{
"NDC": [
{
"NDCCode": "64942-1637-1",
"PackageDescription": "400 mL in 1 CONTAINER (64942-1637-1) ",
"NDC11Code": "64942-1637-01",
"ProductNDC": "64942-1637",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Re-fresh Scalp Care",
"NonProprietaryName": "Salicylic Acid",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190510",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part358H",
"LabelerName": "Conopco, Inc. d/b/a/ Unilever",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": "2",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2023-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20190510",
"SamplePackage": "N",
"IndicationAndUsage": " Helps prevent and control recurrence of itching and flaking associated with dandruff.",
"Description": "RE-fresh Scalp Care Sea Mineral + Hydrate Anti-Dandruff Conditioner."
},
{
"NDCCode": "0395-1637-92",
"PackageDescription": "59 mL in 1 BOTTLE (0395-1637-92)",
"NDC11Code": "00395-1637-92",
"ProductNDC": "0395-1637",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Humco Mercuroclear",
"NonProprietaryName": "Benzalkonium Chloride And Lidocaine Hydrochloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "19990225",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Humco Holding Group, Inc",
"SubstanceName": "BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE",
"StrengthNumber": "1.3; 25",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2017-08-29"
},
{
"NDCCode": "0395-1637-93",
"PackageDescription": "90 mL in 1 BOTTLE, SPRAY (0395-1637-93)",
"NDC11Code": "00395-1637-93",
"ProductNDC": "0395-1637",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Humco Mercuroclear",
"NonProprietaryName": "Benzalkonium Chloride And Lidocaine Hydrochloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "19990225",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Humco Holding Group, Inc",
"SubstanceName": "BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE",
"StrengthNumber": "1.3; 25",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2017-08-29"
},
{
"NDCCode": "10191-1637-2",
"PackageDescription": "137 PELLET in 1 VIAL, GLASS (10191-1637-2)",
"NDC11Code": "10191-1637-02",
"ProductNDC": "10191-1637",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mercurius Solubilis",
"NonProprietaryName": "Soluble Mercury",
"DosageFormName": "PELLET",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20011116",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Remedy Makers",
"SubstanceName": "MERCURIUS SOLUBILIS",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Free from yeast, wheat, corn, and soy.DIRECTIONS: Dissolve 3 or 4 pelletsin mouth or under tongue 3 times a day or as directed by a physician.Children 2 years and older take 1/2adult dose.INDICATIONS: To be used accordingto standard homeopathic indicationsfor self limiting conditions such asthose indicated on the front panel or as directed by a physician.Warnings: *Use only if cap andseal are unbroken. * Keep this and all medications out of reach of children.* If symptoms persist for more then 3days, consult your physician. *As with any drug, if your are pregnant or nursing a baby, seek the advice of ahealth professional before using this product.*Store tightly closed in a cool, dark place.Made according to The Homeopathic Pharmacopoeia of the United States by: Remedy Makers, Pomona, CA 91768."
},
{
"NDCCode": "36987-1637-1",
"PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (36987-1637-1)",
"NDC11Code": "36987-1637-01",
"ProductNDC": "36987-1637",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Coffee",
"NonProprietaryName": "Coffee",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "ARABICA COFFEE BEAN",
"StrengthNumber": ".1",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Seed Storage Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
"Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
},
{
"NDCCode": "36987-1637-2",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (36987-1637-2)",
"NDC11Code": "36987-1637-02",
"ProductNDC": "36987-1637",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Coffee",
"NonProprietaryName": "Coffee",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "ARABICA COFFEE BEAN",
"StrengthNumber": ".1",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Seed Storage Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
"Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
},
{
"NDCCode": "36987-1637-3",
"PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (36987-1637-3)",
"NDC11Code": "36987-1637-03",
"ProductNDC": "36987-1637",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Coffee",
"NonProprietaryName": "Coffee",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "ARABICA COFFEE BEAN",
"StrengthNumber": ".1",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Seed Storage Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
"Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
},
{
"NDCCode": "36987-1637-4",
"PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (36987-1637-4)",
"NDC11Code": "36987-1637-04",
"ProductNDC": "36987-1637",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Coffee",
"NonProprietaryName": "Coffee",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "ARABICA COFFEE BEAN",
"StrengthNumber": ".1",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Seed Storage Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
"Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
},
{
"NDCCode": "37662-1637-1",
"PackageDescription": "10000 PELLET in 1 BOTTLE, GLASS (37662-1637-1) ",
"NDC11Code": "37662-1637-01",
"ProductNDC": "37662-1637",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Verbascum Thapsus",
"NonProprietaryName": "Verbascum Thapsus",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220928",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "VERBASCUM THAPSUS",
"StrengthNumber": "1",
"StrengthUnit": "[hp_Q]/1",
"Status": "Active",
"LastUpdate": "2022-09-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220928",
"SamplePackage": "N"
},
{
"NDCCode": "43742-1637-1",
"PackageDescription": "960 mL in 1 BOTTLE (43742-1637-1) ",
"NDC11Code": "43742-1637-01",
"ProductNDC": "43742-1637",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Human Coronavirus (rna)",
"DosageFormName": "LIQUID",
"StartMarketingDate": "20200331",
"EndMarketingDate": "20250521",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Deseret Biologicals, Inc.",
"SubstanceName": "SACCHAROMYCES CEREVISIAE RNA",
"StrengthNumber": "60",
"StrengthUnit": "[hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"StartMarketingDatePackage": "31-MAR-20",
"EndMarketingDatePackage": "21-MAY-25"
},
{
"NDCCode": "51552-1637-1",
"PackageDescription": "1 kg in 1 CONTAINER (51552-1637-1) ",
"NDC11Code": "51552-1637-01",
"ProductNDC": "51552-1637",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Dilucap Sld",
"DosageFormName": "POWDER",
"StartMarketingDate": "20221024",
"EndMarketingDate": "20241231",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Fagron Inc",
"SubstanceName": "MICROCRYSTALLINE CELLULOSE 101; SILICON DIOXIDE; STARCH, CORN; TALC",
"StrengthNumber": "1; 1; 1; 1",
"StrengthUnit": "kg/kg; kg/kg; kg/kg; kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"StartMarketingDatePackage": "24-OCT-22",
"EndMarketingDatePackage": "31-DEC-24"
},
{
"NDCCode": "53002-1637-1",
"PackageDescription": "1 BLISTER PACK in 1 PACKAGE (53002-1637-1) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "53002-1637-01",
"ProductNDC": "53002-1637",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Low-ogestrel",
"NonProprietaryName": "Norgestrel And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20160803",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075288",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20170901",
"SamplePackage": "N",
"IndicationAndUsage": "Low-Ogestrel is indicated for use by females of reproductive potential to prevent pregnancy. In a study of 1,287 women with a total of 11,085 cycles or 852.7 women-years of usage, the pregnancy rate in women age 15-40 years was approximately 1 pregnancy per 100 women-years of use.",
"Description": "Low-Ogestrel is a combination oral contraceptive containing the progestational compound norgestrel and the estrogenic compound ethinyl estradiol. Norgestrel is designated as (2) (±)-13 Ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one and ethinyl estradiol is designated as (19-nor-17α-pregna-1,3,5 (10)-trien-20-yne-3,17-diol). Each white active Low-Ogestrel tablet contains 0.3 mg norgestrel and 0.03 mg ethinyl estradiol and the following inert ingredients: croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, and povidone. Each peach placebo tablet contains only the following inert ingredients: anhydrous lactose, FD&C Yellow No. 6 Lake, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Each pill pack contains 21 white active tablets and 7 peach inert tablets."
},
{
"NDCCode": "53002-1637-3",
"PackageDescription": "3 BLISTER PACK in 1 PACKAGE (53002-1637-3) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "53002-1637-03",
"ProductNDC": "53002-1637",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Low-ogestrel",
"NonProprietaryName": "Norgestrel And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20160803",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075288",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20170901",
"SamplePackage": "N",
"IndicationAndUsage": "Low-Ogestrel is indicated for use by females of reproductive potential to prevent pregnancy. In a study of 1,287 women with a total of 11,085 cycles or 852.7 women-years of usage, the pregnancy rate in women age 15-40 years was approximately 1 pregnancy per 100 women-years of use.",
"Description": "Low-Ogestrel is a combination oral contraceptive containing the progestational compound norgestrel and the estrogenic compound ethinyl estradiol. Norgestrel is designated as (2) (±)-13 Ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one and ethinyl estradiol is designated as (19-nor-17α-pregna-1,3,5 (10)-trien-20-yne-3,17-diol). Each white active Low-Ogestrel tablet contains 0.3 mg norgestrel and 0.03 mg ethinyl estradiol and the following inert ingredients: croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, and povidone. Each peach placebo tablet contains only the following inert ingredients: anhydrous lactose, FD&C Yellow No. 6 Lake, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Each pill pack contains 21 white active tablets and 7 peach inert tablets."
},
{
"NDCCode": "53002-1637-6",
"PackageDescription": "6 BLISTER PACK in 1 PACKAGE (53002-1637-6) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "53002-1637-06",
"ProductNDC": "53002-1637",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Low-ogestrel",
"NonProprietaryName": "Norgestrel And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20160803",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075288",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20170901",
"SamplePackage": "N",
"IndicationAndUsage": "Low-Ogestrel is indicated for use by females of reproductive potential to prevent pregnancy. In a study of 1,287 women with a total of 11,085 cycles or 852.7 women-years of usage, the pregnancy rate in women age 15-40 years was approximately 1 pregnancy per 100 women-years of use.",
"Description": "Low-Ogestrel is a combination oral contraceptive containing the progestational compound norgestrel and the estrogenic compound ethinyl estradiol. Norgestrel is designated as (2) (±)-13 Ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one and ethinyl estradiol is designated as (19-nor-17α-pregna-1,3,5 (10)-trien-20-yne-3,17-diol). Each white active Low-Ogestrel tablet contains 0.3 mg norgestrel and 0.03 mg ethinyl estradiol and the following inert ingredients: croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, and povidone. Each peach placebo tablet contains only the following inert ingredients: anhydrous lactose, FD&C Yellow No. 6 Lake, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Each pill pack contains 21 white active tablets and 7 peach inert tablets."
},
{
"NDCCode": "60219-1637-3",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (60219-1637-3) ",
"NDC11Code": "60219-1637-03",
"ProductNDC": "60219-1637",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aminocaproic Acid",
"NonProprietaryName": "Aminocaproic Acid",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20191130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212492",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "AMINOCAPROIC ACID",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20191130",
"SamplePackage": "N",
"IndicationAndUsage": "Aminocaproic acid tablets are useful in enhancing hemostasis when fibrinolysis contributes to bleeding. In life-threatening situations, transfusion of appropriate blood products and other emergency measures may be required. Fibrinolytic bleeding may frequently be associated with surgical complications following heart surgery (with or without cardiac bypass procedures) and portacaval shunt; hematological disorders such as amegakaryocytic thrombocytopenia (accompanying aplastic anemia); acute and life-threatening abruptio placentae; hepatic cirrhosis; and neoplastic disease such as carcinoma of the prostate, lung, stomach, and cervix. Urinary fibrinolysis, usualIy a normal physiological phenomenon, may contribute to excessive urinary tract fibrinolytic bleeding associated with surgical hematuria (following prostatectomy and nephrectomy) or nonsurgical hematuria (accompanying polycystic or neoplastic diseases of the genitourinary system) (see WARNINGS).",
"Description": "Aminocaproic acid is 6-aminohexanoic acid, which acts as an inhibitor of fibrinolysis. Its chemical structure is. Aminocaproic acid, USP is a fine, white to almost white, crystalline powder. It is freely soluble in water, in acids, and in alkaline solutions; it is slightly soluble in methanol and practically insoluble in chloroform and in ether. Each aminocaproic acid tablet, USP for oral administration contains 500 mg of aminocaproic acid, USP and the following inactive ingredients: crospovidone type B, magnesium stearate, povidone and stearic acid. Meets USP Dissolution Test 2."
},
{
"NDCCode": "62839-1637-1",
"PackageDescription": "1 CARTRIDGE in 1 CARTON (62839-1637-1) > 28 mL in 1 CARTRIDGE",
"NDC11Code": "62839-1637-01",
"ProductNDC": "62839-1637",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nu Skin Ageloc Me Day T9 Broad Spectrum Spf 25",
"NonProprietaryName": "Octinoxate, Avobenzone, Octocrylene, And Homosalate",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160501",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "NSE Products, Inc.",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTOCRYLENE",
"StrengthNumber": "23; 20; 40; 20",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20160501",
"SamplePackage": "N",
"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."
},
{
"NDCCode": "67046-1637-3",
"PackageDescription": "30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1637-3) ",
"NDC11Code": "67046-1637-03",
"ProductNDC": "67046-1637",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lurasidone Hydrochloride",
"NonProprietaryName": "Lurasidone Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20251231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213248",
"LabelerName": "Coupler LLC",
"SubstanceName": "LURASIDONE HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251231",
"SamplePackage": "N",
"IndicationAndUsage": "Lurasidone hydrochloride tablets are indicated for: 1 Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)]. , 2 Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)].",
"Description": "Lurasidone hydrochloride is an atypical antipsychotic belonging to the chemical class of benzisothiazol derivatives. Its chemical name is (3a R,4 S,7 R,7a S)-2-{(1 R,2 R)-2-[4-(1,2-benzisothiazol-3-yl)piperazin-1 ylmethyl] cyclohexylmethyl}hexahydro-4,7-methano-2 H-isoindole-1,3-dione hydrochloride. Its molecular formula is C 28H 36N 4O 2S·HCl and its molecular weight is 529.14. The chemical structure is:. Lurasidone hydrochloride is a white to cream powder. It is very slightly soluble to insoluble in water, sparingly soluble in methanol. Practically insoluble in toluene. Lurasidone hydrochloride tablets are intended for oral administration only. Each tablet contains 20 mg, 40 mg, 60 mg, 80 mg or 120 mg of lurasidone hydrochloride. Inactive ingredients are corn starch, croscarmellose sodium, hypromellose, magnesium stearate and mannitol. The tablets are film-coated with coating material containing hypromellose, polyethylene glycol 8000 and titanium dioxide. Additionally, the 80 mg tablet contains FD&C Blue No. 2 Aluminum Lake and iron oxide yellow."
},
{
"NDCCode": "67296-1637-2",
"PackageDescription": "20 TABLET in 1 BOTTLE (67296-1637-2) ",
"NDC11Code": "67296-1637-02",
"ProductNDC": "67296-1637",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbamazepine",
"NonProprietaryName": "Carbamazepine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075948",
"LabelerName": "RedPharm Drug, Inc.",
"SubstanceName": "CARBAMAZEPINE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190101",
"SamplePackage": "N",
"IndicationAndUsage": "Carbamazepine tablets, USP are indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types: 1 Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvement than those with other types. , 2 Generalized tonic-clonic seizures (grand mal). , 3 Mixed seizure patterns which include the above, or other partial or generalized seizures. Absence seizures (petit mal) do not appear to be controlled by carbamazepine (see PRECAUTIONS, General). .",
"Description": "Carbamazepine USP, is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as tablets of 200 mg. Its chemical name is 5 H-dibenz[ b,f]azepine-5-carboxamide, and its structural formula is:. Carbamazepine USP is a white to off-white powder, practically insoluble in water and soluble in alcohol and in acetone. Its molecular weight is 236.27 g/mol. Carbamazepine tablets, USP 200 mg contain the active ingredient, carbamazepine USP, and the inactive ingredients: croscarmellose sodium, magnesium stearate, and microcrystalline cellulose. Carbamazepine tablets, 200 mg meets USP Dissolution Test 2."
},
{
"NDCCode": "68071-1637-2",
"PackageDescription": "20 TABLET, FILM COATED in 1 BOTTLE (68071-1637-2) ",
"NDC11Code": "68071-1637-02",
"ProductNDC": "68071-1637",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cefuroxime Axetil",
"NonProprietaryName": "Cefuroxime Axetil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20101201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065496",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "CEFUROXIME AXETIL",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC], Cephalosporins [CS]",
"Status": "Active",
"LastUpdate": "2024-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190304",
"SamplePackage": "N",
"IndicationAndUsage": "Cefuroxime axetil tablet is a cephalosporin antibacterial drug indicated for the treatment of the following infections due to susceptible bacteria: Pharyngitis/tonsillitis (adults and pediatric patients) ( 1.1) : 1 Acute bacterial otitis media (pediatric patients) ( 1.2) , 2 Acute bacterial maxillary sinusitis (adults and pediatric patients) ( 1.3) , 3 Acute bacterial exacerbations of chronic bronchitis (adults and pediatric patients 13 years and older) ( 1.4) , 4 Uncomplicated skin and skin-structure infections (adults and pediatric patients 13 years and older) ( 1.5) , 5 Uncomplicated urinary tract infections (adults and pediatric patients 13 years and older) ( 1.6) , 6 Uncomplicated gonorrhea (adults and pediatric patients 13 years and older) ( 1.7) , 7 Early Lyme disease (adults and pediatric patients 13 years and older) ( 1.8) .",
"Description": "Cefuroxime axetil tablets, USP contain cefuroxime as cefuroxime axetil. Cefuroxime axetil is a semisynthetic, cephalosporin antibacterial drug for oral administration. The chemical name of cefuroxime axetil (1-(acetyloxy) ethyl ester of cefuroxime) is ( RS)-1 hydroxyethyl (6 R,7 R)-7-[2-(2-furyl)glyoxyl-amido]-3-(hydroxymethyl)-8-oxo-5-thia-1 azabicyclo[4.2.0]-oct-2-ene-2-carboxylate, 72-( Z)-( O-methyl-oxime), 1-acetate 3-carbamate. Its molecular formula is C 20H 22N 4O 10S, and it has a molecular weight of 510.48. Cefuroxime axetil is in the amorphous form and has the following structural formula. Cefuroxime axetil tablets, USP are film-coated and contain the equivalent of 250 or 500 mg of cefuroxime as cefuroxime axetil. Cefuroxime axetil tablets, USP contain the inactive ingredients microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, colloidal silicon dioxide, calcium stearate, calcium carbonate, crospovidone, hypromellose, titanium dioxide, propylene glycol, FD &C blue no.1 Aluminium lake."
},
{
"NDCCode": "69238-1637-3",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (69238-1637-3) ",
"NDC11Code": "69238-1637-03",
"ProductNDC": "69238-1637",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aminocaproic Acid",
"NonProprietaryName": "Aminocaproic Acid",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20191130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212492",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "AMINOCAPROIC ACID",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]",
"Status": "Active",
"LastUpdate": "2026-07-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20191130",
"SamplePackage": "N",
"IndicationAndUsage": "Aminocaproic acid tablets are useful in enhancing hemostasis when fibrinolysis contributes to bleeding. In life-threatening situations, transfusion of appropriate blood products and other emergency measures may be required. Fibrinolytic bleeding may frequently be associated with surgical complications following heart surgery (with or without cardiac bypass procedures) and portacaval shunt; hematological disorders such as amegakaryocytic thrombocytopenia (accompanying aplastic anemia); acute and life-threatening abruptio placentae; hepatic cirrhosis; and neoplastic disease such as carcinoma of the prostate, lung, stomach, and cervix. Urinary fibrinolysis, usualIy a normal physiological phenomenon, may contribute to excessive urinary tract fibrinolytic bleeding associated with surgical hematuria (following prostatectomy and nephrectomy) or nonsurgical hematuria (accompanying polycystic or neoplastic diseases of the genitourinary system) (see WARNINGS).",
"Description": "Aminocaproic acid is 6-aminohexanoic acid, which acts as an inhibitor of fibrinolysis. Its chemical structure is. Aminocaproic acid, USP is a fine, white to almost white, crystalline powder. It is freely soluble in water, in acids, and in alkaline solutions; it is slightly soluble in methanol and practically insoluble in chloroform and in ether. Each aminocaproic acid tablet, USP for oral administration contains 500 mg of aminocaproic acid, USP and the following inactive ingredients: crospovidone type B, magnesium stearate, povidone and stearic acid. Meets USP Dissolution Test 2."
},
{
"NDCCode": "70121-1637-5",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 CARTON (70121-1637-5) / 1 mL in 1 VIAL, SINGLE-DOSE (70121-1637-1) ",
"NDC11Code": "70121-1637-05",
"ProductNDC": "70121-1637",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ephedrine Sulfate",
"NonProprietaryName": "Ephedrine Sulfate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20191023",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212932",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "EPHEDRINE SULFATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Increased Norepinephrine Activity [PE], Norepinephrine Releasing Agent [EPC], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191023",
"SamplePackage": "N",
"IndicationAndUsage": "Ephedrine sulfate injection is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia.",
"Description": "Ephedrine is an alpha- and beta-adrenergic agonist and a norepinephrine-releasing agent. Ephedrine sulfate injection, USP is a clear, colorless, sterile solution for intravenous injection. It must be diluted before intravenous administration. The chemical name of ephedrine sulfate is (1R,2S)-(-)-2-methylamine-1-phenylpropan-1-ol sulfate, and the molecular weight is 428.5 g/mol. Its molecular formula is (C10H15NO)2.H2SO4 and structural formula is depicted below. Ephedrine sulfate, USP is a white to off-white powder; it is freely soluble in water and slightly soluble in alcohol. Each mL contains ephedrine sulfate, USP 50 mg (equivalent to 38 mg ephedrine base) in water for injection. The pH is adjusted with sodium hydroxide and/or glacial acetic acid if necessary. The pH range is 4.5 to 7.0."
},
{
"NDCCode": "70121-1637-7",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (70121-1637-7) / 1 mL in 1 VIAL, SINGLE-DOSE (70121-1637-1) ",
"NDC11Code": "70121-1637-07",
"ProductNDC": "70121-1637",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ephedrine Sulfate",
"NonProprietaryName": "Ephedrine Sulfate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20191023",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212932",
"LabelerName": "Amneal Pharmaceuticals LLC",
"SubstanceName": "EPHEDRINE SULFATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Increased Norepinephrine Activity [PE], Norepinephrine Releasing Agent [EPC], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191023",
"SamplePackage": "N",
"IndicationAndUsage": "Ephedrine sulfate injection is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia.",
"Description": "Ephedrine is an alpha- and beta-adrenergic agonist and a norepinephrine-releasing agent. Ephedrine sulfate injection, USP is a clear, colorless, sterile solution for intravenous injection. It must be diluted before intravenous administration. The chemical name of ephedrine sulfate is (1R,2S)-(-)-2-methylamine-1-phenylpropan-1-ol sulfate, and the molecular weight is 428.5 g/mol. Its molecular formula is (C10H15NO)2.H2SO4 and structural formula is depicted below. Ephedrine sulfate, USP is a white to off-white powder; it is freely soluble in water and slightly soluble in alcohol. Each mL contains ephedrine sulfate, USP 50 mg (equivalent to 38 mg ephedrine base) in water for injection. The pH is adjusted with sodium hydroxide and/or glacial acetic acid if necessary. The pH range is 4.5 to 7.0."
},
{
"NDCCode": "70518-1637-0",
"PackageDescription": "1 TUBE in 1 CARTON (70518-1637-0) / 30 g in 1 TUBE",
"NDC11Code": "70518-1637-00",
"ProductNDC": "70518-1637",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ketoconazole",
"NonProprietaryName": "Ketoconazole",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20181106",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076294",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "KETOCONAZOLE",
"StrengthNumber": "20",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-06-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20181106",
"SamplePackage": "N",
"IndicationAndUsage": "Ketoconazole Cream 2% is indicated for the topical treatment of tinea corporis, tinea cruris and tinea pedis caused by Trichophyton rubrum, T. mentagrophytesand Epidermophyton floccosum;in the treatment of tinea (pityriasis) versicolor caused by Malassezia furfur (Pityrosporum orbiculare); in the treatment of cutaneous candidiasis caused by Candida spp.and in the treatment of seborrheic dermatitis.",
"Description": "Ketoconazole Cream 2%, for topical administration only, contains the broad-spectrum synthetic antifungal agent, ketoconazole 2%, formulated in an aqueous cream vehicle consisting of propylene glycol, stearyl and cetyl alcohols, sorbitan monostearate, polysorbate 60, isopropyl myristate, sodium sulfite anhydrous, polysorbate 80 and purified water. Ketoconazole is cis-1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1 H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazine and has the following structural formula:."
},
{
"NDCCode": "71335-1637-1",
"PackageDescription": "30 TABLET in 1 BOTTLE (71335-1637-1) ",
"NDC11Code": "71335-1637-01",
"ProductNDC": "71335-1637",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levothyroxine Sodium",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190507",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021116",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": "175",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200609",
"SamplePackage": "N",
"IndicationAndUsage": "Hypothyroidism. Levothyroxine Sodium Tablets are indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression. Levothyroxine Sodium Tablets are indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: 1 Levothyroxine Sodium Tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with Levothyroxine Sodium Tablets may induce hyperthyroidism [see Warnings and Precautions (5.1)]., 2 Levothyroxine Sodium Tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.",
"Description": "Levothyroxine Sodium Tablets are L-thyroxine (T4) and contain the active ingredient, levothyroxine, a synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C15H10I4NNaO4H2O, molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown. Levothyroxine Sodium Tablets are for oral administration and are available in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each levothyroxine sodium tablet contains the inactive ingredients butylated hydroxytoluene, calcium phosphate dibasic dihydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, and color additive(s). Table 9 provides a listing of the color additives by tablet strength."
},
{
"NDCCode": "71335-1637-2",
"PackageDescription": "90 TABLET in 1 BOTTLE (71335-1637-2) ",
"NDC11Code": "71335-1637-02",
"ProductNDC": "71335-1637",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levothyroxine Sodium",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190507",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021116",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": "175",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200609",
"SamplePackage": "N",
"IndicationAndUsage": "Hypothyroidism. Levothyroxine Sodium Tablets are indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression. Levothyroxine Sodium Tablets are indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: 1 Levothyroxine Sodium Tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with Levothyroxine Sodium Tablets may induce hyperthyroidism [see Warnings and Precautions (5.1)]., 2 Levothyroxine Sodium Tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.",
"Description": "Levothyroxine Sodium Tablets are L-thyroxine (T4) and contain the active ingredient, levothyroxine, a synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C15H10I4NNaO4H2O, molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown. Levothyroxine Sodium Tablets are for oral administration and are available in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each levothyroxine sodium tablet contains the inactive ingredients butylated hydroxytoluene, calcium phosphate dibasic dihydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, and color additive(s). Table 9 provides a listing of the color additives by tablet strength."
},
{
"NDCCode": "71335-1637-3",
"PackageDescription": "100 TABLET in 1 BOTTLE (71335-1637-3) ",
"NDC11Code": "71335-1637-03",
"ProductNDC": "71335-1637",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levothyroxine Sodium",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190507",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021116",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": "175",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200609",
"SamplePackage": "N",
"IndicationAndUsage": "Hypothyroidism. Levothyroxine Sodium Tablets are indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression. Levothyroxine Sodium Tablets are indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: 1 Levothyroxine Sodium Tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with Levothyroxine Sodium Tablets may induce hyperthyroidism [see Warnings and Precautions (5.1)]., 2 Levothyroxine Sodium Tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.",
"Description": "Levothyroxine Sodium Tablets are L-thyroxine (T4) and contain the active ingredient, levothyroxine, a synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C15H10I4NNaO4H2O, molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown. Levothyroxine Sodium Tablets are for oral administration and are available in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each levothyroxine sodium tablet contains the inactive ingredients butylated hydroxytoluene, calcium phosphate dibasic dihydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, and color additive(s). Table 9 provides a listing of the color additives by tablet strength."
},
{
"NDCCode": "71335-1637-4",
"PackageDescription": "38 TABLET in 1 BOTTLE (71335-1637-4) ",
"NDC11Code": "71335-1637-04",
"ProductNDC": "71335-1637",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levothyroxine Sodium",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190507",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021116",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": "175",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200609",
"SamplePackage": "N",
"IndicationAndUsage": "Hypothyroidism. Levothyroxine Sodium Tablets are indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression. Levothyroxine Sodium Tablets are indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: 1 Levothyroxine Sodium Tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with Levothyroxine Sodium Tablets may induce hyperthyroidism [see Warnings and Precautions (5.1)]., 2 Levothyroxine Sodium Tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.",
"Description": "Levothyroxine Sodium Tablets are L-thyroxine (T4) and contain the active ingredient, levothyroxine, a synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C15H10I4NNaO4H2O, molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown. Levothyroxine Sodium Tablets are for oral administration and are available in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each levothyroxine sodium tablet contains the inactive ingredients butylated hydroxytoluene, calcium phosphate dibasic dihydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, and color additive(s). Table 9 provides a listing of the color additives by tablet strength."
},
{
"NDCCode": "71335-1637-5",
"PackageDescription": "28 TABLET in 1 BOTTLE (71335-1637-5) ",
"NDC11Code": "71335-1637-05",
"ProductNDC": "71335-1637",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levothyroxine Sodium",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190507",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021116",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": "175",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20200609",
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"IndicationAndUsage": "Hypothyroidism. Levothyroxine Sodium Tablets are indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression. Levothyroxine Sodium Tablets are indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: 1 Levothyroxine Sodium Tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with Levothyroxine Sodium Tablets may induce hyperthyroidism [see Warnings and Precautions (5.1)]., 2 Levothyroxine Sodium Tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.",
"Description": "Levothyroxine Sodium Tablets are L-thyroxine (T4) and contain the active ingredient, levothyroxine, a synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C15H10I4NNaO4H2O, molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown. Levothyroxine Sodium Tablets are for oral administration and are available in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each levothyroxine sodium tablet contains the inactive ingredients butylated hydroxytoluene, calcium phosphate dibasic dihydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, and color additive(s). Table 9 provides a listing of the color additives by tablet strength."
},
{
"NDCCode": "71335-1637-6",
"PackageDescription": "60 TABLET in 1 BOTTLE (71335-1637-6) ",
"NDC11Code": "71335-1637-06",
"ProductNDC": "71335-1637",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levothyroxine Sodium",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190507",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021116",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": "175",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200609",
"SamplePackage": "N",
"IndicationAndUsage": "Hypothyroidism. Levothyroxine Sodium Tablets are indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression. Levothyroxine Sodium Tablets are indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: 1 Levothyroxine Sodium Tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with Levothyroxine Sodium Tablets may induce hyperthyroidism [see Warnings and Precautions (5.1)]., 2 Levothyroxine Sodium Tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.",
"Description": "Levothyroxine Sodium Tablets are L-thyroxine (T4) and contain the active ingredient, levothyroxine, a synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C15H10I4NNaO4H2O, molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown. Levothyroxine Sodium Tablets are for oral administration and are available in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each levothyroxine sodium tablet contains the inactive ingredients butylated hydroxytoluene, calcium phosphate dibasic dihydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, and color additive(s). Table 9 provides a listing of the color additives by tablet strength."
},
{
"NDCCode": "82640-1637-1",
"PackageDescription": "1 BOTTLE, WITH APPLICATOR in 1 CARTON (82640-1637-1) / 150 mL in 1 BOTTLE, WITH APPLICATOR",
"NDC11Code": "82640-1637-01",
"ProductNDC": "82640-1637",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aqua Maris Extra Strong",
"NonProprietaryName": "Sodium Chloride",
"DosageFormName": "SPRAY",
"RouteName": "NASAL",
"StartMarketingDate": "20221222",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part349",
"LabelerName": "JGL d. d.",
"SubstanceName": "SODIUM CHLORIDE",
"StrengthNumber": "21",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-07-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20221222",
"SamplePackage": "N"
}
]
}
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<PackageDescription>400 mL in 1 CONTAINER (64942-1637-1) </PackageDescription>
<NDC11Code>64942-1637-01</NDC11Code>
<ProductNDC>64942-1637</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Re-fresh Scalp Care</ProprietaryName>
<NonProprietaryName>Salicylic Acid</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190510</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part358H</ApplicationNumber>
<LabelerName>Conopco, Inc. d/b/a/ Unilever</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190510</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> Helps prevent and control recurrence of itching and flaking associated with dandruff.</IndicationAndUsage>
<Description>RE-fresh Scalp Care Sea Mineral + Hydrate Anti-Dandruff Conditioner.</Description>
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<NDC>
<NDCCode>0395-1637-92</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE (0395-1637-92)</PackageDescription>
<NDC11Code>00395-1637-92</NDC11Code>
<ProductNDC>0395-1637</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Humco Mercuroclear</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride And Lidocaine Hydrochloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19990225</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Humco Holding Group, Inc</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1.3; 25</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-08-29</LastUpdate>
</NDC>
<NDC>
<NDCCode>0395-1637-93</NDCCode>
<PackageDescription>90 mL in 1 BOTTLE, SPRAY (0395-1637-93)</PackageDescription>
<NDC11Code>00395-1637-93</NDC11Code>
<ProductNDC>0395-1637</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Humco Mercuroclear</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride And Lidocaine Hydrochloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
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<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Humco Holding Group, Inc</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1.3; 25</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-08-29</LastUpdate>
</NDC>
<NDC>
<NDCCode>10191-1637-2</NDCCode>
<PackageDescription>137 PELLET in 1 VIAL, GLASS (10191-1637-2)</PackageDescription>
<NDC11Code>10191-1637-02</NDC11Code>
<ProductNDC>10191-1637</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mercurius Solubilis</ProprietaryName>
<NonProprietaryName>Soluble Mercury</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20011116</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Remedy Makers</LabelerName>
<SubstanceName>MERCURIUS SOLUBILIS</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Free from yeast, wheat, corn, and soy.DIRECTIONS: Dissolve 3 or 4 pelletsin mouth or under tongue 3 times a day or as directed by a physician.Children 2 years and older take 1/2adult dose.INDICATIONS: To be used accordingto standard homeopathic indicationsfor self limiting conditions such asthose indicated on the front panel or as directed by a physician.Warnings: *Use only if cap andseal are unbroken. * Keep this and all medications out of reach of children.* If symptoms persist for more then 3days, consult your physician. *As with any drug, if your are pregnant or nursing a baby, seek the advice of ahealth professional before using this product.*Store tightly closed in a cool, dark place.Made according to The Homeopathic Pharmacopoeia of the United States by: Remedy Makers, Pomona, CA 91768.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>36987-1637-1</NDCCode>
<PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (36987-1637-1)</PackageDescription>
<NDC11Code>36987-1637-01</NDC11Code>
<ProductNDC>36987-1637</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Coffee</ProprietaryName>
<NonProprietaryName>Coffee</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>ARABICA COFFEE BEAN</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
<Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
</NDC>
<NDC>
<NDCCode>36987-1637-2</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (36987-1637-2)</PackageDescription>
<NDC11Code>36987-1637-02</NDC11Code>
<ProductNDC>36987-1637</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Coffee</ProprietaryName>
<NonProprietaryName>Coffee</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>ARABICA COFFEE BEAN</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
<Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
</NDC>
<NDC>
<NDCCode>36987-1637-3</NDCCode>
<PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (36987-1637-3)</PackageDescription>
<NDC11Code>36987-1637-03</NDC11Code>
<ProductNDC>36987-1637</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Coffee</ProprietaryName>
<NonProprietaryName>Coffee</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>ARABICA COFFEE BEAN</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
<Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
</NDC>
<NDC>
<NDCCode>36987-1637-4</NDCCode>
<PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (36987-1637-4)</PackageDescription>
<NDC11Code>36987-1637-04</NDC11Code>
<ProductNDC>36987-1637</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Coffee</ProprietaryName>
<NonProprietaryName>Coffee</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>ARABICA COFFEE BEAN</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
<Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
</NDC>
<NDC>
<NDCCode>37662-1637-1</NDCCode>
<PackageDescription>10000 PELLET in 1 BOTTLE, GLASS (37662-1637-1) </PackageDescription>
<NDC11Code>37662-1637-01</NDC11Code>
<ProductNDC>37662-1637</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Verbascum Thapsus</ProprietaryName>
<NonProprietaryName>Verbascum Thapsus</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220928</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>VERBASCUM THAPSUS</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_Q]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-09-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220928</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>43742-1637-1</NDCCode>
<PackageDescription>960 mL in 1 BOTTLE (43742-1637-1) </PackageDescription>
<NDC11Code>43742-1637-01</NDC11Code>
<ProductNDC>43742-1637</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Human Coronavirus (rna)</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<StartMarketingDate>20200331</StartMarketingDate>
<EndMarketingDate>20250521</EndMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Deseret Biologicals, Inc.</LabelerName>
<SubstanceName>SACCHAROMYCES CEREVISIAE RNA</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>[hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<StartMarketingDatePackage>31-MAR-20</StartMarketingDatePackage>
<EndMarketingDatePackage>21-MAY-25</EndMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>51552-1637-1</NDCCode>
<PackageDescription>1 kg in 1 CONTAINER (51552-1637-1) </PackageDescription>
<NDC11Code>51552-1637-01</NDC11Code>
<ProductNDC>51552-1637</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Dilucap Sld</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20221024</StartMarketingDate>
<EndMarketingDate>20241231</EndMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Fagron Inc</LabelerName>
<SubstanceName>MICROCRYSTALLINE CELLULOSE 101; SILICON DIOXIDE; STARCH, CORN; TALC</SubstanceName>
<StrengthNumber>1; 1; 1; 1</StrengthNumber>
<StrengthUnit>kg/kg; kg/kg; kg/kg; kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<StartMarketingDatePackage>24-OCT-22</StartMarketingDatePackage>
<EndMarketingDatePackage>31-DEC-24</EndMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>53002-1637-1</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 PACKAGE (53002-1637-1) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>53002-1637-01</NDC11Code>
<ProductNDC>53002-1637</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Low-ogestrel</ProprietaryName>
<NonProprietaryName>Norgestrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20160803</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075288</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Low-Ogestrel is indicated for use by females of reproductive potential to prevent pregnancy. In a study of 1,287 women with a total of 11,085 cycles or 852.7 women-years of usage, the pregnancy rate in women age 15-40 years was approximately 1 pregnancy per 100 women-years of use.</IndicationAndUsage>
<Description>Low-Ogestrel is a combination oral contraceptive containing the progestational compound norgestrel and the estrogenic compound ethinyl estradiol. Norgestrel is designated as (2) (±)-13 Ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one and ethinyl estradiol is designated as (19-nor-17α-pregna-1,3,5 (10)-trien-20-yne-3,17-diol). Each white active Low-Ogestrel tablet contains 0.3 mg norgestrel and 0.03 mg ethinyl estradiol and the following inert ingredients: croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, and povidone. Each peach placebo tablet contains only the following inert ingredients: anhydrous lactose, FD&C Yellow No. 6 Lake, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Each pill pack contains 21 white active tablets and 7 peach inert tablets.</Description>
</NDC>
<NDC>
<NDCCode>53002-1637-3</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 PACKAGE (53002-1637-3) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>53002-1637-03</NDC11Code>
<ProductNDC>53002-1637</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Low-ogestrel</ProprietaryName>
<NonProprietaryName>Norgestrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20160803</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075288</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Low-Ogestrel is indicated for use by females of reproductive potential to prevent pregnancy. In a study of 1,287 women with a total of 11,085 cycles or 852.7 women-years of usage, the pregnancy rate in women age 15-40 years was approximately 1 pregnancy per 100 women-years of use.</IndicationAndUsage>
<Description>Low-Ogestrel is a combination oral contraceptive containing the progestational compound norgestrel and the estrogenic compound ethinyl estradiol. Norgestrel is designated as (2) (±)-13 Ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one and ethinyl estradiol is designated as (19-nor-17α-pregna-1,3,5 (10)-trien-20-yne-3,17-diol). Each white active Low-Ogestrel tablet contains 0.3 mg norgestrel and 0.03 mg ethinyl estradiol and the following inert ingredients: croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, and povidone. Each peach placebo tablet contains only the following inert ingredients: anhydrous lactose, FD&C Yellow No. 6 Lake, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Each pill pack contains 21 white active tablets and 7 peach inert tablets.</Description>
</NDC>
<NDC>
<NDCCode>53002-1637-6</NDCCode>
<PackageDescription>6 BLISTER PACK in 1 PACKAGE (53002-1637-6) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>53002-1637-06</NDC11Code>
<ProductNDC>53002-1637</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Low-ogestrel</ProprietaryName>
<NonProprietaryName>Norgestrel And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20160803</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075288</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Low-Ogestrel is indicated for use by females of reproductive potential to prevent pregnancy. In a study of 1,287 women with a total of 11,085 cycles or 852.7 women-years of usage, the pregnancy rate in women age 15-40 years was approximately 1 pregnancy per 100 women-years of use.</IndicationAndUsage>
<Description>Low-Ogestrel is a combination oral contraceptive containing the progestational compound norgestrel and the estrogenic compound ethinyl estradiol. Norgestrel is designated as (2) (±)-13 Ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one and ethinyl estradiol is designated as (19-nor-17α-pregna-1,3,5 (10)-trien-20-yne-3,17-diol). Each white active Low-Ogestrel tablet contains 0.3 mg norgestrel and 0.03 mg ethinyl estradiol and the following inert ingredients: croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, and povidone. Each peach placebo tablet contains only the following inert ingredients: anhydrous lactose, FD&C Yellow No. 6 Lake, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. Each pill pack contains 21 white active tablets and 7 peach inert tablets.</Description>
</NDC>
<NDC>
<NDCCode>60219-1637-3</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (60219-1637-3) </PackageDescription>
<NDC11Code>60219-1637-03</NDC11Code>
<ProductNDC>60219-1637</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aminocaproic Acid</ProprietaryName>
<NonProprietaryName>Aminocaproic Acid</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212492</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>AMINOCAPROIC ACID</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aminocaproic acid tablets are useful in enhancing hemostasis when fibrinolysis contributes to bleeding. In life-threatening situations, transfusion of appropriate blood products and other emergency measures may be required. Fibrinolytic bleeding may frequently be associated with surgical complications following heart surgery (with or without cardiac bypass procedures) and portacaval shunt; hematological disorders such as amegakaryocytic thrombocytopenia (accompanying aplastic anemia); acute and life-threatening abruptio placentae; hepatic cirrhosis; and neoplastic disease such as carcinoma of the prostate, lung, stomach, and cervix. Urinary fibrinolysis, usualIy a normal physiological phenomenon, may contribute to excessive urinary tract fibrinolytic bleeding associated with surgical hematuria (following prostatectomy and nephrectomy) or nonsurgical hematuria (accompanying polycystic or neoplastic diseases of the genitourinary system) (see WARNINGS).</IndicationAndUsage>
<Description>Aminocaproic acid is 6-aminohexanoic acid, which acts as an inhibitor of fibrinolysis. Its chemical structure is. Aminocaproic acid, USP is a fine, white to almost white, crystalline powder. It is freely soluble in water, in acids, and in alkaline solutions; it is slightly soluble in methanol and practically insoluble in chloroform and in ether. Each aminocaproic acid tablet, USP for oral administration contains 500 mg of aminocaproic acid, USP and the following inactive ingredients: crospovidone type B, magnesium stearate, povidone and stearic acid. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>62839-1637-1</NDCCode>
<PackageDescription>1 CARTRIDGE in 1 CARTON (62839-1637-1) > 28 mL in 1 CARTRIDGE</PackageDescription>
<NDC11Code>62839-1637-01</NDC11Code>
<ProductNDC>62839-1637</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nu Skin Ageloc Me Day T9 Broad Spectrum Spf 25</ProprietaryName>
<NonProprietaryName>Octinoxate, Avobenzone, Octocrylene, And Homosalate</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160501</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>NSE Products, Inc.</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>23; 20; 40; 20</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160501</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>67046-1637-3</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1637-3) </PackageDescription>
<NDC11Code>67046-1637-03</NDC11Code>
<ProductNDC>67046-1637</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lurasidone Hydrochloride</ProprietaryName>
<NonProprietaryName>Lurasidone Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20251231</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213248</ApplicationNumber>
<LabelerName>Coupler LLC</LabelerName>
<SubstanceName>LURASIDONE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251231</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lurasidone hydrochloride tablets are indicated for: 1 Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)]. , 2 Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies (14.2)].</IndicationAndUsage>
<Description>Lurasidone hydrochloride is an atypical antipsychotic belonging to the chemical class of benzisothiazol derivatives. Its chemical name is (3a R,4 S,7 R,7a S)-2-{(1 R,2 R)-2-[4-(1,2-benzisothiazol-3-yl)piperazin-1 ylmethyl] cyclohexylmethyl}hexahydro-4,7-methano-2 H-isoindole-1,3-dione hydrochloride. Its molecular formula is C 28H 36N 4O 2S·HCl and its molecular weight is 529.14. The chemical structure is:. Lurasidone hydrochloride is a white to cream powder. It is very slightly soluble to insoluble in water, sparingly soluble in methanol. Practically insoluble in toluene. Lurasidone hydrochloride tablets are intended for oral administration only. Each tablet contains 20 mg, 40 mg, 60 mg, 80 mg or 120 mg of lurasidone hydrochloride. Inactive ingredients are corn starch, croscarmellose sodium, hypromellose, magnesium stearate and mannitol. The tablets are film-coated with coating material containing hypromellose, polyethylene glycol 8000 and titanium dioxide. Additionally, the 80 mg tablet contains FD&C Blue No. 2 Aluminum Lake and iron oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>67296-1637-2</NDCCode>
<PackageDescription>20 TABLET in 1 BOTTLE (67296-1637-2) </PackageDescription>
<NDC11Code>67296-1637-02</NDC11Code>
<ProductNDC>67296-1637</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carbamazepine</ProprietaryName>
<NonProprietaryName>Carbamazepine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075948</ApplicationNumber>
<LabelerName>RedPharm Drug, Inc.</LabelerName>
<SubstanceName>CARBAMAZEPINE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Carbamazepine tablets, USP are indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types: 1 Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvement than those with other types. , 2 Generalized tonic-clonic seizures (grand mal). , 3 Mixed seizure patterns which include the above, or other partial or generalized seizures. Absence seizures (petit mal) do not appear to be controlled by carbamazepine (see PRECAUTIONS, General). .</IndicationAndUsage>
<Description>Carbamazepine USP, is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as tablets of 200 mg. Its chemical name is 5 H-dibenz[ b,f]azepine-5-carboxamide, and its structural formula is:. Carbamazepine USP is a white to off-white powder, practically insoluble in water and soluble in alcohol and in acetone. Its molecular weight is 236.27 g/mol. Carbamazepine tablets, USP 200 mg contain the active ingredient, carbamazepine USP, and the inactive ingredients: croscarmellose sodium, magnesium stearate, and microcrystalline cellulose. Carbamazepine tablets, 200 mg meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>68071-1637-2</NDCCode>
<PackageDescription>20 TABLET, FILM COATED in 1 BOTTLE (68071-1637-2) </PackageDescription>
<NDC11Code>68071-1637-02</NDC11Code>
<ProductNDC>68071-1637</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cefuroxime Axetil</ProprietaryName>
<NonProprietaryName>Cefuroxime Axetil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065496</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>CEFUROXIME AXETIL</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190304</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cefuroxime axetil tablet is a cephalosporin antibacterial drug indicated for the treatment of the following infections due to susceptible bacteria: Pharyngitis/tonsillitis (adults and pediatric patients) ( 1.1) : 1 Acute bacterial otitis media (pediatric patients) ( 1.2) , 2 Acute bacterial maxillary sinusitis (adults and pediatric patients) ( 1.3) , 3 Acute bacterial exacerbations of chronic bronchitis (adults and pediatric patients 13 years and older) ( 1.4) , 4 Uncomplicated skin and skin-structure infections (adults and pediatric patients 13 years and older) ( 1.5) , 5 Uncomplicated urinary tract infections (adults and pediatric patients 13 years and older) ( 1.6) , 6 Uncomplicated gonorrhea (adults and pediatric patients 13 years and older) ( 1.7) , 7 Early Lyme disease (adults and pediatric patients 13 years and older) ( 1.8) .</IndicationAndUsage>
<Description>Cefuroxime axetil tablets, USP contain cefuroxime as cefuroxime axetil. Cefuroxime axetil is a semisynthetic, cephalosporin antibacterial drug for oral administration. The chemical name of cefuroxime axetil (1-(acetyloxy) ethyl ester of cefuroxime) is ( RS)-1 hydroxyethyl (6 R,7 R)-7-[2-(2-furyl)glyoxyl-amido]-3-(hydroxymethyl)-8-oxo-5-thia-1 azabicyclo[4.2.0]-oct-2-ene-2-carboxylate, 72-( Z)-( O-methyl-oxime), 1-acetate 3-carbamate. Its molecular formula is C 20H 22N 4O 10S, and it has a molecular weight of 510.48. Cefuroxime axetil is in the amorphous form and has the following structural formula. Cefuroxime axetil tablets, USP are film-coated and contain the equivalent of 250 or 500 mg of cefuroxime as cefuroxime axetil. Cefuroxime axetil tablets, USP contain the inactive ingredients microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, colloidal silicon dioxide, calcium stearate, calcium carbonate, crospovidone, hypromellose, titanium dioxide, propylene glycol, FD &C blue no.1 Aluminium lake.</Description>
</NDC>
<NDC>
<NDCCode>69238-1637-3</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (69238-1637-3) </PackageDescription>
<NDC11Code>69238-1637-03</NDC11Code>
<ProductNDC>69238-1637</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aminocaproic Acid</ProprietaryName>
<NonProprietaryName>Aminocaproic Acid</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191130</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212492</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>AMINOCAPROIC ACID</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191130</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aminocaproic acid tablets are useful in enhancing hemostasis when fibrinolysis contributes to bleeding. In life-threatening situations, transfusion of appropriate blood products and other emergency measures may be required. Fibrinolytic bleeding may frequently be associated with surgical complications following heart surgery (with or without cardiac bypass procedures) and portacaval shunt; hematological disorders such as amegakaryocytic thrombocytopenia (accompanying aplastic anemia); acute and life-threatening abruptio placentae; hepatic cirrhosis; and neoplastic disease such as carcinoma of the prostate, lung, stomach, and cervix. Urinary fibrinolysis, usualIy a normal physiological phenomenon, may contribute to excessive urinary tract fibrinolytic bleeding associated with surgical hematuria (following prostatectomy and nephrectomy) or nonsurgical hematuria (accompanying polycystic or neoplastic diseases of the genitourinary system) (see WARNINGS).</IndicationAndUsage>
<Description>Aminocaproic acid is 6-aminohexanoic acid, which acts as an inhibitor of fibrinolysis. Its chemical structure is. Aminocaproic acid, USP is a fine, white to almost white, crystalline powder. It is freely soluble in water, in acids, and in alkaline solutions; it is slightly soluble in methanol and practically insoluble in chloroform and in ether. Each aminocaproic acid tablet, USP for oral administration contains 500 mg of aminocaproic acid, USP and the following inactive ingredients: crospovidone type B, magnesium stearate, povidone and stearic acid. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>70121-1637-5</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (70121-1637-5) / 1 mL in 1 VIAL, SINGLE-DOSE (70121-1637-1) </PackageDescription>
<NDC11Code>70121-1637-05</NDC11Code>
<ProductNDC>70121-1637</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ephedrine Sulfate</ProprietaryName>
<NonProprietaryName>Ephedrine Sulfate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20191023</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212932</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>EPHEDRINE SULFATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Increased Norepinephrine Activity [PE], Norepinephrine Releasing Agent [EPC], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191023</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ephedrine sulfate injection is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia.</IndicationAndUsage>
<Description>Ephedrine is an alpha- and beta-adrenergic agonist and a norepinephrine-releasing agent. Ephedrine sulfate injection, USP is a clear, colorless, sterile solution for intravenous injection. It must be diluted before intravenous administration. The chemical name of ephedrine sulfate is (1R,2S)-(-)-2-methylamine-1-phenylpropan-1-ol sulfate, and the molecular weight is 428.5 g/mol. Its molecular formula is (C10H15NO)2.H2SO4 and structural formula is depicted below. Ephedrine sulfate, USP is a white to off-white powder; it is freely soluble in water and slightly soluble in alcohol. Each mL contains ephedrine sulfate, USP 50 mg (equivalent to 38 mg ephedrine base) in water for injection. The pH is adjusted with sodium hydroxide and/or glacial acetic acid if necessary. The pH range is 4.5 to 7.0.</Description>
</NDC>
<NDC>
<NDCCode>70121-1637-7</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (70121-1637-7) / 1 mL in 1 VIAL, SINGLE-DOSE (70121-1637-1) </PackageDescription>
<NDC11Code>70121-1637-07</NDC11Code>
<ProductNDC>70121-1637</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ephedrine Sulfate</ProprietaryName>
<NonProprietaryName>Ephedrine Sulfate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20191023</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212932</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals LLC</LabelerName>
<SubstanceName>EPHEDRINE SULFATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Increased Norepinephrine Activity [PE], Norepinephrine Releasing Agent [EPC], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191023</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ephedrine sulfate injection is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia.</IndicationAndUsage>
<Description>Ephedrine is an alpha- and beta-adrenergic agonist and a norepinephrine-releasing agent. Ephedrine sulfate injection, USP is a clear, colorless, sterile solution for intravenous injection. It must be diluted before intravenous administration. The chemical name of ephedrine sulfate is (1R,2S)-(-)-2-methylamine-1-phenylpropan-1-ol sulfate, and the molecular weight is 428.5 g/mol. Its molecular formula is (C10H15NO)2.H2SO4 and structural formula is depicted below. Ephedrine sulfate, USP is a white to off-white powder; it is freely soluble in water and slightly soluble in alcohol. Each mL contains ephedrine sulfate, USP 50 mg (equivalent to 38 mg ephedrine base) in water for injection. The pH is adjusted with sodium hydroxide and/or glacial acetic acid if necessary. The pH range is 4.5 to 7.0.</Description>
</NDC>
<NDC>
<NDCCode>70518-1637-0</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (70518-1637-0) / 30 g in 1 TUBE</PackageDescription>
<NDC11Code>70518-1637-00</NDC11Code>
<ProductNDC>70518-1637</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ketoconazole</ProprietaryName>
<NonProprietaryName>Ketoconazole</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20181106</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076294</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>KETOCONAZOLE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181106</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ketoconazole Cream 2% is indicated for the topical treatment of tinea corporis, tinea cruris and tinea pedis caused by Trichophyton rubrum, T. mentagrophytesand Epidermophyton floccosum;in the treatment of tinea (pityriasis) versicolor caused by Malassezia furfur (Pityrosporum orbiculare); in the treatment of cutaneous candidiasis caused by Candida spp.and in the treatment of seborrheic dermatitis.</IndicationAndUsage>
<Description>Ketoconazole Cream 2%, for topical administration only, contains the broad-spectrum synthetic antifungal agent, ketoconazole 2%, formulated in an aqueous cream vehicle consisting of propylene glycol, stearyl and cetyl alcohols, sorbitan monostearate, polysorbate 60, isopropyl myristate, sodium sulfite anhydrous, polysorbate 80 and purified water. Ketoconazole is cis-1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1 H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazine and has the following structural formula:.</Description>
</NDC>
<NDC>
<NDCCode>71335-1637-1</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (71335-1637-1) </PackageDescription>
<NDC11Code>71335-1637-01</NDC11Code>
<ProductNDC>71335-1637</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levothyroxine Sodium</ProprietaryName>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190507</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021116</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>175</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Thyroxine [CS], l-Thyroxine [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200609</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hypothyroidism. Levothyroxine Sodium Tablets are indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression. Levothyroxine Sodium Tablets are indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: 1 Levothyroxine Sodium Tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with Levothyroxine Sodium Tablets may induce hyperthyroidism [see Warnings and Precautions (5.1)]., 2 Levothyroxine Sodium Tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.</IndicationAndUsage>
<Description>Levothyroxine Sodium Tablets are L-thyroxine (T4) and contain the active ingredient, levothyroxine, a synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C15H10I4NNaO4H2O, molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown. Levothyroxine Sodium Tablets are for oral administration and are available in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each levothyroxine sodium tablet contains the inactive ingredients butylated hydroxytoluene, calcium phosphate dibasic dihydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, and color additive(s). Table 9 provides a listing of the color additives by tablet strength.</Description>
</NDC>
<NDC>
<NDCCode>71335-1637-2</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (71335-1637-2) </PackageDescription>
<NDC11Code>71335-1637-02</NDC11Code>
<ProductNDC>71335-1637</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levothyroxine Sodium</ProprietaryName>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190507</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021116</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>175</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Thyroxine [CS], l-Thyroxine [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200609</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hypothyroidism. Levothyroxine Sodium Tablets are indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression. Levothyroxine Sodium Tablets are indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: 1 Levothyroxine Sodium Tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with Levothyroxine Sodium Tablets may induce hyperthyroidism [see Warnings and Precautions (5.1)]., 2 Levothyroxine Sodium Tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.</IndicationAndUsage>
<Description>Levothyroxine Sodium Tablets are L-thyroxine (T4) and contain the active ingredient, levothyroxine, a synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C15H10I4NNaO4H2O, molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown. Levothyroxine Sodium Tablets are for oral administration and are available in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each levothyroxine sodium tablet contains the inactive ingredients butylated hydroxytoluene, calcium phosphate dibasic dihydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, and color additive(s). Table 9 provides a listing of the color additives by tablet strength.</Description>
</NDC>
<NDC>
<NDCCode>71335-1637-3</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (71335-1637-3) </PackageDescription>
<NDC11Code>71335-1637-03</NDC11Code>
<ProductNDC>71335-1637</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levothyroxine Sodium</ProprietaryName>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190507</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021116</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>175</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Thyroxine [CS], l-Thyroxine [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200609</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hypothyroidism. Levothyroxine Sodium Tablets are indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression. Levothyroxine Sodium Tablets are indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: 1 Levothyroxine Sodium Tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with Levothyroxine Sodium Tablets may induce hyperthyroidism [see Warnings and Precautions (5.1)]., 2 Levothyroxine Sodium Tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.</IndicationAndUsage>
<Description>Levothyroxine Sodium Tablets are L-thyroxine (T4) and contain the active ingredient, levothyroxine, a synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C15H10I4NNaO4H2O, molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown. Levothyroxine Sodium Tablets are for oral administration and are available in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each levothyroxine sodium tablet contains the inactive ingredients butylated hydroxytoluene, calcium phosphate dibasic dihydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, and color additive(s). Table 9 provides a listing of the color additives by tablet strength.</Description>
</NDC>
<NDC>
<NDCCode>71335-1637-4</NDCCode>
<PackageDescription>38 TABLET in 1 BOTTLE (71335-1637-4) </PackageDescription>
<NDC11Code>71335-1637-04</NDC11Code>
<ProductNDC>71335-1637</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levothyroxine Sodium</ProprietaryName>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190507</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021116</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>175</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Thyroxine [CS], l-Thyroxine [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200609</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hypothyroidism. Levothyroxine Sodium Tablets are indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression. Levothyroxine Sodium Tablets are indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: 1 Levothyroxine Sodium Tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with Levothyroxine Sodium Tablets may induce hyperthyroidism [see Warnings and Precautions (5.1)]., 2 Levothyroxine Sodium Tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.</IndicationAndUsage>
<Description>Levothyroxine Sodium Tablets are L-thyroxine (T4) and contain the active ingredient, levothyroxine, a synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C15H10I4NNaO4H2O, molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown. Levothyroxine Sodium Tablets are for oral administration and are available in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each levothyroxine sodium tablet contains the inactive ingredients butylated hydroxytoluene, calcium phosphate dibasic dihydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, and color additive(s). Table 9 provides a listing of the color additives by tablet strength.</Description>
</NDC>
<NDC>
<NDCCode>71335-1637-5</NDCCode>
<PackageDescription>28 TABLET in 1 BOTTLE (71335-1637-5) </PackageDescription>
<NDC11Code>71335-1637-05</NDC11Code>
<ProductNDC>71335-1637</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levothyroxine Sodium</ProprietaryName>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190507</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021116</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>175</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Thyroxine [CS], l-Thyroxine [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200609</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hypothyroidism. Levothyroxine Sodium Tablets are indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression. Levothyroxine Sodium Tablets are indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: 1 Levothyroxine Sodium Tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with Levothyroxine Sodium Tablets may induce hyperthyroidism [see Warnings and Precautions (5.1)]., 2 Levothyroxine Sodium Tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.</IndicationAndUsage>
<Description>Levothyroxine Sodium Tablets are L-thyroxine (T4) and contain the active ingredient, levothyroxine, a synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C15H10I4NNaO4H2O, molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown. Levothyroxine Sodium Tablets are for oral administration and are available in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each levothyroxine sodium tablet contains the inactive ingredients butylated hydroxytoluene, calcium phosphate dibasic dihydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, and color additive(s). Table 9 provides a listing of the color additives by tablet strength.</Description>
</NDC>
<NDC>
<NDCCode>71335-1637-6</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (71335-1637-6) </PackageDescription>
<NDC11Code>71335-1637-06</NDC11Code>
<ProductNDC>71335-1637</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levothyroxine Sodium</ProprietaryName>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190507</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021116</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>175</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Thyroxine [CS], l-Thyroxine [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200609</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hypothyroidism. Levothyroxine Sodium Tablets are indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression. Levothyroxine Sodium Tablets are indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: 1 Levothyroxine Sodium Tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with Levothyroxine Sodium Tablets may induce hyperthyroidism [see Warnings and Precautions (5.1)]., 2 Levothyroxine Sodium Tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.</IndicationAndUsage>
<Description>Levothyroxine Sodium Tablets are L-thyroxine (T4) and contain the active ingredient, levothyroxine, a synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C15H10I4NNaO4H2O, molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown. Levothyroxine Sodium Tablets are for oral administration and are available in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each levothyroxine sodium tablet contains the inactive ingredients butylated hydroxytoluene, calcium phosphate dibasic dihydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, and color additive(s). Table 9 provides a listing of the color additives by tablet strength.</Description>
</NDC>
<NDC>
<NDCCode>82640-1637-1</NDCCode>
<PackageDescription>1 BOTTLE, WITH APPLICATOR in 1 CARTON (82640-1637-1) / 150 mL in 1 BOTTLE, WITH APPLICATOR</PackageDescription>
<NDC11Code>82640-1637-01</NDC11Code>
<ProductNDC>82640-1637</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aqua Maris Extra Strong</ProprietaryName>
<NonProprietaryName>Sodium Chloride</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20221222</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part349</ApplicationNumber>
<LabelerName>JGL d. d.</LabelerName>
<SubstanceName>SODIUM CHLORIDE</SubstanceName>
<StrengthNumber>21</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-07-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>