{
"NDC": [
{
"NDCCode": "63505-157-08",
"PackageDescription": "60 mL in 1 BOTTLE, PLASTIC (63505-157-08)",
"NDC11Code": "63505-0157-08",
"ProductNDC": "63505-157",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fraicheur Verveine Antiperspirant And Deodorant Roll-on",
"NonProprietaryName": "Aluminum Sesquichlorohydrate",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20080701",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part350",
"LabelerName": "YVES ROCHER NORTH AMERICA INC",
"SubstanceName": "ALUMINUM SESQUICHLOROHYDRATE",
"StrengthNumber": "15",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "UseReduces underarm perspiration."
},
{
"NDCCode": "63505-156-08",
"PackageDescription": "150 mL in 1 BOTTLE, PLASTIC (63505-156-08)",
"NDC11Code": "63505-0156-08",
"ProductNDC": "63505-156",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Protectyl Soleil Moisturizing Sunscreen Lotion High Protection Spf 30",
"NonProprietaryName": "Titanium Dioxide, Octinoxate And Octocrylene",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20070501",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Yves Rocher North America Inc",
"SubstanceName": "OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE",
"StrengthNumber": "7.5; 7; 8.4",
"StrengthUnit": "mL/100mL; mL/100mL; mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "63505-158-08",
"PackageDescription": "60 mL in 1 BOTTLE, PLASTIC (63505-158-08)",
"NDC11Code": "63505-0158-08",
"ProductNDC": "63505-158",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fraicheur Cedre Bleu Antiperspirant And Deodorant Roll-on",
"NonProprietaryName": "Aluminum Sesquichlorohydrate",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20081001",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part350",
"LabelerName": "YVES ROCHER NORTH AMERICA INC",
"SubstanceName": "ALUMINUM SESQUICHLOROHYDRATE",
"StrengthNumber": "15",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "UseReduces underarm perspiration."
},
{
"NDCCode": "63505-159-08",
"PackageDescription": "60 mL in 1 BOTTLE, PLASTIC (63505-159-08)",
"NDC11Code": "63505-0159-08",
"ProductNDC": "63505-159",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fraicheur The Vert Antiperspirant And Deodorant Roll-on",
"NonProprietaryName": "Aluminum Sesquichlorohydrate",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20081001",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part350",
"LabelerName": "YVES ROCHER NORTH AMERICA INC",
"SubstanceName": "ALUMINUM SESQUICHLOROHYDRATE",
"StrengthNumber": "15",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "UseReduces underarm perspiration."
},
{
"NDCCode": "63505-160-08",
"PackageDescription": "60 mL in 1 BOTTLE, PLASTIC (63505-160-08)",
"NDC11Code": "63505-0160-08",
"ProductNDC": "63505-160",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fraicheur Bambou Antiperspirant And Deodorant Roll-on",
"NonProprietaryName": "Aluminum Sesquichlorohydrate",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20081001",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part350",
"LabelerName": "YVES ROCHER NORTH AMERICA INC",
"SubstanceName": "ALUMINUM SESQUICHLOROHYDRATE",
"StrengthNumber": "15",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "UseReduces underarm perspiration."
},
{
"NDCCode": "63505-161-08",
"PackageDescription": "60 mL in 1 BOTTLE, PLASTIC (63505-161-08)",
"NDC11Code": "63505-0161-08",
"ProductNDC": "63505-161",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Fraicheur Chevrefeuille Antiperspirant And Deodorant Roll-on",
"NonProprietaryName": "Aluminum Sesquichlorohydrate",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20090201",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part350",
"LabelerName": "YVES ROCHER NORTH AMERICA INC",
"SubstanceName": "ALUMINUM SESQUICHLOROHYDRATE",
"StrengthNumber": "15",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "UseReduces underarm perspiration."
},
{
"NDCCode": "15127-157-08",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (15127-157-08) > 9 TABLET, CHEWABLE in 1 BLISTER PACK",
"NDC11Code": "15127-0157-08",
"ProductNDC": "15127-157",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Gas Relief",
"NonProprietaryName": "Simethicone",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20090202",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part332",
"LabelerName": "Select Brand",
"SubstanceName": "DIMETHICONE",
"StrengthNumber": "125",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "relieves: 1 pressure, 2 bloating, 3 symptoms referred to as gas."
},
{
"NDCCode": "27241-157-08",
"PackageDescription": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (27241-157-08) ",
"NDC11Code": "27241-0157-08",
"ProductNDC": "27241-157",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxybutynin Chloride",
"NonProprietaryName": "Oxybutynin Chloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20190228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211655",
"LabelerName": "Ajanta Pharma USA Inc.",
"SubstanceName": "OXYBUTYNIN CHLORIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20190228",
"SamplePackage": "N",
"IndicationAndUsage": "Oxybutynin chloride is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. Oxybutynin chloride extended-release tablets is also indicated for the treatment of pediatric patients aged 6 years and older with symptoms of detrusor overactivity associated with a neurological condition (e.g., spina bifida).",
"Description": "Oxybutynin chloride, USP is an antispasmodic, muscarinic antagonist. Each oxybutynin chloride extended-release tablet, USP contains 5 mg, 10 mg, or 15 mg of oxybutynin chloride USP, formulated as a once-a-day controlled-release tablet for oral administration. Oxybutynin chloride, USP is administered as a racemate of R- and S-enantiomers. Chemically, oxybutynin chloride, USP is 4(diethylamino-but-2-ynyl (RS) 2-cyclohexyl-2-hydroxy 2 phenyl acetate hydrochloride. The molecular formula of oxybutynin chloride, USP is C22H31NO3HCl. Its structural formula is. Oxybutynin chloride, USP is a white crystalline powder with a molecular weight of 393.95. It is freely soluble in water and in alcohol, very soluble in methanol and in chloroform, soluble in acetone, slightly soluble in ether, very slightly soluble in hexane. Oxybutynin chloride extended-release tablets, USP also contains the following inert ingredients: anhydrous dibasic calcium phosphate, povidone, hypromellose, colloidal silicon dioxide, magnesium stearate, polyethylene glycol, methacrylic acid copolymer type c, talc, titanium dioxide, triethyl citrate, sodium bicarbonate, sodium lauryl sulfate, ferrosoferric oxide, ferric oxide red (in 10 mg only) and iron oxide yellow (in 5 mg and 15 mg only). The imprinting material contains: shellac glaze, black iron oxide, propylene glycol and ammonium hydroxide.Meets USP Dissolution Test 9.System Components and Performance. Oxybutynin chloride extended-release tablets, USP are formulated to deliver oxybutynin chloride at a controlled rate over approximately 24 hours. The dosage form is comprised of a hydrophilic cellulose polymer matrix tablet surrounded by an enteric coating system. The enteric coat is insoluble in the low pH environment of the stomach. As the tablet passes through the stomach and enters the higher pH environment of the small intestine, the enteric coating dissolves and/or erodes to expose the polymer matrix tablet which swells and releases drug at a controlled rate via diffusion and/or erosion."
},
{
"NDCCode": "55151-123-08",
"PackageDescription": "157 L in 1 CYLINDER (55151-123-08) ",
"NDC11Code": "55151-0123-08",
"ProductNDC": "55151-123",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxygen",
"NonProprietaryName": "Oxygen",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20110101",
"MarketingCategoryName": "UNAPPROVED MEDICAL GAS",
"LabelerName": "E-Z Oxygen LLC, dba AO2",
"SubstanceName": "OXYGEN",
"StrengthNumber": "99",
"StrengthUnit": "L/100L",
"Status": "Active",
"LastUpdate": "2025-11-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110101",
"SamplePackage": "N"
},
{
"NDCCode": "59779-157-08",
"PackageDescription": "1 BOTTLE in 1 CARTON (59779-157-08) > 24 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "59779-0157-08",
"ProductNDC": "59779-157",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aspirin",
"NonProprietaryName": "Aspirin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19960210",
"EndMarketingDate": "20211108",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "CVS Pharmacy",
"SubstanceName": "ASPIRIN",
"StrengthNumber": "325",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19960210",
"EndMarketingDatePackage": "20211108",
"SamplePackage": "N"
},
{
"NDCCode": "70942-157-08",
"PackageDescription": "237 mL in 1 BOTTLE, PUMP (70942-157-08) ",
"NDC11Code": "70942-0157-08",
"ProductNDC": "70942-157",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer",
"ProprietaryNameSuffix": "Dr. Butler",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200326",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Beyond Health P.A.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "62",
"StrengthUnit": "g/mL",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20200326",
"SamplePackage": "N",
"IndicationAndUsage": "To decrease bacteria on the skin that could cause disease. Recommended for repeated use."
},
{
"NDCCode": "71919-157-08",
"PackageDescription": "30 mL in 1 VIAL, GLASS (71919-157-08) ",
"NDC11Code": "71919-0157-08",
"ProductNDC": "71919-157",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Candida Parapsilosis",
"NonProprietaryName": "Candida Parapsilosis",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20100204",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Washington Homeopathic Products",
"SubstanceName": "CANDIDA PARAPSILOSIS",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2022-03-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20100204",
"SamplePackage": "N"
},
{
"NDCCode": "72839-157-08",
"PackageDescription": "237 mL in 1 BOTTLE, PLASTIC (72839-157-08) ",
"NDC11Code": "72839-0157-08",
"ProductNDC": "72839-157",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dcr Labs Hand Sanitizer",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200326",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Derma Care Research Labs, LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "62",
"StrengthUnit": "g/mL",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20200326",
"SamplePackage": "N",
"IndicationAndUsage": "To decrease bacteria on the skin that could cause disease. Recommended for repeated use."
},
{
"NDCCode": "83589-157-08",
"PackageDescription": "100 g in 1 BOTTLE (83589-157-08) ",
"NDC11Code": "83589-0157-08",
"ProductNDC": "83589-157",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Penetratin",
"DosageFormName": "POWDER",
"StartMarketingDate": "20260225",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Nanjing Chengong Pharmaceutical Co., Ltd.",
"SubstanceName": "PENETRATIN",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "25-FEB-26"
},
{
"NDCCode": "63505-004-01",
"PackageDescription": "40 mL in 1 BOTTLE (63505-004-01)",
"NDC11Code": "63505-0004-01",
"ProductNDC": "63505-004",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pure System Stop Blemish",
"NonProprietaryName": "Salicylic Acid",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120619",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333D",
"LabelerName": "Yves Rocher North America Inc",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2017-06-08"
},
{
"NDCCode": "0025-0325-01",
"PackageDescription": "1 KIT in 1 CARTON (0025-0325-01) / 1 KIT in 1 KIT * .8 mL in 1 SYRINGE (0025-0318-01) * 1 mL in 1 PACKET (0069-1111-01) ",
"NDC11Code": "00025-0325-01",
"ProductNDC": "0025-0325",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abrilada",
"NonProprietaryName": "Adalimumab-afzb",
"DosageFormName": "KIT",
"StartMarketingDate": "20231214",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761118",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"Status": "Active",
"LastUpdate": "2026-05-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231214",
"SamplePackage": "N",
"IndicationAndUsage": "ABRILADA is a tumor necrosis factor (TNF) blocker indicated for: 1 Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1), 2 Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2), 3 Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3), 4 Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4), 5 Treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. (1.5), 6 Treatment of moderately to severely active ulcerative colitis in adult patients. (1.6)Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. , 7 Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. (1.7), 8 Treatment of moderate to severe hidradenitis suppurativa in adult patients. (1.8), 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adult patients. (1.9).",
"Description": "Adalimumab-afzb is a tumor necrosis factor (TNF) blocker. Adalimumab-afzb is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-afzb is produced by recombinant DNA technology in Chinese hamster ovary cells and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. ABRILADA (adalimumab-afzb) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose prefilled pen (ABRILADA pen), as a single-dose 1 mL prefilled glass syringe, or as a single-dose institutional use vial. Enclosed within the pen is a single-dose 1 mL prefilled glass syringe. The solution of ABRILADA is clear and colorless to very light brown, with a pH of about 5.5. Each 40 mg/0.8 mL prefilled syringe, prefilled pen, or single-dose institutional use vial delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of ABRILADA contains adalimumab-afzb (40 mg), edetate disodium dihydrate (0.04 mg), L-histidine (0.63mg), L-histidine hydrochloride monohydrate (2.51 mg), L-methionine (0.16 mg), polysorbate 80 (0.16 mg), sucrose (68 mg), and Water for Injection, USP. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of ABRILADA contains adalimumab-afzb (20 mg), edetate disodium dihydrate (0.02 mg), L-histidine (0.314 mg), L-histidine hydrochloride monohydrate (1.253 mg), L-methionine (0.08 mg), polysorbate 80 (0.08 mg), sucrose (34 mg), and Water for Injection, USP. Each 10 mg/0.2 mL prefilled syringe delivers 0.2 mL (10 mg) of drug product. Each 0.2 mL of ABRILADA contains adalimumab-afzb (10 mg), edetate disodium dihydrate (0.01 mg), L-histidine (0.157 mg), L-histidine hydrochloride monohydrate (0.626 mg), L-methionine (0.04 mg), polysorbate 80 (0.04 mg), sucrose (17 mg), and Water for Injection, USP."
},
{
"NDCCode": "0025-0325-02",
"PackageDescription": "2 KIT in 1 CARTON (0025-0325-02) / 1 KIT in 1 KIT * .8 mL in 1 SYRINGE (0025-0318-01) * 1 mL in 1 PACKET (0069-1111-01) ",
"NDC11Code": "00025-0325-02",
"ProductNDC": "0025-0325",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abrilada",
"NonProprietaryName": "Adalimumab-afzb",
"DosageFormName": "KIT",
"StartMarketingDate": "20231214",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761118",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"Status": "Active",
"LastUpdate": "2026-05-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231214",
"SamplePackage": "N",
"IndicationAndUsage": "ABRILADA is a tumor necrosis factor (TNF) blocker indicated for: 1 Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1), 2 Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2), 3 Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3), 4 Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4), 5 Treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. (1.5), 6 Treatment of moderately to severely active ulcerative colitis in adult patients. (1.6)Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. , 7 Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. (1.7), 8 Treatment of moderate to severe hidradenitis suppurativa in adult patients. (1.8), 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adult patients. (1.9).",
"Description": "Adalimumab-afzb is a tumor necrosis factor (TNF) blocker. Adalimumab-afzb is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-afzb is produced by recombinant DNA technology in Chinese hamster ovary cells and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. ABRILADA (adalimumab-afzb) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose prefilled pen (ABRILADA pen), as a single-dose 1 mL prefilled glass syringe, or as a single-dose institutional use vial. Enclosed within the pen is a single-dose 1 mL prefilled glass syringe. The solution of ABRILADA is clear and colorless to very light brown, with a pH of about 5.5. Each 40 mg/0.8 mL prefilled syringe, prefilled pen, or single-dose institutional use vial delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of ABRILADA contains adalimumab-afzb (40 mg), edetate disodium dihydrate (0.04 mg), L-histidine (0.63mg), L-histidine hydrochloride monohydrate (2.51 mg), L-methionine (0.16 mg), polysorbate 80 (0.16 mg), sucrose (68 mg), and Water for Injection, USP. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of ABRILADA contains adalimumab-afzb (20 mg), edetate disodium dihydrate (0.02 mg), L-histidine (0.314 mg), L-histidine hydrochloride monohydrate (1.253 mg), L-methionine (0.08 mg), polysorbate 80 (0.08 mg), sucrose (34 mg), and Water for Injection, USP. Each 10 mg/0.2 mL prefilled syringe delivers 0.2 mL (10 mg) of drug product. Each 0.2 mL of ABRILADA contains adalimumab-afzb (10 mg), edetate disodium dihydrate (0.01 mg), L-histidine (0.157 mg), L-histidine hydrochloride monohydrate (0.626 mg), L-methionine (0.04 mg), polysorbate 80 (0.04 mg), sucrose (17 mg), and Water for Injection, USP."
},
{
"NDCCode": "0025-0328-02",
"PackageDescription": "2 KIT in 1 CARTON (0025-0328-02) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .8 mL in 1 SYRINGE (0025-0317-01) * 1 mL in 1 PACKET (0069-1111-01) ",
"NDC11Code": "00025-0328-02",
"ProductNDC": "0025-0328",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abrilada",
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"IndicationAndUsage": "ABRILADA is a tumor necrosis factor (TNF) blocker indicated for: 1 Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1), 2 Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2), 3 Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3), 4 Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4), 5 Treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. (1.5), 6 Treatment of moderately to severely active ulcerative colitis in adult patients. (1.6)Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. , 7 Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. (1.7), 8 Treatment of moderate to severe hidradenitis suppurativa in adult patients. (1.8), 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adult patients. (1.9).",
"Description": "Adalimumab-afzb is a tumor necrosis factor (TNF) blocker. Adalimumab-afzb is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-afzb is produced by recombinant DNA technology in Chinese hamster ovary cells and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. ABRILADA (adalimumab-afzb) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose prefilled pen (ABRILADA pen), as a single-dose 1 mL prefilled glass syringe, or as a single-dose institutional use vial. Enclosed within the pen is a single-dose 1 mL prefilled glass syringe. The solution of ABRILADA is clear and colorless to very light brown, with a pH of about 5.5. Each 40 mg/0.8 mL prefilled syringe, prefilled pen, or single-dose institutional use vial delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of ABRILADA contains adalimumab-afzb (40 mg), edetate disodium dihydrate (0.04 mg), L-histidine (0.63mg), L-histidine hydrochloride monohydrate (2.51 mg), L-methionine (0.16 mg), polysorbate 80 (0.16 mg), sucrose (68 mg), and Water for Injection, USP. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of ABRILADA contains adalimumab-afzb (20 mg), edetate disodium dihydrate (0.02 mg), L-histidine (0.314 mg), L-histidine hydrochloride monohydrate (1.253 mg), L-methionine (0.08 mg), polysorbate 80 (0.08 mg), sucrose (34 mg), and Water for Injection, USP. Each 10 mg/0.2 mL prefilled syringe delivers 0.2 mL (10 mg) of drug product. Each 0.2 mL of ABRILADA contains adalimumab-afzb (10 mg), edetate disodium dihydrate (0.01 mg), L-histidine (0.157 mg), L-histidine hydrochloride monohydrate (0.626 mg), L-methionine (0.04 mg), polysorbate 80 (0.04 mg), sucrose (17 mg), and Water for Injection, USP."
},
{
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"PackageDescription": "2 KIT in 1 CARTON (0025-0333-02) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE (0025-0329-01) * 1 mL in 1 PACKET (0069-1111-01) ",
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"IndicationAndUsage": "ABRILADA is a tumor necrosis factor (TNF) blocker indicated for: 1 Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1), 2 Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2), 3 Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3), 4 Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4), 5 Treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. (1.5), 6 Treatment of moderately to severely active ulcerative colitis in adult patients. (1.6)Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. , 7 Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. (1.7), 8 Treatment of moderate to severe hidradenitis suppurativa in adult patients. (1.8), 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adult patients. (1.9).",
"Description": "Adalimumab-afzb is a tumor necrosis factor (TNF) blocker. Adalimumab-afzb is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-afzb is produced by recombinant DNA technology in Chinese hamster ovary cells and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. ABRILADA (adalimumab-afzb) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose prefilled pen (ABRILADA pen), as a single-dose 1 mL prefilled glass syringe, or as a single-dose institutional use vial. Enclosed within the pen is a single-dose 1 mL prefilled glass syringe. The solution of ABRILADA is clear and colorless to very light brown, with a pH of about 5.5. Each 40 mg/0.8 mL prefilled syringe, prefilled pen, or single-dose institutional use vial delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of ABRILADA contains adalimumab-afzb (40 mg), edetate disodium dihydrate (0.04 mg), L-histidine (0.63mg), L-histidine hydrochloride monohydrate (2.51 mg), L-methionine (0.16 mg), polysorbate 80 (0.16 mg), sucrose (68 mg), and Water for Injection, USP. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of ABRILADA contains adalimumab-afzb (20 mg), edetate disodium dihydrate (0.02 mg), L-histidine (0.314 mg), L-histidine hydrochloride monohydrate (1.253 mg), L-methionine (0.08 mg), polysorbate 80 (0.08 mg), sucrose (34 mg), and Water for Injection, USP. Each 10 mg/0.2 mL prefilled syringe delivers 0.2 mL (10 mg) of drug product. Each 0.2 mL of ABRILADA contains adalimumab-afzb (10 mg), edetate disodium dihydrate (0.01 mg), L-histidine (0.157 mg), L-histidine hydrochloride monohydrate (0.626 mg), L-methionine (0.04 mg), polysorbate 80 (0.04 mg), sucrose (17 mg), and Water for Injection, USP."
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{
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"PackageDescription": "1 KIT in 1 CARTON (0069-0325-01) / 1 KIT in 1 KIT * .8 mL in 1 SYRINGE (0069-0318-01) * 1 mL in 1 PACKET (0069-1111-01) ",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abrilada",
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"MarketingCategoryName": "BLA",
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"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
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"IndicationAndUsage": "ABRILADA is a tumor necrosis factor (TNF) blocker indicated for: 1 Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1), 2 Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2), 3 Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3), 4 Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4), 5 Treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. (1.5), 6 Treatment of moderately to severely active ulcerative colitis in adult patients. (1.6)Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. , 7 Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. (1.7), 8 Treatment of moderate to severe hidradenitis suppurativa in adult patients. (1.8), 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adult patients. (1.9).",
"Description": "Adalimumab-afzb is a tumor necrosis factor (TNF) blocker. Adalimumab-afzb is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-afzb is produced by recombinant DNA technology in Chinese hamster ovary cells and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. ABRILADA (adalimumab-afzb) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose prefilled pen (ABRILADA pen), as a single-dose 1 mL prefilled glass syringe, or as a single-dose institutional use vial. Enclosed within the pen is a single-dose 1 mL prefilled glass syringe. The solution of ABRILADA is clear and colorless to very light brown, with a pH of about 5.5. Each 40 mg/0.8 mL prefilled syringe, prefilled pen, or single-dose institutional use vial delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of ABRILADA contains adalimumab-afzb (40 mg), edetate disodium dihydrate (0.04 mg), L-histidine (0.63mg), L-histidine hydrochloride monohydrate (2.51 mg), L-methionine (0.16 mg), polysorbate 80 (0.16 mg), sucrose (68 mg), and Water for Injection, USP. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of ABRILADA contains adalimumab-afzb (20 mg), edetate disodium dihydrate (0.02 mg), L-histidine (0.314 mg), L-histidine hydrochloride monohydrate (1.253 mg), L-methionine (0.08 mg), polysorbate 80 (0.08 mg), sucrose (34 mg), and Water for Injection, USP. Each 10 mg/0.2 mL prefilled syringe delivers 0.2 mL (10 mg) of drug product. Each 0.2 mL of ABRILADA contains adalimumab-afzb (10 mg), edetate disodium dihydrate (0.01 mg), L-histidine (0.157 mg), L-histidine hydrochloride monohydrate (0.626 mg), L-methionine (0.04 mg), polysorbate 80 (0.04 mg), sucrose (17 mg), and Water for Injection, USP."
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{
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"PackageDescription": "2 KIT in 1 CARTON (0069-0325-02) / 1 KIT in 1 KIT * .8 mL in 1 SYRINGE (0069-0318-01) * 1 mL in 1 PACKET (0069-1111-01) ",
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"IndicationAndUsage": "ABRILADA is a tumor necrosis factor (TNF) blocker indicated for: 1 Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1), 2 Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2), 3 Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3), 4 Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4), 5 Treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. (1.5), 6 Treatment of moderately to severely active ulcerative colitis in adult patients. (1.6)Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. , 7 Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. (1.7), 8 Treatment of moderate to severe hidradenitis suppurativa in adult patients. (1.8), 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adult patients. (1.9).",
"Description": "Adalimumab-afzb is a tumor necrosis factor (TNF) blocker. Adalimumab-afzb is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-afzb is produced by recombinant DNA technology in Chinese hamster ovary cells and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. ABRILADA (adalimumab-afzb) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose prefilled pen (ABRILADA pen), as a single-dose 1 mL prefilled glass syringe, or as a single-dose institutional use vial. Enclosed within the pen is a single-dose 1 mL prefilled glass syringe. The solution of ABRILADA is clear and colorless to very light brown, with a pH of about 5.5. Each 40 mg/0.8 mL prefilled syringe, prefilled pen, or single-dose institutional use vial delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of ABRILADA contains adalimumab-afzb (40 mg), edetate disodium dihydrate (0.04 mg), L-histidine (0.63mg), L-histidine hydrochloride monohydrate (2.51 mg), L-methionine (0.16 mg), polysorbate 80 (0.16 mg), sucrose (68 mg), and Water for Injection, USP. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of ABRILADA contains adalimumab-afzb (20 mg), edetate disodium dihydrate (0.02 mg), L-histidine (0.314 mg), L-histidine hydrochloride monohydrate (1.253 mg), L-methionine (0.08 mg), polysorbate 80 (0.08 mg), sucrose (34 mg), and Water for Injection, USP. Each 10 mg/0.2 mL prefilled syringe delivers 0.2 mL (10 mg) of drug product. Each 0.2 mL of ABRILADA contains adalimumab-afzb (10 mg), edetate disodium dihydrate (0.01 mg), L-histidine (0.157 mg), L-histidine hydrochloride monohydrate (0.626 mg), L-methionine (0.04 mg), polysorbate 80 (0.04 mg), sucrose (17 mg), and Water for Injection, USP."
},
{
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"PackageDescription": "1 KIT in 1 CARTON (0069-0328-01) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .8 mL in 1 SYRINGE (0069-0317-01) * 1 mL in 1 PACKET (0069-1111-01) ",
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"IndicationAndUsage": "ABRILADA is a tumor necrosis factor (TNF) blocker indicated for: 1 Rheumatoid Arthritis (RA) (1.1): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA., 2 Juvenile Idiopathic Arthritis (JIA) (1.2): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older., 3 Psoriatic Arthritis (PsA) (1.3): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA., 4 Ankylosing Spondylitis (AS) (1.4): reducing signs and symptoms in adult patients with active AS., 5 Crohn's Disease (CD) (1.5): treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older., 6 Ulcerative Colitis (UC) (1.6): treatment of moderately to severely active ulcerative colitis in adult patients.Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. , 7 Plaque Psoriasis (Ps) (1.7): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate., 8 Hidradenitis Suppurativa (HS) (1.8): treatment of moderate to severe hidradenitis suppurativa in adult patients., 9 Uveitis (UV) (1.9): treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.",
"Description": "Adalimumab-afzb is a tumor necrosis factor (TNF) blocker. Adalimumab-afzb is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-afzb is produced by recombinant DNA technology in Chinese hamster ovary cells and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. ABRILADA (adalimumab-afzb) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose prefilled pen (ABRILADA pen), as a single-dose 1 mL prefilled glass syringe, or as a single-dose institutional use vial. Enclosed within the pen is a single-dose 1 mL prefilled glass syringe. The solution of ABRILADA is clear and colorless to very light brown, with a pH of about 5.5. Each 40 mg/0.8 mL prefilled syringe, prefilled pen, or single-dose institutional use vial delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of ABRILADA contains adalimumab-afzb (40 mg), edetate disodium dihydrate (0.04 mg), L-histidine (0.63mg), L-histidine hydrochloride monohydrate (2.51 mg), L-methionine (0.16 mg), polysorbate 80 (0.16 mg), sucrose (68 mg), and Water for Injection, USP. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of ABRILADA contains adalimumab-afzb (20 mg), edetate disodium dihydrate (0.02 mg), L-histidine (0.314 mg), L-histidine hydrochloride monohydrate (1.253 mg), L-methionine (0.08 mg), polysorbate 80 (0.08 mg), sucrose (34 mg), and Water for Injection, USP. Each 10 mg/0.2 mL prefilled syringe delivers 0.2 mL (10 mg) of drug product. Each 0.2 mL of ABRILADA contains adalimumab-afzb (10 mg), edetate disodium dihydrate (0.01 mg), L-histidine (0.157 mg), L-histidine hydrochloride monohydrate (0.626 mg), L-methionine (0.04 mg), polysorbate 80 (0.04 mg), sucrose (17 mg), and Water for Injection, USP."
},
{
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"PackageDescription": "2 KIT in 1 CARTON (0069-0328-02) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .8 mL in 1 SYRINGE (0069-0317-01) * 1 mL in 1 PACKET (0069-1111-01) ",
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"IndicationAndUsage": "ABRILADA is a tumor necrosis factor (TNF) blocker indicated for: 1 Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1), 2 Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2), 3 Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3), 4 Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4), 5 Treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. (1.5), 6 Treatment of moderately to severely active ulcerative colitis in adult patients. (1.6)Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. , 7 Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. (1.7), 8 Treatment of moderate to severe hidradenitis suppurativa in adult patients. (1.8), 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adult patients. (1.9).",
"Description": "Adalimumab-afzb is a tumor necrosis factor (TNF) blocker. Adalimumab-afzb is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-afzb is produced by recombinant DNA technology in Chinese hamster ovary cells and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. ABRILADA (adalimumab-afzb) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose prefilled pen (ABRILADA pen), as a single-dose 1 mL prefilled glass syringe, or as a single-dose institutional use vial. Enclosed within the pen is a single-dose 1 mL prefilled glass syringe. The solution of ABRILADA is clear and colorless to very light brown, with a pH of about 5.5. Each 40 mg/0.8 mL prefilled syringe, prefilled pen, or single-dose institutional use vial delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of ABRILADA contains adalimumab-afzb (40 mg), edetate disodium dihydrate (0.04 mg), L-histidine (0.63mg), L-histidine hydrochloride monohydrate (2.51 mg), L-methionine (0.16 mg), polysorbate 80 (0.16 mg), sucrose (68 mg), and Water for Injection, USP. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of ABRILADA contains adalimumab-afzb (20 mg), edetate disodium dihydrate (0.02 mg), L-histidine (0.314 mg), L-histidine hydrochloride monohydrate (1.253 mg), L-methionine (0.08 mg), polysorbate 80 (0.08 mg), sucrose (34 mg), and Water for Injection, USP. Each 10 mg/0.2 mL prefilled syringe delivers 0.2 mL (10 mg) of drug product. Each 0.2 mL of ABRILADA contains adalimumab-afzb (10 mg), edetate disodium dihydrate (0.01 mg), L-histidine (0.157 mg), L-histidine hydrochloride monohydrate (0.626 mg), L-methionine (0.04 mg), polysorbate 80 (0.04 mg), sucrose (17 mg), and Water for Injection, USP."
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"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
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"SamplePackage": "N",
"IndicationAndUsage": "ABRILADA is a tumor necrosis factor (TNF) blocker indicated for: 1 Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1), 2 Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2), 3 Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3), 4 Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4), 5 Treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. (1.5), 6 Treatment of moderately to severely active ulcerative colitis in adult patients. (1.6)Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. , 7 Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. (1.7), 8 Treatment of moderate to severe hidradenitis suppurativa in adult patients. (1.8), 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adult patients. (1.9).",
"Description": "Adalimumab-afzb is a tumor necrosis factor (TNF) blocker. Adalimumab-afzb is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-afzb is produced by recombinant DNA technology in Chinese hamster ovary cells and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. ABRILADA (adalimumab-afzb) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose prefilled pen (ABRILADA pen), as a single-dose 1 mL prefilled glass syringe, or as a single-dose institutional use vial. Enclosed within the pen is a single-dose 1 mL prefilled glass syringe. The solution of ABRILADA is clear and colorless to very light brown, with a pH of about 5.5. Each 40 mg/0.8 mL prefilled syringe, prefilled pen, or single-dose institutional use vial delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of ABRILADA contains adalimumab-afzb (40 mg), edetate disodium dihydrate (0.04 mg), L-histidine (0.63mg), L-histidine hydrochloride monohydrate (2.51 mg), L-methionine (0.16 mg), polysorbate 80 (0.16 mg), sucrose (68 mg), and Water for Injection, USP. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of ABRILADA contains adalimumab-afzb (20 mg), edetate disodium dihydrate (0.02 mg), L-histidine (0.314 mg), L-histidine hydrochloride monohydrate (1.253 mg), L-methionine (0.08 mg), polysorbate 80 (0.08 mg), sucrose (34 mg), and Water for Injection, USP. Each 10 mg/0.2 mL prefilled syringe delivers 0.2 mL (10 mg) of drug product. Each 0.2 mL of ABRILADA contains adalimumab-afzb (10 mg), edetate disodium dihydrate (0.01 mg), L-histidine (0.157 mg), L-histidine hydrochloride monohydrate (0.626 mg), L-methionine (0.04 mg), polysorbate 80 (0.04 mg), sucrose (17 mg), and Water for Injection, USP."
},
{
"NDCCode": "0409-1060-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0409-1060-01) / 4.2 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00409-1060-01",
"ProductNDC": "0409-1060",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pemetrexed",
"NonProprietaryName": "Pemetrexed",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20220620",
"EndMarketingDate": "20250731",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208746",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "PEMETREXED TROMETHAMINE ANHYDROUS",
"StrengthNumber": "25",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20220620",
"EndMarketingDatePackage": "20250731",
"SamplePackage": "N",
"IndicationAndUsage": "Pemetrexed for Injection is a folate analog metabolic inhibitor indicated: 1 In combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous, non-small cell lung cancer (NSCLC). (1.1), 2 As a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. (1.1), 3 As a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy. (1.1), 4 Limitations of Use: Pemetrexed for Injection is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer. (1.1), 5 Initial treatment, in combination with cisplatin, of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery. (1.2).",
"Description": "Pemetrexed is a folate analog metabolic inhibitor. The drug substance, pemetrexed ditromethamine, has the chemical name L-glutamic acid, N-[4-[2-(2-amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3-d] pyrimidin-5-yl)ethyl]benzoyl]-, ditromethamine dihydrate with a molecular formula of C28H47N7O14 and a molecular weight of 705.68. The structural formula is as follows. Pemetrexed for Injection is a sterile white-to-light yellow or green-yellow lyophilized powder in single-dose vials to be reconstituted for intravenous infusion. Each 100-mg vial of Pemetrexed for Injection contains 100 mg pemetrexed (equivalent to 157 mg pemetrexed ditromethamine) and 106 mg mannitol. Each 500-mg vial of Pemetrexed for Injection contains 500 mg pemetrexed (equivalent to 783 mg pemetrexed ditromethamine) and 500 mg mannitol. Each 1-gram vial of Pemetrexed for Injection contains 1 gram pemetrexed (equivalent to 1.57 gram pemetrexed ditromethamine) and 1 gram mannitol."
},
{
"NDCCode": "0517-0960-01",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (0517-0960-01) > 10 mL in 1 VIAL, GLASS",
"NDC11Code": "00517-0960-01",
"ProductNDC": "0517-0960",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tranexamic Acid",
"NonProprietaryName": "Tranexamic Acid",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20111115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201885",
"LabelerName": "American Regent, Inc.",
"SubstanceName": "TRANEXAMIC ACID",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]",
"Status": "Deprecated",
"LastUpdate": "2026-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20111115",
"SamplePackage": "N",
"IndicationAndUsage": "Tranexamic acid injection, USP is indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.",
"Description": "Tranexamic acid is trans-4-(aminomethyl)cyclohexanecarboxylic acid, an antifibrinolytic agent. Tranexamic acid is a white crystalline powder. The structural formula is. Empirical Formula: C8H15NO2 Molecular Weight: 157.2. Each mL of the sterile solution for intravenous injection contains 100 mg tranexamic acid and Water for Injection to 1 mL. The aqueous solution for injection has a pH of 6.5 to 8.0."
},
{
"NDCCode": "0517-0960-10",
"PackageDescription": "10 VIAL, GLASS in 1 CARTON (0517-0960-10) > 10 mL in 1 VIAL, GLASS",
"NDC11Code": "00517-0960-10",
"ProductNDC": "0517-0960",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tranexamic Acid",
"NonProprietaryName": "Tranexamic Acid",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20111115",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA201885",
"LabelerName": "American Regent, Inc.",
"SubstanceName": "TRANEXAMIC ACID",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]",
"Status": "Deprecated",
"LastUpdate": "2026-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20111115",
"SamplePackage": "N",
"IndicationAndUsage": "Tranexamic acid injection, USP is indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.",
"Description": "Tranexamic acid is trans-4-(aminomethyl)cyclohexanecarboxylic acid, an antifibrinolytic agent. Tranexamic acid is a white crystalline powder. The structural formula is. Empirical Formula: C8H15NO2 Molecular Weight: 157.2. Each mL of the sterile solution for intravenous injection contains 100 mg tranexamic acid and Water for Injection to 1 mL. The aqueous solution for injection has a pH of 6.5 to 8.0."
},
{
"NDCCode": "11788-157-60",
"PackageDescription": "60 TABLET in 1 BOTTLE (11788-157-60) ",
"NDC11Code": "11788-0157-60",
"ProductNDC": "11788-157",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ticagrelor",
"NonProprietaryName": "Ticagrelor",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260610",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA219006",
"LabelerName": "AiPing Pharmaceutical, Inc",
"SubstanceName": "TICAGRELOR",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 3A4 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P-Glycoprotein Inhibitors [MoA], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260610",
"SamplePackage": "N",
"Description": "Ticagrelor tablets contains ticagrelor, a cyclopentyltriazolopyrimidine, inhibitor of platelet activation and aggregation mediated by the P2Y12 ADP-receptor. Chemically it is (1S,2S,3R,5S)-3-[7-{[(1R,2S)-2-(3,4-difluorophenyl)cyclopropyl]amino}-5-(propylthio)-3H-[1,2,3]-triazolo[4,5-d]pyrimidin-3-yl]-5-(2-hydroxyethoxy)cyclopentane-1,2-diol. The empirical formula of ticagrelor is C23H28F2N6O4S and its molecular weight is 522.57. The chemical structure of ticagrelor is. Ticagrelor is a crystalline powder with an aqueous solubility of approximately 10 μg/mL at room temperature. Ticagrelor 90 mg tablets for oral administration contain 90 mg of ticagrelor and the following ingredients: mannitol, dibasic calcium phosphate dihydrate, croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, hypromellose, calcium carbonate, talc, polyethylene glycol 6000, ferric oxide red, and ferric oxide yellow. Ticagrelor 60 mg tablets for oral administration contain 60 mg of ticagrelor and the following ingredients: mannitol, dibasic calcium phosphate dihydrate, croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, hypromellose, calcium carbonate, talc, polyethylene glycol 6000, and ferric oxide red."
},
{
"NDCCode": "14789-115-05",
"PackageDescription": "10 BAG in 1 CARTON (14789-115-05) / 100 mL in 1 BAG (14789-115-08) ",
"NDC11Code": "14789-0115-05",
"ProductNDC": "14789-115",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tranexamic Acid",
"NonProprietaryName": "Tranexamic Acid",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20240625",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216877",
"LabelerName": "Nexus Pharmaceuticals LLC",
"SubstanceName": "TRANEXAMIC ACID",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]",
"Status": "Active",
"LastUpdate": "2025-02-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240625",
"SamplePackage": "N",
"IndicationAndUsage": "Tranexamic Acid in Sodium Chloride Injection is indicated in patients with hemophilia for short-term use (two to eight days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.",
"Description": "Tranexamic acid is trans-4-(aminomethyl)cyclohexanecarboxylic acid, an antifibrinolytic agent. Tranexamic acid is a white crystalline powder. The structural formula is. Empirical Formula: C 8H 15NO 2 Molecular Weight: 157.2. Tranexamic Acid in Sodium Chloride Injection is a clear to colorless sterile, nonpyrogenic injectable solution for intravenous administration. Each IV bag contains 1,000 mg tranexamic acid, USP, 700 mg of sodium chloride, USP and Water for Injection, USP. The aqueous solution has a pH of 6.5 to 8.0."
},
{
"NDCCode": "14789-115-08",
"PackageDescription": "100 mL in 1 BAG (14789-115-08) ",
"NDC11Code": "14789-0115-08",
"ProductNDC": "14789-115",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tranexamic Acid",
"NonProprietaryName": "Tranexamic Acid",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20240625",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216877",
"LabelerName": "Nexus Pharmaceuticals LLC",
"SubstanceName": "TRANEXAMIC ACID",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-02-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20240625",
"SamplePackage": "N",
"IndicationAndUsage": "Tranexamic Acid in Sodium Chloride Injection is indicated in patients with hemophilia for short-term use (two to eight days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.",
"Description": "Tranexamic acid is trans-4-(aminomethyl)cyclohexanecarboxylic acid, an antifibrinolytic agent. Tranexamic acid is a white crystalline powder. The structural formula is. Empirical Formula: C8H15NO2 Molecular Weight: 157.2. Tranexamic Acid in Sodium Chloride Injection is a clear to colorless sterile, nonpyrogenic injectable solution for intravenous administration. Each IV bag contains 1,000 mg tranexamic acid, USP, 700 mg of sodium chloride, USP and Water for Injection, USP. The aqueous solution has a pH of 6.5 to 8.0."
}
]
}
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<NDCList>
<NDC>
<NDCCode>63505-157-08</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE, PLASTIC (63505-157-08)</PackageDescription>
<NDC11Code>63505-0157-08</NDC11Code>
<ProductNDC>63505-157</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fraicheur Verveine Antiperspirant And Deodorant Roll-on</ProprietaryName>
<NonProprietaryName>Aluminum Sesquichlorohydrate</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20080701</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part350</ApplicationNumber>
<LabelerName>YVES ROCHER NORTH AMERICA INC</LabelerName>
<SubstanceName>ALUMINUM SESQUICHLOROHYDRATE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>UseReduces underarm perspiration.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63505-156-08</NDCCode>
<PackageDescription>150 mL in 1 BOTTLE, PLASTIC (63505-156-08)</PackageDescription>
<NDC11Code>63505-0156-08</NDC11Code>
<ProductNDC>63505-156</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Protectyl Soleil Moisturizing Sunscreen Lotion High Protection Spf 30</ProprietaryName>
<NonProprietaryName>Titanium Dioxide, Octinoxate And Octocrylene</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20070501</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Yves Rocher North America Inc</LabelerName>
<SubstanceName>OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>7.5; 7; 8.4</StrengthNumber>
<StrengthUnit>mL/100mL; mL/100mL; mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>63505-158-08</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE, PLASTIC (63505-158-08)</PackageDescription>
<NDC11Code>63505-0158-08</NDC11Code>
<ProductNDC>63505-158</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fraicheur Cedre Bleu Antiperspirant And Deodorant Roll-on</ProprietaryName>
<NonProprietaryName>Aluminum Sesquichlorohydrate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20081001</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part350</ApplicationNumber>
<LabelerName>YVES ROCHER NORTH AMERICA INC</LabelerName>
<SubstanceName>ALUMINUM SESQUICHLOROHYDRATE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>UseReduces underarm perspiration.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63505-159-08</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE, PLASTIC (63505-159-08)</PackageDescription>
<NDC11Code>63505-0159-08</NDC11Code>
<ProductNDC>63505-159</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fraicheur The Vert Antiperspirant And Deodorant Roll-on</ProprietaryName>
<NonProprietaryName>Aluminum Sesquichlorohydrate</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20081001</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part350</ApplicationNumber>
<LabelerName>YVES ROCHER NORTH AMERICA INC</LabelerName>
<SubstanceName>ALUMINUM SESQUICHLOROHYDRATE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>UseReduces underarm perspiration.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63505-160-08</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE, PLASTIC (63505-160-08)</PackageDescription>
<NDC11Code>63505-0160-08</NDC11Code>
<ProductNDC>63505-160</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fraicheur Bambou Antiperspirant And Deodorant Roll-on</ProprietaryName>
<NonProprietaryName>Aluminum Sesquichlorohydrate</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20081001</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part350</ApplicationNumber>
<LabelerName>YVES ROCHER NORTH AMERICA INC</LabelerName>
<SubstanceName>ALUMINUM SESQUICHLOROHYDRATE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>UseReduces underarm perspiration.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63505-161-08</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE, PLASTIC (63505-161-08)</PackageDescription>
<NDC11Code>63505-0161-08</NDC11Code>
<ProductNDC>63505-161</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Fraicheur Chevrefeuille Antiperspirant And Deodorant Roll-on</ProprietaryName>
<NonProprietaryName>Aluminum Sesquichlorohydrate</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20090201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part350</ApplicationNumber>
<LabelerName>YVES ROCHER NORTH AMERICA INC</LabelerName>
<SubstanceName>ALUMINUM SESQUICHLOROHYDRATE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>UseReduces underarm perspiration.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>15127-157-08</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (15127-157-08) > 9 TABLET, CHEWABLE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>15127-0157-08</NDC11Code>
<ProductNDC>15127-157</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Gas Relief</ProprietaryName>
<NonProprietaryName>Simethicone</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090202</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part332</ApplicationNumber>
<LabelerName>Select Brand</LabelerName>
<SubstanceName>DIMETHICONE</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>relieves: 1 pressure, 2 bloating, 3 symptoms referred to as gas.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>27241-157-08</NDCCode>
<PackageDescription>500 TABLET, EXTENDED RELEASE in 1 BOTTLE (27241-157-08) </PackageDescription>
<NDC11Code>27241-0157-08</NDC11Code>
<ProductNDC>27241-157</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxybutynin Chloride</ProprietaryName>
<NonProprietaryName>Oxybutynin Chloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211655</ApplicationNumber>
<LabelerName>Ajanta Pharma USA Inc.</LabelerName>
<SubstanceName>OXYBUTYNIN CHLORIDE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Oxybutynin chloride is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. Oxybutynin chloride extended-release tablets is also indicated for the treatment of pediatric patients aged 6 years and older with symptoms of detrusor overactivity associated with a neurological condition (e.g., spina bifida).</IndicationAndUsage>
<Description>Oxybutynin chloride, USP is an antispasmodic, muscarinic antagonist. Each oxybutynin chloride extended-release tablet, USP contains 5 mg, 10 mg, or 15 mg of oxybutynin chloride USP, formulated as a once-a-day controlled-release tablet for oral administration. Oxybutynin chloride, USP is administered as a racemate of R- and S-enantiomers. Chemically, oxybutynin chloride, USP is 4(diethylamino-but-2-ynyl (RS) 2-cyclohexyl-2-hydroxy 2 phenyl acetate hydrochloride. The molecular formula of oxybutynin chloride, USP is C22H31NO3HCl. Its structural formula is. Oxybutynin chloride, USP is a white crystalline powder with a molecular weight of 393.95. It is freely soluble in water and in alcohol, very soluble in methanol and in chloroform, soluble in acetone, slightly soluble in ether, very slightly soluble in hexane. Oxybutynin chloride extended-release tablets, USP also contains the following inert ingredients: anhydrous dibasic calcium phosphate, povidone, hypromellose, colloidal silicon dioxide, magnesium stearate, polyethylene glycol, methacrylic acid copolymer type c, talc, titanium dioxide, triethyl citrate, sodium bicarbonate, sodium lauryl sulfate, ferrosoferric oxide, ferric oxide red (in 10 mg only) and iron oxide yellow (in 5 mg and 15 mg only). The imprinting material contains: shellac glaze, black iron oxide, propylene glycol and ammonium hydroxide.Meets USP Dissolution Test 9.System Components and Performance. Oxybutynin chloride extended-release tablets, USP are formulated to deliver oxybutynin chloride at a controlled rate over approximately 24 hours. The dosage form is comprised of a hydrophilic cellulose polymer matrix tablet surrounded by an enteric coating system. The enteric coat is insoluble in the low pH environment of the stomach. As the tablet passes through the stomach and enters the higher pH environment of the small intestine, the enteric coating dissolves and/or erodes to expose the polymer matrix tablet which swells and releases drug at a controlled rate via diffusion and/or erosion.</Description>
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<NDCCode>55151-123-08</NDCCode>
<PackageDescription>157 L in 1 CYLINDER (55151-123-08) </PackageDescription>
<NDC11Code>55151-0123-08</NDC11Code>
<ProductNDC>55151-123</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
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<LabelerName>E-Z Oxygen LLC, dba AO2</LabelerName>
<SubstanceName>OXYGEN</SubstanceName>
<StrengthNumber>99</StrengthNumber>
<StrengthUnit>L/100L</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-11-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>59779-157-08</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (59779-157-08) > 24 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>59779-0157-08</NDC11Code>
<ProductNDC>59779-157</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aspirin</ProprietaryName>
<NonProprietaryName>Aspirin</NonProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>19960210</StartMarketingDate>
<EndMarketingDate>20211108</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>CVS Pharmacy</LabelerName>
<SubstanceName>ASPIRIN</SubstanceName>
<StrengthNumber>325</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19960210</StartMarketingDatePackage>
<EndMarketingDatePackage>20211108</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70942-157-08</NDCCode>
<PackageDescription>237 mL in 1 BOTTLE, PUMP (70942-157-08) </PackageDescription>
<NDC11Code>70942-0157-08</NDC11Code>
<ProductNDC>70942-157</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer</ProprietaryName>
<ProprietaryNameSuffix>Dr. Butler</ProprietaryNameSuffix>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200326</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Beyond Health P.A.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>62</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200326</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To decrease bacteria on the skin that could cause disease. Recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71919-157-08</NDCCode>
<PackageDescription>30 mL in 1 VIAL, GLASS (71919-157-08) </PackageDescription>
<NDC11Code>71919-0157-08</NDC11Code>
<ProductNDC>71919-157</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Candida Parapsilosis</ProprietaryName>
<NonProprietaryName>Candida Parapsilosis</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100204</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Washington Homeopathic Products</LabelerName>
<SubstanceName>CANDIDA PARAPSILOSIS</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-03-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100204</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>72839-157-08</NDCCode>
<PackageDescription>237 mL in 1 BOTTLE, PLASTIC (72839-157-08) </PackageDescription>
<NDC11Code>72839-0157-08</NDC11Code>
<ProductNDC>72839-157</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dcr Labs Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200326</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Derma Care Research Labs, LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>62</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200326</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To decrease bacteria on the skin that could cause disease. Recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>83589-157-08</NDCCode>
<PackageDescription>100 g in 1 BOTTLE (83589-157-08) </PackageDescription>
<NDC11Code>83589-0157-08</NDC11Code>
<ProductNDC>83589-157</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Penetratin</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20260225</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Nanjing Chengong Pharmaceutical Co., Ltd.</LabelerName>
<SubstanceName>PENETRATIN</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>25-FEB-26</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>63505-004-01</NDCCode>
<PackageDescription>40 mL in 1 BOTTLE (63505-004-01)</PackageDescription>
<NDC11Code>63505-0004-01</NDC11Code>
<ProductNDC>63505-004</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pure System Stop Blemish</ProprietaryName>
<NonProprietaryName>Salicylic Acid</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120619</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333D</ApplicationNumber>
<LabelerName>Yves Rocher North America Inc</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-06-08</LastUpdate>
</NDC>
<NDC>
<NDCCode>0025-0325-01</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0025-0325-01) / 1 KIT in 1 KIT * .8 mL in 1 SYRINGE (0025-0318-01) * 1 mL in 1 PACKET (0069-1111-01) </PackageDescription>
<NDC11Code>00025-0325-01</NDC11Code>
<ProductNDC>0025-0325</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Abrilada</ProprietaryName>
<NonProprietaryName>Adalimumab-afzb</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20231214</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761118</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-05-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ABRILADA is a tumor necrosis factor (TNF) blocker indicated for: 1 Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1), 2 Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2), 3 Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3), 4 Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4), 5 Treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. (1.5), 6 Treatment of moderately to severely active ulcerative colitis in adult patients. (1.6)Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. , 7 Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. (1.7), 8 Treatment of moderate to severe hidradenitis suppurativa in adult patients. (1.8), 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adult patients. (1.9).</IndicationAndUsage>
<Description>Adalimumab-afzb is a tumor necrosis factor (TNF) blocker. Adalimumab-afzb is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-afzb is produced by recombinant DNA technology in Chinese hamster ovary cells and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. ABRILADA (adalimumab-afzb) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose prefilled pen (ABRILADA pen), as a single-dose 1 mL prefilled glass syringe, or as a single-dose institutional use vial. Enclosed within the pen is a single-dose 1 mL prefilled glass syringe. The solution of ABRILADA is clear and colorless to very light brown, with a pH of about 5.5. Each 40 mg/0.8 mL prefilled syringe, prefilled pen, or single-dose institutional use vial delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of ABRILADA contains adalimumab-afzb (40 mg), edetate disodium dihydrate (0.04 mg), L-histidine (0.63mg), L-histidine hydrochloride monohydrate (2.51 mg), L-methionine (0.16 mg), polysorbate 80 (0.16 mg), sucrose (68 mg), and Water for Injection, USP. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of ABRILADA contains adalimumab-afzb (20 mg), edetate disodium dihydrate (0.02 mg), L-histidine (0.314 mg), L-histidine hydrochloride monohydrate (1.253 mg), L-methionine (0.08 mg), polysorbate 80 (0.08 mg), sucrose (34 mg), and Water for Injection, USP. Each 10 mg/0.2 mL prefilled syringe delivers 0.2 mL (10 mg) of drug product. Each 0.2 mL of ABRILADA contains adalimumab-afzb (10 mg), edetate disodium dihydrate (0.01 mg), L-histidine (0.157 mg), L-histidine hydrochloride monohydrate (0.626 mg), L-methionine (0.04 mg), polysorbate 80 (0.04 mg), sucrose (17 mg), and Water for Injection, USP.</Description>
</NDC>
<NDC>
<NDCCode>0025-0325-02</NDCCode>
<PackageDescription>2 KIT in 1 CARTON (0025-0325-02) / 1 KIT in 1 KIT * .8 mL in 1 SYRINGE (0025-0318-01) * 1 mL in 1 PACKET (0069-1111-01) </PackageDescription>
<NDC11Code>00025-0325-02</NDC11Code>
<ProductNDC>0025-0325</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Abrilada</ProprietaryName>
<NonProprietaryName>Adalimumab-afzb</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20231214</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761118</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-05-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ABRILADA is a tumor necrosis factor (TNF) blocker indicated for: 1 Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1), 2 Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2), 3 Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3), 4 Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4), 5 Treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. (1.5), 6 Treatment of moderately to severely active ulcerative colitis in adult patients. (1.6)Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. , 7 Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. (1.7), 8 Treatment of moderate to severe hidradenitis suppurativa in adult patients. (1.8), 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adult patients. (1.9).</IndicationAndUsage>
<Description>Adalimumab-afzb is a tumor necrosis factor (TNF) blocker. Adalimumab-afzb is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-afzb is produced by recombinant DNA technology in Chinese hamster ovary cells and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. ABRILADA (adalimumab-afzb) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose prefilled pen (ABRILADA pen), as a single-dose 1 mL prefilled glass syringe, or as a single-dose institutional use vial. Enclosed within the pen is a single-dose 1 mL prefilled glass syringe. The solution of ABRILADA is clear and colorless to very light brown, with a pH of about 5.5. Each 40 mg/0.8 mL prefilled syringe, prefilled pen, or single-dose institutional use vial delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of ABRILADA contains adalimumab-afzb (40 mg), edetate disodium dihydrate (0.04 mg), L-histidine (0.63mg), L-histidine hydrochloride monohydrate (2.51 mg), L-methionine (0.16 mg), polysorbate 80 (0.16 mg), sucrose (68 mg), and Water for Injection, USP. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of ABRILADA contains adalimumab-afzb (20 mg), edetate disodium dihydrate (0.02 mg), L-histidine (0.314 mg), L-histidine hydrochloride monohydrate (1.253 mg), L-methionine (0.08 mg), polysorbate 80 (0.08 mg), sucrose (34 mg), and Water for Injection, USP. Each 10 mg/0.2 mL prefilled syringe delivers 0.2 mL (10 mg) of drug product. Each 0.2 mL of ABRILADA contains adalimumab-afzb (10 mg), edetate disodium dihydrate (0.01 mg), L-histidine (0.157 mg), L-histidine hydrochloride monohydrate (0.626 mg), L-methionine (0.04 mg), polysorbate 80 (0.04 mg), sucrose (17 mg), and Water for Injection, USP.</Description>
</NDC>
<NDC>
<NDCCode>0025-0328-02</NDCCode>
<PackageDescription>2 KIT in 1 CARTON (0025-0328-02) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .8 mL in 1 SYRINGE (0025-0317-01) * 1 mL in 1 PACKET (0069-1111-01) </PackageDescription>
<NDC11Code>00025-0328-02</NDC11Code>
<ProductNDC>0025-0328</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Abrilada</ProprietaryName>
<NonProprietaryName>Adalimumab-afzb</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20231214</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761118</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-05-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ABRILADA is a tumor necrosis factor (TNF) blocker indicated for: 1 Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1), 2 Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2), 3 Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3), 4 Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4), 5 Treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. (1.5), 6 Treatment of moderately to severely active ulcerative colitis in adult patients. (1.6)Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. , 7 Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. (1.7), 8 Treatment of moderate to severe hidradenitis suppurativa in adult patients. (1.8), 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adult patients. (1.9).</IndicationAndUsage>
<Description>Adalimumab-afzb is a tumor necrosis factor (TNF) blocker. Adalimumab-afzb is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-afzb is produced by recombinant DNA technology in Chinese hamster ovary cells and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. ABRILADA (adalimumab-afzb) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose prefilled pen (ABRILADA pen), as a single-dose 1 mL prefilled glass syringe, or as a single-dose institutional use vial. Enclosed within the pen is a single-dose 1 mL prefilled glass syringe. The solution of ABRILADA is clear and colorless to very light brown, with a pH of about 5.5. Each 40 mg/0.8 mL prefilled syringe, prefilled pen, or single-dose institutional use vial delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of ABRILADA contains adalimumab-afzb (40 mg), edetate disodium dihydrate (0.04 mg), L-histidine (0.63mg), L-histidine hydrochloride monohydrate (2.51 mg), L-methionine (0.16 mg), polysorbate 80 (0.16 mg), sucrose (68 mg), and Water for Injection, USP. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of ABRILADA contains adalimumab-afzb (20 mg), edetate disodium dihydrate (0.02 mg), L-histidine (0.314 mg), L-histidine hydrochloride monohydrate (1.253 mg), L-methionine (0.08 mg), polysorbate 80 (0.08 mg), sucrose (34 mg), and Water for Injection, USP. Each 10 mg/0.2 mL prefilled syringe delivers 0.2 mL (10 mg) of drug product. Each 0.2 mL of ABRILADA contains adalimumab-afzb (10 mg), edetate disodium dihydrate (0.01 mg), L-histidine (0.157 mg), L-histidine hydrochloride monohydrate (0.626 mg), L-methionine (0.04 mg), polysorbate 80 (0.04 mg), sucrose (17 mg), and Water for Injection, USP.</Description>
</NDC>
<NDC>
<NDCCode>0025-0333-02</NDCCode>
<PackageDescription>2 KIT in 1 CARTON (0025-0333-02) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / .4 mL in 1 SYRINGE (0025-0329-01) * 1 mL in 1 PACKET (0069-1111-01) </PackageDescription>
<NDC11Code>00025-0333-02</NDC11Code>
<ProductNDC>0025-0333</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Abrilada</ProprietaryName>
<NonProprietaryName>Adalimumab-afzb</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20231214</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761118</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-05-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231214</StartMarketingDatePackage>
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<IndicationAndUsage>ABRILADA is a tumor necrosis factor (TNF) blocker indicated for: 1 Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1), 2 Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2), 3 Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3), 4 Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4), 5 Treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. (1.5), 6 Treatment of moderately to severely active ulcerative colitis in adult patients. (1.6)Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. , 7 Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. (1.7), 8 Treatment of moderate to severe hidradenitis suppurativa in adult patients. (1.8), 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adult patients. (1.9).</IndicationAndUsage>
<Description>Adalimumab-afzb is a tumor necrosis factor (TNF) blocker. Adalimumab-afzb is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-afzb is produced by recombinant DNA technology in Chinese hamster ovary cells and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. ABRILADA (adalimumab-afzb) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose prefilled pen (ABRILADA pen), as a single-dose 1 mL prefilled glass syringe, or as a single-dose institutional use vial. Enclosed within the pen is a single-dose 1 mL prefilled glass syringe. The solution of ABRILADA is clear and colorless to very light brown, with a pH of about 5.5. Each 40 mg/0.8 mL prefilled syringe, prefilled pen, or single-dose institutional use vial delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of ABRILADA contains adalimumab-afzb (40 mg), edetate disodium dihydrate (0.04 mg), L-histidine (0.63mg), L-histidine hydrochloride monohydrate (2.51 mg), L-methionine (0.16 mg), polysorbate 80 (0.16 mg), sucrose (68 mg), and Water for Injection, USP. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of ABRILADA contains adalimumab-afzb (20 mg), edetate disodium dihydrate (0.02 mg), L-histidine (0.314 mg), L-histidine hydrochloride monohydrate (1.253 mg), L-methionine (0.08 mg), polysorbate 80 (0.08 mg), sucrose (34 mg), and Water for Injection, USP. Each 10 mg/0.2 mL prefilled syringe delivers 0.2 mL (10 mg) of drug product. Each 0.2 mL of ABRILADA contains adalimumab-afzb (10 mg), edetate disodium dihydrate (0.01 mg), L-histidine (0.157 mg), L-histidine hydrochloride monohydrate (0.626 mg), L-methionine (0.04 mg), polysorbate 80 (0.04 mg), sucrose (17 mg), and Water for Injection, USP.</Description>
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<IndicationAndUsage>ABRILADA is a tumor necrosis factor (TNF) blocker indicated for: 1 Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1), 2 Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2), 3 Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3), 4 Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4), 5 Treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. (1.5), 6 Treatment of moderately to severely active ulcerative colitis in adult patients. (1.6)Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. , 7 Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. (1.7), 8 Treatment of moderate to severe hidradenitis suppurativa in adult patients. (1.8), 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adult patients. (1.9).</IndicationAndUsage>
<Description>Adalimumab-afzb is a tumor necrosis factor (TNF) blocker. Adalimumab-afzb is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-afzb is produced by recombinant DNA technology in Chinese hamster ovary cells and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. ABRILADA (adalimumab-afzb) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose prefilled pen (ABRILADA pen), as a single-dose 1 mL prefilled glass syringe, or as a single-dose institutional use vial. Enclosed within the pen is a single-dose 1 mL prefilled glass syringe. The solution of ABRILADA is clear and colorless to very light brown, with a pH of about 5.5. Each 40 mg/0.8 mL prefilled syringe, prefilled pen, or single-dose institutional use vial delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of ABRILADA contains adalimumab-afzb (40 mg), edetate disodium dihydrate (0.04 mg), L-histidine (0.63mg), L-histidine hydrochloride monohydrate (2.51 mg), L-methionine (0.16 mg), polysorbate 80 (0.16 mg), sucrose (68 mg), and Water for Injection, USP. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of ABRILADA contains adalimumab-afzb (20 mg), edetate disodium dihydrate (0.02 mg), L-histidine (0.314 mg), L-histidine hydrochloride monohydrate (1.253 mg), L-methionine (0.08 mg), polysorbate 80 (0.08 mg), sucrose (34 mg), and Water for Injection, USP. Each 10 mg/0.2 mL prefilled syringe delivers 0.2 mL (10 mg) of drug product. Each 0.2 mL of ABRILADA contains adalimumab-afzb (10 mg), edetate disodium dihydrate (0.01 mg), L-histidine (0.157 mg), L-histidine hydrochloride monohydrate (0.626 mg), L-methionine (0.04 mg), polysorbate 80 (0.04 mg), sucrose (17 mg), and Water for Injection, USP.</Description>
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<IndicationAndUsage>ABRILADA is a tumor necrosis factor (TNF) blocker indicated for: 1 Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1), 2 Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2), 3 Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3), 4 Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4), 5 Treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. (1.5), 6 Treatment of moderately to severely active ulcerative colitis in adult patients. (1.6)Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. , 7 Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. (1.7), 8 Treatment of moderate to severe hidradenitis suppurativa in adult patients. (1.8), 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adult patients. (1.9).</IndicationAndUsage>
<Description>Adalimumab-afzb is a tumor necrosis factor (TNF) blocker. Adalimumab-afzb is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-afzb is produced by recombinant DNA technology in Chinese hamster ovary cells and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. ABRILADA (adalimumab-afzb) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose prefilled pen (ABRILADA pen), as a single-dose 1 mL prefilled glass syringe, or as a single-dose institutional use vial. Enclosed within the pen is a single-dose 1 mL prefilled glass syringe. The solution of ABRILADA is clear and colorless to very light brown, with a pH of about 5.5. Each 40 mg/0.8 mL prefilled syringe, prefilled pen, or single-dose institutional use vial delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of ABRILADA contains adalimumab-afzb (40 mg), edetate disodium dihydrate (0.04 mg), L-histidine (0.63mg), L-histidine hydrochloride monohydrate (2.51 mg), L-methionine (0.16 mg), polysorbate 80 (0.16 mg), sucrose (68 mg), and Water for Injection, USP. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of ABRILADA contains adalimumab-afzb (20 mg), edetate disodium dihydrate (0.02 mg), L-histidine (0.314 mg), L-histidine hydrochloride monohydrate (1.253 mg), L-methionine (0.08 mg), polysorbate 80 (0.08 mg), sucrose (34 mg), and Water for Injection, USP. Each 10 mg/0.2 mL prefilled syringe delivers 0.2 mL (10 mg) of drug product. Each 0.2 mL of ABRILADA contains adalimumab-afzb (10 mg), edetate disodium dihydrate (0.01 mg), L-histidine (0.157 mg), L-histidine hydrochloride monohydrate (0.626 mg), L-methionine (0.04 mg), polysorbate 80 (0.04 mg), sucrose (17 mg), and Water for Injection, USP.</Description>
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<IndicationAndUsage>ABRILADA is a tumor necrosis factor (TNF) blocker indicated for: 1 Rheumatoid Arthritis (RA) (1.1): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA., 2 Juvenile Idiopathic Arthritis (JIA) (1.2): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older., 3 Psoriatic Arthritis (PsA) (1.3): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA., 4 Ankylosing Spondylitis (AS) (1.4): reducing signs and symptoms in adult patients with active AS., 5 Crohn's Disease (CD) (1.5): treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older., 6 Ulcerative Colitis (UC) (1.6): treatment of moderately to severely active ulcerative colitis in adult patients.Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. , 7 Plaque Psoriasis (Ps) (1.7): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate., 8 Hidradenitis Suppurativa (HS) (1.8): treatment of moderate to severe hidradenitis suppurativa in adult patients., 9 Uveitis (UV) (1.9): treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.</IndicationAndUsage>
<Description>Adalimumab-afzb is a tumor necrosis factor (TNF) blocker. Adalimumab-afzb is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-afzb is produced by recombinant DNA technology in Chinese hamster ovary cells and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. ABRILADA (adalimumab-afzb) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose prefilled pen (ABRILADA pen), as a single-dose 1 mL prefilled glass syringe, or as a single-dose institutional use vial. Enclosed within the pen is a single-dose 1 mL prefilled glass syringe. The solution of ABRILADA is clear and colorless to very light brown, with a pH of about 5.5. Each 40 mg/0.8 mL prefilled syringe, prefilled pen, or single-dose institutional use vial delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of ABRILADA contains adalimumab-afzb (40 mg), edetate disodium dihydrate (0.04 mg), L-histidine (0.63mg), L-histidine hydrochloride monohydrate (2.51 mg), L-methionine (0.16 mg), polysorbate 80 (0.16 mg), sucrose (68 mg), and Water for Injection, USP. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of ABRILADA contains adalimumab-afzb (20 mg), edetate disodium dihydrate (0.02 mg), L-histidine (0.314 mg), L-histidine hydrochloride monohydrate (1.253 mg), L-methionine (0.08 mg), polysorbate 80 (0.08 mg), sucrose (34 mg), and Water for Injection, USP. Each 10 mg/0.2 mL prefilled syringe delivers 0.2 mL (10 mg) of drug product. Each 0.2 mL of ABRILADA contains adalimumab-afzb (10 mg), edetate disodium dihydrate (0.01 mg), L-histidine (0.157 mg), L-histidine hydrochloride monohydrate (0.626 mg), L-methionine (0.04 mg), polysorbate 80 (0.04 mg), sucrose (17 mg), and Water for Injection, USP.</Description>
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<IndicationAndUsage>ABRILADA is a tumor necrosis factor (TNF) blocker indicated for: 1 Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1), 2 Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2), 3 Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3), 4 Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4), 5 Treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. (1.5), 6 Treatment of moderately to severely active ulcerative colitis in adult patients. (1.6)Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. , 7 Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. (1.7), 8 Treatment of moderate to severe hidradenitis suppurativa in adult patients. (1.8), 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adult patients. (1.9).</IndicationAndUsage>
<Description>Adalimumab-afzb is a tumor necrosis factor (TNF) blocker. Adalimumab-afzb is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-afzb is produced by recombinant DNA technology in Chinese hamster ovary cells and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. ABRILADA (adalimumab-afzb) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose prefilled pen (ABRILADA pen), as a single-dose 1 mL prefilled glass syringe, or as a single-dose institutional use vial. Enclosed within the pen is a single-dose 1 mL prefilled glass syringe. The solution of ABRILADA is clear and colorless to very light brown, with a pH of about 5.5. Each 40 mg/0.8 mL prefilled syringe, prefilled pen, or single-dose institutional use vial delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of ABRILADA contains adalimumab-afzb (40 mg), edetate disodium dihydrate (0.04 mg), L-histidine (0.63mg), L-histidine hydrochloride monohydrate (2.51 mg), L-methionine (0.16 mg), polysorbate 80 (0.16 mg), sucrose (68 mg), and Water for Injection, USP. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of ABRILADA contains adalimumab-afzb (20 mg), edetate disodium dihydrate (0.02 mg), L-histidine (0.314 mg), L-histidine hydrochloride monohydrate (1.253 mg), L-methionine (0.08 mg), polysorbate 80 (0.08 mg), sucrose (34 mg), and Water for Injection, USP. Each 10 mg/0.2 mL prefilled syringe delivers 0.2 mL (10 mg) of drug product. Each 0.2 mL of ABRILADA contains adalimumab-afzb (10 mg), edetate disodium dihydrate (0.01 mg), L-histidine (0.157 mg), L-histidine hydrochloride monohydrate (0.626 mg), L-methionine (0.04 mg), polysorbate 80 (0.04 mg), sucrose (17 mg), and Water for Injection, USP.</Description>
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<IndicationAndUsage>ABRILADA is a tumor necrosis factor (TNF) blocker indicated for: 1 Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1), 2 Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2), 3 Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3), 4 Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4), 5 Treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. (1.5), 6 Treatment of moderately to severely active ulcerative colitis in adult patients. (1.6)Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. , 7 Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. (1.7), 8 Treatment of moderate to severe hidradenitis suppurativa in adult patients. (1.8), 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adult patients. (1.9).</IndicationAndUsage>
<Description>Adalimumab-afzb is a tumor necrosis factor (TNF) blocker. Adalimumab-afzb is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-afzb is produced by recombinant DNA technology in Chinese hamster ovary cells and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. ABRILADA (adalimumab-afzb) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose prefilled pen (ABRILADA pen), as a single-dose 1 mL prefilled glass syringe, or as a single-dose institutional use vial. Enclosed within the pen is a single-dose 1 mL prefilled glass syringe. The solution of ABRILADA is clear and colorless to very light brown, with a pH of about 5.5. Each 40 mg/0.8 mL prefilled syringe, prefilled pen, or single-dose institutional use vial delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of ABRILADA contains adalimumab-afzb (40 mg), edetate disodium dihydrate (0.04 mg), L-histidine (0.63mg), L-histidine hydrochloride monohydrate (2.51 mg), L-methionine (0.16 mg), polysorbate 80 (0.16 mg), sucrose (68 mg), and Water for Injection, USP. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of ABRILADA contains adalimumab-afzb (20 mg), edetate disodium dihydrate (0.02 mg), L-histidine (0.314 mg), L-histidine hydrochloride monohydrate (1.253 mg), L-methionine (0.08 mg), polysorbate 80 (0.08 mg), sucrose (34 mg), and Water for Injection, USP. Each 10 mg/0.2 mL prefilled syringe delivers 0.2 mL (10 mg) of drug product. Each 0.2 mL of ABRILADA contains adalimumab-afzb (10 mg), edetate disodium dihydrate (0.01 mg), L-histidine (0.157 mg), L-histidine hydrochloride monohydrate (0.626 mg), L-methionine (0.04 mg), polysorbate 80 (0.04 mg), sucrose (17 mg), and Water for Injection, USP.</Description>
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<EndMarketingDatePackage>20250731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pemetrexed for Injection is a folate analog metabolic inhibitor indicated: 1 In combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous, non-small cell lung cancer (NSCLC). (1.1), 2 As a single agent for the maintenance treatment of patients with locally advanced or metastatic, non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. (1.1), 3 As a single agent for the treatment of patients with recurrent, metastatic non-squamous, NSCLC after prior chemotherapy. (1.1), 4 Limitations of Use: Pemetrexed for Injection is not indicated for the treatment of patients with squamous cell, non-small cell lung cancer. (1.1), 5 Initial treatment, in combination with cisplatin, of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery. (1.2).</IndicationAndUsage>
<Description>Pemetrexed is a folate analog metabolic inhibitor. The drug substance, pemetrexed ditromethamine, has the chemical name L-glutamic acid, N-[4-[2-(2-amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3-d] pyrimidin-5-yl)ethyl]benzoyl]-, ditromethamine dihydrate with a molecular formula of C28H47N7O14 and a molecular weight of 705.68. The structural formula is as follows. Pemetrexed for Injection is a sterile white-to-light yellow or green-yellow lyophilized powder in single-dose vials to be reconstituted for intravenous infusion. Each 100-mg vial of Pemetrexed for Injection contains 100 mg pemetrexed (equivalent to 157 mg pemetrexed ditromethamine) and 106 mg mannitol. Each 500-mg vial of Pemetrexed for Injection contains 500 mg pemetrexed (equivalent to 783 mg pemetrexed ditromethamine) and 500 mg mannitol. Each 1-gram vial of Pemetrexed for Injection contains 1 gram pemetrexed (equivalent to 1.57 gram pemetrexed ditromethamine) and 1 gram mannitol.</Description>
</NDC>
<NDC>
<NDCCode>0517-0960-01</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (0517-0960-01) > 10 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>00517-0960-01</NDC11Code>
<ProductNDC>0517-0960</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tranexamic Acid</ProprietaryName>
<NonProprietaryName>Tranexamic Acid</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20111115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201885</ApplicationNumber>
<LabelerName>American Regent, Inc.</LabelerName>
<SubstanceName>TRANEXAMIC ACID</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tranexamic acid injection, USP is indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.</IndicationAndUsage>
<Description>Tranexamic acid is trans-4-(aminomethyl)cyclohexanecarboxylic acid, an antifibrinolytic agent. Tranexamic acid is a white crystalline powder. The structural formula is. Empirical Formula: C8H15NO2 Molecular Weight: 157.2. Each mL of the sterile solution for intravenous injection contains 100 mg tranexamic acid and Water for Injection to 1 mL. The aqueous solution for injection has a pH of 6.5 to 8.0.</Description>
</NDC>
<NDC>
<NDCCode>0517-0960-10</NDCCode>
<PackageDescription>10 VIAL, GLASS in 1 CARTON (0517-0960-10) > 10 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>00517-0960-10</NDC11Code>
<ProductNDC>0517-0960</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tranexamic Acid</ProprietaryName>
<NonProprietaryName>Tranexamic Acid</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20111115</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA201885</ApplicationNumber>
<LabelerName>American Regent, Inc.</LabelerName>
<SubstanceName>TRANEXAMIC ACID</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20111115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tranexamic acid injection, USP is indicated in patients with hemophilia for short-term use (2 to 8 days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.</IndicationAndUsage>
<Description>Tranexamic acid is trans-4-(aminomethyl)cyclohexanecarboxylic acid, an antifibrinolytic agent. Tranexamic acid is a white crystalline powder. The structural formula is. Empirical Formula: C8H15NO2 Molecular Weight: 157.2. Each mL of the sterile solution for intravenous injection contains 100 mg tranexamic acid and Water for Injection to 1 mL. The aqueous solution for injection has a pH of 6.5 to 8.0.</Description>
</NDC>
<NDC>
<NDCCode>11788-157-60</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (11788-157-60) </PackageDescription>
<NDC11Code>11788-0157-60</NDC11Code>
<ProductNDC>11788-157</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ticagrelor</ProprietaryName>
<NonProprietaryName>Ticagrelor</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260610</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA219006</ApplicationNumber>
<LabelerName>AiPing Pharmaceutical, Inc</LabelerName>
<SubstanceName>TICAGRELOR</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 3A4 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P-Glycoprotein Inhibitors [MoA], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260610</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Ticagrelor tablets contains ticagrelor, a cyclopentyltriazolopyrimidine, inhibitor of platelet activation and aggregation mediated by the P2Y12 ADP-receptor. Chemically it is (1S,2S,3R,5S)-3-[7-{[(1R,2S)-2-(3,4-difluorophenyl)cyclopropyl]amino}-5-(propylthio)-3H-[1,2,3]-triazolo[4,5-d]pyrimidin-3-yl]-5-(2-hydroxyethoxy)cyclopentane-1,2-diol. The empirical formula of ticagrelor is C23H28F2N6O4S and its molecular weight is 522.57. The chemical structure of ticagrelor is. Ticagrelor is a crystalline powder with an aqueous solubility of approximately 10 μg/mL at room temperature. Ticagrelor 90 mg tablets for oral administration contain 90 mg of ticagrelor and the following ingredients: mannitol, dibasic calcium phosphate dihydrate, croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, hypromellose, calcium carbonate, talc, polyethylene glycol 6000, ferric oxide red, and ferric oxide yellow. Ticagrelor 60 mg tablets for oral administration contain 60 mg of ticagrelor and the following ingredients: mannitol, dibasic calcium phosphate dihydrate, croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate, hypromellose, calcium carbonate, talc, polyethylene glycol 6000, and ferric oxide red.</Description>
</NDC>
<NDC>
<NDCCode>14789-115-05</NDCCode>
<PackageDescription>10 BAG in 1 CARTON (14789-115-05) / 100 mL in 1 BAG (14789-115-08) </PackageDescription>
<NDC11Code>14789-0115-05</NDC11Code>
<ProductNDC>14789-115</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tranexamic Acid</ProprietaryName>
<NonProprietaryName>Tranexamic Acid</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20240625</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216877</ApplicationNumber>
<LabelerName>Nexus Pharmaceuticals LLC</LabelerName>
<SubstanceName>TRANEXAMIC ACID</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240625</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tranexamic Acid in Sodium Chloride Injection is indicated in patients with hemophilia for short-term use (two to eight days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.</IndicationAndUsage>
<Description>Tranexamic acid is trans-4-(aminomethyl)cyclohexanecarboxylic acid, an antifibrinolytic agent. Tranexamic acid is a white crystalline powder. The structural formula is. Empirical Formula: C 8H 15NO 2 Molecular Weight: 157.2. Tranexamic Acid in Sodium Chloride Injection is a clear to colorless sterile, nonpyrogenic injectable solution for intravenous administration. Each IV bag contains 1,000 mg tranexamic acid, USP, 700 mg of sodium chloride, USP and Water for Injection, USP. The aqueous solution has a pH of 6.5 to 8.0.</Description>
</NDC>
<NDC>
<NDCCode>14789-115-08</NDCCode>
<PackageDescription>100 mL in 1 BAG (14789-115-08) </PackageDescription>
<NDC11Code>14789-0115-08</NDC11Code>
<ProductNDC>14789-115</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tranexamic Acid</ProprietaryName>
<NonProprietaryName>Tranexamic Acid</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20240625</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216877</ApplicationNumber>
<LabelerName>Nexus Pharmaceuticals LLC</LabelerName>
<SubstanceName>TRANEXAMIC ACID</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-02-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240625</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tranexamic Acid in Sodium Chloride Injection is indicated in patients with hemophilia for short-term use (two to eight days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.</IndicationAndUsage>
<Description>Tranexamic acid is trans-4-(aminomethyl)cyclohexanecarboxylic acid, an antifibrinolytic agent. Tranexamic acid is a white crystalline powder. The structural formula is. Empirical Formula: C8H15NO2 Molecular Weight: 157.2. Tranexamic Acid in Sodium Chloride Injection is a clear to colorless sterile, nonpyrogenic injectable solution for intravenous administration. Each IV bag contains 1,000 mg tranexamic acid, USP, 700 mg of sodium chloride, USP and Water for Injection, USP. The aqueous solution has a pH of 6.5 to 8.0.</Description>
</NDC>
</NDCList>