{
"NDC": [
{
"NDCCode": "54046-560-00",
"PackageDescription": "1.5 g in 1 PACKET (54046-560-00)",
"NDC11Code": "54046-0560-00",
"ProductNDC": "54046-560",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antiseptic Cleansing Wipe",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "SWAB",
"RouteName": "TOPICAL",
"StartMarketingDate": "20141001",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Baoying County Fukang Medical Appliance Co., Ltd.",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".13",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2018-01-15",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "54046-000-00",
"PackageDescription": ".5 mL in 1 POUCH (54046-000-00)",
"NDC11Code": "54046-0000-00",
"ProductNDC": "54046-000",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Protector Alcohol Prep Pad",
"NonProprietaryName": "Isopropyl Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20121128",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Baoying County Fukang Medical Appliance Co., Ltd.",
"SubstanceName": "ISOPROPYL ALCOHOL",
"StrengthNumber": "700",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2018-01-15",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "51862-560-00",
"PackageDescription": "1 BOTTLE in 1 CARTON (51862-560-00) / 6 TABLET, DELAYED RELEASE in 1 BOTTLE",
"NDC11Code": "51862-0560-00",
"ProductNDC": "51862-560",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doryx Mpc",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20230102",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050795",
"LabelerName": "Mayne Pharma Commercial LLC",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Active",
"LastUpdate": "2026-02-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230102",
"SamplePackage": "N",
"IndicationAndUsage": "DORYX MPC is a tetracycline class drug indicated for: 1 Rickettsial Infections ( 1.1) , 2 Sexually Transmitted Infections ( 1.2) , 3 Respiratory Tract Infections( 1.3) , 4 Specific Bacterial Infections ( 1.4) , 5 Ophthalmic Infections ( 1.5) , 6 Anthrax, Including Inhalational Anthrax (Post-Exposure) ( 1.6) , 7 Alternative Treatment for Selected Infections when Penicillin is Contraindicated ( 1.7) , 8 Adjunctive Therapy in Acute Intestinal Amebiasis and Severe Acne ( 1.8) , 9 Prophylaxis of Malaria ( 1.9) .",
"Description": "Doryx MPC (doxycycline hyclate delayed-release tablets) for oral use, contain doxycycline hyclate, a tetracycline class drug synthetically derived from oxytetracycline, in a delayed-release formulation consisting of pellets with a modified polymer enteric coat that has increased acid resistance. The structural formula for doxycycline hyclate is. with a molecular formula of C 22H 24N 2O 8, HCl, ½ C 2H 6O, ½ H 2O and a molecular weight of 512.9. The chemical name for doxycycline hyclate is [4S(4aR,5S,5aR,6R,12aS)]-4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-deoxonaphthacene-2-carboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline hyclate is a yellow crystalline powder soluble in water and in solutions of alkali hydroxides and carbonates. Doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each tablet contains doxycycline 60 mg (equivalent to doxycycline hyclate 69.4 mg) or doxycycline 120 mg (equivalent to doxycycline hyclate 138.8 mg). Inactive ingredients in the tablet formulation are: lactose monohydrate; microcrystalline cellulose; sodium lauryl sulfate; sodium chloride; talc; anhydrous lactose; corn starch; crospovidone; magnesium stearate; cellulosic polymer coating. Each DORYX MPC 60 mg Tablet contains 3.6 mg (0.157 mEq) of sodium. Each DORYX MPC 120 mg Tablet contains 7.2 mg (0.313 mEq) of sodium."
},
{
"NDCCode": "62579-560-00",
"PackageDescription": "29595 TABLET, FILM COATED in 1 DRUM (62579-560-00) ",
"NDC11Code": "62579-0560-00",
"ProductNDC": "62579-560",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Diphenhydramine Hydrochloride And Phenylephrine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"StartMarketingDate": "20170111",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Janssen Cilag SpA",
"SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "25; 10",
"StrengthUnit": "mg/1; mg/1",
"Status": "Unfinished",
"LastUpdate": "2026-01-12",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "11-JAN-17"
},
{
"NDCCode": "67457-560-50",
"PackageDescription": "10 VIAL in 1 CARTON (67457-560-50) > 50 mL in 1 VIAL (67457-560-00)",
"NDC11Code": "67457-0560-50",
"ProductNDC": "67457-560",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine Hydrochloride",
"NonProprietaryName": "Lidocaine Hydrochloride",
"DosageFormName": "INJECTION",
"RouteName": "INFILTRATION; INTRAVENOUS",
"StartMarketingDate": "20100912",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091056",
"LabelerName": "Mylan Institutional LLC",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2017-11-10"
},
{
"NDCCode": "68016-560-00",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (68016-560-00) / 10 GUM, CHEWING in 1 BLISTER PACK",
"NDC11Code": "68016-0560-00",
"ProductNDC": "68016-560",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nicotine Polacrilex",
"ProprietaryNameSuffix": "Coated Mint",
"NonProprietaryName": "Nicotine Polacrilex",
"DosageFormName": "GUM, CHEWING",
"RouteName": "BUCCAL",
"StartMarketingDate": "20141001",
"EndMarketingDate": "20261231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078697",
"LabelerName": "Chain Drug Consortium, LLC",
"SubstanceName": "NICOTINE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]",
"Status": "Active",
"LastUpdate": "2026-03-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20141001",
"EndMarketingDatePackage": "20261231",
"SamplePackage": "N",
"IndicationAndUsage": "reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking."
},
{
"NDCCode": "81352-560-00",
"PackageDescription": "1 BOTTLE, DROPPER in 1 BOX (81352-560-00) / 60 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "81352-0560-00",
"ProductNDC": "81352-560",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Santo Remedio Mens Hair Regrowth Treatment Minoxidil Topical Solution Extra Strength Unscented",
"NonProprietaryName": "Minoxidil",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241108",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078176",
"LabelerName": "SANTO REMEDIO LLC",
"SubstanceName": "MINOXIDIL",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241108",
"SamplePackage": "N",
"IndicationAndUsage": "to regrow hair on the top of the scalp (vertex only, see picture on side of carton)."
},
{
"NDCCode": "50090-4147-0",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (50090-4147-0) / 10 mL in 1 VIAL, GLASS",
"NDC11Code": "50090-4147-00",
"ProductNDC": "50090-4147",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Testosterone Cypionate",
"NonProprietaryName": "Testosterone Cypionate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20071221",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040530",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "TESTOSTERONE CYPIONATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190219",
"SamplePackage": "N",
"IndicationAndUsage": "Testosterone cypionate injection is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone. : 1 1.Primary hypogonadism (congenital or acquired)-testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy., 2 2.Hypogonadotropic hypogonadism (congenital or acquired)-gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation.",
"Description": "Testosterone cypionate injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. It is insoluble in water, freely soluble in alcohol, chloroform, dioxane, ether, and soluble in vegetable oils. The chemical name for testosterone cypionate is androst-4-en-3-one, 17-(3-cyclopentyl-1-oxopropoxy)-, (17β)-. Its molecular formula is C27H40O3, and the molecular weight 412.61. The structural formula is represented below. Testosterone cypionate injection is available in one strength, 200 mg/mL testosterone cypionate. Each mL of the solution contains Testosterone Cypionate, 200 mg; Benzyl Benzoate, 0.2 mL; Cottonseed Oil, 560 mg; Benzyl Alcohol (as preservative), 9.45 mg."
},
{
"NDCCode": "50090-4446-0",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (50090-4446-0) > 10 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "50090-4446-00",
"ProductNDC": "50090-4446",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Testosterone Cypionate",
"NonProprietaryName": "Testosterone Cypionate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20130617",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201720",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "TESTOSTERONE CYPIONATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190802",
"SamplePackage": "N",
"IndicationAndUsage": "Testosterone cypionate injection is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone. 1. Primary hypogonadism (congenital or acquired)- testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy. 2. Hypogonadotropic hypogonadism (congenital or acquired)- gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. Safety and efficacy of testosterone cypionate in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established.",
"Description": "Testosterone cypionate injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)- cyclopentylpropionate ester of the androgenic hormone testosterone.Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. It is insoluble in water, freely soluble in alcohol, chloroform, dioxane, ether, and soluble in vegetable oils.The chemical name for testosterone cypionate is androst-4-en-3-one,17-(3-cyclopentyl-1-oxopropoxy)-, (17β)-. Its molecular formula is C27H40O3, and the molecular weight 412.61.The structural formula is represented below. Testosterone cypionate injection, USP is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate, USP.Each mL of the 100 mg/mL solution contains:Testosterone cypionate............................................................................... 100 mgBenzyl benzoate .......................................................................................... 0.1 mLCottonseed oil ............................................................................................. 736 mgBenzyl alcohol (as preservative).................................................................. 9.45 mgEach mL of the 200 mg/mL solution contains:Testosterone cypionate............................................................................... 200 mg Benzyl benzoate........................................................................................... 0.2 mL Cottonseed oil............................................................................................. 560 mgBenzyl alcohol (as preservative).................................................................. 9.45 mg."
},
{
"NDCCode": "50090-4920-0",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (50090-4920-0) / 10 mL in 1 VIAL, GLASS",
"NDC11Code": "50090-4920-00",
"ProductNDC": "50090-4920",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Testosterone Cypionate",
"NonProprietaryName": "Testosterone Cypionate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20140501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091244",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "TESTOSTERONE CYPIONATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2024-07-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200219",
"SamplePackage": "N",
"IndicationAndUsage": "Testosterone Cypionate Injection, USP is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone. : 1 1.Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy., 2 2.Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation.",
"Description": "Testosterone Cypionate Injection, USP for intramuscular injection, contains Testosterone Cypionate, USP which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone. Testosterone Cypionate, USP is a white or creamy white crystalline powder, odorless or nearly so and stable in air. It is insoluble in water, freely soluble in alcohol, chloroform, dioxane, ether, and soluble in vegetable oils. The chemical name for Testosterone Cypionate, USP is androst-4-en-3-one,17-(3-cyclopentyl-1- oxopropoxy)-, (17ß)-. Its molecular formula is C27H40O3, and the molecular weight 412.61. The structural formula is represented below. Testosterone Cypionate Injection, USP is available in one strength, 200 mg/mL Testosterone Cypionate, USP. Each mL of the 200 mg/mL solution contains: 1 Testosterone Cypionate, USP 200 mg, 2 Benzyl Benzoate, USP 0.2 mL, 3 Cottonseed Oil, USP 560 mg, 4 Benzyl Alcohol, USP (as preservative) 9.45 mg."
},
{
"NDCCode": "54868-0216-0",
"PackageDescription": "1 VIAL in 1 CARTON (54868-0216-0) > 10 mL in 1 VIAL",
"NDC11Code": "54868-0216-00",
"ProductNDC": "54868-0216",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Depo-testosterone",
"NonProprietaryName": "Testosterone Cypionate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "19940712",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA085635",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "TESTOSTERONE CYPIONATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "DEPO-Testosterone Injection is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone. 1. Primary hypogonadism (congenital or acquired)-testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy. 2. Hypogonadotropic hypogonadism (congenital or acquired)-idiopathic gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation.",
"Description": "DEPO-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)- cyclopentylpropionate ester of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. It is insoluble in water, freely soluble in alcohol, chloroform, dioxane, ether, and soluble in vegetable oils. The chemical name for testosterone cypionate is androst-4-en-3-one,17-(3-cyclopentyl-1-oxopropoxy)-, (17β)-. Its molecular formula is C27H40O3, and the molecular weight 412.61. The structural formula is represented below. DEPO-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate. Each mL of the 100 mg/mL solution contains: Testosterone cypionate................................................................................... 100 mg Benzyl benzoate .............................................................................................. 0.1 mL Cottonseed oil ................................................................................................ 736 mg Benzyl alcohol (as preservative) ..................................................................... 9.45 mg. Each mL of the 200 mg/mL solution contains: Testosterone cypionate .................................................................................. 200 mg Benzyl benzoate .............................................................................................. 0.2 mL Cottonseed oil ................................................................................................ 560 mg Benzyl alcohol (as preservative) ..................................................................... 9.45 mg."
},
{
"NDCCode": "54868-3618-0",
"PackageDescription": "1 VIAL in 1 CARTON (54868-3618-0) > 10 mL in 1 VIAL",
"NDC11Code": "54868-3618-00",
"ProductNDC": "54868-3618",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Testosterone Cypionate",
"NonProprietaryName": "Testosterone Cypionate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20070810",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040530",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "TESTOSTERONE CYPIONATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Testosterone cypionate injection is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone. : 1 Primary hypogonadism (congenital or acquired)-testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy., 2 Hypogonadotropic hypogonadism (congenital or acquired)-idiopathic gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation.",
"Description": "Testosterone cypionate injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. It is insoluble in water, freely soluble in alcohol, chloroform, dioxane, ether, and soluble in vegetable oils. The chemical name for testosterone cypionate is androst-4-en-3-one, 17-(3-cyclopentyl-1-oxopropoxy)-, (17β)-. Its molecular formula is C27H40O3, and the molecular weight 412.61. The structural formula is represented below. Testosterone cypionate injection is available in one strength, 200 mg/mL testosterone cypionate. Each mL of the solution contains Testosterone Cypionate, 200 mg; Benzyl Benzoate, 0.2 mL; Cottonseed Oil, 560 mg; Benzyl Alcohol (as preservative), 9.45 mg."
},
{
"NDCCode": "58032-2026-0",
"PackageDescription": "1 kg in 1 DRUM (58032-2026-0) ",
"NDC11Code": "58032-2026-00",
"ProductNDC": "58032-2026",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Sd-560 D3-pirfenidone",
"DosageFormName": "POWDER",
"StartMarketingDate": "20171219",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Neuland Laboratories Limited",
"SubstanceName": "PIRFENIDONE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2023-12-28",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "19-DEC-17"
},
{
"NDCCode": "70518-4538-0",
"PackageDescription": "1 mL in 1 VIAL, GLASS (70518-4538-0) ",
"NDC11Code": "70518-4538-00",
"ProductNDC": "70518-4538",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Testosterone Cypionate",
"NonProprietaryName": "Testosterone Cypionate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20251217",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210362",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "TESTOSTERONE CYPIONATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-09-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20251217",
"SamplePackage": "N",
"IndicationAndUsage": "Testosterone cypionate injection is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone. : 1 Primary hypogonadism (congenital or acquired)-testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy., 2 Hypogonadotropic hypogonadism (congenital or acquired)-gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation.",
"Description": "Testosterone cypionate, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. It is insoluble in water, freely soluble in alcohol, chloroform, dioxane, ether, and soluble in vegetable oils. The chemical name for testosterone cypionate is androst-4-en-3-one, 17-(3-cyclopentyl- 1-oxopropoxy)-, (17ß)-. Its molecular formula is C 27H 40O 3, and the molecular weight 412.61. The structural formula is represented below. Testosterone cypionate injection, USP is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate. Each mL of the 100 mg/mLsolution contains:. Testosterone cypionate............................................................................................100 mg. Benzyl benzoate ......................................................................................................0.1 mL. Cottonseed oil .........................................................................................................736 mg. Benzyl alcohol (as preservative) .............................................................................9.45 mg. Each mL of the 200 mg/mLsolution contains:. Testosterone cypionate .............................................................................................200 mg. Benzyl benzoate ........................................................................................................0.2 mL. Cottonseed oil ...........................................................................................................560 mg. Benzyl alcohol (as preservative) ...............................................................................9.45 mg."
},
{
"NDCCode": "76519-1210-0",
"PackageDescription": "1 mL in 1 VIAL, MULTI-DOSE (76519-1210-0) ",
"NDC11Code": "76519-1210-00",
"ProductNDC": "76519-1210",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Testosterone Cypionate",
"NonProprietaryName": "Testosterone Cypionate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20120501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091244",
"LabelerName": "H.J. Harkins Company, Inc.",
"SubstanceName": "TESTOSTERONE CYPIONATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/10mL",
"Pharm_Classes": "Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2018-11-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20120501",
"SamplePackage": "N",
"IndicationAndUsage": "Testosterone Cypionate Injection, USP is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone. Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy. Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. Safety and efficacy of testosterone cypionate in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established.",
"Description": "Testosterone Cypionate Injection, USP for intramuscular injection, contains Testosterone Cypionate, USP which is the oil-soluble 17 (beta)- cyclopentylpropionate ester of the androgenic hormone testosterone. Testosterone Cypionate, USP is a white or creamy white crystalline powder, odorless or nearly so and stable in air. It is insoluble in water, freely soluble in alcohol, chloroform, dioxane, ether, and soluble in vegetable oils. The chemical name for Testosterone Cypionate, USP is androst-4-en-3-one,17-(3-cyclopentyl-1-oxopropoxy)-, (17β)-. Its molecular formula is C27H40O3, and the molecular weight 412.61. The structural formula is represented below. Testosterone Cypionate Injection, USP is available in one strength, 200 mg/mL Testosterone Cypionate, USP. Each mL of the 200 mg/mL solution contains: Testosterone Cypionate, USP 200 mg Benzyl Benzoate, USP 0.2 mL Cottonseed Oil, USP 560 mg Benzyl Alcohol, USP (as preservative) 9.45 mg."
},
{
"NDCCode": "0113-7219-13",
"PackageDescription": "5 POUCH in 1 CARTON (0113-7219-13) > 1 PATCH in 1 POUCH",
"NDC11Code": "00113-7219-13",
"ProductNDC": "0113-7219",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Basic Care Lidocaine",
"NonProprietaryName": "Lidocaine",
"DosageFormName": "PATCH",
"RouteName": "PERCUTANEOUS; TOPICAL; TRANSDERMAL",
"StartMarketingDate": "20190823",
"EndMarketingDate": "20230601",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "L. Perrigo Company",
"SubstanceName": "LIDOCAINE",
"StrengthNumber": "560",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190823",
"EndMarketingDatePackage": "20230601",
"SamplePackage": "N"
},
{
"NDCCode": "0113-7700-91",
"PackageDescription": "6 POUCH in 1 CARTON (0113-7700-91) > 1 PATCH in 1 POUCH",
"NDC11Code": "00113-7700-91",
"ProductNDC": "0113-7700",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Basic Care Lidocaine",
"NonProprietaryName": "Lidocaine",
"DosageFormName": "PATCH",
"RouteName": "PERCUTANEOUS; TOPICAL; TRANSDERMAL",
"StartMarketingDate": "20190925",
"EndMarketingDate": "20230101",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "L. Perrigo Company",
"SubstanceName": "LIDOCAINE",
"StrengthNumber": "560",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190925",
"EndMarketingDatePackage": "20230101",
"SamplePackage": "N"
},
{
"NDCCode": "0121-0970-05",
"PackageDescription": "12 CARTON in 1 CASE (0121-0970-05) / 5 POUCH in 1 CARTON / 1 PATCH in 1 POUCH (0121-0970-01) ",
"NDC11Code": "00121-0970-05",
"ProductNDC": "0121-0970",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lidocaine Pain Relief",
"NonProprietaryName": "Lidocaine Pain Relief",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230403",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "PAI Holdings, LLC dba PAI Pharma",
"SubstanceName": "LIDOCAINE",
"StrengthNumber": "560",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2026-03-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230403",
"EndMarketingDatePackage": "20260228",
"SamplePackage": "N",
"IndicationAndUsage": "Temporary relief of pain."
},
{
"NDCCode": "0121-0970-30",
"PackageDescription": "6 CARTON in 1 CASE (0121-0970-30) / 30 POUCH in 1 CARTON / 1 PATCH in 1 POUCH (0121-0970-01) ",
"NDC11Code": "00121-0970-30",
"ProductNDC": "0121-0970",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lidocaine Pain Relief",
"NonProprietaryName": "Lidocaine Pain Relief",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230403",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "PAI Holdings, LLC dba PAI Pharma",
"SubstanceName": "LIDOCAINE",
"StrengthNumber": "560",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2026-02-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240729",
"SamplePackage": "N",
"IndicationAndUsage": "Temporary relief of pain."
},
{
"NDCCode": "0143-9005-01",
"PackageDescription": "1 VIAL in 1 CARTON (0143-9005-01) / 10 mL in 1 VIAL",
"NDC11Code": "00143-9005-01",
"ProductNDC": "0143-9005",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Testosterone Cypionate",
"NonProprietaryName": "Testosterone Cypionate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20211122",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091244",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "TESTOSTERONE CYPIONATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-05-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20211122",
"SamplePackage": "N",
"IndicationAndUsage": "Testosterone Cypionate Injection, USP is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone. : 1 Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy., 2 Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation.",
"Description": "Testosterone Cypionate Injection, USP for intramuscular injection, contains Testosterone Cypionate, USP which is the oil-soluble 17 (beta)- cyclopentylpropionate ester of the androgenic hormone testosterone. Testosterone Cypionate, USP is a white or creamy white crystalline powder, odorless or nearly so and stable in air. It is insoluble in water, freely soluble in alcohol, chloroform, dioxane, ether, and soluble in vegetable oils. The chemical name for Testosterone Cypionate, USP is androst-4-en-3-one,17-(3-cyclopentyl-1-oxopropoxy)-, (17β)-. Its molecular formula is C27H40O3, and the molecular weight 412.61. The structural formula is represented below. Testosterone Cypionate Injection, USP is available in one strength, 200 mg/mL Testosterone Cypionate, USP. Each mL of the 200 mg/mL solution contains: Testosterone Cypionate, USP 200 mg Benzyl Benzoate, USP 0.2 mL Cottonseed Oil, USP 560 mg Benzyl Alcohol, USP (as preservative) 9.45 mg."
},
{
"NDCCode": "0143-9659-01",
"PackageDescription": "1 mL in 1 VIAL (0143-9659-01) ",
"NDC11Code": "00143-9659-01",
"ProductNDC": "0143-9659",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Testosterone Cypionate",
"NonProprietaryName": "Testosterone Cypionate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20120501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091244",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "TESTOSTERONE CYPIONATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-05-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120501",
"SamplePackage": "N",
"IndicationAndUsage": "Testosterone Cypionate Injection, USP is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone. : 1 Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy., 2 Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation.",
"Description": "Testosterone Cypionate Injection, USP for intramuscular injection, contains Testosterone Cypionate, USP which is the oil-soluble 17 (beta)- cyclopentylpropionate ester of the androgenic hormone testosterone. Testosterone Cypionate, USP is a white or creamy white crystalline powder, odorless or nearly so and stable in air. It is insoluble in water, freely soluble in alcohol, chloroform, dioxane, ether, and soluble in vegetable oils. The chemical name for Testosterone Cypionate, USP is androst-4-en-3-one,17-(3-cyclopentyl-1-oxopropoxy)-, (17β)-. Its molecular formula is C27H40O3, and the molecular weight 412.61. The structural formula is represented below. Testosterone Cypionate Injection, USP is available in one strength, 200 mg/mL Testosterone Cypionate, USP. Each mL of the 200 mg/mL solution contains: Testosterone Cypionate, USP 200 mg Benzyl Benzoate, USP 0.2 mL Cottonseed Oil, USP 560 mg Benzyl Alcohol, USP (as preservative) 9.45 mg."
},
{
"NDCCode": "0143-9726-01",
"PackageDescription": "10 mL in 1 VIAL (0143-9726-01) ",
"NDC11Code": "00143-9726-01",
"ProductNDC": "0143-9726",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Testosterone Cypionate",
"NonProprietaryName": "Testosterone Cypionate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20120501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091244",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "TESTOSTERONE CYPIONATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2026-05-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120501",
"SamplePackage": "N",
"IndicationAndUsage": "Testosterone Cypionate Injection, USP is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone. : 1 Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy., 2 Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation.",
"Description": "Testosterone Cypionate Injection, USP for intramuscular injection, contains Testosterone Cypionate, USP which is the oil-soluble 17 (beta)- cyclopentylpropionate ester of the androgenic hormone testosterone. Testosterone Cypionate, USP is a white or creamy white crystalline powder, odorless or nearly so and stable in air. It is insoluble in water, freely soluble in alcohol, chloroform, dioxane, ether, and soluble in vegetable oils. The chemical name for Testosterone Cypionate, USP is androst-4-en-3-one,17-(3-cyclopentyl-1-oxopropoxy)-, (17β)-. Its molecular formula is C27H40O3, and the molecular weight 412.61. The structural formula is represented below. Testosterone Cypionate Injection, USP is available in one strength, 200 mg/mL Testosterone Cypionate, USP. Each mL of the 200 mg/mL solution contains: Testosterone Cypionate, USP 200 mg Benzyl Benzoate, USP 0.2 mL Cottonseed Oil, USP 560 mg Benzyl Alcohol, USP (as preservative) 9.45 mg."
},
{
"NDCCode": "0338-0644-03",
"PackageDescription": "500 mL in 1 BAG (0338-0644-03) ",
"NDC11Code": "00338-0644-03",
"ProductNDC": "0338-0644",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Travasol",
"NonProprietaryName": "Leucine, Phenylalanine, Lysine Hydrochloride, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Tyrosine, Serine",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19840823",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018931",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "LEUCINE; PHENYLALANINE; LYSINE HYDROCHLORIDE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; TYROSINE; SERINE",
"StrengthNumber": "730; 560; 580; 400; 600; 580; 480; 420; 180; 2.07; 1.03; 1.15; 680; 40; 500",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL; g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Amino Acid [EPC], Amino Acids [CS]",
"Status": "Active",
"LastUpdate": "2025-02-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19840823",
"SamplePackage": "N",
"IndicationAndUsage": "TRAVASOL is indicated as a source of amino acids for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. TRAVASOL may be used to treat negative nitrogen balance in patients.",
"Description": "TRAVASOL 10% (amino acids) injection is a sterile, nonpyrogenic hypertonic solution of essential and nonessential amino acids supplied in a flexible container as a Pharmacy Bulk Package. A Pharmacy Bulk Package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program [see Dosage and Administration (2.1)]. TRAVASOL is not for direct intravenous infusion. The formulas for the individual amino acids found in TRAVASOL are provided in Table 4. TRAVASOL contains no more than 25 mcg/L of aluminum."
},
{
"NDCCode": "0338-0644-04",
"PackageDescription": "1000 mL in 1 BAG (0338-0644-04) ",
"NDC11Code": "00338-0644-04",
"ProductNDC": "0338-0644",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Travasol",
"NonProprietaryName": "Leucine, Phenylalanine, Lysine Hydrochloride, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Tyrosine, Serine",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19840823",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018931",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "LEUCINE; PHENYLALANINE; LYSINE HYDROCHLORIDE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; TYROSINE; SERINE",
"StrengthNumber": "730; 560; 580; 400; 600; 580; 480; 420; 180; 2.07; 1.03; 1.15; 680; 40; 500",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL; g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Amino Acid [EPC], Amino Acids [CS]",
"Status": "Active",
"LastUpdate": "2025-02-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19840823",
"SamplePackage": "N",
"IndicationAndUsage": "TRAVASOL is indicated as a source of amino acids for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. TRAVASOL may be used to treat negative nitrogen balance in patients.",
"Description": "TRAVASOL 10% (amino acids) injection is a sterile, nonpyrogenic hypertonic solution of essential and nonessential amino acids supplied in a flexible container as a Pharmacy Bulk Package. A Pharmacy Bulk Package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program [see Dosage and Administration (2.1)]. TRAVASOL is not for direct intravenous infusion. The formulas for the individual amino acids found in TRAVASOL are provided in Table 4. TRAVASOL contains no more than 25 mcg/L of aluminum."
},
{
"NDCCode": "0338-0644-06",
"PackageDescription": "2000 mL in 1 BAG (0338-0644-06) ",
"NDC11Code": "00338-0644-06",
"ProductNDC": "0338-0644",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Travasol",
"NonProprietaryName": "Leucine, Phenylalanine, Lysine Hydrochloride, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Tyrosine, Serine",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "19840823",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018931",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "LEUCINE; PHENYLALANINE; LYSINE HYDROCHLORIDE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; TYROSINE; SERINE",
"StrengthNumber": "730; 560; 580; 400; 600; 580; 480; 420; 180; 2.07; 1.03; 1.15; 680; 40; 500",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL; g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Amino Acid [EPC], Amino Acids [CS]",
"Status": "Active",
"LastUpdate": "2025-02-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19840823",
"SamplePackage": "N",
"IndicationAndUsage": "TRAVASOL is indicated as a source of amino acids for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. TRAVASOL may be used to treat negative nitrogen balance in patients.",
"Description": "TRAVASOL 10% (amino acids) injection is a sterile, nonpyrogenic hypertonic solution of essential and nonessential amino acids supplied in a flexible container as a Pharmacy Bulk Package. A Pharmacy Bulk Package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program [see Dosage and Administration (2.1)]. TRAVASOL is not for direct intravenous infusion. The formulas for the individual amino acids found in TRAVASOL are provided in Table 4. TRAVASOL contains no more than 25 mcg/L of aluminum."
},
{
"NDCCode": "0409-4200-03",
"PackageDescription": "12 POUCH in 1 CASE (0409-4200-03) > 1 BAG in 1 POUCH > 500 mL in 1 BAG",
"NDC11Code": "00409-4200-03",
"ProductNDC": "0409-4200",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aminosyn",
"NonProprietaryName": "Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Histidine, Proline, Serine, Tyrosine, Glycine, Sodium Chloride, Magnesium Chloride, Sodium Phosphate, Dibasic, And Potassium Chloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20110323",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017789",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ALANINE; ARGININE; HISTIDINE; PROLINE; SERINE; TYROSINE; GLYCINE; SODIUM CHLORIDE; MAGNESIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC; POTASSIUM CHLORIDE",
"StrengthNumber": "510; 660; 510; 280; 310; 370; 120; 560; 900; 690; 210; 610; 300; 44; 900; 28; 102; 425; 487",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Amino Acid [EPC],Amino Acids [CS],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-04-20",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0517-1830-01",
"PackageDescription": "1 VIAL in 1 BOX (0517-1830-01) > 1 mL in 1 VIAL",
"NDC11Code": "00517-1830-01",
"ProductNDC": "0517-1830",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Testosterone Cypionate",
"NonProprietaryName": "Testosterone Cypionate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20190719",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA207742",
"LabelerName": "American Regent, Inc.",
"SubstanceName": "TESTOSTERONE CYPIONATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2026-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190719",
"SamplePackage": "N",
"IndicationAndUsage": "Testosterone cypionate injection is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone. 1. Primary hypogonadism (congenital or acquired)-testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy. 2. Hypogonadotropic hypogonadism (congenital or acquired)-gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. Safety and efficacy of testosterone cypionate injection in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established.",
"Description": "Testosterone Cypionate Injection, USP, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)- cyclopentylpropionate ester of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. It is insoluble in water, freely soluble in alcohol, chloroform, dioxane, ether, and soluble in vegetable oils. The chemical name for testosterone cypionate is androst-4-en-3-one,17-(3-cyclopentyl-1-oxopropoxy)-, (17β)-. Its molecular formula is C27H40O3, and the molecular weight 412.61. The structural formula is represented below. Testosterone Cypionate Injection, USP is available as 200 mg/mL testosterone cypionate. Each mL of the solution contains Testosterone Cypionate, 200 mg; Benzyl Benzoate, 0.2 mL; Cottonseed Oil, 560 mg; Benzyl Alcohol (as preservative), 9.45 mg."
},
{
"NDCCode": "0574-0820-01",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (0574-0820-01) / 1 mL in 1 VIAL, GLASS",
"NDC11Code": "00574-0820-01",
"ProductNDC": "0574-0820",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Testosterone Cypionate",
"NonProprietaryName": "Testosterone Cypionate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20071221",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040530",
"LabelerName": "Padagis US LLC",
"SubstanceName": "TESTOSTERONE CYPIONATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2025-06-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150109",
"SamplePackage": "N",
"IndicationAndUsage": "Testosterone cypionate injection is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone. : 1 1.Primary hypogonadism (congenital or acquired)-testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy., 2 2.Hypogonadotropic hypogonadism (congenital or acquired)-gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation.",
"Description": "Testosterone cypionate injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. It is insoluble in water, freely soluble in alcohol, chloroform, dioxane, ether, and soluble in vegetable oils. The chemical name for testosterone cypionate is androst-4-en-3-one, 17-(3-cyclopentyl-1-oxopropoxy)-, (17β)-. Its molecular formula is C27H40O3, and the molecular weight 412.61. The structural formula is represented below. Testosterone cypionate injection is available in one strength, 200 mg/mL testosterone cypionate. Each mL of the solution contains Testosterone Cypionate, 200 mg; Benzyl Benzoate, 0.2 mL; Cottonseed Oil, 560 mg; Benzyl Alcohol (as preservative), 9.45 mg."
},
{
"NDCCode": "0574-0820-10",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (0574-0820-10) / 10 mL in 1 VIAL, GLASS",
"NDC11Code": "00574-0820-10",
"ProductNDC": "0574-0820",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Testosterone Cypionate",
"NonProprietaryName": "Testosterone Cypionate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20071221",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040530",
"LabelerName": "Padagis US LLC",
"SubstanceName": "TESTOSTERONE CYPIONATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2025-06-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20141216",
"SamplePackage": "N",
"IndicationAndUsage": "Testosterone cypionate injection is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone. : 1 1.Primary hypogonadism (congenital or acquired)-testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy., 2 2.Hypogonadotropic hypogonadism (congenital or acquired)-gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation.",
"Description": "Testosterone cypionate injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. It is insoluble in water, freely soluble in alcohol, chloroform, dioxane, ether, and soluble in vegetable oils. The chemical name for testosterone cypionate is androst-4-en-3-one, 17-(3-cyclopentyl-1-oxopropoxy)-, (17β)-. Its molecular formula is C27H40O3, and the molecular weight 412.61. The structural formula is represented below. Testosterone cypionate injection is available in one strength, 200 mg/mL testosterone cypionate. Each mL of the solution contains Testosterone Cypionate, 200 mg; Benzyl Benzoate, 0.2 mL; Cottonseed Oil, 560 mg; Benzyl Alcohol (as preservative), 9.45 mg."
},
{
"NDCCode": "0574-0827-01",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (0574-0827-01) / 1 mL in 1 VIAL, GLASS",
"NDC11Code": "00574-0827-01",
"ProductNDC": "0574-0827",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Testosterone Cypionate",
"NonProprietaryName": "Testosterone Cypionate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20140501",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091244",
"LabelerName": "Padagis US LLC",
"SubstanceName": "TESTOSTERONE CYPIONATE",
"StrengthNumber": "200",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2024-12-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190304",
"SamplePackage": "N",
"IndicationAndUsage": "Testosterone Cypionate Injection, USP is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency, or absence of endogenous testosterone. : 1 1.Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy., 2 2.Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation.",
"Description": "Testosterone Cypionate Injection, USP for intramuscular injection, contains Testosterone Cypionate, USP which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone. Testosterone Cypionate, USP is a white or creamy white crystalline powder, odorless or nearly so and stable in air. It is insoluble in water, freely soluble in alcohol, chloroform, dioxane, ether, and soluble in vegetable oils. The chemical name for Testosterone Cypionate, USP is androst-4-en-3-one,17-(3-cyclopentyl-1- oxopropoxy)-, (17ß)-. Its molecular formula is C27H40O3, and the molecular weight 412.61. The structural formula is represented below. Testosterone Cypionate Injection, USP is available in one strength, 200 mg/mL Testosterone Cypionate, USP. Each mL of the 200 mg/mL solution contains: 1 Testosterone Cypionate, USP 200 mg, 2 Benzyl Benzoate, USP 0.2 mL, 3 Cottonseed Oil, USP 560 mg, 4 Benzyl Alcohol, USP (as preservative) 9.45 mg."
}
]
}
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antiseptic Cleansing Wipe</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>SWAB</DosageFormName>
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<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Baoying County Fukang Medical Appliance Co., Ltd.</LabelerName>
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<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-01-15</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>54046-000-00</NDCCode>
<PackageDescription>.5 mL in 1 POUCH (54046-000-00)</PackageDescription>
<NDC11Code>54046-0000-00</NDC11Code>
<ProductNDC>54046-000</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Protector Alcohol Prep Pad</ProprietaryName>
<NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
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<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Baoying County Fukang Medical Appliance Co., Ltd.</LabelerName>
<SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
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<StrengthUnit>mg/mL</StrengthUnit>
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<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
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<NDC>
<NDCCode>51862-560-00</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (51862-560-00) / 6 TABLET, DELAYED RELEASE in 1 BOTTLE</PackageDescription>
<NDC11Code>51862-0560-00</NDC11Code>
<ProductNDC>51862-560</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doryx Mpc</ProprietaryName>
<NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230102</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
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<LabelerName>Mayne Pharma Commercial LLC</LabelerName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DORYX MPC is a tetracycline class drug indicated for: 1 Rickettsial Infections ( 1.1) , 2 Sexually Transmitted Infections ( 1.2) , 3 Respiratory Tract Infections( 1.3) , 4 Specific Bacterial Infections ( 1.4) , 5 Ophthalmic Infections ( 1.5) , 6 Anthrax, Including Inhalational Anthrax (Post-Exposure) ( 1.6) , 7 Alternative Treatment for Selected Infections when Penicillin is Contraindicated ( 1.7) , 8 Adjunctive Therapy in Acute Intestinal Amebiasis and Severe Acne ( 1.8) , 9 Prophylaxis of Malaria ( 1.9) .</IndicationAndUsage>
<Description>Doryx MPC (doxycycline hyclate delayed-release tablets) for oral use, contain doxycycline hyclate, a tetracycline class drug synthetically derived from oxytetracycline, in a delayed-release formulation consisting of pellets with a modified polymer enteric coat that has increased acid resistance. The structural formula for doxycycline hyclate is. with a molecular formula of C 22H 24N 2O 8, HCl, ½ C 2H 6O, ½ H 2O and a molecular weight of 512.9. The chemical name for doxycycline hyclate is [4S(4aR,5S,5aR,6R,12aS)]-4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-deoxonaphthacene-2-carboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. Doxycycline hyclate is a yellow crystalline powder soluble in water and in solutions of alkali hydroxides and carbonates. Doxycycline has a high degree of lipid solubility and a low affinity for calcium binding. It is highly stable in normal human serum. Doxycycline will not degrade into an epianhydro form. Each tablet contains doxycycline 60 mg (equivalent to doxycycline hyclate 69.4 mg) or doxycycline 120 mg (equivalent to doxycycline hyclate 138.8 mg). Inactive ingredients in the tablet formulation are: lactose monohydrate; microcrystalline cellulose; sodium lauryl sulfate; sodium chloride; talc; anhydrous lactose; corn starch; crospovidone; magnesium stearate; cellulosic polymer coating. Each DORYX MPC 60 mg Tablet contains 3.6 mg (0.157 mEq) of sodium. Each DORYX MPC 120 mg Tablet contains 7.2 mg (0.313 mEq) of sodium.</Description>
</NDC>
<NDC>
<NDCCode>62579-560-00</NDCCode>
<PackageDescription>29595 TABLET, FILM COATED in 1 DRUM (62579-560-00) </PackageDescription>
<NDC11Code>62579-0560-00</NDC11Code>
<ProductNDC>62579-560</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Diphenhydramine Hydrochloride And Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<StartMarketingDate>20170111</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Janssen Cilag SpA</LabelerName>
<SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-01-12</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>11-JAN-17</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>67457-560-50</NDCCode>
<PackageDescription>10 VIAL in 1 CARTON (67457-560-50) > 50 mL in 1 VIAL (67457-560-00)</PackageDescription>
<NDC11Code>67457-0560-50</NDC11Code>
<ProductNDC>67457-560</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine Hydrochloride</ProprietaryName>
<NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INFILTRATION; INTRAVENOUS</RouteName>
<StartMarketingDate>20100912</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091056</ApplicationNumber>
<LabelerName>Mylan Institutional LLC</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-11-10</LastUpdate>
</NDC>
<NDC>
<NDCCode>68016-560-00</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (68016-560-00) / 10 GUM, CHEWING in 1 BLISTER PACK</PackageDescription>
<NDC11Code>68016-0560-00</NDC11Code>
<ProductNDC>68016-560</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nicotine Polacrilex</ProprietaryName>
<ProprietaryNameSuffix>Coated Mint</ProprietaryNameSuffix>
<NonProprietaryName>Nicotine Polacrilex</NonProprietaryName>
<DosageFormName>GUM, CHEWING</DosageFormName>
<RouteName>BUCCAL</RouteName>
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<EndMarketingDate>20261231</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078697</ApplicationNumber>
<LabelerName>Chain Drug Consortium, LLC</LabelerName>
<SubstanceName>NICOTINE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Nicotinic Agonist [EPC], Nicotine [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20141001</StartMarketingDatePackage>
<EndMarketingDatePackage>20261231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.</IndicationAndUsage>
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<NDC>
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<PackageDescription>1 BOTTLE, DROPPER in 1 BOX (81352-560-00) / 60 mL in 1 BOTTLE, DROPPER</PackageDescription>
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<ProductNDC>81352-560</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Santo Remedio Mens Hair Regrowth Treatment Minoxidil Topical Solution Extra Strength Unscented</ProprietaryName>
<NonProprietaryName>Minoxidil</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241108</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078176</ApplicationNumber>
<LabelerName>SANTO REMEDIO LLC</LabelerName>
<SubstanceName>MINOXIDIL</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241108</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>to regrow hair on the top of the scalp (vertex only, see picture on side of carton).</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50090-4147-0</NDCCode>
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<ProductNDC>50090-4147</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Testosterone Cypionate</ProprietaryName>
<NonProprietaryName>Testosterone Cypionate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20071221</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040530</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>TESTOSTERONE CYPIONATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-06-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Testosterone cypionate injection is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone. : 1 1.Primary hypogonadism (congenital or acquired)-testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy., 2 2.Hypogonadotropic hypogonadism (congenital or acquired)-gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation.</IndicationAndUsage>
<Description>Testosterone cypionate injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. It is insoluble in water, freely soluble in alcohol, chloroform, dioxane, ether, and soluble in vegetable oils. The chemical name for testosterone cypionate is androst-4-en-3-one, 17-(3-cyclopentyl-1-oxopropoxy)-, (17β)-. Its molecular formula is C27H40O3, and the molecular weight 412.61. The structural formula is represented below. Testosterone cypionate injection is available in one strength, 200 mg/mL testosterone cypionate. Each mL of the solution contains Testosterone Cypionate, 200 mg; Benzyl Benzoate, 0.2 mL; Cottonseed Oil, 560 mg; Benzyl Alcohol (as preservative), 9.45 mg.</Description>
</NDC>
<NDC>
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<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (50090-4446-0) > 10 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>50090-4446-00</NDC11Code>
<ProductNDC>50090-4446</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Testosterone Cypionate</ProprietaryName>
<NonProprietaryName>Testosterone Cypionate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20130617</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201720</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>TESTOSTERONE CYPIONATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190802</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Testosterone cypionate injection is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone. 1. Primary hypogonadism (congenital or acquired)- testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy. 2. Hypogonadotropic hypogonadism (congenital or acquired)- gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. Safety and efficacy of testosterone cypionate in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established.</IndicationAndUsage>
<Description>Testosterone cypionate injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)- cyclopentylpropionate ester of the androgenic hormone testosterone.Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. It is insoluble in water, freely soluble in alcohol, chloroform, dioxane, ether, and soluble in vegetable oils.The chemical name for testosterone cypionate is androst-4-en-3-one,17-(3-cyclopentyl-1-oxopropoxy)-, (17β)-. Its molecular formula is C27H40O3, and the molecular weight 412.61.The structural formula is represented below. Testosterone cypionate injection, USP is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate, USP.Each mL of the 100 mg/mL solution contains:Testosterone cypionate............................................................................... 100 mgBenzyl benzoate .......................................................................................... 0.1 mLCottonseed oil ............................................................................................. 736 mgBenzyl alcohol (as preservative).................................................................. 9.45 mgEach mL of the 200 mg/mL solution contains:Testosterone cypionate............................................................................... 200 mg Benzyl benzoate........................................................................................... 0.2 mL Cottonseed oil............................................................................................. 560 mgBenzyl alcohol (as preservative).................................................................. 9.45 mg.</Description>
</NDC>
<NDC>
<NDCCode>50090-4920-0</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (50090-4920-0) / 10 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>50090-4920-00</NDC11Code>
<ProductNDC>50090-4920</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Testosterone Cypionate</ProprietaryName>
<NonProprietaryName>Testosterone Cypionate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20140501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091244</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>TESTOSTERONE CYPIONATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-07-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Testosterone Cypionate Injection, USP is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone. : 1 1.Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy., 2 2.Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation.</IndicationAndUsage>
<Description>Testosterone Cypionate Injection, USP for intramuscular injection, contains Testosterone Cypionate, USP which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone. Testosterone Cypionate, USP is a white or creamy white crystalline powder, odorless or nearly so and stable in air. It is insoluble in water, freely soluble in alcohol, chloroform, dioxane, ether, and soluble in vegetable oils. The chemical name for Testosterone Cypionate, USP is androst-4-en-3-one,17-(3-cyclopentyl-1- oxopropoxy)-, (17ß)-. Its molecular formula is C27H40O3, and the molecular weight 412.61. The structural formula is represented below. Testosterone Cypionate Injection, USP is available in one strength, 200 mg/mL Testosterone Cypionate, USP. Each mL of the 200 mg/mL solution contains: 1 Testosterone Cypionate, USP 200 mg, 2 Benzyl Benzoate, USP 0.2 mL, 3 Cottonseed Oil, USP 560 mg, 4 Benzyl Alcohol, USP (as preservative) 9.45 mg.</Description>
</NDC>
<NDC>
<NDCCode>54868-0216-0</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (54868-0216-0) > 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>54868-0216-00</NDC11Code>
<ProductNDC>54868-0216</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Depo-testosterone</ProprietaryName>
<NonProprietaryName>Testosterone Cypionate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>19940712</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA085635</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>TESTOSTERONE CYPIONATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>DEPO-Testosterone Injection is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone. 1. Primary hypogonadism (congenital or acquired)-testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy. 2. Hypogonadotropic hypogonadism (congenital or acquired)-idiopathic gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation.</IndicationAndUsage>
<Description>DEPO-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)- cyclopentylpropionate ester of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. It is insoluble in water, freely soluble in alcohol, chloroform, dioxane, ether, and soluble in vegetable oils. The chemical name for testosterone cypionate is androst-4-en-3-one,17-(3-cyclopentyl-1-oxopropoxy)-, (17β)-. Its molecular formula is C27H40O3, and the molecular weight 412.61. The structural formula is represented below. DEPO-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate. Each mL of the 100 mg/mL solution contains: Testosterone cypionate................................................................................... 100 mg Benzyl benzoate .............................................................................................. 0.1 mL Cottonseed oil ................................................................................................ 736 mg Benzyl alcohol (as preservative) ..................................................................... 9.45 mg. Each mL of the 200 mg/mL solution contains: Testosterone cypionate .................................................................................. 200 mg Benzyl benzoate .............................................................................................. 0.2 mL Cottonseed oil ................................................................................................ 560 mg Benzyl alcohol (as preservative) ..................................................................... 9.45 mg.</Description>
</NDC>
<NDC>
<NDCCode>54868-3618-0</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (54868-3618-0) > 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>54868-3618-00</NDC11Code>
<ProductNDC>54868-3618</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Testosterone Cypionate</ProprietaryName>
<NonProprietaryName>Testosterone Cypionate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20070810</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040530</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>TESTOSTERONE CYPIONATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Testosterone cypionate injection is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone. : 1 Primary hypogonadism (congenital or acquired)-testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy., 2 Hypogonadotropic hypogonadism (congenital or acquired)-idiopathic gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation.</IndicationAndUsage>
<Description>Testosterone cypionate injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. It is insoluble in water, freely soluble in alcohol, chloroform, dioxane, ether, and soluble in vegetable oils. The chemical name for testosterone cypionate is androst-4-en-3-one, 17-(3-cyclopentyl-1-oxopropoxy)-, (17β)-. Its molecular formula is C27H40O3, and the molecular weight 412.61. The structural formula is represented below. Testosterone cypionate injection is available in one strength, 200 mg/mL testosterone cypionate. Each mL of the solution contains Testosterone Cypionate, 200 mg; Benzyl Benzoate, 0.2 mL; Cottonseed Oil, 560 mg; Benzyl Alcohol (as preservative), 9.45 mg.</Description>
</NDC>
<NDC>
<NDCCode>58032-2026-0</NDCCode>
<PackageDescription>1 kg in 1 DRUM (58032-2026-0) </PackageDescription>
<NDC11Code>58032-2026-00</NDC11Code>
<ProductNDC>58032-2026</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Sd-560 D3-pirfenidone</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20171219</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Neuland Laboratories Limited</LabelerName>
<SubstanceName>PIRFENIDONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2023-12-28</LastUpdate>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19-DEC-17</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>70518-4538-0</NDCCode>
<PackageDescription>1 mL in 1 VIAL, GLASS (70518-4538-0) </PackageDescription>
<NDC11Code>70518-4538-00</NDC11Code>
<ProductNDC>70518-4538</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Testosterone Cypionate</ProprietaryName>
<NonProprietaryName>Testosterone Cypionate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20251217</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210362</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>TESTOSTERONE CYPIONATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-09-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251217</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Testosterone cypionate injection is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone. : 1 Primary hypogonadism (congenital or acquired)-testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy., 2 Hypogonadotropic hypogonadism (congenital or acquired)-gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation.</IndicationAndUsage>
<Description>Testosterone cypionate, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. It is insoluble in water, freely soluble in alcohol, chloroform, dioxane, ether, and soluble in vegetable oils. The chemical name for testosterone cypionate is androst-4-en-3-one, 17-(3-cyclopentyl- 1-oxopropoxy)-, (17ß)-. Its molecular formula is C 27H 40O 3, and the molecular weight 412.61. The structural formula is represented below. Testosterone cypionate injection, USP is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate. Each mL of the 100 mg/mLsolution contains:. Testosterone cypionate............................................................................................100 mg. Benzyl benzoate ......................................................................................................0.1 mL. Cottonseed oil .........................................................................................................736 mg. Benzyl alcohol (as preservative) .............................................................................9.45 mg. Each mL of the 200 mg/mLsolution contains:. Testosterone cypionate .............................................................................................200 mg. Benzyl benzoate ........................................................................................................0.2 mL. Cottonseed oil ...........................................................................................................560 mg. Benzyl alcohol (as preservative) ...............................................................................9.45 mg.</Description>
</NDC>
<NDC>
<NDCCode>76519-1210-0</NDCCode>
<PackageDescription>1 mL in 1 VIAL, MULTI-DOSE (76519-1210-0) </PackageDescription>
<NDC11Code>76519-1210-00</NDC11Code>
<ProductNDC>76519-1210</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Testosterone Cypionate</ProprietaryName>
<NonProprietaryName>Testosterone Cypionate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20120501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091244</ApplicationNumber>
<LabelerName>H.J. Harkins Company, Inc.</LabelerName>
<SubstanceName>TESTOSTERONE CYPIONATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/10mL</StrengthUnit>
<Pharm_Classes>Androgen [EPC],Androgen Receptor Agonists [MoA],Androstanes [Chemical/Ingredient]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-11-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Testosterone Cypionate Injection, USP is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone. Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy. Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. Safety and efficacy of testosterone cypionate in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established.</IndicationAndUsage>
<Description>Testosterone Cypionate Injection, USP for intramuscular injection, contains Testosterone Cypionate, USP which is the oil-soluble 17 (beta)- cyclopentylpropionate ester of the androgenic hormone testosterone. Testosterone Cypionate, USP is a white or creamy white crystalline powder, odorless or nearly so and stable in air. It is insoluble in water, freely soluble in alcohol, chloroform, dioxane, ether, and soluble in vegetable oils. The chemical name for Testosterone Cypionate, USP is androst-4-en-3-one,17-(3-cyclopentyl-1-oxopropoxy)-, (17β)-. Its molecular formula is C27H40O3, and the molecular weight 412.61. The structural formula is represented below. Testosterone Cypionate Injection, USP is available in one strength, 200 mg/mL Testosterone Cypionate, USP. Each mL of the 200 mg/mL solution contains: Testosterone Cypionate, USP 200 mg Benzyl Benzoate, USP 0.2 mL Cottonseed Oil, USP 560 mg Benzyl Alcohol, USP (as preservative) 9.45 mg.</Description>
</NDC>
<NDC>
<NDCCode>0113-7219-13</NDCCode>
<PackageDescription>5 POUCH in 1 CARTON (0113-7219-13) > 1 PATCH in 1 POUCH</PackageDescription>
<NDC11Code>00113-7219-13</NDC11Code>
<ProductNDC>0113-7219</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Basic Care Lidocaine</ProprietaryName>
<NonProprietaryName>Lidocaine</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>PERCUTANEOUS; TOPICAL; TRANSDERMAL</RouteName>
<StartMarketingDate>20190823</StartMarketingDate>
<EndMarketingDate>20230601</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>L. Perrigo Company</LabelerName>
<SubstanceName>LIDOCAINE</SubstanceName>
<StrengthNumber>560</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190823</StartMarketingDatePackage>
<EndMarketingDatePackage>20230601</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0113-7700-91</NDCCode>
<PackageDescription>6 POUCH in 1 CARTON (0113-7700-91) > 1 PATCH in 1 POUCH</PackageDescription>
<NDC11Code>00113-7700-91</NDC11Code>
<ProductNDC>0113-7700</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Basic Care Lidocaine</ProprietaryName>
<NonProprietaryName>Lidocaine</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>PERCUTANEOUS; TOPICAL; TRANSDERMAL</RouteName>
<StartMarketingDate>20190925</StartMarketingDate>
<EndMarketingDate>20230101</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>L. Perrigo Company</LabelerName>
<SubstanceName>LIDOCAINE</SubstanceName>
<StrengthNumber>560</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190925</StartMarketingDatePackage>
<EndMarketingDatePackage>20230101</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0121-0970-05</NDCCode>
<PackageDescription>12 CARTON in 1 CASE (0121-0970-05) / 5 POUCH in 1 CARTON / 1 PATCH in 1 POUCH (0121-0970-01) </PackageDescription>
<NDC11Code>00121-0970-05</NDC11Code>
<ProductNDC>0121-0970</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lidocaine Pain Relief</ProprietaryName>
<NonProprietaryName>Lidocaine Pain Relief</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230403</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>PAI Holdings, LLC dba PAI Pharma</LabelerName>
<SubstanceName>LIDOCAINE</SubstanceName>
<StrengthNumber>560</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-03-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230403</StartMarketingDatePackage>
<EndMarketingDatePackage>20260228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporary relief of pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0121-0970-30</NDCCode>
<PackageDescription>6 CARTON in 1 CASE (0121-0970-30) / 30 POUCH in 1 CARTON / 1 PATCH in 1 POUCH (0121-0970-01) </PackageDescription>
<NDC11Code>00121-0970-30</NDC11Code>
<ProductNDC>0121-0970</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lidocaine Pain Relief</ProprietaryName>
<NonProprietaryName>Lidocaine Pain Relief</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230403</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>PAI Holdings, LLC dba PAI Pharma</LabelerName>
<SubstanceName>LIDOCAINE</SubstanceName>
<StrengthNumber>560</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240729</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporary relief of pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0143-9005-01</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (0143-9005-01) / 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>00143-9005-01</NDC11Code>
<ProductNDC>0143-9005</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Testosterone Cypionate</ProprietaryName>
<NonProprietaryName>Testosterone Cypionate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20211122</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091244</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>TESTOSTERONE CYPIONATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-05-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211122</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Testosterone Cypionate Injection, USP is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone. : 1 Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy., 2 Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation.</IndicationAndUsage>
<Description>Testosterone Cypionate Injection, USP for intramuscular injection, contains Testosterone Cypionate, USP which is the oil-soluble 17 (beta)- cyclopentylpropionate ester of the androgenic hormone testosterone. Testosterone Cypionate, USP is a white or creamy white crystalline powder, odorless or nearly so and stable in air. It is insoluble in water, freely soluble in alcohol, chloroform, dioxane, ether, and soluble in vegetable oils. The chemical name for Testosterone Cypionate, USP is androst-4-en-3-one,17-(3-cyclopentyl-1-oxopropoxy)-, (17β)-. Its molecular formula is C27H40O3, and the molecular weight 412.61. The structural formula is represented below. Testosterone Cypionate Injection, USP is available in one strength, 200 mg/mL Testosterone Cypionate, USP. Each mL of the 200 mg/mL solution contains: Testosterone Cypionate, USP 200 mg Benzyl Benzoate, USP 0.2 mL Cottonseed Oil, USP 560 mg Benzyl Alcohol, USP (as preservative) 9.45 mg.</Description>
</NDC>
<NDC>
<NDCCode>0143-9659-01</NDCCode>
<PackageDescription>1 mL in 1 VIAL (0143-9659-01) </PackageDescription>
<NDC11Code>00143-9659-01</NDC11Code>
<ProductNDC>0143-9659</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Testosterone Cypionate</ProprietaryName>
<NonProprietaryName>Testosterone Cypionate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20120501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091244</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>TESTOSTERONE CYPIONATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-05-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Testosterone Cypionate Injection, USP is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone. : 1 Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy., 2 Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation.</IndicationAndUsage>
<Description>Testosterone Cypionate Injection, USP for intramuscular injection, contains Testosterone Cypionate, USP which is the oil-soluble 17 (beta)- cyclopentylpropionate ester of the androgenic hormone testosterone. Testosterone Cypionate, USP is a white or creamy white crystalline powder, odorless or nearly so and stable in air. It is insoluble in water, freely soluble in alcohol, chloroform, dioxane, ether, and soluble in vegetable oils. The chemical name for Testosterone Cypionate, USP is androst-4-en-3-one,17-(3-cyclopentyl-1-oxopropoxy)-, (17β)-. Its molecular formula is C27H40O3, and the molecular weight 412.61. The structural formula is represented below. Testosterone Cypionate Injection, USP is available in one strength, 200 mg/mL Testosterone Cypionate, USP. Each mL of the 200 mg/mL solution contains: Testosterone Cypionate, USP 200 mg Benzyl Benzoate, USP 0.2 mL Cottonseed Oil, USP 560 mg Benzyl Alcohol, USP (as preservative) 9.45 mg.</Description>
</NDC>
<NDC>
<NDCCode>0143-9726-01</NDCCode>
<PackageDescription>10 mL in 1 VIAL (0143-9726-01) </PackageDescription>
<NDC11Code>00143-9726-01</NDC11Code>
<ProductNDC>0143-9726</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Testosterone Cypionate</ProprietaryName>
<NonProprietaryName>Testosterone Cypionate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20120501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091244</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>TESTOSTERONE CYPIONATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-05-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Testosterone Cypionate Injection, USP is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone. : 1 Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy., 2 Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation.</IndicationAndUsage>
<Description>Testosterone Cypionate Injection, USP for intramuscular injection, contains Testosterone Cypionate, USP which is the oil-soluble 17 (beta)- cyclopentylpropionate ester of the androgenic hormone testosterone. Testosterone Cypionate, USP is a white or creamy white crystalline powder, odorless or nearly so and stable in air. It is insoluble in water, freely soluble in alcohol, chloroform, dioxane, ether, and soluble in vegetable oils. The chemical name for Testosterone Cypionate, USP is androst-4-en-3-one,17-(3-cyclopentyl-1-oxopropoxy)-, (17β)-. Its molecular formula is C27H40O3, and the molecular weight 412.61. The structural formula is represented below. Testosterone Cypionate Injection, USP is available in one strength, 200 mg/mL Testosterone Cypionate, USP. Each mL of the 200 mg/mL solution contains: Testosterone Cypionate, USP 200 mg Benzyl Benzoate, USP 0.2 mL Cottonseed Oil, USP 560 mg Benzyl Alcohol, USP (as preservative) 9.45 mg.</Description>
</NDC>
<NDC>
<NDCCode>0338-0644-03</NDCCode>
<PackageDescription>500 mL in 1 BAG (0338-0644-03) </PackageDescription>
<NDC11Code>00338-0644-03</NDC11Code>
<ProductNDC>0338-0644</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Travasol</ProprietaryName>
<NonProprietaryName>Leucine, Phenylalanine, Lysine Hydrochloride, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Tyrosine, Serine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19840823</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018931</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>LEUCINE; PHENYLALANINE; LYSINE HYDROCHLORIDE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; TYROSINE; SERINE</SubstanceName>
<StrengthNumber>730; 560; 580; 400; 600; 580; 480; 420; 180; 2.07; 1.03; 1.15; 680; 40; 500</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL; g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Amino Acid [EPC], Amino Acids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19840823</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TRAVASOL is indicated as a source of amino acids for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. TRAVASOL may be used to treat negative nitrogen balance in patients.</IndicationAndUsage>
<Description>TRAVASOL 10% (amino acids) injection is a sterile, nonpyrogenic hypertonic solution of essential and nonessential amino acids supplied in a flexible container as a Pharmacy Bulk Package. A Pharmacy Bulk Package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program [see Dosage and Administration (2.1)]. TRAVASOL is not for direct intravenous infusion. The formulas for the individual amino acids found in TRAVASOL are provided in Table 4. TRAVASOL contains no more than 25 mcg/L of aluminum.</Description>
</NDC>
<NDC>
<NDCCode>0338-0644-04</NDCCode>
<PackageDescription>1000 mL in 1 BAG (0338-0644-04) </PackageDescription>
<NDC11Code>00338-0644-04</NDC11Code>
<ProductNDC>0338-0644</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Travasol</ProprietaryName>
<NonProprietaryName>Leucine, Phenylalanine, Lysine Hydrochloride, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Tyrosine, Serine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19840823</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018931</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>LEUCINE; PHENYLALANINE; LYSINE HYDROCHLORIDE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; TYROSINE; SERINE</SubstanceName>
<StrengthNumber>730; 560; 580; 400; 600; 580; 480; 420; 180; 2.07; 1.03; 1.15; 680; 40; 500</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL; g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Amino Acid [EPC], Amino Acids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19840823</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TRAVASOL is indicated as a source of amino acids for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. TRAVASOL may be used to treat negative nitrogen balance in patients.</IndicationAndUsage>
<Description>TRAVASOL 10% (amino acids) injection is a sterile, nonpyrogenic hypertonic solution of essential and nonessential amino acids supplied in a flexible container as a Pharmacy Bulk Package. A Pharmacy Bulk Package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program [see Dosage and Administration (2.1)]. TRAVASOL is not for direct intravenous infusion. The formulas for the individual amino acids found in TRAVASOL are provided in Table 4. TRAVASOL contains no more than 25 mcg/L of aluminum.</Description>
</NDC>
<NDC>
<NDCCode>0338-0644-06</NDCCode>
<PackageDescription>2000 mL in 1 BAG (0338-0644-06) </PackageDescription>
<NDC11Code>00338-0644-06</NDC11Code>
<ProductNDC>0338-0644</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Travasol</ProprietaryName>
<NonProprietaryName>Leucine, Phenylalanine, Lysine Hydrochloride, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Tyrosine, Serine</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>19840823</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018931</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>LEUCINE; PHENYLALANINE; LYSINE HYDROCHLORIDE; METHIONINE; ISOLEUCINE; VALINE; HISTIDINE; THREONINE; TRYPTOPHAN; ALANINE; GLYCINE; ARGININE; PROLINE; TYROSINE; SERINE</SubstanceName>
<StrengthNumber>730; 560; 580; 400; 600; 580; 480; 420; 180; 2.07; 1.03; 1.15; 680; 40; 500</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; g/100mL; g/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Amino Acid [EPC], Amino Acids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19840823</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TRAVASOL is indicated as a source of amino acids for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. TRAVASOL may be used to treat negative nitrogen balance in patients.</IndicationAndUsage>
<Description>TRAVASOL 10% (amino acids) injection is a sterile, nonpyrogenic hypertonic solution of essential and nonessential amino acids supplied in a flexible container as a Pharmacy Bulk Package. A Pharmacy Bulk Package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program [see Dosage and Administration (2.1)]. TRAVASOL is not for direct intravenous infusion. The formulas for the individual amino acids found in TRAVASOL are provided in Table 4. TRAVASOL contains no more than 25 mcg/L of aluminum.</Description>
</NDC>
<NDC>
<NDCCode>0409-4200-03</NDCCode>
<PackageDescription>12 POUCH in 1 CASE (0409-4200-03) > 1 BAG in 1 POUCH > 500 mL in 1 BAG</PackageDescription>
<NDC11Code>00409-4200-03</NDC11Code>
<ProductNDC>0409-4200</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aminosyn</ProprietaryName>
<NonProprietaryName>Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Histidine, Proline, Serine, Tyrosine, Glycine, Sodium Chloride, Magnesium Chloride, Sodium Phosphate, Dibasic, And Potassium Chloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20110323</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017789</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>ISOLEUCINE; LEUCINE; LYSINE ACETATE; METHIONINE; PHENYLALANINE; THREONINE; TRYPTOPHAN; VALINE; ALANINE; ARGININE; HISTIDINE; PROLINE; SERINE; TYROSINE; GLYCINE; SODIUM CHLORIDE; MAGNESIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC; POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>510; 660; 510; 280; 310; 370; 120; 560; 900; 690; 210; 610; 300; 44; 900; 28; 102; 425; 487</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Amino Acid [EPC],Amino Acids [CS],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-04-20</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0517-1830-01</NDCCode>
<PackageDescription>1 VIAL in 1 BOX (0517-1830-01) > 1 mL in 1 VIAL</PackageDescription>
<NDC11Code>00517-1830-01</NDC11Code>
<ProductNDC>0517-1830</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Testosterone Cypionate</ProprietaryName>
<NonProprietaryName>Testosterone Cypionate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20190719</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207742</ApplicationNumber>
<LabelerName>American Regent, Inc.</LabelerName>
<SubstanceName>TESTOSTERONE CYPIONATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2026-08-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190719</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Testosterone cypionate injection is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone. 1. Primary hypogonadism (congenital or acquired)-testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy. 2. Hypogonadotropic hypogonadism (congenital or acquired)-gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. Safety and efficacy of testosterone cypionate injection in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established.</IndicationAndUsage>
<Description>Testosterone Cypionate Injection, USP, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)- cyclopentylpropionate ester of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. It is insoluble in water, freely soluble in alcohol, chloroform, dioxane, ether, and soluble in vegetable oils. The chemical name for testosterone cypionate is androst-4-en-3-one,17-(3-cyclopentyl-1-oxopropoxy)-, (17β)-. Its molecular formula is C27H40O3, and the molecular weight 412.61. The structural formula is represented below. Testosterone Cypionate Injection, USP is available as 200 mg/mL testosterone cypionate. Each mL of the solution contains Testosterone Cypionate, 200 mg; Benzyl Benzoate, 0.2 mL; Cottonseed Oil, 560 mg; Benzyl Alcohol (as preservative), 9.45 mg.</Description>
</NDC>
<NDC>
<NDCCode>0574-0820-01</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (0574-0820-01) / 1 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>00574-0820-01</NDC11Code>
<ProductNDC>0574-0820</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Testosterone Cypionate</ProprietaryName>
<NonProprietaryName>Testosterone Cypionate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20071221</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040530</ApplicationNumber>
<LabelerName>Padagis US LLC</LabelerName>
<SubstanceName>TESTOSTERONE CYPIONATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-06-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150109</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Testosterone cypionate injection is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone. : 1 1.Primary hypogonadism (congenital or acquired)-testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy., 2 2.Hypogonadotropic hypogonadism (congenital or acquired)-gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation.</IndicationAndUsage>
<Description>Testosterone cypionate injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. It is insoluble in water, freely soluble in alcohol, chloroform, dioxane, ether, and soluble in vegetable oils. The chemical name for testosterone cypionate is androst-4-en-3-one, 17-(3-cyclopentyl-1-oxopropoxy)-, (17β)-. Its molecular formula is C27H40O3, and the molecular weight 412.61. The structural formula is represented below. Testosterone cypionate injection is available in one strength, 200 mg/mL testosterone cypionate. Each mL of the solution contains Testosterone Cypionate, 200 mg; Benzyl Benzoate, 0.2 mL; Cottonseed Oil, 560 mg; Benzyl Alcohol (as preservative), 9.45 mg.</Description>
</NDC>
<NDC>
<NDCCode>0574-0820-10</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (0574-0820-10) / 10 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>00574-0820-10</NDC11Code>
<ProductNDC>0574-0820</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Testosterone Cypionate</ProprietaryName>
<NonProprietaryName>Testosterone Cypionate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20071221</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040530</ApplicationNumber>
<LabelerName>Padagis US LLC</LabelerName>
<SubstanceName>TESTOSTERONE CYPIONATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-06-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141216</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Testosterone cypionate injection is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone. : 1 1.Primary hypogonadism (congenital or acquired)-testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy., 2 2.Hypogonadotropic hypogonadism (congenital or acquired)-gonadotropin or LHRH deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation.</IndicationAndUsage>
<Description>Testosterone cypionate injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. It is insoluble in water, freely soluble in alcohol, chloroform, dioxane, ether, and soluble in vegetable oils. The chemical name for testosterone cypionate is androst-4-en-3-one, 17-(3-cyclopentyl-1-oxopropoxy)-, (17β)-. Its molecular formula is C27H40O3, and the molecular weight 412.61. The structural formula is represented below. Testosterone cypionate injection is available in one strength, 200 mg/mL testosterone cypionate. Each mL of the solution contains Testosterone Cypionate, 200 mg; Benzyl Benzoate, 0.2 mL; Cottonseed Oil, 560 mg; Benzyl Alcohol (as preservative), 9.45 mg.</Description>
</NDC>
<NDC>
<NDCCode>0574-0827-01</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (0574-0827-01) / 1 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>00574-0827-01</NDC11Code>
<ProductNDC>0574-0827</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Testosterone Cypionate</ProprietaryName>
<NonProprietaryName>Testosterone Cypionate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20140501</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091244</ApplicationNumber>
<LabelerName>Padagis US LLC</LabelerName>
<SubstanceName>TESTOSTERONE CYPIONATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-12-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190304</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Testosterone Cypionate Injection, USP is indicated for replacement therapy in the male in conditions associated with symptoms of deficiency, or absence of endogenous testosterone. : 1 1.Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome; or orchidectomy., 2 2.Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation.</IndicationAndUsage>
<Description>Testosterone Cypionate Injection, USP for intramuscular injection, contains Testosterone Cypionate, USP which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone. Testosterone Cypionate, USP is a white or creamy white crystalline powder, odorless or nearly so and stable in air. It is insoluble in water, freely soluble in alcohol, chloroform, dioxane, ether, and soluble in vegetable oils. The chemical name for Testosterone Cypionate, USP is androst-4-en-3-one,17-(3-cyclopentyl-1- oxopropoxy)-, (17ß)-. Its molecular formula is C27H40O3, and the molecular weight 412.61. The structural formula is represented below. Testosterone Cypionate Injection, USP is available in one strength, 200 mg/mL Testosterone Cypionate, USP. Each mL of the 200 mg/mL solution contains: 1 Testosterone Cypionate, USP 200 mg, 2 Benzyl Benzoate, USP 0.2 mL, 3 Cottonseed Oil, USP 560 mg, 4 Benzyl Alcohol, USP (as preservative) 9.45 mg.</Description>
</NDC>
</NDCList>