{
"NDC": [
{
"NDCCode": "54973-3114-3",
"PackageDescription": "3 POUCH in 1 CARTON (54973-3114-3) > 4 TABLET, SOLUBLE in 1 POUCH (54973-3114-1) ",
"NDC11Code": "54973-3114-03",
"ProductNDC": "54973-3114",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Leg Cramps",
"NonProprietaryName": "Cinchona Officinalis Bark, Aconitum Napellus, Pseudognaphalium Obtusifolium, Ledum Palustre Twig, Magnesium Phosphate, Dibasic Trihydrate, Toxicodendron Pubescens Leaf, And Viscum Album Fruiting Top",
"DosageFormName": "TABLET, SOLUBLE",
"RouteName": "ORAL",
"StartMarketingDate": "19951204",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hyland's Inc.",
"SubstanceName": "CINCHONA OFFICINALIS BARK; ACONITUM NAPELLUS; PSEUDOGNAPHALIUM OBTUSIFOLIUM; LEDUM PALUSTRE TWIG; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; TOXICODENDRON PUBESCENS LEAF; VISCUM ALBUM FRUITING TOP",
"StrengthNumber": "3; 6; 3; 6; 6; 6; 3",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2022-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19951204",
"SamplePackage": "N",
"IndicationAndUsage": "■ Helps temporarily relieve symptoms of. ■ stiness ■ pain in limbs, joints or legs ■ cramps in calves, feet or legs."
},
{
"NDCCode": "54973-3114-4",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (54973-3114-4) > 100 TABLET, SOLUBLE in 1 BOTTLE, PLASTIC",
"NDC11Code": "54973-3114-04",
"ProductNDC": "54973-3114",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Leg Cramps",
"NonProprietaryName": "Cinchona Officinalis Bark, Aconitum Napellus, Pseudognaphalium Obtusifolium, Ledum Palustre Twig, Magnesium Phosphate, Dibasic Trihydrate, Toxicodendron Pubescens Leaf, And Viscum Album Fruiting Top",
"DosageFormName": "TABLET, SOLUBLE",
"RouteName": "ORAL",
"StartMarketingDate": "19951204",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hyland's Inc.",
"SubstanceName": "CINCHONA OFFICINALIS BARK; ACONITUM NAPELLUS; PSEUDOGNAPHALIUM OBTUSIFOLIUM; LEDUM PALUSTRE TWIG; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; TOXICODENDRON PUBESCENS LEAF; VISCUM ALBUM FRUITING TOP",
"StrengthNumber": "3; 6; 3; 6; 6; 6; 3",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2022-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19951204",
"SamplePackage": "N",
"IndicationAndUsage": "■ Helps temporarily relieve symptoms of. ■ stiness ■ pain in limbs, joints or legs ■ cramps in calves, feet or legs."
},
{
"NDCCode": "36987-3114-4",
"PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (36987-3114-4)",
"NDC11Code": "36987-3114-04",
"ProductNDC": "36987-3114",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Poplar",
"NonProprietaryName": "Poplar",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "POPULUS DELTOIDES POLLEN",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [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": "37662-3114-4",
"PackageDescription": "10000 PELLET in 1 BOTTLE, GLASS (37662-3114-4) ",
"NDC11Code": "37662-3114-04",
"ProductNDC": "37662-3114",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Zirconium Iodatum",
"NonProprietaryName": "Zirconium Iodatum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230503",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "ZIRCONIUM IODIDE",
"StrengthNumber": "1",
"StrengthUnit": "[hp_M]/1",
"Status": "Active",
"LastUpdate": "2023-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230503",
"SamplePackage": "N"
},
{
"NDCCode": "54973-3114-2",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (54973-3114-2) > 40 TABLET, SOLUBLE in 1 BOTTLE, PLASTIC",
"NDC11Code": "54973-3114-02",
"ProductNDC": "54973-3114",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Leg Cramps",
"NonProprietaryName": "Cinchona Officinalis Bark, Aconitum Napellus, Pseudognaphalium Obtusifolium, Ledum Palustre Twig, Magnesium Phosphate, Dibasic Trihydrate, Toxicodendron Pubescens Leaf, And Viscum Album Fruiting Top",
"DosageFormName": "TABLET, SOLUBLE",
"RouteName": "ORAL",
"StartMarketingDate": "19951204",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hyland's Inc.",
"SubstanceName": "CINCHONA OFFICINALIS BARK; ACONITUM NAPELLUS; PSEUDOGNAPHALIUM OBTUSIFOLIUM; LEDUM PALUSTRE TWIG; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; TOXICODENDRON PUBESCENS LEAF; VISCUM ALBUM FRUITING TOP",
"StrengthNumber": "3; 6; 3; 6; 6; 6; 3",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2022-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19951204",
"SamplePackage": "N",
"IndicationAndUsage": "■ Helps temporarily relieve symptoms of. ■ stiness ■ pain in limbs, joints or legs ■ cramps in calves, feet or legs."
},
{
"NDCCode": "54973-3114-5",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (54973-3114-5) > 16 TABLET, SOLUBLE in 1 BOTTLE, PLASTIC",
"NDC11Code": "54973-3114-05",
"ProductNDC": "54973-3114",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Leg Cramps",
"NonProprietaryName": "Cinchona Officinalis Bark, Aconitum Napellus, Pseudognaphalium Obtusifolium, Ledum Palustre Twig, Magnesium Phosphate, Dibasic Trihydrate, Toxicodendron Pubescens Leaf, And Viscum Album Fruiting Top",
"DosageFormName": "TABLET, SOLUBLE",
"RouteName": "ORAL",
"StartMarketingDate": "19951204",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hyland's Inc.",
"SubstanceName": "CINCHONA OFFICINALIS BARK; ACONITUM NAPELLUS; PSEUDOGNAPHALIUM OBTUSIFOLIUM; LEDUM PALUSTRE TWIG; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; TOXICODENDRON PUBESCENS LEAF; VISCUM ALBUM FRUITING TOP",
"StrengthNumber": "3; 6; 3; 6; 6; 6; 3",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2022-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19951204",
"SamplePackage": "N",
"IndicationAndUsage": "■ Helps temporarily relieve symptoms of. ■ stiness ■ pain in limbs, joints or legs ■ cramps in calves, feet or legs."
},
{
"NDCCode": "54973-3114-7",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (54973-3114-7) > 16 TABLET, SOLUBLE in 1 BOTTLE, PLASTIC",
"NDC11Code": "54973-3114-07",
"ProductNDC": "54973-3114",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Leg Cramps",
"NonProprietaryName": "Cinchona Officinalis Bark, Aconitum Napellus, Pseudognaphalium Obtusifolium, Ledum Palustre Twig, Magnesium Phosphate, Dibasic Trihydrate, Toxicodendron Pubescens Leaf, And Viscum Album Fruiting Top",
"DosageFormName": "TABLET, SOLUBLE",
"RouteName": "ORAL",
"StartMarketingDate": "19951204",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hyland's Inc.",
"SubstanceName": "CINCHONA OFFICINALIS BARK; ACONITUM NAPELLUS; PSEUDOGNAPHALIUM OBTUSIFOLIUM; LEDUM PALUSTRE TWIG; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; TOXICODENDRON PUBESCENS LEAF; VISCUM ALBUM FRUITING TOP",
"StrengthNumber": "3; 6; 3; 6; 6; 6; 3",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2022-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19951204",
"SamplePackage": "N",
"IndicationAndUsage": "■ Helps temporarily relieve symptoms of. ■ stiness ■ pain in limbs, joints or legs ■ cramps in calves, feet or legs."
},
{
"NDCCode": "0264-3114-11",
"PackageDescription": "24 CONTAINER in 1 CASE (0264-3114-11) > 50 mL in 1 CONTAINER",
"NDC11Code": "00264-3114-11",
"ProductNDC": "0264-3114",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cefuroxime And Dextrose",
"NonProprietaryName": "Cefuroxime And Dextrose",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20010221",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050780",
"LabelerName": "B. Braun Medical Inc.",
"SubstanceName": "CEFUROXIME SODIUM",
"StrengthNumber": "1.5",
"StrengthUnit": "g/50mL",
"Pharm_Classes": "Cephalosporin Antibacterial [EPC], Cephalosporins [CS]",
"Status": "Active",
"LastUpdate": "2020-12-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20010221",
"SamplePackage": "N",
"IndicationAndUsage": "Cefuroxime for Injection USP and Dextrose Injection USP is indicated for the treatment of patients with infections caused by susceptible strains of the designated organisms in the following diseases: 1 Lower Respiratory Tract Infections, including pneumonia, caused by Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin-resistant strains), Klebsiella spp., Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pyogenes, and Escherichia coli. , 2 Urinary Tract Infections caused by Escherichia coli and Klebsiella spp. , 3 Skin and Skin-Structure Infections caused by Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pyogenes, Escherichia coli, Klebsiella spp., and Enterobacter spp. , 4 Septicemia caused by Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae (including ampicillin-resistant strains), and Klebsiella spp. , 5 Meningitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin-resistant strains), Neisseria meningitidis, and Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains). , 6 Gonorrhea: Uncomplicated and disseminated gonococcal infections due to Neisseria gonorrhoeae (penicillinase- and non-penicillinase-producing strains) in both males and females. , 7 Bone and Joint Infections caused by Staphylococcus aureus (penicillinase- and non-penicillinase producing strains).",
"Description": "Cefuroxime for Injection USP and Dextrose Injection USP is a sterile, nonpyrogenic, single use, packaged combination of Cefuroxime Sodium USP (crystalline) and Dextrose Injection USP (diluent) in the DUPLEX® sterile container. The DUPLEX® Container is a flexible dual chamber container. The drug chamber is filled with sterile crystalline Cefuroxime for Injection USP, a semi-synthetic, broad-spectrum, cephalosporin antibacterial for parenteral administration. It is the sodium salt of (6R,7R)-7-[2-(2-furyl)glyoxylamido]-3-(hydroxymethyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate, 72-(Z)-(O-methyloxime), carbamate (ester). Cefuroxime Sodium USP has the following structural formula. The empirical formula is C16H15N4NaO8S, representing a molecular weight of 446.4. Cefuroxime contains approximately 54.2 mg (2.4 mEq) of sodium per gram of cefuroxime activity. The diluent chamber contains Dextrose Injection USP. The concentration of Hydrous Dextrose USP has been adjusted to render the reconstituted drug product iso-osmotic. Dextrose Injection USP is sterile, nonpyrogenic, and contains no bacteriostatic or antimicrobial agents. Hydrous Dextrose USP has the following structural (molecular) formula. The molecular weight of Hydrous Dextrose USP is 198.17. Dextrose hydrous USP has been added to the diluent to adjust osmolality (approximately 2.05 g and 1.45 g to 750 mg and 1.5 g dosages, respectively). After removing the peelable foil strip, activating the seals, and thoroughly mixing, the reconstituted drug product is intended for single intravenous use. When reconstituted, the approximate osmolality of the reconstituted solution for Cefuroxime for Injection USP and Dextrose Injection USP is 290 mOsmol/kg. Not made with natural rubber latex, PVC or Di (2-ethylhexyl) phthalate (DEHP). The DUPLEX® dual chamber container is made from a specially formulated material. The product (diluent and drug) contact layer is a mixture of thermoplastic rubber and a polypropylene ethylene copolymer that contains no plasticizers. The safety of the container system is supported by USP biological evaluation procedures."
},
{
"NDCCode": "0781-3114-95",
"PackageDescription": "10 VIAL, SINGLE-USE in 1 CARTON (0781-3114-95) / 20 mL in 1 VIAL, SINGLE-USE (0781-3114-91) ",
"NDC11Code": "00781-3114-95",
"ProductNDC": "0781-3114",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Piperacillin And Tazobactam",
"NonProprietaryName": "Piperacillin And Tazobactam",
"DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
"RouteName": "INTRAVENOUS; PARENTERAL",
"StartMarketingDate": "20101021",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065362",
"LabelerName": "Sandoz Inc",
"SubstanceName": "PIPERACILLIN SODIUM; TAZOBACTAM SODIUM",
"StrengthNumber": "4; .5",
"StrengthUnit": "g/20mL; g/20mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20101021",
"SamplePackage": "N",
"IndicationAndUsage": "Piperacillin and tazobactam for injection is a combination of piperacillin, a penicillin-class antibacterial and tazobactam, a beta-lactamase inhibitor, indicated for the treatment of: 1 Intra-abdominal infections in adult and pediatric patients 2 months of age and older (1.1), 2 Nosocomial pneumonia in adult and pediatric patients 2 months of age and older (1.2), 3 Skin and skin structure infections in adults (1.3), 4 Female pelvic infections in adults (1.4), 5 Community-acquired pneumonia in adults (1.5).",
"Description": "Piperacillin and tazobactam for injection, USP is an injectable antibacterial combination product consisting of the semisynthetic antibacterial piperacillin sodium and the beta-lactamase inhibitor tazobactam sodium for intravenous administration. Piperacillin sodium is derived from D(-)-α-aminobenzyl-penicillin. The chemical name of piperacillin sodium is sodium (2S,5R,6R)-6-[(R)-2-(4-ethyl-2,3-dioxo-1-piperazine‑carboxamido)-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2‑carboxylate. The chemical formula is C23H26N5NaO7S and the molecular weight is 539.5. The chemical structure of piperacillin sodium is. Tazobactam sodium, a derivative of the penicillin nucleus, is a penicillanic acid sulfone. Its chemical name is sodium (2S,3S,5R)-3-methyl-7-oxo-3-(1H-1,2,3-triazol-1-ylmethyl)-4-thia-1‑azabicyclo[3.2.0]heptane-2-carboxylate-4,4-dioxide. The chemical formula is C10H11N4NaO5S and the molecular weight is 322.3. The chemical structure of tazobactam sodium is. Piperacillin and tazobactam for injection, USP, is a white to yellowish sterile, cryodesiccated powder consisting of piperacillin and tazobactam as their sodium salts packaged in glass vials. The product does not contain excipients or preservatives. Dilute solutions are colorless to yellowish. Each piperacillin and tazobactam for injection, USP 2.25 g single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 2 grams of piperacillin and tazobactam sodium equivalent to 0.25 g of tazobactam. Each vial contains 4.69 mEq (108 mg) of sodium. Each piperacillin and tazobactam for injection, USP 3.375 g single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 3 grams of piperacillin and tazobactam sodium equivalent to 0.375 g of tazobactam. Each vial contains 7.04 mEq (162 mg) of sodium. Each piperacillin and tazobactam for injection, USP 4.5 g single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 4 grams of piperacillin and tazobactam sodium equivalent to 0.5 g of tazobactam. Each vial contains 9.39 mEq (216 mg) of sodium. Piperacillin and tazobactam for injection, USP contains a total of 2.35 mEq (54 mg) of sodium (Na+) per gram of piperacillin in the combination product. Meets USP Organic Impurities Procedure 3."
},
{
"NDCCode": "54868-3114-0",
"PackageDescription": "30 TABLET in 1 BOTTLE (54868-3114-0)",
"NDC11Code": "54868-3114-00",
"ProductNDC": "54868-3114",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Estropipate",
"NonProprietaryName": "Estropipate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20030321",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA081213",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "ESTROPIPATE",
"StrengthNumber": ".75",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Estropipate tablets are indicated in the: 1 Treatment of moderate to severe vasomotor symptoms associated with the menopause., 2 Treatment of moderate to severe symptoms of vulval and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered., 3 Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure., 4 Prevention of postmenopausal osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and for whom non-estrogen medications are not considered to be appropriate.",
"Description": "Estropipate (formerly piperazine estrone sulfate), is a natural estrogenic substance prepared from purified crystalline estrone, solubilized as the sulfate and stabilized with piperazine. It is appreciably soluble in water and has almost no odor or taste — properties which are ideally suited for oral administration. The amount of piperazine in estropipate is not sufficient to exert a pharmacological action. Its addition ensures solubility, stability, and uniform potency of the estrone sulfate. Chemically estropipate, molecular weight: 436.56, is represented by estra-1,3,5(10)-trien-17-one,3-(sulfooxy)-, compound with piperazine (1:1). The structural formula may be represented as follows. Estropipate is available as tablets for oral administration containing either 0.75 mg, 1.5 mg, 3 mg, or 6 mg estropipate (calculated as sodium estrone sulfate 0.625 mg, 1.25 mg, 2.5 mg and 5 mg, respectively). Each tablet contains: lactose NF, magnesium stearate NF, piperazine USP, pregelatinized starch NF, talc USP, and coloring agents: 0.75 mg—D&C Yellow #10; 1.5 mg—FD&C Yellow #6; 3 mg—FD&C Blue #2; 6 mg—FD&C Blue #2 and D&C Yellow #10."
},
{
"NDCCode": "54868-3114-1",
"PackageDescription": "100 TABLET in 1 BOTTLE (54868-3114-1)",
"NDC11Code": "54868-3114-01",
"ProductNDC": "54868-3114",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Estropipate",
"NonProprietaryName": "Estropipate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20030321",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA081213",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "ESTROPIPATE",
"StrengthNumber": ".75",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Estropipate tablets are indicated in the: 1 Treatment of moderate to severe vasomotor symptoms associated with the menopause., 2 Treatment of moderate to severe symptoms of vulval and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered., 3 Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure., 4 Prevention of postmenopausal osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and for whom non-estrogen medications are not considered to be appropriate.",
"Description": "Estropipate (formerly piperazine estrone sulfate), is a natural estrogenic substance prepared from purified crystalline estrone, solubilized as the sulfate and stabilized with piperazine. It is appreciably soluble in water and has almost no odor or taste — properties which are ideally suited for oral administration. The amount of piperazine in estropipate is not sufficient to exert a pharmacological action. Its addition ensures solubility, stability, and uniform potency of the estrone sulfate. Chemically estropipate, molecular weight: 436.56, is represented by estra-1,3,5(10)-trien-17-one,3-(sulfooxy)-, compound with piperazine (1:1). The structural formula may be represented as follows. Estropipate is available as tablets for oral administration containing either 0.75 mg, 1.5 mg, 3 mg, or 6 mg estropipate (calculated as sodium estrone sulfate 0.625 mg, 1.25 mg, 2.5 mg and 5 mg, respectively). Each tablet contains: lactose NF, magnesium stearate NF, piperazine USP, pregelatinized starch NF, talc USP, and coloring agents: 0.75 mg—D&C Yellow #10; 1.5 mg—FD&C Yellow #6; 3 mg—FD&C Blue #2; 6 mg—FD&C Blue #2 and D&C Yellow #10."
},
{
"NDCCode": "60505-3114-0",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (60505-3114-0) / 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "60505-3114-00",
"ProductNDC": "60505-3114",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120423",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090798",
"LabelerName": "Apotex Corp.",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120423",
"SamplePackage": "N",
"IndicationAndUsage": "Olanzapine tablets are an atypical antipsychotic indicated. As oral formulation for the: 1 Treatment of schizophrenia. (1.1)Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1) Adolescents (ages 13 to 17): Efficacy was established in one 6- week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1), 2 Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2)Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2) Adolescents (ages 13 to 17): Efficacy was established in one 3- week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2), 3 Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3), 4 Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2)Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated. .",
"Description": "Olanzapine is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.43. The chemical structure is:. Olanzapine is a yellow powder. Olanzapine tablets, USP are intended for oral administration only. Each tablet contains olanzapine equivalent to 2.5 mg (8 mcmol), 5 mg (16 mcmol), 7.5 mg (24 mcmol), 10 mg (32 mcmol), 15 mg (48 mcmol), or 20 mg (64 mcmol). Inactive ingredients are lactose, magnesium stearate, microcrystalline cellulose, starch. The color coating contains FD&C blue No.2 aluminum lake (15 mg), ferric oxide red (20 mg), ferric oxide yellow (20 mg), hydroxypropyl cellulose, hypromellose, polyethylene glycol and titanium dioxide (all strengths). FDA approved UV identification test differs from USP infrared identification test."
},
{
"NDCCode": "60505-3114-3",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (60505-3114-3) ",
"NDC11Code": "60505-3114-03",
"ProductNDC": "60505-3114",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120423",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090798",
"LabelerName": "Apotex Corp.",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120423",
"SamplePackage": "N",
"IndicationAndUsage": "Olanzapine tablets are an atypical antipsychotic indicated. As oral formulation for the: 1 Treatment of schizophrenia. (1.1)Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1) Adolescents (ages 13 to 17): Efficacy was established in one 6- week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1), 2 Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2)Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2) Adolescents (ages 13 to 17): Efficacy was established in one 3- week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2), 3 Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3), 4 Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2)Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated. .",
"Description": "Olanzapine is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.43. The chemical structure is:. Olanzapine is a yellow powder. Olanzapine tablets, USP are intended for oral administration only. Each tablet contains olanzapine equivalent to 2.5 mg (8 mcmol), 5 mg (16 mcmol), 7.5 mg (24 mcmol), 10 mg (32 mcmol), 15 mg (48 mcmol), or 20 mg (64 mcmol). Inactive ingredients are lactose, magnesium stearate, microcrystalline cellulose, starch. The color coating contains FD&C blue No.2 aluminum lake (15 mg), ferric oxide red (20 mg), ferric oxide yellow (20 mg), hydroxypropyl cellulose, hypromellose, polyethylene glycol and titanium dioxide (all strengths). FDA approved UV identification test differs from USP infrared identification test."
},
{
"NDCCode": "60505-3114-8",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (60505-3114-8) ",
"NDC11Code": "60505-3114-08",
"ProductNDC": "60505-3114",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120423",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090798",
"LabelerName": "Apotex Corp.",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "15",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120423",
"SamplePackage": "N",
"IndicationAndUsage": "Olanzapine tablets are an atypical antipsychotic indicated. As oral formulation for the: 1 Treatment of schizophrenia. (1.1)Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1) Adolescents (ages 13 to 17): Efficacy was established in one 6- week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1), 2 Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2)Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2) Adolescents (ages 13 to 17): Efficacy was established in one 3- week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2), 3 Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3), 4 Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2)Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated. .",
"Description": "Olanzapine is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.43. The chemical structure is:. Olanzapine is a yellow powder. Olanzapine tablets, USP are intended for oral administration only. Each tablet contains olanzapine equivalent to 2.5 mg (8 mcmol), 5 mg (16 mcmol), 7.5 mg (24 mcmol), 10 mg (32 mcmol), 15 mg (48 mcmol), or 20 mg (64 mcmol). Inactive ingredients are lactose, magnesium stearate, microcrystalline cellulose, starch. The color coating contains FD&C blue No.2 aluminum lake (15 mg), ferric oxide red (20 mg), ferric oxide yellow (20 mg), hydroxypropyl cellulose, hypromellose, polyethylene glycol and titanium dioxide (all strengths). FDA approved UV identification test differs from USP infrared identification test."
},
{
"NDCCode": "54973-0229-2",
"PackageDescription": "4 TABLET, SOLUBLE in 1 POUCH (54973-0229-2) ",
"NDC11Code": "54973-0229-02",
"ProductNDC": "54973-0229",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Arnicaid",
"NonProprietaryName": "Arnica Montana, Hypericum Perforatum, Ruta Graveolens Flowering Top, Ledum Palustre Twig, And Bellis Perennis",
"DosageFormName": "TABLET, SOLUBLE",
"RouteName": "ORAL",
"StartMarketingDate": "19910717",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hyland's Inc.",
"SubstanceName": "ARNICA MONTANA; BELLIS PERENNIS; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; RUTA GRAVEOLENS FLOWERING TOP",
"StrengthNumber": "30; 6; 6; 6; 6",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2023-09-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "19910717",
"SamplePackage": "Y"
},
{
"NDCCode": "54973-0229-3",
"PackageDescription": "4 POUCH in 1 CARTON (54973-0229-3) > 4 TABLET, SOLUBLE in 1 POUCH",
"NDC11Code": "54973-0229-03",
"ProductNDC": "54973-0229",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Arnicaid",
"NonProprietaryName": "Arnica Montana, Hypericum Perforatum, Ruta Graveolens Flowering Top, Ledum Palustre Twig, And Bellis Perennis",
"DosageFormName": "TABLET, SOLUBLE",
"RouteName": "ORAL",
"StartMarketingDate": "19910717",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hyland's Inc.",
"SubstanceName": "ARNICA MONTANA; BELLIS PERENNIS; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; RUTA GRAVEOLENS FLOWERING TOP",
"StrengthNumber": "30; 6; 6; 6; 6",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2023-09-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "19910717",
"SamplePackage": "N"
},
{
"NDCCode": "54973-0232-2",
"PackageDescription": "4 TABLET, SOLUBLE in 1 POUCH (54973-0232-2) ",
"NDC11Code": "54973-0232-02",
"ProductNDC": "54973-0232",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Arnisport",
"NonProprietaryName": "Arnica Montana, Hypericum Perforatum, Ruta Graveolens Flowering Top, Ledum Palustre Twig, Bellis Perennis, Calcium Fluoride, Tribasic Calcium Phosphate, Calcium Sulfate Anhydrous, Ferrosoferric Phosphate, Potassium Chloride, Potassium Phosphate, Dibasic, Potassium Sulfate, Magnesium Phosphate, Dibasic Trihydrate, Sodium Chloride, Sodium Phosphate, Dibasic, Heptahydrate, Sodium Sulfate, And Silicon Dioxide",
"DosageFormName": "TABLET, SOLUBLE",
"RouteName": "ORAL",
"StartMarketingDate": "20000428",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hyland's Inc.",
"SubstanceName": "ARNICA MONTANA; BELLIS PERENNIS; CALCIUM FLUORIDE; CALCIUM SULFATE ANHYDROUS; FERRUM PHOSPHORICUM; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM SULFATE; RUTA GRAVEOLENS FLOWERING TOP; SILICON DIOXIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM SULFATE; TRIBASIC CALCIUM PHOSPHATE",
"StrengthNumber": "30; 6; 6; 3; 3; 6; 6; 3; 3; 3; 3; 6; 6; 6; 3; 3; 3",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [EPC], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-09-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20000428",
"SamplePackage": "Y"
},
{
"NDCCode": "54973-0232-3",
"PackageDescription": "4 POUCH in 1 CARTON (54973-0232-3) / 4 TABLET, SOLUBLE in 1 POUCH",
"NDC11Code": "54973-0232-03",
"ProductNDC": "54973-0232",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Arnisport",
"NonProprietaryName": "Arnica Montana, Hypericum Perforatum, Ruta Graveolens Flowering Top, Ledum Palustre Twig, Bellis Perennis, Calcium Fluoride, Tribasic Calcium Phosphate, Calcium Sulfate Anhydrous, Ferrosoferric Phosphate, Potassium Chloride, Potassium Phosphate, Dibasic, Potassium Sulfate, Magnesium Phosphate, Dibasic Trihydrate, Sodium Chloride, Sodium Phosphate, Dibasic, Heptahydrate, Sodium Sulfate, And Silicon Dioxide",
"DosageFormName": "TABLET, SOLUBLE",
"RouteName": "ORAL",
"StartMarketingDate": "20000428",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hyland's Inc.",
"SubstanceName": "ARNICA MONTANA; BELLIS PERENNIS; CALCIUM FLUORIDE; CALCIUM SULFATE ANHYDROUS; FERRUM PHOSPHORICUM; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM SULFATE; RUTA GRAVEOLENS FLOWERING TOP; SILICON DIOXIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM SULFATE; TRIBASIC CALCIUM PHOSPHATE",
"StrengthNumber": "30; 6; 6; 3; 3; 6; 6; 3; 3; 3; 3; 6; 6; 6; 3; 3; 3",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [EPC], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-09-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20000428",
"SamplePackage": "N"
},
{
"NDCCode": "54973-0600-4",
"PackageDescription": "250 TABLET in 1 BOTTLE, PLASTIC (54973-0600-4) ",
"NDC11Code": "54973-0600-04",
"ProductNDC": "54973-0600",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aconite Napellis",
"NonProprietaryName": "Aconitum Napellus Root",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19550101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hyland's",
"SubstanceName": "ACONITUM NAPELLUS ROOT",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2021-12-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "19550101",
"SamplePackage": "N"
},
{
"NDCCode": "54973-0601-4",
"PackageDescription": "250 TABLET in 1 BOTTLE, PLASTIC (54973-0601-4) ",
"NDC11Code": "54973-0601-04",
"ProductNDC": "54973-0601",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allium Cepa",
"NonProprietaryName": "Onion",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19550101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hyland's",
"SubstanceName": "ONION",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2021-12-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "19550101",
"SamplePackage": "N"
},
{
"NDCCode": "54973-0602-4",
"PackageDescription": "250 TABLET in 1 BOTTLE, PLASTIC (54973-0602-4) ",
"NDC11Code": "54973-0602-04",
"ProductNDC": "54973-0602",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antimonium Tart",
"NonProprietaryName": "Antimony Potassium Tartrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19550101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hyland's",
"SubstanceName": "ANTIMONY POTASSIUM TARTRATE",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2021-12-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "19550101",
"SamplePackage": "N"
},
{
"NDCCode": "54973-0603-4",
"PackageDescription": "250 TABLET in 1 BOTTLE, PLASTIC (54973-0603-4) ",
"NDC11Code": "54973-0603-04",
"ProductNDC": "54973-0603",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Apis Mellifica",
"NonProprietaryName": "Apis Mellifera",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19550101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hyland's",
"SubstanceName": "APIS MELLIFERA",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2021-12-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "19550101",
"SamplePackage": "N"
},
{
"NDCCode": "54973-0604-4",
"PackageDescription": "250 TABLET in 1 BOTTLE, PLASTIC (54973-0604-4) ",
"NDC11Code": "54973-0604-04",
"ProductNDC": "54973-0604",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Arnica Montana",
"NonProprietaryName": "Arnica Montana",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19550101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hyland's Inc.",
"SubstanceName": "ARNICA MONTANA",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2025-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "19550101",
"SamplePackage": "N",
"IndicationAndUsage": "Bruises or Muscle Soreness."
},
{
"NDCCode": "54973-0605-4",
"PackageDescription": "250 TABLET in 1 BOTTLE, PLASTIC (54973-0605-4) ",
"NDC11Code": "54973-0605-04",
"ProductNDC": "54973-0605",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Arsenicum Album",
"NonProprietaryName": "Arsenic Trioxide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19550101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hyland's Inc.",
"SubstanceName": "ARSENIC TRIOXIDE",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2025-04-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "19550101",
"SamplePackage": "N",
"IndicationAndUsage": "BURNING NASAL DISCHARGE OR DIARRHEA."
},
{
"NDCCode": "54973-0606-4",
"PackageDescription": "250 TABLET in 1 BOTTLE, PLASTIC (54973-0606-4) ",
"NDC11Code": "54973-0606-04",
"ProductNDC": "54973-0606",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Belladonna",
"NonProprietaryName": "Atropa Belladonna Root",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19550101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hyland's",
"SubstanceName": "ATROPA BELLADONNA ROOT",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2021-12-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "19550101",
"SamplePackage": "N"
},
{
"NDCCode": "54973-0607-4",
"PackageDescription": "250 TABLET in 1 BOTTLE, PLASTIC (54973-0607-4) ",
"NDC11Code": "54973-0607-04",
"ProductNDC": "54973-0607",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bryonia Alba",
"NonProprietaryName": "Bryonia Alba Root",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19550101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hyland's",
"SubstanceName": "BRYONIA ALBA ROOT",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2021-12-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "19550101",
"SamplePackage": "N"
},
{
"NDCCode": "54973-0609-4",
"PackageDescription": "250 TABLET in 1 BOTTLE, PLASTIC (54973-0609-4) ",
"NDC11Code": "54973-0609-04",
"ProductNDC": "54973-0609",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cantharis",
"NonProprietaryName": "Lytta Vesicatoria",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19550101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hyland's",
"SubstanceName": "LYTTA VESICATORIA",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2021-12-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "19550101",
"SamplePackage": "N"
},
{
"NDCCode": "54973-0610-4",
"PackageDescription": "250 TABLET in 1 BOTTLE, PLASTIC (54973-0610-4) ",
"NDC11Code": "54973-0610-04",
"ProductNDC": "54973-0610",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Carbo Veg",
"NonProprietaryName": "Activated Charcoal",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19550101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hyland's",
"SubstanceName": "ACTIVATED CHARCOAL",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2021-12-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "19550101",
"SamplePackage": "N"
},
{
"NDCCode": "54973-0611-4",
"PackageDescription": "250 TABLET in 1 BOTTLE, PLASTIC (54973-0611-4) ",
"NDC11Code": "54973-0611-04",
"ProductNDC": "54973-0611",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Chamomilla",
"NonProprietaryName": "Matricaria Chamomilla Flowering Top Oil",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19550101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hyland's",
"SubstanceName": "MATRICARIA CHAMOMILLA FLOWERING TOP OIL",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2021-12-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20130524",
"SamplePackage": "N"
},
{
"NDCCode": "54973-0613-4",
"PackageDescription": "250 TABLET in 1 BOTTLE, PLASTIC (54973-0613-4) ",
"NDC11Code": "54973-0613-04",
"ProductNDC": "54973-0613",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Gelsemium Semp",
"NonProprietaryName": "Gelsemium Sempervirens Root",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19550101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hyland's",
"SubstanceName": "GELSEMIUM SEMPERVIRENS ROOT",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2021-12-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "19550101",
"SamplePackage": "N"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>54973-3114-3</NDCCode>
<PackageDescription>3 POUCH in 1 CARTON (54973-3114-3) > 4 TABLET, SOLUBLE in 1 POUCH (54973-3114-1) </PackageDescription>
<NDC11Code>54973-3114-03</NDC11Code>
<ProductNDC>54973-3114</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Leg Cramps</ProprietaryName>
<NonProprietaryName>Cinchona Officinalis Bark, Aconitum Napellus, Pseudognaphalium Obtusifolium, Ledum Palustre Twig, Magnesium Phosphate, Dibasic Trihydrate, Toxicodendron Pubescens Leaf, And Viscum Album Fruiting Top</NonProprietaryName>
<DosageFormName>TABLET, SOLUBLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19951204</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hyland's Inc.</LabelerName>
<SubstanceName>CINCHONA OFFICINALIS BARK; ACONITUM NAPELLUS; PSEUDOGNAPHALIUM OBTUSIFOLIUM; LEDUM PALUSTRE TWIG; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; TOXICODENDRON PUBESCENS LEAF; VISCUM ALBUM FRUITING TOP</SubstanceName>
<StrengthNumber>3; 6; 3; 6; 6; 6; 3</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19951204</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>■ Helps temporarily relieve symptoms of. ■ stiness ■ pain in limbs, joints or legs ■ cramps in calves, feet or legs.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>54973-3114-4</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (54973-3114-4) > 100 TABLET, SOLUBLE in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>54973-3114-04</NDC11Code>
<ProductNDC>54973-3114</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Leg Cramps</ProprietaryName>
<NonProprietaryName>Cinchona Officinalis Bark, Aconitum Napellus, Pseudognaphalium Obtusifolium, Ledum Palustre Twig, Magnesium Phosphate, Dibasic Trihydrate, Toxicodendron Pubescens Leaf, And Viscum Album Fruiting Top</NonProprietaryName>
<DosageFormName>TABLET, SOLUBLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19951204</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hyland's Inc.</LabelerName>
<SubstanceName>CINCHONA OFFICINALIS BARK; ACONITUM NAPELLUS; PSEUDOGNAPHALIUM OBTUSIFOLIUM; LEDUM PALUSTRE TWIG; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; TOXICODENDRON PUBESCENS LEAF; VISCUM ALBUM FRUITING TOP</SubstanceName>
<StrengthNumber>3; 6; 3; 6; 6; 6; 3</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19951204</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>■ Helps temporarily relieve symptoms of. ■ stiness ■ pain in limbs, joints or legs ■ cramps in calves, feet or legs.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>36987-3114-4</NDCCode>
<PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (36987-3114-4)</PackageDescription>
<NDC11Code>36987-3114-04</NDC11Code>
<ProductNDC>36987-3114</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Poplar</ProprietaryName>
<NonProprietaryName>Poplar</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>POPULUS DELTOIDES POLLEN</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [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>37662-3114-4</NDCCode>
<PackageDescription>10000 PELLET in 1 BOTTLE, GLASS (37662-3114-4) </PackageDescription>
<NDC11Code>37662-3114-04</NDC11Code>
<ProductNDC>37662-3114</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Zirconium Iodatum</ProprietaryName>
<NonProprietaryName>Zirconium Iodatum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230503</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>ZIRCONIUM IODIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_M]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230503</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>54973-3114-2</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (54973-3114-2) > 40 TABLET, SOLUBLE in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>54973-3114-02</NDC11Code>
<ProductNDC>54973-3114</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Leg Cramps</ProprietaryName>
<NonProprietaryName>Cinchona Officinalis Bark, Aconitum Napellus, Pseudognaphalium Obtusifolium, Ledum Palustre Twig, Magnesium Phosphate, Dibasic Trihydrate, Toxicodendron Pubescens Leaf, And Viscum Album Fruiting Top</NonProprietaryName>
<DosageFormName>TABLET, SOLUBLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19951204</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hyland's Inc.</LabelerName>
<SubstanceName>CINCHONA OFFICINALIS BARK; ACONITUM NAPELLUS; PSEUDOGNAPHALIUM OBTUSIFOLIUM; LEDUM PALUSTRE TWIG; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; TOXICODENDRON PUBESCENS LEAF; VISCUM ALBUM FRUITING TOP</SubstanceName>
<StrengthNumber>3; 6; 3; 6; 6; 6; 3</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19951204</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>■ Helps temporarily relieve symptoms of. ■ stiness ■ pain in limbs, joints or legs ■ cramps in calves, feet or legs.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>54973-3114-5</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (54973-3114-5) > 16 TABLET, SOLUBLE in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>54973-3114-05</NDC11Code>
<ProductNDC>54973-3114</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Leg Cramps</ProprietaryName>
<NonProprietaryName>Cinchona Officinalis Bark, Aconitum Napellus, Pseudognaphalium Obtusifolium, Ledum Palustre Twig, Magnesium Phosphate, Dibasic Trihydrate, Toxicodendron Pubescens Leaf, And Viscum Album Fruiting Top</NonProprietaryName>
<DosageFormName>TABLET, SOLUBLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19951204</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hyland's Inc.</LabelerName>
<SubstanceName>CINCHONA OFFICINALIS BARK; ACONITUM NAPELLUS; PSEUDOGNAPHALIUM OBTUSIFOLIUM; LEDUM PALUSTRE TWIG; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; TOXICODENDRON PUBESCENS LEAF; VISCUM ALBUM FRUITING TOP</SubstanceName>
<StrengthNumber>3; 6; 3; 6; 6; 6; 3</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19951204</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>■ Helps temporarily relieve symptoms of. ■ stiness ■ pain in limbs, joints or legs ■ cramps in calves, feet or legs.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>54973-3114-7</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (54973-3114-7) > 16 TABLET, SOLUBLE in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>54973-3114-07</NDC11Code>
<ProductNDC>54973-3114</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Leg Cramps</ProprietaryName>
<NonProprietaryName>Cinchona Officinalis Bark, Aconitum Napellus, Pseudognaphalium Obtusifolium, Ledum Palustre Twig, Magnesium Phosphate, Dibasic Trihydrate, Toxicodendron Pubescens Leaf, And Viscum Album Fruiting Top</NonProprietaryName>
<DosageFormName>TABLET, SOLUBLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19951204</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hyland's Inc.</LabelerName>
<SubstanceName>CINCHONA OFFICINALIS BARK; ACONITUM NAPELLUS; PSEUDOGNAPHALIUM OBTUSIFOLIUM; LEDUM PALUSTRE TWIG; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; TOXICODENDRON PUBESCENS LEAF; VISCUM ALBUM FRUITING TOP</SubstanceName>
<StrengthNumber>3; 6; 3; 6; 6; 6; 3</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19951204</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>■ Helps temporarily relieve symptoms of. ■ stiness ■ pain in limbs, joints or legs ■ cramps in calves, feet or legs.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0264-3114-11</NDCCode>
<PackageDescription>24 CONTAINER in 1 CASE (0264-3114-11) > 50 mL in 1 CONTAINER</PackageDescription>
<NDC11Code>00264-3114-11</NDC11Code>
<ProductNDC>0264-3114</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cefuroxime And Dextrose</ProprietaryName>
<NonProprietaryName>Cefuroxime And Dextrose</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20010221</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050780</ApplicationNumber>
<LabelerName>B. Braun Medical Inc.</LabelerName>
<SubstanceName>CEFUROXIME SODIUM</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>g/50mL</StrengthUnit>
<Pharm_Classes>Cephalosporin Antibacterial [EPC], Cephalosporins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2020-12-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20010221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cefuroxime for Injection USP and Dextrose Injection USP is indicated for the treatment of patients with infections caused by susceptible strains of the designated organisms in the following diseases: 1 Lower Respiratory Tract Infections, including pneumonia, caused by Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin-resistant strains), Klebsiella spp., Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pyogenes, and Escherichia coli. , 2 Urinary Tract Infections caused by Escherichia coli and Klebsiella spp. , 3 Skin and Skin-Structure Infections caused by Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pyogenes, Escherichia coli, Klebsiella spp., and Enterobacter spp. , 4 Septicemia caused by Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae (including ampicillin-resistant strains), and Klebsiella spp. , 5 Meningitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin-resistant strains), Neisseria meningitidis, and Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains). , 6 Gonorrhea: Uncomplicated and disseminated gonococcal infections due to Neisseria gonorrhoeae (penicillinase- and non-penicillinase-producing strains) in both males and females. , 7 Bone and Joint Infections caused by Staphylococcus aureus (penicillinase- and non-penicillinase producing strains).</IndicationAndUsage>
<Description>Cefuroxime for Injection USP and Dextrose Injection USP is a sterile, nonpyrogenic, single use, packaged combination of Cefuroxime Sodium USP (crystalline) and Dextrose Injection USP (diluent) in the DUPLEX® sterile container. The DUPLEX® Container is a flexible dual chamber container. The drug chamber is filled with sterile crystalline Cefuroxime for Injection USP, a semi-synthetic, broad-spectrum, cephalosporin antibacterial for parenteral administration. It is the sodium salt of (6R,7R)-7-[2-(2-furyl)glyoxylamido]-3-(hydroxymethyl)-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate, 72-(Z)-(O-methyloxime), carbamate (ester). Cefuroxime Sodium USP has the following structural formula. The empirical formula is C16H15N4NaO8S, representing a molecular weight of 446.4. Cefuroxime contains approximately 54.2 mg (2.4 mEq) of sodium per gram of cefuroxime activity. The diluent chamber contains Dextrose Injection USP. The concentration of Hydrous Dextrose USP has been adjusted to render the reconstituted drug product iso-osmotic. Dextrose Injection USP is sterile, nonpyrogenic, and contains no bacteriostatic or antimicrobial agents. Hydrous Dextrose USP has the following structural (molecular) formula. The molecular weight of Hydrous Dextrose USP is 198.17. Dextrose hydrous USP has been added to the diluent to adjust osmolality (approximately 2.05 g and 1.45 g to 750 mg and 1.5 g dosages, respectively). After removing the peelable foil strip, activating the seals, and thoroughly mixing, the reconstituted drug product is intended for single intravenous use. When reconstituted, the approximate osmolality of the reconstituted solution for Cefuroxime for Injection USP and Dextrose Injection USP is 290 mOsmol/kg. Not made with natural rubber latex, PVC or Di (2-ethylhexyl) phthalate (DEHP). The DUPLEX® dual chamber container is made from a specially formulated material. The product (diluent and drug) contact layer is a mixture of thermoplastic rubber and a polypropylene ethylene copolymer that contains no plasticizers. The safety of the container system is supported by USP biological evaluation procedures.</Description>
</NDC>
<NDC>
<NDCCode>0781-3114-95</NDCCode>
<PackageDescription>10 VIAL, SINGLE-USE in 1 CARTON (0781-3114-95) / 20 mL in 1 VIAL, SINGLE-USE (0781-3114-91) </PackageDescription>
<NDC11Code>00781-3114-95</NDC11Code>
<ProductNDC>0781-3114</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Piperacillin And Tazobactam</ProprietaryName>
<NonProprietaryName>Piperacillin And Tazobactam</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS; PARENTERAL</RouteName>
<StartMarketingDate>20101021</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065362</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>PIPERACILLIN SODIUM; TAZOBACTAM SODIUM</SubstanceName>
<StrengthNumber>4; .5</StrengthNumber>
<StrengthUnit>g/20mL; g/20mL</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20101021</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Piperacillin and tazobactam for injection is a combination of piperacillin, a penicillin-class antibacterial and tazobactam, a beta-lactamase inhibitor, indicated for the treatment of: 1 Intra-abdominal infections in adult and pediatric patients 2 months of age and older (1.1), 2 Nosocomial pneumonia in adult and pediatric patients 2 months of age and older (1.2), 3 Skin and skin structure infections in adults (1.3), 4 Female pelvic infections in adults (1.4), 5 Community-acquired pneumonia in adults (1.5).</IndicationAndUsage>
<Description>Piperacillin and tazobactam for injection, USP is an injectable antibacterial combination product consisting of the semisynthetic antibacterial piperacillin sodium and the beta-lactamase inhibitor tazobactam sodium for intravenous administration. Piperacillin sodium is derived from D(-)-α-aminobenzyl-penicillin. The chemical name of piperacillin sodium is sodium (2S,5R,6R)-6-[(R)-2-(4-ethyl-2,3-dioxo-1-piperazine‑carboxamido)-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2‑carboxylate. The chemical formula is C23H26N5NaO7S and the molecular weight is 539.5. The chemical structure of piperacillin sodium is. Tazobactam sodium, a derivative of the penicillin nucleus, is a penicillanic acid sulfone. Its chemical name is sodium (2S,3S,5R)-3-methyl-7-oxo-3-(1H-1,2,3-triazol-1-ylmethyl)-4-thia-1‑azabicyclo[3.2.0]heptane-2-carboxylate-4,4-dioxide. The chemical formula is C10H11N4NaO5S and the molecular weight is 322.3. The chemical structure of tazobactam sodium is. Piperacillin and tazobactam for injection, USP, is a white to yellowish sterile, cryodesiccated powder consisting of piperacillin and tazobactam as their sodium salts packaged in glass vials. The product does not contain excipients or preservatives. Dilute solutions are colorless to yellowish. Each piperacillin and tazobactam for injection, USP 2.25 g single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 2 grams of piperacillin and tazobactam sodium equivalent to 0.25 g of tazobactam. Each vial contains 4.69 mEq (108 mg) of sodium. Each piperacillin and tazobactam for injection, USP 3.375 g single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 3 grams of piperacillin and tazobactam sodium equivalent to 0.375 g of tazobactam. Each vial contains 7.04 mEq (162 mg) of sodium. Each piperacillin and tazobactam for injection, USP 4.5 g single-dose vial contains an amount of drug sufficient for withdrawal of piperacillin sodium equivalent to 4 grams of piperacillin and tazobactam sodium equivalent to 0.5 g of tazobactam. Each vial contains 9.39 mEq (216 mg) of sodium. Piperacillin and tazobactam for injection, USP contains a total of 2.35 mEq (54 mg) of sodium (Na+) per gram of piperacillin in the combination product. Meets USP Organic Impurities Procedure 3.</Description>
</NDC>
<NDC>
<NDCCode>54868-3114-0</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (54868-3114-0)</PackageDescription>
<NDC11Code>54868-3114-00</NDC11Code>
<ProductNDC>54868-3114</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Estropipate</ProprietaryName>
<NonProprietaryName>Estropipate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030321</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA081213</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>ESTROPIPATE</SubstanceName>
<StrengthNumber>.75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Estropipate tablets are indicated in the: 1 Treatment of moderate to severe vasomotor symptoms associated with the menopause., 2 Treatment of moderate to severe symptoms of vulval and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered., 3 Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure., 4 Prevention of postmenopausal osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and for whom non-estrogen medications are not considered to be appropriate.</IndicationAndUsage>
<Description>Estropipate (formerly piperazine estrone sulfate), is a natural estrogenic substance prepared from purified crystalline estrone, solubilized as the sulfate and stabilized with piperazine. It is appreciably soluble in water and has almost no odor or taste — properties which are ideally suited for oral administration. The amount of piperazine in estropipate is not sufficient to exert a pharmacological action. Its addition ensures solubility, stability, and uniform potency of the estrone sulfate. Chemically estropipate, molecular weight: 436.56, is represented by estra-1,3,5(10)-trien-17-one,3-(sulfooxy)-, compound with piperazine (1:1). The structural formula may be represented as follows. Estropipate is available as tablets for oral administration containing either 0.75 mg, 1.5 mg, 3 mg, or 6 mg estropipate (calculated as sodium estrone sulfate 0.625 mg, 1.25 mg, 2.5 mg and 5 mg, respectively). Each tablet contains: lactose NF, magnesium stearate NF, piperazine USP, pregelatinized starch NF, talc USP, and coloring agents: 0.75 mg—D&C Yellow #10; 1.5 mg—FD&C Yellow #6; 3 mg—FD&C Blue #2; 6 mg—FD&C Blue #2 and D&C Yellow #10.</Description>
</NDC>
<NDC>
<NDCCode>54868-3114-1</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (54868-3114-1)</PackageDescription>
<NDC11Code>54868-3114-01</NDC11Code>
<ProductNDC>54868-3114</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Estropipate</ProprietaryName>
<NonProprietaryName>Estropipate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030321</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA081213</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>ESTROPIPATE</SubstanceName>
<StrengthNumber>.75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Estropipate tablets are indicated in the: 1 Treatment of moderate to severe vasomotor symptoms associated with the menopause., 2 Treatment of moderate to severe symptoms of vulval and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered., 3 Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure., 4 Prevention of postmenopausal osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and for whom non-estrogen medications are not considered to be appropriate.</IndicationAndUsage>
<Description>Estropipate (formerly piperazine estrone sulfate), is a natural estrogenic substance prepared from purified crystalline estrone, solubilized as the sulfate and stabilized with piperazine. It is appreciably soluble in water and has almost no odor or taste — properties which are ideally suited for oral administration. The amount of piperazine in estropipate is not sufficient to exert a pharmacological action. Its addition ensures solubility, stability, and uniform potency of the estrone sulfate. Chemically estropipate, molecular weight: 436.56, is represented by estra-1,3,5(10)-trien-17-one,3-(sulfooxy)-, compound with piperazine (1:1). The structural formula may be represented as follows. Estropipate is available as tablets for oral administration containing either 0.75 mg, 1.5 mg, 3 mg, or 6 mg estropipate (calculated as sodium estrone sulfate 0.625 mg, 1.25 mg, 2.5 mg and 5 mg, respectively). Each tablet contains: lactose NF, magnesium stearate NF, piperazine USP, pregelatinized starch NF, talc USP, and coloring agents: 0.75 mg—D&C Yellow #10; 1.5 mg—FD&C Yellow #6; 3 mg—FD&C Blue #2; 6 mg—FD&C Blue #2 and D&C Yellow #10.</Description>
</NDC>
<NDC>
<NDCCode>60505-3114-0</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (60505-3114-0) / 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>60505-3114-00</NDC11Code>
<ProductNDC>60505-3114</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120423</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090798</ApplicationNumber>
<LabelerName>Apotex Corp.</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120423</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olanzapine tablets are an atypical antipsychotic indicated. As oral formulation for the: 1 Treatment of schizophrenia. (1.1)Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1) Adolescents (ages 13 to 17): Efficacy was established in one 6- week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1), 2 Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2)Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2) Adolescents (ages 13 to 17): Efficacy was established in one 3- week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2), 3 Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3), 4 Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2)Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated. .</IndicationAndUsage>
<Description>Olanzapine is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.43. The chemical structure is:. Olanzapine is a yellow powder. Olanzapine tablets, USP are intended for oral administration only. Each tablet contains olanzapine equivalent to 2.5 mg (8 mcmol), 5 mg (16 mcmol), 7.5 mg (24 mcmol), 10 mg (32 mcmol), 15 mg (48 mcmol), or 20 mg (64 mcmol). Inactive ingredients are lactose, magnesium stearate, microcrystalline cellulose, starch. The color coating contains FD&C blue No.2 aluminum lake (15 mg), ferric oxide red (20 mg), ferric oxide yellow (20 mg), hydroxypropyl cellulose, hypromellose, polyethylene glycol and titanium dioxide (all strengths). FDA approved UV identification test differs from USP infrared identification test.</Description>
</NDC>
<NDC>
<NDCCode>60505-3114-3</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (60505-3114-3) </PackageDescription>
<NDC11Code>60505-3114-03</NDC11Code>
<ProductNDC>60505-3114</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120423</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090798</ApplicationNumber>
<LabelerName>Apotex Corp.</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120423</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olanzapine tablets are an atypical antipsychotic indicated. As oral formulation for the: 1 Treatment of schizophrenia. (1.1)Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1) Adolescents (ages 13 to 17): Efficacy was established in one 6- week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1), 2 Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2)Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2) Adolescents (ages 13 to 17): Efficacy was established in one 3- week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2), 3 Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3), 4 Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2)Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated. .</IndicationAndUsage>
<Description>Olanzapine is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.43. The chemical structure is:. Olanzapine is a yellow powder. Olanzapine tablets, USP are intended for oral administration only. Each tablet contains olanzapine equivalent to 2.5 mg (8 mcmol), 5 mg (16 mcmol), 7.5 mg (24 mcmol), 10 mg (32 mcmol), 15 mg (48 mcmol), or 20 mg (64 mcmol). Inactive ingredients are lactose, magnesium stearate, microcrystalline cellulose, starch. The color coating contains FD&C blue No.2 aluminum lake (15 mg), ferric oxide red (20 mg), ferric oxide yellow (20 mg), hydroxypropyl cellulose, hypromellose, polyethylene glycol and titanium dioxide (all strengths). FDA approved UV identification test differs from USP infrared identification test.</Description>
</NDC>
<NDC>
<NDCCode>60505-3114-8</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (60505-3114-8) </PackageDescription>
<NDC11Code>60505-3114-08</NDC11Code>
<ProductNDC>60505-3114</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120423</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090798</ApplicationNumber>
<LabelerName>Apotex Corp.</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120423</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Olanzapine tablets are an atypical antipsychotic indicated. As oral formulation for the: 1 Treatment of schizophrenia. (1.1)Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1) Adolescents (ages 13 to 17): Efficacy was established in one 6- week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1), 2 Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2)Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2) Adolescents (ages 13 to 17): Efficacy was established in one 3- week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2), 3 Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3), 4 Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2)Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated. .</IndicationAndUsage>
<Description>Olanzapine is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.43. The chemical structure is:. Olanzapine is a yellow powder. Olanzapine tablets, USP are intended for oral administration only. Each tablet contains olanzapine equivalent to 2.5 mg (8 mcmol), 5 mg (16 mcmol), 7.5 mg (24 mcmol), 10 mg (32 mcmol), 15 mg (48 mcmol), or 20 mg (64 mcmol). Inactive ingredients are lactose, magnesium stearate, microcrystalline cellulose, starch. The color coating contains FD&C blue No.2 aluminum lake (15 mg), ferric oxide red (20 mg), ferric oxide yellow (20 mg), hydroxypropyl cellulose, hypromellose, polyethylene glycol and titanium dioxide (all strengths). FDA approved UV identification test differs from USP infrared identification test.</Description>
</NDC>
<NDC>
<NDCCode>54973-0229-2</NDCCode>
<PackageDescription>4 TABLET, SOLUBLE in 1 POUCH (54973-0229-2) </PackageDescription>
<NDC11Code>54973-0229-02</NDC11Code>
<ProductNDC>54973-0229</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Arnicaid</ProprietaryName>
<NonProprietaryName>Arnica Montana, Hypericum Perforatum, Ruta Graveolens Flowering Top, Ledum Palustre Twig, And Bellis Perennis</NonProprietaryName>
<DosageFormName>TABLET, SOLUBLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19910717</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hyland's Inc.</LabelerName>
<SubstanceName>ARNICA MONTANA; BELLIS PERENNIS; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; RUTA GRAVEOLENS FLOWERING TOP</SubstanceName>
<StrengthNumber>30; 6; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-09-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19910717</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
</NDC>
<NDC>
<NDCCode>54973-0229-3</NDCCode>
<PackageDescription>4 POUCH in 1 CARTON (54973-0229-3) > 4 TABLET, SOLUBLE in 1 POUCH</PackageDescription>
<NDC11Code>54973-0229-03</NDC11Code>
<ProductNDC>54973-0229</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Arnicaid</ProprietaryName>
<NonProprietaryName>Arnica Montana, Hypericum Perforatum, Ruta Graveolens Flowering Top, Ledum Palustre Twig, And Bellis Perennis</NonProprietaryName>
<DosageFormName>TABLET, SOLUBLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19910717</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hyland's Inc.</LabelerName>
<SubstanceName>ARNICA MONTANA; BELLIS PERENNIS; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; RUTA GRAVEOLENS FLOWERING TOP</SubstanceName>
<StrengthNumber>30; 6; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-09-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19910717</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>54973-0232-2</NDCCode>
<PackageDescription>4 TABLET, SOLUBLE in 1 POUCH (54973-0232-2) </PackageDescription>
<NDC11Code>54973-0232-02</NDC11Code>
<ProductNDC>54973-0232</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Arnisport</ProprietaryName>
<NonProprietaryName>Arnica Montana, Hypericum Perforatum, Ruta Graveolens Flowering Top, Ledum Palustre Twig, Bellis Perennis, Calcium Fluoride, Tribasic Calcium Phosphate, Calcium Sulfate Anhydrous, Ferrosoferric Phosphate, Potassium Chloride, Potassium Phosphate, Dibasic, Potassium Sulfate, Magnesium Phosphate, Dibasic Trihydrate, Sodium Chloride, Sodium Phosphate, Dibasic, Heptahydrate, Sodium Sulfate, And Silicon Dioxide</NonProprietaryName>
<DosageFormName>TABLET, SOLUBLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20000428</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hyland's Inc.</LabelerName>
<SubstanceName>ARNICA MONTANA; BELLIS PERENNIS; CALCIUM FLUORIDE; CALCIUM SULFATE ANHYDROUS; FERRUM PHOSPHORICUM; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM SULFATE; RUTA GRAVEOLENS FLOWERING TOP; SILICON DIOXIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM SULFATE; TRIBASIC CALCIUM PHOSPHATE</SubstanceName>
<StrengthNumber>30; 6; 6; 3; 3; 6; 6; 3; 3; 3; 3; 6; 6; 6; 3; 3; 3</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [EPC], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-09-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20000428</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
</NDC>
<NDC>
<NDCCode>54973-0232-3</NDCCode>
<PackageDescription>4 POUCH in 1 CARTON (54973-0232-3) / 4 TABLET, SOLUBLE in 1 POUCH</PackageDescription>
<NDC11Code>54973-0232-03</NDC11Code>
<ProductNDC>54973-0232</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Arnisport</ProprietaryName>
<NonProprietaryName>Arnica Montana, Hypericum Perforatum, Ruta Graveolens Flowering Top, Ledum Palustre Twig, Bellis Perennis, Calcium Fluoride, Tribasic Calcium Phosphate, Calcium Sulfate Anhydrous, Ferrosoferric Phosphate, Potassium Chloride, Potassium Phosphate, Dibasic, Potassium Sulfate, Magnesium Phosphate, Dibasic Trihydrate, Sodium Chloride, Sodium Phosphate, Dibasic, Heptahydrate, Sodium Sulfate, And Silicon Dioxide</NonProprietaryName>
<DosageFormName>TABLET, SOLUBLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20000428</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hyland's Inc.</LabelerName>
<SubstanceName>ARNICA MONTANA; BELLIS PERENNIS; CALCIUM FLUORIDE; CALCIUM SULFATE ANHYDROUS; FERRUM PHOSPHORICUM; HYPERICUM PERFORATUM; LEDUM PALUSTRE TWIG; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM SULFATE; RUTA GRAVEOLENS FLOWERING TOP; SILICON DIOXIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM SULFATE; TRIBASIC CALCIUM PHOSPHATE</SubstanceName>
<StrengthNumber>30; 6; 6; 3; 3; 6; 6; 3; 3; 3; 3; 6; 6; 6; 3; 3; 3</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [EPC], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-09-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20000428</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>54973-0600-4</NDCCode>
<PackageDescription>250 TABLET in 1 BOTTLE, PLASTIC (54973-0600-4) </PackageDescription>
<NDC11Code>54973-0600-04</NDC11Code>
<ProductNDC>54973-0600</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aconite Napellis</ProprietaryName>
<NonProprietaryName>Aconitum Napellus Root</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19550101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hyland's</LabelerName>
<SubstanceName>ACONITUM NAPELLUS ROOT</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-12-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19550101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>54973-0601-4</NDCCode>
<PackageDescription>250 TABLET in 1 BOTTLE, PLASTIC (54973-0601-4) </PackageDescription>
<NDC11Code>54973-0601-04</NDC11Code>
<ProductNDC>54973-0601</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allium Cepa</ProprietaryName>
<NonProprietaryName>Onion</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19550101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hyland's</LabelerName>
<SubstanceName>ONION</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-12-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19550101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>54973-0602-4</NDCCode>
<PackageDescription>250 TABLET in 1 BOTTLE, PLASTIC (54973-0602-4) </PackageDescription>
<NDC11Code>54973-0602-04</NDC11Code>
<ProductNDC>54973-0602</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antimonium Tart</ProprietaryName>
<NonProprietaryName>Antimony Potassium Tartrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19550101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hyland's</LabelerName>
<SubstanceName>ANTIMONY POTASSIUM TARTRATE</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-12-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19550101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>54973-0603-4</NDCCode>
<PackageDescription>250 TABLET in 1 BOTTLE, PLASTIC (54973-0603-4) </PackageDescription>
<NDC11Code>54973-0603-04</NDC11Code>
<ProductNDC>54973-0603</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Apis Mellifica</ProprietaryName>
<NonProprietaryName>Apis Mellifera</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19550101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hyland's</LabelerName>
<SubstanceName>APIS MELLIFERA</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-12-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19550101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>54973-0604-4</NDCCode>
<PackageDescription>250 TABLET in 1 BOTTLE, PLASTIC (54973-0604-4) </PackageDescription>
<NDC11Code>54973-0604-04</NDC11Code>
<ProductNDC>54973-0604</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Arnica Montana</ProprietaryName>
<NonProprietaryName>Arnica Montana</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19550101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hyland's Inc.</LabelerName>
<SubstanceName>ARNICA MONTANA</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19550101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bruises or Muscle Soreness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>54973-0605-4</NDCCode>
<PackageDescription>250 TABLET in 1 BOTTLE, PLASTIC (54973-0605-4) </PackageDescription>
<NDC11Code>54973-0605-04</NDC11Code>
<ProductNDC>54973-0605</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Arsenicum Album</ProprietaryName>
<NonProprietaryName>Arsenic Trioxide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19550101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hyland's Inc.</LabelerName>
<SubstanceName>ARSENIC TRIOXIDE</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-04-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19550101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BURNING NASAL DISCHARGE OR DIARRHEA.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>54973-0606-4</NDCCode>
<PackageDescription>250 TABLET in 1 BOTTLE, PLASTIC (54973-0606-4) </PackageDescription>
<NDC11Code>54973-0606-04</NDC11Code>
<ProductNDC>54973-0606</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Belladonna</ProprietaryName>
<NonProprietaryName>Atropa Belladonna Root</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19550101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hyland's</LabelerName>
<SubstanceName>ATROPA BELLADONNA ROOT</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-12-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19550101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>54973-0607-4</NDCCode>
<PackageDescription>250 TABLET in 1 BOTTLE, PLASTIC (54973-0607-4) </PackageDescription>
<NDC11Code>54973-0607-04</NDC11Code>
<ProductNDC>54973-0607</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bryonia Alba</ProprietaryName>
<NonProprietaryName>Bryonia Alba Root</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19550101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hyland's</LabelerName>
<SubstanceName>BRYONIA ALBA ROOT</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-12-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19550101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>54973-0609-4</NDCCode>
<PackageDescription>250 TABLET in 1 BOTTLE, PLASTIC (54973-0609-4) </PackageDescription>
<NDC11Code>54973-0609-04</NDC11Code>
<ProductNDC>54973-0609</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cantharis</ProprietaryName>
<NonProprietaryName>Lytta Vesicatoria</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19550101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hyland's</LabelerName>
<SubstanceName>LYTTA VESICATORIA</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-12-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19550101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>54973-0610-4</NDCCode>
<PackageDescription>250 TABLET in 1 BOTTLE, PLASTIC (54973-0610-4) </PackageDescription>
<NDC11Code>54973-0610-04</NDC11Code>
<ProductNDC>54973-0610</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Carbo Veg</ProprietaryName>
<NonProprietaryName>Activated Charcoal</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19550101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hyland's</LabelerName>
<SubstanceName>ACTIVATED CHARCOAL</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-12-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19550101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>54973-0611-4</NDCCode>
<PackageDescription>250 TABLET in 1 BOTTLE, PLASTIC (54973-0611-4) </PackageDescription>
<NDC11Code>54973-0611-04</NDC11Code>
<ProductNDC>54973-0611</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Chamomilla</ProprietaryName>
<NonProprietaryName>Matricaria Chamomilla Flowering Top Oil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19550101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hyland's</LabelerName>
<SubstanceName>MATRICARIA CHAMOMILLA FLOWERING TOP OIL</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-12-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130524</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>54973-0613-4</NDCCode>
<PackageDescription>250 TABLET in 1 BOTTLE, PLASTIC (54973-0613-4) </PackageDescription>
<NDC11Code>54973-0613-04</NDC11Code>
<ProductNDC>54973-0613</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Gelsemium Semp</ProprietaryName>
<NonProprietaryName>Gelsemium Sempervirens Root</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19550101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hyland's</LabelerName>
<SubstanceName>GELSEMIUM SEMPERVIRENS ROOT</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-12-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19550101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>