{
"NDC": [
{
"NDCCode": "52490-300-27",
"PackageDescription": "2000 PACKET in 1 BOX (52490-300-27) > 2 mL in 1 PACKET",
"NDC11Code": "52490-0300-27",
"ProductNDC": "52490-300",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "B4 Hand Sanitizer Alcohol-free",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20151021",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "MIDWAY ADVANCED PRODUCTS LLC",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "1.3",
"StrengthUnit": "mg/100mL",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "52490-400-27",
"PackageDescription": "2000 PACKET in 1 BOX (52490-400-27) > .7 mL in 1 PACKET",
"NDC11Code": "52490-0400-27",
"ProductNDC": "52490-400",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "B4 Hand Sanitizer Alcohol-free",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160517",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "MIDWAY ADVANCED PRODUCTS LLC",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "1.3",
"StrengthUnit": "mg/100mL",
"Status": "Deprecated",
"LastUpdate": "2017-12-13",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "52490-300-06",
"PackageDescription": "500 PACKET in 1 BOX (52490-300-06) > 1.2 mL in 1 PACKET",
"NDC11Code": "52490-0300-06",
"ProductNDC": "52490-300",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "B4 Hand Sanitizer Alcohol-free",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20151021",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "MIDWAY ADVANCED PRODUCTS LLC",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "1.3",
"StrengthUnit": "mg/100mL",
"Status": "Deprecated",
"LastUpdate": "2017-12-13",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "52490-300-07",
"PackageDescription": "15 mL in 1 TUBE (52490-300-07)",
"NDC11Code": "52490-0300-07",
"ProductNDC": "52490-300",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "B4 Hand Sanitizer Alcohol-free",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20151021",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "MIDWAY ADVANCED PRODUCTS LLC",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "1.3",
"StrengthUnit": "mg/100mL",
"Status": "Deprecated",
"LastUpdate": "2017-12-13",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "52490-300-28",
"PackageDescription": "500 PACKET in 1 BOX (52490-300-28) > 2 mL in 1 PACKET",
"NDC11Code": "52490-0300-28",
"ProductNDC": "52490-300",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "B4 Hand Sanitizer Alcohol-free",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20151021",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "MIDWAY ADVANCED PRODUCTS LLC",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "1.3",
"StrengthUnit": "mg/100mL",
"Status": "Deprecated",
"LastUpdate": "2017-12-13",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "11084-300-27",
"PackageDescription": "1000 mL in 1 BOTTLE, PLASTIC (11084-300-27) ",
"NDC11Code": "11084-0300-27",
"ProductNDC": "11084-300",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Instant Foam Non-alcohol Pure Hand Sanitizer",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150415",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "SC Johnson Professional USA, Inc.",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".13",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200415",
"EndMarketingDatePackage": "20241231",
"SamplePackage": "N",
"IndicationAndUsage": "to decrease bacteria on the skin that could cause disease."
},
{
"NDCCode": "12784-300-27",
"PackageDescription": "205 kg in 1 CONTAINER (12784-300-27)",
"NDC11Code": "12784-0300-27",
"ProductNDC": "12784-300",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Aluminum Hydroxide",
"DosageFormName": "GEL",
"StartMarketingDate": "20100422",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "SPI Pharma, Inc.",
"SubstanceName": "ALGELDRATE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "42291-300-27",
"PackageDescription": "270 CAPSULE in 1 BOTTLE (42291-300-27)",
"NDC11Code": "42291-0300-27",
"ProductNDC": "42291-300",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20120504",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078428",
"LabelerName": "AvKARE, Inc.",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2016-01-22"
},
{
"NDCCode": "51619-300-25",
"PackageDescription": "2.27 kg in 1 BAG (51619-300-25)",
"NDC11Code": "51619-0300-25",
"ProductNDC": "51619-300",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pepsom Sports Wintergreen",
"NonProprietaryName": "Magnesium Sulfate",
"DosageFormName": "FOR SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20080905",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "The Pepsom Group, Inc.",
"SubstanceName": "MAGNESIUM SULFATE, UNSPECIFIED",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "For relieving muscle strains and soreness from working out."
},
{
"NDCCode": "57817-300-27",
"PackageDescription": "6 g in 1 PACKAGE (57817-300-27)",
"NDC11Code": "57817-0300-27",
"ProductNDC": "57817-300",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Spf 30 Sunscreen",
"NonProprietaryName": "Octinoxate Oxybenzone Octisalate",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130418",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Hangzhou Haorun Technology CO.,LTD.",
"SubstanceName": "OCTINOXATE; OXYBENZONE; OCTISALATE",
"StrengthNumber": "6; 4; 5",
"StrengthUnit": "g/100g; g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Protection from the sun’s damaging effects."
},
{
"NDCCode": "62672-300-27",
"PackageDescription": "800 mL in 1 CARTRIDGE (62672-300-27) ",
"NDC11Code": "62672-0300-27",
"ProductNDC": "62672-300",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Osceola Supply Inc 6176",
"NonProprietaryName": "Chloroxylenol",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160722",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "OSCEOLA SUPPLY, INC.",
"SubstanceName": "CHLOROXYLENOL",
"StrengthNumber": "6",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2025-11-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160722",
"SamplePackage": "N",
"IndicationAndUsage": "for hand-washing to decrease bacteria on the skin."
},
{
"NDCCode": "63187-300-27",
"PackageDescription": "27 TABLET in 1 BOTTLE (63187-300-27) ",
"NDC11Code": "63187-0300-27",
"ProductNDC": "63187-300",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prednisone",
"NonProprietaryName": "Prednisone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20010829",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040362",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "PREDNISONE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2023-09-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20171101",
"SamplePackage": "N",
"IndicationAndUsage": "Prednisone Tablets, USP are indicated in the following conditions. 1. Endocrine Disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance). Congenital adrenal hyperplasiaNonsuppurative thyroiditis. 2. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in. Psoriatic arthritisRheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)Ankylosing spondylitisAcute and subacute bursitisAcute nonspecific tenosynovitis Acute gouty arthritisPost-traumatic osteoarthritis Synovitis of osteoarthritisEpicondylitis. 3. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of. Systemic lupus erythematosusSystemic derznatomyositis (polymyositis)Acute rheumatic carditis. 4. Dermatologic Diseases. PemphigusBullous dermatitis herpetiformisSevere erythema multiforme (Stevens-Johnson syndrome)Exfoliative dermatitisMycosis fungoidesSevere psoriasisSevere seborrheic dermatitis. 5. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment. Seasonal or perennial allergic rhinitisBronchial asthmaContact dermatitisAtopic dermatitis Serum sickness Drug hypersensitivity reactions. 6. Ophthalmic Diseases. Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as. Allergic corneal marginal ulcersHerpes zoster ophthalmicusAnterior segment inflammationDiffuse posterior uveitis and choroiditisSympathetic ophthalmiaAllergic conjunctivitisKeratitisChorioretinitisOptic neuritisIritis and iridocyclitis. 7. Respiratory Diseases. Symptomatic sarcoidosisLoeffler’s syndrome not manageable by other meansBerylliosisFulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy.Aspiration pneumonitis. 8. Hematologic Disorders. Idiopathic thrombocytopenic purpura in adultsSecondary thrombocytopenia in adultsAcquired (autoimmune) hemolytic anemiaErythroblastopenia (RBC anemia)Congenital (erythroid) hypoplastic anemia. 9. Neoplastic Diseases. For palliative management of. Leukemias and lymphomas in adultsAcute leukemia of childhood. 10. Edematous States. To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 11. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in. Ulcerative colitisRegional enteritis. 12. Nervous System. Acute exacerbations of multiple sclerosis. 13. Miscellaneous. Tuberculous meningitis with subarachnoid block or, impending block when used concurrently with appropriate antituberculous chemotherapy Trichinosis with neurologic or myocardial involvement.",
"Description": "Prednisone is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, in chloroform, in dioxane, and in methanol. The chemical name for prednisone is pregna-1, 4-diene-3, 11, 20-trione, 17, 21-dihydroxy-. The structural formula is represented below. Molecular weight: 358.44. Prednisone Tablets, USP are available in three strengths: 5 mg, 10 mg, and 20 mg. In addition, each tablet contains the following Inactive Ingredients: Lactose Monohydrate, Magnesium Stearate, Pregelatinized Starch, Sodium Lauryl Sulfate and Sodium Starch Glycolate. Also Prednisone Tablets USP, 20 mg contains FD & C yellow #6 aluminum lake HT 15-18%."
},
{
"NDCCode": "64169-001-27",
"PackageDescription": "300 L in 1 DEWAR (64169-001-27) ",
"NDC11Code": "64169-0001-27",
"ProductNDC": "64169-001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxygen",
"NonProprietaryName": "Oxygen",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19971001",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205767",
"LabelerName": "EUGENE WELDERS SUPPLY CO",
"SubstanceName": "OXYGEN",
"StrengthNumber": "990",
"StrengthUnit": "mL/L",
"Status": "Active",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19971001",
"SamplePackage": "N"
},
{
"NDCCode": "69863-300-27",
"PackageDescription": "798 mL in 1 BOTTLE, PLASTIC (69863-300-27) ",
"NDC11Code": "69863-0300-27",
"ProductNDC": "69863-300",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "HATCHBEAUTY PRODUCTS, LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "80",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2020-06-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200420",
"SamplePackage": "N"
},
{
"NDCCode": "73069-300-27",
"PackageDescription": "25 VIAL, MULTI-DOSE in 1 BOX (73069-300-27) > 2 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "73069-0300-27",
"ProductNDC": "73069-300",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Viatrexx-liver",
"NonProprietaryName": "Carduus Benedictus, Carduus Marianus, Ceanothus Americanus, Chelidonium Majus, Chionanthus Virginica, Choline, Coelliac Plexus, Duodenum, Fumaric Acid, Gall Bladder, Inositol, Il 4, Kalium Sulfuricum, Liver, Lycopodium Clavatum, Natrium Oxalaceticum, Natrium Pyruvicum, Natrium Sulphuricum, Niacin, Pancreas, Spleen, Taraxacum, Vein, Vitamin B1, Vitamin B12, Vitamin B2, Vitamin B6",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "CENTAUREA BENEDICTA; MILK THISTLE; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CHOLINE; BOS TAURUS SOLAR PLEXUS; SUS SCROFA SOLAR PLEXUS; BOS TAURUS DUODENUM; SUS SCROFA DUODENUM; FUMARIC ACID; BOS TAURUS GALLBLADDER; SUS SCROFA GALLBLADDER; INOSITOL; BINETRAKIN; POTASSIUM SULFATE; BEEF LIVER; PORK LIVER; LYCOPODIUM CLAVATUM SPORE; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SODIUM SULFATE; NIACIN; BOS TAURUS PANCREAS; SUS SCROFA PANCREAS; BOS TAURUS SPLEEN; SUS SCROFA SPLEEN; TARAXACUM OFFICINALE; BOS TAURUS VEIN; SUS SCROFA VEIN; THIAMINE; CYANOCOBALAMIN; RIBOFLAVIN; PYRIDOXINE",
"StrengthNumber": "31; 31; 4; 31; 4; 31; 201; 201; 31; 31; 31; 31; 31; 31; 201; 31; 201; 201; 31; 31; 31; 31; 31; 201; 201; 201; 201; 31; 31; 31; 31; 31; 31; 31",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Nicotinic Acid [EPC],Nicotinic Acids [CS],Vitamin B 12 [CS],Vitamin B12 [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190506",
"SamplePackage": "N"
},
{
"NDCCode": "75990-300-27",
"PackageDescription": "800 mL in 1 CARTRIDGE (75990-300-27)",
"NDC11Code": "75990-0300-27",
"ProductNDC": "75990-300",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Purgo Ultra Pc",
"NonProprietaryName": "Chloroxylenol",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110425",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Certus Medical, Inc.",
"SubstanceName": "CHLOROXYLENOL",
"StrengthNumber": "6",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "for hand-washing to decrease bacteria on the skin."
},
{
"NDCCode": "79467-101-27",
"PackageDescription": "300 CLOTH in 1 PAIL (79467-101-27) ",
"NDC11Code": "79467-0101-27",
"ProductNDC": "79467-101",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "75% Alcohol Sanitary Wipes",
"NonProprietaryName": "Alcohol",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Shandong Qingran Biological Technology Co., Ltd.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "3.15",
"StrengthUnit": "mL/1",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200330",
"SamplePackage": "N",
"IndicationAndUsage": "75% alcohol sanitary wipes to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "79467-201-27",
"PackageDescription": "300 CLOTH in 1 PAIL (79467-201-27) ",
"NDC11Code": "79467-0201-27",
"ProductNDC": "79467-201",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sanitary Wipes",
"NonProprietaryName": "Didecyl Dimethyl Ammonium Chloride",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Shandong Qingran Biological Technology Co., Ltd.",
"SubstanceName": "BENZALKONIUM CHLORIDE; DIDECYLDIMONIUM CHLORIDE",
"StrengthNumber": "1.89; 1.68",
"StrengthUnit": "ug/1; ug/1",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200330",
"SamplePackage": "N",
"IndicationAndUsage": "Sanitary wipes to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "0002-1220-48",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CAN (0002-1220-48) / 100 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "00002-1220-48",
"ProductNDC": "0002-1220",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tauvid",
"NonProprietaryName": "Flortaucipir F-18",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220701",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA212123",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "FLORTAUCIPIR F-18",
"StrengthNumber": "100",
"StrengthUnit": "mCi/mL",
"Status": "Active",
"LastUpdate": "2026-01-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20221025",
"SamplePackage": "N",
"IndicationAndUsage": "TAUVID is indicated for use with positron emission tomography (PET) imaging of the brain to estimate the density and distribution of aggregated tau neurofibrillary tangles (NFTs) in adult patients with cognitive impairment who are being evaluated for Alzheimer's disease (AD).",
"Description": "TAUVID contains flortaucipir fluorine 18 (F 18). Chemically, flortaucipir F 18 is 7-(6-[F-18]fluoropyridin-3-yl)-5H-pyrido[4,3-b]indole. The molecular weight is 262.27, the molecular formula is C16H10[18F]N3, and the structural formula is:. TAUVID is a sterile, non-pyrogenic solution for intravenous injection. The clear, colorless solution free of visible particulate matter is supplied ready to use, and each milliliter contains up to 2 micrograms of flortaucipir and 300 to 3,700 MBq (8.1 to 100 mCi) flortaucipir F 18 at end of synthesis, 1.5 mg of L-cysteine hydrochloride monohydrate USP, 2.1 mg of dibasic sodium phosphate anhydrous USP, up to 55 of micrograms hydrogen chloride and 0.1 mL dehydrated alcohol in 0.9% sodium chloride injection USP. The pH of the solution is between 5.5 and 7.5."
},
{
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"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CAN (0002-1220-50) / 50 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "00002-1220-50",
"ProductNDC": "0002-1220",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tauvid",
"NonProprietaryName": "Flortaucipir F-18",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220701",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA212123",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "FLORTAUCIPIR F-18",
"StrengthNumber": "100",
"StrengthUnit": "mCi/mL",
"Status": "Active",
"LastUpdate": "2026-01-14",
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"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
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"IndicationAndUsage": "TAUVID is indicated for use with positron emission tomography (PET) imaging of the brain to estimate the density and distribution of aggregated tau neurofibrillary tangles (NFTs) in adult patients with cognitive impairment who are being evaluated for Alzheimer's disease (AD).",
"Description": "TAUVID contains flortaucipir fluorine 18 (F 18). Chemically, flortaucipir F 18 is 7-(6-[F-18]fluoropyridin-3-yl)-5H-pyrido[4,3-b]indole. The molecular weight is 262.27, the molecular formula is C16H10[18F]N3, and the structural formula is:. TAUVID is a sterile, non-pyrogenic solution for intravenous injection. The clear, colorless solution free of visible particulate matter is supplied ready to use, and each milliliter contains up to 2 micrograms of flortaucipir and 300 to 3,700 MBq (8.1 to 100 mCi) flortaucipir F 18 at end of synthesis, 1.5 mg of L-cysteine hydrochloride monohydrate USP, 2.1 mg of dibasic sodium phosphate anhydrous USP, up to 55 of micrograms hydrogen chloride and 0.1 mL dehydrated alcohol in 0.9% sodium chloride injection USP. The pH of the solution is between 5.5 and 7.5."
},
{
"NDCCode": "0013-2626-81",
"PackageDescription": "1 CARTRIDGE in 1 CARTON (0013-2626-81) / 1 KIT in 1 CARTRIDGE",
"NDC11Code": "00013-2626-81",
"ProductNDC": "0013-2626",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Genotropin",
"NonProprietaryName": "Somatropin",
"DosageFormName": "KIT",
"StartMarketingDate": "19951220",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA020280",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"Status": "Active",
"LastUpdate": "2026-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19951220",
"SamplePackage": "N",
"IndicationAndUsage": "GENOTROPIN is a recombinant human growth hormone indicated for: 1 Pediatric: Treatment of children with growth failure due to growth hormone deficiency (GHD), Prader-Willi syndrome, Small for Gestational Age, Turner syndrome, and Idiopathic Short Stature (1.1), 2 Adult: Treatment of adults with either adult onset or childhood onset GHD (1.2).",
"Description": "Somatropin is a human growth hormone produced by recombinant DNA technology in Escherichia coli. The protein is comprised of 191 amino acid residues and has a molecular weight of 22,124 daltons. The amino acid sequence is identical to that of human growth hormone of pituitary origin. GENOTROPIN (somatropin) for injection is a sterile, white, lyophilized powder in a single-patient-use or single-dose, two-chamber cartridge intended for subcutaneous injection after reconstitution. The front chamber contains somatropin and the rear chamber contains diluent. GENOTROPIN 5 mg is a single-patient-use, two-chamber cartridge. GENOTROPIN 5 mg is designed for use with a reusable device (GENOTROPIN PEN 5) for product reconstitution and drug delivery. After reconstitution, each mL contains 5 mg of somatropin, dibasic sodium phosphate (0.27 mg), glycine (2 mg), mannitol (41 mg), metacresol (3 mg) (as a preservative), monobasic sodium phosphate (0.28 mg) and water for injection. The reconstituted concentration is 5 mg/mL with a deliverable volume of 1 mL. GENOTROPIN 12 mg is a single‑patient‑use, two-chamber cartridge. GENOTROPIN 12 mg is designed for use with a reusable device (GENOTROPIN PEN 12) for product reconstitution and drug delivery. After reconstitution, each mL contains 12 mg of somatropin, dibasic sodium phosphate (0.4 mg), glycine (2 mg), mannitol (40 mg), metacresol (3 mg) (as a preservative), monobasic sodium phosphate (0.41 mg) and water for injection. The reconstituted concentration is 12 mg/mL with a deliverable volume of 1 mL. GENOTROPIN MINIQUICK is a single-dose Growth Hormone Delivery Device containing a two-chamber cartridge supplied in the following strengths: 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1 mg, 1.2 mg, 1.4 mg, 1.6 mg, 1.8 mg, or 2 mg. After reconstitution, each 0.25 mL contains 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1 mg, 1.2 mg, 1.4 mg, 1.6 mg, 1.8 mg, or 2 mg of somatropin, dibasic sodium phosphate (0.03 mg), glycine (0.21 mg), mannitol (12.5 mg), monobasic sodium phosphate (0.05 mg) and water for injection. Each cartridge provides a deliverable volume of 0.25 mL. The reconstituted recombinant somatropin solution has an osmolality of approximately 300 mOsm/kg, and a pH of approximately 6.7."
},
{
"NDCCode": "0013-2646-81",
"PackageDescription": "1 CARTRIDGE in 1 CARTON (0013-2646-81) / 1 KIT in 1 CARTRIDGE",
"NDC11Code": "00013-2646-81",
"ProductNDC": "0013-2646",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Genotropin",
"NonProprietaryName": "Somatropin",
"DosageFormName": "KIT",
"StartMarketingDate": "19951220",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA020280",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"Status": "Active",
"LastUpdate": "2026-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19951220",
"SamplePackage": "N",
"IndicationAndUsage": "GENOTROPIN is a recombinant human growth hormone indicated for: 1 Pediatric: Treatment of children with growth failure due to growth hormone deficiency (GHD), Prader-Willi syndrome, Small for Gestational Age, Turner syndrome, and Idiopathic Short Stature (1.1), 2 Adult: Treatment of adults with either adult onset or childhood onset GHD (1.2).",
"Description": "Somatropin is a human growth hormone produced by recombinant DNA technology in Escherichia coli. The protein is comprised of 191 amino acid residues and has a molecular weight of 22,124 daltons. The amino acid sequence is identical to that of human growth hormone of pituitary origin. GENOTROPIN (somatropin) for injection is a sterile, white, lyophilized powder in a single-patient-use or single-dose, two-chamber cartridge intended for subcutaneous injection after reconstitution. The front chamber contains somatropin and the rear chamber contains diluent. GENOTROPIN 5 mg is a single-patient-use, two-chamber cartridge. GENOTROPIN 5 mg is designed for use with a reusable device (GENOTROPIN PEN 5) for product reconstitution and drug delivery. After reconstitution, each mL contains 5 mg of somatropin, dibasic sodium phosphate (0.27 mg), glycine (2 mg), mannitol (41 mg), metacresol (3 mg) (as a preservative), monobasic sodium phosphate (0.28 mg) and water for injection. The reconstituted concentration is 5 mg/mL with a deliverable volume of 1 mL. GENOTROPIN 12 mg is a single‑patient‑use, two-chamber cartridge. GENOTROPIN 12 mg is designed for use with a reusable device (GENOTROPIN PEN 12) for product reconstitution and drug delivery. After reconstitution, each mL contains 12 mg of somatropin, dibasic sodium phosphate (0.4 mg), glycine (2 mg), mannitol (40 mg), metacresol (3 mg) (as a preservative), monobasic sodium phosphate (0.41 mg) and water for injection. The reconstituted concentration is 12 mg/mL with a deliverable volume of 1 mL. GENOTROPIN MINIQUICK is a single-dose Growth Hormone Delivery Device containing a two-chamber cartridge supplied in the following strengths: 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1 mg, 1.2 mg, 1.4 mg, 1.6 mg, 1.8 mg, or 2 mg. After reconstitution, each 0.25 mL contains 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1 mg, 1.2 mg, 1.4 mg, 1.6 mg, 1.8 mg, or 2 mg of somatropin, dibasic sodium phosphate (0.03 mg), glycine (0.21 mg), mannitol (12.5 mg), monobasic sodium phosphate (0.05 mg) and water for injection. Each cartridge provides a deliverable volume of 0.25 mL. The reconstituted recombinant somatropin solution has an osmolality of approximately 300 mOsm/kg, and a pH of approximately 6.7."
},
{
"NDCCode": "0013-2649-02",
"PackageDescription": "7 CARTRIDGE in 1 CARTON (0013-2649-02) / 1 KIT in 1 CARTRIDGE",
"NDC11Code": "00013-2649-02",
"ProductNDC": "0013-2649",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Genotropin",
"NonProprietaryName": "Somatropin",
"DosageFormName": "KIT",
"StartMarketingDate": "19951220",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA020280",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"Status": "Active",
"LastUpdate": "2026-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19951220",
"SamplePackage": "N",
"IndicationAndUsage": "GENOTROPIN is a recombinant human growth hormone indicated for: 1 Pediatric: Treatment of children with growth failure due to growth hormone deficiency (GHD), Prader-Willi syndrome, Small for Gestational Age, Turner syndrome, and Idiopathic Short Stature (1.1), 2 Adult: Treatment of adults with either adult onset or childhood onset GHD (1.2).",
"Description": "Somatropin is a human growth hormone produced by recombinant DNA technology in Escherichia coli. The protein is comprised of 191 amino acid residues and has a molecular weight of 22,124 daltons. The amino acid sequence is identical to that of human growth hormone of pituitary origin. GENOTROPIN (somatropin) for injection is a sterile, white, lyophilized powder in a single-patient-use or single-dose, two-chamber cartridge intended for subcutaneous injection after reconstitution. The front chamber contains somatropin and the rear chamber contains diluent. GENOTROPIN 5 mg is a single-patient-use, two-chamber cartridge. GENOTROPIN 5 mg is designed for use with a reusable device (GENOTROPIN PEN 5) for product reconstitution and drug delivery. After reconstitution, each mL contains 5 mg of somatropin, dibasic sodium phosphate (0.27 mg), glycine (2 mg), mannitol (41 mg), metacresol (3 mg) (as a preservative), monobasic sodium phosphate (0.28 mg) and water for injection. The reconstituted concentration is 5 mg/mL with a deliverable volume of 1 mL. GENOTROPIN 12 mg is a single‑patient‑use, two-chamber cartridge. GENOTROPIN 12 mg is designed for use with a reusable device (GENOTROPIN PEN 12) for product reconstitution and drug delivery. After reconstitution, each mL contains 12 mg of somatropin, dibasic sodium phosphate (0.4 mg), glycine (2 mg), mannitol (40 mg), metacresol (3 mg) (as a preservative), monobasic sodium phosphate (0.41 mg) and water for injection. The reconstituted concentration is 12 mg/mL with a deliverable volume of 1 mL. GENOTROPIN MINIQUICK is a single-dose Growth Hormone Delivery Device containing a two-chamber cartridge supplied in the following strengths: 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1 mg, 1.2 mg, 1.4 mg, 1.6 mg, 1.8 mg, or 2 mg. After reconstitution, each 0.25 mL contains 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1 mg, 1.2 mg, 1.4 mg, 1.6 mg, 1.8 mg, or 2 mg of somatropin, dibasic sodium phosphate (0.03 mg), glycine (0.21 mg), mannitol (12.5 mg), monobasic sodium phosphate (0.05 mg) and water for injection. Each cartridge provides a deliverable volume of 0.25 mL. The reconstituted recombinant somatropin solution has an osmolality of approximately 300 mOsm/kg, and a pH of approximately 6.7."
},
{
"NDCCode": "0013-2650-02",
"PackageDescription": "7 CARTRIDGE in 1 CARTON (0013-2650-02) / 1 KIT in 1 CARTRIDGE",
"NDC11Code": "00013-2650-02",
"ProductNDC": "0013-2650",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Genotropin",
"NonProprietaryName": "Somatropin",
"DosageFormName": "KIT",
"StartMarketingDate": "19951220",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA020280",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"Status": "Active",
"LastUpdate": "2026-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19951220",
"SamplePackage": "N",
"IndicationAndUsage": "GENOTROPIN is a recombinant human growth hormone indicated for: 1 Pediatric: Treatment of children with growth failure due to growth hormone deficiency (GHD), Prader-Willi syndrome, Small for Gestational Age, Turner syndrome, and Idiopathic Short Stature (1.1), 2 Adult: Treatment of adults with either adult onset or childhood onset GHD (1.2).",
"Description": "Somatropin is a human growth hormone produced by recombinant DNA technology in Escherichia coli. The protein is comprised of 191 amino acid residues and has a molecular weight of 22,124 daltons. The amino acid sequence is identical to that of human growth hormone of pituitary origin. GENOTROPIN (somatropin) for injection is a sterile, white, lyophilized powder in a single-patient-use or single-dose, two-chamber cartridge intended for subcutaneous injection after reconstitution. The front chamber contains somatropin and the rear chamber contains diluent. GENOTROPIN 5 mg is a single-patient-use, two-chamber cartridge. GENOTROPIN 5 mg is designed for use with a reusable device (GENOTROPIN PEN 5) for product reconstitution and drug delivery. After reconstitution, each mL contains 5 mg of somatropin, dibasic sodium phosphate (0.27 mg), glycine (2 mg), mannitol (41 mg), metacresol (3 mg) (as a preservative), monobasic sodium phosphate (0.28 mg) and water for injection. The reconstituted concentration is 5 mg/mL with a deliverable volume of 1 mL. GENOTROPIN 12 mg is a single‑patient‑use, two-chamber cartridge. GENOTROPIN 12 mg is designed for use with a reusable device (GENOTROPIN PEN 12) for product reconstitution and drug delivery. After reconstitution, each mL contains 12 mg of somatropin, dibasic sodium phosphate (0.4 mg), glycine (2 mg), mannitol (40 mg), metacresol (3 mg) (as a preservative), monobasic sodium phosphate (0.41 mg) and water for injection. The reconstituted concentration is 12 mg/mL with a deliverable volume of 1 mL. GENOTROPIN MINIQUICK is a single-dose Growth Hormone Delivery Device containing a two-chamber cartridge supplied in the following strengths: 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1 mg, 1.2 mg, 1.4 mg, 1.6 mg, 1.8 mg, or 2 mg. After reconstitution, each 0.25 mL contains 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1 mg, 1.2 mg, 1.4 mg, 1.6 mg, 1.8 mg, or 2 mg of somatropin, dibasic sodium phosphate (0.03 mg), glycine (0.21 mg), mannitol (12.5 mg), monobasic sodium phosphate (0.05 mg) and water for injection. Each cartridge provides a deliverable volume of 0.25 mL. The reconstituted recombinant somatropin solution has an osmolality of approximately 300 mOsm/kg, and a pH of approximately 6.7."
},
{
"NDCCode": "0013-2651-02",
"PackageDescription": "7 CARTRIDGE in 1 CARTON (0013-2651-02) / 1 KIT in 1 CARTRIDGE",
"NDC11Code": "00013-2651-02",
"ProductNDC": "0013-2651",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Genotropin",
"NonProprietaryName": "Somatropin",
"DosageFormName": "KIT",
"StartMarketingDate": "19951220",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA020280",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"Status": "Active",
"LastUpdate": "2026-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19951220",
"SamplePackage": "N",
"IndicationAndUsage": "GENOTROPIN is a recombinant human growth hormone indicated for: 1 Pediatric: Treatment of children with growth failure due to growth hormone deficiency (GHD), Prader-Willi syndrome, Small for Gestational Age, Turner syndrome, and Idiopathic Short Stature (1.1), 2 Adult: Treatment of adults with either adult onset or childhood onset GHD (1.2).",
"Description": "Somatropin is a human growth hormone produced by recombinant DNA technology in Escherichia coli. The protein is comprised of 191 amino acid residues and has a molecular weight of 22,124 daltons. The amino acid sequence is identical to that of human growth hormone of pituitary origin. GENOTROPIN (somatropin) for injection is a sterile, white, lyophilized powder in a single-patient-use or single-dose, two-chamber cartridge intended for subcutaneous injection after reconstitution. The front chamber contains somatropin and the rear chamber contains diluent. GENOTROPIN 5 mg is a single-patient-use, two-chamber cartridge. GENOTROPIN 5 mg is designed for use with a reusable device (GENOTROPIN PEN 5) for product reconstitution and drug delivery. After reconstitution, each mL contains 5 mg of somatropin, dibasic sodium phosphate (0.27 mg), glycine (2 mg), mannitol (41 mg), metacresol (3 mg) (as a preservative), monobasic sodium phosphate (0.28 mg) and water for injection. The reconstituted concentration is 5 mg/mL with a deliverable volume of 1 mL. GENOTROPIN 12 mg is a single‑patient‑use, two-chamber cartridge. GENOTROPIN 12 mg is designed for use with a reusable device (GENOTROPIN PEN 12) for product reconstitution and drug delivery. After reconstitution, each mL contains 12 mg of somatropin, dibasic sodium phosphate (0.4 mg), glycine (2 mg), mannitol (40 mg), metacresol (3 mg) (as a preservative), monobasic sodium phosphate (0.41 mg) and water for injection. The reconstituted concentration is 12 mg/mL with a deliverable volume of 1 mL. GENOTROPIN MINIQUICK is a single-dose Growth Hormone Delivery Device containing a two-chamber cartridge supplied in the following strengths: 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1 mg, 1.2 mg, 1.4 mg, 1.6 mg, 1.8 mg, or 2 mg. After reconstitution, each 0.25 mL contains 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1 mg, 1.2 mg, 1.4 mg, 1.6 mg, 1.8 mg, or 2 mg of somatropin, dibasic sodium phosphate (0.03 mg), glycine (0.21 mg), mannitol (12.5 mg), monobasic sodium phosphate (0.05 mg) and water for injection. Each cartridge provides a deliverable volume of 0.25 mL. The reconstituted recombinant somatropin solution has an osmolality of approximately 300 mOsm/kg, and a pH of approximately 6.7."
},
{
"NDCCode": "0013-2652-02",
"PackageDescription": "7 CARTRIDGE in 1 CARTON (0013-2652-02) / 1 KIT in 1 CARTRIDGE",
"NDC11Code": "00013-2652-02",
"ProductNDC": "0013-2652",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Genotropin",
"NonProprietaryName": "Somatropin",
"DosageFormName": "KIT",
"StartMarketingDate": "19951220",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA020280",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"Status": "Active",
"LastUpdate": "2026-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19951220",
"SamplePackage": "N",
"IndicationAndUsage": "GENOTROPIN is a recombinant human growth hormone indicated for: 1 Pediatric: Treatment of children with growth failure due to growth hormone deficiency (GHD), Prader-Willi syndrome, Small for Gestational Age, Turner syndrome, and Idiopathic Short Stature (1.1), 2 Adult: Treatment of adults with either adult onset or childhood onset GHD (1.2).",
"Description": "Somatropin is a human growth hormone produced by recombinant DNA technology in Escherichia coli. The protein is comprised of 191 amino acid residues and has a molecular weight of 22,124 daltons. The amino acid sequence is identical to that of human growth hormone of pituitary origin. GENOTROPIN (somatropin) for injection is a sterile, white, lyophilized powder in a single-patient-use or single-dose, two-chamber cartridge intended for subcutaneous injection after reconstitution. The front chamber contains somatropin and the rear chamber contains diluent. GENOTROPIN 5 mg is a single-patient-use, two-chamber cartridge. GENOTROPIN 5 mg is designed for use with a reusable device (GENOTROPIN PEN 5) for product reconstitution and drug delivery. After reconstitution, each mL contains 5 mg of somatropin, dibasic sodium phosphate (0.27 mg), glycine (2 mg), mannitol (41 mg), metacresol (3 mg) (as a preservative), monobasic sodium phosphate (0.28 mg) and water for injection. The reconstituted concentration is 5 mg/mL with a deliverable volume of 1 mL. GENOTROPIN 12 mg is a single‑patient‑use, two-chamber cartridge. GENOTROPIN 12 mg is designed for use with a reusable device (GENOTROPIN PEN 12) for product reconstitution and drug delivery. After reconstitution, each mL contains 12 mg of somatropin, dibasic sodium phosphate (0.4 mg), glycine (2 mg), mannitol (40 mg), metacresol (3 mg) (as a preservative), monobasic sodium phosphate (0.41 mg) and water for injection. The reconstituted concentration is 12 mg/mL with a deliverable volume of 1 mL. GENOTROPIN MINIQUICK is a single-dose Growth Hormone Delivery Device containing a two-chamber cartridge supplied in the following strengths: 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1 mg, 1.2 mg, 1.4 mg, 1.6 mg, 1.8 mg, or 2 mg. After reconstitution, each 0.25 mL contains 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1 mg, 1.2 mg, 1.4 mg, 1.6 mg, 1.8 mg, or 2 mg of somatropin, dibasic sodium phosphate (0.03 mg), glycine (0.21 mg), mannitol (12.5 mg), monobasic sodium phosphate (0.05 mg) and water for injection. Each cartridge provides a deliverable volume of 0.25 mL. The reconstituted recombinant somatropin solution has an osmolality of approximately 300 mOsm/kg, and a pH of approximately 6.7."
},
{
"NDCCode": "0013-2653-02",
"PackageDescription": "7 CARTRIDGE in 1 CARTON (0013-2653-02) / 1 KIT in 1 CARTRIDGE",
"NDC11Code": "00013-2653-02",
"ProductNDC": "0013-2653",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Genotropin",
"NonProprietaryName": "Somatropin",
"DosageFormName": "KIT",
"StartMarketingDate": "19951220",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA020280",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"Status": "Active",
"LastUpdate": "2026-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19951220",
"SamplePackage": "N",
"IndicationAndUsage": "GENOTROPIN is a recombinant human growth hormone indicated for: 1 Pediatric: Treatment of children with growth failure due to growth hormone deficiency (GHD), Prader-Willi syndrome, Small for Gestational Age, Turner syndrome, and Idiopathic Short Stature (1.1), 2 Adult: Treatment of adults with either adult onset or childhood onset GHD (1.2).",
"Description": "Somatropin is a human growth hormone produced by recombinant DNA technology in Escherichia coli. The protein is comprised of 191 amino acid residues and has a molecular weight of 22,124 daltons. The amino acid sequence is identical to that of human growth hormone of pituitary origin. GENOTROPIN (somatropin) for injection is a sterile, white, lyophilized powder in a single-patient-use or single-dose, two-chamber cartridge intended for subcutaneous injection after reconstitution. The front chamber contains somatropin and the rear chamber contains diluent. GENOTROPIN 5 mg is a single-patient-use, two-chamber cartridge. GENOTROPIN 5 mg is designed for use with a reusable device (GENOTROPIN PEN 5) for product reconstitution and drug delivery. After reconstitution, each mL contains 5 mg of somatropin, dibasic sodium phosphate (0.27 mg), glycine (2 mg), mannitol (41 mg), metacresol (3 mg) (as a preservative), monobasic sodium phosphate (0.28 mg) and water for injection. The reconstituted concentration is 5 mg/mL with a deliverable volume of 1 mL. GENOTROPIN 12 mg is a single‑patient‑use, two-chamber cartridge. GENOTROPIN 12 mg is designed for use with a reusable device (GENOTROPIN PEN 12) for product reconstitution and drug delivery. After reconstitution, each mL contains 12 mg of somatropin, dibasic sodium phosphate (0.4 mg), glycine (2 mg), mannitol (40 mg), metacresol (3 mg) (as a preservative), monobasic sodium phosphate (0.41 mg) and water for injection. The reconstituted concentration is 12 mg/mL with a deliverable volume of 1 mL. GENOTROPIN MINIQUICK is a single-dose Growth Hormone Delivery Device containing a two-chamber cartridge supplied in the following strengths: 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1 mg, 1.2 mg, 1.4 mg, 1.6 mg, 1.8 mg, or 2 mg. After reconstitution, each 0.25 mL contains 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1 mg, 1.2 mg, 1.4 mg, 1.6 mg, 1.8 mg, or 2 mg of somatropin, dibasic sodium phosphate (0.03 mg), glycine (0.21 mg), mannitol (12.5 mg), monobasic sodium phosphate (0.05 mg) and water for injection. Each cartridge provides a deliverable volume of 0.25 mL. The reconstituted recombinant somatropin solution has an osmolality of approximately 300 mOsm/kg, and a pH of approximately 6.7."
},
{
"NDCCode": "0013-2654-02",
"PackageDescription": "7 CARTRIDGE in 1 CARTON (0013-2654-02) / 1 KIT in 1 CARTRIDGE",
"NDC11Code": "00013-2654-02",
"ProductNDC": "0013-2654",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Genotropin",
"NonProprietaryName": "Somatropin",
"DosageFormName": "KIT",
"StartMarketingDate": "19951220",
"MarketingCategoryName": "BLA",
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"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
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"IndicationAndUsage": "GENOTROPIN is a recombinant human growth hormone indicated for: 1 Pediatric: Treatment of children with growth failure due to growth hormone deficiency (GHD), Prader-Willi syndrome, Small for Gestational Age, Turner syndrome, and Idiopathic Short Stature (1.1), 2 Adult: Treatment of adults with either adult onset or childhood onset GHD (1.2).",
"Description": "Somatropin is a human growth hormone produced by recombinant DNA technology in Escherichia coli. The protein is comprised of 191 amino acid residues and has a molecular weight of 22,124 daltons. The amino acid sequence is identical to that of human growth hormone of pituitary origin. GENOTROPIN (somatropin) for injection is a sterile, white, lyophilized powder in a single-patient-use or single-dose, two-chamber cartridge intended for subcutaneous injection after reconstitution. The front chamber contains somatropin and the rear chamber contains diluent. GENOTROPIN 5 mg is a single-patient-use, two-chamber cartridge. GENOTROPIN 5 mg is designed for use with a reusable device (GENOTROPIN PEN 5) for product reconstitution and drug delivery. After reconstitution, each mL contains 5 mg of somatropin, dibasic sodium phosphate (0.27 mg), glycine (2 mg), mannitol (41 mg), metacresol (3 mg) (as a preservative), monobasic sodium phosphate (0.28 mg) and water for injection. The reconstituted concentration is 5 mg/mL with a deliverable volume of 1 mL. GENOTROPIN 12 mg is a single‑patient‑use, two-chamber cartridge. GENOTROPIN 12 mg is designed for use with a reusable device (GENOTROPIN PEN 12) for product reconstitution and drug delivery. After reconstitution, each mL contains 12 mg of somatropin, dibasic sodium phosphate (0.4 mg), glycine (2 mg), mannitol (40 mg), metacresol (3 mg) (as a preservative), monobasic sodium phosphate (0.41 mg) and water for injection. The reconstituted concentration is 12 mg/mL with a deliverable volume of 1 mL. GENOTROPIN MINIQUICK is a single-dose Growth Hormone Delivery Device containing a two-chamber cartridge supplied in the following strengths: 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1 mg, 1.2 mg, 1.4 mg, 1.6 mg, 1.8 mg, or 2 mg. After reconstitution, each 0.25 mL contains 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1 mg, 1.2 mg, 1.4 mg, 1.6 mg, 1.8 mg, or 2 mg of somatropin, dibasic sodium phosphate (0.03 mg), glycine (0.21 mg), mannitol (12.5 mg), monobasic sodium phosphate (0.05 mg) and water for injection. Each cartridge provides a deliverable volume of 0.25 mL. The reconstituted recombinant somatropin solution has an osmolality of approximately 300 mOsm/kg, and a pH of approximately 6.7."
},
{
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"Description": "Somatropin is a human growth hormone produced by recombinant DNA technology in Escherichia coli. The protein is comprised of 191 amino acid residues and has a molecular weight of 22,124 daltons. The amino acid sequence is identical to that of human growth hormone of pituitary origin. GENOTROPIN (somatropin) for injection is a sterile, white, lyophilized powder in a single-patient-use or single-dose, two-chamber cartridge intended for subcutaneous injection after reconstitution. The front chamber contains somatropin and the rear chamber contains diluent. GENOTROPIN 5 mg is a single-patient-use, two-chamber cartridge. GENOTROPIN 5 mg is designed for use with a reusable device (GENOTROPIN PEN 5) for product reconstitution and drug delivery. After reconstitution, each mL contains 5 mg of somatropin, dibasic sodium phosphate (0.27 mg), glycine (2 mg), mannitol (41 mg), metacresol (3 mg) (as a preservative), monobasic sodium phosphate (0.28 mg) and water for injection. The reconstituted concentration is 5 mg/mL with a deliverable volume of 1 mL. GENOTROPIN 12 mg is a single‑patient‑use, two-chamber cartridge. GENOTROPIN 12 mg is designed for use with a reusable device (GENOTROPIN PEN 12) for product reconstitution and drug delivery. After reconstitution, each mL contains 12 mg of somatropin, dibasic sodium phosphate (0.4 mg), glycine (2 mg), mannitol (40 mg), metacresol (3 mg) (as a preservative), monobasic sodium phosphate (0.41 mg) and water for injection. The reconstituted concentration is 12 mg/mL with a deliverable volume of 1 mL. GENOTROPIN MINIQUICK is a single-dose Growth Hormone Delivery Device containing a two-chamber cartridge supplied in the following strengths: 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1 mg, 1.2 mg, 1.4 mg, 1.6 mg, 1.8 mg, or 2 mg. After reconstitution, each 0.25 mL contains 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1 mg, 1.2 mg, 1.4 mg, 1.6 mg, 1.8 mg, or 2 mg of somatropin, dibasic sodium phosphate (0.03 mg), glycine (0.21 mg), mannitol (12.5 mg), monobasic sodium phosphate (0.05 mg) and water for injection. Each cartridge provides a deliverable volume of 0.25 mL. The reconstituted recombinant somatropin solution has an osmolality of approximately 300 mOsm/kg, and a pH of approximately 6.7."
},
{
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"IndicationAndUsage": "GENOTROPIN is a recombinant human growth hormone indicated for: 1 Pediatric: Treatment of children with growth failure due to growth hormone deficiency (GHD), Prader-Willi syndrome, Small for Gestational Age, Turner syndrome, and Idiopathic Short Stature (1.1), 2 Adult: Treatment of adults with either adult onset or childhood onset GHD (1.2).",
"Description": "Somatropin is a human growth hormone produced by recombinant DNA technology in Escherichia coli. The protein is comprised of 191 amino acid residues and has a molecular weight of 22,124 daltons. The amino acid sequence is identical to that of human growth hormone of pituitary origin. GENOTROPIN (somatropin) for injection is a sterile, white, lyophilized powder in a single-patient-use or single-dose, two-chamber cartridge intended for subcutaneous injection after reconstitution. The front chamber contains somatropin and the rear chamber contains diluent. GENOTROPIN 5 mg is a single-patient-use, two-chamber cartridge. GENOTROPIN 5 mg is designed for use with a reusable device (GENOTROPIN PEN 5) for product reconstitution and drug delivery. After reconstitution, each mL contains 5 mg of somatropin, dibasic sodium phosphate (0.27 mg), glycine (2 mg), mannitol (41 mg), metacresol (3 mg) (as a preservative), monobasic sodium phosphate (0.28 mg) and water for injection. The reconstituted concentration is 5 mg/mL with a deliverable volume of 1 mL. GENOTROPIN 12 mg is a single‑patient‑use, two-chamber cartridge. GENOTROPIN 12 mg is designed for use with a reusable device (GENOTROPIN PEN 12) for product reconstitution and drug delivery. After reconstitution, each mL contains 12 mg of somatropin, dibasic sodium phosphate (0.4 mg), glycine (2 mg), mannitol (40 mg), metacresol (3 mg) (as a preservative), monobasic sodium phosphate (0.41 mg) and water for injection. The reconstituted concentration is 12 mg/mL with a deliverable volume of 1 mL. GENOTROPIN MINIQUICK is a single-dose Growth Hormone Delivery Device containing a two-chamber cartridge supplied in the following strengths: 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1 mg, 1.2 mg, 1.4 mg, 1.6 mg, 1.8 mg, or 2 mg. After reconstitution, each 0.25 mL contains 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1 mg, 1.2 mg, 1.4 mg, 1.6 mg, 1.8 mg, or 2 mg of somatropin, dibasic sodium phosphate (0.03 mg), glycine (0.21 mg), mannitol (12.5 mg), monobasic sodium phosphate (0.05 mg) and water for injection. Each cartridge provides a deliverable volume of 0.25 mL. The reconstituted recombinant somatropin solution has an osmolality of approximately 300 mOsm/kg, and a pH of approximately 6.7."
}
]
}
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<StartMarketingDatePackage>20171101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Prednisone Tablets, USP are indicated in the following conditions. 1. Endocrine Disorders. Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance). Congenital adrenal hyperplasiaNonsuppurative thyroiditis. 2. Rheumatic Disorders. As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in. Psoriatic arthritisRheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)Ankylosing spondylitisAcute and subacute bursitisAcute nonspecific tenosynovitis Acute gouty arthritisPost-traumatic osteoarthritis Synovitis of osteoarthritisEpicondylitis. 3. Collagen Diseases. During an exacerbation or as maintenance therapy in selected cases of. Systemic lupus erythematosusSystemic derznatomyositis (polymyositis)Acute rheumatic carditis. 4. Dermatologic Diseases. PemphigusBullous dermatitis herpetiformisSevere erythema multiforme (Stevens-Johnson syndrome)Exfoliative dermatitisMycosis fungoidesSevere psoriasisSevere seborrheic dermatitis. 5. Allergic States. Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment. Seasonal or perennial allergic rhinitisBronchial asthmaContact dermatitisAtopic dermatitis Serum sickness Drug hypersensitivity reactions. 6. Ophthalmic Diseases. Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as. Allergic corneal marginal ulcersHerpes zoster ophthalmicusAnterior segment inflammationDiffuse posterior uveitis and choroiditisSympathetic ophthalmiaAllergic conjunctivitisKeratitisChorioretinitisOptic neuritisIritis and iridocyclitis. 7. Respiratory Diseases. Symptomatic sarcoidosisLoeffler’s syndrome not manageable by other meansBerylliosisFulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy.Aspiration pneumonitis. 8. Hematologic Disorders. Idiopathic thrombocytopenic purpura in adultsSecondary thrombocytopenia in adultsAcquired (autoimmune) hemolytic anemiaErythroblastopenia (RBC anemia)Congenital (erythroid) hypoplastic anemia. 9. Neoplastic Diseases. For palliative management of. Leukemias and lymphomas in adultsAcute leukemia of childhood. 10. Edematous States. To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 11. Gastrointestinal Diseases. To tide the patient over a critical period of the disease in. Ulcerative colitisRegional enteritis. 12. Nervous System. Acute exacerbations of multiple sclerosis. 13. Miscellaneous. Tuberculous meningitis with subarachnoid block or, impending block when used concurrently with appropriate antituberculous chemotherapy Trichinosis with neurologic or myocardial involvement.</IndicationAndUsage>
<Description>Prednisone is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, in chloroform, in dioxane, and in methanol. The chemical name for prednisone is pregna-1, 4-diene-3, 11, 20-trione, 17, 21-dihydroxy-. The structural formula is represented below. Molecular weight: 358.44. Prednisone Tablets, USP are available in three strengths: 5 mg, 10 mg, and 20 mg. In addition, each tablet contains the following Inactive Ingredients: Lactose Monohydrate, Magnesium Stearate, Pregelatinized Starch, Sodium Lauryl Sulfate and Sodium Starch Glycolate. Also Prednisone Tablets USP, 20 mg contains FD & C yellow #6 aluminum lake HT 15-18%.</Description>
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<LastUpdate>2025-11-04</LastUpdate>
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<SamplePackage>N</SamplePackage>
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<LabelerName>HATCHBEAUTY PRODUCTS, LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
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<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-06-09</LastUpdate>
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<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
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<NDC11Code>73069-0300-27</NDC11Code>
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<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-liver</ProprietaryName>
<NonProprietaryName>Carduus Benedictus, Carduus Marianus, Ceanothus Americanus, Chelidonium Majus, Chionanthus Virginica, Choline, Coelliac Plexus, Duodenum, Fumaric Acid, Gall Bladder, Inositol, Il 4, Kalium Sulfuricum, Liver, Lycopodium Clavatum, Natrium Oxalaceticum, Natrium Pyruvicum, Natrium Sulphuricum, Niacin, Pancreas, Spleen, Taraxacum, Vein, Vitamin B1, Vitamin B12, Vitamin B2, Vitamin B6</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS; PARENTERAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>CENTAUREA BENEDICTA; MILK THISTLE; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; CHIONANTHUS VIRGINICUS BARK; CHOLINE; BOS TAURUS SOLAR PLEXUS; SUS SCROFA SOLAR PLEXUS; BOS TAURUS DUODENUM; SUS SCROFA DUODENUM; FUMARIC ACID; BOS TAURUS GALLBLADDER; SUS SCROFA GALLBLADDER; INOSITOL; BINETRAKIN; POTASSIUM SULFATE; BEEF LIVER; PORK LIVER; LYCOPODIUM CLAVATUM SPORE; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SODIUM SULFATE; NIACIN; BOS TAURUS PANCREAS; SUS SCROFA PANCREAS; BOS TAURUS SPLEEN; SUS SCROFA SPLEEN; TARAXACUM OFFICINALE; BOS TAURUS VEIN; SUS SCROFA VEIN; THIAMINE; CYANOCOBALAMIN; RIBOFLAVIN; PYRIDOXINE</SubstanceName>
<StrengthNumber>31; 31; 4; 31; 4; 31; 201; 201; 31; 31; 31; 31; 31; 31; 201; 31; 201; 201; 31; 31; 31; 31; 31; 201; 201; 201; 201; 31; 31; 31; 31; 31; 31; 31</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Meat Proteins [EXT],Nicotinic Acid [EPC],Nicotinic Acids [CS],Vitamin B 12 [CS],Vitamin B12 [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>75990-300-27</NDCCode>
<PackageDescription>800 mL in 1 CARTRIDGE (75990-300-27)</PackageDescription>
<NDC11Code>75990-0300-27</NDC11Code>
<ProductNDC>75990-300</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Purgo Ultra Pc</ProprietaryName>
<NonProprietaryName>Chloroxylenol</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110425</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Certus Medical, Inc.</LabelerName>
<SubstanceName>CHLOROXYLENOL</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>for hand-washing to decrease bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>79467-101-27</NDCCode>
<PackageDescription>300 CLOTH in 1 PAIL (79467-101-27) </PackageDescription>
<NDC11Code>79467-0101-27</NDC11Code>
<ProductNDC>79467-101</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>75% Alcohol Sanitary Wipes</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200330</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Shandong Qingran Biological Technology Co., Ltd.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>3.15</StrengthNumber>
<StrengthUnit>mL/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>75% alcohol sanitary wipes to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>79467-201-27</NDCCode>
<PackageDescription>300 CLOTH in 1 PAIL (79467-201-27) </PackageDescription>
<NDC11Code>79467-0201-27</NDC11Code>
<ProductNDC>79467-201</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sanitary Wipes</ProprietaryName>
<NonProprietaryName>Didecyl Dimethyl Ammonium Chloride</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200330</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Shandong Qingran Biological Technology Co., Ltd.</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE; DIDECYLDIMONIUM CHLORIDE</SubstanceName>
<StrengthNumber>1.89; 1.68</StrengthNumber>
<StrengthUnit>ug/1; ug/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sanitary wipes to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0002-1220-48</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CAN (0002-1220-48) / 100 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>00002-1220-48</NDC11Code>
<ProductNDC>0002-1220</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tauvid</ProprietaryName>
<NonProprietaryName>Flortaucipir F-18</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20220701</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA212123</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>FLORTAUCIPIR F-18</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mCi/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221025</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TAUVID is indicated for use with positron emission tomography (PET) imaging of the brain to estimate the density and distribution of aggregated tau neurofibrillary tangles (NFTs) in adult patients with cognitive impairment who are being evaluated for Alzheimer's disease (AD).</IndicationAndUsage>
<Description>TAUVID contains flortaucipir fluorine 18 (F 18). Chemically, flortaucipir F 18 is 7-(6-[F-18]fluoropyridin-3-yl)-5H-pyrido[4,3-b]indole. The molecular weight is 262.27, the molecular formula is C16H10[18F]N3, and the structural formula is:. TAUVID is a sterile, non-pyrogenic solution for intravenous injection. The clear, colorless solution free of visible particulate matter is supplied ready to use, and each milliliter contains up to 2 micrograms of flortaucipir and 300 to 3,700 MBq (8.1 to 100 mCi) flortaucipir F 18 at end of synthesis, 1.5 mg of L-cysteine hydrochloride monohydrate USP, 2.1 mg of dibasic sodium phosphate anhydrous USP, up to 55 of micrograms hydrogen chloride and 0.1 mL dehydrated alcohol in 0.9% sodium chloride injection USP. The pH of the solution is between 5.5 and 7.5.</Description>
</NDC>
<NDC>
<NDCCode>0002-1220-50</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CAN (0002-1220-50) / 50 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>00002-1220-50</NDC11Code>
<ProductNDC>0002-1220</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tauvid</ProprietaryName>
<NonProprietaryName>Flortaucipir F-18</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20220701</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA212123</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>FLORTAUCIPIR F-18</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mCi/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221025</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TAUVID is indicated for use with positron emission tomography (PET) imaging of the brain to estimate the density and distribution of aggregated tau neurofibrillary tangles (NFTs) in adult patients with cognitive impairment who are being evaluated for Alzheimer's disease (AD).</IndicationAndUsage>
<Description>TAUVID contains flortaucipir fluorine 18 (F 18). Chemically, flortaucipir F 18 is 7-(6-[F-18]fluoropyridin-3-yl)-5H-pyrido[4,3-b]indole. The molecular weight is 262.27, the molecular formula is C16H10[18F]N3, and the structural formula is:. TAUVID is a sterile, non-pyrogenic solution for intravenous injection. The clear, colorless solution free of visible particulate matter is supplied ready to use, and each milliliter contains up to 2 micrograms of flortaucipir and 300 to 3,700 MBq (8.1 to 100 mCi) flortaucipir F 18 at end of synthesis, 1.5 mg of L-cysteine hydrochloride monohydrate USP, 2.1 mg of dibasic sodium phosphate anhydrous USP, up to 55 of micrograms hydrogen chloride and 0.1 mL dehydrated alcohol in 0.9% sodium chloride injection USP. The pH of the solution is between 5.5 and 7.5.</Description>
</NDC>
<NDC>
<NDCCode>0013-2626-81</NDCCode>
<PackageDescription>1 CARTRIDGE in 1 CARTON (0013-2626-81) / 1 KIT in 1 CARTRIDGE</PackageDescription>
<NDC11Code>00013-2626-81</NDC11Code>
<ProductNDC>0013-2626</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Genotropin</ProprietaryName>
<NonProprietaryName>Somatropin</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>19951220</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA020280</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19951220</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>GENOTROPIN is a recombinant human growth hormone indicated for: 1 Pediatric: Treatment of children with growth failure due to growth hormone deficiency (GHD), Prader-Willi syndrome, Small for Gestational Age, Turner syndrome, and Idiopathic Short Stature (1.1), 2 Adult: Treatment of adults with either adult onset or childhood onset GHD (1.2).</IndicationAndUsage>
<Description>Somatropin is a human growth hormone produced by recombinant DNA technology in Escherichia coli. The protein is comprised of 191 amino acid residues and has a molecular weight of 22,124 daltons. The amino acid sequence is identical to that of human growth hormone of pituitary origin. GENOTROPIN (somatropin) for injection is a sterile, white, lyophilized powder in a single-patient-use or single-dose, two-chamber cartridge intended for subcutaneous injection after reconstitution. The front chamber contains somatropin and the rear chamber contains diluent. GENOTROPIN 5 mg is a single-patient-use, two-chamber cartridge. GENOTROPIN 5 mg is designed for use with a reusable device (GENOTROPIN PEN 5) for product reconstitution and drug delivery. After reconstitution, each mL contains 5 mg of somatropin, dibasic sodium phosphate (0.27 mg), glycine (2 mg), mannitol (41 mg), metacresol (3 mg) (as a preservative), monobasic sodium phosphate (0.28 mg) and water for injection. The reconstituted concentration is 5 mg/mL with a deliverable volume of 1 mL. GENOTROPIN 12 mg is a single‑patient‑use, two-chamber cartridge. GENOTROPIN 12 mg is designed for use with a reusable device (GENOTROPIN PEN 12) for product reconstitution and drug delivery. After reconstitution, each mL contains 12 mg of somatropin, dibasic sodium phosphate (0.4 mg), glycine (2 mg), mannitol (40 mg), metacresol (3 mg) (as a preservative), monobasic sodium phosphate (0.41 mg) and water for injection. The reconstituted concentration is 12 mg/mL with a deliverable volume of 1 mL. GENOTROPIN MINIQUICK is a single-dose Growth Hormone Delivery Device containing a two-chamber cartridge supplied in the following strengths: 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1 mg, 1.2 mg, 1.4 mg, 1.6 mg, 1.8 mg, or 2 mg. After reconstitution, each 0.25 mL contains 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1 mg, 1.2 mg, 1.4 mg, 1.6 mg, 1.8 mg, or 2 mg of somatropin, dibasic sodium phosphate (0.03 mg), glycine (0.21 mg), mannitol (12.5 mg), monobasic sodium phosphate (0.05 mg) and water for injection. Each cartridge provides a deliverable volume of 0.25 mL. The reconstituted recombinant somatropin solution has an osmolality of approximately 300 mOsm/kg, and a pH of approximately 6.7.</Description>
</NDC>
<NDC>
<NDCCode>0013-2646-81</NDCCode>
<PackageDescription>1 CARTRIDGE in 1 CARTON (0013-2646-81) / 1 KIT in 1 CARTRIDGE</PackageDescription>
<NDC11Code>00013-2646-81</NDC11Code>
<ProductNDC>0013-2646</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Genotropin</ProprietaryName>
<NonProprietaryName>Somatropin</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>19951220</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA020280</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19951220</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>GENOTROPIN is a recombinant human growth hormone indicated for: 1 Pediatric: Treatment of children with growth failure due to growth hormone deficiency (GHD), Prader-Willi syndrome, Small for Gestational Age, Turner syndrome, and Idiopathic Short Stature (1.1), 2 Adult: Treatment of adults with either adult onset or childhood onset GHD (1.2).</IndicationAndUsage>
<Description>Somatropin is a human growth hormone produced by recombinant DNA technology in Escherichia coli. The protein is comprised of 191 amino acid residues and has a molecular weight of 22,124 daltons. The amino acid sequence is identical to that of human growth hormone of pituitary origin. GENOTROPIN (somatropin) for injection is a sterile, white, lyophilized powder in a single-patient-use or single-dose, two-chamber cartridge intended for subcutaneous injection after reconstitution. The front chamber contains somatropin and the rear chamber contains diluent. GENOTROPIN 5 mg is a single-patient-use, two-chamber cartridge. GENOTROPIN 5 mg is designed for use with a reusable device (GENOTROPIN PEN 5) for product reconstitution and drug delivery. After reconstitution, each mL contains 5 mg of somatropin, dibasic sodium phosphate (0.27 mg), glycine (2 mg), mannitol (41 mg), metacresol (3 mg) (as a preservative), monobasic sodium phosphate (0.28 mg) and water for injection. The reconstituted concentration is 5 mg/mL with a deliverable volume of 1 mL. GENOTROPIN 12 mg is a single‑patient‑use, two-chamber cartridge. GENOTROPIN 12 mg is designed for use with a reusable device (GENOTROPIN PEN 12) for product reconstitution and drug delivery. After reconstitution, each mL contains 12 mg of somatropin, dibasic sodium phosphate (0.4 mg), glycine (2 mg), mannitol (40 mg), metacresol (3 mg) (as a preservative), monobasic sodium phosphate (0.41 mg) and water for injection. The reconstituted concentration is 12 mg/mL with a deliverable volume of 1 mL. GENOTROPIN MINIQUICK is a single-dose Growth Hormone Delivery Device containing a two-chamber cartridge supplied in the following strengths: 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1 mg, 1.2 mg, 1.4 mg, 1.6 mg, 1.8 mg, or 2 mg. After reconstitution, each 0.25 mL contains 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1 mg, 1.2 mg, 1.4 mg, 1.6 mg, 1.8 mg, or 2 mg of somatropin, dibasic sodium phosphate (0.03 mg), glycine (0.21 mg), mannitol (12.5 mg), monobasic sodium phosphate (0.05 mg) and water for injection. Each cartridge provides a deliverable volume of 0.25 mL. The reconstituted recombinant somatropin solution has an osmolality of approximately 300 mOsm/kg, and a pH of approximately 6.7.</Description>
</NDC>
<NDC>
<NDCCode>0013-2649-02</NDCCode>
<PackageDescription>7 CARTRIDGE in 1 CARTON (0013-2649-02) / 1 KIT in 1 CARTRIDGE</PackageDescription>
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<Description>Somatropin is a human growth hormone produced by recombinant DNA technology in Escherichia coli. The protein is comprised of 191 amino acid residues and has a molecular weight of 22,124 daltons. The amino acid sequence is identical to that of human growth hormone of pituitary origin. GENOTROPIN (somatropin) for injection is a sterile, white, lyophilized powder in a single-patient-use or single-dose, two-chamber cartridge intended for subcutaneous injection after reconstitution. The front chamber contains somatropin and the rear chamber contains diluent. GENOTROPIN 5 mg is a single-patient-use, two-chamber cartridge. GENOTROPIN 5 mg is designed for use with a reusable device (GENOTROPIN PEN 5) for product reconstitution and drug delivery. After reconstitution, each mL contains 5 mg of somatropin, dibasic sodium phosphate (0.27 mg), glycine (2 mg), mannitol (41 mg), metacresol (3 mg) (as a preservative), monobasic sodium phosphate (0.28 mg) and water for injection. The reconstituted concentration is 5 mg/mL with a deliverable volume of 1 mL. GENOTROPIN 12 mg is a single‑patient‑use, two-chamber cartridge. GENOTROPIN 12 mg is designed for use with a reusable device (GENOTROPIN PEN 12) for product reconstitution and drug delivery. After reconstitution, each mL contains 12 mg of somatropin, dibasic sodium phosphate (0.4 mg), glycine (2 mg), mannitol (40 mg), metacresol (3 mg) (as a preservative), monobasic sodium phosphate (0.41 mg) and water for injection. The reconstituted concentration is 12 mg/mL with a deliverable volume of 1 mL. GENOTROPIN MINIQUICK is a single-dose Growth Hormone Delivery Device containing a two-chamber cartridge supplied in the following strengths: 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1 mg, 1.2 mg, 1.4 mg, 1.6 mg, 1.8 mg, or 2 mg. After reconstitution, each 0.25 mL contains 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1 mg, 1.2 mg, 1.4 mg, 1.6 mg, 1.8 mg, or 2 mg of somatropin, dibasic sodium phosphate (0.03 mg), glycine (0.21 mg), mannitol (12.5 mg), monobasic sodium phosphate (0.05 mg) and water for injection. Each cartridge provides a deliverable volume of 0.25 mL. The reconstituted recombinant somatropin solution has an osmolality of approximately 300 mOsm/kg, and a pH of approximately 6.7.</Description>
</NDC>
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<IndicationAndUsage>GENOTROPIN is a recombinant human growth hormone indicated for: 1 Pediatric: Treatment of children with growth failure due to growth hormone deficiency (GHD), Prader-Willi syndrome, Small for Gestational Age, Turner syndrome, and Idiopathic Short Stature (1.1), 2 Adult: Treatment of adults with either adult onset or childhood onset GHD (1.2).</IndicationAndUsage>
<Description>Somatropin is a human growth hormone produced by recombinant DNA technology in Escherichia coli. The protein is comprised of 191 amino acid residues and has a molecular weight of 22,124 daltons. The amino acid sequence is identical to that of human growth hormone of pituitary origin. GENOTROPIN (somatropin) for injection is a sterile, white, lyophilized powder in a single-patient-use or single-dose, two-chamber cartridge intended for subcutaneous injection after reconstitution. The front chamber contains somatropin and the rear chamber contains diluent. GENOTROPIN 5 mg is a single-patient-use, two-chamber cartridge. GENOTROPIN 5 mg is designed for use with a reusable device (GENOTROPIN PEN 5) for product reconstitution and drug delivery. After reconstitution, each mL contains 5 mg of somatropin, dibasic sodium phosphate (0.27 mg), glycine (2 mg), mannitol (41 mg), metacresol (3 mg) (as a preservative), monobasic sodium phosphate (0.28 mg) and water for injection. The reconstituted concentration is 5 mg/mL with a deliverable volume of 1 mL. GENOTROPIN 12 mg is a single‑patient‑use, two-chamber cartridge. GENOTROPIN 12 mg is designed for use with a reusable device (GENOTROPIN PEN 12) for product reconstitution and drug delivery. After reconstitution, each mL contains 12 mg of somatropin, dibasic sodium phosphate (0.4 mg), glycine (2 mg), mannitol (40 mg), metacresol (3 mg) (as a preservative), monobasic sodium phosphate (0.41 mg) and water for injection. The reconstituted concentration is 12 mg/mL with a deliverable volume of 1 mL. GENOTROPIN MINIQUICK is a single-dose Growth Hormone Delivery Device containing a two-chamber cartridge supplied in the following strengths: 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1 mg, 1.2 mg, 1.4 mg, 1.6 mg, 1.8 mg, or 2 mg. After reconstitution, each 0.25 mL contains 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1 mg, 1.2 mg, 1.4 mg, 1.6 mg, 1.8 mg, or 2 mg of somatropin, dibasic sodium phosphate (0.03 mg), glycine (0.21 mg), mannitol (12.5 mg), monobasic sodium phosphate (0.05 mg) and water for injection. Each cartridge provides a deliverable volume of 0.25 mL. The reconstituted recombinant somatropin solution has an osmolality of approximately 300 mOsm/kg, and a pH of approximately 6.7.</Description>
</NDC>
<NDC>
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<IndicationAndUsage>GENOTROPIN is a recombinant human growth hormone indicated for: 1 Pediatric: Treatment of children with growth failure due to growth hormone deficiency (GHD), Prader-Willi syndrome, Small for Gestational Age, Turner syndrome, and Idiopathic Short Stature (1.1), 2 Adult: Treatment of adults with either adult onset or childhood onset GHD (1.2).</IndicationAndUsage>
<Description>Somatropin is a human growth hormone produced by recombinant DNA technology in Escherichia coli. The protein is comprised of 191 amino acid residues and has a molecular weight of 22,124 daltons. The amino acid sequence is identical to that of human growth hormone of pituitary origin. GENOTROPIN (somatropin) for injection is a sterile, white, lyophilized powder in a single-patient-use or single-dose, two-chamber cartridge intended for subcutaneous injection after reconstitution. The front chamber contains somatropin and the rear chamber contains diluent. GENOTROPIN 5 mg is a single-patient-use, two-chamber cartridge. GENOTROPIN 5 mg is designed for use with a reusable device (GENOTROPIN PEN 5) for product reconstitution and drug delivery. After reconstitution, each mL contains 5 mg of somatropin, dibasic sodium phosphate (0.27 mg), glycine (2 mg), mannitol (41 mg), metacresol (3 mg) (as a preservative), monobasic sodium phosphate (0.28 mg) and water for injection. The reconstituted concentration is 5 mg/mL with a deliverable volume of 1 mL. GENOTROPIN 12 mg is a single‑patient‑use, two-chamber cartridge. GENOTROPIN 12 mg is designed for use with a reusable device (GENOTROPIN PEN 12) for product reconstitution and drug delivery. After reconstitution, each mL contains 12 mg of somatropin, dibasic sodium phosphate (0.4 mg), glycine (2 mg), mannitol (40 mg), metacresol (3 mg) (as a preservative), monobasic sodium phosphate (0.41 mg) and water for injection. The reconstituted concentration is 12 mg/mL with a deliverable volume of 1 mL. GENOTROPIN MINIQUICK is a single-dose Growth Hormone Delivery Device containing a two-chamber cartridge supplied in the following strengths: 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1 mg, 1.2 mg, 1.4 mg, 1.6 mg, 1.8 mg, or 2 mg. After reconstitution, each 0.25 mL contains 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1 mg, 1.2 mg, 1.4 mg, 1.6 mg, 1.8 mg, or 2 mg of somatropin, dibasic sodium phosphate (0.03 mg), glycine (0.21 mg), mannitol (12.5 mg), monobasic sodium phosphate (0.05 mg) and water for injection. Each cartridge provides a deliverable volume of 0.25 mL. The reconstituted recombinant somatropin solution has an osmolality of approximately 300 mOsm/kg, and a pH of approximately 6.7.</Description>
</NDC>
<NDC>
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<IndicationAndUsage>GENOTROPIN is a recombinant human growth hormone indicated for: 1 Pediatric: Treatment of children with growth failure due to growth hormone deficiency (GHD), Prader-Willi syndrome, Small for Gestational Age, Turner syndrome, and Idiopathic Short Stature (1.1), 2 Adult: Treatment of adults with either adult onset or childhood onset GHD (1.2).</IndicationAndUsage>
<Description>Somatropin is a human growth hormone produced by recombinant DNA technology in Escherichia coli. The protein is comprised of 191 amino acid residues and has a molecular weight of 22,124 daltons. The amino acid sequence is identical to that of human growth hormone of pituitary origin. GENOTROPIN (somatropin) for injection is a sterile, white, lyophilized powder in a single-patient-use or single-dose, two-chamber cartridge intended for subcutaneous injection after reconstitution. The front chamber contains somatropin and the rear chamber contains diluent. GENOTROPIN 5 mg is a single-patient-use, two-chamber cartridge. GENOTROPIN 5 mg is designed for use with a reusable device (GENOTROPIN PEN 5) for product reconstitution and drug delivery. After reconstitution, each mL contains 5 mg of somatropin, dibasic sodium phosphate (0.27 mg), glycine (2 mg), mannitol (41 mg), metacresol (3 mg) (as a preservative), monobasic sodium phosphate (0.28 mg) and water for injection. The reconstituted concentration is 5 mg/mL with a deliverable volume of 1 mL. GENOTROPIN 12 mg is a single‑patient‑use, two-chamber cartridge. GENOTROPIN 12 mg is designed for use with a reusable device (GENOTROPIN PEN 12) for product reconstitution and drug delivery. After reconstitution, each mL contains 12 mg of somatropin, dibasic sodium phosphate (0.4 mg), glycine (2 mg), mannitol (40 mg), metacresol (3 mg) (as a preservative), monobasic sodium phosphate (0.41 mg) and water for injection. The reconstituted concentration is 12 mg/mL with a deliverable volume of 1 mL. GENOTROPIN MINIQUICK is a single-dose Growth Hormone Delivery Device containing a two-chamber cartridge supplied in the following strengths: 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1 mg, 1.2 mg, 1.4 mg, 1.6 mg, 1.8 mg, or 2 mg. After reconstitution, each 0.25 mL contains 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1 mg, 1.2 mg, 1.4 mg, 1.6 mg, 1.8 mg, or 2 mg of somatropin, dibasic sodium phosphate (0.03 mg), glycine (0.21 mg), mannitol (12.5 mg), monobasic sodium phosphate (0.05 mg) and water for injection. Each cartridge provides a deliverable volume of 0.25 mL. The reconstituted recombinant somatropin solution has an osmolality of approximately 300 mOsm/kg, and a pH of approximately 6.7.</Description>
</NDC>
<NDC>
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<IndicationAndUsage>GENOTROPIN is a recombinant human growth hormone indicated for: 1 Pediatric: Treatment of children with growth failure due to growth hormone deficiency (GHD), Prader-Willi syndrome, Small for Gestational Age, Turner syndrome, and Idiopathic Short Stature (1.1), 2 Adult: Treatment of adults with either adult onset or childhood onset GHD (1.2).</IndicationAndUsage>
<Description>Somatropin is a human growth hormone produced by recombinant DNA technology in Escherichia coli. The protein is comprised of 191 amino acid residues and has a molecular weight of 22,124 daltons. The amino acid sequence is identical to that of human growth hormone of pituitary origin. GENOTROPIN (somatropin) for injection is a sterile, white, lyophilized powder in a single-patient-use or single-dose, two-chamber cartridge intended for subcutaneous injection after reconstitution. The front chamber contains somatropin and the rear chamber contains diluent. GENOTROPIN 5 mg is a single-patient-use, two-chamber cartridge. GENOTROPIN 5 mg is designed for use with a reusable device (GENOTROPIN PEN 5) for product reconstitution and drug delivery. After reconstitution, each mL contains 5 mg of somatropin, dibasic sodium phosphate (0.27 mg), glycine (2 mg), mannitol (41 mg), metacresol (3 mg) (as a preservative), monobasic sodium phosphate (0.28 mg) and water for injection. The reconstituted concentration is 5 mg/mL with a deliverable volume of 1 mL. GENOTROPIN 12 mg is a single‑patient‑use, two-chamber cartridge. GENOTROPIN 12 mg is designed for use with a reusable device (GENOTROPIN PEN 12) for product reconstitution and drug delivery. After reconstitution, each mL contains 12 mg of somatropin, dibasic sodium phosphate (0.4 mg), glycine (2 mg), mannitol (40 mg), metacresol (3 mg) (as a preservative), monobasic sodium phosphate (0.41 mg) and water for injection. The reconstituted concentration is 12 mg/mL with a deliverable volume of 1 mL. GENOTROPIN MINIQUICK is a single-dose Growth Hormone Delivery Device containing a two-chamber cartridge supplied in the following strengths: 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1 mg, 1.2 mg, 1.4 mg, 1.6 mg, 1.8 mg, or 2 mg. After reconstitution, each 0.25 mL contains 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1 mg, 1.2 mg, 1.4 mg, 1.6 mg, 1.8 mg, or 2 mg of somatropin, dibasic sodium phosphate (0.03 mg), glycine (0.21 mg), mannitol (12.5 mg), monobasic sodium phosphate (0.05 mg) and water for injection. Each cartridge provides a deliverable volume of 0.25 mL. The reconstituted recombinant somatropin solution has an osmolality of approximately 300 mOsm/kg, and a pH of approximately 6.7.</Description>
</NDC>
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<IndicationAndUsage>GENOTROPIN is a recombinant human growth hormone indicated for: 1 Pediatric: Treatment of children with growth failure due to growth hormone deficiency (GHD), Prader-Willi syndrome, Small for Gestational Age, Turner syndrome, and Idiopathic Short Stature (1.1), 2 Adult: Treatment of adults with either adult onset or childhood onset GHD (1.2).</IndicationAndUsage>
<Description>Somatropin is a human growth hormone produced by recombinant DNA technology in Escherichia coli. The protein is comprised of 191 amino acid residues and has a molecular weight of 22,124 daltons. The amino acid sequence is identical to that of human growth hormone of pituitary origin. GENOTROPIN (somatropin) for injection is a sterile, white, lyophilized powder in a single-patient-use or single-dose, two-chamber cartridge intended for subcutaneous injection after reconstitution. The front chamber contains somatropin and the rear chamber contains diluent. GENOTROPIN 5 mg is a single-patient-use, two-chamber cartridge. GENOTROPIN 5 mg is designed for use with a reusable device (GENOTROPIN PEN 5) for product reconstitution and drug delivery. After reconstitution, each mL contains 5 mg of somatropin, dibasic sodium phosphate (0.27 mg), glycine (2 mg), mannitol (41 mg), metacresol (3 mg) (as a preservative), monobasic sodium phosphate (0.28 mg) and water for injection. The reconstituted concentration is 5 mg/mL with a deliverable volume of 1 mL. GENOTROPIN 12 mg is a single‑patient‑use, two-chamber cartridge. GENOTROPIN 12 mg is designed for use with a reusable device (GENOTROPIN PEN 12) for product reconstitution and drug delivery. After reconstitution, each mL contains 12 mg of somatropin, dibasic sodium phosphate (0.4 mg), glycine (2 mg), mannitol (40 mg), metacresol (3 mg) (as a preservative), monobasic sodium phosphate (0.41 mg) and water for injection. The reconstituted concentration is 12 mg/mL with a deliverable volume of 1 mL. GENOTROPIN MINIQUICK is a single-dose Growth Hormone Delivery Device containing a two-chamber cartridge supplied in the following strengths: 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1 mg, 1.2 mg, 1.4 mg, 1.6 mg, 1.8 mg, or 2 mg. After reconstitution, each 0.25 mL contains 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1 mg, 1.2 mg, 1.4 mg, 1.6 mg, 1.8 mg, or 2 mg of somatropin, dibasic sodium phosphate (0.03 mg), glycine (0.21 mg), mannitol (12.5 mg), monobasic sodium phosphate (0.05 mg) and water for injection. Each cartridge provides a deliverable volume of 0.25 mL. The reconstituted recombinant somatropin solution has an osmolality of approximately 300 mOsm/kg, and a pH of approximately 6.7.</Description>
</NDC>
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<IndicationAndUsage>GENOTROPIN is a recombinant human growth hormone indicated for: 1 Pediatric: Treatment of children with growth failure due to growth hormone deficiency (GHD), Prader-Willi syndrome, Small for Gestational Age, Turner syndrome, and Idiopathic Short Stature (1.1), 2 Adult: Treatment of adults with either adult onset or childhood onset GHD (1.2).</IndicationAndUsage>
<Description>Somatropin is a human growth hormone produced by recombinant DNA technology in Escherichia coli. The protein is comprised of 191 amino acid residues and has a molecular weight of 22,124 daltons. The amino acid sequence is identical to that of human growth hormone of pituitary origin. GENOTROPIN (somatropin) for injection is a sterile, white, lyophilized powder in a single-patient-use or single-dose, two-chamber cartridge intended for subcutaneous injection after reconstitution. The front chamber contains somatropin and the rear chamber contains diluent. GENOTROPIN 5 mg is a single-patient-use, two-chamber cartridge. GENOTROPIN 5 mg is designed for use with a reusable device (GENOTROPIN PEN 5) for product reconstitution and drug delivery. After reconstitution, each mL contains 5 mg of somatropin, dibasic sodium phosphate (0.27 mg), glycine (2 mg), mannitol (41 mg), metacresol (3 mg) (as a preservative), monobasic sodium phosphate (0.28 mg) and water for injection. The reconstituted concentration is 5 mg/mL with a deliverable volume of 1 mL. GENOTROPIN 12 mg is a single‑patient‑use, two-chamber cartridge. GENOTROPIN 12 mg is designed for use with a reusable device (GENOTROPIN PEN 12) for product reconstitution and drug delivery. After reconstitution, each mL contains 12 mg of somatropin, dibasic sodium phosphate (0.4 mg), glycine (2 mg), mannitol (40 mg), metacresol (3 mg) (as a preservative), monobasic sodium phosphate (0.41 mg) and water for injection. The reconstituted concentration is 12 mg/mL with a deliverable volume of 1 mL. GENOTROPIN MINIQUICK is a single-dose Growth Hormone Delivery Device containing a two-chamber cartridge supplied in the following strengths: 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1 mg, 1.2 mg, 1.4 mg, 1.6 mg, 1.8 mg, or 2 mg. After reconstitution, each 0.25 mL contains 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1 mg, 1.2 mg, 1.4 mg, 1.6 mg, 1.8 mg, or 2 mg of somatropin, dibasic sodium phosphate (0.03 mg), glycine (0.21 mg), mannitol (12.5 mg), monobasic sodium phosphate (0.05 mg) and water for injection. Each cartridge provides a deliverable volume of 0.25 mL. The reconstituted recombinant somatropin solution has an osmolality of approximately 300 mOsm/kg, and a pH of approximately 6.7.</Description>
</NDC>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>GENOTROPIN is a recombinant human growth hormone indicated for: 1 Pediatric: Treatment of children with growth failure due to growth hormone deficiency (GHD), Prader-Willi syndrome, Small for Gestational Age, Turner syndrome, and Idiopathic Short Stature (1.1), 2 Adult: Treatment of adults with either adult onset or childhood onset GHD (1.2).</IndicationAndUsage>
<Description>Somatropin is a human growth hormone produced by recombinant DNA technology in Escherichia coli. The protein is comprised of 191 amino acid residues and has a molecular weight of 22,124 daltons. The amino acid sequence is identical to that of human growth hormone of pituitary origin. GENOTROPIN (somatropin) for injection is a sterile, white, lyophilized powder in a single-patient-use or single-dose, two-chamber cartridge intended for subcutaneous injection after reconstitution. The front chamber contains somatropin and the rear chamber contains diluent. GENOTROPIN 5 mg is a single-patient-use, two-chamber cartridge. GENOTROPIN 5 mg is designed for use with a reusable device (GENOTROPIN PEN 5) for product reconstitution and drug delivery. After reconstitution, each mL contains 5 mg of somatropin, dibasic sodium phosphate (0.27 mg), glycine (2 mg), mannitol (41 mg), metacresol (3 mg) (as a preservative), monobasic sodium phosphate (0.28 mg) and water for injection. The reconstituted concentration is 5 mg/mL with a deliverable volume of 1 mL. GENOTROPIN 12 mg is a single‑patient‑use, two-chamber cartridge. GENOTROPIN 12 mg is designed for use with a reusable device (GENOTROPIN PEN 12) for product reconstitution and drug delivery. After reconstitution, each mL contains 12 mg of somatropin, dibasic sodium phosphate (0.4 mg), glycine (2 mg), mannitol (40 mg), metacresol (3 mg) (as a preservative), monobasic sodium phosphate (0.41 mg) and water for injection. The reconstituted concentration is 12 mg/mL with a deliverable volume of 1 mL. GENOTROPIN MINIQUICK is a single-dose Growth Hormone Delivery Device containing a two-chamber cartridge supplied in the following strengths: 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1 mg, 1.2 mg, 1.4 mg, 1.6 mg, 1.8 mg, or 2 mg. After reconstitution, each 0.25 mL contains 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1 mg, 1.2 mg, 1.4 mg, 1.6 mg, 1.8 mg, or 2 mg of somatropin, dibasic sodium phosphate (0.03 mg), glycine (0.21 mg), mannitol (12.5 mg), monobasic sodium phosphate (0.05 mg) and water for injection. Each cartridge provides a deliverable volume of 0.25 mL. The reconstituted recombinant somatropin solution has an osmolality of approximately 300 mOsm/kg, and a pH of approximately 6.7.</Description>
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