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"IndicationAndUsage": "Lisinopril and Hydrochlorothiazide Tablets is 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 lisinopril and hydrochlorothiazide. 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. These fixed-dose combinations are not indicated for initial therapy (see DOSAGE AND ADMINISTRATION). In using Lisinopril and Hydrochlorothiazide Tablets, consideration should be given to the fact that an angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that lisinopril does not have a similar risk (see WARNINGS). In considering use of Lisinopril and Hydrochlorothiazide Tablets, it should be noted that Black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to non- Blacks (see WARNINGS, Head and Neck Angioedema).",
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"Description": "Lisinopril and Hydrochlorothiazide Tablets, USP combine an angiotensin converting enzyme inhibitor, lisinopril, USP and a diuretic, hydrochlorothiazide, USP. Lisinopril, USP a synthetic peptide derivative, is an oral long-acting angiotensin converting enzyme inhibitor. It is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21H31N3O52H2O and its structural formula is. Lisinopril, USP is a white to off-white, crystalline powder, with a molecular weight of 441.52. It is soluble in water, sparingly soluble in methanol, and practically insoluble in ethanol. Hydrochlorothiazide, USP is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide, USP is a white, or practically white, crystalline powder with a molecular weight of 297.74, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Lisinopril and Hydrochlorothiazide Tablets, USP are available for oral use in three tablet combinations of lisinopril with hydrochlorothiazide: Lisinopril and Hydrochlorothiazide Tablets USP, 10/12.5, which contains 10 mg lisinopril and 12.5 mg hydrochlorothiazide, USP; Lisinopril and Hydrochlorothiazide Tablets USP, 20/12.5, which contains 20 mg lisinopril, USP and 12.5 mg hydrochlorothiazide, USP; and Lisinopril and Hydrochlorothiazide Tablets USP, 20/25, which contains 20 mg lisinopril, USP and 25 mg hydrochlorothiazide, USP. Inactive ingredients are colloidal silicon dioxide, dibasic calcium phosphate, magnesium stearate, mannitol, and pregelatinized corn starch. The 10 mg/12.5 mg and 20 mg/25 mg tablets also contain FD&C Red #40 Aluminum Lake. The 20 mg/12.5 mg tablet also contains FD&C Blue #2 Aluminum Lake."
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"Description": "Lisinopril and Hydrochlorothiazide Tablets, USP combine an angiotensin converting enzyme inhibitor, lisinopril, USP and a diuretic, hydrochlorothiazide, USP. Lisinopril, USP a synthetic peptide derivative, is an oral long-acting angiotensin converting enzyme inhibitor. It is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21H31N3O52H2O and its structural formula is. Lisinopril, USP is a white to off-white, crystalline powder, with a molecular weight of 441.52. It is soluble in water, sparingly soluble in methanol, and practically insoluble in ethanol. Hydrochlorothiazide, USP is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide, USP is a white, or practically white, crystalline powder with a molecular weight of 297.74, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Lisinopril and Hydrochlorothiazide Tablets, USP are available for oral use in three tablet combinations of lisinopril with hydrochlorothiazide: Lisinopril and Hydrochlorothiazide Tablets USP, 10/12.5, which contains 10 mg lisinopril and 12.5 mg hydrochlorothiazide, USP; Lisinopril and Hydrochlorothiazide Tablets USP, 20/12.5, which contains 20 mg lisinopril, USP and 12.5 mg hydrochlorothiazide, USP; and Lisinopril and Hydrochlorothiazide Tablets USP, 20/25, which contains 20 mg lisinopril, USP and 25 mg hydrochlorothiazide, USP. Inactive ingredients are colloidal silicon dioxide, dibasic calcium phosphate, magnesium stearate, mannitol, and pregelatinized corn starch. The 10 mg/12.5 mg and 20 mg/25 mg tablets also contain FD&C Red #40 Aluminum Lake. The 20 mg/12.5 mg tablet also contains FD&C Blue #2 Aluminum Lake."
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"Description": "Lisinopril and Hydrochlorothiazide Tablets, USP combine an angiotensin converting enzyme inhibitor, lisinopril, USP and a diuretic, hydrochlorothiazide, USP. Lisinopril, USP a synthetic peptide derivative, is an oral long-acting angiotensin converting enzyme inhibitor. It is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21H31N3O52H2O and its structural formula is. Lisinopril, USP is a white to off-white, crystalline powder, with a molecular weight of 441.52. It is soluble in water, sparingly soluble in methanol, and practically insoluble in ethanol. Hydrochlorothiazide, USP is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide, USP is a white, or practically white, crystalline powder with a molecular weight of 297.74, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Lisinopril and Hydrochlorothiazide Tablets, USP are available for oral use in three tablet combinations of lisinopril with hydrochlorothiazide: Lisinopril and Hydrochlorothiazide Tablets USP, 10/12.5, which contains 10 mg lisinopril and 12.5 mg hydrochlorothiazide, USP; Lisinopril and Hydrochlorothiazide Tablets USP, 20/12.5, which contains 20 mg lisinopril, USP and 12.5 mg hydrochlorothiazide, USP; and Lisinopril and Hydrochlorothiazide Tablets USP, 20/25, which contains 20 mg lisinopril, USP and 25 mg hydrochlorothiazide, USP. Inactive ingredients are colloidal silicon dioxide, dibasic calcium phosphate, magnesium stearate, mannitol, and pregelatinized corn starch. The 10 mg/12.5 mg and 20 mg/25 mg tablets also contain FD&C Red #40 Aluminum Lake. The 20 mg/12.5 mg tablet also contains FD&C Blue #2 Aluminum Lake."
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"Pharm_Classes": "Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-12-02",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "0039-0060-50",
"PackageDescription": "500 TABLET in 1 BOTTLE (0039-0060-50)",
"NDC11Code": "00039-0060-50",
"ProductNDC": "0039-0060",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lasix",
"NonProprietaryName": "Furosemide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19660701",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA016273",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "FUROSEMIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-12-02",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "0039-0060-70",
"PackageDescription": "1000 TABLET in 1 BOTTLE (0039-0060-70)",
"NDC11Code": "00039-0060-70",
"ProductNDC": "0039-0060",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lasix",
"NonProprietaryName": "Furosemide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19660701",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA016273",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "FUROSEMIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-12-02",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "0168-0060-15",
"PackageDescription": "15 g in 1 TUBE (0168-0060-15)",
"NDC11Code": "00168-0060-15",
"ProductNDC": "0168-0060",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluocinolone Acetonide",
"NonProprietaryName": "Fluocinolone Acetonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19821216",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088169",
"LabelerName": "E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.",
"SubstanceName": "FLUOCINOLONE ACETONIDE",
"StrengthNumber": ".25",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "0168-0060-60",
"PackageDescription": "60 g in 1 TUBE (0168-0060-60)",
"NDC11Code": "00168-0060-60",
"ProductNDC": "0168-0060",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluocinolone Acetonide",
"NonProprietaryName": "Fluocinolone Acetonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19821216",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088169",
"LabelerName": "E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.",
"SubstanceName": "FLUOCINOLONE ACETONIDE",
"StrengthNumber": ".25",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "0179-0060-30",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (0179-0060-30)",
"NDC11Code": "00179-0060-30",
"ProductNDC": "0179-0060",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluoxetine Hydrochloride",
"NonProprietaryName": "Fluoxetine Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100414",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075245",
"LabelerName": "KAISER FOUNDATION HOSPITALS",
"SubstanceName": "FLUOXETINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-12-28",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0220-0060-41",
"PackageDescription": "5 [hp_C] in 1 TUBE (0220-0060-41) ",
"NDC11Code": "00220-0060-41",
"ProductNDC": "0220-0060",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Actaea Spicata",
"NonProprietaryName": "Actaea Spicata Root",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "19830303",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Boiron",
"SubstanceName": "ACTAEA SPICATA ROOT",
"StrengthNumber": "5",
"StrengthUnit": "[hp_C]/5[hp_C]",
"Status": "Active",
"LastUpdate": "2025-08-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19830303",
"SamplePackage": "N",
"IndicationAndUsage": "Relieves minor arthritis pain in fingers and toes *. Uses: See symptoms on front panel."
},
{
"NDCCode": "0268-0060-10",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (0268-0060-10) ",
"NDC11Code": "00268-0060-10",
"ProductNDC": "0268-0060",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Center-al - Populus Deltoides Ssp. Monilifera Pollen",
"NonProprietaryName": "Populus Deltoides Subsp. Monilifera Pollen",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "19750115",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103753",
"LabelerName": "ALK-Abello, Inc.",
"SubstanceName": "POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN",
"StrengthNumber": "10000",
"StrengthUnit": "[PNU]/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-05-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "19750115",
"SamplePackage": "N"
},
{
"NDCCode": "0268-0060-30",
"PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (0268-0060-30) ",
"NDC11Code": "00268-0060-30",
"ProductNDC": "0268-0060",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Center-al - Populus Deltoides Ssp. Monilifera Pollen",
"NonProprietaryName": "Populus Deltoides Subsp. Monilifera Pollen",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "19750115",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103753",
"LabelerName": "ALK-Abello, Inc.",
"SubstanceName": "POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN",
"StrengthNumber": "10000",
"StrengthUnit": "[PNU]/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]",
"Status": "Deprecated",
"LastUpdate": "2023-05-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "19750115",
"SamplePackage": "N"
},
{
"NDCCode": "0280-0060-01",
"PackageDescription": "10 POUCH in 1 CARTON (0280-0060-01) / 2 TABLET, EFFERVESCENT in 1 POUCH",
"NDC11Code": "00280-0060-01",
"ProductNDC": "0280-0060",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Alka-seltzer Plus Cold Sparkling Original Powerfast Fizz",
"NonProprietaryName": "Aspirin, Chlorpheniramine Maleate, Phenylephrine Bitartrate",
"DosageFormName": "TABLET, EFFERVESCENT",
"RouteName": "ORAL",
"StartMarketingDate": "20210615",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Bayer HealthCare LLC.",
"SubstanceName": "ASPIRIN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE BITARTRATE",
"StrengthNumber": "325; 2; 7.8",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210615",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to a cold: 1 minor aches and pains, 2 headache, 3 runny nose, 4 nasal congestion, 5 sneezing, 6 sore throat, 7 sinus congestion and pressure."
},
{
"NDCCode": "0280-0060-02",
"PackageDescription": "18 POUCH in 1 CARTON (0280-0060-02) / 2 TABLET, EFFERVESCENT in 1 POUCH",
"NDC11Code": "00280-0060-02",
"ProductNDC": "0280-0060",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Alka-seltzer Plus Cold Sparkling Original Powerfast Fizz",
"NonProprietaryName": "Aspirin, Chlorpheniramine Maleate, Phenylephrine Bitartrate",
"DosageFormName": "TABLET, EFFERVESCENT",
"RouteName": "ORAL",
"StartMarketingDate": "20210615",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Bayer HealthCare LLC.",
"SubstanceName": "ASPIRIN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE BITARTRATE",
"StrengthNumber": "325; 2; 7.8",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210615",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to a cold: 1 minor aches and pains, 2 headache, 3 runny nose, 4 nasal congestion, 5 sneezing, 6 sore throat, 7 sinus congestion and pressure."
},
{
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"PackageDescription": "2 POUCH in 1 CARTON (0280-0060-03) / 2 TABLET, EFFERVESCENT in 1 POUCH",
"NDC11Code": "00280-0060-03",
"ProductNDC": "0280-0060",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Alka-seltzer Plus Cold Sparkling Original Powerfast Fizz",
"NonProprietaryName": "Aspirin, Chlorpheniramine Maleate, Phenylephrine Bitartrate",
"DosageFormName": "TABLET, EFFERVESCENT",
"RouteName": "ORAL",
"StartMarketingDate": "20210615",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Bayer HealthCare LLC.",
"SubstanceName": "ASPIRIN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE BITARTRATE",
"StrengthNumber": "325; 2; 7.8",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220401",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to a cold: 1 minor aches and pains, 2 headache, 3 runny nose, 4 nasal congestion, 5 sneezing, 6 sore throat, 7 sinus congestion and pressure."
},
{
"NDCCode": "0280-0060-04",
"PackageDescription": "12 POUCH in 1 CARTON (0280-0060-04) / 2 TABLET, EFFERVESCENT in 1 POUCH",
"NDC11Code": "00280-0060-04",
"ProductNDC": "0280-0060",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Alka-seltzer Plus Cold Sparkling Original Powerfast Fizz",
"NonProprietaryName": "Aspirin, Chlorpheniramine Maleate, Phenylephrine Bitartrate",
"DosageFormName": "TABLET, EFFERVESCENT",
"RouteName": "ORAL",
"StartMarketingDate": "20210615",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Bayer HealthCare LLC.",
"SubstanceName": "ASPIRIN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE BITARTRATE",
"StrengthNumber": "325; 2; 7.8",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230330",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to a cold: 1 minor aches and pains, 2 headache, 3 runny nose, 4 nasal congestion, 5 sneezing, 6 sore throat, 7 sinus congestion and pressure."
},
{
"NDCCode": "0280-0060-05",
"PackageDescription": "2 TABLET, EFFERVESCENT in 1 POUCH (0280-0060-05) ",
"NDC11Code": "00280-0060-05",
"ProductNDC": "0280-0060",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Alka-seltzer Plus Cold Sparkling Original Powerfast Fizz",
"NonProprietaryName": "Aspirin, Chlorpheniramine Maleate, Phenylephrine Bitartrate",
"DosageFormName": "TABLET, EFFERVESCENT",
"RouteName": "ORAL",
"StartMarketingDate": "20210615",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Bayer HealthCare LLC.",
"SubstanceName": "ASPIRIN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE BITARTRATE",
"StrengthNumber": "325; 2; 7.8",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210615",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to a cold: 1 minor aches and pains, 2 headache, 3 runny nose, 4 nasal congestion, 5 sneezing, 6 sore throat, 7 sinus congestion and pressure."
},
{
"NDCCode": "0280-0060-06",
"PackageDescription": "24 POUCH in 1 CARTON (0280-0060-06) / 2 TABLET, EFFERVESCENT in 1 POUCH",
"NDC11Code": "00280-0060-06",
"ProductNDC": "0280-0060",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Alka-seltzer Plus Cold Sparkling Original Powerfast Fizz",
"NonProprietaryName": "Aspirin, Chlorpheniramine Maleate, Phenylephrine Bitartrate",
"DosageFormName": "TABLET, EFFERVESCENT",
"RouteName": "ORAL",
"StartMarketingDate": "20210615",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Bayer HealthCare LLC.",
"SubstanceName": "ASPIRIN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE BITARTRATE",
"StrengthNumber": "325; 2; 7.8",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230330",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to a cold: 1 minor aches and pains, 2 headache, 3 runny nose, 4 nasal congestion, 5 sneezing, 6 sore throat, 7 sinus congestion and pressure."
},
{
"NDCCode": "0363-0060-24",
"PackageDescription": "24 BLISTER PACK in 1 CARTON (0363-0060-24) > 2 CAPSULE, GELATIN COATED in 1 BLISTER PACK",
"NDC11Code": "00363-0060-24",
"ProductNDC": "0363-0060",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Wal-sleep Z",
"ProprietaryNameSuffix": "Diphenhydramine Hcl / Sleep Aid",
"NonProprietaryName": "Diphenhydramine Hydrochloride",
"DosageFormName": "CAPSULE, GELATIN COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20111208",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part338",
"LabelerName": "Walgreen Company",
"SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/21",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "for the relief of occasional sleeplessness. reduces time to fall asleep if you have difficulty falling asleep."
},
{
"NDCCode": "0378-0060-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0060-01) ",
"NDC11Code": "00378-0060-01",
"ProductNDC": "0378-0060",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Maprotiline Hydrochloride",
"NonProprietaryName": "Maprotiline Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19881003",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072285",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "MAPROTILINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2021-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "19881003",
"SamplePackage": "N"
},
{
"NDCCode": "0456-0060-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (0456-0060-01) ",
"NDC11Code": "00456-0060-01",
"ProductNDC": "0456-0060",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Thyrolar",
"NonProprietaryName": "Liothyronine Sodium, Levothyroxine Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19691121",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA016807",
"LabelerName": "Allergan, Inc.",
"SubstanceName": "LIOTHYRONINE SODIUM; LEVOTHYROXINE SODIUM",
"StrengthNumber": "37.5; 150",
"StrengthUnit": "ug/1; ug/1",
"Pharm_Classes": "l-Triiodothyronine [EPC],Triiodothyronine [CS],l-Thyroxine [EPC],Thyroxine [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-11-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "19691121",
"SamplePackage": "N"
},
{
"NDCCode": "10210-0060-1",
"PackageDescription": "1 KIT in 1 BLISTER PACK (10210-0060-1) / 1 KIT in 1 KIT * 10 g in 1 TUBE (10210-0022-6) * 4.25 g in 1 CYLINDER (10210-0030-1) ",
"NDC11Code": "10210-0060-01",
"ProductNDC": "10210-0060",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Carmex Classic Lip Balm Medicated Free Cupcake Batter Stick Sunscreen Spf 15",
"NonProprietaryName": "Camphor (synthetic), White Petrolatum, Octinoxate, Oxybenzone",
"DosageFormName": "KIT",
"StartMarketingDate": "20230101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Carma Laboratories, Inc.",
"Status": "Active",
"LastUpdate": "2023-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230101",
"SamplePackage": "N"
},
{
"NDCCode": "10828-0060-6",
"PackageDescription": "25 kg in 1 DRUM (10828-0060-6)",
"NDC11Code": "10828-0060-06",
"ProductNDC": "10828-0060",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Ciprofloxacin",
"DosageFormName": "POWDER",
"StartMarketingDate": "20090101",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Smruthi Organics Limited",
"SubstanceName": "CIPROFLOXACIN",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "11014-0060-1",
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<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisinopril and Hydrochlorothiazide Tablets is 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 lisinopril and hydrochlorothiazide. 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. These fixed-dose combinations are not indicated for initial therapy (see DOSAGE AND ADMINISTRATION). In using Lisinopril and Hydrochlorothiazide Tablets, consideration should be given to the fact that an angiotensin converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that lisinopril does not have a similar risk (see WARNINGS). In considering use of Lisinopril and Hydrochlorothiazide Tablets, it should be noted that Black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to non- Blacks (see WARNINGS, Head and Neck Angioedema).</IndicationAndUsage>
<Description>Lisinopril and Hydrochlorothiazide Tablets, USP combine an angiotensin converting enzyme inhibitor, lisinopril, USP and a diuretic, hydrochlorothiazide, USP. Lisinopril, USP a synthetic peptide derivative, is an oral long-acting angiotensin converting enzyme inhibitor. It is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21H31N3O52H2O and its structural formula is. Lisinopril, USP is a white to off-white, crystalline powder, with a molecular weight of 441.52. It is soluble in water, sparingly soluble in methanol, and practically insoluble in ethanol. Hydrochlorothiazide, USP is 6-chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide, USP is a white, or practically white, crystalline powder with a molecular weight of 297.74, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Lisinopril and Hydrochlorothiazide Tablets, USP are available for oral use in three tablet combinations of lisinopril with hydrochlorothiazide: Lisinopril and Hydrochlorothiazide Tablets USP, 10/12.5, which contains 10 mg lisinopril and 12.5 mg hydrochlorothiazide, USP; Lisinopril and Hydrochlorothiazide Tablets USP, 20/12.5, which contains 20 mg lisinopril, USP and 12.5 mg hydrochlorothiazide, USP; and Lisinopril and Hydrochlorothiazide Tablets USP, 20/25, which contains 20 mg lisinopril, USP and 25 mg hydrochlorothiazide, USP. Inactive ingredients are colloidal silicon dioxide, dibasic calcium phosphate, magnesium stearate, mannitol, and pregelatinized corn starch. The 10 mg/12.5 mg and 20 mg/25 mg tablets also contain FD&C Red #40 Aluminum Lake. The 20 mg/12.5 mg tablet also contains FD&C Blue #2 Aluminum Lake.</Description>
</NDC>
<NDC>
<NDCCode>0009-0060-01</NDCCode>
<PackageDescription>100 kg in 1 DRUM (0009-0060-01)</PackageDescription>
<NDC11Code>00009-0060-01</NDC11Code>
<ProductNDC>0009-0060</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Eplerenone</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20150826</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Pharmacia and Upjohn Company LLC</LabelerName>
<SubstanceName>EPLERENONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0039-0060-13</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0039-0060-13)</PackageDescription>
<NDC11Code>00039-0060-13</NDC11Code>
<ProductNDC>0039-0060</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lasix</ProprietaryName>
<NonProprietaryName>Furosemide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19660701</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA016273</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>FUROSEMIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-12-02</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0039-0060-50</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (0039-0060-50)</PackageDescription>
<NDC11Code>00039-0060-50</NDC11Code>
<ProductNDC>0039-0060</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lasix</ProprietaryName>
<NonProprietaryName>Furosemide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19660701</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA016273</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>FUROSEMIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-12-02</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0039-0060-70</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (0039-0060-70)</PackageDescription>
<NDC11Code>00039-0060-70</NDC11Code>
<ProductNDC>0039-0060</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lasix</ProprietaryName>
<NonProprietaryName>Furosemide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19660701</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA016273</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>FUROSEMIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Diuresis at Loop of Henle [PE],Loop Diuretic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-12-02</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0168-0060-15</NDCCode>
<PackageDescription>15 g in 1 TUBE (0168-0060-15)</PackageDescription>
<NDC11Code>00168-0060-15</NDC11Code>
<ProductNDC>0168-0060</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluocinolone Acetonide</ProprietaryName>
<NonProprietaryName>Fluocinolone Acetonide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19821216</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088169</ApplicationNumber>
<LabelerName>E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.</LabelerName>
<SubstanceName>FLUOCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0168-0060-60</NDCCode>
<PackageDescription>60 g in 1 TUBE (0168-0060-60)</PackageDescription>
<NDC11Code>00168-0060-60</NDC11Code>
<ProductNDC>0168-0060</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluocinolone Acetonide</ProprietaryName>
<NonProprietaryName>Fluocinolone Acetonide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19821216</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088169</ApplicationNumber>
<LabelerName>E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.</LabelerName>
<SubstanceName>FLUOCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0179-0060-30</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (0179-0060-30)</PackageDescription>
<NDC11Code>00179-0060-30</NDC11Code>
<ProductNDC>0179-0060</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluoxetine Hydrochloride</ProprietaryName>
<NonProprietaryName>Fluoxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100414</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075245</ApplicationNumber>
<LabelerName>KAISER FOUNDATION HOSPITALS</LabelerName>
<SubstanceName>FLUOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-12-28</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0220-0060-41</NDCCode>
<PackageDescription>5 [hp_C] in 1 TUBE (0220-0060-41) </PackageDescription>
<NDC11Code>00220-0060-41</NDC11Code>
<ProductNDC>0220-0060</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Actaea Spicata</ProprietaryName>
<NonProprietaryName>Actaea Spicata Root</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19830303</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Boiron</LabelerName>
<SubstanceName>ACTAEA SPICATA ROOT</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>[hp_C]/5[hp_C]</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-08-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19830303</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Relieves minor arthritis pain in fingers and toes *. Uses: See symptoms on front panel.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0268-0060-10</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (0268-0060-10) </PackageDescription>
<NDC11Code>00268-0060-10</NDC11Code>
<ProductNDC>0268-0060</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Center-al - Populus Deltoides Ssp. Monilifera Pollen</ProprietaryName>
<NonProprietaryName>Populus Deltoides Subsp. Monilifera Pollen</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>19750115</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103753</ApplicationNumber>
<LabelerName>ALK-Abello, Inc.</LabelerName>
<SubstanceName>POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN</SubstanceName>
<StrengthNumber>10000</StrengthNumber>
<StrengthUnit>[PNU]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-05-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19750115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0268-0060-30</NDCCode>
<PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (0268-0060-30) </PackageDescription>
<NDC11Code>00268-0060-30</NDC11Code>
<ProductNDC>0268-0060</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Center-al - Populus Deltoides Ssp. Monilifera Pollen</ProprietaryName>
<NonProprietaryName>Populus Deltoides Subsp. Monilifera Pollen</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>19750115</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103753</ApplicationNumber>
<LabelerName>ALK-Abello, Inc.</LabelerName>
<SubstanceName>POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN</SubstanceName>
<StrengthNumber>10000</StrengthNumber>
<StrengthUnit>[PNU]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-05-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19750115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0280-0060-01</NDCCode>
<PackageDescription>10 POUCH in 1 CARTON (0280-0060-01) / 2 TABLET, EFFERVESCENT in 1 POUCH</PackageDescription>
<NDC11Code>00280-0060-01</NDC11Code>
<ProductNDC>0280-0060</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Alka-seltzer Plus Cold Sparkling Original Powerfast Fizz</ProprietaryName>
<NonProprietaryName>Aspirin, Chlorpheniramine Maleate, Phenylephrine Bitartrate</NonProprietaryName>
<DosageFormName>TABLET, EFFERVESCENT</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210615</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Bayer HealthCare LLC.</LabelerName>
<SubstanceName>ASPIRIN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE BITARTRATE</SubstanceName>
<StrengthNumber>325; 2; 7.8</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210615</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to a cold: 1 minor aches and pains, 2 headache, 3 runny nose, 4 nasal congestion, 5 sneezing, 6 sore throat, 7 sinus congestion and pressure.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0280-0060-02</NDCCode>
<PackageDescription>18 POUCH in 1 CARTON (0280-0060-02) / 2 TABLET, EFFERVESCENT in 1 POUCH</PackageDescription>
<NDC11Code>00280-0060-02</NDC11Code>
<ProductNDC>0280-0060</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Alka-seltzer Plus Cold Sparkling Original Powerfast Fizz</ProprietaryName>
<NonProprietaryName>Aspirin, Chlorpheniramine Maleate, Phenylephrine Bitartrate</NonProprietaryName>
<DosageFormName>TABLET, EFFERVESCENT</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210615</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Bayer HealthCare LLC.</LabelerName>
<SubstanceName>ASPIRIN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE BITARTRATE</SubstanceName>
<StrengthNumber>325; 2; 7.8</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210615</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to a cold: 1 minor aches and pains, 2 headache, 3 runny nose, 4 nasal congestion, 5 sneezing, 6 sore throat, 7 sinus congestion and pressure.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0280-0060-03</NDCCode>
<PackageDescription>2 POUCH in 1 CARTON (0280-0060-03) / 2 TABLET, EFFERVESCENT in 1 POUCH</PackageDescription>
<NDC11Code>00280-0060-03</NDC11Code>
<ProductNDC>0280-0060</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Alka-seltzer Plus Cold Sparkling Original Powerfast Fizz</ProprietaryName>
<NonProprietaryName>Aspirin, Chlorpheniramine Maleate, Phenylephrine Bitartrate</NonProprietaryName>
<DosageFormName>TABLET, EFFERVESCENT</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210615</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Bayer HealthCare LLC.</LabelerName>
<SubstanceName>ASPIRIN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE BITARTRATE</SubstanceName>
<StrengthNumber>325; 2; 7.8</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to a cold: 1 minor aches and pains, 2 headache, 3 runny nose, 4 nasal congestion, 5 sneezing, 6 sore throat, 7 sinus congestion and pressure.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0280-0060-04</NDCCode>
<PackageDescription>12 POUCH in 1 CARTON (0280-0060-04) / 2 TABLET, EFFERVESCENT in 1 POUCH</PackageDescription>
<NDC11Code>00280-0060-04</NDC11Code>
<ProductNDC>0280-0060</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Alka-seltzer Plus Cold Sparkling Original Powerfast Fizz</ProprietaryName>
<NonProprietaryName>Aspirin, Chlorpheniramine Maleate, Phenylephrine Bitartrate</NonProprietaryName>
<DosageFormName>TABLET, EFFERVESCENT</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210615</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Bayer HealthCare LLC.</LabelerName>
<SubstanceName>ASPIRIN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE BITARTRATE</SubstanceName>
<StrengthNumber>325; 2; 7.8</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to a cold: 1 minor aches and pains, 2 headache, 3 runny nose, 4 nasal congestion, 5 sneezing, 6 sore throat, 7 sinus congestion and pressure.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0280-0060-05</NDCCode>
<PackageDescription>2 TABLET, EFFERVESCENT in 1 POUCH (0280-0060-05) </PackageDescription>
<NDC11Code>00280-0060-05</NDC11Code>
<ProductNDC>0280-0060</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Alka-seltzer Plus Cold Sparkling Original Powerfast Fizz</ProprietaryName>
<NonProprietaryName>Aspirin, Chlorpheniramine Maleate, Phenylephrine Bitartrate</NonProprietaryName>
<DosageFormName>TABLET, EFFERVESCENT</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210615</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Bayer HealthCare LLC.</LabelerName>
<SubstanceName>ASPIRIN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE BITARTRATE</SubstanceName>
<StrengthNumber>325; 2; 7.8</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210615</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to a cold: 1 minor aches and pains, 2 headache, 3 runny nose, 4 nasal congestion, 5 sneezing, 6 sore throat, 7 sinus congestion and pressure.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0280-0060-06</NDCCode>
<PackageDescription>24 POUCH in 1 CARTON (0280-0060-06) / 2 TABLET, EFFERVESCENT in 1 POUCH</PackageDescription>
<NDC11Code>00280-0060-06</NDC11Code>
<ProductNDC>0280-0060</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Alka-seltzer Plus Cold Sparkling Original Powerfast Fizz</ProprietaryName>
<NonProprietaryName>Aspirin, Chlorpheniramine Maleate, Phenylephrine Bitartrate</NonProprietaryName>
<DosageFormName>TABLET, EFFERVESCENT</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210615</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Bayer HealthCare LLC.</LabelerName>
<SubstanceName>ASPIRIN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE BITARTRATE</SubstanceName>
<StrengthNumber>325; 2; 7.8</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to a cold: 1 minor aches and pains, 2 headache, 3 runny nose, 4 nasal congestion, 5 sneezing, 6 sore throat, 7 sinus congestion and pressure.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0363-0060-24</NDCCode>
<PackageDescription>24 BLISTER PACK in 1 CARTON (0363-0060-24) > 2 CAPSULE, GELATIN COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00363-0060-24</NDC11Code>
<ProductNDC>0363-0060</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Wal-sleep Z</ProprietaryName>
<ProprietaryNameSuffix>Diphenhydramine Hcl / Sleep Aid</ProprietaryNameSuffix>
<NonProprietaryName>Diphenhydramine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, GELATIN COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111208</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part338</ApplicationNumber>
<LabelerName>Walgreen Company</LabelerName>
<SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/21</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>for the relief of occasional sleeplessness. reduces time to fall asleep if you have difficulty falling asleep.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0378-0060-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0060-01) </PackageDescription>
<NDC11Code>00378-0060-01</NDC11Code>
<ProductNDC>0378-0060</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Maprotiline Hydrochloride</ProprietaryName>
<NonProprietaryName>Maprotiline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19881003</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072285</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>MAPROTILINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19881003</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0456-0060-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0456-0060-01) </PackageDescription>
<NDC11Code>00456-0060-01</NDC11Code>
<ProductNDC>0456-0060</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Thyrolar</ProprietaryName>
<NonProprietaryName>Liothyronine Sodium, Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19691121</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA016807</ApplicationNumber>
<LabelerName>Allergan, Inc.</LabelerName>
<SubstanceName>LIOTHYRONINE SODIUM; LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>37.5; 150</StrengthNumber>
<StrengthUnit>ug/1; ug/1</StrengthUnit>
<Pharm_Classes>l-Triiodothyronine [EPC],Triiodothyronine [CS],l-Thyroxine [EPC],Thyroxine [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-11-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19691121</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>10210-0060-1</NDCCode>
<PackageDescription>1 KIT in 1 BLISTER PACK (10210-0060-1) / 1 KIT in 1 KIT * 10 g in 1 TUBE (10210-0022-6) * 4.25 g in 1 CYLINDER (10210-0030-1) </PackageDescription>
<NDC11Code>10210-0060-01</NDC11Code>
<ProductNDC>10210-0060</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Carmex Classic Lip Balm Medicated Free Cupcake Batter Stick Sunscreen Spf 15</ProprietaryName>
<NonProprietaryName>Camphor (synthetic), White Petrolatum, Octinoxate, Oxybenzone</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20230101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Carma Laboratories, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2023-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>10828-0060-6</NDCCode>
<PackageDescription>25 kg in 1 DRUM (10828-0060-6)</PackageDescription>
<NDC11Code>10828-0060-06</NDC11Code>
<ProductNDC>10828-0060</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Ciprofloxacin</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20090101</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Smruthi Organics Limited</LabelerName>
<SubstanceName>CIPROFLOXACIN</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>11014-0060-1</NDCCode>
<PackageDescription>1 BOTTLE in 1 PACKAGE (11014-0060-1) > 30 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>11014-0060-01</NDC11Code>
<ProductNDC>11014-0060</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Povidone-iodine</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<StartMarketingDate>20000401</StartMarketingDate>
<EndMarketingDate>20180321</EndMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Catalent Pharma Solutions, LLC</LabelerName>
<SubstanceName>POVIDONE-IODINE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20180321</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>11822-0060-1</NDCCode>
<PackageDescription>42 g in 1 CONTAINER (11822-0060-1) </PackageDescription>
<NDC11Code>11822-0060-01</NDC11Code>
<ProductNDC>11822-0060</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Rite Aid Mineral Zinc Oxide Sunscreen Broad Spectrum Spf 50</ProprietaryName>
<NonProprietaryName>Zinc Oxide</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230208</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Rite Aid</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
<StrengthNumber>216</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-11-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230208</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>12828-0060-1</NDCCode>
<PackageDescription>25 kg in 1 DRUM (12828-0060-1) </PackageDescription>
<NDC11Code>12828-0060-01</NDC11Code>
<ProductNDC>12828-0060</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Clonazepam</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>19960308</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Cambrex Profarmaco Milano Srl</LabelerName>
<SubstanceName>CLONAZEPAM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Unfinished</Status>
<LastUpdate>2023-02-09</LastUpdate>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>08-MAR-96</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>12828-0060-2</NDCCode>
<PackageDescription>5 kg in 1 DRUM (12828-0060-2) </PackageDescription>
<NDC11Code>12828-0060-02</NDC11Code>
<ProductNDC>12828-0060</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Clonazepam</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>19960308</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Cambrex Profarmaco Milano Srl</LabelerName>
<SubstanceName>CLONAZEPAM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Unfinished</Status>
<LastUpdate>2023-02-09</LastUpdate>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>08-MAR-96</StartMarketingDatePackage>
</NDC>
</NDCList>