 12.5 mg, 25 mg, 50 mg, or 75 mg of eltrombopag free acid. The inactive ingredients of PROMACTA tablets are. Tablet Core: magnesium stearate, mannitol, microcrystalline cellulose, povidone, and sodium starch glycolate.Coating: FD&C Blue No. 2 aluminum lake (50-mg tablet), FD&C Yellow No. 6 aluminum lake (25-mg tablet), hypromellose, Iron Oxide Black and Iron Oxide Red (75-mg tablet), polyethylene glycol 400, polysorbate 80 (12.5-mg tablet), or titanium dioxide. PROMACTA (eltrombopag) for oral suspension packets contain a reddish-brown to yellow powder which produces a reddish-brown suspension when reconstituted with water. Each packet delivers eltrombopag olamine equivalent to 12.5 mg or 25 mg of eltrombopag free acid. The inactive ingredients of PROMACTA for oral suspension are mannitol, sucralose, and xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>0078-0687-15</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (0078-0687-15) </PackageDescription>
<NDC11Code>00078-0687-15</NDC11Code>
<ProductNDC>0078-0687</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promacta</ProprietaryName>
<NonProprietaryName>Eltrombopag Olamine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160401</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022291</ApplicationNumber>
<LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
<SubstanceName>ELTROMBOPAG OLAMINE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Increased Megakaryocyte Maturation [PE], Increased Platelet Production [PE], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Thrombopoietin Receptor Agonist [EPC], Thrombopoietin Receptor Agonists [MoA], UGT1A1 Inhibitors [MoA], UGT1A3 Inhibitors [MoA], UGT1A4 Inhibitors [MoA], UGT1A6 Inhibitors [MoA], UGT1A9 Inhibitors [MoA], UGT2B15 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PROMACTA is a thrombopoietin receptor agonist indicated: 1 for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. PROMACTA should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. (1.1), 2 for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. PROMACTA should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy. (1.2), 3 in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia. (1.3), 4 for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. (1.3).</IndicationAndUsage>
<Description>PROMACTA (eltrombopag) tablets contain eltrombopag olamine, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag olamine is a biphenyl hydrazone. The chemical name for eltrombopag olamine is 3'-{(2Z)-2-[1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]hydrazino}-2'-hydroxy-3-biphenylcarboxylic acid - 2-aminoethanol (1:2). It has the molecular formula C25H22N4O4 2(C2H7NO). The molecular weight is 564.65 g/mol for eltrombopag olamine and 442.5 g/mol for eltrombopag free acid. Eltrombopag olamine has the following structural formula. Eltrombopag olamine is practically insoluble in aqueous buffer across a pH range of 1 to 7.4, and is sparingly soluble in water. PROMACTA (eltrombopag) tablets contain eltrombopag olamine in the amount equivalent to 12.5 mg, 25 mg, 50 mg, or 75 mg of eltrombopag free acid. The inactive ingredients of PROMACTA tablets are. Tablet Core: magnesium stearate, mannitol, microcrystalline cellulose, povidone, and sodium starch glycolate.Coating: FD&C Blue No. 2 aluminum lake (50-mg tablet), FD&C Yellow No. 6 aluminum lake (25-mg tablet), hypromellose, Iron Oxide Black and Iron Oxide Red (75-mg tablet), polyethylene glycol 400, polysorbate 80 (12.5-mg tablet), or titanium dioxide. PROMACTA (eltrombopag) for oral suspension packets contain a reddish-brown to yellow powder which produces a reddish-brown suspension when reconstituted with water. Each packet delivers eltrombopag olamine equivalent to 12.5 mg or 25 mg of eltrombopag free acid. The inactive ingredients of PROMACTA for oral suspension are mannitol, sucralose, and xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>0078-0697-61</NDCCode>
<PackageDescription>1 CARTON in 1 KIT (0078-0697-61) / 30 PACKET in 1 CARTON (0078-0697-23) / 1 POWDER, FOR SUSPENSION in 1 PACKET (0078-0697-19) </PackageDescription>
<NDC11Code>00078-0697-61</NDC11Code>
<ProductNDC>0078-0697</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promacta</ProprietaryName>
<NonProprietaryName>Eltrombopag Olamine</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180927</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207027</ApplicationNumber>
<LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
<SubstanceName>ELTROMBOPAG OLAMINE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Increased Megakaryocyte Maturation [PE], Increased Platelet Production [PE], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Thrombopoietin Receptor Agonist [EPC], Thrombopoietin Receptor Agonists [MoA], UGT1A1 Inhibitors [MoA], UGT1A3 Inhibitors [MoA], UGT1A4 Inhibitors [MoA], UGT1A6 Inhibitors [MoA], UGT1A9 Inhibitors [MoA], UGT2B15 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200327</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PROMACTA is a thrombopoietin receptor agonist indicated: 1 for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. PROMACTA should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. (1.1), 2 for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. PROMACTA should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy. (1.2), 3 in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia. (1.3), 4 for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. (1.3).</IndicationAndUsage>
<Description>PROMACTA (eltrombopag) tablets contain eltrombopag olamine, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag olamine is a biphenyl hydrazone. The chemical name for eltrombopag olamine is 3'-{(2Z)-2-[1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]hydrazino}-2'-hydroxy-3-biphenylcarboxylic acid - 2-aminoethanol (1:2). It has the molecular formula C25H22N4O4 2(C2H7NO). The molecular weight is 564.65 g/mol for eltrombopag olamine and 442.5 g/mol for eltrombopag free acid. Eltrombopag olamine has the following structural formula. Eltrombopag olamine is practically insoluble in aqueous buffer across a pH range of 1 to 7.4, and is sparingly soluble in water. PROMACTA (eltrombopag) tablets contain eltrombopag olamine in the amount equivalent to 12.5 mg, 25 mg, 50 mg, or 75 mg of eltrombopag free acid. The inactive ingredients of PROMACTA tablets are. Tablet Core: magnesium stearate, mannitol, microcrystalline cellulose, povidone, and sodium starch glycolate.Coating: FD&C Blue No. 2 aluminum lake (50-mg tablet), FD&C Yellow No. 6 aluminum lake (25-mg tablet), hypromellose, Iron Oxide Black and Iron Oxide Red (75-mg tablet), polyethylene glycol 400, polysorbate 80 (12.5-mg tablet), or titanium dioxide. PROMACTA (eltrombopag) for oral suspension packets contain a reddish-brown to yellow powder which produces a reddish-brown suspension when reconstituted with water. Each packet delivers eltrombopag olamine equivalent to 12.5 mg or 25 mg of eltrombopag free acid. The inactive ingredients of PROMACTA for oral suspension are mannitol, sucralose, and xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>0078-0972-61</NDCCode>
<PackageDescription>1 CARTON in 1 KIT (0078-0972-61) / 30 PACKET in 1 CARTON (0078-0972-23) / 1 POWDER, FOR SUSPENSION in 1 PACKET (0078-0972-19) </PackageDescription>
<NDC11Code>00078-0972-61</NDC11Code>
<ProductNDC>0078-0972</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Promacta</ProprietaryName>
<NonProprietaryName>Eltrombopag Olamine</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180927</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207027</ApplicationNumber>
<LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
<SubstanceName>ELTROMBOPAG OLAMINE</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Breast Cancer Resistance Protein Inhibitors [MoA], Increased Megakaryocyte Maturation [PE], Increased Platelet Production [PE], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Thrombopoietin Receptor Agonist [EPC], Thrombopoietin Receptor Agonists [MoA], UGT1A1 Inhibitors [MoA], UGT1A3 Inhibitors [MoA], UGT1A4 Inhibitors [MoA], UGT1A6 Inhibitors [MoA], UGT1A9 Inhibitors [MoA], UGT2B15 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180927</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PROMACTA is a thrombopoietin receptor agonist indicated: 1 for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. PROMACTA should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. (1.1), 2 for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. PROMACTA should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy. (1.2), 3 in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia. (1.3), 4 for the treatment of patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. (1.3).</IndicationAndUsage>
<Description>PROMACTA (eltrombopag) tablets contain eltrombopag olamine, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag olamine is a biphenyl hydrazone. The chemical name for eltrombopag olamine is 3'-{(2Z)-2-[1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4H-pyrazol-4-ylidene]hydrazino}-2'-hydroxy-3-biphenylcarboxylic acid - 2-aminoethanol (1:2). It has the molecular formula C25H22N4O4 2(C2H7NO). The molecular weight is 564.65 g/mol for eltrombopag olamine and 442.5 g/mol for eltrombopag free acid. Eltrombopag olamine has the following structural formula. Eltrombopag olamine is practically insoluble in aqueous buffer across a pH range of 1 to 7.4, and is sparingly soluble in water. PROMACTA (eltrombopag) tablets contain eltrombopag olamine in the amount equivalent to 12.5 mg, 25 mg, 50 mg, or 75 mg of eltrombopag free acid. The inactive ingredients of PROMACTA tablets are. Tablet Core: magnesium stearate, mannitol, microcrystalline cellulose, povidone, and sodium starch glycolate.Coating: FD&C Blue No. 2 aluminum lake (50-mg tablet), FD&C Yellow No. 6 aluminum lake (25-mg tablet), hypromellose, Iron Oxide Black and Iron Oxide Red (75-mg tablet), polyethylene glycol 400, polysorbate 80 (12.5-mg tablet), or titanium dioxide. PROMACTA (eltrombopag) for oral suspension packets contain a reddish-brown to yellow powder which produces a reddish-brown suspension when reconstituted with water. Each packet delivers eltrombopag olamine equivalent to 12.5 mg or 25 mg of eltrombopag free acid. The inactive ingredients of PROMACTA for oral suspension are mannitol, sucralose, and xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>10544-564-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (10544-564-30)</PackageDescription>
<NDC11Code>10544-0564-30</NDC11Code>
<ProductNDC>10544-564</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisinopril And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Lisinopril And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100504</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077912</ApplicationNumber>
<LabelerName>Blenheim Pharmacal, Inc.</LabelerName>
<SubstanceName>LISINOPRIL; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>20; 12.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Lisinopril and hydrochlorothiazide tablets are indicated for the treatment of hypertension. These fixed-dose combinations are not indicated for initial therapy (see DOSAGE AND ADMINISTRATION). In using lisinopril and hydrochlorothiazide tablets, consideration should be given to the fact that an angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that lisinopril does not have a similar risk. (See WARNINGS.). In considering use of lisinopril and hydrochlorothiazide tablets, it should be noted that Black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to non-Blacks. (See WARNINGS, Head and Neck Angioedema.).</IndicationAndUsage>
<Description>Lisinopril and hydrochlorothiazide tablets combines an angiotensin converting enzyme inhibitor, lisinopril, and a diuretic, hydrochlorothiazide. Lisinopril, a synthetic peptide derivative, is an oral long-acting angiotensin converting enzyme inhibitor. It is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21H31N3O52H2O and its structural formula is. Lisinopril is a white to off-white, crystalline powder, with a molecular weight of 441.52. It is soluble in water, sparingly soluble in methanol, and practically insoluble in ethanol. Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide is a white, or practically white, crystalline powder with a molecular weight of 297.73, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Lisinopril and hydrochlorothiazide tablets are available for oral use in three tablet combinations of lisinopril with hydrochlorothiazide: lisinopril and hydrochlorothiazide tablets 10 mg/12.5 mg, containing 10 mg lisinopril and 12.5 mg hydrochlorothiazide, lisinopril and hydrochlorothiazide tablets 20 mg/12.5 mg, containing 20 mg lisinopril and 12.5 mg hydrochlorothiazide and lisinopril and hydrochlorothiazide tablets 20 mg/25 mg, containing 20 mg lisinopril and 25 mg hydrochlorothiazide. Inactive ingredients are dibasic calcium phosphate, magnesium stearate, mannitol, pregelatinized starch and starch. Lisinopril and hydrochlorothiazide tablets 10 mg/12.5 mg also contains FD&C Blue No. 2 Aluminum Lake. Lisinopril and hydrochlorothiazide tablets 20 mg/12.5 mg also contains yellow iron oxide and lisinopril and hydrochlorothiazide tablets 20 mg/25 mg also contain red iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>16714-564-01</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (16714-564-01) </PackageDescription>
<NDC11Code>16714-0564-01</NDC11Code>
<ProductNDC>16714-564</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dexmethylphenidate Hydrochloride</ProprietaryName>
<NonProprietaryName>Dexmethylphenidate Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220121</StartMarketingDate>
<EndMarketingDate>20250731</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206734</ApplicationNumber>
<LabelerName>Northstar Rx LLC</LabelerName>
<SubstanceName>DEXMETHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20220121</StartMarketingDatePackage>
<EndMarketingDatePackage>20250731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dexmethylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [ see Clinical Studies ( 14)].</IndicationAndUsage>
<Description>Dexmethylphenidate hydrochloride extended-release capsules contain dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the d- threoenantiomer of racemic methylphenidate hydrochloride. Dexmethylphenidate hydrochloride extended-release capsules are an extended-release formulation of dexmethylphenidate with a bi-modal release profile. Each bead-filled dexmethylphenidate hydrochloride extended-release capsule contains half the dose as immediate-release beads and half as enteric-coated, delayed-release beads, thus providing an immediate release of dexmethylphenidate and a delayed release of dexmethylphenidate. Dexmethylphenidate hydrochloride extended-release capsules are intended for oral administration and are available as 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg, 35 mg, and 40 mg extended-release capsules. Chemically, dexmethylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, (R,R’)-(+)-. Its molecular formula is C 14H 19NO 2HCl. Its structural formula is:. Note* = asymmetric carbon center. Dexmethylphenidate hydrochloride is a white to off-white powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Inactive ingredients: ammonio methacrylate copolymer (Type B), black iron oxide, D&C Red No. 28 (15 mg, and 40 mg strengths), FD&C Blue No. 1 (15 mg, and 40 mg strengths), FD&C Blue No. 2 (5 mg, 25 mg, and 35 mg strengths), gelatin, hypromellose, methacrylic acid and methyl methacrylate copolymer (1:1), methacrylic acid and methyl methacrylate copolymer (1:2), polyethylene glycol, propylene glycol, shellac, sugar spheres, talc, titanium dioxide, triethyl citrate, and yellow iron oxide (10 mg, 15 mg, 30 mg, 35 mg, and 40 mg strengths).</Description>
</NDC>
<NDC>
<NDCCode>43598-599-60</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE (43598-599-60) </PackageDescription>
<NDC11Code>43598-0599-60</NDC11Code>
<ProductNDC>43598-599</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dasatinib</ProprietaryName>
<NonProprietaryName>Dasatinib</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250303</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213383</ApplicationNumber>
<LabelerName>Dr.Reddys Laboratories Inc</LabelerName>
<SubstanceName>DASATINIB</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250303</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dasatinib tablets are indicated for the treatment of adult patients with. newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. Dasatinib tablets are indicated for the treatment of pediatric patients 1 year of age and older with Ph+ CML in chronic phase. newly diagnosed Ph+ ALL in combination with chemotherapy.</IndicationAndUsage>
<Description>Dasatinib is a kinase inhibitor. The chemical name for dasatinib (S)-propylene glycol is N-(2-chloro-6-methylphenyl)-2-[[6-[4-(2-hydroxyethyl)-1-piperazinyl]-2-methyl-4-pyrimidinyl]amino]-5-thiazolecarboxamide S-1, 2-Propanediol. The molecular formula is C22H26ClN7O2S C3H8O2, which corresponds to a formula weight of 564.11 ((S)-Propylene Glycol). The free base has a molecular weight of 488.01. Dasatinib (S)-propylene glycol has the following chemical structure:. Dasatinib (S)-propylene glycol is a white to brown colored powder. The drug substance is freely soluble in dimethyl formamide & N-methyl-2-pyrrolodine while practically insoluble in dichloromethane, methanol, ethanol, acetone, n-heptane, n-hexane, tertrahydrofuran, toluene, ethyl acetate, petroleum ether, (S)-propylene glycol and water. Dasatinib tablets are white to off-white, round/oval, film-coated tablets containing dasatinib (S)-propylene glycol, with the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, hydrogenated castor oil, magnesium stearate and microcrystalline cellulose. The tablet coating consists of hypromellose, titanium dioxide, and triacetin.</Description>
</NDC>
</NDCList>