{
"NDC": [
{
"NDCCode": "59088-112-66",
"PackageDescription": "90 CAPSULE in 1 BOTTLE, PLASTIC (59088-112-66) ",
"NDC11Code": "59088-0112-66",
"ProductNDC": "59088-112",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Purevit Dualfe Plus",
"NonProprietaryName": "Ferrous Fumarate, Polysaccharide Iron Complex",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20110601",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "CUPRIC SULFATE; FERROUS FUMARATE; IRON DEXTRAN; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM PANTOTHENATE; SODIUM ASCORBATE; THIAMINE MONONITRATE; ZINC SULFATE; MANGANESE SULFATE",
"StrengthNumber": ".8; 53; 53; 6; 30; 5; 1; 15; 10; 200; 10; 18.2; 1.3",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Iron [CS], Magnetic Resonance Contrast Activity [MoA], Paramagnetic Contrast Agent [EPC], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC]",
"Status": "Active",
"LastUpdate": "2023-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110601",
"SamplePackage": "N",
"IndicationAndUsage": "PureVit DualFe Plus is indicated for the treatment of iron deficiency anemia and folate deficiency as in extended convalescence, menorrhagia, pregnancy, puberty, excessive blood loss and advanced age. Also for treatment of condition in which iron deficiency and vitamin C deficiency occur together, along with a deficient intake or increased need for B-Complex vitamins in chronic and acute illness, as well as cases of metabolic stress, and in convalescence."
},
{
"NDCCode": "55111-112-66",
"PackageDescription": "5 BLISTER PACK in 1 CARTON (55111-112-66) > 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-112-79) ",
"NDC11Code": "55111-0112-66",
"ProductNDC": "55111-112",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Moxifloxacin",
"NonProprietaryName": "Moxifloxacin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140305",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076938",
"LabelerName": "Dr. Reddy's Laboratories Limited",
"SubstanceName": "MOXIFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Quinolone Antimicrobial [EPC], Quinolones [CS]",
"Status": "Active",
"LastUpdate": "2021-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140305",
"SamplePackage": "N",
"Description": "Moxifloxacin hydrochloride USP is a synthetic antibacterial agent for oral administration. Moxifloxacin, a fluoroquinolone, is available as the monohydrochloride salt of 1-cyclopropyl-7-[(S,S)-2,8-diazabicyclo[4.3.0]non-8-yl]-6-fluoro-8-methoxy-1,4-dihydro-4-oxo-3 quinoline carboxylic acid. It is a slightly yellow to yellow powder or crystals with a molecular weight of 437.9. Its molecular formula is C21H24FN3O4*HCl and its chemical structure is as follows."
},
{
"NDCCode": "59088-353-00",
"PackageDescription": "1 KIT in 1 CARTON (59088-353-00) * 237 mL in 1 BOTTLE, PLASTIC (0116-1061-08) * 118 mL in 1 TUBE (59088-333-08) * 1 TUBE in 1 CARTON (45802-112-22) > 22 g in 1 TUBE",
"NDC11Code": "59088-0353-00",
"ProductNDC": "59088-353",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dermacinrx Surgical Pharmapak",
"NonProprietaryName": "Mupirocin Ointment Kit",
"DosageFormName": "KIT",
"StartMarketingDate": "20150827",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"Status": "Deprecated",
"LastUpdate": "2021-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20150827",
"SamplePackage": "N"
},
{
"NDCCode": "59088-391-00",
"PackageDescription": "1 KIT in 1 CARTON (59088-391-00) * 237 mL in 1 BOTTLE, PLASTIC (0116-1061-08) * 118 mL in 1 TUBE (59088-333-08) * 1 TUBE in 1 CARTON (45802-112-22) / 22 g in 1 TUBE",
"NDC11Code": "59088-0391-00",
"ProductNDC": "59088-391",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dermacinrx Clorhexacin",
"NonProprietaryName": "Mupirocin Ointment",
"DosageFormName": "KIT",
"StartMarketingDate": "20160602",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"Status": "Active",
"LastUpdate": "2024-12-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160602",
"SamplePackage": "N",
"Description": "Each gram of Mupirocin Ointment USP, 2% contains 20 mg mupirocin in a bland water miscible ointment base (polyethylene glycol ointment, NF) consisting of polyethylene glycol 400 and polyethylene glycol 3350. Mupirocin is a naturally occurring antibiotic. The chemical name is ( E)-(2 S,3 R,4 R,5 S)-5-[(2 S,3 S,4 S,5 S)-2,3-Epoxy-5-hydroxy-4-methylhexyl]tetrahydro-3,4-dihydroxy-β-methyl-2H-pyran-2-crotonic acid, ester with 9-hydroxynonanoic acid. The molecular formula of mupirocin is C 26H 44O 9 and the molecular weight is 500.62. The chemical structure is:."
},
{
"NDCCode": "59088-113-66",
"PackageDescription": "90 CAPSULE in 1 BOTTLE, PLASTIC (59088-113-66)",
"NDC11Code": "59088-0113-66",
"ProductNDC": "59088-113",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Purefe Ob Plus",
"NonProprietaryName": "Ferrous Fumarate And Polysaccharide Iron Complex",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20110601",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "FERROUS FUMARATE; IRON DEXTRAN; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM PANTOTHENATE; SODIUM ASCORBATE; THIAMINE MONONITRATE; MAGNESIUM SULFATE, UNSPECIFIED; ZINC SULFATE; CUPRIC SULFATE; MANGANESE SULFATE",
"StrengthNumber": "53; 53; 6; 30; 5; 1; 15; 10; 200; 10; 6.9; 18.2; .8; 1.3",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Nicotinic Acid [EPC],Nicotinic Acids [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Copper [CS],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE]",
"Status": "Deprecated",
"LastUpdate": "2019-05-31",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "59088-709-00",
"PackageDescription": "1 KIT in 1 PACKAGE (59088-709-00) * 1 TUBE in 1 CARTON (65162-833-66) / 100 g in 1 TUBE",
"NDC11Code": "59088-0709-00",
"ProductNDC": "59088-709",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venngel One",
"NonProprietaryName": "Diclofenac Sodium, Isopropyl Alcohol",
"DosageFormName": "KIT",
"StartMarketingDate": "20180502",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"Status": "Active",
"LastUpdate": "2024-12-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180502",
"SamplePackage": "N",
"Description": "Diclofenac sodium topical gel, 1% w/w is a non-steroidal anti-inflammatory drug (NSAID) for topical use only. It contains the active ingredient, diclofenac sodium, USP, in an opaque, white to off-white gel base. Diclofenac sodium, USP is a white to off-white crystalline powder. Diclofenac sodium, USP is a benzeneacetic acid derivative. The chemical name is 2-[(2,6-dichlorophenyl)amino]benzeneacetic acid, monosodium salt. The molecular weight is 318.13. Its molecular formula is C 14H 10Cl 2NNaO 2. It has the following structural formula:. Diclofenac sodium topical gel, 1% also contains carbomer homopolymer Type C, cocoyl caprylocaprate, fragrance, isopropyl alcohol, mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water, and strong ammonia solution."
},
{
"NDCCode": "59088-660-16",
"PackageDescription": "237 mL in 1 BOTTLE (59088-660-16) ",
"NDC11Code": "59088-0660-16",
"ProductNDC": "59088-660",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Livita Children",
"NonProprietaryName": "Folate, Multivitamin",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20231218",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "CHOLINE BITARTRATE; CHOLECALCIFEROL; VITAMIN A ACETATE; ASCORBIC ACID; .ALPHA.-TOCOPHEROL ACETATE, D-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; LEVOMEFOLATE CALCIUM; METHYLCOBALAMIN; BIOTIN; ZINC PICOLINATE; MAGNESIUM CITRATE; CALCIUM PANTOTHENATE; CALCIUM CITRATE; INULIN",
"StrengthNumber": "66.67; 3.33; 300; 66.67; 10; .4; .43; 2.67; .57; 333; .8; 10; .67; 33.33; 1.67; 66.67; 166.67",
"StrengthUnit": "mg/mL; ug/mL; ug/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; ug/mL; ug/mL; ug/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Folate Analog [EPC], Folic Acid [CS], Increased Coagulation Factor Activity [PE], 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], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-08-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231218",
"SamplePackage": "N",
"IndicationAndUsage": "Livita liquid is indicated to provide significant amounts of essential vitamins and minerals, including Vitamins A, C, D, E, thiamine, riboflavin, niacin, vitamin B6, vitamin B12, folate, calcium, magnesium, and zinc, to supplement the diet. This comprehensive nutrient profile helps prevent nutritional deficiencies of these vitamins and minerals, ensuring that the specific dietary needs of adults and children are met to support overall health, energy, and vitality. The product is specially formulated to target common vitamin and mineral gaps in adults, thus promoting optimal health, immune function, bone strength, and metabolic balance. It is intended to be used under the guidance of a licensed healthcare practitioner to ensure that any potential for nutritional deficiency is addressed in a manner that supports the individual's overall health and wellbeing.",
"Description": "Serving Size: 15 mL Servings per container: 47. Vitamin A (as Retinyl Acetate)........................ 300 mcg RAE Vitamin C (as Ascorbic Acid)............................... 66.67 mg Vitamin D3 (as Cholecalciferol)............................ 3.33 mcg Vitamin E (as D-Alpha Tocopheryl Acetate)............. 10 mg Thiamin (as Thiamine Mononitrate)......................... 0.4 mg Riboflavin .............................................................. 0.43 mg Niacin (as Niacinamide)......................................... 2.67 mg Vitamin B6 (as Pyridoxine Hydrochloride)............. 0.57 mg Folate (as L-5-Methyltetrahydrofolate calcium salt)...566 mcg DFE (333 mcg of L-5-Methylfolate) Vitamin B12 (as Methylcobalamin)......................... 0.8 mcg Biotin (as D-Biotin)................................................. 10 mcg Pantothenic Acid (as D-Calcium Pantothenate)..... 1.67 mg Choline (as Choline Bitartrate)............................. 66.67 mg Calcium (as Calcium Citrate)............................... 66.67 mg Magnesium (as Magnesium Citrate)...................... 33.3 mg Zinc (as Zinc Picolinate)........................................ 0.67 mg Inulin (as Helianthus Tuberosus Root Extract)... 166.67 mg. Other Ingredients: Aqua (Water), Organic Agave Syrup, Carrageenan, Citrus Extract, Flavor, Glycerin, Hydroxocobalamin Acetate, Potassium Sorbate, Organic Stevia Rebaudiana Leaf Extract."
},
{
"NDCCode": "59088-786-31",
"PackageDescription": "480 mL in 1 BOTTLE (59088-786-31) ",
"NDC11Code": "59088-0786-31",
"ProductNDC": "59088-786",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Liquical With Magnesium",
"NonProprietaryName": "Multivitamin",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20231227",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "CALCIUM CITRATE; CHOLECALCIFEROL; MAGNESIUM CITRATE; ZINC CITRATE",
"StrengthNumber": "168; 66; 48; 1.4",
"StrengthUnit": "mg/mL; [iU]/mL; mg/mL; mg/mL",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Coagulation Factor Activity [PE], 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], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-04-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20231227",
"SamplePackage": "N",
"IndicationAndUsage": "LiquiCal with Magnesium is indicated to provide support in children's healthy bone growth and development.",
"Description": "Vitamin D3 (Cholecalciferol): Vitamin D3 plays a pivotal role in maintaining bone health and may also help mitigate mood disturbances. It is recommended to seek a supplement offering 600-800 IU of Vitamin D3 daily, although personal dosing should be discussed with a licensed healthcare practitioner. Calcium (Calcium Citrate): Calcium is a key mineral that fortifies bones, particularly crucial during menopause due to heightened osteoporosis risks. Women over 50 typically require around 1000-1300 mg of calcium daily, although intake should be calibrated based on diet. Magnesium (Magnesium Citrate): Magnesium offers relief from muscle cramps, mood fluctuations, and sleep disturbances. Zinc Citrate: Zinc is an essential trace element that has a critical role in maintaining structural and catalytic functions of >200 enzymes involved in major metabolic pathways, including nucleic acid metabolism, protein synthesis, and cell division. OTHER INGREDIENTS: Aqua (Purified Water), Citric Acid, Orange Flavor, Potassium Sorbate, Xanthan Gum, Xylitol."
},
{
"NDCCode": "55150-112-10",
"PackageDescription": "10 VIAL in 1 BOX (55150-112-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL",
"NDC11Code": "55150-0112-10",
"ProductNDC": "55150-112",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ampicillin",
"NonProprietaryName": "Ampicillin Sodium",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20120201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065499",
"LabelerName": "Eugia US LLC",
"SubstanceName": "AMPICILLIN SODIUM",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Active",
"LastUpdate": "2025-08-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120201",
"SamplePackage": "N",
"IndicationAndUsage": "Ampicillin for injection is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the following conditions: Respiratory Tract Infections caused by Streptococcus pneumoniae, Staphylococcus aureus (penicillinase and nonpenicillinase-producing), H. influenzae, and Group A beta-hemolytic streptococci. Bacterial Meningitis caused by E. coli, Group B Streptococci, and other Gram-negative bacteria (Listeria monocytogenes, N. meningitidis). The addition of an aminoglycoside with ampicillin may increase its effectiveness against Gram-negative bacteria.Septicemia and Endocarditis caused by susceptible Gram-positive organisms including Streptococcus spp., penicillin G-susceptible staphylococci, and enterococci. Gram-negative sepsis caused by E. coli, Proteus mirabilis and Salmonella spp. responds to ampicillin. Endocarditis due to enterococcal strains usually respond to intravenous therapy. The addition of an aminoglycoside may enhance the effectiveness of ampicillin when treating streptococcal endocarditis. Urinary Tract Infections caused by sensitive strains of E. coli and Proteus mirabilis. Gastrointestinal Infections caused by Salmonella typhi (typhoid fever), other Salmonella spp., and Shigella spp. (dysentery) usually respond to oral or intravenous therapy. Bacteriology studies to determine the causative organisms and their susceptibility to ampicillin should be performed. Therapy may be instituted prior to obtaining results of susceptibility testing. It is advisable to reserve the parenteral form of this drug for moderately severe and severe infections and for patients who are unable to take the oral forms. A change to oral ampicillin may be made as soon as appropriate. To reduce the development of drug-resistant bacteria and maintain the effectiveness of ampicillin for injection and other antibacterial drugs, ampicillin for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Indicated surgical procedures should be performed.",
"Description": "Ampicillin for injection, USP the monosodium salt of [2S-[2α, 5α, 6β(S*)]]-6-[(aminophenylacetyl)amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid, is a synthetic penicillin. It is an antibacterial agent with a broad spectrum of bactericidal activity against both penicillin-susceptible Gram-positive organisms and many common Gram-negative pathogens. Ampicillin for injection, USP is a white to off-white crystalline powder. The reconstituted solution is clear, colorless and free from visible particulates. Each vial of ampicillin for injection, USP contains ampicillin sodium equivalent to 250 mg, 500 mg, 1 gram or 2 grams ampicillin. Ampicillin for injection, USP contains sodium content as 16.46 mg (0.72 mEq) per 250 mg, 32.91 mg (1.43 mEq) per 500 mg, 65.83 mg (2.86 mEq) per 1 g or 131.66 mg (5.72 mEq) per 2 g of ampicillin. It has the following molecular structure: The molecular formula is C16H18N3NaO4S, and the molecular weight is 371.39. The pH range of the reconstituted solution is 8 to 10."
},
{
"NDCCode": "71335-0949-5",
"PackageDescription": "112 TABLET in 1 BOTTLE (71335-0949-5) ",
"NDC11Code": "71335-0949-05",
"ProductNDC": "71335-0949",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Baclofen",
"NonProprietaryName": "Baclofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180401",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209102",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "BACLOFEN",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-06-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240529",
"SamplePackage": "N",
"IndicationAndUsage": "Baclofen tablets, USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen tablets, USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets, USP are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson's disease has not been established and, therefore, it is not recommended for these conditions.",
"Description": "Baclofen, USP is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. The structural formula is. C 10H 12ClNO 2M.W. 213.66. Baclofen, USP is a white to off-white odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol and insoluble in chloroform. Each tablet, for oral administration, contains 5 mg, 10 mg, 15 mg or 20 mg baclofen, USP. In addition, each tablet contains the following inactive ingredients: Microcrystalline Cellulose, Pregelatinized Starch, Sodium Starch Glycolate, Colloidal Silicon dioxide and Magnesium Stearate."
},
{
"NDCCode": "71335-1356-5",
"PackageDescription": "112 TABLET in 1 BOTTLE (71335-1356-5) ",
"NDC11Code": "71335-1356-05",
"ProductNDC": "71335-1356",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Baclofen",
"NonProprietaryName": "Baclofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20181206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211659",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "BACLOFEN",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-09-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240905",
"SamplePackage": "N",
"IndicationAndUsage": "Baclofen tablets USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen tablets USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets USP are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson's disease has not been established and, therefore, it is not recommended for these conditions.",
"Description": "Baclofen, USP is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. The structural formula is. C10H12ClNO2 M.W. 213.66. Baclofen, USP is a white to off-white odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol and insoluble in chloroform. Each tablet, for oral administration, contains 5 mg, 10 mg, 15 mg or 20 mg baclofen, USP. In addition, each tablet contains the following inactive ingredients: dibasic calcium phosphate anhydrous, magnesium stearate, microcrystalline cellulose, pregelatinized starch, povidone and sodium starch glycolate."
},
{
"NDCCode": "71335-1643-0",
"PackageDescription": "112 TABLET in 1 BOTTLE (71335-1643-0) ",
"NDC11Code": "71335-1643-00",
"ProductNDC": "71335-1643",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Baclofen",
"NonProprietaryName": "Baclofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210527",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211555",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "BACLOFEN",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20220429",
"SamplePackage": "N",
"IndicationAndUsage": "Baclofen Tablets, USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen Tablets, USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen Tablets, USP are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson’s disease has not been established and, therefore, it is not recommended for these conditions.",
"Description": "Baclofen USP, is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. The structural formula is. C10H12ClNO2 M.W. 213.66. Baclofen USP is a white to off-white odorless or practically odorless crystalline powder, with a molecular weight of 213.66. It is slightly soluble in water, very slightly soluble in methanol, and insoluble in chloroform. Each tablet, for oral administration, contains 5 mg, 10 mg or 20 mg baclofen, USP. In addition, each tablet contains the following inactive ingredients: Microcrystalline Cellulose, Mannitol, Pre-Gelatinized Starch, Hypromellose, Sodium Starch Glycolate, Colloidal Silicon Dioxide, Magnesium Stearate."
},
{
"NDCCode": "71335-1664-5",
"PackageDescription": "112 TABLET in 1 BOTTLE (71335-1664-5) ",
"NDC11Code": "71335-1664-05",
"ProductNDC": "71335-1664",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Baclofen",
"NonProprietaryName": "Baclofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210527",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211555",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "BACLOFEN",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220429",
"SamplePackage": "N",
"IndicationAndUsage": "Baclofen Tablets, USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen Tablets, USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen Tablets, USP are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson’s disease has not been established and, therefore, it is not recommended for these conditions.",
"Description": "Baclofen USP, is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. The structural formula is. C10H12ClNO2 M.W. 213.66. Baclofen USP is a white to off-white crystalline powder, with a molecular weight of 213.66. It is slightly soluble in water, very slightly soluble in methanol, and insoluble in chloroform. Each tablet, for oral administration, contains 5 mg, 10 mg or 20 mg baclofen, USP. In addition, each tablet contains the following inactive ingredients: Colloidal Silicon Dioxide, Anhydrous Dibasic Calcium Phosphate, Microcrystalline Cellulose, Lactose Monohydrate, Sodium Starch Glycolate, Magnesium Stearate."
},
{
"NDCCode": "71335-2219-5",
"PackageDescription": "112 TABLET in 1 BOTTLE (71335-2219-5) ",
"NDC11Code": "71335-2219-05",
"ProductNDC": "71335-2219",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Baclofen",
"NonProprietaryName": "Baclofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210713",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214099",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "BACLOFEN",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-08-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230815",
"SamplePackage": "N",
"IndicationAndUsage": "Baclofen tablets are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen tablets treatment will aid in restoring residual function. Baclofen tablets may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson’s disease has not been established and, therefore, it is not recommended for these conditions.",
"Description": "Baclofen USP, is a muscle relaxant and antispastic, available as 10 mg and 20 mg tablets for oral administration. Its chemical name is 4-amino-3-(4-chlorophenyl)- butanoic acid, and its structural formula is. Baclofen USP is a white to off-white crystalline powder, with a molecular weight of 213.66. It is slightly soluble in water, very slightly soluble in methanol and in 96% ethanol, practically insoluble in acetone, insoluble in chloroform, dissolves in dilute mineral acids and in dilute solutions of alkali hydroxides. Inactive Ingredients. Colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose and pregelatinized starch (maize). FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "71335-2392-0",
"PackageDescription": "112 TABLET in 1 BOTTLE (71335-2392-0) ",
"NDC11Code": "71335-2392-00",
"ProductNDC": "71335-2392",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Baclofen",
"NonProprietaryName": "Baclofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200709",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212067",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "BACLOFEN",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-08-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240529",
"SamplePackage": "N",
"IndicationAndUsage": "Baclofen tablets are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen tablets treatment will aid in restoring residual function. Baclofen tablets may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen tablets in stroke, cerebral palsy, and Parkinson's disease has not been established and, therefore, it is not recommended for these conditions.",
"Description": "Baclofen USP, is a muscle relaxant and antispastic, available as 5-mg, 10-mg and 20-mg tablets for oral administration. Its chemical name is 4-amino-3-(4-chlorophenyl)- butanoic acid, and its structural formula is. Baclofen USP is a white or creamy white powder, with a molecular weight of 213.66. It is slightly soluble in water, insoluble in organic solvents, dissolves in dilute mineral acids and alkali hydroxides. Inactive Ingredients. colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinized starch."
},
{
"NDCCode": "71335-2497-5",
"PackageDescription": "112 TABLET in 1 BOTTLE (71335-2497-5) ",
"NDC11Code": "71335-2497-05",
"ProductNDC": "71335-2497",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Baclofen",
"NonProprietaryName": "Baclofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240301",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214374",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "BACLOFEN",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-09-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240916",
"SamplePackage": "N",
"IndicationAndUsage": "Baclofen tablets are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen tablets, USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson’s disease has not been established and, therefore, it is not recommended for these conditions.",
"Description": "Baclofen, USP is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. The structural formula is. C10H12ClNO2 M.W. 213.66. Baclofen, USP is a white to off-white odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol and insoluble in chloroform. Each tablet, for oral administration, contains 5 mg, 10 mg or 20 mg baclofen, USP. In addition, each tablet contains the following inactive ingredients: Microcrystalline Cellulose, Primecel, Starch 1500, Pre-gelatinized Maize Starch, Povidone K-30, Colloidal Silicone dioxide, and Magnesium Stearate."
},
{
"NDCCode": "71335-2756-5",
"PackageDescription": "112 TABLET in 1 BOTTLE (71335-2756-5) ",
"NDC11Code": "71335-2756-05",
"ProductNDC": "71335-2756",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Baclofen",
"NonProprietaryName": "Baclofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200709",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212067",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "BACLOFEN",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251003",
"SamplePackage": "N",
"IndicationAndUsage": "Baclofen tablets are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen tablets treatment will aid in restoring residual function. Baclofen tablets may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen tablets in stroke, cerebral palsy, and Parkinson's disease has not been established and, therefore, it is not recommended for these conditions.",
"Description": "Baclofen USP, is a muscle relaxant and antispastic, available as 5-mg, 10-mg and 20-mg tablets for oral administration. Its chemical name is 4-amino-3-(4-chlorophenyl)- butanoic acid, and its structural formula is. Baclofen USP is a white or creamy white powder, with a molecular weight of 213.66. It is slightly soluble in water, insoluble in organic solvents, dissolves in dilute mineral acids and alkali hydroxides. Inactive Ingredients. colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinized starch."
},
{
"NDCCode": "71335-9638-0",
"PackageDescription": "112 TABLET in 1 BOTTLE (71335-9638-0) ",
"NDC11Code": "71335-9638-00",
"ProductNDC": "71335-9638",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Baclofen",
"NonProprietaryName": "Baclofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180401",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209102",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "BACLOFEN",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240530",
"SamplePackage": "N",
"IndicationAndUsage": "Baclofen tablets, USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen tablets, USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets, USP are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson's disease has not been established and, therefore, it is not recommended for these conditions.",
"Description": "Baclofen, USP is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. The structural formula is. C 10H 12ClNO 2M.W. 213.66. Baclofen, USP is a white to off-white odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol and insoluble in chloroform. Each tablet, for oral administration, contains 5 mg, 10 mg, 15 mg or 20 mg baclofen, USP. In addition, each tablet contains the following inactive ingredients: Microcrystalline Cellulose, Pregelatinized Starch, Sodium Starch Glycolate, Colloidal Silicon dioxide and Magnesium Stearate."
},
{
"NDCCode": "71335-9759-0",
"PackageDescription": "112 TABLET in 1 BOTTLE (71335-9759-0) ",
"NDC11Code": "71335-9759-00",
"ProductNDC": "71335-9759",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Baclofen",
"NonProprietaryName": "Baclofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214374",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "BACLOFEN",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2023-08-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230811",
"SamplePackage": "N",
"IndicationAndUsage": "Baclofen tablets are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen tablets may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson’s disease has not been established and, therefore, it is not recommended for these conditions.",
"Description": "Baclofen, USP is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. The structural formula is. C10H12ClNO2 M.W. 213.66. Baclofen, USP is a white to off-white odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol and insoluble in chloroform. Each tablet, for oral administration, contains 5 mg, 10 mg or 20 mg baclofen, USP. In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, starch 1500 pre-gelatinized maize starch, povidone K-30, colloidal silicon dioxide, and magnesium stearate."
},
{
"NDCCode": "72663-112-12",
"PackageDescription": "12 POUCH in 1 BOX (72663-112-12) > .9 mL in 1 POUCH (72663-112-23) ",
"NDC11Code": "72663-0112-12",
"ProductNDC": "72663-112",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Welly Clean Hands",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190827",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Welly Health PBC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "66.5",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190827",
"SamplePackage": "N",
"IndicationAndUsage": "For handwashing to decrease bacteria on skin without soap and water. Recommended for repeated use."
},
{
"NDCCode": "84386-112-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (84386-112-01) ",
"NDC11Code": "84386-0112-01",
"ProductNDC": "84386-112",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cinacalcet",
"NonProprietaryName": "Cinacalcet",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260323",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206125",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "CINACALCET HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium-sensing Receptor Agonist [EPC], Increased Calcium-sensing Receptor Sensitivity [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260323",
"SamplePackage": "N",
"IndicationAndUsage": "Cinacalcet is a positive modulator of the calcium sensing receptor indicated for: 1 Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. (1.1).",
"Description": "Cinacalcet tablets contain the hydrochloride salt of the active ingredient cinacalcet, a positive modulator of the calcium sensing receptor. The molecular formula for cinacalcet is C22H22F3N⋅HCl with a molecular weight of 393.9 g/mol (hydrochloride salt) and 357.4 g/mol (free base). It has one chiral center having an R-absolute configuration. The R-enantiomer is the more potent enantiomer and has been shown to be responsible for pharmacodynamic activity. The hydrochloride salt of cinacalcet is a white to off-white powder that is soluble in methanol or 95% ethanol and slightly soluble in water. The hydrochloride salt of cinacalcet is described chemically as N-[1-(R)-(-)-(1-naphthyl)ethyl]-3-[3-(trifluoromethyl)phenyl]-1-aminopropane hydrochloride and has the following structural formula: Cinacalcet tablets are formulated as light green, film-coated, oval shaped tablets for oral administration in strengths of 30 mg, 60 mg, and 90 mg of cinacalcet as the free base equivalent (33 mg, 66 mg, and 99 mg as the hydrochloride salt, respectively). Inactive Ingredients. The following are the inactive ingredients in cinacalcet tablets: ascorbic acid, colloidal silicon dioxide, crospovidone, FD&C blue #2/indigo carmine aluminum lake, hypromellose, iron oxide yellow, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch (maize), sodium stearyl fumarate, titanium dioxide and triacetin."
},
{
"NDCCode": "84386-112-05",
"PackageDescription": "500 TABLET, FILM COATED in 1 BOTTLE (84386-112-05) ",
"NDC11Code": "84386-0112-05",
"ProductNDC": "84386-112",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cinacalcet",
"NonProprietaryName": "Cinacalcet",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260323",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206125",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "CINACALCET HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium-sensing Receptor Agonist [EPC], Increased Calcium-sensing Receptor Sensitivity [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260323",
"SamplePackage": "N",
"IndicationAndUsage": "Cinacalcet is a positive modulator of the calcium sensing receptor indicated for: 1 Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. (1.1).",
"Description": "Cinacalcet tablets contain the hydrochloride salt of the active ingredient cinacalcet, a positive modulator of the calcium sensing receptor. The molecular formula for cinacalcet is C22H22F3N⋅HCl with a molecular weight of 393.9 g/mol (hydrochloride salt) and 357.4 g/mol (free base). It has one chiral center having an R-absolute configuration. The R-enantiomer is the more potent enantiomer and has been shown to be responsible for pharmacodynamic activity. The hydrochloride salt of cinacalcet is a white to off-white powder that is soluble in methanol or 95% ethanol and slightly soluble in water. The hydrochloride salt of cinacalcet is described chemically as N-[1-(R)-(-)-(1-naphthyl)ethyl]-3-[3-(trifluoromethyl)phenyl]-1-aminopropane hydrochloride and has the following structural formula: Cinacalcet tablets are formulated as light green, film-coated, oval shaped tablets for oral administration in strengths of 30 mg, 60 mg, and 90 mg of cinacalcet as the free base equivalent (33 mg, 66 mg, and 99 mg as the hydrochloride salt, respectively). Inactive Ingredients. The following are the inactive ingredients in cinacalcet tablets: ascorbic acid, colloidal silicon dioxide, crospovidone, FD&C blue #2/indigo carmine aluminum lake, hypromellose, iron oxide yellow, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch (maize), sodium stearyl fumarate, titanium dioxide and triacetin."
},
{
"NDCCode": "84386-112-30",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (84386-112-30) ",
"NDC11Code": "84386-0112-30",
"ProductNDC": "84386-112",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cinacalcet",
"NonProprietaryName": "Cinacalcet",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260323",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206125",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "CINACALCET HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium-sensing Receptor Agonist [EPC], Increased Calcium-sensing Receptor Sensitivity [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260323",
"SamplePackage": "N",
"IndicationAndUsage": "Cinacalcet is a positive modulator of the calcium sensing receptor indicated for: 1 Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. (1.1).",
"Description": "Cinacalcet tablets contain the hydrochloride salt of the active ingredient cinacalcet, a positive modulator of the calcium sensing receptor. The molecular formula for cinacalcet is C22H22F3N⋅HCl with a molecular weight of 393.9 g/mol (hydrochloride salt) and 357.4 g/mol (free base). It has one chiral center having an R-absolute configuration. The R-enantiomer is the more potent enantiomer and has been shown to be responsible for pharmacodynamic activity. The hydrochloride salt of cinacalcet is a white to off-white powder that is soluble in methanol or 95% ethanol and slightly soluble in water. The hydrochloride salt of cinacalcet is described chemically as N-[1-(R)-(-)-(1-naphthyl)ethyl]-3-[3-(trifluoromethyl)phenyl]-1-aminopropane hydrochloride and has the following structural formula: Cinacalcet tablets are formulated as light green, film-coated, oval shaped tablets for oral administration in strengths of 30 mg, 60 mg, and 90 mg of cinacalcet as the free base equivalent (33 mg, 66 mg, and 99 mg as the hydrochloride salt, respectively). Inactive Ingredients. The following are the inactive ingredients in cinacalcet tablets: ascorbic acid, colloidal silicon dioxide, crospovidone, FD&C blue #2/indigo carmine aluminum lake, hypromellose, iron oxide yellow, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch (maize), sodium stearyl fumarate, titanium dioxide and triacetin."
},
{
"NDCCode": "84386-112-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (84386-112-90) ",
"NDC11Code": "84386-0112-90",
"ProductNDC": "84386-112",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cinacalcet",
"NonProprietaryName": "Cinacalcet",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260323",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206125",
"LabelerName": "Aurobindo Pharma Limited",
"SubstanceName": "CINACALCET HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium-sensing Receptor Agonist [EPC], Increased Calcium-sensing Receptor Sensitivity [MoA]",
"Status": "Active",
"LastUpdate": "2026-04-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260323",
"SamplePackage": "N",
"IndicationAndUsage": "Cinacalcet is a positive modulator of the calcium sensing receptor indicated for: 1 Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. (1.1).",
"Description": "Cinacalcet tablets contain the hydrochloride salt of the active ingredient cinacalcet, a positive modulator of the calcium sensing receptor. The molecular formula for cinacalcet is C22H22F3N⋅HCl with a molecular weight of 393.9 g/mol (hydrochloride salt) and 357.4 g/mol (free base). It has one chiral center having an R-absolute configuration. The R-enantiomer is the more potent enantiomer and has been shown to be responsible for pharmacodynamic activity. The hydrochloride salt of cinacalcet is a white to off-white powder that is soluble in methanol or 95% ethanol and slightly soluble in water. The hydrochloride salt of cinacalcet is described chemically as N-[1-(R)-(-)-(1-naphthyl)ethyl]-3-[3-(trifluoromethyl)phenyl]-1-aminopropane hydrochloride and has the following structural formula: Cinacalcet tablets are formulated as light green, film-coated, oval shaped tablets for oral administration in strengths of 30 mg, 60 mg, and 90 mg of cinacalcet as the free base equivalent (33 mg, 66 mg, and 99 mg as the hydrochloride salt, respectively). Inactive Ingredients. The following are the inactive ingredients in cinacalcet tablets: ascorbic acid, colloidal silicon dioxide, crospovidone, FD&C blue #2/indigo carmine aluminum lake, hypromellose, iron oxide yellow, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch (maize), sodium stearyl fumarate, titanium dioxide and triacetin."
},
{
"NDCCode": "87903-112-32",
"PackageDescription": "5 BAG in 1 BOX (87903-112-32) / 1 LIQUID in 1 BAG",
"NDC11Code": "87903-0112-32",
"ProductNDC": "87903-112",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Green Bud Soothing Massage Fluid",
"NonProprietaryName": "Green Bud Soothing Massage Fluid",
"DosageFormName": "LIQUID",
"RouteName": "CUTANEOUS",
"StartMarketingDate": "20260729",
"EndMarketingDate": "20270729",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "WANWANG INC",
"SubstanceName": "CARTHAMUS TINCTORIUS (SAFFLOWER) FLOWER POWDER; CLOVE; ANGELICA PUBESCENS ROOT; HORSE CHESTNUT; MENTHOL",
"StrengthNumber": "3.25; 2.31; 2.29; 1.66; .59",
"StrengthUnit": "g/1; g/1; g/1; g/1; g/1",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]",
"Status": "Active",
"LastUpdate": "2026-07-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20260729",
"EndMarketingDatePackage": "20270729",
"SamplePackage": "N",
"IndicationAndUsage": "Before use, ensure hands areclean. Press the sponge tipwith your thumb to dispensegently until fully absorbed.For best results, repeat 3-4 times daily."
},
{
"NDCCode": "59088-003-81",
"PackageDescription": "14 TABLET in 1 BOTTLE, PLASTIC (59088-003-81) ",
"NDC11Code": "59088-0003-81",
"ProductNDC": "59088-003",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bruselix Bruising",
"NonProprietaryName": "Vitamin C, Zinc, Arnica Montana Extract, Bromelain, Diosmin, Rutin, Citrus Bioflavonoids, Hesperidin Methyl Chalcone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20241011",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Puretek Corporation",
"SubstanceName": "ARNICA MONTANA FLOWER; STEM BROMELAIN; SODIUM ASCORBATE; HESPERIDIN METHYLCHALCONE; RUTIN; DIOSMIN; HESPERIDIN; ZINC PICOLINATE",
"StrengthNumber": "50; 400; 120; 25; 50; 200; 25; 10",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Ascorbic Acid [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Vitamin C [EPC]",
"Status": "Active",
"LastUpdate": "2024-10-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241011",
"SamplePackage": "N",
"IndicationAndUsage": "Bruselix Bruising Tablets are formulated to provide nutritional support during the body’s natural recovery process. They may be helpful for individuals experiencing bruising due to minor injuries, surgical procedures, or sensitive skin. The formula contains antioxidants, enzymes, and natural extracts that are traditionally used to support overall skin health and recovery.",
"Description": "Active Ingredients Each tablet contains: Vitamin C (as Sodium Ascorbate) ...............................................................120 mg Zinc (as Zinc Picolinate) ...............................................................................10 mg Arnica Montana Extract 10:1 (equivalent to 500 mg Arnica Montana Powder) ...50 mg Bromelain 2400 GDU/g (from Pineapple) ...................................................400 mg Diosmin (Citrus Aurantium) Fruit Extract.....................................................200 mg Rutin (Sophora Japonica) Flower Extract......................................................50 mg Citrus Bioflavonoids (from pulp and peel of lemon, orange, quince) ............25 mg Hesperidin Methyl Chalcone..........................................................................25 mg. Other Ingredients: Croscarmellose Sodium, Dicalcium Phosphate, Magnesium Stearate, Microcrystalline Cellulose, Silicon Dioxide, Stearic Acid (Vegetable Source), Coating (Hydroxypropyl Methylcellulose, PEG-8)."
},
{
"NDCCode": "59088-005-54",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (59088-005-54) ",
"NDC11Code": "59088-0005-54",
"ProductNDC": "59088-005",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Multitol-m",
"NonProprietaryName": "Multivitamin, Folate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240417",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": ".ALPHA.-TOCOPHEROL ACETATE, DL-; MAGNESIUM OXIDE; CHROMIUM NICOTINATE; PYRIDOXINE HYDROCHLORIDE; MOLYBDENUM; SELENIUM; CHOLECALCIFEROL; RIBOFLAVIN; NIACINAMIDE; ASCORBIC ACID; LEVOMEFOLATE CALCIUM; METHYLCOBALAMIN; CALCIUM CARBONATE; VITAMIN A ACETATE; THIAMINE MONONITRATE; ZINC OXIDE; MANGANESE SULFATE",
"StrengthNumber": "13.5; 200; 35; 20; 45; 55; 20; 3.4; 20; 120; 2040; 8; 200; 1500; 3; 25; 2.3",
"StrengthUnit": "mg/1; mg/1; ug/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Folate Analog [EPC], Folic Acid [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2024-04-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240417",
"SamplePackage": "N",
"IndicationAndUsage": "Multitol-M is indicated to provide vitamins and minerals supplement to men and women. Folate is effective in the treatment of megaloblastic anemias due to a deficiency of folate (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, or childhood.",
"Description": "Each caplet contains. Vitamin A (as Retinyl Acetate)………………........ 1500 mcg RAE Vitamin C (as Ascorbic Acid) .………………..………...… 120 mg Vitamin D3 (As Cholecalciferol) ..……………….. 20 mcg (800 IU) Vitamin E (DL-alpha Tocopheryl Acetate) .……………….. 13.5 mg Thiamin (As Thiamine Mononitrate) …….………………..… 3 mg Riboflavin …………………………….….…..………….... 3.4 mg Niacin (as Niacinamide)…………………………………… 20 mg Vitamin B6 (as Pyridoxine Hydrochloride)…………………. 20 mg Folate (as L-5-Methyltetrahydrofolate calcium salt) …2040 mcg DFE (1200 mcg as L-5-Methylfolate) Vitamin B12 (as Methylcobalamin)………………………….. 8 mcg Calcium (as Calcium Carbonate)…………………………. 200 mg Magnesium (as Magnesium Oxide)……………………… 200 mg Zinc (as Zinc Oxide)……………………………………….. 25 mg Selenium (as Selenium Amino Acid Chelate)……………. 55 mcg Manganese (as Manganese Sulfate)……………………… 2.3 mg Chromium (as Chromium Polynicotinate)……………….. 35 mcg Molybdenum (as Molybdenum Amino Acid Chelate).……. 45 mcg Other Ingredients: Organic Cocoa Powder, Croscarmellose Sodium, Crospovidone, Magnesium Stearate, Microcrystalline Cellulose, Silicon Dioxide, Stearic Acid. Coating: (Hydroxypropyl Methylcellulose [HPMC], PEG-8)."
},
{
"NDCCode": "59088-008-54",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (59088-008-54) ",
"NDC11Code": "59088-0008-54",
"ProductNDC": "59088-008",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Finazol",
"NonProprietaryName": "Ferrous Fumarate, Folate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20241011",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "VITAMIN A ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; LEVOMEFOLATE CALCIUM; METHYLCOBALAMIN; BIOTIN; PANTOTHENIC ACID; CALCIUM CARBONATE; FERROUS FUMARATE; POTASSIUM IODIDE; MAGNESIUM OXIDE; ZINC CITRATE; SELENIUM; CUPROUS OXIDE; MANGANESE SULFATE; CHROMIUM NICOTINATE; MOLYBDENUM; POTASSIUM CHLORIDE; BORON",
"StrengthNumber": "1500; 200; 10; 45; 3.25; 3.35; 22.5; 6; 1000; 26; 100; 15; 100; 18; 25; 50; 30; 30; 1; .75; 37.5; 25; 24.5; 25",
"StrengthUnit": "ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; ug/1; ug/1; mg/1; ug/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Folate Analog [EPC], Folic Acid [CS], Increased Coagulation Factor Activity [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 Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Nicotinic Acid [EPC], Nicotinic Acids [CS], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2024-11-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241011",
"SamplePackage": "N",
"IndicationAndUsage": "Finazol is indicated for iron deficiency anemia and folate deficiency as in extended convalescence, menorrhagia, pregnancy, puberty, excessive blood loss and advanced age. Also, for conditions in which iron deficiency and vitamin C deficiency occur together, along with a deficient intake or increased need for B-Complex vitamins in chronic and acute illness, as well as cases of metabolic stress, and in convalescence.",
"Description": "Full Prescribing Information: DESCRIPTION: Active Ingredients: Each caplet contains: Vitamin A (as Retinyl Acetate) ……………………………….....1500 mcg RAE Vitamin C (as Ascorbic Acid) ….…..….…………………….……….....200 mg Vitamin D3 (as Cholecalciferol) ….…………………………....10 mcg (400 IU) Vitamin E (as DL-alpha Tocopheryl Acetate) ………………………….....45 mg Thiamin (as Thiamine Mononitrate) …..…..…………………………...3.25 mg Riboflavin (as Vitamin B2) …..…..…..…..………………………….…3.35 mg Niacin (as Niacinamide)……………………………………………..…22.5 mg Vitamin B6 (as Pyridoxine HCl)……………………………………………6 mg Folate (as L-5-Methyltetrahydrofolate calcium salt) …………………1700 mcg DFE (1000 mcg as L-5-Methylfolate) Vitamin B12 (as Methylcobalamin)……………………………………..26 mcg Biotin………………………………………………………………….100 mcg Pantothenic Acid (as Calcium Pantothenate)………………………….....15 mg Calcium (as Calcium Carbonate)………………………………………..100 mg Iron (as Ferrous Fumarate)……………………………………………....18 mg Iodine (as Potassium Iodide)…………………………………………...25 mcg Magnesium (as Magnesium Oxide)……………………………………...50 mg Zinc (as Zinc Citrate)……………………………………………………..30 mg Selenium (as Selenomethionine)….…………………………………….30 mcg Copper (as Copper Oxide)………………………………………………....1 mg Manganese (as Manganese Sulfate)…………………………………...0.75 mg Chromium (as Chromium Polynicotinate)…………………………….37.5 mcg Molybdenum (as Sodium Molybdate)…………………………………..25 mcg Potassium (as Potassium Chloride) ……………………………….…..24.5 mg Boron (as Boron Citrate)……………………………………..…………25 mcg. Other Ingredients: Crospovidone, Dextrin, Dextrose Monohydrate, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake, Magnesium Stearate, Microcrystalline Cellulose, Purified Stearic Acid, Silicon Dioxide, Sodium Carboxymethylcellulose, Titanium Dioxide."
},
{
"NDCCode": "59088-009-54",
"PackageDescription": "30 TABLET in 1 BOTTLE (59088-009-54) ",
"NDC11Code": "59088-0009-54",
"ProductNDC": "59088-009",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prenatol-m",
"NonProprietaryName": "Multivitamin",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20240506",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "CHOLECALCIFEROL; FERROUS FUMARATE; MOLYBDENUM; ASCORBIC ACID; ZINC OXIDE; CHOLINE BITARTRATE; RIBOFLAVIN; MAGNESIUM OXIDE; .ALPHA.-TOCOPHEROL ACETATE, DL-; VITAMIN A ACETATE; SELENIUM; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; CALCIUM CARBONATE; CHROMIUM NICOTINATE; MANGANESE SULFATE; POTASSIUM IODIDE; METHYLCOBALAMIN; LEVOMEFOLATE CALCIUM; THIAMINE MONONITRATE",
"StrengthNumber": "20; 27; 50; 120; 25; 55; 3.4; 200; 13.5; 1500; 70; 20; 50; 200; 45; 2.6; 150; 10; 2040; 3",
"StrengthUnit": "ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; ug/1; ug/1; ug/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Folate Analog [EPC], Folic Acid [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Active",
"LastUpdate": "2024-05-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240506",
"SamplePackage": "N",
"IndicationAndUsage": "Indications and Usage: Prenatol-M is indicated to provide vitamins and minerals to women throughout pregnancy and during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years. Prenatol-M may be beneficial in improving the nutritional status of women prior to conception.",
"Description": "Each caplet contains: Vitamin A (as Retinyl Acetate) ………………....… 1500 mcg RAE Vitamin C (as Ascorbic Acid) ………………….………… 120 mg Vitamin D3 (as Cholecalciferol).……………....... 20 mcg (800 IU) Vitamin E (as Dl-Alpha Tocopheryl Acetate) ….......….…. 13.5 mg Thiamin (as Thiamine Mononitrate) …………...…………… 3 mg Riboflavin ……………………….…………………….…. 3.4 mg Niacin (as Niacinamide) ………………..……………….… 20 mg Vitamin B6 (as Pyridoxine Hydrochloride) …....…………... 50 mg Folate (as L-5-Methyltetrahydrofolate calcium salt) ….... 2040 mcg DFE (1200 mcg as L-5-Methylfolate) Vitamin B12 (as Methylcobalamin) ……….……………... 10 mcg Choline (as Choline Bitartrate) …….……………………… 55 mg Calcium (as Calcium Carbonate) ……...…………………. 200 mg Iron (as Ferrous Fumarate) ………..……………………… 27 mg Iodine (as Potassium Iodine) …...……………………….150 mcg Magnesium (as Magnesium Oxide) …...………………… 200 mg Zinc (as Zinc Oxide) ………………...…………………….. 25 mg Selenium (as Selenium Amino Acid Chelate) ……………. 70 mcg Manganese (as Manganese Sulfate) ……………………… 2.6 mg Chromium (as Chromium Polynicotinate) ……………….. 45 mcg Molybdenum (as Molybdenum Amino Acid Chelate)…...… 50 mcg."
},
{
"NDCCode": "59088-013-06",
"PackageDescription": "60 g in 1 JAR (59088-013-06) ",
"NDC11Code": "59088-0013-06",
"ProductNDC": "59088-013",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Methylten",
"NonProprietaryName": "Methyl Salicylate 10%",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250113",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Puretek Corporation",
"SubstanceName": "METHYL SALICYLATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2025-01-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250113",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of minor aches and pains of muscles and joints."
}
]
}
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<ProductNDC>59088-112</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Purevit Dualfe Plus</ProprietaryName>
<NonProprietaryName>Ferrous Fumarate, Polysaccharide Iron Complex</NonProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20110601</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>CUPRIC SULFATE; FERROUS FUMARATE; IRON DEXTRAN; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM PANTOTHENATE; SODIUM ASCORBATE; THIAMINE MONONITRATE; ZINC SULFATE; MANGANESE SULFATE</SubstanceName>
<StrengthNumber>.8; 53; 53; 6; 30; 5; 1; 15; 10; 200; 10; 18.2; 1.3</StrengthNumber>
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<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Iron [CS], Magnetic Resonance Contrast Activity [MoA], Paramagnetic Contrast Agent [EPC], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PureVit DualFe Plus is indicated for the treatment of iron deficiency anemia and folate deficiency as in extended convalescence, menorrhagia, pregnancy, puberty, excessive blood loss and advanced age. Also for treatment of condition in which iron deficiency and vitamin C deficiency occur together, along with a deficient intake or increased need for B-Complex vitamins in chronic and acute illness, as well as cases of metabolic stress, and in convalescence.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55111-112-66</NDCCode>
<PackageDescription>5 BLISTER PACK in 1 CARTON (55111-112-66) > 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-112-79) </PackageDescription>
<NDC11Code>55111-0112-66</NDC11Code>
<ProductNDC>55111-112</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Moxifloxacin</ProprietaryName>
<NonProprietaryName>Moxifloxacin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140305</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076938</ApplicationNumber>
<LabelerName>Dr. Reddy's Laboratories Limited</LabelerName>
<SubstanceName>MOXIFLOXACIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Quinolone Antimicrobial [EPC], Quinolones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140305</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Moxifloxacin hydrochloride USP is a synthetic antibacterial agent for oral administration. Moxifloxacin, a fluoroquinolone, is available as the monohydrochloride salt of 1-cyclopropyl-7-[(S,S)-2,8-diazabicyclo[4.3.0]non-8-yl]-6-fluoro-8-methoxy-1,4-dihydro-4-oxo-3 quinoline carboxylic acid. It is a slightly yellow to yellow powder or crystals with a molecular weight of 437.9. Its molecular formula is C21H24FN3O4*HCl and its chemical structure is as follows.</Description>
</NDC>
<NDC>
<NDCCode>59088-353-00</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (59088-353-00) * 237 mL in 1 BOTTLE, PLASTIC (0116-1061-08) * 118 mL in 1 TUBE (59088-333-08) * 1 TUBE in 1 CARTON (45802-112-22) > 22 g in 1 TUBE</PackageDescription>
<NDC11Code>59088-0353-00</NDC11Code>
<ProductNDC>59088-353</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dermacinrx Surgical Pharmapak</ProprietaryName>
<NonProprietaryName>Mupirocin Ointment Kit</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20150827</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2021-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150827</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>59088-391-00</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (59088-391-00) * 237 mL in 1 BOTTLE, PLASTIC (0116-1061-08) * 118 mL in 1 TUBE (59088-333-08) * 1 TUBE in 1 CARTON (45802-112-22) / 22 g in 1 TUBE</PackageDescription>
<NDC11Code>59088-0391-00</NDC11Code>
<ProductNDC>59088-391</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dermacinrx Clorhexacin</ProprietaryName>
<NonProprietaryName>Mupirocin Ointment</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20160602</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<Status>Active</Status>
<LastUpdate>2024-12-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160602</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Each gram of Mupirocin Ointment USP, 2% contains 20 mg mupirocin in a bland water miscible ointment base (polyethylene glycol ointment, NF) consisting of polyethylene glycol 400 and polyethylene glycol 3350. Mupirocin is a naturally occurring antibiotic. The chemical name is ( E)-(2 S,3 R,4 R,5 S)-5-[(2 S,3 S,4 S,5 S)-2,3-Epoxy-5-hydroxy-4-methylhexyl]tetrahydro-3,4-dihydroxy-β-methyl-2H-pyran-2-crotonic acid, ester with 9-hydroxynonanoic acid. The molecular formula of mupirocin is C 26H 44O 9 and the molecular weight is 500.62. The chemical structure is:.</Description>
</NDC>
<NDC>
<NDCCode>59088-113-66</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE, PLASTIC (59088-113-66)</PackageDescription>
<NDC11Code>59088-0113-66</NDC11Code>
<ProductNDC>59088-113</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Purefe Ob Plus</ProprietaryName>
<NonProprietaryName>Ferrous Fumarate And Polysaccharide Iron Complex</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110601</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>FERROUS FUMARATE; IRON DEXTRAN; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM PANTOTHENATE; SODIUM ASCORBATE; THIAMINE MONONITRATE; MAGNESIUM SULFATE, UNSPECIFIED; ZINC SULFATE; CUPRIC SULFATE; MANGANESE SULFATE</SubstanceName>
<StrengthNumber>53; 53; 6; 30; 5; 1; 15; 10; 200; 10; 6.9; 18.2; .8; 1.3</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Nicotinic Acid [EPC],Nicotinic Acids [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Copper [CS],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-05-31</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>59088-709-00</NDCCode>
<PackageDescription>1 KIT in 1 PACKAGE (59088-709-00) * 1 TUBE in 1 CARTON (65162-833-66) / 100 g in 1 TUBE</PackageDescription>
<NDC11Code>59088-0709-00</NDC11Code>
<ProductNDC>59088-709</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venngel One</ProprietaryName>
<NonProprietaryName>Diclofenac Sodium, Isopropyl Alcohol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20180502</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<Status>Active</Status>
<LastUpdate>2024-12-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180502</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Diclofenac sodium topical gel, 1% w/w is a non-steroidal anti-inflammatory drug (NSAID) for topical use only. It contains the active ingredient, diclofenac sodium, USP, in an opaque, white to off-white gel base. Diclofenac sodium, USP is a white to off-white crystalline powder. Diclofenac sodium, USP is a benzeneacetic acid derivative. The chemical name is 2-[(2,6-dichlorophenyl)amino]benzeneacetic acid, monosodium salt. The molecular weight is 318.13. Its molecular formula is C 14H 10Cl 2NNaO 2. It has the following structural formula:. Diclofenac sodium topical gel, 1% also contains carbomer homopolymer Type C, cocoyl caprylocaprate, fragrance, isopropyl alcohol, mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water, and strong ammonia solution.</Description>
</NDC>
<NDC>
<NDCCode>59088-660-16</NDCCode>
<PackageDescription>237 mL in 1 BOTTLE (59088-660-16) </PackageDescription>
<NDC11Code>59088-0660-16</NDC11Code>
<ProductNDC>59088-660</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Livita Children</ProprietaryName>
<NonProprietaryName>Folate, Multivitamin</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231218</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>CHOLINE BITARTRATE; CHOLECALCIFEROL; VITAMIN A ACETATE; ASCORBIC ACID; .ALPHA.-TOCOPHEROL ACETATE, D-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; LEVOMEFOLATE CALCIUM; METHYLCOBALAMIN; BIOTIN; ZINC PICOLINATE; MAGNESIUM CITRATE; CALCIUM PANTOTHENATE; CALCIUM CITRATE; INULIN</SubstanceName>
<StrengthNumber>66.67; 3.33; 300; 66.67; 10; .4; .43; 2.67; .57; 333; .8; 10; .67; 33.33; 1.67; 66.67; 166.67</StrengthNumber>
<StrengthUnit>mg/mL; ug/mL; ug/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; ug/mL; ug/mL; ug/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Folate Analog [EPC], Folic Acid [CS], Increased Coagulation Factor Activity [PE], 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], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231218</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Livita liquid is indicated to provide significant amounts of essential vitamins and minerals, including Vitamins A, C, D, E, thiamine, riboflavin, niacin, vitamin B6, vitamin B12, folate, calcium, magnesium, and zinc, to supplement the diet. This comprehensive nutrient profile helps prevent nutritional deficiencies of these vitamins and minerals, ensuring that the specific dietary needs of adults and children are met to support overall health, energy, and vitality. The product is specially formulated to target common vitamin and mineral gaps in adults, thus promoting optimal health, immune function, bone strength, and metabolic balance. It is intended to be used under the guidance of a licensed healthcare practitioner to ensure that any potential for nutritional deficiency is addressed in a manner that supports the individual's overall health and wellbeing.</IndicationAndUsage>
<Description>Serving Size: 15 mL Servings per container: 47. Vitamin A (as Retinyl Acetate)........................ 300 mcg RAE Vitamin C (as Ascorbic Acid)............................... 66.67 mg Vitamin D3 (as Cholecalciferol)............................ 3.33 mcg Vitamin E (as D-Alpha Tocopheryl Acetate)............. 10 mg Thiamin (as Thiamine Mononitrate)......................... 0.4 mg Riboflavin .............................................................. 0.43 mg Niacin (as Niacinamide)......................................... 2.67 mg Vitamin B6 (as Pyridoxine Hydrochloride)............. 0.57 mg Folate (as L-5-Methyltetrahydrofolate calcium salt)...566 mcg DFE (333 mcg of L-5-Methylfolate) Vitamin B12 (as Methylcobalamin)......................... 0.8 mcg Biotin (as D-Biotin)................................................. 10 mcg Pantothenic Acid (as D-Calcium Pantothenate)..... 1.67 mg Choline (as Choline Bitartrate)............................. 66.67 mg Calcium (as Calcium Citrate)............................... 66.67 mg Magnesium (as Magnesium Citrate)...................... 33.3 mg Zinc (as Zinc Picolinate)........................................ 0.67 mg Inulin (as Helianthus Tuberosus Root Extract)... 166.67 mg. Other Ingredients: Aqua (Water), Organic Agave Syrup, Carrageenan, Citrus Extract, Flavor, Glycerin, Hydroxocobalamin Acetate, Potassium Sorbate, Organic Stevia Rebaudiana Leaf Extract.</Description>
</NDC>
<NDC>
<NDCCode>59088-786-31</NDCCode>
<PackageDescription>480 mL in 1 BOTTLE (59088-786-31) </PackageDescription>
<NDC11Code>59088-0786-31</NDC11Code>
<ProductNDC>59088-786</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Liquical With Magnesium</ProprietaryName>
<NonProprietaryName>Multivitamin</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231227</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>CALCIUM CITRATE; CHOLECALCIFEROL; MAGNESIUM CITRATE; ZINC CITRATE</SubstanceName>
<StrengthNumber>168; 66; 48; 1.4</StrengthNumber>
<StrengthUnit>mg/mL; [iU]/mL; mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Coagulation Factor Activity [PE], 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], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-04-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LiquiCal with Magnesium is indicated to provide support in children's healthy bone growth and development.</IndicationAndUsage>
<Description>Vitamin D3 (Cholecalciferol): Vitamin D3 plays a pivotal role in maintaining bone health and may also help mitigate mood disturbances. It is recommended to seek a supplement offering 600-800 IU of Vitamin D3 daily, although personal dosing should be discussed with a licensed healthcare practitioner. Calcium (Calcium Citrate): Calcium is a key mineral that fortifies bones, particularly crucial during menopause due to heightened osteoporosis risks. Women over 50 typically require around 1000-1300 mg of calcium daily, although intake should be calibrated based on diet. Magnesium (Magnesium Citrate): Magnesium offers relief from muscle cramps, mood fluctuations, and sleep disturbances. Zinc Citrate: Zinc is an essential trace element that has a critical role in maintaining structural and catalytic functions of >200 enzymes involved in major metabolic pathways, including nucleic acid metabolism, protein synthesis, and cell division. OTHER INGREDIENTS: Aqua (Purified Water), Citric Acid, Orange Flavor, Potassium Sorbate, Xanthan Gum, Xylitol.</Description>
</NDC>
<NDC>
<NDCCode>55150-112-10</NDCCode>
<PackageDescription>10 VIAL in 1 BOX (55150-112-10) / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL</PackageDescription>
<NDC11Code>55150-0112-10</NDC11Code>
<ProductNDC>55150-112</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ampicillin</ProprietaryName>
<NonProprietaryName>Ampicillin Sodium</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20120201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065499</ApplicationNumber>
<LabelerName>Eugia US LLC</LabelerName>
<SubstanceName>AMPICILLIN SODIUM</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ampicillin for injection is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the following conditions: Respiratory Tract Infections caused by Streptococcus pneumoniae, Staphylococcus aureus (penicillinase and nonpenicillinase-producing), H. influenzae, and Group A beta-hemolytic streptococci. Bacterial Meningitis caused by E. coli, Group B Streptococci, and other Gram-negative bacteria (Listeria monocytogenes, N. meningitidis). The addition of an aminoglycoside with ampicillin may increase its effectiveness against Gram-negative bacteria.Septicemia and Endocarditis caused by susceptible Gram-positive organisms including Streptococcus spp., penicillin G-susceptible staphylococci, and enterococci. Gram-negative sepsis caused by E. coli, Proteus mirabilis and Salmonella spp. responds to ampicillin. Endocarditis due to enterococcal strains usually respond to intravenous therapy. The addition of an aminoglycoside may enhance the effectiveness of ampicillin when treating streptococcal endocarditis. Urinary Tract Infections caused by sensitive strains of E. coli and Proteus mirabilis. Gastrointestinal Infections caused by Salmonella typhi (typhoid fever), other Salmonella spp., and Shigella spp. (dysentery) usually respond to oral or intravenous therapy. Bacteriology studies to determine the causative organisms and their susceptibility to ampicillin should be performed. Therapy may be instituted prior to obtaining results of susceptibility testing. It is advisable to reserve the parenteral form of this drug for moderately severe and severe infections and for patients who are unable to take the oral forms. A change to oral ampicillin may be made as soon as appropriate. To reduce the development of drug-resistant bacteria and maintain the effectiveness of ampicillin for injection and other antibacterial drugs, ampicillin for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Indicated surgical procedures should be performed.</IndicationAndUsage>
<Description>Ampicillin for injection, USP the monosodium salt of [2S-[2α, 5α, 6β(S*)]]-6-[(aminophenylacetyl)amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid, is a synthetic penicillin. It is an antibacterial agent with a broad spectrum of bactericidal activity against both penicillin-susceptible Gram-positive organisms and many common Gram-negative pathogens. Ampicillin for injection, USP is a white to off-white crystalline powder. The reconstituted solution is clear, colorless and free from visible particulates. Each vial of ampicillin for injection, USP contains ampicillin sodium equivalent to 250 mg, 500 mg, 1 gram or 2 grams ampicillin. Ampicillin for injection, USP contains sodium content as 16.46 mg (0.72 mEq) per 250 mg, 32.91 mg (1.43 mEq) per 500 mg, 65.83 mg (2.86 mEq) per 1 g or 131.66 mg (5.72 mEq) per 2 g of ampicillin. It has the following molecular structure: The molecular formula is C16H18N3NaO4S, and the molecular weight is 371.39. The pH range of the reconstituted solution is 8 to 10.</Description>
</NDC>
<NDC>
<NDCCode>71335-0949-5</NDCCode>
<PackageDescription>112 TABLET in 1 BOTTLE (71335-0949-5) </PackageDescription>
<NDC11Code>71335-0949-05</NDC11Code>
<ProductNDC>71335-0949</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Baclofen</ProprietaryName>
<NonProprietaryName>Baclofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180401</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209102</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>BACLOFEN</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240529</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Baclofen tablets, USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen tablets, USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets, USP are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson's disease has not been established and, therefore, it is not recommended for these conditions.</IndicationAndUsage>
<Description>Baclofen, USP is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. The structural formula is. C 10H 12ClNO 2M.W. 213.66. Baclofen, USP is a white to off-white odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol and insoluble in chloroform. Each tablet, for oral administration, contains 5 mg, 10 mg, 15 mg or 20 mg baclofen, USP. In addition, each tablet contains the following inactive ingredients: Microcrystalline Cellulose, Pregelatinized Starch, Sodium Starch Glycolate, Colloidal Silicon dioxide and Magnesium Stearate.</Description>
</NDC>
<NDC>
<NDCCode>71335-1356-5</NDCCode>
<PackageDescription>112 TABLET in 1 BOTTLE (71335-1356-5) </PackageDescription>
<NDC11Code>71335-1356-05</NDC11Code>
<ProductNDC>71335-1356</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Baclofen</ProprietaryName>
<NonProprietaryName>Baclofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211659</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>BACLOFEN</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-09-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240905</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Baclofen tablets USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen tablets USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets USP are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson's disease has not been established and, therefore, it is not recommended for these conditions.</IndicationAndUsage>
<Description>Baclofen, USP is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. The structural formula is. C10H12ClNO2 M.W. 213.66. Baclofen, USP is a white to off-white odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol and insoluble in chloroform. Each tablet, for oral administration, contains 5 mg, 10 mg, 15 mg or 20 mg baclofen, USP. In addition, each tablet contains the following inactive ingredients: dibasic calcium phosphate anhydrous, magnesium stearate, microcrystalline cellulose, pregelatinized starch, povidone and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>71335-1643-0</NDCCode>
<PackageDescription>112 TABLET in 1 BOTTLE (71335-1643-0) </PackageDescription>
<NDC11Code>71335-1643-00</NDC11Code>
<ProductNDC>71335-1643</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Baclofen</ProprietaryName>
<NonProprietaryName>Baclofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210527</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211555</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>BACLOFEN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220429</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Baclofen Tablets, USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen Tablets, USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen Tablets, USP are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson’s disease has not been established and, therefore, it is not recommended for these conditions.</IndicationAndUsage>
<Description>Baclofen USP, is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. The structural formula is. C10H12ClNO2 M.W. 213.66. Baclofen USP is a white to off-white odorless or practically odorless crystalline powder, with a molecular weight of 213.66. It is slightly soluble in water, very slightly soluble in methanol, and insoluble in chloroform. Each tablet, for oral administration, contains 5 mg, 10 mg or 20 mg baclofen, USP. In addition, each tablet contains the following inactive ingredients: Microcrystalline Cellulose, Mannitol, Pre-Gelatinized Starch, Hypromellose, Sodium Starch Glycolate, Colloidal Silicon Dioxide, Magnesium Stearate.</Description>
</NDC>
<NDC>
<NDCCode>71335-1664-5</NDCCode>
<PackageDescription>112 TABLET in 1 BOTTLE (71335-1664-5) </PackageDescription>
<NDC11Code>71335-1664-05</NDC11Code>
<ProductNDC>71335-1664</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Baclofen</ProprietaryName>
<NonProprietaryName>Baclofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210527</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211555</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>BACLOFEN</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220429</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Baclofen Tablets, USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen Tablets, USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen Tablets, USP are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson’s disease has not been established and, therefore, it is not recommended for these conditions.</IndicationAndUsage>
<Description>Baclofen USP, is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. The structural formula is. C10H12ClNO2 M.W. 213.66. Baclofen USP is a white to off-white crystalline powder, with a molecular weight of 213.66. It is slightly soluble in water, very slightly soluble in methanol, and insoluble in chloroform. Each tablet, for oral administration, contains 5 mg, 10 mg or 20 mg baclofen, USP. In addition, each tablet contains the following inactive ingredients: Colloidal Silicon Dioxide, Anhydrous Dibasic Calcium Phosphate, Microcrystalline Cellulose, Lactose Monohydrate, Sodium Starch Glycolate, Magnesium Stearate.</Description>
</NDC>
<NDC>
<NDCCode>71335-2219-5</NDCCode>
<PackageDescription>112 TABLET in 1 BOTTLE (71335-2219-5) </PackageDescription>
<NDC11Code>71335-2219-05</NDC11Code>
<ProductNDC>71335-2219</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Baclofen</ProprietaryName>
<NonProprietaryName>Baclofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210713</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214099</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>BACLOFEN</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Baclofen tablets are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen tablets treatment will aid in restoring residual function. Baclofen tablets may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson’s disease has not been established and, therefore, it is not recommended for these conditions.</IndicationAndUsage>
<Description>Baclofen USP, is a muscle relaxant and antispastic, available as 10 mg and 20 mg tablets for oral administration. Its chemical name is 4-amino-3-(4-chlorophenyl)- butanoic acid, and its structural formula is. Baclofen USP is a white to off-white crystalline powder, with a molecular weight of 213.66. It is slightly soluble in water, very slightly soluble in methanol and in 96% ethanol, practically insoluble in acetone, insoluble in chloroform, dissolves in dilute mineral acids and in dilute solutions of alkali hydroxides. Inactive Ingredients. Colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose and pregelatinized starch (maize). FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>71335-2392-0</NDCCode>
<PackageDescription>112 TABLET in 1 BOTTLE (71335-2392-0) </PackageDescription>
<NDC11Code>71335-2392-00</NDC11Code>
<ProductNDC>71335-2392</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Baclofen</ProprietaryName>
<NonProprietaryName>Baclofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200709</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212067</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>BACLOFEN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-08-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240529</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Baclofen tablets are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen tablets treatment will aid in restoring residual function. Baclofen tablets may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen tablets in stroke, cerebral palsy, and Parkinson's disease has not been established and, therefore, it is not recommended for these conditions.</IndicationAndUsage>
<Description>Baclofen USP, is a muscle relaxant and antispastic, available as 5-mg, 10-mg and 20-mg tablets for oral administration. Its chemical name is 4-amino-3-(4-chlorophenyl)- butanoic acid, and its structural formula is. Baclofen USP is a white or creamy white powder, with a molecular weight of 213.66. It is slightly soluble in water, insoluble in organic solvents, dissolves in dilute mineral acids and alkali hydroxides. Inactive Ingredients. colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinized starch.</Description>
</NDC>
<NDC>
<NDCCode>71335-2497-5</NDCCode>
<PackageDescription>112 TABLET in 1 BOTTLE (71335-2497-5) </PackageDescription>
<NDC11Code>71335-2497-05</NDC11Code>
<ProductNDC>71335-2497</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Baclofen</ProprietaryName>
<NonProprietaryName>Baclofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240301</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214374</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>BACLOFEN</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-09-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240916</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Baclofen tablets are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen tablets, USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson’s disease has not been established and, therefore, it is not recommended for these conditions.</IndicationAndUsage>
<Description>Baclofen, USP is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. The structural formula is. C10H12ClNO2 M.W. 213.66. Baclofen, USP is a white to off-white odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol and insoluble in chloroform. Each tablet, for oral administration, contains 5 mg, 10 mg or 20 mg baclofen, USP. In addition, each tablet contains the following inactive ingredients: Microcrystalline Cellulose, Primecel, Starch 1500, Pre-gelatinized Maize Starch, Povidone K-30, Colloidal Silicone dioxide, and Magnesium Stearate.</Description>
</NDC>
<NDC>
<NDCCode>71335-2756-5</NDCCode>
<PackageDescription>112 TABLET in 1 BOTTLE (71335-2756-5) </PackageDescription>
<NDC11Code>71335-2756-05</NDC11Code>
<ProductNDC>71335-2756</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Baclofen</ProprietaryName>
<NonProprietaryName>Baclofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200709</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212067</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>BACLOFEN</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251003</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Baclofen tablets are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen tablets treatment will aid in restoring residual function. Baclofen tablets may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen tablets in stroke, cerebral palsy, and Parkinson's disease has not been established and, therefore, it is not recommended for these conditions.</IndicationAndUsage>
<Description>Baclofen USP, is a muscle relaxant and antispastic, available as 5-mg, 10-mg and 20-mg tablets for oral administration. Its chemical name is 4-amino-3-(4-chlorophenyl)- butanoic acid, and its structural formula is. Baclofen USP is a white or creamy white powder, with a molecular weight of 213.66. It is slightly soluble in water, insoluble in organic solvents, dissolves in dilute mineral acids and alkali hydroxides. Inactive Ingredients. colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinized starch.</Description>
</NDC>
<NDC>
<NDCCode>71335-9638-0</NDCCode>
<PackageDescription>112 TABLET in 1 BOTTLE (71335-9638-0) </PackageDescription>
<NDC11Code>71335-9638-00</NDC11Code>
<ProductNDC>71335-9638</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Baclofen</ProprietaryName>
<NonProprietaryName>Baclofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180401</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209102</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>BACLOFEN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240530</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Baclofen tablets, USP are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen tablets, USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets, USP are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson's disease has not been established and, therefore, it is not recommended for these conditions.</IndicationAndUsage>
<Description>Baclofen, USP is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. The structural formula is. C 10H 12ClNO 2M.W. 213.66. Baclofen, USP is a white to off-white odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol and insoluble in chloroform. Each tablet, for oral administration, contains 5 mg, 10 mg, 15 mg or 20 mg baclofen, USP. In addition, each tablet contains the following inactive ingredients: Microcrystalline Cellulose, Pregelatinized Starch, Sodium Starch Glycolate, Colloidal Silicon dioxide and Magnesium Stearate.</Description>
</NDC>
<NDC>
<NDCCode>71335-9759-0</NDCCode>
<PackageDescription>112 TABLET in 1 BOTTLE (71335-9759-0) </PackageDescription>
<NDC11Code>71335-9759-00</NDC11Code>
<ProductNDC>71335-9759</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Baclofen</ProprietaryName>
<NonProprietaryName>Baclofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214374</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>BACLOFEN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-08-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230811</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Baclofen tablets are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen tablets may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson’s disease has not been established and, therefore, it is not recommended for these conditions.</IndicationAndUsage>
<Description>Baclofen, USP is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. The structural formula is. C10H12ClNO2 M.W. 213.66. Baclofen, USP is a white to off-white odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol and insoluble in chloroform. Each tablet, for oral administration, contains 5 mg, 10 mg or 20 mg baclofen, USP. In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, starch 1500 pre-gelatinized maize starch, povidone K-30, colloidal silicon dioxide, and magnesium stearate.</Description>
</NDC>
<NDC>
<NDCCode>72663-112-12</NDCCode>
<PackageDescription>12 POUCH in 1 BOX (72663-112-12) > .9 mL in 1 POUCH (72663-112-23) </PackageDescription>
<NDC11Code>72663-0112-12</NDC11Code>
<ProductNDC>72663-112</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Welly Clean Hands</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190827</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Welly Health PBC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>66.5</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190827</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For handwashing to decrease bacteria on skin without soap and water. Recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>84386-112-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (84386-112-01) </PackageDescription>
<NDC11Code>84386-0112-01</NDC11Code>
<ProductNDC>84386-112</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cinacalcet</ProprietaryName>
<NonProprietaryName>Cinacalcet</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260323</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206125</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>CINACALCET HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium-sensing Receptor Agonist [EPC], Increased Calcium-sensing Receptor Sensitivity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260323</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cinacalcet is a positive modulator of the calcium sensing receptor indicated for: 1 Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. (1.1).</IndicationAndUsage>
<Description>Cinacalcet tablets contain the hydrochloride salt of the active ingredient cinacalcet, a positive modulator of the calcium sensing receptor. The molecular formula for cinacalcet is C22H22F3N⋅HCl with a molecular weight of 393.9 g/mol (hydrochloride salt) and 357.4 g/mol (free base). It has one chiral center having an R-absolute configuration. The R-enantiomer is the more potent enantiomer and has been shown to be responsible for pharmacodynamic activity. The hydrochloride salt of cinacalcet is a white to off-white powder that is soluble in methanol or 95% ethanol and slightly soluble in water. The hydrochloride salt of cinacalcet is described chemically as N-[1-(R)-(-)-(1-naphthyl)ethyl]-3-[3-(trifluoromethyl)phenyl]-1-aminopropane hydrochloride and has the following structural formula: Cinacalcet tablets are formulated as light green, film-coated, oval shaped tablets for oral administration in strengths of 30 mg, 60 mg, and 90 mg of cinacalcet as the free base equivalent (33 mg, 66 mg, and 99 mg as the hydrochloride salt, respectively). Inactive Ingredients. The following are the inactive ingredients in cinacalcet tablets: ascorbic acid, colloidal silicon dioxide, crospovidone, FD&C blue #2/indigo carmine aluminum lake, hypromellose, iron oxide yellow, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch (maize), sodium stearyl fumarate, titanium dioxide and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>84386-112-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED in 1 BOTTLE (84386-112-05) </PackageDescription>
<NDC11Code>84386-0112-05</NDC11Code>
<ProductNDC>84386-112</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cinacalcet</ProprietaryName>
<NonProprietaryName>Cinacalcet</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260323</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206125</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>CINACALCET HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium-sensing Receptor Agonist [EPC], Increased Calcium-sensing Receptor Sensitivity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260323</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cinacalcet is a positive modulator of the calcium sensing receptor indicated for: 1 Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. (1.1).</IndicationAndUsage>
<Description>Cinacalcet tablets contain the hydrochloride salt of the active ingredient cinacalcet, a positive modulator of the calcium sensing receptor. The molecular formula for cinacalcet is C22H22F3N⋅HCl with a molecular weight of 393.9 g/mol (hydrochloride salt) and 357.4 g/mol (free base). It has one chiral center having an R-absolute configuration. The R-enantiomer is the more potent enantiomer and has been shown to be responsible for pharmacodynamic activity. The hydrochloride salt of cinacalcet is a white to off-white powder that is soluble in methanol or 95% ethanol and slightly soluble in water. The hydrochloride salt of cinacalcet is described chemically as N-[1-(R)-(-)-(1-naphthyl)ethyl]-3-[3-(trifluoromethyl)phenyl]-1-aminopropane hydrochloride and has the following structural formula: Cinacalcet tablets are formulated as light green, film-coated, oval shaped tablets for oral administration in strengths of 30 mg, 60 mg, and 90 mg of cinacalcet as the free base equivalent (33 mg, 66 mg, and 99 mg as the hydrochloride salt, respectively). Inactive Ingredients. The following are the inactive ingredients in cinacalcet tablets: ascorbic acid, colloidal silicon dioxide, crospovidone, FD&C blue #2/indigo carmine aluminum lake, hypromellose, iron oxide yellow, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch (maize), sodium stearyl fumarate, titanium dioxide and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>84386-112-30</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (84386-112-30) </PackageDescription>
<NDC11Code>84386-0112-30</NDC11Code>
<ProductNDC>84386-112</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cinacalcet</ProprietaryName>
<NonProprietaryName>Cinacalcet</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260323</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206125</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>CINACALCET HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium-sensing Receptor Agonist [EPC], Increased Calcium-sensing Receptor Sensitivity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260323</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cinacalcet is a positive modulator of the calcium sensing receptor indicated for: 1 Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. (1.1).</IndicationAndUsage>
<Description>Cinacalcet tablets contain the hydrochloride salt of the active ingredient cinacalcet, a positive modulator of the calcium sensing receptor. The molecular formula for cinacalcet is C22H22F3N⋅HCl with a molecular weight of 393.9 g/mol (hydrochloride salt) and 357.4 g/mol (free base). It has one chiral center having an R-absolute configuration. The R-enantiomer is the more potent enantiomer and has been shown to be responsible for pharmacodynamic activity. The hydrochloride salt of cinacalcet is a white to off-white powder that is soluble in methanol or 95% ethanol and slightly soluble in water. The hydrochloride salt of cinacalcet is described chemically as N-[1-(R)-(-)-(1-naphthyl)ethyl]-3-[3-(trifluoromethyl)phenyl]-1-aminopropane hydrochloride and has the following structural formula: Cinacalcet tablets are formulated as light green, film-coated, oval shaped tablets for oral administration in strengths of 30 mg, 60 mg, and 90 mg of cinacalcet as the free base equivalent (33 mg, 66 mg, and 99 mg as the hydrochloride salt, respectively). Inactive Ingredients. The following are the inactive ingredients in cinacalcet tablets: ascorbic acid, colloidal silicon dioxide, crospovidone, FD&C blue #2/indigo carmine aluminum lake, hypromellose, iron oxide yellow, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch (maize), sodium stearyl fumarate, titanium dioxide and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>84386-112-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (84386-112-90) </PackageDescription>
<NDC11Code>84386-0112-90</NDC11Code>
<ProductNDC>84386-112</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cinacalcet</ProprietaryName>
<NonProprietaryName>Cinacalcet</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260323</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206125</ApplicationNumber>
<LabelerName>Aurobindo Pharma Limited</LabelerName>
<SubstanceName>CINACALCET HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Calcium-sensing Receptor Agonist [EPC], Increased Calcium-sensing Receptor Sensitivity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-04-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260323</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cinacalcet is a positive modulator of the calcium sensing receptor indicated for: 1 Secondary Hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on dialysis. (1.1).</IndicationAndUsage>
<Description>Cinacalcet tablets contain the hydrochloride salt of the active ingredient cinacalcet, a positive modulator of the calcium sensing receptor. The molecular formula for cinacalcet is C22H22F3N⋅HCl with a molecular weight of 393.9 g/mol (hydrochloride salt) and 357.4 g/mol (free base). It has one chiral center having an R-absolute configuration. The R-enantiomer is the more potent enantiomer and has been shown to be responsible for pharmacodynamic activity. The hydrochloride salt of cinacalcet is a white to off-white powder that is soluble in methanol or 95% ethanol and slightly soluble in water. The hydrochloride salt of cinacalcet is described chemically as N-[1-(R)-(-)-(1-naphthyl)ethyl]-3-[3-(trifluoromethyl)phenyl]-1-aminopropane hydrochloride and has the following structural formula: Cinacalcet tablets are formulated as light green, film-coated, oval shaped tablets for oral administration in strengths of 30 mg, 60 mg, and 90 mg of cinacalcet as the free base equivalent (33 mg, 66 mg, and 99 mg as the hydrochloride salt, respectively). Inactive Ingredients. The following are the inactive ingredients in cinacalcet tablets: ascorbic acid, colloidal silicon dioxide, crospovidone, FD&C blue #2/indigo carmine aluminum lake, hypromellose, iron oxide yellow, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch (maize), sodium stearyl fumarate, titanium dioxide and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>87903-112-32</NDCCode>
<PackageDescription>5 BAG in 1 BOX (87903-112-32) / 1 LIQUID in 1 BAG</PackageDescription>
<NDC11Code>87903-0112-32</NDC11Code>
<ProductNDC>87903-112</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Green Bud Soothing Massage Fluid</ProprietaryName>
<NonProprietaryName>Green Bud Soothing Massage Fluid</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>CUTANEOUS</RouteName>
<StartMarketingDate>20260729</StartMarketingDate>
<EndMarketingDate>20270729</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>WANWANG INC</LabelerName>
<SubstanceName>CARTHAMUS TINCTORIUS (SAFFLOWER) FLOWER POWDER; CLOVE; ANGELICA PUBESCENS ROOT; HORSE CHESTNUT; MENTHOL</SubstanceName>
<StrengthNumber>3.25; 2.31; 2.29; 1.66; .59</StrengthNumber>
<StrengthUnit>g/1; g/1; g/1; g/1; g/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20260729</StartMarketingDatePackage>
<EndMarketingDatePackage>20270729</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Before use, ensure hands areclean. Press the sponge tipwith your thumb to dispensegently until fully absorbed.For best results, repeat 3-4 times daily.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59088-003-81</NDCCode>
<PackageDescription>14 TABLET in 1 BOTTLE, PLASTIC (59088-003-81) </PackageDescription>
<NDC11Code>59088-0003-81</NDC11Code>
<ProductNDC>59088-003</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bruselix Bruising</ProprietaryName>
<NonProprietaryName>Vitamin C, Zinc, Arnica Montana Extract, Bromelain, Diosmin, Rutin, Citrus Bioflavonoids, Hesperidin Methyl Chalcone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241011</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Puretek Corporation</LabelerName>
<SubstanceName>ARNICA MONTANA FLOWER; STEM BROMELAIN; SODIUM ASCORBATE; HESPERIDIN METHYLCHALCONE; RUTIN; DIOSMIN; HESPERIDIN; ZINC PICOLINATE</SubstanceName>
<StrengthNumber>50; 400; 120; 25; 50; 200; 25; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Ascorbic Acid [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Vitamin C [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241011</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bruselix Bruising Tablets are formulated to provide nutritional support during the body’s natural recovery process. They may be helpful for individuals experiencing bruising due to minor injuries, surgical procedures, or sensitive skin. The formula contains antioxidants, enzymes, and natural extracts that are traditionally used to support overall skin health and recovery.</IndicationAndUsage>
<Description>Active Ingredients Each tablet contains: Vitamin C (as Sodium Ascorbate) ...............................................................120 mg Zinc (as Zinc Picolinate) ...............................................................................10 mg Arnica Montana Extract 10:1 (equivalent to 500 mg Arnica Montana Powder) ...50 mg Bromelain 2400 GDU/g (from Pineapple) ...................................................400 mg Diosmin (Citrus Aurantium) Fruit Extract.....................................................200 mg Rutin (Sophora Japonica) Flower Extract......................................................50 mg Citrus Bioflavonoids (from pulp and peel of lemon, orange, quince) ............25 mg Hesperidin Methyl Chalcone..........................................................................25 mg. Other Ingredients: Croscarmellose Sodium, Dicalcium Phosphate, Magnesium Stearate, Microcrystalline Cellulose, Silicon Dioxide, Stearic Acid (Vegetable Source), Coating (Hydroxypropyl Methylcellulose, PEG-8).</Description>
</NDC>
<NDC>
<NDCCode>59088-005-54</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (59088-005-54) </PackageDescription>
<NDC11Code>59088-0005-54</NDC11Code>
<ProductNDC>59088-005</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Multitol-m</ProprietaryName>
<NonProprietaryName>Multivitamin, Folate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240417</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>.ALPHA.-TOCOPHEROL ACETATE, DL-; MAGNESIUM OXIDE; CHROMIUM NICOTINATE; PYRIDOXINE HYDROCHLORIDE; MOLYBDENUM; SELENIUM; CHOLECALCIFEROL; RIBOFLAVIN; NIACINAMIDE; ASCORBIC ACID; LEVOMEFOLATE CALCIUM; METHYLCOBALAMIN; CALCIUM CARBONATE; VITAMIN A ACETATE; THIAMINE MONONITRATE; ZINC OXIDE; MANGANESE SULFATE</SubstanceName>
<StrengthNumber>13.5; 200; 35; 20; 45; 55; 20; 3.4; 20; 120; 2040; 8; 200; 1500; 3; 25; 2.3</StrengthNumber>
<StrengthUnit>mg/1; mg/1; ug/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; ug/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Folate Analog [EPC], Folic Acid [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-04-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240417</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Multitol-M is indicated to provide vitamins and minerals supplement to men and women. Folate is effective in the treatment of megaloblastic anemias due to a deficiency of folate (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, or childhood.</IndicationAndUsage>
<Description>Each caplet contains. Vitamin A (as Retinyl Acetate)………………........ 1500 mcg RAE Vitamin C (as Ascorbic Acid) .………………..………...… 120 mg Vitamin D3 (As Cholecalciferol) ..……………….. 20 mcg (800 IU) Vitamin E (DL-alpha Tocopheryl Acetate) .……………….. 13.5 mg Thiamin (As Thiamine Mononitrate) …….………………..… 3 mg Riboflavin …………………………….….…..………….... 3.4 mg Niacin (as Niacinamide)…………………………………… 20 mg Vitamin B6 (as Pyridoxine Hydrochloride)…………………. 20 mg Folate (as L-5-Methyltetrahydrofolate calcium salt) …2040 mcg DFE (1200 mcg as L-5-Methylfolate) Vitamin B12 (as Methylcobalamin)………………………….. 8 mcg Calcium (as Calcium Carbonate)…………………………. 200 mg Magnesium (as Magnesium Oxide)……………………… 200 mg Zinc (as Zinc Oxide)……………………………………….. 25 mg Selenium (as Selenium Amino Acid Chelate)……………. 55 mcg Manganese (as Manganese Sulfate)……………………… 2.3 mg Chromium (as Chromium Polynicotinate)……………….. 35 mcg Molybdenum (as Molybdenum Amino Acid Chelate).……. 45 mcg Other Ingredients: Organic Cocoa Powder, Croscarmellose Sodium, Crospovidone, Magnesium Stearate, Microcrystalline Cellulose, Silicon Dioxide, Stearic Acid. Coating: (Hydroxypropyl Methylcellulose [HPMC], PEG-8).</Description>
</NDC>
<NDC>
<NDCCode>59088-008-54</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (59088-008-54) </PackageDescription>
<NDC11Code>59088-0008-54</NDC11Code>
<ProductNDC>59088-008</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Finazol</ProprietaryName>
<NonProprietaryName>Ferrous Fumarate, Folate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20241011</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>VITAMIN A ACETATE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; LEVOMEFOLATE CALCIUM; METHYLCOBALAMIN; BIOTIN; PANTOTHENIC ACID; CALCIUM CARBONATE; FERROUS FUMARATE; POTASSIUM IODIDE; MAGNESIUM OXIDE; ZINC CITRATE; SELENIUM; CUPROUS OXIDE; MANGANESE SULFATE; CHROMIUM NICOTINATE; MOLYBDENUM; POTASSIUM CHLORIDE; BORON</SubstanceName>
<StrengthNumber>1500; 200; 10; 45; 3.25; 3.35; 22.5; 6; 1000; 26; 100; 15; 100; 18; 25; 50; 30; 30; 1; .75; 37.5; 25; 24.5; 25</StrengthNumber>
<StrengthUnit>ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; ug/1; mg/1; mg/1; ug/1; ug/1; mg/1; ug/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Folate Analog [EPC], Folic Acid [CS], Increased Coagulation Factor Activity [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 Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Nicotinic Acid [EPC], Nicotinic Acids [CS], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-11-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241011</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Finazol is indicated for iron deficiency anemia and folate deficiency as in extended convalescence, menorrhagia, pregnancy, puberty, excessive blood loss and advanced age. Also, for conditions in which iron deficiency and vitamin C deficiency occur together, along with a deficient intake or increased need for B-Complex vitamins in chronic and acute illness, as well as cases of metabolic stress, and in convalescence.</IndicationAndUsage>
<Description>Full Prescribing Information: DESCRIPTION: Active Ingredients: Each caplet contains: Vitamin A (as Retinyl Acetate) ……………………………….....1500 mcg RAE Vitamin C (as Ascorbic Acid) ….…..….…………………….……….....200 mg Vitamin D3 (as Cholecalciferol) ….…………………………....10 mcg (400 IU) Vitamin E (as DL-alpha Tocopheryl Acetate) ………………………….....45 mg Thiamin (as Thiamine Mononitrate) …..…..…………………………...3.25 mg Riboflavin (as Vitamin B2) …..…..…..…..………………………….…3.35 mg Niacin (as Niacinamide)……………………………………………..…22.5 mg Vitamin B6 (as Pyridoxine HCl)……………………………………………6 mg Folate (as L-5-Methyltetrahydrofolate calcium salt) …………………1700 mcg DFE (1000 mcg as L-5-Methylfolate) Vitamin B12 (as Methylcobalamin)……………………………………..26 mcg Biotin………………………………………………………………….100 mcg Pantothenic Acid (as Calcium Pantothenate)………………………….....15 mg Calcium (as Calcium Carbonate)………………………………………..100 mg Iron (as Ferrous Fumarate)……………………………………………....18 mg Iodine (as Potassium Iodide)…………………………………………...25 mcg Magnesium (as Magnesium Oxide)……………………………………...50 mg Zinc (as Zinc Citrate)……………………………………………………..30 mg Selenium (as Selenomethionine)….…………………………………….30 mcg Copper (as Copper Oxide)………………………………………………....1 mg Manganese (as Manganese Sulfate)…………………………………...0.75 mg Chromium (as Chromium Polynicotinate)…………………………….37.5 mcg Molybdenum (as Sodium Molybdate)…………………………………..25 mcg Potassium (as Potassium Chloride) ……………………………….…..24.5 mg Boron (as Boron Citrate)……………………………………..…………25 mcg. Other Ingredients: Crospovidone, Dextrin, Dextrose Monohydrate, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake, Magnesium Stearate, Microcrystalline Cellulose, Purified Stearic Acid, Silicon Dioxide, Sodium Carboxymethylcellulose, Titanium Dioxide.</Description>
</NDC>
<NDC>
<NDCCode>59088-009-54</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (59088-009-54) </PackageDescription>
<NDC11Code>59088-0009-54</NDC11Code>
<ProductNDC>59088-009</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prenatol-m</ProprietaryName>
<NonProprietaryName>Multivitamin</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240506</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>CHOLECALCIFEROL; FERROUS FUMARATE; MOLYBDENUM; ASCORBIC ACID; ZINC OXIDE; CHOLINE BITARTRATE; RIBOFLAVIN; MAGNESIUM OXIDE; .ALPHA.-TOCOPHEROL ACETATE, DL-; VITAMIN A ACETATE; SELENIUM; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; CALCIUM CARBONATE; CHROMIUM NICOTINATE; MANGANESE SULFATE; POTASSIUM IODIDE; METHYLCOBALAMIN; LEVOMEFOLATE CALCIUM; THIAMINE MONONITRATE</SubstanceName>
<StrengthNumber>20; 27; 50; 120; 25; 55; 3.4; 200; 13.5; 1500; 70; 20; 50; 200; 45; 2.6; 150; 10; 2040; 3</StrengthNumber>
<StrengthUnit>ug/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; ug/1; ug/1; ug/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Folate Analog [EPC], Folic Acid [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Magnetic Resonance Contrast Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Paramagnetic Contrast Agent [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-05-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240506</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indications and Usage: Prenatol-M is indicated to provide vitamins and minerals to women throughout pregnancy and during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years. Prenatol-M may be beneficial in improving the nutritional status of women prior to conception.</IndicationAndUsage>
<Description>Each caplet contains: Vitamin A (as Retinyl Acetate) ………………....… 1500 mcg RAE Vitamin C (as Ascorbic Acid) ………………….………… 120 mg Vitamin D3 (as Cholecalciferol).……………....... 20 mcg (800 IU) Vitamin E (as Dl-Alpha Tocopheryl Acetate) ….......….…. 13.5 mg Thiamin (as Thiamine Mononitrate) …………...…………… 3 mg Riboflavin ……………………….…………………….…. 3.4 mg Niacin (as Niacinamide) ………………..……………….… 20 mg Vitamin B6 (as Pyridoxine Hydrochloride) …....…………... 50 mg Folate (as L-5-Methyltetrahydrofolate calcium salt) ….... 2040 mcg DFE (1200 mcg as L-5-Methylfolate) Vitamin B12 (as Methylcobalamin) ……….……………... 10 mcg Choline (as Choline Bitartrate) …….……………………… 55 mg Calcium (as Calcium Carbonate) ……...…………………. 200 mg Iron (as Ferrous Fumarate) ………..……………………… 27 mg Iodine (as Potassium Iodine) …...……………………….150 mcg Magnesium (as Magnesium Oxide) …...………………… 200 mg Zinc (as Zinc Oxide) ………………...…………………….. 25 mg Selenium (as Selenium Amino Acid Chelate) ……………. 70 mcg Manganese (as Manganese Sulfate) ……………………… 2.6 mg Chromium (as Chromium Polynicotinate) ……………….. 45 mcg Molybdenum (as Molybdenum Amino Acid Chelate)…...… 50 mcg.</Description>
</NDC>
<NDC>
<NDCCode>59088-013-06</NDCCode>
<PackageDescription>60 g in 1 JAR (59088-013-06) </PackageDescription>
<NDC11Code>59088-0013-06</NDC11Code>
<ProductNDC>59088-013</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Methylten</ProprietaryName>
<NonProprietaryName>Methyl Salicylate 10%</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250113</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>Puretek Corporation</LabelerName>
<SubstanceName>METHYL SALICYLATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-01-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250113</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of minor aches and pains of muscles and joints.</IndicationAndUsage>
</NDC>
</NDCList>