{
"NDC": [
{
"NDCCode": "62211-196-00",
"PackageDescription": "12500 TABLET, CHEWABLE in 1 BOX (62211-196-00) ",
"NDC11Code": "62211-0196-00",
"ProductNDC": "62211-196",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "D-cal Kids",
"NonProprietaryName": "Calcium Carbonate",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "19970917",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part331",
"LabelerName": "A&Z Pharmaceutical, Inc.",
"SubstanceName": "CALCIUM CARBONATE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-03-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "19970917",
"SamplePackage": "N"
},
{
"NDCCode": "62211-196-30",
"PackageDescription": "30 TABLET, CHEWABLE in 1 BOTTLE (62211-196-30) ",
"NDC11Code": "62211-0196-30",
"ProductNDC": "62211-196",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "D-cal Kids",
"NonProprietaryName": "Calcium Carbonate",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "19970917",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part331",
"LabelerName": "A&Z Pharmaceutical, Inc.",
"SubstanceName": "CALCIUM CARBONATE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "19970917",
"SamplePackage": "N",
"IndicationAndUsage": "Relieves : 1 heartburn , 2 acid indigestion , 3 sour stomach , 4 upset stomach due to these symptoms."
},
{
"NDCCode": "62211-196-99",
"PackageDescription": "12500 TABLET, CHEWABLE in 1 CARTON (62211-196-99)",
"NDC11Code": "62211-0196-99",
"ProductNDC": "62211-196",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Calcium Carbonate",
"DosageFormName": "TABLET, CHEWABLE",
"StartMarketingDate": "19970917",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "A&Z Pharmaceutical, Inc.",
"SubstanceName": "CALCIUM CARBONATE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "62211-166-00",
"PackageDescription": "12500 TABLET, CHEWABLE in 1 BOX (62211-166-00) ",
"NDC11Code": "62211-0166-00",
"ProductNDC": "62211-166",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "D-cal",
"NonProprietaryName": "Calcium Carbonate",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "19970917",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part331",
"LabelerName": "A&Z Pharmaceutical Inc.",
"SubstanceName": "CALCIUM CARBONATE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-03-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "19970917",
"SamplePackage": "N"
},
{
"NDCCode": "62211-240-00",
"PackageDescription": "12500 TABLET, CHEWABLE in 1 BOX (62211-240-00)",
"NDC11Code": "62211-0240-00",
"ProductNDC": "62211-240",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Calcium Carbonate",
"DosageFormName": "TABLET, CHEWABLE",
"StartMarketingDate": "19970917",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "A&Z Pharmaceutical Inc.",
"SubstanceName": "CALCIUM CARBONATE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "62211-241-00",
"PackageDescription": "12500 TABLET, CHEWABLE in 1 BOX (62211-241-00)",
"NDC11Code": "62211-0241-00",
"ProductNDC": "62211-241",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Calcium Carbonate",
"DosageFormName": "TABLET, CHEWABLE",
"StartMarketingDate": "19970917",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "A&Z Pharmaceutical, Inc.",
"SubstanceName": "CALCIUM CARBONATE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "50988-196-00",
"PackageDescription": "50.275 mL in 1 BOTTLE, PUMP (50988-196-00)",
"NDC11Code": "50988-0196-00",
"ProductNDC": "50988-196",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antibacterial Foaming Hand Sanitizer",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100803",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Jets, Sets, & Elephants Beauty Corp.",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".055",
"StrengthUnit": "mL/50.275mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "to decrease bacteria on the skin and clean hands. recommended for repeated use."
},
{
"NDCCode": "52584-196-00",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 BAG (52584-196-00) > 2 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "52584-0196-00",
"ProductNDC": "52584-196",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Thiamine Hydrochloride",
"NonProprietaryName": "Thiamine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20130821",
"EndMarketingDate": "20230831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091623",
"LabelerName": "General Injectables & Vaccines, Inc",
"SubstanceName": "THIAMINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2023-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20130821",
"EndMarketingDatePackage": "20230831",
"SamplePackage": "N"
},
{
"NDCCode": "52817-196-00",
"PackageDescription": "1000 TABLET, COATED in 1 BOTTLE (52817-196-00) ",
"NDC11Code": "52817-0196-00",
"ProductNDC": "52817-196",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tramadol Hydrochloride",
"NonProprietaryName": "Tramadol Hydrochloride",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200224",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208708",
"LabelerName": "TRUPHARMA LLC",
"SubstanceName": "TRAMADOL HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2021-02-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200224",
"SamplePackage": "N",
"IndicationAndUsage": "Tramadol hydrochloride tablets, USP are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)] , reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: : 1 Have not been tolerated or are not expected to be tolerated., 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.",
"Description": "Tramadol Hydrochloride Tablets, USP for oral use, are an opioid agonist. The chemical name for tramadol hydrochloride is (±) cis-2-[(dimethylamino) methyl]-1-(3- methoxyphenyl) cyclohexanol hydrochloride. The structural formula is:. The molecular weight of tramadol hydrochloride is 299.8. Tramadol hydrochloride is a white crystalline powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol Hydrochloride Tablets ,USP 50 mg and Tramadol Hydrochloride Tablets ,USP 100 mg contains 50 mg and 100 mg of tramadol hydrochloride respectively and are white in color. Inactive ingredients in the tablet are hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch,sodium starch glycolate and titanium dioxide."
},
{
"NDCCode": "67457-196-02",
"PackageDescription": "25 VIAL, MULTI-DOSE in 1 CARTON (67457-196-02) > 2 mL in 1 VIAL, MULTI-DOSE (67457-196-00) ",
"NDC11Code": "67457-0196-02",
"ProductNDC": "67457-196",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Thiamine Hydrochloride",
"NonProprietaryName": "Thiamine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20130604",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091623",
"LabelerName": "Mylan Institutional LLC",
"SubstanceName": "THIAMINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2021-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20130604",
"SamplePackage": "N",
"IndicationAndUsage": "Thiamine hydrochloride injection is effective for the treatment of thiamine deficiency or beriberi whether of the dry (major symptoms related to the nervous system) or wet (major symptoms related to the cardiovascular system) variety. Thiamine hydrochloride injection should be used where rapid restoration of thiamine is necessary, as in Wernicke’s encephalopathy, infantile beriberi with acute collapse, cardiovascular disease due to thiamine deficiency, or neuritis of pregnancy if vomiting is severe. It is also indicated when giving IV dextrose to individuals with marginal thiamine status to avoid precipitation of heart failure. Thiamine hydrochloride injection is also indicated in patients with established thiamine deficiency who cannot take thiamine orally due to coexisting severe anorexia, nausea, vomiting, or malabsorption. Thiamine hydrochloride injection is not usually indicated for conditions of decreased oral intake or decreased gastrointestinal absorption, because multiple vitamins should usually be given.",
"Description": "Thiamine hydrochloride injection, USP is a sterile solution of thiamine hydrochloride in Water for Injection for intramuscular (IM) or slow intravenous (IV) administration. Each mL contains: Thiamine hydrochloride 100 mg; monothioglycerol 0.5%; Water for Injection q.s. Sodium hydroxide may have been added for pH adjustment (2.5 to 4.5). Thiamine hydrochloride, or vitamin B1, occurs as white crystals or crystalline powder that usually has a slight characteristic odor. Freely soluble in water; soluble in glycerin; slightly soluble in alcohol; insoluble in ether and benzene. Thiamine is rapidly destroyed in neutral or alkaline solutions but is stable in the dry state. It is reasonably stable to heat in acid solution. The chemical name of thiamine hydrochloride is thiazolium,3-[(4-amino-2-methyl-5-pyrimidinyl)methyl]-5-(2-hydroxyethyl)-4-methylchloride, monohydrochloride and it has the following structural formula."
},
{
"NDCCode": "68001-196-00",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (68001-196-00) ",
"NDC11Code": "68001-0196-00",
"ProductNDC": "68001-196",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Escitalopram",
"NonProprietaryName": "Escitalopram Oxalate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140206",
"EndMarketingDate": "20240131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202280",
"LabelerName": "BluePoint Laboratories",
"SubstanceName": "ESCITALOPRAM OXALATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-02-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20140206",
"EndMarketingDatePackage": "20240131",
"SamplePackage": "N",
"IndicationAndUsage": "Escitalopram is a selective serotonin reuptake inhibitor (SSRI) indicated for: 1 Acute and Maintenance Treatment of Major Depressive Disorder (MDD) in adults and adolescents aged 12 -17 years ( 1.1) , 2 Acute Treatment of Generalized Anxiety Disorder (GAD) in adults ( 1.2) .",
"Description": "Escitalopram tablets, USP contains escitalopram oxalate an orally administered selective serotonin reuptake inhibitor (SSRI). Escitalopram is the pure S-enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram. Escitalopram oxalate is designated S-(+)-1-[3-(dimethyl-amino) propyl]-1-( p-fluorophenyl)-5-phthalancarbonitrile oxalate with the following structural formula:. The molecular formula is C 20H 21FN 2O C 2H 2O 4 and the molecular weight is 414.43. Escitalopram oxalate, USP occurs as white to almost white crystalline powder and is soluble in methanol. Escitalopram tablets, USP are film-coated, containing escitalopram oxalate, USP in strengths equivalent to 5 mg, 10 mg, and 20 mg, respectively of escitalopram base. The 10 and 20 mg tablets are scored. The tablets also contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and talc. The film coating contains polyethylene glycol, hypromellose, and titanium dioxide."
},
{
"NDCCode": "68016-196-00",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (68016-196-00) > 30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC",
"NDC11Code": "68016-0196-00",
"ProductNDC": "68016-196",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Premier Value Childrens Acetaminophen Melts",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20041206",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "Chain Drug Consortium",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to: the common cold headache flu sore throat toothache. temporarily reduces fever."
},
{
"NDCCode": "76339-196-00",
"PackageDescription": "1 BAG in 1 DRUM (76339-196-00) / 1 BAG in 1 BAG / .999 kg in 1 BAG",
"NDC11Code": "76339-0196-00",
"ProductNDC": "76339-196",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Sevelamer Hydrochloride",
"DosageFormName": "POWDER",
"StartMarketingDate": "20231124",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Apothecon Pharmaceuticals Pvt Ltd",
"SubstanceName": "SEVELAMER HYDROCHLORIDE",
"StrengthNumber": "24.999",
"StrengthUnit": "kg/24.999kg",
"Status": "Unfinished",
"LastUpdate": "2023-12-01",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "24-NOV-23"
},
{
"NDCCode": "0832-0510-00",
"PackageDescription": "100 TABLET in 1 BOTTLE (0832-0510-00) ",
"NDC11Code": "00832-0510-00",
"ProductNDC": "0832-0510",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bethanechol Chloride",
"NonProprietaryName": "Bethanechol Chloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100124",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040633",
"LabelerName": "Upsher-Smith Laboratories, LLC",
"SubstanceName": "BETHANECHOL CHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Agonist [EPC], Cholinergic Muscarinic Agonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100124",
"SamplePackage": "N",
"IndicationAndUsage": "Bethanechol chloride tablets are indicated for the treatment of acute postoperative and postpartum nonobstructive (functional) urinary retention and for neurogenic atony of the urinary bladder with retention.",
"Description": "Bethanechol chloride, USP, a cholinergic agent, is a synthetic ester which is structurally and pharmacologically related to acetylcholine. It is designated chemically as 2-[(aminocarbonyl)oxy]- N, N, N-trimethyl-1-propanaminium chloride. Its molecular formula is C 7H 17ClN 2O 2and its structural formula is:. It is a white, hygroscopic crystalline powder having a slight amine-like odor, freely soluble in water, and has a molecular weight of 196.68. Each tablet for oral administration contains 5 mg, 10 mg, 25 mg or 50 mg bethanechol chloride, USP. Tablets also contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, (25 mg and 50 mg) D&C Yellow #10 Lake and FD&C Yellow #6 Lake."
},
{
"NDCCode": "0832-0511-00",
"PackageDescription": "100 TABLET in 1 BOTTLE (0832-0511-00) ",
"NDC11Code": "00832-0511-00",
"ProductNDC": "0832-0511",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bethanechol Chloride",
"NonProprietaryName": "Bethanechol Chloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100124",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040634",
"LabelerName": "Upsher-Smith Laboratories, LLC",
"SubstanceName": "BETHANECHOL CHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Agonist [EPC], Cholinergic Muscarinic Agonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100124",
"SamplePackage": "N",
"IndicationAndUsage": "Bethanechol chloride tablets are indicated for the treatment of acute postoperative and postpartum nonobstructive (functional) urinary retention and for neurogenic atony of the urinary bladder with retention.",
"Description": "Bethanechol chloride, USP, a cholinergic agent, is a synthetic ester which is structurally and pharmacologically related to acetylcholine. It is designated chemically as 2-[(aminocarbonyl)oxy]- N, N, N-trimethyl-1-propanaminium chloride. Its molecular formula is C 7H 17ClN 2O 2and its structural formula is:. It is a white, hygroscopic crystalline powder having a slight amine-like odor, freely soluble in water, and has a molecular weight of 196.68. Each tablet for oral administration contains 5 mg, 10 mg, 25 mg or 50 mg bethanechol chloride, USP. Tablets also contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, (25 mg and 50 mg) D&C Yellow #10 Lake and FD&C Yellow #6 Lake."
},
{
"NDCCode": "0832-0512-00",
"PackageDescription": "100 TABLET in 1 BOTTLE (0832-0512-00) ",
"NDC11Code": "00832-0512-00",
"ProductNDC": "0832-0512",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bethanechol Chloride",
"NonProprietaryName": "Bethanechol Chloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100124",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040635",
"LabelerName": "Upsher-Smith Laboratories, LLC",
"SubstanceName": "BETHANECHOL CHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Agonist [EPC], Cholinergic Muscarinic Agonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100124",
"SamplePackage": "N",
"IndicationAndUsage": "Bethanechol chloride tablets are indicated for the treatment of acute postoperative and postpartum nonobstructive (functional) urinary retention and for neurogenic atony of the urinary bladder with retention.",
"Description": "Bethanechol chloride, USP, a cholinergic agent, is a synthetic ester which is structurally and pharmacologically related to acetylcholine. It is designated chemically as 2-[(aminocarbonyl)oxy]- N, N, N-trimethyl-1-propanaminium chloride. Its molecular formula is C 7H 17ClN 2O 2and its structural formula is:. It is a white, hygroscopic crystalline powder having a slight amine-like odor, freely soluble in water, and has a molecular weight of 196.68. Each tablet for oral administration contains 5 mg, 10 mg, 25 mg or 50 mg bethanechol chloride, USP. Tablets also contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, (25 mg and 50 mg) D&C Yellow #10 Lake and FD&C Yellow #6 Lake."
},
{
"NDCCode": "0832-0513-00",
"PackageDescription": "100 TABLET in 1 BOTTLE (0832-0513-00) ",
"NDC11Code": "00832-0513-00",
"ProductNDC": "0832-0513",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bethanechol Chloride",
"NonProprietaryName": "Bethanechol Chloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100124",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040636",
"LabelerName": "Upsher-Smith Laboratories, LLC",
"SubstanceName": "BETHANECHOL CHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinergic Muscarinic Agonist [EPC], Cholinergic Muscarinic Agonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100124",
"SamplePackage": "N",
"IndicationAndUsage": "Bethanechol chloride tablets are indicated for the treatment of acute postoperative and postpartum nonobstructive (functional) urinary retention and for neurogenic atony of the urinary bladder with retention.",
"Description": "Bethanechol chloride, USP, a cholinergic agent, is a synthetic ester which is structurally and pharmacologically related to acetylcholine. It is designated chemically as 2-[(aminocarbonyl)oxy]- N, N, N-trimethyl-1-propanaminium chloride. Its molecular formula is C 7H 17ClN 2O 2and its structural formula is:. It is a white, hygroscopic crystalline powder having a slight amine-like odor, freely soluble in water, and has a molecular weight of 196.68. Each tablet for oral administration contains 5 mg, 10 mg, 25 mg or 50 mg bethanechol chloride, USP. Tablets also contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, (25 mg and 50 mg) D&C Yellow #10 Lake and FD&C Yellow #6 Lake."
},
{
"NDCCode": "10875-4432-0",
"PackageDescription": "196 kg in 1 PAIL (10875-4432-0)",
"NDC11Code": "10875-4432-00",
"ProductNDC": "10875-4432",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Mineral Oil",
"DosageFormName": "LIQUID",
"StartMarketingDate": "20140626",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Calumet Karns City Refining LLC",
"SubstanceName": "MINERAL OIL",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "50090-0137-0",
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"Description": "HydrALAZINE hydrochloride, USP, is an antihypertensive, for oral administration. Its chemical name is 1 -hydrazinophthalazine monohydrochloride, and its structural formula is. C8H8N4.HCl HydrALAZINE hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275oC, with decomposition, and has a molecular weight of 196.64. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg or 100 mg hydrALAZINE hydrochloride, USP. Tablets also contain anhydrous lactose, microcrystalline cellulose, sodium starch glycolate, stearic acid and FD&C Yellow # 6."
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{
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"Description": "HydrALAZINE hydrochloride, USP, is an antihypertensive, for oral administration. Its chemical name is 1 -hydrazinophthalazine monohydrochloride, and its structural formula is. C8H8N4.HCl HydrALAZINE hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275oC, with decomposition, and has a molecular weight of 196.64. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg or 100 mg hydrALAZINE hydrochloride, USP. Tablets also contain anhydrous lactose, microcrystalline cellulose, sodium starch glycolate, stearic acid and FD&C Yellow # 6."
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{
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"Description": "HydrALAZINE hydrochloride, USP, is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. HydrALAZINE hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition, and has a molecular weight of 196.64. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg, or 100 mg hydrALAZINE hydrochloride, USP. Tablets also contain FD&C Red #40/Allura Red AC Aluminum Lake, hypromellose, lactose anhydrous, light mineral oil, microcrystalline cellulose, magnesium stearate, pregelatinized starch, sodium lauryl sulfate, and titanium dioxide."
},
{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"LabelerName": "A-S Medication Solutions",
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"Description": "Hydralazine Hydrochloride Tablets USP is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. C8H8N4·HCl M.W. 196.64. Hydralazine hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg or 100 mg hydralazine hydrochloride, USP. Tablets also contain anhydrous lactose, FD&C yellow no. 6 aluminum lake, microcrystalline cellulose, sodium starch glycolate, and stearic acid."
},
{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"LabelerName": "A-S Medication Solutions",
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"IndicationAndUsage": "Essential hypertension, alone or as an adjunct.",
"Description": "HydrALAZINE hydrochloride, USP, is an antihypertensive, for oral administration. Its chemical name is 1 -hydrazinophthalazine monohydrochloride, and its structural formula is. HydrALAZINE hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275 oC, with decomposition, and has a molecular weight of 196.64. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg or 100 mg hydrALAZINE hydrochloride, USP. Tablets also contain anhydrous lactose, microcrystalline cellulose, sodium starch glycolate, stearic acid and FD&C Yellow # 6."
},
{
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"PackageDescription": "2 SYRINGE in 1 CARTON (50090-6704-0) / .4 mL in 1 SYRINGE",
"NDC11Code": "50090-6704-00",
"ProductNDC": "50090-6704",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hadlima",
"NonProprietaryName": "Adalimumab-bwwd",
"DosageFormName": "SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20230701",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761059",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "ADALIMUMAB",
"StrengthNumber": "40",
"StrengthUnit": "mg/.4mL",
"Pharm_Classes": "Antibodies, Monoclonal [CS], Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-11-04",
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"StartMarketingDatePackage": "20230926",
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"IndicationAndUsage": "HADLIMA 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-bwwd is a tumor necrosis factor blocker. Adalimumab-bwwd is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-bwwd is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system 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. HADLIMA (adalimumab-bwwd) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled autoinjector (HADLIMA PushTouch) or as a single-dose, 1 mL prefilled glass syringe or as a single-dose institutional use vial. Enclosed within the autoinjector is a single-dose, 1 mL prefilled glass syringe. The solution of HADLIMA is clear to opalescent, and colorless to pale brown, with a pH of about 5.2. Each 40 mg/0.8 mL prefilled syringe, autoinjector, or single-dose institutional use vial delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of HADLIMA contains adalimumab-bwwd (40 mg), citric acid monohydrate (0.544 mg), L‑histidine (0.96 mg), L‑histidine hydrochloride monohydrate (8.64 mg), polysorbate 20 (0.64 mg), sodium citrate dihydrate (1.6 mg), sorbitol (20 mg), and Water for Injection, USP. Each 40 mg/0.4 mL prefilled syringe or autoinjector delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of HADLIMA contains adalimumab-bwwd (40 mg), L‑histidine (0.376 mg), L‑histidine hydrochloride monohydrate (4.436 mg), mannitol (12.00 mg), polysorbate 20 (0.32 mg), sodium phosphate dibasic heptahydrate (0.008 mg), sodium phosphate monobasic monohydrate (0.14 mg), sodium succinate dibasic (0.196 mg), succinic acid (0.096 mg), and Water for Injection, USP."
},
{
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"PackageDescription": "1 SYRINGE in 1 CARTON (50090-6705-0) / .8 mL in 1 SYRINGE",
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"ProductNDC": "50090-6705",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hadlima",
"NonProprietaryName": "Adalimumab-bwwd",
"DosageFormName": "SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20230701",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761059",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "ADALIMUMAB",
"StrengthNumber": "40",
"StrengthUnit": "mg/.8mL",
"Pharm_Classes": "Antibodies, Monoclonal [CS], Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]",
"Status": "Active",
"LastUpdate": "2023-11-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230927",
"SamplePackage": "N",
"IndicationAndUsage": "HADLIMA 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-bwwd is a tumor necrosis factor blocker. Adalimumab-bwwd is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-bwwd is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system 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. HADLIMA (adalimumab-bwwd) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled autoinjector (HADLIMA PushTouch) or as a single-dose, 1 mL prefilled glass syringe or as a single-dose institutional use vial. Enclosed within the autoinjector is a single-dose, 1 mL prefilled glass syringe. The solution of HADLIMA is clear to opalescent, and colorless to pale brown, with a pH of about 5.2. Each 40 mg/0.8 mL prefilled syringe, autoinjector, or single-dose institutional use vial delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of HADLIMA contains adalimumab-bwwd (40 mg), citric acid monohydrate (0.544 mg), L‑histidine (0.96 mg), L‑histidine hydrochloride monohydrate (8.64 mg), polysorbate 20 (0.64 mg), sodium citrate dihydrate (1.6 mg), sorbitol (20 mg), and Water for Injection, USP. Each 40 mg/0.4 mL prefilled syringe or autoinjector delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of HADLIMA contains adalimumab-bwwd (40 mg), L‑histidine (0.376 mg), L‑histidine hydrochloride monohydrate (4.436 mg), mannitol (12.00 mg), polysorbate 20 (0.32 mg), sodium phosphate dibasic heptahydrate (0.008 mg), sodium phosphate monobasic monohydrate (0.14 mg), sodium succinate dibasic (0.196 mg), succinic acid (0.096 mg), and Water for Injection, USP."
},
{
"NDCCode": "50090-6706-0",
"PackageDescription": "2 CARTON in 1 CARTON (50090-6706-0) / 1 mL in 1 CARTON",
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"ProductNDC": "50090-6706",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hadlima",
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"DosageFormName": "SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20230701",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761059",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "ADALIMUMAB",
"StrengthNumber": "40",
"StrengthUnit": "mg/.8mL",
"Pharm_Classes": "Antibodies, Monoclonal [CS], Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]",
"Status": "Active",
"LastUpdate": "2023-10-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230927",
"SamplePackage": "N",
"IndicationAndUsage": "HADLIMA 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-bwwd is a tumor necrosis factor blocker. Adalimumab-bwwd is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-bwwd is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system 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. HADLIMA (adalimumab-bwwd) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled autoinjector (HADLIMA PushTouch) or as a single-dose, 1 mL prefilled glass syringe or as a single-dose institutional use vial. Enclosed within the autoinjector is a single-dose, 1 mL prefilled glass syringe. The solution of HADLIMA is clear to opalescent, and colorless to pale brown, with a pH of about 5.2. Each 40 mg/0.8 mL prefilled syringe, autoinjector, or single-dose institutional use vial delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of HADLIMA contains adalimumab-bwwd (40 mg), citric acid monohydrate (0.544 mg), L‑histidine (0.96 mg), L‑histidine hydrochloride monohydrate (8.64 mg), polysorbate 20 (0.64 mg), sodium citrate dihydrate (1.6 mg), sorbitol (20 mg), and Water for Injection, USP. Each 40 mg/0.4 mL prefilled syringe or autoinjector delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of HADLIMA contains adalimumab-bwwd (40 mg), L‑histidine (0.376 mg), L‑histidine hydrochloride monohydrate (4.436 mg), mannitol (12.00 mg), polysorbate 20 (0.32 mg), sodium phosphate dibasic heptahydrate (0.008 mg), sodium phosphate monobasic monohydrate (0.14 mg), sodium succinate dibasic (0.196 mg), succinic acid (0.096 mg), and Water for Injection, USP."
},
{
"NDCCode": "50090-6707-0",
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"NDC11Code": "50090-6707-00",
"ProductNDC": "50090-6707",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hadlima",
"NonProprietaryName": "Adalimumab-bwwd",
"DosageFormName": "SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20230701",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761059",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "ADALIMUMAB",
"StrengthNumber": "40",
"StrengthUnit": "mg/.4mL",
"Pharm_Classes": "Antibodies, Monoclonal [CS], Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]",
"Status": "Active",
"LastUpdate": "2026-05-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230927",
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"IndicationAndUsage": "HADLIMA 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-bwwd is a tumor necrosis factor blocker. Adalimumab-bwwd is a recombinant human IgG1 monoclonal antibody created using phage display technology resulting in an antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-bwwd is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system 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. HADLIMA (adalimumab-bwwd) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled autoinjector (HADLIMA PushTouch) or as a single-dose, 1 mL prefilled glass syringe or as a single-dose institutional use vial. Enclosed within the autoinjector is a single-dose, 1 mL prefilled glass syringe. The solution of HADLIMA is clear to opalescent, and colorless to pale brown, with a pH of about 5.2. Each 40 mg/0.8 mL prefilled syringe, autoinjector, or single-dose institutional use vial delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of HADLIMA contains adalimumab-bwwd (40 mg), citric acid monohydrate (0.544 mg), L‑histidine (0.96 mg), L‑histidine hydrochloride monohydrate (8.64 mg), polysorbate 20 (0.64 mg), sodium citrate dihydrate (1.6 mg), sorbitol (20 mg), and Water for Injection, USP. Each 40 mg/0.4 mL prefilled syringe or autoinjector delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of HADLIMA contains adalimumab-bwwd (40 mg), L‑histidine (0.376 mg), L‑histidine hydrochloride monohydrate (4.436 mg), mannitol (12.00 mg), polysorbate 20 (0.32 mg), sodium phosphate dibasic heptahydrate (0.008 mg), sodium phosphate monobasic monohydrate (0.14 mg), sodium succinate dibasic (0.196 mg), succinic acid (0.096 mg), and Water for Injection, USP."
},
{
"NDCCode": "50090-7212-0",
"PackageDescription": "90 TABLET in 1 BOTTLE (50090-7212-0) ",
"NDC11Code": "50090-7212-00",
"ProductNDC": "50090-7212",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydralazine Hydrochloride",
"NonProprietaryName": "Hydralazine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170526",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205236",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "HYDRALAZINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]",
"Status": "Active",
"LastUpdate": "2024-08-08",
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"IndicationAndUsage": "Essential hypertension, alone or as an adjunct.",
"Description": "Hydralazine Hydrochloride tablets USP, is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. C 8H 8N 4.HCl M.W. 196.64. Hydralazine Hydrochloride USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol. It melts at about 275°C, with decomposition. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg or 100 mg hydralazine hydrochloride, USP. Tablets also contain anhydrous lactose, FD&C yellow no. 6 aluminum lake, microcrystalline cellulose, sodium starch glycolate, and stearic acid."
},
{
"NDCCode": "54868-0536-0",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (54868-0536-0)",
"NDC11Code": "54868-0536-00",
"ProductNDC": "54868-0536",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydralazine Hydrochloride",
"NonProprietaryName": "Hydralazine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
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"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA086242",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "HYDRALAZINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
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"IndicationAndUsage": "Essential hypertension, alone or as an adjunct.",
"Description": "HydrALAZINE hydrochloride, USP, is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. HydrALAZINE hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition, and has a molecular weight of 196.64. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg, or 100 mg hydrALAZINE hydrochloride, USP. Tablets also contain FD&C Red #40/Allura Red AC Aluminum Lake, hypromellose, lactose anhydrous, light mineral oil, microcrystalline cellulose, magnesium stearate, pregelatinized starch, sodium lauryl sulfate, and titanium dioxide."
},
{
"NDCCode": "54868-1949-0",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (54868-1949-0)",
"NDC11Code": "54868-1949-00",
"ProductNDC": "54868-1949",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydralazine Hydrochloride",
"NonProprietaryName": "Hydralazine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20070917",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA086242",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "HYDRALAZINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Essential hypertension, alone or as an adjunct.",
"Description": "HydrALAZINE hydrochloride, USP, is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. HydrALAZINE hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition, and has a molecular weight of 196.64. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg, or 100 mg hydrALAZINE hydrochloride, USP. Tablets also contain FD&C Red #40/Allura Red AC Aluminum Lake, hypromellose, lactose anhydrous, light mineral oil, microcrystalline cellulose, magnesium stearate, pregelatinized starch, sodium lauryl sulfate, and titanium dioxide."
}
]
}
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<LabelerName>A&Z Pharmaceutical, Inc.</LabelerName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Relieves : 1 heartburn , 2 acid indigestion , 3 sour stomach , 4 upset stomach due to these symptoms.</IndicationAndUsage>
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<NDCCode>62211-196-99</NDCCode>
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<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>A&Z Pharmaceutical, Inc.</LabelerName>
<SubstanceName>CALCIUM CARBONATE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>62211-166-00</NDCCode>
<PackageDescription>12500 TABLET, CHEWABLE in 1 BOX (62211-166-00) </PackageDescription>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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<LabelerName>A&Z Pharmaceutical Inc.</LabelerName>
<SubstanceName>CALCIUM CARBONATE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-03-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19970917</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62211-240-00</NDCCode>
<PackageDescription>12500 TABLET, CHEWABLE in 1 BOX (62211-240-00)</PackageDescription>
<NDC11Code>62211-0240-00</NDC11Code>
<ProductNDC>62211-240</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Calcium Carbonate</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<StartMarketingDate>19970917</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>A&Z Pharmaceutical Inc.</LabelerName>
<SubstanceName>CALCIUM CARBONATE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
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<NDC>
<NDCCode>62211-241-00</NDCCode>
<PackageDescription>12500 TABLET, CHEWABLE in 1 BOX (62211-241-00)</PackageDescription>
<NDC11Code>62211-0241-00</NDC11Code>
<ProductNDC>62211-241</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Calcium Carbonate</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<StartMarketingDate>19970917</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>A&Z Pharmaceutical, Inc.</LabelerName>
<SubstanceName>CALCIUM CARBONATE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>50988-196-00</NDCCode>
<PackageDescription>50.275 mL in 1 BOTTLE, PUMP (50988-196-00)</PackageDescription>
<NDC11Code>50988-0196-00</NDC11Code>
<ProductNDC>50988-196</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antibacterial Foaming Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100803</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Jets, Sets, & Elephants Beauty Corp.</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.055</StrengthNumber>
<StrengthUnit>mL/50.275mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>to decrease bacteria on the skin and clean hands. recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>52584-196-00</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 BAG (52584-196-00) > 2 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>52584-0196-00</NDC11Code>
<ProductNDC>52584-196</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Thiamine Hydrochloride</ProprietaryName>
<NonProprietaryName>Thiamine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20130821</StartMarketingDate>
<EndMarketingDate>20230831</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091623</ApplicationNumber>
<LabelerName>General Injectables & Vaccines, Inc</LabelerName>
<SubstanceName>THIAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20130821</StartMarketingDatePackage>
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<SamplePackage>N</SamplePackage>
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<NDCCode>52817-196-00</NDCCode>
<PackageDescription>1000 TABLET, COATED in 1 BOTTLE (52817-196-00) </PackageDescription>
<NDC11Code>52817-0196-00</NDC11Code>
<ProductNDC>52817-196</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tramadol Hydrochloride</ProprietaryName>
<NonProprietaryName>Tramadol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200224</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208708</ApplicationNumber>
<LabelerName>TRUPHARMA LLC</LabelerName>
<SubstanceName>TRAMADOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2021-02-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200224</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tramadol hydrochloride tablets, USP are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use. Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)] , reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]: : 1 Have not been tolerated or are not expected to be tolerated., 2 Have not provided adequate analgesia or are not expected to provide adequate analgesia.</IndicationAndUsage>
<Description>Tramadol Hydrochloride Tablets, USP for oral use, are an opioid agonist. The chemical name for tramadol hydrochloride is (±) cis-2-[(dimethylamino) methyl]-1-(3- methoxyphenyl) cyclohexanol hydrochloride. The structural formula is:. The molecular weight of tramadol hydrochloride is 299.8. Tramadol hydrochloride is a white crystalline powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. Tramadol Hydrochloride Tablets ,USP 50 mg and Tramadol Hydrochloride Tablets ,USP 100 mg contains 50 mg and 100 mg of tramadol hydrochloride respectively and are white in color. Inactive ingredients in the tablet are hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch,sodium starch glycolate and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>67457-196-02</NDCCode>
<PackageDescription>25 VIAL, MULTI-DOSE in 1 CARTON (67457-196-02) > 2 mL in 1 VIAL, MULTI-DOSE (67457-196-00) </PackageDescription>
<NDC11Code>67457-0196-02</NDC11Code>
<ProductNDC>67457-196</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Thiamine Hydrochloride</ProprietaryName>
<NonProprietaryName>Thiamine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20130604</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091623</ApplicationNumber>
<LabelerName>Mylan Institutional LLC</LabelerName>
<SubstanceName>THIAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2021-06-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130604</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Thiamine hydrochloride injection is effective for the treatment of thiamine deficiency or beriberi whether of the dry (major symptoms related to the nervous system) or wet (major symptoms related to the cardiovascular system) variety. Thiamine hydrochloride injection should be used where rapid restoration of thiamine is necessary, as in Wernicke’s encephalopathy, infantile beriberi with acute collapse, cardiovascular disease due to thiamine deficiency, or neuritis of pregnancy if vomiting is severe. It is also indicated when giving IV dextrose to individuals with marginal thiamine status to avoid precipitation of heart failure. Thiamine hydrochloride injection is also indicated in patients with established thiamine deficiency who cannot take thiamine orally due to coexisting severe anorexia, nausea, vomiting, or malabsorption. Thiamine hydrochloride injection is not usually indicated for conditions of decreased oral intake or decreased gastrointestinal absorption, because multiple vitamins should usually be given.</IndicationAndUsage>
<Description>Thiamine hydrochloride injection, USP is a sterile solution of thiamine hydrochloride in Water for Injection for intramuscular (IM) or slow intravenous (IV) administration. Each mL contains: Thiamine hydrochloride 100 mg; monothioglycerol 0.5%; Water for Injection q.s. Sodium hydroxide may have been added for pH adjustment (2.5 to 4.5). Thiamine hydrochloride, or vitamin B1, occurs as white crystals or crystalline powder that usually has a slight characteristic odor. Freely soluble in water; soluble in glycerin; slightly soluble in alcohol; insoluble in ether and benzene. Thiamine is rapidly destroyed in neutral or alkaline solutions but is stable in the dry state. It is reasonably stable to heat in acid solution. The chemical name of thiamine hydrochloride is thiazolium,3-[(4-amino-2-methyl-5-pyrimidinyl)methyl]-5-(2-hydroxyethyl)-4-methylchloride, monohydrochloride and it has the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>68001-196-00</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (68001-196-00) </PackageDescription>
<NDC11Code>68001-0196-00</NDC11Code>
<ProductNDC>68001-196</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Escitalopram</ProprietaryName>
<NonProprietaryName>Escitalopram Oxalate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140206</StartMarketingDate>
<EndMarketingDate>20240131</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202280</ApplicationNumber>
<LabelerName>BluePoint Laboratories</LabelerName>
<SubstanceName>ESCITALOPRAM OXALATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-02-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20140206</StartMarketingDatePackage>
<EndMarketingDatePackage>20240131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Escitalopram is a selective serotonin reuptake inhibitor (SSRI) indicated for: 1 Acute and Maintenance Treatment of Major Depressive Disorder (MDD) in adults and adolescents aged 12 -17 years ( 1.1) , 2 Acute Treatment of Generalized Anxiety Disorder (GAD) in adults ( 1.2) .</IndicationAndUsage>
<Description>Escitalopram tablets, USP contains escitalopram oxalate an orally administered selective serotonin reuptake inhibitor (SSRI). Escitalopram is the pure S-enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram. Escitalopram oxalate is designated S-(+)-1-[3-(dimethyl-amino) propyl]-1-( p-fluorophenyl)-5-phthalancarbonitrile oxalate with the following structural formula:. The molecular formula is C 20H 21FN 2O C 2H 2O 4 and the molecular weight is 414.43. Escitalopram oxalate, USP occurs as white to almost white crystalline powder and is soluble in methanol. Escitalopram tablets, USP are film-coated, containing escitalopram oxalate, USP in strengths equivalent to 5 mg, 10 mg, and 20 mg, respectively of escitalopram base. The 10 and 20 mg tablets are scored. The tablets also contain the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and talc. The film coating contains polyethylene glycol, hypromellose, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>68016-196-00</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (68016-196-00) > 30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>68016-0196-00</NDC11Code>
<ProductNDC>68016-196</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Premier Value Childrens Acetaminophen Melts</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20041206</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>Chain Drug Consortium</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>temporarily relieves minor aches and pains due to: the common cold headache flu sore throat toothache. temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>76339-196-00</NDCCode>
<PackageDescription>1 BAG in 1 DRUM (76339-196-00) / 1 BAG in 1 BAG / .999 kg in 1 BAG</PackageDescription>
<NDC11Code>76339-0196-00</NDC11Code>
<ProductNDC>76339-196</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Sevelamer Hydrochloride</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20231124</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Apothecon Pharmaceuticals Pvt Ltd</LabelerName>
<SubstanceName>SEVELAMER HYDROCHLORIDE</SubstanceName>
<StrengthNumber>24.999</StrengthNumber>
<StrengthUnit>kg/24.999kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2023-12-01</LastUpdate>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>24-NOV-23</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>0832-0510-00</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0832-0510-00) </PackageDescription>
<NDC11Code>00832-0510-00</NDC11Code>
<ProductNDC>0832-0510</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bethanechol Chloride</ProprietaryName>
<NonProprietaryName>Bethanechol Chloride</NonProprietaryName>
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<RouteName>ORAL</RouteName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040633</ApplicationNumber>
<LabelerName>Upsher-Smith Laboratories, LLC</LabelerName>
<SubstanceName>BETHANECHOL CHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Muscarinic Agonist [EPC], Cholinergic Muscarinic Agonists [MoA]</Pharm_Classes>
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<LastUpdate>2025-12-24</LastUpdate>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bethanechol chloride tablets are indicated for the treatment of acute postoperative and postpartum nonobstructive (functional) urinary retention and for neurogenic atony of the urinary bladder with retention.</IndicationAndUsage>
<Description>Bethanechol chloride, USP, a cholinergic agent, is a synthetic ester which is structurally and pharmacologically related to acetylcholine. It is designated chemically as 2-[(aminocarbonyl)oxy]- N, N, N-trimethyl-1-propanaminium chloride. Its molecular formula is C 7H 17ClN 2O 2and its structural formula is:. It is a white, hygroscopic crystalline powder having a slight amine-like odor, freely soluble in water, and has a molecular weight of 196.68. Each tablet for oral administration contains 5 mg, 10 mg, 25 mg or 50 mg bethanechol chloride, USP. Tablets also contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, (25 mg and 50 mg) D&C Yellow #10 Lake and FD&C Yellow #6 Lake.</Description>
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<ProductNDC>0832-0511</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Muscarinic Agonist [EPC], Cholinergic Muscarinic Agonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-24</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bethanechol chloride tablets are indicated for the treatment of acute postoperative and postpartum nonobstructive (functional) urinary retention and for neurogenic atony of the urinary bladder with retention.</IndicationAndUsage>
<Description>Bethanechol chloride, USP, a cholinergic agent, is a synthetic ester which is structurally and pharmacologically related to acetylcholine. It is designated chemically as 2-[(aminocarbonyl)oxy]- N, N, N-trimethyl-1-propanaminium chloride. Its molecular formula is C 7H 17ClN 2O 2and its structural formula is:. It is a white, hygroscopic crystalline powder having a slight amine-like odor, freely soluble in water, and has a molecular weight of 196.68. Each tablet for oral administration contains 5 mg, 10 mg, 25 mg or 50 mg bethanechol chloride, USP. Tablets also contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, (25 mg and 50 mg) D&C Yellow #10 Lake and FD&C Yellow #6 Lake.</Description>
</NDC>
<NDC>
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<ProductNDC>0832-0512</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bethanechol Chloride</ProprietaryName>
<NonProprietaryName>Bethanechol Chloride</NonProprietaryName>
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<ApplicationNumber>ANDA040635</ApplicationNumber>
<LabelerName>Upsher-Smith Laboratories, LLC</LabelerName>
<SubstanceName>BETHANECHOL CHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Muscarinic Agonist [EPC], Cholinergic Muscarinic Agonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-24</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100124</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bethanechol chloride tablets are indicated for the treatment of acute postoperative and postpartum nonobstructive (functional) urinary retention and for neurogenic atony of the urinary bladder with retention.</IndicationAndUsage>
<Description>Bethanechol chloride, USP, a cholinergic agent, is a synthetic ester which is structurally and pharmacologically related to acetylcholine. It is designated chemically as 2-[(aminocarbonyl)oxy]- N, N, N-trimethyl-1-propanaminium chloride. Its molecular formula is C 7H 17ClN 2O 2and its structural formula is:. It is a white, hygroscopic crystalline powder having a slight amine-like odor, freely soluble in water, and has a molecular weight of 196.68. Each tablet for oral administration contains 5 mg, 10 mg, 25 mg or 50 mg bethanechol chloride, USP. Tablets also contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, (25 mg and 50 mg) D&C Yellow #10 Lake and FD&C Yellow #6 Lake.</Description>
</NDC>
<NDC>
<NDCCode>0832-0513-00</NDCCode>
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<ProductNDC>0832-0513</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bethanechol Chloride</ProprietaryName>
<NonProprietaryName>Bethanechol Chloride</NonProprietaryName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040636</ApplicationNumber>
<LabelerName>Upsher-Smith Laboratories, LLC</LabelerName>
<SubstanceName>BETHANECHOL CHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cholinergic Muscarinic Agonist [EPC], Cholinergic Muscarinic Agonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-24</LastUpdate>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100124</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bethanechol chloride tablets are indicated for the treatment of acute postoperative and postpartum nonobstructive (functional) urinary retention and for neurogenic atony of the urinary bladder with retention.</IndicationAndUsage>
<Description>Bethanechol chloride, USP, a cholinergic agent, is a synthetic ester which is structurally and pharmacologically related to acetylcholine. It is designated chemically as 2-[(aminocarbonyl)oxy]- N, N, N-trimethyl-1-propanaminium chloride. Its molecular formula is C 7H 17ClN 2O 2and its structural formula is:. It is a white, hygroscopic crystalline powder having a slight amine-like odor, freely soluble in water, and has a molecular weight of 196.68. Each tablet for oral administration contains 5 mg, 10 mg, 25 mg or 50 mg bethanechol chloride, USP. Tablets also contain the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, (25 mg and 50 mg) D&C Yellow #10 Lake and FD&C Yellow #6 Lake.</Description>
</NDC>
<NDC>
<NDCCode>10875-4432-0</NDCCode>
<PackageDescription>196 kg in 1 PAIL (10875-4432-0)</PackageDescription>
<NDC11Code>10875-4432-00</NDC11Code>
<ProductNDC>10875-4432</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Mineral Oil</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<StartMarketingDate>20140626</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Calumet Karns City Refining LLC</LabelerName>
<SubstanceName>MINERAL OIL</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>50090-0137-0</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (50090-0137-0) </PackageDescription>
<NDC11Code>50090-0137-00</NDC11Code>
<ProductNDC>50090-0137</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydralazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydralazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040901</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>HYDRALAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201012</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Essential hypertension, alone or as an adjunct.</IndicationAndUsage>
<Description>HydrALAZINE hydrochloride, USP, is an antihypertensive, for oral administration. Its chemical name is 1 -hydrazinophthalazine monohydrochloride, and its structural formula is. C8H8N4.HCl HydrALAZINE hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275oC, with decomposition, and has a molecular weight of 196.64. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg or 100 mg hydrALAZINE hydrochloride, USP. Tablets also contain anhydrous lactose, microcrystalline cellulose, sodium starch glycolate, stearic acid and FD&C Yellow # 6.</Description>
</NDC>
<NDC>
<NDCCode>50090-0139-0</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (50090-0139-0) </PackageDescription>
<NDC11Code>50090-0139-00</NDC11Code>
<ProductNDC>50090-0139</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydralazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydralazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040901</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>HYDRALAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Essential hypertension, alone or as an adjunct.</IndicationAndUsage>
<Description>HydrALAZINE hydrochloride, USP, is an antihypertensive, for oral administration. Its chemical name is 1 -hydrazinophthalazine monohydrochloride, and its structural formula is. C8H8N4.HCl HydrALAZINE hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275oC, with decomposition, and has a molecular weight of 196.64. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg or 100 mg hydrALAZINE hydrochloride, USP. Tablets also contain anhydrous lactose, microcrystalline cellulose, sodium starch glycolate, stearic acid and FD&C Yellow # 6.</Description>
</NDC>
<NDC>
<NDCCode>50090-4641-0</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (50090-4641-0) </PackageDescription>
<NDC11Code>50090-4641-00</NDC11Code>
<ProductNDC>50090-4641</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydralazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydralazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070406</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA086242</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>HYDRALAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-09-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191023</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Essential hypertension, alone or as an adjunct.</IndicationAndUsage>
<Description>HydrALAZINE hydrochloride, USP, is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. HydrALAZINE hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition, and has a molecular weight of 196.64. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg, or 100 mg hydrALAZINE hydrochloride, USP. Tablets also contain FD&C Red #40/Allura Red AC Aluminum Lake, hypromellose, lactose anhydrous, light mineral oil, microcrystalline cellulose, magnesium stearate, pregelatinized starch, sodium lauryl sulfate, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>50090-6608-0</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (50090-6608-0) </PackageDescription>
<NDC11Code>50090-6608-00</NDC11Code>
<ProductNDC>50090-6608</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydralazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydralazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19900930</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088468</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>HYDRALAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230822</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Essential hypertension, alone or as an adjunct.</IndicationAndUsage>
<Description>Hydralazine Hydrochloride Tablets USP is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. C8H8N4·HCl M.W. 196.64. Hydralazine hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg or 100 mg hydralazine hydrochloride, USP. Tablets also contain anhydrous lactose, FD&C yellow no. 6 aluminum lake, microcrystalline cellulose, sodium starch glycolate, and stearic acid.</Description>
</NDC>
<NDC>
<NDCCode>50090-6684-0</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (50090-6684-0) </PackageDescription>
<NDC11Code>50090-6684-00</NDC11Code>
<ProductNDC>50090-6684</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydralazine Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydralazine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040901</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>HYDRALAZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230914</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Essential hypertension, alone or as an adjunct.</IndicationAndUsage>
<Description>HydrALAZINE hydrochloride, USP, is an antihypertensive, for oral administration. Its chemical name is 1 -hydrazinophthalazine monohydrochloride, and its structural formula is. HydrALAZINE hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275 oC, with decomposition, and has a molecular weight of 196.64. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg or 100 mg hydrALAZINE hydrochloride, USP. Tablets also contain anhydrous lactose, microcrystalline cellulose, sodium starch glycolate, stearic acid and FD&C Yellow # 6.</Description>
</NDC>
<NDC>
<NDCCode>50090-6704-0</NDCCode>
<PackageDescription>2 SYRINGE in 1 CARTON (50090-6704-0) / .4 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>50090-6704-00</NDC11Code>
<ProductNDC>50090-6704</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hadlima</ProprietaryName>
<NonProprietaryName>Adalimumab-bwwd</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20230701</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761059</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>ADALIMUMAB</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/.4mL</StrengthUnit>
<Pharm_Classes>Antibodies, Monoclonal [CS], Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230926</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>HADLIMA 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-bwwd is a tumor necrosis factor blocker. Adalimumab-bwwd is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-bwwd is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system 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. HADLIMA (adalimumab-bwwd) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled autoinjector (HADLIMA PushTouch) or as a single-dose, 1 mL prefilled glass syringe or as a single-dose institutional use vial. Enclosed within the autoinjector is a single-dose, 1 mL prefilled glass syringe. The solution of HADLIMA is clear to opalescent, and colorless to pale brown, with a pH of about 5.2. Each 40 mg/0.8 mL prefilled syringe, autoinjector, or single-dose institutional use vial delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of HADLIMA contains adalimumab-bwwd (40 mg), citric acid monohydrate (0.544 mg), L‑histidine (0.96 mg), L‑histidine hydrochloride monohydrate (8.64 mg), polysorbate 20 (0.64 mg), sodium citrate dihydrate (1.6 mg), sorbitol (20 mg), and Water for Injection, USP. Each 40 mg/0.4 mL prefilled syringe or autoinjector delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of HADLIMA contains adalimumab-bwwd (40 mg), L‑histidine (0.376 mg), L‑histidine hydrochloride monohydrate (4.436 mg), mannitol (12.00 mg), polysorbate 20 (0.32 mg), sodium phosphate dibasic heptahydrate (0.008 mg), sodium phosphate monobasic monohydrate (0.14 mg), sodium succinate dibasic (0.196 mg), succinic acid (0.096 mg), and Water for Injection, USP.</Description>
</NDC>
<NDC>
<NDCCode>50090-6705-0</NDCCode>
<PackageDescription>1 SYRINGE in 1 CARTON (50090-6705-0) / .8 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>50090-6705-00</NDC11Code>
<ProductNDC>50090-6705</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hadlima</ProprietaryName>
<NonProprietaryName>Adalimumab-bwwd</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20230701</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761059</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>ADALIMUMAB</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/.8mL</StrengthUnit>
<Pharm_Classes>Antibodies, Monoclonal [CS], Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-11-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230927</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>HADLIMA 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-bwwd is a tumor necrosis factor blocker. Adalimumab-bwwd is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-bwwd is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system 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. HADLIMA (adalimumab-bwwd) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled autoinjector (HADLIMA PushTouch) or as a single-dose, 1 mL prefilled glass syringe or as a single-dose institutional use vial. Enclosed within the autoinjector is a single-dose, 1 mL prefilled glass syringe. The solution of HADLIMA is clear to opalescent, and colorless to pale brown, with a pH of about 5.2. Each 40 mg/0.8 mL prefilled syringe, autoinjector, or single-dose institutional use vial delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of HADLIMA contains adalimumab-bwwd (40 mg), citric acid monohydrate (0.544 mg), L‑histidine (0.96 mg), L‑histidine hydrochloride monohydrate (8.64 mg), polysorbate 20 (0.64 mg), sodium citrate dihydrate (1.6 mg), sorbitol (20 mg), and Water for Injection, USP. Each 40 mg/0.4 mL prefilled syringe or autoinjector delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of HADLIMA contains adalimumab-bwwd (40 mg), L‑histidine (0.376 mg), L‑histidine hydrochloride monohydrate (4.436 mg), mannitol (12.00 mg), polysorbate 20 (0.32 mg), sodium phosphate dibasic heptahydrate (0.008 mg), sodium phosphate monobasic monohydrate (0.14 mg), sodium succinate dibasic (0.196 mg), succinic acid (0.096 mg), and Water for Injection, USP.</Description>
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<IndicationAndUsage>HADLIMA 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-bwwd is a tumor necrosis factor blocker. Adalimumab-bwwd is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-bwwd is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system 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. HADLIMA (adalimumab-bwwd) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled autoinjector (HADLIMA PushTouch) or as a single-dose, 1 mL prefilled glass syringe or as a single-dose institutional use vial. Enclosed within the autoinjector is a single-dose, 1 mL prefilled glass syringe. The solution of HADLIMA is clear to opalescent, and colorless to pale brown, with a pH of about 5.2. Each 40 mg/0.8 mL prefilled syringe, autoinjector, or single-dose institutional use vial delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of HADLIMA contains adalimumab-bwwd (40 mg), citric acid monohydrate (0.544 mg), L‑histidine (0.96 mg), L‑histidine hydrochloride monohydrate (8.64 mg), polysorbate 20 (0.64 mg), sodium citrate dihydrate (1.6 mg), sorbitol (20 mg), and Water for Injection, USP. Each 40 mg/0.4 mL prefilled syringe or autoinjector delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of HADLIMA contains adalimumab-bwwd (40 mg), L‑histidine (0.376 mg), L‑histidine hydrochloride monohydrate (4.436 mg), mannitol (12.00 mg), polysorbate 20 (0.32 mg), sodium phosphate dibasic heptahydrate (0.008 mg), sodium phosphate monobasic monohydrate (0.14 mg), sodium succinate dibasic (0.196 mg), succinic acid (0.096 mg), and Water for Injection, USP.</Description>
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<IndicationAndUsage>HADLIMA 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-bwwd is a tumor necrosis factor blocker. Adalimumab-bwwd is a recombinant human IgG1 monoclonal antibody created using phage display technology resulting in an antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab-bwwd is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system 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. HADLIMA (adalimumab-bwwd) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled autoinjector (HADLIMA PushTouch) or as a single-dose, 1 mL prefilled glass syringe or as a single-dose institutional use vial. Enclosed within the autoinjector is a single-dose, 1 mL prefilled glass syringe. The solution of HADLIMA is clear to opalescent, and colorless to pale brown, with a pH of about 5.2. Each 40 mg/0.8 mL prefilled syringe, autoinjector, or single-dose institutional use vial delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of HADLIMA contains adalimumab-bwwd (40 mg), citric acid monohydrate (0.544 mg), L‑histidine (0.96 mg), L‑histidine hydrochloride monohydrate (8.64 mg), polysorbate 20 (0.64 mg), sodium citrate dihydrate (1.6 mg), sorbitol (20 mg), and Water for Injection, USP. Each 40 mg/0.4 mL prefilled syringe or autoinjector delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of HADLIMA contains adalimumab-bwwd (40 mg), L‑histidine (0.376 mg), L‑histidine hydrochloride monohydrate (4.436 mg), mannitol (12.00 mg), polysorbate 20 (0.32 mg), sodium phosphate dibasic heptahydrate (0.008 mg), sodium phosphate monobasic monohydrate (0.14 mg), sodium succinate dibasic (0.196 mg), succinic acid (0.096 mg), and Water for Injection, USP.</Description>
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<IndicationAndUsage>Essential hypertension, alone or as an adjunct.</IndicationAndUsage>
<Description>Hydralazine Hydrochloride tablets USP, is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. C 8H 8N 4.HCl M.W. 196.64. Hydralazine Hydrochloride USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol. It melts at about 275°C, with decomposition. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg or 100 mg hydralazine hydrochloride, USP. Tablets also contain anhydrous lactose, FD&C yellow no. 6 aluminum lake, microcrystalline cellulose, sodium starch glycolate, and stearic acid.</Description>
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<LabelerName>Physicians Total Care, Inc.</LabelerName>
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<IndicationAndUsage>Essential hypertension, alone or as an adjunct.</IndicationAndUsage>
<Description>HydrALAZINE hydrochloride, USP, is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. HydrALAZINE hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition, and has a molecular weight of 196.64. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg, or 100 mg hydrALAZINE hydrochloride, USP. Tablets also contain FD&C Red #40/Allura Red AC Aluminum Lake, hypromellose, lactose anhydrous, light mineral oil, microcrystalline cellulose, magnesium stearate, pregelatinized starch, sodium lauryl sulfate, and titanium dioxide.</Description>
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<LabelerName>Physicians Total Care, Inc.</LabelerName>
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<IndicationAndUsage>Essential hypertension, alone or as an adjunct.</IndicationAndUsage>
<Description>HydrALAZINE hydrochloride, USP, is an antihypertensive, for oral administration. Its chemical name is 1-hydrazinophthalazine monohydrochloride, and its structural formula is. HydrALAZINE hydrochloride, USP is a white to off-white, odorless crystalline powder. It is soluble in water, slightly soluble in alcohol, and very slightly soluble in ether. It melts at about 275°C, with decomposition, and has a molecular weight of 196.64. Each tablet for oral administration contains 10 mg, 25 mg, 50 mg, or 100 mg hydrALAZINE hydrochloride, USP. Tablets also contain FD&C Red #40/Allura Red AC Aluminum Lake, hypromellose, lactose anhydrous, light mineral oil, microcrystalline cellulose, magnesium stearate, pregelatinized starch, sodium lauryl sulfate, and titanium dioxide.</Description>
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