{
"NDC": [
{
"NDCCode": "0378-1667-19",
"PackageDescription": "150 CAPSULE in 1 BOTTLE, PLASTIC (0378-1667-19)",
"NDC11Code": "00378-1667-19",
"ProductNDC": "0378-1667",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tizanidine Hydrochloride",
"NonProprietaryName": "Tizanidine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20130301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091502",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "TIZANIDINE HYDROCHLORIDE",
"StrengthNumber": "6",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-01-26",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0378-1667-05",
"PackageDescription": "500 CAPSULE in 1 BOTTLE, PLASTIC (0378-1667-05)",
"NDC11Code": "00378-1667-05",
"ProductNDC": "0378-1667",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tizanidine Hydrochloride",
"NonProprietaryName": "Tizanidine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20121109",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091502",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "TIZANIDINE HYDROCHLORIDE",
"StrengthNumber": "6",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2014-07-28"
},
{
"NDCCode": "0378-0722-19",
"PackageDescription": "150 TABLET in 1 BOTTLE, PLASTIC (0378-0722-19) ",
"NDC11Code": "00378-0722-19",
"ProductNDC": "0378-0722",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tizanidine",
"NonProprietaryName": "Tizanidine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20030506",
"EndMarketingDate": "20201231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076354",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "TIZANIDINE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20030506",
"EndMarketingDatePackage": "20201231",
"SamplePackage": "N"
},
{
"NDCCode": "0378-0724-19",
"PackageDescription": "150 TABLET in 1 BOTTLE, PLASTIC (0378-0724-19) ",
"NDC11Code": "00378-0724-19",
"ProductNDC": "0378-0724",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tizanidine",
"NonProprietaryName": "Tizanidine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20030506",
"EndMarketingDate": "20210228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076354",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "TIZANIDINE HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-03-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20030506",
"EndMarketingDatePackage": "20210228",
"SamplePackage": "N"
},
{
"NDCCode": "0378-1665-19",
"PackageDescription": "150 CAPSULE in 1 BOTTLE, PLASTIC (0378-1665-19)",
"NDC11Code": "00378-1665-19",
"ProductNDC": "0378-1665",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tizanidine Hydrochloride",
"NonProprietaryName": "Tizanidine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20130301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091502",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "TIZANIDINE HYDROCHLORIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-01-26",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0378-1666-19",
"PackageDescription": "150 CAPSULE in 1 BOTTLE, PLASTIC (0378-1666-19)",
"NDC11Code": "00378-1666-19",
"ProductNDC": "0378-1666",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tizanidine Hydrochloride",
"NonProprietaryName": "Tizanidine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20130301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091502",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "TIZANIDINE HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-01-26",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "29300-378-19",
"PackageDescription": "90 TABLET in 1 BOTTLE (29300-378-19) ",
"NDC11Code": "29300-0378-19",
"ProductNDC": "29300-378",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nebivolol Hydrochloride",
"NonProprietaryName": "Nebivolol Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220404",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213830",
"LabelerName": "Unichem Pharmaceuticals (USA), Inc.",
"SubstanceName": "NEBIVOLOL HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2023-07-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220404",
"SamplePackage": "N",
"IndicationAndUsage": "Nebivolol is a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1).",
"Description": "The chemical name for the active ingredient in nebivolol tablets is (1RS,1'RS)-1,1'-[(2RS,2'SR)-bis(6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl)]-2,2'-iminodiethanol hydrochloride. Nebivolol is a racemate composed of d-Nebivolol and l-Nebivolol with the stereochemical designations of [SRRR]-nebivolol and [RSSS]-nebivolol, respectively. Nebivolol's molecular formula is (C22H25F2NO4HCl) with the following structural formula. Nebivolol hydrochloride is a white to off white powder that is sparingly soluble in methanol. Nebivolol as tablets for oral administration contains nebivolol hydrochloride equivalent to 2.5 mg, 5 mg, 10 mg, and 20 mg of nebivolol base. In addition, nebivolol tablets contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, polysorbate 80 and sodium lauryl sulfate. Additionally, the 2.5 mg and 5 mg tablets contain FD&C yellow no. 6 aluminium lake and the 10 mg tablets contain FD&C blue #2."
},
{
"NDCCode": "43742-1667-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (43742-1667-1) ",
"NDC11Code": "43742-1667-01",
"ProductNDC": "43742-1667",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bio Lymph Phase",
"NonProprietaryName": "Teucrium Scorodonia, Veronica Officinalis, Equisetum Hyemale, Fumaria Officinalis, Geranium Robertianum, Nasturtium Aquaticum, Natrum Sulphuricum, Pinus Sylvestris, Gentiana Lutea, Juglans Regia, Aranea Diadema, Sarsaparilla (smilax Regelii), Ascorbicum Acidum, Quercetin, Scrophularia Nodosa, Myosotis Arvensis, Calcarea Phosphorica, Ferrum Iodatum, Thyroidinum (suis), Gaertner Bacillus (bach)",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20200807",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Deseret Biologicals, Inc.",
"SubstanceName": "TEUCRIUM SCORODONIA FLOWERING TOP; VERONICA OFFICINALIS FLOWERING TOP; EQUISETUM HYEMALE WHOLE; FUMARIA OFFICINALIS FLOWERING TOP; GERANIUM ROBERTIANUM WHOLE; NASTURTIUM OFFICINALE; SODIUM SULFATE; PINUS SYLVESTRIS LEAFY TWIG; GENTIANA LUTEA ROOT; JUGLANS REGIA LEAF; ARANEUS DIADEMATUS; SMILAX ORNATA ROOT; ASCORBIC ACID; QUERCETIN; SCROPHULARIA NODOSA WHOLE; MYOSOTIS ARVENSIS WHOLE; TRIBASIC CALCIUM PHOSPHATE; FERROUS IODIDE; THYROID; SALMONELLA ENTERICA ENTERICA SEROVAR ENTERITIDIS",
"StrengthNumber": "3; 3; 4; 4; 4; 4; 4; 4; 5; 5; 6; 6; 6; 6; 8; 9; 12; 12; 12; 30",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL",
"Pharm_Classes": "Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Vitamin C [EPC]",
"Status": "Active",
"LastUpdate": "2024-03-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200807",
"SamplePackage": "N",
"IndicationAndUsage": " For the temporary relief of symptoms including. swelling minor injury. These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration."
},
{
"NDCCode": "0078-0378-42",
"PackageDescription": "8 PATCH in 1 CARTON (0078-0378-42) > 3.5 d in 1 PATCH",
"NDC11Code": "00078-0378-42",
"ProductNDC": "0078-0378",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Combipatch",
"NonProprietaryName": "Estradiol And Norethindrone Acetate",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20000101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020870",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"SubstanceName": "ESTRADIOL; NORETHINDRONE ACETATE",
"StrengthNumber": ".05; .25",
"StrengthUnit": "mg/d; mg/d",
"Pharm_Classes": "Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-09-19"
},
{
"NDCCode": "0078-0378-45",
"PackageDescription": "24 POUCH in 1 CARTON (0078-0378-45) > 3.5 d in 1 POUCH",
"NDC11Code": "00078-0378-45",
"ProductNDC": "0078-0378",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Combipatch",
"NonProprietaryName": "Estradiol And Norethindrone Acetate",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20000101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020870",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"SubstanceName": "ESTRADIOL; NORETHINDRONE ACETATE",
"StrengthNumber": ".05; .25",
"StrengthUnit": "mg/d; mg/d",
"Pharm_Classes": "Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-09-19"
},
{
"NDCCode": "0078-0378-62",
"PackageDescription": "3.5 d in 1 PATCH (0078-0378-62)",
"NDC11Code": "00078-0378-62",
"ProductNDC": "0078-0378",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Combipatch",
"NonProprietaryName": "Estradiol And Norethindrone Acetate",
"DosageFormName": "PATCH, EXTENDED RELEASE",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20000101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020870",
"LabelerName": "Novartis Pharmaceuticals Corporation",
"SubstanceName": "ESTRADIOL; NORETHINDRONE ACETATE",
"StrengthNumber": ".05; .25",
"StrengthUnit": "mg/d; mg/d",
"Pharm_Classes": "Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-09-19"
},
{
"NDCCode": "0378-0088-01",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0088-01) ",
"NDC11Code": "00378-0088-01",
"ProductNDC": "0378-0088",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbidopa And Levodopa",
"NonProprietaryName": "Carbidopa And Levodopa",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20000426",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075091",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "CARBIDOPA; LEVODOPA",
"StrengthNumber": "25; 100",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20000426",
"SamplePackage": "N",
"IndicationAndUsage": "Carbidopa and levodopa extended-release tablets are indicated in the treatment of Parkinson’s disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication.",
"Description": "Carbidopa and levodopa extended-release tablets, USP are an extended-release combination of carbidopa and levodopa for the treatment of Parkinson’s disease and syndrome. Carbidopa, USP, an inhibitor of aromatic amino acid decarboxylation, is a white to creamy white powder, slightly soluble in water, with a molecular weight of 244.24. It is designated chemically as (-)-L-α-Hydrazino-3,4-dihydroxy-α-methylhydrocinnamic acid monohydrate. Its empirical formula is C10H14N2O4H2O, and its structural formula is. Tablet content is expressed in terms of anhydrous carbidopa, which has a molecular weight of 226.23. Levodopa, USP, an aromatic amino acid, is a white to off-white crystalline powder, slightly soluble in water, with a molecular weight of 197.19. It is designated chemically as (-)-3-(3,4-Dihydroxyphenyl)-L-alanine. Its empirical formula is C9H11NO4, and its structural formula is. Each extended-release tablet, for oral administration, contains either 25 mg of carbidopa and 100 mg of levodopa, or 50 mg of carbidopa and 200 mg of levodopa. In addition, each tablet contains the following inactive ingredients: FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, hydroxypropyl cellulose, hypromellose, and magnesium stearate. The 25 mg/100 mg tablets are purple, oval, unscored tablets debossed with MYLAN on one side of the tablet and 88 on the other side of the tablet. The 50 mg/200 mg tablets are purple, oval, scored tablets debossed with MYLAN on one side of the tablet and 9 to the left of the score and 4 to the right of the score on the other side of the tablet. Carbidopa and levodopa extended-release tablets are designed in a drug delivery system that controls the release of carbidopa and levodopa as the tablets slowly erode. The 25 mg/100 mg carbidopa and levodopa extended-release tablet is available to facilitate titration and as an alternative to the half-tablet of 50 mg/200 mg carbidopa and levodopa extended-release. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "0378-0094-01",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0094-01) ",
"NDC11Code": "00378-0094-01",
"ProductNDC": "0378-0094",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbidopa And Levodopa",
"NonProprietaryName": "Carbidopa And Levodopa",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19991006",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075091",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "CARBIDOPA; LEVODOPA",
"StrengthNumber": "50; 200",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19991006",
"SamplePackage": "N",
"IndicationAndUsage": "Carbidopa and levodopa extended-release tablets are indicated in the treatment of Parkinson’s disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication.",
"Description": "Carbidopa and levodopa extended-release tablets, USP are an extended-release combination of carbidopa and levodopa for the treatment of Parkinson’s disease and syndrome. Carbidopa, USP, an inhibitor of aromatic amino acid decarboxylation, is a white to creamy white powder, slightly soluble in water, with a molecular weight of 244.24. It is designated chemically as (-)-L-α-Hydrazino-3,4-dihydroxy-α-methylhydrocinnamic acid monohydrate. Its empirical formula is C10H14N2O4H2O, and its structural formula is. Tablet content is expressed in terms of anhydrous carbidopa, which has a molecular weight of 226.23. Levodopa, USP, an aromatic amino acid, is a white to off-white crystalline powder, slightly soluble in water, with a molecular weight of 197.19. It is designated chemically as (-)-3-(3,4-Dihydroxyphenyl)-L-alanine. Its empirical formula is C9H11NO4, and its structural formula is. Each extended-release tablet, for oral administration, contains either 25 mg of carbidopa and 100 mg of levodopa, or 50 mg of carbidopa and 200 mg of levodopa. In addition, each tablet contains the following inactive ingredients: FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, hydroxypropyl cellulose, hypromellose, and magnesium stearate. The 25 mg/100 mg tablets are purple, oval, unscored tablets debossed with MYLAN on one side of the tablet and 88 on the other side of the tablet. The 50 mg/200 mg tablets are purple, oval, scored tablets debossed with MYLAN on one side of the tablet and 9 to the left of the score and 4 to the right of the score on the other side of the tablet. Carbidopa and levodopa extended-release tablets are designed in a drug delivery system that controls the release of carbidopa and levodopa as the tablets slowly erode. The 25 mg/100 mg carbidopa and levodopa extended-release tablet is available to facilitate titration and as an alternative to the half-tablet of 50 mg/200 mg carbidopa and levodopa extended-release. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "0378-0218-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (0378-0218-01) ",
"NDC11Code": "00378-0218-01",
"ProductNDC": "0378-0218",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atenolol",
"NonProprietaryName": "Atenolol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19990617",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA073457",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "ATENOLOL",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19990617",
"SamplePackage": "N",
"IndicationAndUsage": "Atenolol tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including atenolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Atenolol tablets may be administered with other antihypertensive agents.",
"Description": "Atenolol, USP, a synthetic, beta1-selective (cardioselective) adrenoreceptor blocking agent, may be chemically described as Benzeneacetamide, 4-[2-hydroxy-3-[(1-methylethyl)amino] propoxy]-. The molecular and structural formulas are. Atenolol (free base) has a molecular weight of 266.34. It is a relatively polar hydrophilic compound with a water solubility of 26.5 mg/mL at 37°C and a log partition coefficient (octanol/water) of 0.23. It is freely soluble in 1N HCl (300 mg/mL at 25°C) and less soluble in chloroform (3 mg/mL at 25°C). Atenolol tablets are available as 25 mg, 50 mg and 100 mg tablets for oral administration. Inactive Ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate and sodium starch glycolate (potato)."
},
{
"NDCCode": "0378-0218-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE, PLASTIC (0378-0218-10) ",
"NDC11Code": "00378-0218-10",
"ProductNDC": "0378-0218",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atenolol",
"NonProprietaryName": "Atenolol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19990617",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA073457",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "ATENOLOL",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19990617",
"SamplePackage": "N",
"IndicationAndUsage": "Atenolol tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including atenolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Atenolol tablets may be administered with other antihypertensive agents.",
"Description": "Atenolol, USP, a synthetic, beta1-selective (cardioselective) adrenoreceptor blocking agent, may be chemically described as Benzeneacetamide, 4-[2-hydroxy-3-[(1-methylethyl)amino] propoxy]-. The molecular and structural formulas are. Atenolol (free base) has a molecular weight of 266.34. It is a relatively polar hydrophilic compound with a water solubility of 26.5 mg/mL at 37°C and a log partition coefficient (octanol/water) of 0.23. It is freely soluble in 1N HCl (300 mg/mL at 25°C) and less soluble in chloroform (3 mg/mL at 25°C). Atenolol tablets are available as 25 mg, 50 mg and 100 mg tablets for oral administration. Inactive Ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate and sodium starch glycolate (potato)."
},
{
"NDCCode": "0378-0231-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (0378-0231-01) ",
"NDC11Code": "00378-0231-01",
"ProductNDC": "0378-0231",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atenolol",
"NonProprietaryName": "Atenolol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19920124",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA073457",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "ATENOLOL",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19920124",
"SamplePackage": "N",
"IndicationAndUsage": "Atenolol tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including atenolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Atenolol tablets may be administered with other antihypertensive agents.",
"Description": "Atenolol, USP, a synthetic, beta1-selective (cardioselective) adrenoreceptor blocking agent, may be chemically described as Benzeneacetamide, 4-[2-hydroxy-3-[(1-methylethyl)amino] propoxy]-. The molecular and structural formulas are. Atenolol (free base) has a molecular weight of 266.34. It is a relatively polar hydrophilic compound with a water solubility of 26.5 mg/mL at 37°C and a log partition coefficient (octanol/water) of 0.23. It is freely soluble in 1N HCl (300 mg/mL at 25°C) and less soluble in chloroform (3 mg/mL at 25°C). Atenolol tablets are available as 25 mg, 50 mg and 100 mg tablets for oral administration. Inactive Ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate and sodium starch glycolate (potato)."
},
{
"NDCCode": "0378-0231-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE, PLASTIC (0378-0231-10) ",
"NDC11Code": "00378-0231-10",
"ProductNDC": "0378-0231",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atenolol",
"NonProprietaryName": "Atenolol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19920124",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA073457",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "ATENOLOL",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19920124",
"SamplePackage": "N",
"IndicationAndUsage": "Atenolol tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including atenolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Atenolol tablets may be administered with other antihypertensive agents.",
"Description": "Atenolol, USP, a synthetic, beta1-selective (cardioselective) adrenoreceptor blocking agent, may be chemically described as Benzeneacetamide, 4-[2-hydroxy-3-[(1-methylethyl)amino] propoxy]-. The molecular and structural formulas are. Atenolol (free base) has a molecular weight of 266.34. It is a relatively polar hydrophilic compound with a water solubility of 26.5 mg/mL at 37°C and a log partition coefficient (octanol/water) of 0.23. It is freely soluble in 1N HCl (300 mg/mL at 25°C) and less soluble in chloroform (3 mg/mL at 25°C). Atenolol tablets are available as 25 mg, 50 mg and 100 mg tablets for oral administration. Inactive Ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate and sodium starch glycolate (potato)."
},
{
"NDCCode": "0378-0265-91",
"PackageDescription": "60 CAPSULE in 1 BOTTLE, PLASTIC (0378-0265-91) ",
"NDC11Code": "00378-0265-91",
"ProductNDC": "0378-0265",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dabigatran Etexilate",
"NonProprietaryName": "Dabigatran Etexilate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20250225",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208067",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "DABIGATRAN ETEXILATE MESYLATE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250225",
"SamplePackage": "N",
"IndicationAndUsage": "Dabigatran etexilate capsules are a direct thrombin inhibitor indicated: : 1 To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (1.1) , 2 For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5-10 days (1.2) , 3 To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated (1.3), 4 For the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery (1.4), 5 For the treatment of venous thromboembolic events (VTE) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days (1.5), 6 To reduce the risk of recurrence of VTE in pediatric patients 8 to less than 18 years of age who have been previously treated (1.6).",
"Description": "The chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is Ethyl 3-{[(2-{[(4-{[(hexyloxy)carbonyl]carbamimidoyl}phenyl)amino]methyl}-1-methyl-1H-benzimidazol-5-yl)carbonyl](pyridin-2-yl)amino}propanoate, monomethanesulfonate. The empirical formula is C34H41N7O5CH4O3S and the molecular weight is 723.86 (mesylate salt), 627.75 (free base). The structural formula is. Dabigatran etexilate mesylate is a white to yellow powder. A saturated solution in pure water has a solubility of 1.8 mg/mL. It is freely soluble in methanol, slightly soluble in ethanol, and sparingly soluble in isopropanol. Dabigatran etexilate capsules are supplied in 75 mg and 150 mg strengths for oral administration. Each capsule contains dabigatran etexilate mesylate as the active ingredient: 150 mg dabigatran etexilate (equivalent to 172.95 mg dabigatran etexilate mesylate) or 75 mg dabigatran etexilate (equivalent to 86.48 mg dabigatran etexilate mesylate) along with the following inactive ingredients: colloidal silicon dioxide, crospovidone, fumaric acid, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate and titanium dioxide. The 150 mg capsules also contain black iron oxide and red iron oxide. In addition, the black imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution."
},
{
"NDCCode": "0378-0266-91",
"PackageDescription": "60 CAPSULE in 1 BOTTLE, PLASTIC (0378-0266-91) ",
"NDC11Code": "00378-0266-91",
"ProductNDC": "0378-0266",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dabigatran Etexilate",
"NonProprietaryName": "Dabigatran Etexilate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20250225",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208067",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "DABIGATRAN ETEXILATE MESYLATE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-09-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250225",
"SamplePackage": "N",
"IndicationAndUsage": "Dabigatran etexilate capsules are a direct thrombin inhibitor indicated: : 1 To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (1.1) , 2 For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5-10 days (1.2) , 3 To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated (1.3), 4 For the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery (1.4), 5 For the treatment of venous thromboembolic events (VTE) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days (1.5), 6 To reduce the risk of recurrence of VTE in pediatric patients 8 to less than 18 years of age who have been previously treated (1.6).",
"Description": "The chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is Ethyl 3-{[(2-{[(4-{[(hexyloxy)carbonyl]carbamimidoyl}phenyl)amino]methyl}-1-methyl-1H-benzimidazol-5-yl)carbonyl](pyridin-2-yl)amino}propanoate, monomethanesulfonate. The empirical formula is C34H41N7O5CH4O3S and the molecular weight is 723.86 (mesylate salt), 627.75 (free base). The structural formula is. Dabigatran etexilate mesylate is a white to yellow powder. A saturated solution in pure water has a solubility of 1.8 mg/mL. It is freely soluble in methanol, slightly soluble in ethanol, and sparingly soluble in isopropanol. Dabigatran etexilate capsules are supplied in 75 mg and 150 mg strengths for oral administration. Each capsule contains dabigatran etexilate mesylate as the active ingredient: 150 mg dabigatran etexilate (equivalent to 172.95 mg dabigatran etexilate mesylate) or 75 mg dabigatran etexilate (equivalent to 86.48 mg dabigatran etexilate mesylate) along with the following inactive ingredients: colloidal silicon dioxide, crospovidone, fumaric acid, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate and titanium dioxide. The 150 mg capsules also contain black iron oxide and red iron oxide. In addition, the black imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution."
},
{
"NDCCode": "0378-0757-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (0378-0757-01) ",
"NDC11Code": "00378-0757-01",
"ProductNDC": "0378-0757",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atenolol",
"NonProprietaryName": "Atenolol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19920124",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA073457",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "ATENOLOL",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19920124",
"SamplePackage": "N",
"IndicationAndUsage": "Atenolol tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including atenolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Atenolol tablets may be administered with other antihypertensive agents.",
"Description": "Atenolol, USP, a synthetic, beta1-selective (cardioselective) adrenoreceptor blocking agent, may be chemically described as Benzeneacetamide, 4-[2-hydroxy-3-[(1-methylethyl)amino] propoxy]-. The molecular and structural formulas are. Atenolol (free base) has a molecular weight of 266.34. It is a relatively polar hydrophilic compound with a water solubility of 26.5 mg/mL at 37°C and a log partition coefficient (octanol/water) of 0.23. It is freely soluble in 1N HCl (300 mg/mL at 25°C) and less soluble in chloroform (3 mg/mL at 25°C). Atenolol tablets are available as 25 mg, 50 mg and 100 mg tablets for oral administration. Inactive Ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate and sodium starch glycolate (potato)."
},
{
"NDCCode": "0378-0757-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE, PLASTIC (0378-0757-10) ",
"NDC11Code": "00378-0757-10",
"ProductNDC": "0378-0757",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atenolol",
"NonProprietaryName": "Atenolol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19920124",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA073457",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "ATENOLOL",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19920124",
"SamplePackage": "N",
"IndicationAndUsage": "Atenolol tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including atenolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Atenolol tablets may be administered with other antihypertensive agents.",
"Description": "Atenolol, USP, a synthetic, beta1-selective (cardioselective) adrenoreceptor blocking agent, may be chemically described as Benzeneacetamide, 4-[2-hydroxy-3-[(1-methylethyl)amino] propoxy]-. The molecular and structural formulas are. Atenolol (free base) has a molecular weight of 266.34. It is a relatively polar hydrophilic compound with a water solubility of 26.5 mg/mL at 37°C and a log partition coefficient (octanol/water) of 0.23. It is freely soluble in 1N HCl (300 mg/mL at 25°C) and less soluble in chloroform (3 mg/mL at 25°C). Atenolol tablets are available as 25 mg, 50 mg and 100 mg tablets for oral administration. Inactive Ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate and sodium starch glycolate (potato)."
},
{
"NDCCode": "0378-1086-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1086-01) ",
"NDC11Code": "00378-1086-01",
"ProductNDC": "0378-1086",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Colchicine",
"NonProprietaryName": "Colchicine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20191125",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209470",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "COLCHICINE",
"StrengthNumber": ".6",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Alkaloid [EPC], Alkaloids [CS]",
"Status": "Active",
"LastUpdate": "2024-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191125",
"SamplePackage": "N",
"IndicationAndUsage": "Colchicine tablets are an alkaloid indicated for: 1 Prophylaxis and treatment of gout flares in adults (1.1). , 2 Familial Mediterranean fever (FMF) in adults and children 4 years or older (1.2). .",
"Description": "Colchicine is an alkaloid chemically described as Acetamide, N-(5,6,7,9-tetrahydro-1,2,3,10-tetramethoxy-9-oxobenzo[a]heptalen-7-yl)-, (S)- with a molecular formula of C22H25NO6 and a molecular weight of 399.44. The structural formula of colchicine is given below. Colchicine, USP occurs as a white to pale yellow powder that is soluble in water. Colchicine tablets, USP are supplied for oral administration as red, film-coated, oval, scored tablets (0.1770” × 0.3240”), debossed with M on one side of the tablet and CC to the left of the score and 2 to the right of the score on the other side, containing 0.6 mg of the active ingredient colchicine, USP. Inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn), polydextrose, polyethylene glycol, red iron oxide, sodium starch glycolate (potato), titanium dioxide and yellow iron oxide."
},
{
"NDCCode": "0378-1134-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1134-01) ",
"NDC11Code": "00378-1134-01",
"ProductNDC": "0378-1134",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ketorolac Tromethamine",
"NonProprietaryName": "Ketorolac Tromethamine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130516",
"EndMarketingDate": "20280731",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074761",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "KETOROLAC TROMETHAMINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-06-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20130516",
"EndMarketingDatePackage": "20280731",
"SamplePackage": "N",
"IndicationAndUsage": "Carefully consider the potential benefits and risks of ketorolac tromethamine tablets and other treatment options before deciding to use ketorolac tromethamine tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.",
"Description": "Ketorolac tromethamine is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs). The chemical name for ketorolac tromethamine is (±)-5-Benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol, and the structural formula is. Ketorolac tromethamine is a racemic mixture of [-]S and [+]R ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. Ketorolac tromethamine has a pKa of 3.5 and an n-octanol/water partition coefficient of 0.26. The molecular weight of ketorolac tromethamine is 376.41. Each tablet for oral administration contains 10 mg ketorolac tromethamine, USP. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, glyceryl triacetate, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium lauryl sulfate and titanium dioxide."
},
{
"NDCCode": "0378-1700-05",
"PackageDescription": "500 CAPSULE in 1 BOTTLE, PLASTIC (0378-1700-05) ",
"NDC11Code": "00378-1700-05",
"ProductNDC": "0378-1700",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nitrofurantoin (macrocrystals)",
"NonProprietaryName": "Nitrofurantoin (macrocrystals)",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20040921",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077025",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "NITROFURANTOIN",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Nitrofurans [CS],Nitrofuran Antibacterial [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-01-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20040921",
"SamplePackage": "N"
},
{
"NDCCode": "0378-2045-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE, PLASTIC (0378-2045-01) ",
"NDC11Code": "00378-2045-01",
"ProductNDC": "0378-2045",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tacrolimus",
"NonProprietaryName": "Tacrolimus",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100917",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090596",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "TACROLIMUS",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100917",
"SamplePackage": "N",
"IndicationAndUsage": "Tacrolimus capsules are a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric patients receiving allogeneic liver, kidney, or heart transplants, in combination with other immunosuppressants. (1.1).",
"Description": "Tacrolimus, previously known as FK506, is the active ingredient in tacrolimus capsules. Tacrolimus is a calcineurin-inhibitor immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus is designated as (‒)-(3S,4R,5S,8R,9E,12S,14S,15R,16S,18R,19R,26aS)-8-Allyl-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[(E)-2-[(1R,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylvinyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-15,19-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone monohydrate. The chemical structure of tacrolimus is. Tacrolimus has a molecular formula of C44H69NO12H2O and a formula weight of 822.03. Tacrolimus, USP appears as a white to off-white powder. It is insoluble in water, very soluble in ethanol, and soluble in methanol and chloroform. Tacrolimus capsules, USP are available for oral administration as capsules containing the equivalent of 0.5 mg, 1 mg or 5 mg of anhydrous tacrolimus. Inactive ingredients include anhydrous lactose, black iron oxide, colloidal silicon dioxide, croscarmellose sodium, gelatin, hypromellose, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, titanium dioxide and yellow iron oxide. The 0.5 mg capsules also contain D&C Red No. 28, D&C Yellow No. 10 and FD&C Red No. 40, the 1 mg capsules also contain FD&C Blue No. 1 and FD&C Red No. 3 and the 5 mg capsules also contain D&C Red No. 33, D&C Red No. 28 and D&C Yellow No. 10. In addition, the black imprinting ink contains black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze. Meets USP Dissolution Test 5."
},
{
"NDCCode": "0378-2046-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE, PLASTIC (0378-2046-01) ",
"NDC11Code": "00378-2046-01",
"ProductNDC": "0378-2046",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tacrolimus",
"NonProprietaryName": "Tacrolimus",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100917",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090596",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "TACROLIMUS",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100917",
"SamplePackage": "N",
"IndicationAndUsage": "Tacrolimus capsules are a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric patients receiving allogeneic liver, kidney, or heart transplants, in combination with other immunosuppressants. (1.1).",
"Description": "Tacrolimus, previously known as FK506, is the active ingredient in tacrolimus capsules. Tacrolimus is a calcineurin-inhibitor immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus is designated as (‒)-(3S,4R,5S,8R,9E,12S,14S,15R,16S,18R,19R,26aS)-8-Allyl-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[(E)-2-[(1R,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylvinyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-15,19-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone monohydrate. The chemical structure of tacrolimus is. Tacrolimus has a molecular formula of C44H69NO12H2O and a formula weight of 822.03. Tacrolimus, USP appears as a white to off-white powder. It is insoluble in water, very soluble in ethanol, and soluble in methanol and chloroform. Tacrolimus capsules, USP are available for oral administration as capsules containing the equivalent of 0.5 mg, 1 mg or 5 mg of anhydrous tacrolimus. Inactive ingredients include anhydrous lactose, black iron oxide, colloidal silicon dioxide, croscarmellose sodium, gelatin, hypromellose, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, titanium dioxide and yellow iron oxide. The 0.5 mg capsules also contain D&C Red No. 28, D&C Yellow No. 10 and FD&C Red No. 40, the 1 mg capsules also contain FD&C Blue No. 1 and FD&C Red No. 3 and the 5 mg capsules also contain D&C Red No. 33, D&C Red No. 28 and D&C Yellow No. 10. In addition, the black imprinting ink contains black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze. Meets USP Dissolution Test 5."
},
{
"NDCCode": "0378-2047-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE, PLASTIC (0378-2047-01) ",
"NDC11Code": "00378-2047-01",
"ProductNDC": "0378-2047",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tacrolimus",
"NonProprietaryName": "Tacrolimus",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100917",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090596",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "TACROLIMUS",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100917",
"SamplePackage": "N",
"IndicationAndUsage": "Tacrolimus capsules are a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric patients receiving allogeneic liver, kidney, or heart transplants, in combination with other immunosuppressants. (1.1).",
"Description": "Tacrolimus, previously known as FK506, is the active ingredient in tacrolimus capsules. Tacrolimus is a calcineurin-inhibitor immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus is designated as (‒)-(3S,4R,5S,8R,9E,12S,14S,15R,16S,18R,19R,26aS)-8-Allyl-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[(E)-2-[(1R,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylvinyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-15,19-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone monohydrate. The chemical structure of tacrolimus is. Tacrolimus has a molecular formula of C44H69NO12H2O and a formula weight of 822.03. Tacrolimus, USP appears as a white to off-white powder. It is insoluble in water, very soluble in ethanol, and soluble in methanol and chloroform. Tacrolimus capsules, USP are available for oral administration as capsules containing the equivalent of 0.5 mg, 1 mg or 5 mg of anhydrous tacrolimus. Inactive ingredients include anhydrous lactose, black iron oxide, colloidal silicon dioxide, croscarmellose sodium, gelatin, hypromellose, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, titanium dioxide and yellow iron oxide. The 0.5 mg capsules also contain D&C Red No. 28, D&C Yellow No. 10 and FD&C Red No. 40, the 1 mg capsules also contain FD&C Blue No. 1 and FD&C Red No. 3 and the 5 mg capsules also contain D&C Red No. 33, D&C Red No. 28 and D&C Yellow No. 10. In addition, the black imprinting ink contains black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze. Meets USP Dissolution Test 5."
},
{
"NDCCode": "0378-2245-77",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-2245-77) ",
"NDC11Code": "00378-2245-77",
"ProductNDC": "0378-2245",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Imatinib Mesylate",
"NonProprietaryName": "Imatinib",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170928",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204644",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "IMATINIB MESYLATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170928",
"SamplePackage": "N",
"IndicationAndUsage": "Imatinib mesylate tablets are a kinase inhibitor indicated for the treatment of: 1 Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. (1.1), 2 Patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha therapy. (1.2), 3 Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL). (1.3), 4 Pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy. (1.4), 5 Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements. (1.5), 6 Adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-Kit mutation or with c-Kit mutational status unknown. (1.6), 7 Adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRα fusion kinase (mutational analysis or fluorescence in situ hybridization [FISH] demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFRα fusion kinase negative or unknown. (1.7), 8 Adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP). (1.8), 9 Patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST). (1.9) , 10 Adjuvant treatment of adult patients following resection of Kit (CD117) positive GIST. (1.10).",
"Description": "Imatinib is a small molecule kinase inhibitor. Imatinib mesylate film-coated tablets are supplied as 100 mg or 400 mg tablets for oral administration. Each 100 mg tablet contains 119.5 mg of imatinib mesylate equivalent to 100 mg of imatinib free base. Each 400 mg tablet contains 478 mg of imatinib mesylate equivalent to 400 mg of imatinib free base. Imatinib mesylate is designated chemically as Benzamide, 4-[(4-methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]aminophenyl]-methanesulfonate salt and its structural formula is. Imatinib mesylate is a white to off-white to brownish or yellowish tinged crystalline powder. Its molecular formula is C29H31N7O CH4SO3 and its molecular weight is 589.71 g/mol. Imatinib mesylate is soluble in aqueous buffers less than or equal to pH 5.5 but is very slightly soluble to insoluble in neutral/alkaline aqueous buffers. In non-aqueous solvents, the drug substance is freely soluble to very slightly soluble in dimethyl sulfoxide, methanol, and ethanol, but is insoluble in n-octanol, acetone, and acetonitrile. Inactive Ingredients: colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, red iron oxide, talc, titanium dioxide and yellow iron oxide."
},
{
"NDCCode": "0378-2246-93",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-2246-93) ",
"NDC11Code": "00378-2246-93",
"ProductNDC": "0378-2246",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Imatinib Mesylate",
"NonProprietaryName": "Imatinib",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170928",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204644",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "IMATINIB MESYLATE",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170928",
"SamplePackage": "N",
"IndicationAndUsage": "Imatinib mesylate tablets are a kinase inhibitor indicated for the treatment of: 1 Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. (1.1), 2 Patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha therapy. (1.2), 3 Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL). (1.3), 4 Pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy. (1.4), 5 Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements. (1.5), 6 Adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-Kit mutation or with c-Kit mutational status unknown. (1.6), 7 Adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRα fusion kinase (mutational analysis or fluorescence in situ hybridization [FISH] demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFRα fusion kinase negative or unknown. (1.7), 8 Adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP). (1.8), 9 Patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST). (1.9) , 10 Adjuvant treatment of adult patients following resection of Kit (CD117) positive GIST. (1.10).",
"Description": "Imatinib is a small molecule kinase inhibitor. Imatinib mesylate film-coated tablets are supplied as 100 mg or 400 mg tablets for oral administration. Each 100 mg tablet contains 119.5 mg of imatinib mesylate equivalent to 100 mg of imatinib free base. Each 400 mg tablet contains 478 mg of imatinib mesylate equivalent to 400 mg of imatinib free base. Imatinib mesylate is designated chemically as Benzamide, 4-[(4-methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]aminophenyl]-methanesulfonate salt and its structural formula is. Imatinib mesylate is a white to off-white to brownish or yellowish tinged crystalline powder. Its molecular formula is C29H31N7O CH4SO3 and its molecular weight is 589.71 g/mol. Imatinib mesylate is soluble in aqueous buffers less than or equal to pH 5.5 but is very slightly soluble to insoluble in neutral/alkaline aqueous buffers. In non-aqueous solvents, the drug substance is freely soluble to very slightly soluble in dimethyl sulfoxide, methanol, and ethanol, but is insoluble in n-octanol, acetone, and acetonitrile. Inactive Ingredients: colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, red iron oxide, talc, titanium dioxide and yellow iron oxide."
},
{
"NDCCode": "0378-2350-77",
"PackageDescription": "90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (0378-2350-77) ",
"NDC11Code": "00378-2350-77",
"ProductNDC": "0378-2350",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Esomeprazole Magnesium",
"NonProprietaryName": "Esomeprazole Magnesium",
"DosageFormName": "CAPSULE, DELAYED RELEASE PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20150803",
"EndMarketingDate": "20261130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078936",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "ESOMEPRAZOLE MAGNESIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160111",
"EndMarketingDatePackage": "20261130",
"SamplePackage": "N",
"IndicationAndUsage": "Esomeprazole magnesium delayed-release capsules are a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules are indicated for the: 1 Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. (1.1), 2 Maintenance of healing of EE in adults. (1.2), 3 Short-term treatment of heartburn and other symptoms associated with GERD in adults and pediatric patients 12 years to 17 years of age. (1.3), 4 Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers. (1.4), 5 Helicobacter pylori eradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin. (1.5), 6 Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults. (1.6).",
"Description": "The active ingredient in esomeprazole magnesium delayed-release capsules for oral administration is 1H-Benzimidazole,5-methoxy-2-[(S)-[4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl], magnesium salt (2:1), a PPI. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is C34H36MgN6O6S2 with molecular weight of 713.12 on an anhydrous basis. The structural formula is. The magnesium salt is an off-white to pale cream colored powder. It is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. Esomeprazole magnesium is supplied in delayed-release capsules. Each esomeprazole magnesium delayed-release capsule contains 20 mg of esomeprazole (equivalent to 22.25 mg esomeprazole magnesium) or 40 mg of esomeprazole (equivalent to 44.50 mg esomeprazole magnesium) in the form of enteric-coated pellets with the following inactive ingredients: crospovidone, hydroxypropyl cellulose, mannitol, methacrylic acid-ethyl acrylate copolymer dispersion, sucrose, sugar spheres (corn starch and sucrose), talc, titanium dioxide and triethyl citrate. The capsule shells have the following inactive ingredients: gelatin and titanium dioxide, and may contain sodium lauryl sulfate. The imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution."
}
]
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<ProprietaryName>Tizanidine</ProprietaryName>
<NonProprietaryName>Tizanidine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030506</StartMarketingDate>
<EndMarketingDate>20210228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076354</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>TIZANIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-03-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20030506</StartMarketingDatePackage>
<EndMarketingDatePackage>20210228</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0378-1665-19</NDCCode>
<PackageDescription>150 CAPSULE in 1 BOTTLE, PLASTIC (0378-1665-19)</PackageDescription>
<NDC11Code>00378-1665-19</NDC11Code>
<ProductNDC>0378-1665</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tizanidine Hydrochloride</ProprietaryName>
<NonProprietaryName>Tizanidine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091502</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>TIZANIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-01-26</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0378-1666-19</NDCCode>
<PackageDescription>150 CAPSULE in 1 BOTTLE, PLASTIC (0378-1666-19)</PackageDescription>
<NDC11Code>00378-1666-19</NDC11Code>
<ProductNDC>0378-1666</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tizanidine Hydrochloride</ProprietaryName>
<NonProprietaryName>Tizanidine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091502</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>TIZANIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-01-26</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>29300-378-19</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (29300-378-19) </PackageDescription>
<NDC11Code>29300-0378-19</NDC11Code>
<ProductNDC>29300-378</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nebivolol Hydrochloride</ProprietaryName>
<NonProprietaryName>Nebivolol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220404</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213830</ApplicationNumber>
<LabelerName>Unichem Pharmaceuticals (USA), Inc.</LabelerName>
<SubstanceName>NEBIVOLOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-07-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220404</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nebivolol is a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1).</IndicationAndUsage>
<Description>The chemical name for the active ingredient in nebivolol tablets is (1RS,1'RS)-1,1'-[(2RS,2'SR)-bis(6-fluoro-3,4-dihydro-2H-1-benzopyran-2-yl)]-2,2'-iminodiethanol hydrochloride. Nebivolol is a racemate composed of d-Nebivolol and l-Nebivolol with the stereochemical designations of [SRRR]-nebivolol and [RSSS]-nebivolol, respectively. Nebivolol's molecular formula is (C22H25F2NO4HCl) with the following structural formula. Nebivolol hydrochloride is a white to off white powder that is sparingly soluble in methanol. Nebivolol as tablets for oral administration contains nebivolol hydrochloride equivalent to 2.5 mg, 5 mg, 10 mg, and 20 mg of nebivolol base. In addition, nebivolol tablets contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, polysorbate 80 and sodium lauryl sulfate. Additionally, the 2.5 mg and 5 mg tablets contain FD&C yellow no. 6 aluminium lake and the 10 mg tablets contain FD&C blue #2.</Description>
</NDC>
<NDC>
<NDCCode>43742-1667-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (43742-1667-1) </PackageDescription>
<NDC11Code>43742-1667-01</NDC11Code>
<ProductNDC>43742-1667</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bio Lymph Phase</ProprietaryName>
<NonProprietaryName>Teucrium Scorodonia, Veronica Officinalis, Equisetum Hyemale, Fumaria Officinalis, Geranium Robertianum, Nasturtium Aquaticum, Natrum Sulphuricum, Pinus Sylvestris, Gentiana Lutea, Juglans Regia, Aranea Diadema, Sarsaparilla (smilax Regelii), Ascorbicum Acidum, Quercetin, Scrophularia Nodosa, Myosotis Arvensis, Calcarea Phosphorica, Ferrum Iodatum, Thyroidinum (suis), Gaertner Bacillus (bach)</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200807</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Deseret Biologicals, Inc.</LabelerName>
<SubstanceName>TEUCRIUM SCORODONIA FLOWERING TOP; VERONICA OFFICINALIS FLOWERING TOP; EQUISETUM HYEMALE WHOLE; FUMARIA OFFICINALIS FLOWERING TOP; GERANIUM ROBERTIANUM WHOLE; NASTURTIUM OFFICINALE; SODIUM SULFATE; PINUS SYLVESTRIS LEAFY TWIG; GENTIANA LUTEA ROOT; JUGLANS REGIA LEAF; ARANEUS DIADEMATUS; SMILAX ORNATA ROOT; ASCORBIC ACID; QUERCETIN; SCROPHULARIA NODOSA WHOLE; MYOSOTIS ARVENSIS WHOLE; TRIBASIC CALCIUM PHOSPHATE; FERROUS IODIDE; THYROID; SALMONELLA ENTERICA ENTERICA SEROVAR ENTERITIDIS</SubstanceName>
<StrengthNumber>3; 3; 4; 4; 4; 4; 4; 4; 5; 5; 6; 6; 6; 6; 8; 9; 12; 12; 12; 30</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL</StrengthUnit>
<Pharm_Classes>Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Vitamin C [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200807</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> For the temporary relief of symptoms including. swelling minor injury. These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0078-0378-42</NDCCode>
<PackageDescription>8 PATCH in 1 CARTON (0078-0378-42) > 3.5 d in 1 PATCH</PackageDescription>
<NDC11Code>00078-0378-42</NDC11Code>
<ProductNDC>0078-0378</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Combipatch</ProprietaryName>
<NonProprietaryName>Estradiol And Norethindrone Acetate</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20000101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020870</ApplicationNumber>
<LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
<SubstanceName>ESTRADIOL; NORETHINDRONE ACETATE</SubstanceName>
<StrengthNumber>.05; .25</StrengthNumber>
<StrengthUnit>mg/d; mg/d</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-09-19</LastUpdate>
</NDC>
<NDC>
<NDCCode>0078-0378-45</NDCCode>
<PackageDescription>24 POUCH in 1 CARTON (0078-0378-45) > 3.5 d in 1 POUCH</PackageDescription>
<NDC11Code>00078-0378-45</NDC11Code>
<ProductNDC>0078-0378</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Combipatch</ProprietaryName>
<NonProprietaryName>Estradiol And Norethindrone Acetate</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20000101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020870</ApplicationNumber>
<LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
<SubstanceName>ESTRADIOL; NORETHINDRONE ACETATE</SubstanceName>
<StrengthNumber>.05; .25</StrengthNumber>
<StrengthUnit>mg/d; mg/d</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-09-19</LastUpdate>
</NDC>
<NDC>
<NDCCode>0078-0378-62</NDCCode>
<PackageDescription>3.5 d in 1 PATCH (0078-0378-62)</PackageDescription>
<NDC11Code>00078-0378-62</NDC11Code>
<ProductNDC>0078-0378</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Combipatch</ProprietaryName>
<NonProprietaryName>Estradiol And Norethindrone Acetate</NonProprietaryName>
<DosageFormName>PATCH, EXTENDED RELEASE</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20000101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020870</ApplicationNumber>
<LabelerName>Novartis Pharmaceuticals Corporation</LabelerName>
<SubstanceName>ESTRADIOL; NORETHINDRONE ACETATE</SubstanceName>
<StrengthNumber>.05; .25</StrengthNumber>
<StrengthUnit>mg/d; mg/d</StrengthUnit>
<Pharm_Classes>Estradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA],Progesterone Congeners [Chemical/Ingredient],Progestin [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-09-19</LastUpdate>
</NDC>
<NDC>
<NDCCode>0378-0088-01</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0088-01) </PackageDescription>
<NDC11Code>00378-0088-01</NDC11Code>
<ProductNDC>0378-0088</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carbidopa And Levodopa</ProprietaryName>
<NonProprietaryName>Carbidopa And Levodopa</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20000426</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075091</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CARBIDOPA; LEVODOPA</SubstanceName>
<StrengthNumber>25; 100</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20000426</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carbidopa and levodopa extended-release tablets are indicated in the treatment of Parkinson’s disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication.</IndicationAndUsage>
<Description>Carbidopa and levodopa extended-release tablets, USP are an extended-release combination of carbidopa and levodopa for the treatment of Parkinson’s disease and syndrome. Carbidopa, USP, an inhibitor of aromatic amino acid decarboxylation, is a white to creamy white powder, slightly soluble in water, with a molecular weight of 244.24. It is designated chemically as (-)-L-α-Hydrazino-3,4-dihydroxy-α-methylhydrocinnamic acid monohydrate. Its empirical formula is C10H14N2O4H2O, and its structural formula is. Tablet content is expressed in terms of anhydrous carbidopa, which has a molecular weight of 226.23. Levodopa, USP, an aromatic amino acid, is a white to off-white crystalline powder, slightly soluble in water, with a molecular weight of 197.19. It is designated chemically as (-)-3-(3,4-Dihydroxyphenyl)-L-alanine. Its empirical formula is C9H11NO4, and its structural formula is. Each extended-release tablet, for oral administration, contains either 25 mg of carbidopa and 100 mg of levodopa, or 50 mg of carbidopa and 200 mg of levodopa. In addition, each tablet contains the following inactive ingredients: FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, hydroxypropyl cellulose, hypromellose, and magnesium stearate. The 25 mg/100 mg tablets are purple, oval, unscored tablets debossed with MYLAN on one side of the tablet and 88 on the other side of the tablet. The 50 mg/200 mg tablets are purple, oval, scored tablets debossed with MYLAN on one side of the tablet and 9 to the left of the score and 4 to the right of the score on the other side of the tablet. Carbidopa and levodopa extended-release tablets are designed in a drug delivery system that controls the release of carbidopa and levodopa as the tablets slowly erode. The 25 mg/100 mg carbidopa and levodopa extended-release tablet is available to facilitate titration and as an alternative to the half-tablet of 50 mg/200 mg carbidopa and levodopa extended-release. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>0378-0094-01</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0094-01) </PackageDescription>
<NDC11Code>00378-0094-01</NDC11Code>
<ProductNDC>0378-0094</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carbidopa And Levodopa</ProprietaryName>
<NonProprietaryName>Carbidopa And Levodopa</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19991006</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075091</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CARBIDOPA; LEVODOPA</SubstanceName>
<StrengthNumber>50; 200</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19991006</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carbidopa and levodopa extended-release tablets are indicated in the treatment of Parkinson’s disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication.</IndicationAndUsage>
<Description>Carbidopa and levodopa extended-release tablets, USP are an extended-release combination of carbidopa and levodopa for the treatment of Parkinson’s disease and syndrome. Carbidopa, USP, an inhibitor of aromatic amino acid decarboxylation, is a white to creamy white powder, slightly soluble in water, with a molecular weight of 244.24. It is designated chemically as (-)-L-α-Hydrazino-3,4-dihydroxy-α-methylhydrocinnamic acid monohydrate. Its empirical formula is C10H14N2O4H2O, and its structural formula is. Tablet content is expressed in terms of anhydrous carbidopa, which has a molecular weight of 226.23. Levodopa, USP, an aromatic amino acid, is a white to off-white crystalline powder, slightly soluble in water, with a molecular weight of 197.19. It is designated chemically as (-)-3-(3,4-Dihydroxyphenyl)-L-alanine. Its empirical formula is C9H11NO4, and its structural formula is. Each extended-release tablet, for oral administration, contains either 25 mg of carbidopa and 100 mg of levodopa, or 50 mg of carbidopa and 200 mg of levodopa. In addition, each tablet contains the following inactive ingredients: FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, hydroxypropyl cellulose, hypromellose, and magnesium stearate. The 25 mg/100 mg tablets are purple, oval, unscored tablets debossed with MYLAN on one side of the tablet and 88 on the other side of the tablet. The 50 mg/200 mg tablets are purple, oval, scored tablets debossed with MYLAN on one side of the tablet and 9 to the left of the score and 4 to the right of the score on the other side of the tablet. Carbidopa and levodopa extended-release tablets are designed in a drug delivery system that controls the release of carbidopa and levodopa as the tablets slowly erode. The 25 mg/100 mg carbidopa and levodopa extended-release tablet is available to facilitate titration and as an alternative to the half-tablet of 50 mg/200 mg carbidopa and levodopa extended-release. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>0378-0218-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (0378-0218-01) </PackageDescription>
<NDC11Code>00378-0218-01</NDC11Code>
<ProductNDC>0378-0218</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atenolol</ProprietaryName>
<NonProprietaryName>Atenolol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19990617</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA073457</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ATENOLOL</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19990617</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atenolol tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including atenolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Atenolol tablets may be administered with other antihypertensive agents.</IndicationAndUsage>
<Description>Atenolol, USP, a synthetic, beta1-selective (cardioselective) adrenoreceptor blocking agent, may be chemically described as Benzeneacetamide, 4-[2-hydroxy-3-[(1-methylethyl)amino] propoxy]-. The molecular and structural formulas are. Atenolol (free base) has a molecular weight of 266.34. It is a relatively polar hydrophilic compound with a water solubility of 26.5 mg/mL at 37°C and a log partition coefficient (octanol/water) of 0.23. It is freely soluble in 1N HCl (300 mg/mL at 25°C) and less soluble in chloroform (3 mg/mL at 25°C). Atenolol tablets are available as 25 mg, 50 mg and 100 mg tablets for oral administration. Inactive Ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate and sodium starch glycolate (potato).</Description>
</NDC>
<NDC>
<NDCCode>0378-0218-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE, PLASTIC (0378-0218-10) </PackageDescription>
<NDC11Code>00378-0218-10</NDC11Code>
<ProductNDC>0378-0218</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atenolol</ProprietaryName>
<NonProprietaryName>Atenolol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19990617</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA073457</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ATENOLOL</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19990617</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atenolol tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including atenolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Atenolol tablets may be administered with other antihypertensive agents.</IndicationAndUsage>
<Description>Atenolol, USP, a synthetic, beta1-selective (cardioselective) adrenoreceptor blocking agent, may be chemically described as Benzeneacetamide, 4-[2-hydroxy-3-[(1-methylethyl)amino] propoxy]-. The molecular and structural formulas are. Atenolol (free base) has a molecular weight of 266.34. It is a relatively polar hydrophilic compound with a water solubility of 26.5 mg/mL at 37°C and a log partition coefficient (octanol/water) of 0.23. It is freely soluble in 1N HCl (300 mg/mL at 25°C) and less soluble in chloroform (3 mg/mL at 25°C). Atenolol tablets are available as 25 mg, 50 mg and 100 mg tablets for oral administration. Inactive Ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate and sodium starch glycolate (potato).</Description>
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<IndicationAndUsage>Atenolol tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including atenolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Atenolol tablets may be administered with other antihypertensive agents.</IndicationAndUsage>
<Description>Atenolol, USP, a synthetic, beta1-selective (cardioselective) adrenoreceptor blocking agent, may be chemically described as Benzeneacetamide, 4-[2-hydroxy-3-[(1-methylethyl)amino] propoxy]-. The molecular and structural formulas are. Atenolol (free base) has a molecular weight of 266.34. It is a relatively polar hydrophilic compound with a water solubility of 26.5 mg/mL at 37°C and a log partition coefficient (octanol/water) of 0.23. It is freely soluble in 1N HCl (300 mg/mL at 25°C) and less soluble in chloroform (3 mg/mL at 25°C). Atenolol tablets are available as 25 mg, 50 mg and 100 mg tablets for oral administration. Inactive Ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate and sodium starch glycolate (potato).</Description>
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<IndicationAndUsage>Atenolol tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including atenolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Atenolol tablets may be administered with other antihypertensive agents.</IndicationAndUsage>
<Description>Atenolol, USP, a synthetic, beta1-selective (cardioselective) adrenoreceptor blocking agent, may be chemically described as Benzeneacetamide, 4-[2-hydroxy-3-[(1-methylethyl)amino] propoxy]-. The molecular and structural formulas are. Atenolol (free base) has a molecular weight of 266.34. It is a relatively polar hydrophilic compound with a water solubility of 26.5 mg/mL at 37°C and a log partition coefficient (octanol/water) of 0.23. It is freely soluble in 1N HCl (300 mg/mL at 25°C) and less soluble in chloroform (3 mg/mL at 25°C). Atenolol tablets are available as 25 mg, 50 mg and 100 mg tablets for oral administration. Inactive Ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate and sodium starch glycolate (potato).</Description>
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<NDC>
<NDCCode>0378-0265-91</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE, PLASTIC (0378-0265-91) </PackageDescription>
<NDC11Code>00378-0265-91</NDC11Code>
<ProductNDC>0378-0265</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dabigatran Etexilate</ProprietaryName>
<NonProprietaryName>Dabigatran Etexilate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250225</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208067</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
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<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-19</LastUpdate>
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<IndicationAndUsage>Dabigatran etexilate capsules are a direct thrombin inhibitor indicated: : 1 To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (1.1) , 2 For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5-10 days (1.2) , 3 To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated (1.3), 4 For the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery (1.4), 5 For the treatment of venous thromboembolic events (VTE) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days (1.5), 6 To reduce the risk of recurrence of VTE in pediatric patients 8 to less than 18 years of age who have been previously treated (1.6).</IndicationAndUsage>
<Description>The chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is Ethyl 3-{[(2-{[(4-{[(hexyloxy)carbonyl]carbamimidoyl}phenyl)amino]methyl}-1-methyl-1H-benzimidazol-5-yl)carbonyl](pyridin-2-yl)amino}propanoate, monomethanesulfonate. The empirical formula is C34H41N7O5CH4O3S and the molecular weight is 723.86 (mesylate salt), 627.75 (free base). The structural formula is. Dabigatran etexilate mesylate is a white to yellow powder. A saturated solution in pure water has a solubility of 1.8 mg/mL. It is freely soluble in methanol, slightly soluble in ethanol, and sparingly soluble in isopropanol. Dabigatran etexilate capsules are supplied in 75 mg and 150 mg strengths for oral administration. Each capsule contains dabigatran etexilate mesylate as the active ingredient: 150 mg dabigatran etexilate (equivalent to 172.95 mg dabigatran etexilate mesylate) or 75 mg dabigatran etexilate (equivalent to 86.48 mg dabigatran etexilate mesylate) along with the following inactive ingredients: colloidal silicon dioxide, crospovidone, fumaric acid, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate and titanium dioxide. The 150 mg capsules also contain black iron oxide and red iron oxide. In addition, the black imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
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<NDCCode>0378-0266-91</NDCCode>
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<ProductNDC>0378-0266</ProductNDC>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208067</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>DABIGATRAN ETEXILATE MESYLATE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250225</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dabigatran etexilate capsules are a direct thrombin inhibitor indicated: : 1 To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (1.1) , 2 For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5-10 days (1.2) , 3 To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated (1.3), 4 For the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery (1.4), 5 For the treatment of venous thromboembolic events (VTE) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days (1.5), 6 To reduce the risk of recurrence of VTE in pediatric patients 8 to less than 18 years of age who have been previously treated (1.6).</IndicationAndUsage>
<Description>The chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is Ethyl 3-{[(2-{[(4-{[(hexyloxy)carbonyl]carbamimidoyl}phenyl)amino]methyl}-1-methyl-1H-benzimidazol-5-yl)carbonyl](pyridin-2-yl)amino}propanoate, monomethanesulfonate. The empirical formula is C34H41N7O5CH4O3S and the molecular weight is 723.86 (mesylate salt), 627.75 (free base). The structural formula is. Dabigatran etexilate mesylate is a white to yellow powder. A saturated solution in pure water has a solubility of 1.8 mg/mL. It is freely soluble in methanol, slightly soluble in ethanol, and sparingly soluble in isopropanol. Dabigatran etexilate capsules are supplied in 75 mg and 150 mg strengths for oral administration. Each capsule contains dabigatran etexilate mesylate as the active ingredient: 150 mg dabigatran etexilate (equivalent to 172.95 mg dabigatran etexilate mesylate) or 75 mg dabigatran etexilate (equivalent to 86.48 mg dabigatran etexilate mesylate) along with the following inactive ingredients: colloidal silicon dioxide, crospovidone, fumaric acid, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate and titanium dioxide. The 150 mg capsules also contain black iron oxide and red iron oxide. In addition, the black imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
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<NDCCode>0378-0757-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (0378-0757-01) </PackageDescription>
<NDC11Code>00378-0757-01</NDC11Code>
<ProductNDC>0378-0757</ProductNDC>
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<ProprietaryName>Atenolol</ProprietaryName>
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<StartMarketingDate>19920124</StartMarketingDate>
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<ApplicationNumber>ANDA073457</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ATENOLOL</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19920124</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Atenolol tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including atenolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Atenolol tablets may be administered with other antihypertensive agents.</IndicationAndUsage>
<Description>Atenolol, USP, a synthetic, beta1-selective (cardioselective) adrenoreceptor blocking agent, may be chemically described as Benzeneacetamide, 4-[2-hydroxy-3-[(1-methylethyl)amino] propoxy]-. The molecular and structural formulas are. Atenolol (free base) has a molecular weight of 266.34. It is a relatively polar hydrophilic compound with a water solubility of 26.5 mg/mL at 37°C and a log partition coefficient (octanol/water) of 0.23. It is freely soluble in 1N HCl (300 mg/mL at 25°C) and less soluble in chloroform (3 mg/mL at 25°C). Atenolol tablets are available as 25 mg, 50 mg and 100 mg tablets for oral administration. Inactive Ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate and sodium starch glycolate (potato).</Description>
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<NDCCode>0378-0757-10</NDCCode>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
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<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ATENOLOL</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
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<IndicationAndUsage>Atenolol tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including atenolol. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Atenolol tablets may be administered with other antihypertensive agents.</IndicationAndUsage>
<Description>Atenolol, USP, a synthetic, beta1-selective (cardioselective) adrenoreceptor blocking agent, may be chemically described as Benzeneacetamide, 4-[2-hydroxy-3-[(1-methylethyl)amino] propoxy]-. The molecular and structural formulas are. Atenolol (free base) has a molecular weight of 266.34. It is a relatively polar hydrophilic compound with a water solubility of 26.5 mg/mL at 37°C and a log partition coefficient (octanol/water) of 0.23. It is freely soluble in 1N HCl (300 mg/mL at 25°C) and less soluble in chloroform (3 mg/mL at 25°C). Atenolol tablets are available as 25 mg, 50 mg and 100 mg tablets for oral administration. Inactive Ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate and sodium starch glycolate (potato).</Description>
</NDC>
<NDC>
<NDCCode>0378-1086-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1086-01) </PackageDescription>
<NDC11Code>00378-1086-01</NDC11Code>
<ProductNDC>0378-1086</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Colchicine</ProprietaryName>
<NonProprietaryName>Colchicine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191125</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209470</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>COLCHICINE</SubstanceName>
<StrengthNumber>.6</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Alkaloid [EPC], Alkaloids [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191125</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Colchicine tablets are an alkaloid indicated for: 1 Prophylaxis and treatment of gout flares in adults (1.1). , 2 Familial Mediterranean fever (FMF) in adults and children 4 years or older (1.2). .</IndicationAndUsage>
<Description>Colchicine is an alkaloid chemically described as Acetamide, N-(5,6,7,9-tetrahydro-1,2,3,10-tetramethoxy-9-oxobenzo[a]heptalen-7-yl)-, (S)- with a molecular formula of C22H25NO6 and a molecular weight of 399.44. The structural formula of colchicine is given below. Colchicine, USP occurs as a white to pale yellow powder that is soluble in water. Colchicine tablets, USP are supplied for oral administration as red, film-coated, oval, scored tablets (0.1770” × 0.3240”), debossed with M on one side of the tablet and CC to the left of the score and 2 to the right of the score on the other side, containing 0.6 mg of the active ingredient colchicine, USP. Inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn), polydextrose, polyethylene glycol, red iron oxide, sodium starch glycolate (potato), titanium dioxide and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>0378-1134-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1134-01) </PackageDescription>
<NDC11Code>00378-1134-01</NDC11Code>
<ProductNDC>0378-1134</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ketorolac Tromethamine</ProprietaryName>
<NonProprietaryName>Ketorolac Tromethamine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130516</StartMarketingDate>
<EndMarketingDate>20280731</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074761</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>KETOROLAC TROMETHAMINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-06-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20130516</StartMarketingDatePackage>
<EndMarketingDatePackage>20280731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carefully consider the potential benefits and risks of ketorolac tromethamine tablets and other treatment options before deciding to use ketorolac tromethamine tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.</IndicationAndUsage>
<Description>Ketorolac tromethamine is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs). The chemical name for ketorolac tromethamine is (±)-5-Benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol, and the structural formula is. Ketorolac tromethamine is a racemic mixture of [-]S and [+]R ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. Ketorolac tromethamine has a pKa of 3.5 and an n-octanol/water partition coefficient of 0.26. The molecular weight of ketorolac tromethamine is 376.41. Each tablet for oral administration contains 10 mg ketorolac tromethamine, USP. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, glyceryl triacetate, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium lauryl sulfate and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0378-1700-05</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE, PLASTIC (0378-1700-05) </PackageDescription>
<NDC11Code>00378-1700-05</NDC11Code>
<ProductNDC>0378-1700</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nitrofurantoin (macrocrystals)</ProprietaryName>
<NonProprietaryName>Nitrofurantoin (macrocrystals)</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040921</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077025</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>NITROFURANTOIN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Nitrofurans [CS],Nitrofuran Antibacterial [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-01-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20040921</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0378-2045-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE, PLASTIC (0378-2045-01) </PackageDescription>
<NDC11Code>00378-2045-01</NDC11Code>
<ProductNDC>0378-2045</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tacrolimus</ProprietaryName>
<NonProprietaryName>Tacrolimus</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100917</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090596</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>TACROLIMUS</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100917</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tacrolimus capsules are a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric patients receiving allogeneic liver, kidney, or heart transplants, in combination with other immunosuppressants. (1.1).</IndicationAndUsage>
<Description>Tacrolimus, previously known as FK506, is the active ingredient in tacrolimus capsules. Tacrolimus is a calcineurin-inhibitor immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus is designated as (‒)-(3S,4R,5S,8R,9E,12S,14S,15R,16S,18R,19R,26aS)-8-Allyl-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[(E)-2-[(1R,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylvinyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-15,19-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone monohydrate. The chemical structure of tacrolimus is. Tacrolimus has a molecular formula of C44H69NO12H2O and a formula weight of 822.03. Tacrolimus, USP appears as a white to off-white powder. It is insoluble in water, very soluble in ethanol, and soluble in methanol and chloroform. Tacrolimus capsules, USP are available for oral administration as capsules containing the equivalent of 0.5 mg, 1 mg or 5 mg of anhydrous tacrolimus. Inactive ingredients include anhydrous lactose, black iron oxide, colloidal silicon dioxide, croscarmellose sodium, gelatin, hypromellose, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, titanium dioxide and yellow iron oxide. The 0.5 mg capsules also contain D&C Red No. 28, D&C Yellow No. 10 and FD&C Red No. 40, the 1 mg capsules also contain FD&C Blue No. 1 and FD&C Red No. 3 and the 5 mg capsules also contain D&C Red No. 33, D&C Red No. 28 and D&C Yellow No. 10. In addition, the black imprinting ink contains black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze. Meets USP Dissolution Test 5.</Description>
</NDC>
<NDC>
<NDCCode>0378-2046-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE, PLASTIC (0378-2046-01) </PackageDescription>
<NDC11Code>00378-2046-01</NDC11Code>
<ProductNDC>0378-2046</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tacrolimus</ProprietaryName>
<NonProprietaryName>Tacrolimus</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100917</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090596</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>TACROLIMUS</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100917</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tacrolimus capsules are a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric patients receiving allogeneic liver, kidney, or heart transplants, in combination with other immunosuppressants. (1.1).</IndicationAndUsage>
<Description>Tacrolimus, previously known as FK506, is the active ingredient in tacrolimus capsules. Tacrolimus is a calcineurin-inhibitor immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus is designated as (‒)-(3S,4R,5S,8R,9E,12S,14S,15R,16S,18R,19R,26aS)-8-Allyl-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[(E)-2-[(1R,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylvinyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-15,19-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone monohydrate. The chemical structure of tacrolimus is. Tacrolimus has a molecular formula of C44H69NO12H2O and a formula weight of 822.03. Tacrolimus, USP appears as a white to off-white powder. It is insoluble in water, very soluble in ethanol, and soluble in methanol and chloroform. Tacrolimus capsules, USP are available for oral administration as capsules containing the equivalent of 0.5 mg, 1 mg or 5 mg of anhydrous tacrolimus. Inactive ingredients include anhydrous lactose, black iron oxide, colloidal silicon dioxide, croscarmellose sodium, gelatin, hypromellose, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, titanium dioxide and yellow iron oxide. The 0.5 mg capsules also contain D&C Red No. 28, D&C Yellow No. 10 and FD&C Red No. 40, the 1 mg capsules also contain FD&C Blue No. 1 and FD&C Red No. 3 and the 5 mg capsules also contain D&C Red No. 33, D&C Red No. 28 and D&C Yellow No. 10. In addition, the black imprinting ink contains black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze. Meets USP Dissolution Test 5.</Description>
</NDC>
<NDC>
<NDCCode>0378-2047-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE, PLASTIC (0378-2047-01) </PackageDescription>
<NDC11Code>00378-2047-01</NDC11Code>
<ProductNDC>0378-2047</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tacrolimus</ProprietaryName>
<NonProprietaryName>Tacrolimus</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100917</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090596</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>TACROLIMUS</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100917</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tacrolimus capsules are a calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric patients receiving allogeneic liver, kidney, or heart transplants, in combination with other immunosuppressants. (1.1).</IndicationAndUsage>
<Description>Tacrolimus, previously known as FK506, is the active ingredient in tacrolimus capsules. Tacrolimus is a calcineurin-inhibitor immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus is designated as (‒)-(3S,4R,5S,8R,9E,12S,14S,15R,16S,18R,19R,26aS)-8-Allyl-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[(E)-2-[(1R,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylvinyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-15,19-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone monohydrate. The chemical structure of tacrolimus is. Tacrolimus has a molecular formula of C44H69NO12H2O and a formula weight of 822.03. Tacrolimus, USP appears as a white to off-white powder. It is insoluble in water, very soluble in ethanol, and soluble in methanol and chloroform. Tacrolimus capsules, USP are available for oral administration as capsules containing the equivalent of 0.5 mg, 1 mg or 5 mg of anhydrous tacrolimus. Inactive ingredients include anhydrous lactose, black iron oxide, colloidal silicon dioxide, croscarmellose sodium, gelatin, hypromellose, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, titanium dioxide and yellow iron oxide. The 0.5 mg capsules also contain D&C Red No. 28, D&C Yellow No. 10 and FD&C Red No. 40, the 1 mg capsules also contain FD&C Blue No. 1 and FD&C Red No. 3 and the 5 mg capsules also contain D&C Red No. 33, D&C Red No. 28 and D&C Yellow No. 10. In addition, the black imprinting ink contains black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze. Meets USP Dissolution Test 5.</Description>
</NDC>
<NDC>
<NDCCode>0378-2245-77</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-2245-77) </PackageDescription>
<NDC11Code>00378-2245-77</NDC11Code>
<ProductNDC>0378-2245</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Imatinib Mesylate</ProprietaryName>
<NonProprietaryName>Imatinib</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170928</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204644</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>IMATINIB MESYLATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170928</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Imatinib mesylate tablets are a kinase inhibitor indicated for the treatment of: 1 Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. (1.1), 2 Patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha therapy. (1.2), 3 Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL). (1.3), 4 Pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy. (1.4), 5 Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements. (1.5), 6 Adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-Kit mutation or with c-Kit mutational status unknown. (1.6), 7 Adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRα fusion kinase (mutational analysis or fluorescence in situ hybridization [FISH] demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFRα fusion kinase negative or unknown. (1.7), 8 Adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP). (1.8), 9 Patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST). (1.9) , 10 Adjuvant treatment of adult patients following resection of Kit (CD117) positive GIST. (1.10).</IndicationAndUsage>
<Description>Imatinib is a small molecule kinase inhibitor. Imatinib mesylate film-coated tablets are supplied as 100 mg or 400 mg tablets for oral administration. Each 100 mg tablet contains 119.5 mg of imatinib mesylate equivalent to 100 mg of imatinib free base. Each 400 mg tablet contains 478 mg of imatinib mesylate equivalent to 400 mg of imatinib free base. Imatinib mesylate is designated chemically as Benzamide, 4-[(4-methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]aminophenyl]-methanesulfonate salt and its structural formula is. Imatinib mesylate is a white to off-white to brownish or yellowish tinged crystalline powder. Its molecular formula is C29H31N7O CH4SO3 and its molecular weight is 589.71 g/mol. Imatinib mesylate is soluble in aqueous buffers less than or equal to pH 5.5 but is very slightly soluble to insoluble in neutral/alkaline aqueous buffers. In non-aqueous solvents, the drug substance is freely soluble to very slightly soluble in dimethyl sulfoxide, methanol, and ethanol, but is insoluble in n-octanol, acetone, and acetonitrile. Inactive Ingredients: colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, red iron oxide, talc, titanium dioxide and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>0378-2246-93</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-2246-93) </PackageDescription>
<NDC11Code>00378-2246-93</NDC11Code>
<ProductNDC>0378-2246</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Imatinib Mesylate</ProprietaryName>
<NonProprietaryName>Imatinib</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170928</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204644</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>IMATINIB MESYLATE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170928</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Imatinib mesylate tablets are a kinase inhibitor indicated for the treatment of: 1 Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. (1.1), 2 Patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha therapy. (1.2), 3 Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL). (1.3), 4 Pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy. (1.4), 5 Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements. (1.5), 6 Adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-Kit mutation or with c-Kit mutational status unknown. (1.6), 7 Adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRα fusion kinase (mutational analysis or fluorescence in situ hybridization [FISH] demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFRα fusion kinase negative or unknown. (1.7), 8 Adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP). (1.8), 9 Patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST). (1.9) , 10 Adjuvant treatment of adult patients following resection of Kit (CD117) positive GIST. (1.10).</IndicationAndUsage>
<Description>Imatinib is a small molecule kinase inhibitor. Imatinib mesylate film-coated tablets are supplied as 100 mg or 400 mg tablets for oral administration. Each 100 mg tablet contains 119.5 mg of imatinib mesylate equivalent to 100 mg of imatinib free base. Each 400 mg tablet contains 478 mg of imatinib mesylate equivalent to 400 mg of imatinib free base. Imatinib mesylate is designated chemically as Benzamide, 4-[(4-methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[[4-(3-pyridinyl)-2-pyrimidinyl]aminophenyl]-methanesulfonate salt and its structural formula is. Imatinib mesylate is a white to off-white to brownish or yellowish tinged crystalline powder. Its molecular formula is C29H31N7O CH4SO3 and its molecular weight is 589.71 g/mol. Imatinib mesylate is soluble in aqueous buffers less than or equal to pH 5.5 but is very slightly soluble to insoluble in neutral/alkaline aqueous buffers. In non-aqueous solvents, the drug substance is freely soluble to very slightly soluble in dimethyl sulfoxide, methanol, and ethanol, but is insoluble in n-octanol, acetone, and acetonitrile. Inactive Ingredients: colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, red iron oxide, talc, titanium dioxide and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>0378-2350-77</NDCCode>
<PackageDescription>90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (0378-2350-77) </PackageDescription>
<NDC11Code>00378-2350-77</NDC11Code>
<ProductNDC>0378-2350</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Esomeprazole Magnesium</ProprietaryName>
<NonProprietaryName>Esomeprazole Magnesium</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE PELLETS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150803</StartMarketingDate>
<EndMarketingDate>20261130</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078936</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ESOMEPRAZOLE MAGNESIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160111</StartMarketingDatePackage>
<EndMarketingDatePackage>20261130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Esomeprazole magnesium delayed-release capsules are a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules are indicated for the: 1 Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. (1.1), 2 Maintenance of healing of EE in adults. (1.2), 3 Short-term treatment of heartburn and other symptoms associated with GERD in adults and pediatric patients 12 years to 17 years of age. (1.3), 4 Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers. (1.4), 5 Helicobacter pylori eradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin. (1.5), 6 Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults. (1.6).</IndicationAndUsage>
<Description>The active ingredient in esomeprazole magnesium delayed-release capsules for oral administration is 1H-Benzimidazole,5-methoxy-2-[(S)-[4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl], magnesium salt (2:1), a PPI. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001). Its molecular formula is C34H36MgN6O6S2 with molecular weight of 713.12 on an anhydrous basis. The structural formula is. The magnesium salt is an off-white to pale cream colored powder. It is slightly soluble in water. The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. Esomeprazole magnesium is supplied in delayed-release capsules. Each esomeprazole magnesium delayed-release capsule contains 20 mg of esomeprazole (equivalent to 22.25 mg esomeprazole magnesium) or 40 mg of esomeprazole (equivalent to 44.50 mg esomeprazole magnesium) in the form of enteric-coated pellets with the following inactive ingredients: crospovidone, hydroxypropyl cellulose, mannitol, methacrylic acid-ethyl acrylate copolymer dispersion, sucrose, sugar spheres (corn starch and sucrose), talc, titanium dioxide and triethyl citrate. The capsule shells have the following inactive ingredients: gelatin and titanium dioxide, and may contain sodium lauryl sulfate. The imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.</Description>
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