{
"NDC": [
{
"NDCCode": "63479-1827-1",
"PackageDescription": "30 mL in 1 BOTTLE, GLASS (63479-1827-1) ",
"NDC11Code": "63479-1827-01",
"ProductNDC": "63479-1827",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "R27",
"ProprietaryNameSuffix": "Eye",
"NonProprietaryName": "Adenosine Triphosphate, Arsenic Trioxide, Arabica Coffee Bean, Lycopodium Clavatum Spore, Pulsatilla Vulgaris Whole, Datura Stramonium, Bilberry",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "19980515",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Apex Energetics Inc.",
"SubstanceName": "ARSENIC TRIOXIDE; ARABICA COFFEE BEAN; LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS; ADENOSINE TRIPHOSPHATE; DATURA STRAMONIUM; BILBERRY",
"StrengthNumber": "7; 7; 2; 2; 5; 2; 3",
"StrengthUnit": "[hp_C]/mL; [hp_C]/mL; [hp_Q]/mL; [hp_Q]/mL; [hp_X]/mL; [hp_Q]/mL; [hp_C]/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]",
"Status": "Active",
"LastUpdate": "2024-01-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19980515",
"SamplePackage": "N",
"IndicationAndUsage": "For temporary relief of minor. red eyes*. dry eyes*. swollen eyes*. eye pains*. burning eyes*. cloudiness of eyes*. *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."
},
{
"NDCCode": "37662-1827-1",
"PackageDescription": "200 PELLET in 1 VIAL, GLASS (37662-1827-1) ",
"NDC11Code": "37662-1827-01",
"ProductNDC": "37662-1827",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mercurius Sulphuricus",
"NonProprietaryName": "Mercurius Sulphuricus",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20221102",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "MERCURIC SULFATE",
"StrengthNumber": "6",
"StrengthUnit": "[hp_C]/1",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]",
"Status": "Active",
"LastUpdate": "2022-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221102",
"SamplePackage": "N"
},
{
"NDCCode": "37662-1827-2",
"PackageDescription": "1200 PELLET in 1 BOTTLE, GLASS (37662-1827-2) ",
"NDC11Code": "37662-1827-02",
"ProductNDC": "37662-1827",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mercurius Sulphuricus",
"NonProprietaryName": "Mercurius Sulphuricus",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20221102",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "MERCURIC SULFATE",
"StrengthNumber": "6",
"StrengthUnit": "[hp_C]/1",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]",
"Status": "Active",
"LastUpdate": "2022-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221102",
"SamplePackage": "N"
},
{
"NDCCode": "37662-1827-3",
"PackageDescription": "4000 PELLET in 1 BOTTLE, GLASS (37662-1827-3) ",
"NDC11Code": "37662-1827-03",
"ProductNDC": "37662-1827",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mercurius Sulphuricus",
"NonProprietaryName": "Mercurius Sulphuricus",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20221102",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "MERCURIC SULFATE",
"StrengthNumber": "6",
"StrengthUnit": "[hp_C]/1",
"Pharm_Classes": "Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]",
"Status": "Active",
"LastUpdate": "2022-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221102",
"SamplePackage": "N"
},
{
"NDCCode": "43742-1827-1",
"PackageDescription": "960 mL in 1 BOTTLE, PLASTIC (43742-1827-1) ",
"NDC11Code": "43742-1827-01",
"ProductNDC": "43742-1827",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Epstein-barr Virus Nosode",
"DosageFormName": "LIQUID",
"StartMarketingDate": "20201209",
"EndMarketingDate": "20260920",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Deseret Biologicals, Inc.",
"SubstanceName": "HUMAN HERPESVIRUS 4",
"StrengthNumber": "1",
"StrengthUnit": "[hp_M]/mL",
"Status": "Unfinished",
"LastUpdate": "2021-11-19",
"StartMarketingDatePackage": "09-DEC-20",
"EndMarketingDatePackage": "20-SEP-26"
},
{
"NDCCode": "50090-1827-0",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (50090-1827-0)",
"NDC11Code": "50090-1827-00",
"ProductNDC": "50090-1827",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tamsulosin Hydrochloride",
"NonProprietaryName": "Tamsulosin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20130430",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202433",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "TAMSULOSIN HYDROCHLORIDE",
"StrengthNumber": ".4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-01-10",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "50090-1827-1",
"PackageDescription": "90 CAPSULE in 1 BOTTLE (50090-1827-1)",
"NDC11Code": "50090-1827-01",
"ProductNDC": "50090-1827",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tamsulosin Hydrochloride",
"NonProprietaryName": "Tamsulosin Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20130430",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202433",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "TAMSULOSIN HYDROCHLORIDE",
"StrengthNumber": ".4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-01-10",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "50436-1827-1",
"PackageDescription": "100 mL in 1 BOTTLE (50436-1827-1)",
"NDC11Code": "50436-1827-01",
"ProductNDC": "50436-1827",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine Hydrochloride",
"NonProprietaryName": "Lidocaine Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "OROPHARYNGEAL",
"StartMarketingDate": "20070227",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040708",
"LabelerName": "Unit Dose Services",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE ANHYDROUS",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Lidocaine hydrochloride oral topical solution USP, 2% (viscous) is indicated for the production of topical anesthesia of irritated or inflamed mucous membranes of the mouth and pharynx. It is also useful for reducing gagging during the taking of X-ray pictures and dental impressions."
},
{
"NDCCode": "54868-1827-1",
"PackageDescription": "100 mL in 1 BOTTLE, PLASTIC (54868-1827-1)",
"NDC11Code": "54868-1827-01",
"ProductNDC": "54868-1827",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine Hydrochloride",
"NonProprietaryName": "Lidocaine Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL; TOPICAL",
"StartMarketingDate": "20030508",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040014",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% is indicated for the production of topical anesthesia of irritated or inflamed mucous membranes of the mouth and pharynx. It is also useful for reducing gagging during the taking of X-ray pictures and dental impressions.",
"Description": "Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% contains a local anesthetic agent and is administered topically. Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% contains lidocaine hydrochloride, which is chemically designated as acetamide, 2-(diethylamino)-N- (2,6-dimethylphenyl)- , monohydrochloride and has the following structural formula. The molecular formula of lidocaine is C14H22N2O. The molecular weight is 234.34. Each mL contains 20 mg of lidocaine HCl. In addition each mL contains the following inactive ingredients: Carboxymethylcellulose sodium, methylparaben, natural orange flavor, propylparaben, purified water, saccharin sodium. The pH is adjusted to 5.0 to 7.0 by means of hydrochloric acid and/or sodium hydroxide."
},
{
"NDCCode": "55154-1827-0",
"PackageDescription": "10 BLISTER PACK in 1 BAG (55154-1827-0) > 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK",
"NDC11Code": "55154-1827-00",
"ProductNDC": "55154-1827",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cymbalta",
"NonProprietaryName": "Duloxetine Hydrochloride",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20040824",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021427",
"LabelerName": "Cardinal Health",
"SubstanceName": "DULOXETINE HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-12-22",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "61589-1827-1",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (61589-1827-1) > 30 mL in 1 BOTTLE, GLASS",
"NDC11Code": "61589-1827-01",
"ProductNDC": "61589-1827",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "No7 Stay Perfect Foundation Sunscreen Spf 15 Mocha",
"ProprietaryNameSuffix": "60",
"NonProprietaryName": "Octinoxate And Titanium Dioxide",
"DosageFormName": "EMULSION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100316",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "BCM Cosmetique SAS",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE",
"StrengthNumber": "1.5; .48",
"StrengthUnit": "mL/30mL; mL/30mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Directions: 1 Use as a normal foundation, 2 Apply evenly at least 15 minutes before sun exposure, 3 Reapply as needed, 4 Not intended for children under the age of 12, 5 Not intended for protection while sunbathing."
},
{
"NDCCode": "64942-1827-1",
"PackageDescription": "59 mL in 1 CONTAINER (64942-1827-1) ",
"NDC11Code": "64942-1827-01",
"ProductNDC": "64942-1827",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Find Your Happy Place",
"NonProprietaryName": "Catching The Sunrise Hand Sanitizer",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210215",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Conopco Inc. d/b/a/ Unilever",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "700",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2024-11-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210215",
"SamplePackage": "N",
"IndicationAndUsage": "Hand sanitizer to help reduce bacteria on the skin.",
"Description": "Find Your Happy Place Catching the Sunrise Hand Sanitizer."
},
{
"NDCCode": "67296-1827-5",
"PackageDescription": "5 TABLET in 1 BOTTLE (67296-1827-5) ",
"NDC11Code": "67296-1827-05",
"ProductNDC": "67296-1827",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prednisone",
"NonProprietaryName": "Prednisone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20181204",
"EndMarketingDate": "20230430",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210525",
"LabelerName": "Redpharm Drug, Inc.",
"SubstanceName": "PREDNISONE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-05-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20181204",
"EndMarketingDatePackage": "20230430",
"SamplePackage": "N"
},
{
"NDCCode": "68071-1827-1",
"PackageDescription": "100 TABLET in 1 BOTTLE (68071-1827-1)",
"NDC11Code": "68071-1827-01",
"ProductNDC": "68071-1827",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ibu",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20081120",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075682",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-10-25",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "70518-1827-0",
"PackageDescription": "30 TABLET, FILM COATED in 1 BLISTER PACK (70518-1827-0) ",
"NDC11Code": "70518-1827-00",
"ProductNDC": "70518-1827",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190126",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078154",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-09-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20190126",
"SamplePackage": "N",
"IndicationAndUsage": "Levetiracetam tablets USP are indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1). Levetiracetam tablets USP are indicated for adjunctive therapy for treatment of: 1 Partial onset seizures in patients one month of age and older with epilepsy ( 1.1) , 2 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy ( 1.2) , 3 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy ( 1.3) .",
"Description": "Levetiracetam USP is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white) tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8H 14N 2O 2and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula:. Levetiracetam USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent). Levetiracetam tablets USP contain the labeled amount of levetiracetam. For 250 mg, 500 mg and 750 mg strengths. Inactive ingredients: colloidal silicon dioxide, corn starch, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, talc, titanium dioxide, and additional agents listed below. 250 mg tablets: FD&C Blue No. 2/indigo carmine Aluminum Lake. 500 mg tablets: Yellow Iron Oxide. 750 mg tablets: FD&C Blue No. 2/indigo carmine Aluminum Lake, FD&C Yellow No. 6/sunset yellow FCF Aluminum Lake, iron oxide red. For 1000 mg strength. Inactive ingredients: colloidal silicon dioxide, corn starch, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, talc and titanium dioxide."
},
{
"NDCCode": "70771-1827-1",
"PackageDescription": "100 TABLET in 1 BOTTLE (70771-1827-1) ",
"NDC11Code": "70771-1827-01",
"ProductNDC": "70771-1827",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Acetazolamide",
"NonProprietaryName": "Acetazolamide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230715",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211069",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "ACETAZOLAMIDE",
"StrengthNumber": "125",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA], Sulfonamides [CS]",
"Status": "Active",
"LastUpdate": "2025-11-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230715",
"SamplePackage": "N",
"IndicationAndUsage": "For adjunctive treatment of: edema due to congestive heart failure; drug-induced edema; centrencephalic epilepsies (petit mal, unlocalized seizures); chronic simple (open-angle) glaucoma, secondary glaucoma, and preoperatively in acute angle-closure glaucoma where delay of surgery is desired in order to lower intraocular pressure. Acetazolamide Tablets are also indicated for the prevention or amelioration of symptoms associated with acute mountain sickness in climbers attempting rapid ascent and in those who are very susceptible to acute mountain sickness despite gradual ascent.",
"Description": "Acetazolamide, an inhibitor of the enzyme carbonic anhydrase is a white to faintly yellowish white crystalline, odorless powder, weakly acidic, very slightly soluble in water and slightly soluble in alcohol. The chemical name for acetazolamide is N-(5-Sulfamoyl-1,3,4-thiadiazol-2-yl)-acetamide and has the following chemical structure. Molecular Weight: 222.25. Molecular Formula: C4H6N4O3S2. Acetazolamide is available as oral tablets containing 125 mg and 250 mg of acetazolamide, respectively, and the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate, povidone and sodium starch glycolate."
},
{
"NDCCode": "71335-1827-1",
"PackageDescription": "30 TABLET in 1 BOTTLE (71335-1827-1) ",
"NDC11Code": "71335-1827-01",
"ProductNDC": "71335-1827",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levothyroxine Sodium",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20201125",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212399",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": "75",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210614",
"SamplePackage": "N",
"IndicationAndUsage": "Hypothyroidism. Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid‑Stimulating Hormone, TSH) Suppression. Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: 1 Levothyroxine sodium tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with levothyroxine sodium may induce hyperthyroidism [see Warnings and Precautions(5.1)]. , 2 Levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.",
"Description": "Levothyroxine sodium tablets, USP is L-thyroxine (T4) and contains synthetic crystalline L-3,3’,5,5’-tetraiodothyronine sodium salt. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C 15H 10I 4N NaO 4 H 2O, molecular weight of 798.86 (anhydrous), and structural formula as shown:. Levothyroxine sodium tablets, USP for oral administration are supplied in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each levothyroxine sodium tablet contains the inactive ingredients microcrystalline sodium, light magnesium oxide, sodium starch glycolate and sodium stearyl fumarate. Levothyroxine sodium tablets, USP contain no ingredients made from a gluten-containing grain (wheat, barley, or rye). Table 9 provides a listing of the color additives by tablet strength. Levothyroxine sodium tablets, USP meets USP Dissolution Test 7."
},
{
"NDCCode": "71335-1827-2",
"PackageDescription": "100 TABLET in 1 BOTTLE (71335-1827-2) ",
"NDC11Code": "71335-1827-02",
"ProductNDC": "71335-1827",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levothyroxine Sodium",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20201125",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212399",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": "75",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220314",
"SamplePackage": "N",
"IndicationAndUsage": "Hypothyroidism. Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid‑Stimulating Hormone, TSH) Suppression. Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: 1 Levothyroxine sodium tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with levothyroxine sodium may induce hyperthyroidism [see Warnings and Precautions(5.1)]. , 2 Levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.",
"Description": "Levothyroxine sodium tablets, USP is L-thyroxine (T4) and contains synthetic crystalline L-3,3’,5,5’-tetraiodothyronine sodium salt. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C 15H 10I 4N NaO 4 H 2O, molecular weight of 798.86 (anhydrous), and structural formula as shown:. Levothyroxine sodium tablets, USP for oral administration are supplied in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each levothyroxine sodium tablet contains the inactive ingredients microcrystalline sodium, light magnesium oxide, sodium starch glycolate and sodium stearyl fumarate. Levothyroxine sodium tablets, USP contain no ingredients made from a gluten-containing grain (wheat, barley, or rye). Table 9 provides a listing of the color additives by tablet strength. Levothyroxine sodium tablets, USP meets USP Dissolution Test 7."
},
{
"NDCCode": "71335-1827-3",
"PackageDescription": "60 TABLET in 1 BOTTLE (71335-1827-3) ",
"NDC11Code": "71335-1827-03",
"ProductNDC": "71335-1827",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levothyroxine Sodium",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20201125",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212399",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": "75",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241211",
"SamplePackage": "N",
"IndicationAndUsage": "Hypothyroidism. Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid‑Stimulating Hormone, TSH) Suppression. Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: 1 Levothyroxine sodium tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with levothyroxine sodium may induce hyperthyroidism [see Warnings and Precautions(5.1)]. , 2 Levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.",
"Description": "Levothyroxine sodium tablets, USP is L-thyroxine (T4) and contains synthetic crystalline L-3,3’,5,5’-tetraiodothyronine sodium salt. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C 15H 10I 4N NaO 4 H 2O, molecular weight of 798.86 (anhydrous), and structural formula as shown:. Levothyroxine sodium tablets, USP for oral administration are supplied in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each levothyroxine sodium tablet contains the inactive ingredients microcrystalline sodium, light magnesium oxide, sodium starch glycolate and sodium stearyl fumarate. Levothyroxine sodium tablets, USP contain no ingredients made from a gluten-containing grain (wheat, barley, or rye). Table 9 provides a listing of the color additives by tablet strength. Levothyroxine sodium tablets, USP meets USP Dissolution Test 7."
},
{
"NDCCode": "71335-1827-4",
"PackageDescription": "90 TABLET in 1 BOTTLE (71335-1827-4) ",
"NDC11Code": "71335-1827-04",
"ProductNDC": "71335-1827",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levothyroxine Sodium",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20201125",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212399",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": "75",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210409",
"SamplePackage": "N",
"IndicationAndUsage": "Hypothyroidism. Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid‑Stimulating Hormone, TSH) Suppression. Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: 1 Levothyroxine sodium tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with levothyroxine sodium may induce hyperthyroidism [see Warnings and Precautions(5.1)]. , 2 Levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.",
"Description": "Levothyroxine sodium tablets, USP is L-thyroxine (T4) and contains synthetic crystalline L-3,3’,5,5’-tetraiodothyronine sodium salt. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C 15H 10I 4N NaO 4 H 2O, molecular weight of 798.86 (anhydrous), and structural formula as shown:. Levothyroxine sodium tablets, USP for oral administration are supplied in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each levothyroxine sodium tablet contains the inactive ingredients microcrystalline sodium, light magnesium oxide, sodium starch glycolate and sodium stearyl fumarate. Levothyroxine sodium tablets, USP contain no ingredients made from a gluten-containing grain (wheat, barley, or rye). Table 9 provides a listing of the color additives by tablet strength. Levothyroxine sodium tablets, USP meets USP Dissolution Test 7."
},
{
"NDCCode": "71335-1827-5",
"PackageDescription": "28 TABLET in 1 BOTTLE (71335-1827-5) ",
"NDC11Code": "71335-1827-05",
"ProductNDC": "71335-1827",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levothyroxine Sodium",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20201125",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212399",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": "75",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241211",
"SamplePackage": "N",
"IndicationAndUsage": "Hypothyroidism. Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid‑Stimulating Hormone, TSH) Suppression. Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: 1 Levothyroxine sodium tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with levothyroxine sodium may induce hyperthyroidism [see Warnings and Precautions(5.1)]. , 2 Levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.",
"Description": "Levothyroxine sodium tablets, USP is L-thyroxine (T4) and contains synthetic crystalline L-3,3’,5,5’-tetraiodothyronine sodium salt. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C 15H 10I 4N NaO 4 H 2O, molecular weight of 798.86 (anhydrous), and structural formula as shown:. Levothyroxine sodium tablets, USP for oral administration are supplied in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each levothyroxine sodium tablet contains the inactive ingredients microcrystalline sodium, light magnesium oxide, sodium starch glycolate and sodium stearyl fumarate. Levothyroxine sodium tablets, USP contain no ingredients made from a gluten-containing grain (wheat, barley, or rye). Table 9 provides a listing of the color additives by tablet strength. Levothyroxine sodium tablets, USP meets USP Dissolution Test 7."
},
{
"NDCCode": "71335-1827-6",
"PackageDescription": "10 TABLET in 1 BOTTLE (71335-1827-6) ",
"NDC11Code": "71335-1827-06",
"ProductNDC": "71335-1827",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levothyroxine Sodium",
"NonProprietaryName": "Levothyroxine Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20201125",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212399",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "LEVOTHYROXINE SODIUM",
"StrengthNumber": "75",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Thyroxine [CS], l-Thyroxine [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241211",
"SamplePackage": "N",
"IndicationAndUsage": "Hypothyroidism. Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid‑Stimulating Hormone, TSH) Suppression. Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: 1 Levothyroxine sodium tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with levothyroxine sodium may induce hyperthyroidism [see Warnings and Precautions(5.1)]. , 2 Levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.",
"Description": "Levothyroxine sodium tablets, USP is L-thyroxine (T4) and contains synthetic crystalline L-3,3’,5,5’-tetraiodothyronine sodium salt. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C 15H 10I 4N NaO 4 H 2O, molecular weight of 798.86 (anhydrous), and structural formula as shown:. Levothyroxine sodium tablets, USP for oral administration are supplied in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each levothyroxine sodium tablet contains the inactive ingredients microcrystalline sodium, light magnesium oxide, sodium starch glycolate and sodium stearyl fumarate. Levothyroxine sodium tablets, USP contain no ingredients made from a gluten-containing grain (wheat, barley, or rye). Table 9 provides a listing of the color additives by tablet strength. Levothyroxine sodium tablets, USP meets USP Dissolution Test 7."
},
{
"NDCCode": "72162-1827-3",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (72162-1827-3) ",
"NDC11Code": "72162-1827-03",
"ProductNDC": "72162-1827",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Temazepam",
"NonProprietaryName": "Temazepam",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20120628",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071457",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "TEMAZEPAM",
"StrengthNumber": "22.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2025-10-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240307",
"SamplePackage": "N",
"IndicationAndUsage": "Temazepam Capsules, USP are indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that Temazepam Capsules should be used for short periods of time (7 to 10 days). The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.",
"Description": "Temazepam is a benzodiazepine hypnotic agent. The chemical name is 7-chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1, 4-benzodiazepin-2-one, and the structural formula is. C16H13ClN2O2 MW = 300.74. Temazepam is a white, crystalline substance, very slightly soluble in water and sparingly soluble in alcohol USP. Temazepam capsules, 7.5 mg, 15 mg, 22.5 mg and 30 mg, are for oral administration.7.5 mg, 15 mg, 22.5 mg and 30 mg CapsulesActive Ingredient: temazepam USP7.5 mg Capsules Inactive Ingredients: Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Red #40 and titanium dioxide. May also include: sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 15 mg Capsules. Inactive Ingredients: Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Blue #1, FD&C yellow # 6, gelatin and titanium dioxide. May also include: sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 22.5 mg Capsules. Inactive Ingredients: Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Blue #1, FD&C Red #40, gelatin and titanium dioxide. May also include: sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 30 mg Capsules. Inactive Ingredients: Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, gelatin and titanium dioxide. May also include: sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide."
},
{
"NDCCode": "63479-0101-1",
"PackageDescription": "30 mL in 1 BOTTLE, GLASS (63479-0101-1) ",
"NDC11Code": "63479-0101-01",
"ProductNDC": "63479-0101",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "A01",
"ProprietaryNameSuffix": "Cellular Recharge",
"NonProprietaryName": "Aceticum Acidum, Arnica Montana, Avena Sativa, Calcarea Carbonica, Calcarea Phosphorica, Calcarea Sulphurica, Ceanothus Americanus, Ceratostigma Illmottianum, Chininum Arsenicosum, Citricum Acidum, English Elm, European Hornbeam, European Olive, Gentianella Amarella, Hydrofluoricum Acidum, Juglans Regia, Lacticum Acidum, Magnesia Phosphorica, Natrum Muriaticum, Natrum Phosphoricum, Natrum Silicofluoricum, Natrum Sulphuricum, Passiflora Incarnata, Phosphoricum Acidum, Sarcolacticum Acidum, Solidago Virgaurea",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "19941215",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Apex Energetics Inc.",
"SubstanceName": "CALCIUM SULFATE ANHYDROUS; CERATOSTIGMA WILLMOTTIANUM FLOWER; LACTIC ACID, L-; ARNICA MONTANA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; ANHYDROUS CITRIC ACID; OLEA EUROPAEA FLOWER; GENTIANELLA AMARELLA FLOWER; ULMUS PROCERA FLOWERING TWIG; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; PHOSPHORIC ACID; CARPINUS BETULUS FLOWER; SOLIDAGO VIRGAUREA FLOWERING TOP; ACETIC ACID; AVENA SATIVA FLOWERING TOP; SODIUM CHLORIDE; TRIBASIC CALCIUM PHOSPHATE; CEANOTHUS AMERICANUS LEAF; SODIUM HEXAFLUOROSILICATE; QUININE ARSENITE; HYDROFLUORIC ACID; JUGLANS REGIA FLOWERING TOP; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM SULFATE; PASSIFLORA INCARNATA FLOWERING TOP; LACTIC ACID, DL-",
"StrengthNumber": "12; 12; 15; 12; 15; 30; 12; 12; 12; 12; 30; 9; 1; 30; 1; 30; 15; 4; 8; 15; 30; 9; 15; 10; 1; 15",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Acidifying Activity [MoA], Anti-coagulant [EPC], Antimalarial [EPC], Blood Coagulation Factor [EPC], Calcium Chelating Activity [MoA], Calcium [CS], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Decreased Coagulation Factor Activity [PE], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2024-01-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19941215",
"SamplePackage": "N",
"IndicationAndUsage": "For temporary relief of minor. fatigue*. irritability*. cramps*. exhaustion*. restlessness*. *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated."
},
{
"NDCCode": "63479-0102-1",
"PackageDescription": "30 mL in 1 BOTTLE, GLASS (63479-0102-1) ",
"NDC11Code": "63479-0102-01",
"ProductNDC": "63479-0102",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "A02",
"ProprietaryNameSuffix": "Gentle Drainage",
"NonProprietaryName": "Alfalfa, Allium Sativum, American Ginseng, Asparagus Officinalis, Avena Sativa, Berberis Vulgaris, Bos Taurus Adrenal Gland, Colon, Kidney, Liver, Lymph Vessel, Pancreas, Calcarea Phosphorica, Carbo Vegetabilis, Crab Apple Flower, European Hornbeam Flower, Gentiana Lutea, Histaminum Hydrochloricum, Juniperus Communis Stem, Lacticum Acidum, Passiflora Incarnata, Phosphorus, Ribes Nigrum Flower Bud, Scrophularia Nodosa, Solidago Virgaurea",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "19880815",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Apex Energetics Inc.",
"SubstanceName": "ACTIVATED CHARCOAL; GENTIANA LUTEA ROOT; SCROPHULARIA NODOSA; SOLIDAGO VIRGAUREA FLOWERING TOP; ALFALFA; MALUS SYLVESTRIS FLOWER; BOS TAURUS ADRENAL GLAND; CARPINUS BETULUS FLOWER; AVENA SATIVA FLOWERING TOP; BEEF KIDNEY; LACTIC ACID, DL-; PHOSPHORUS; RIBES NIGRUM FLOWER BUD; ASPARAGUS; GARLIC; AMERICAN GINSENG; HISTAMINE DIHYDROCHLORIDE; JUNIPERUS COMMUNIS STEM; PASSIFLORA INCARNATA FLOWERING TOP; BERBERIS VULGARIS ROOT BARK; BOS TAURUS COLON; BEEF LIVER; BOS TAURUS LYMPH VESSEL; BOS TAURUS PANCREAS; TRIBASIC CALCIUM PHOSPHATE",
"StrengthNumber": "15; 6; 10; 9; 6; 12; 7; 12; 6; 7; 12; 12; 6; 9; 9; 9; 6; 8; 9; 12; 7; 7; 7; 7; 15",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Meat Proteins [EXT], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Plant Proteins [CS], Vegetable Proteins [CS]",
"Status": "Active",
"LastUpdate": "2024-01-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19880815",
"SamplePackage": "N"
},
{
"NDCCode": "63479-0103-1",
"PackageDescription": "30 mL in 1 BOTTLE, GLASS (63479-0103-1) ",
"NDC11Code": "63479-0103-01",
"ProductNDC": "63479-0103",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "A03",
"ProprietaryNameSuffix": "Ultra Antitox",
"NonProprietaryName": "Alfalfa, American Ginseng, Apis Mellifica, Asparagus Officinalis, Avena Sativa, Baryta Iodata, Berberis Vulgaris, Bryonia, Carduus Marianus, Chamomilla, Chelidonium Majus, Conium Maculatum, Ferrum Iodatum, Lapis Albus, Lycopodium Clavatum, Natrum Carbonicum, Passiflora Incarnata, Scrophularia Nodosa, Solidago Virgaurea, Taraxacum Officinale, Uva Ursi",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "19941215",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Apex Energetics Inc.",
"SubstanceName": "BRYONIA ALBA ROOT; APIS MELLIFERA; ASPARAGUS; AVENA SATIVA FLOWERING TOP; ALFALFA; AMERICAN GINSENG; FERROUS IODIDE; SODIUM CARBONATE; BARIUM IODIDE; PASSIFLORA INCARNATA FLOWERING TOP; CONIUM MACULATUM FLOWERING TOP; LYCOPODIUM CLAVATUM SPORE; SCROPHULARIA NODOSA; TARAXACUM OFFICINALE; CALCIUM HEXAFLUOROSILICATE; ARCTOSTAPHYLOS UVA-URSI LEAF; MATRICARIA CHAMOMILLA; SOLIDAGO VIRGAUREA FLOWERING TOP; BERBERIS VULGARIS ROOT BARK; MILK THISTLE; CHELIDONIUM MAJUS",
"StrengthNumber": "15; 6; 2; 1; 1; 2; 12; 6; 12; 1; 12; 6; 3; 1; 15; 1; 1; 1; 1; 1; 1",
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{
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20130430</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202433</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>TAMSULOSIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Antagonists [MoA],alpha-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-01-10</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>50436-1827-1</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE (50436-1827-1)</PackageDescription>
<NDC11Code>50436-1827-01</NDC11Code>
<ProductNDC>50436-1827</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine Hydrochloride</ProprietaryName>
<NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>OROPHARYNGEAL</RouteName>
<StartMarketingDate>20070227</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040708</ApplicationNumber>
<LabelerName>Unit Dose Services</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE ANHYDROUS</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Lidocaine hydrochloride oral topical solution USP, 2% (viscous) is indicated for the production of topical anesthesia of irritated or inflamed mucous membranes of the mouth and pharynx. It is also useful for reducing gagging during the taking of X-ray pictures and dental impressions.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>54868-1827-1</NDCCode>
<PackageDescription>100 mL in 1 BOTTLE, PLASTIC (54868-1827-1)</PackageDescription>
<NDC11Code>54868-1827-01</NDC11Code>
<ProductNDC>54868-1827</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine Hydrochloride</ProprietaryName>
<NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL; TOPICAL</RouteName>
<StartMarketingDate>20030508</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040014</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% is indicated for the production of topical anesthesia of irritated or inflamed mucous membranes of the mouth and pharynx. It is also useful for reducing gagging during the taking of X-ray pictures and dental impressions.</IndicationAndUsage>
<Description>Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% contains a local anesthetic agent and is administered topically. Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% contains lidocaine hydrochloride, which is chemically designated as acetamide, 2-(diethylamino)-N- (2,6-dimethylphenyl)- , monohydrochloride and has the following structural formula. The molecular formula of lidocaine is C14H22N2O. The molecular weight is 234.34. Each mL contains 20 mg of lidocaine HCl. In addition each mL contains the following inactive ingredients: Carboxymethylcellulose sodium, methylparaben, natural orange flavor, propylparaben, purified water, saccharin sodium. The pH is adjusted to 5.0 to 7.0 by means of hydrochloric acid and/or sodium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>55154-1827-0</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 BAG (55154-1827-0) > 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>55154-1827-00</NDC11Code>
<ProductNDC>55154-1827</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cymbalta</ProprietaryName>
<NonProprietaryName>Duloxetine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040824</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021427</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>60</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-12-22</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>61589-1827-1</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (61589-1827-1) > 30 mL in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>61589-1827-01</NDC11Code>
<ProductNDC>61589-1827</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>No7 Stay Perfect Foundation Sunscreen Spf 15 Mocha</ProprietaryName>
<ProprietaryNameSuffix>60</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate And Titanium Dioxide</NonProprietaryName>
<DosageFormName>EMULSION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100316</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>BCM Cosmetique SAS</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>1.5; .48</StrengthNumber>
<StrengthUnit>mL/30mL; mL/30mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Directions: 1 Use as a normal foundation, 2 Apply evenly at least 15 minutes before sun exposure, 3 Reapply as needed, 4 Not intended for children under the age of 12, 5 Not intended for protection while sunbathing.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>64942-1827-1</NDCCode>
<PackageDescription>59 mL in 1 CONTAINER (64942-1827-1) </PackageDescription>
<NDC11Code>64942-1827-01</NDC11Code>
<ProductNDC>64942-1827</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Find Your Happy Place</ProprietaryName>
<NonProprietaryName>Catching The Sunrise Hand Sanitizer</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210215</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Conopco Inc. d/b/a/ Unilever</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>700</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-11-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand sanitizer to help reduce bacteria on the skin.</IndicationAndUsage>
<Description>Find Your Happy Place Catching the Sunrise Hand Sanitizer.</Description>
</NDC>
<NDC>
<NDCCode>67296-1827-5</NDCCode>
<PackageDescription>5 TABLET in 1 BOTTLE (67296-1827-5) </PackageDescription>
<NDC11Code>67296-1827-05</NDC11Code>
<ProductNDC>67296-1827</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prednisone</ProprietaryName>
<NonProprietaryName>Prednisone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181204</StartMarketingDate>
<EndMarketingDate>20230430</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210525</ApplicationNumber>
<LabelerName>Redpharm Drug, Inc.</LabelerName>
<SubstanceName>PREDNISONE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-05-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20181204</StartMarketingDatePackage>
<EndMarketingDatePackage>20230430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>68071-1827-1</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (68071-1827-1)</PackageDescription>
<NDC11Code>68071-1827-01</NDC11Code>
<ProductNDC>68071-1827</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ibu</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20081120</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075682</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-10-25</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>70518-1827-0</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BLISTER PACK (70518-1827-0) </PackageDescription>
<NDC11Code>70518-1827-00</NDC11Code>
<ProductNDC>70518-1827</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190126</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078154</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-09-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190126</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levetiracetam tablets USP are indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1). Levetiracetam tablets USP are indicated for adjunctive therapy for treatment of: 1 Partial onset seizures in patients one month of age and older with epilepsy ( 1.1) , 2 Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy ( 1.2) , 3 Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy ( 1.3) .</IndicationAndUsage>
<Description>Levetiracetam USP is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white) tablets for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C 8H 14N 2O 2and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula:. Levetiracetam USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent). Levetiracetam tablets USP contain the labeled amount of levetiracetam. For 250 mg, 500 mg and 750 mg strengths. Inactive ingredients: colloidal silicon dioxide, corn starch, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, talc, titanium dioxide, and additional agents listed below. 250 mg tablets: FD&C Blue No. 2/indigo carmine Aluminum Lake. 500 mg tablets: Yellow Iron Oxide. 750 mg tablets: FD&C Blue No. 2/indigo carmine Aluminum Lake, FD&C Yellow No. 6/sunset yellow FCF Aluminum Lake, iron oxide red. For 1000 mg strength. Inactive ingredients: colloidal silicon dioxide, corn starch, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>70771-1827-1</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (70771-1827-1) </PackageDescription>
<NDC11Code>70771-1827-01</NDC11Code>
<ProductNDC>70771-1827</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Acetazolamide</ProprietaryName>
<NonProprietaryName>Acetazolamide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230715</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211069</ApplicationNumber>
<LabelerName>Zydus Lifesciences Limited</LabelerName>
<SubstanceName>ACETAZOLAMIDE</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA], Sulfonamides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230715</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For adjunctive treatment of: edema due to congestive heart failure; drug-induced edema; centrencephalic epilepsies (petit mal, unlocalized seizures); chronic simple (open-angle) glaucoma, secondary glaucoma, and preoperatively in acute angle-closure glaucoma where delay of surgery is desired in order to lower intraocular pressure. Acetazolamide Tablets are also indicated for the prevention or amelioration of symptoms associated with acute mountain sickness in climbers attempting rapid ascent and in those who are very susceptible to acute mountain sickness despite gradual ascent.</IndicationAndUsage>
<Description>Acetazolamide, an inhibitor of the enzyme carbonic anhydrase is a white to faintly yellowish white crystalline, odorless powder, weakly acidic, very slightly soluble in water and slightly soluble in alcohol. The chemical name for acetazolamide is N-(5-Sulfamoyl-1,3,4-thiadiazol-2-yl)-acetamide and has the following chemical structure. Molecular Weight: 222.25. Molecular Formula: C4H6N4O3S2. Acetazolamide is available as oral tablets containing 125 mg and 250 mg of acetazolamide, respectively, and the following inactive ingredients: corn starch, lactose monohydrate, magnesium stearate, povidone and sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>71335-1827-1</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (71335-1827-1) </PackageDescription>
<NDC11Code>71335-1827-01</NDC11Code>
<ProductNDC>71335-1827</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levothyroxine Sodium</ProprietaryName>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201125</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212399</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Thyroxine [CS], l-Thyroxine [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210614</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hypothyroidism. Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid‑Stimulating Hormone, TSH) Suppression. Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: 1 Levothyroxine sodium tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with levothyroxine sodium may induce hyperthyroidism [see Warnings and Precautions(5.1)]. , 2 Levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.</IndicationAndUsage>
<Description>Levothyroxine sodium tablets, USP is L-thyroxine (T4) and contains synthetic crystalline L-3,3’,5,5’-tetraiodothyronine sodium salt. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C 15H 10I 4N NaO 4 H 2O, molecular weight of 798.86 (anhydrous), and structural formula as shown:. Levothyroxine sodium tablets, USP for oral administration are supplied in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each levothyroxine sodium tablet contains the inactive ingredients microcrystalline sodium, light magnesium oxide, sodium starch glycolate and sodium stearyl fumarate. Levothyroxine sodium tablets, USP contain no ingredients made from a gluten-containing grain (wheat, barley, or rye). Table 9 provides a listing of the color additives by tablet strength. Levothyroxine sodium tablets, USP meets USP Dissolution Test 7.</Description>
</NDC>
<NDC>
<NDCCode>71335-1827-2</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (71335-1827-2) </PackageDescription>
<NDC11Code>71335-1827-02</NDC11Code>
<ProductNDC>71335-1827</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levothyroxine Sodium</ProprietaryName>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201125</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212399</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Thyroxine [CS], l-Thyroxine [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220314</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hypothyroidism. Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid‑Stimulating Hormone, TSH) Suppression. Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: 1 Levothyroxine sodium tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with levothyroxine sodium may induce hyperthyroidism [see Warnings and Precautions(5.1)]. , 2 Levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.</IndicationAndUsage>
<Description>Levothyroxine sodium tablets, USP is L-thyroxine (T4) and contains synthetic crystalline L-3,3’,5,5’-tetraiodothyronine sodium salt. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C 15H 10I 4N NaO 4 H 2O, molecular weight of 798.86 (anhydrous), and structural formula as shown:. Levothyroxine sodium tablets, USP for oral administration are supplied in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each levothyroxine sodium tablet contains the inactive ingredients microcrystalline sodium, light magnesium oxide, sodium starch glycolate and sodium stearyl fumarate. Levothyroxine sodium tablets, USP contain no ingredients made from a gluten-containing grain (wheat, barley, or rye). Table 9 provides a listing of the color additives by tablet strength. Levothyroxine sodium tablets, USP meets USP Dissolution Test 7.</Description>
</NDC>
<NDC>
<NDCCode>71335-1827-3</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (71335-1827-3) </PackageDescription>
<NDC11Code>71335-1827-03</NDC11Code>
<ProductNDC>71335-1827</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levothyroxine Sodium</ProprietaryName>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201125</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212399</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Thyroxine [CS], l-Thyroxine [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hypothyroidism. Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid‑Stimulating Hormone, TSH) Suppression. Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: 1 Levothyroxine sodium tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with levothyroxine sodium may induce hyperthyroidism [see Warnings and Precautions(5.1)]. , 2 Levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.</IndicationAndUsage>
<Description>Levothyroxine sodium tablets, USP is L-thyroxine (T4) and contains synthetic crystalline L-3,3’,5,5’-tetraiodothyronine sodium salt. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C 15H 10I 4N NaO 4 H 2O, molecular weight of 798.86 (anhydrous), and structural formula as shown:. Levothyroxine sodium tablets, USP for oral administration are supplied in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each levothyroxine sodium tablet contains the inactive ingredients microcrystalline sodium, light magnesium oxide, sodium starch glycolate and sodium stearyl fumarate. Levothyroxine sodium tablets, USP contain no ingredients made from a gluten-containing grain (wheat, barley, or rye). Table 9 provides a listing of the color additives by tablet strength. Levothyroxine sodium tablets, USP meets USP Dissolution Test 7.</Description>
</NDC>
<NDC>
<NDCCode>71335-1827-4</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (71335-1827-4) </PackageDescription>
<NDC11Code>71335-1827-04</NDC11Code>
<ProductNDC>71335-1827</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levothyroxine Sodium</ProprietaryName>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201125</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212399</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Thyroxine [CS], l-Thyroxine [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210409</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hypothyroidism. Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid‑Stimulating Hormone, TSH) Suppression. Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: 1 Levothyroxine sodium tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with levothyroxine sodium may induce hyperthyroidism [see Warnings and Precautions(5.1)]. , 2 Levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.</IndicationAndUsage>
<Description>Levothyroxine sodium tablets, USP is L-thyroxine (T4) and contains synthetic crystalline L-3,3’,5,5’-tetraiodothyronine sodium salt. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C 15H 10I 4N NaO 4 H 2O, molecular weight of 798.86 (anhydrous), and structural formula as shown:. Levothyroxine sodium tablets, USP for oral administration are supplied in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each levothyroxine sodium tablet contains the inactive ingredients microcrystalline sodium, light magnesium oxide, sodium starch glycolate and sodium stearyl fumarate. Levothyroxine sodium tablets, USP contain no ingredients made from a gluten-containing grain (wheat, barley, or rye). Table 9 provides a listing of the color additives by tablet strength. Levothyroxine sodium tablets, USP meets USP Dissolution Test 7.</Description>
</NDC>
<NDC>
<NDCCode>71335-1827-5</NDCCode>
<PackageDescription>28 TABLET in 1 BOTTLE (71335-1827-5) </PackageDescription>
<NDC11Code>71335-1827-05</NDC11Code>
<ProductNDC>71335-1827</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levothyroxine Sodium</ProprietaryName>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201125</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212399</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Thyroxine [CS], l-Thyroxine [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hypothyroidism. Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid‑Stimulating Hormone, TSH) Suppression. Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: 1 Levothyroxine sodium tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with levothyroxine sodium may induce hyperthyroidism [see Warnings and Precautions(5.1)]. , 2 Levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.</IndicationAndUsage>
<Description>Levothyroxine sodium tablets, USP is L-thyroxine (T4) and contains synthetic crystalline L-3,3’,5,5’-tetraiodothyronine sodium salt. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C 15H 10I 4N NaO 4 H 2O, molecular weight of 798.86 (anhydrous), and structural formula as shown:. Levothyroxine sodium tablets, USP for oral administration are supplied in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each levothyroxine sodium tablet contains the inactive ingredients microcrystalline sodium, light magnesium oxide, sodium starch glycolate and sodium stearyl fumarate. Levothyroxine sodium tablets, USP contain no ingredients made from a gluten-containing grain (wheat, barley, or rye). Table 9 provides a listing of the color additives by tablet strength. Levothyroxine sodium tablets, USP meets USP Dissolution Test 7.</Description>
</NDC>
<NDC>
<NDCCode>71335-1827-6</NDCCode>
<PackageDescription>10 TABLET in 1 BOTTLE (71335-1827-6) </PackageDescription>
<NDC11Code>71335-1827-06</NDC11Code>
<ProductNDC>71335-1827</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levothyroxine Sodium</ProprietaryName>
<NonProprietaryName>Levothyroxine Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201125</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212399</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>LEVOTHYROXINE SODIUM</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Thyroxine [CS], l-Thyroxine [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hypothyroidism. Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid‑Stimulating Hormone, TSH) Suppression. Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Limitations of Use: 1 Levothyroxine sodium tablets are not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with levothyroxine sodium may induce hyperthyroidism [see Warnings and Precautions(5.1)]. , 2 Levothyroxine sodium tablets are not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis.</IndicationAndUsage>
<Description>Levothyroxine sodium tablets, USP is L-thyroxine (T4) and contains synthetic crystalline L-3,3’,5,5’-tetraiodothyronine sodium salt. Synthetic T4 is chemically identical to that produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C 15H 10I 4N NaO 4 H 2O, molecular weight of 798.86 (anhydrous), and structural formula as shown:. Levothyroxine sodium tablets, USP for oral administration are supplied in the following strengths: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Each levothyroxine sodium tablet contains the inactive ingredients microcrystalline sodium, light magnesium oxide, sodium starch glycolate and sodium stearyl fumarate. Levothyroxine sodium tablets, USP contain no ingredients made from a gluten-containing grain (wheat, barley, or rye). Table 9 provides a listing of the color additives by tablet strength. Levothyroxine sodium tablets, USP meets USP Dissolution Test 7.</Description>
</NDC>
<NDC>
<NDCCode>72162-1827-3</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (72162-1827-3) </PackageDescription>
<NDC11Code>72162-1827-03</NDC11Code>
<ProductNDC>72162-1827</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Temazepam</ProprietaryName>
<NonProprietaryName>Temazepam</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120628</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071457</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>TEMAZEPAM</SubstanceName>
<StrengthNumber>22.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-10-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240307</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temazepam Capsules, USP are indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that Temazepam Capsules should be used for short periods of time (7 to 10 days). The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.</IndicationAndUsage>
<Description>Temazepam is a benzodiazepine hypnotic agent. The chemical name is 7-chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-2H-1, 4-benzodiazepin-2-one, and the structural formula is. C16H13ClN2O2 MW = 300.74. Temazepam is a white, crystalline substance, very slightly soluble in water and sparingly soluble in alcohol USP. Temazepam capsules, 7.5 mg, 15 mg, 22.5 mg and 30 mg, are for oral administration.7.5 mg, 15 mg, 22.5 mg and 30 mg CapsulesActive Ingredient: temazepam USP7.5 mg Capsules Inactive Ingredients: Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Red #40 and titanium dioxide. May also include: sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 15 mg Capsules. Inactive Ingredients: Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Blue #1, FD&C yellow # 6, gelatin and titanium dioxide. May also include: sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 22.5 mg Capsules. Inactive Ingredients: Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, FD&C Blue #1, FD&C Red #40, gelatin and titanium dioxide. May also include: sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide. 30 mg Capsules. Inactive Ingredients: Corn starch, lactose anhydrous, magnesium stearate, sodium lauryl sulfate, gelatin and titanium dioxide. May also include: sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl alcohol, butanol, shellac, potassium hydroxide, propylene glycol, and black iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>63479-0101-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, GLASS (63479-0101-1) </PackageDescription>
<NDC11Code>63479-0101-01</NDC11Code>
<ProductNDC>63479-0101</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>A01</ProprietaryName>
<ProprietaryNameSuffix>Cellular Recharge</ProprietaryNameSuffix>
<NonProprietaryName>Aceticum Acidum, Arnica Montana, Avena Sativa, Calcarea Carbonica, Calcarea Phosphorica, Calcarea Sulphurica, Ceanothus Americanus, Ceratostigma Illmottianum, Chininum Arsenicosum, Citricum Acidum, English Elm, European Hornbeam, European Olive, Gentianella Amarella, Hydrofluoricum Acidum, Juglans Regia, Lacticum Acidum, Magnesia Phosphorica, Natrum Muriaticum, Natrum Phosphoricum, Natrum Silicofluoricum, Natrum Sulphuricum, Passiflora Incarnata, Phosphoricum Acidum, Sarcolacticum Acidum, Solidago Virgaurea</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>19941215</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Apex Energetics Inc.</LabelerName>
<SubstanceName>CALCIUM SULFATE ANHYDROUS; CERATOSTIGMA WILLMOTTIANUM FLOWER; LACTIC ACID, L-; ARNICA MONTANA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; ANHYDROUS CITRIC ACID; OLEA EUROPAEA FLOWER; GENTIANELLA AMARELLA FLOWER; ULMUS PROCERA FLOWERING TWIG; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; PHOSPHORIC ACID; CARPINUS BETULUS FLOWER; SOLIDAGO VIRGAUREA FLOWERING TOP; ACETIC ACID; AVENA SATIVA FLOWERING TOP; SODIUM CHLORIDE; TRIBASIC CALCIUM PHOSPHATE; CEANOTHUS AMERICANUS LEAF; SODIUM HEXAFLUOROSILICATE; QUININE ARSENITE; HYDROFLUORIC ACID; JUGLANS REGIA FLOWERING TOP; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM SULFATE; PASSIFLORA INCARNATA FLOWERING TOP; LACTIC ACID, DL-</SubstanceName>
<StrengthNumber>12; 12; 15; 12; 15; 30; 12; 12; 12; 12; 30; 9; 1; 30; 1; 30; 15; 4; 8; 15; 30; 9; 15; 10; 1; 15</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Acidifying Activity [MoA], Anti-coagulant [EPC], Antimalarial [EPC], Blood Coagulation Factor [EPC], Calcium Chelating Activity [MoA], Calcium [CS], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Decreased Coagulation Factor Activity [PE], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19941215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For temporary relief of minor. fatigue*. irritability*. cramps*. exhaustion*. restlessness*. *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63479-0102-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, GLASS (63479-0102-1) </PackageDescription>
<NDC11Code>63479-0102-01</NDC11Code>
<ProductNDC>63479-0102</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>A02</ProprietaryName>
<ProprietaryNameSuffix>Gentle Drainage</ProprietaryNameSuffix>
<NonProprietaryName>Alfalfa, Allium Sativum, American Ginseng, Asparagus Officinalis, Avena Sativa, Berberis Vulgaris, Bos Taurus Adrenal Gland, Colon, Kidney, Liver, Lymph Vessel, Pancreas, Calcarea Phosphorica, Carbo Vegetabilis, Crab Apple Flower, European Hornbeam Flower, Gentiana Lutea, Histaminum Hydrochloricum, Juniperus Communis Stem, Lacticum Acidum, Passiflora Incarnata, Phosphorus, Ribes Nigrum Flower Bud, Scrophularia Nodosa, Solidago Virgaurea</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>19880815</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Apex Energetics Inc.</LabelerName>
<SubstanceName>ACTIVATED CHARCOAL; GENTIANA LUTEA ROOT; SCROPHULARIA NODOSA; SOLIDAGO VIRGAUREA FLOWERING TOP; ALFALFA; MALUS SYLVESTRIS FLOWER; BOS TAURUS ADRENAL GLAND; CARPINUS BETULUS FLOWER; AVENA SATIVA FLOWERING TOP; BEEF KIDNEY; LACTIC ACID, DL-; PHOSPHORUS; RIBES NIGRUM FLOWER BUD; ASPARAGUS; GARLIC; AMERICAN GINSENG; HISTAMINE DIHYDROCHLORIDE; JUNIPERUS COMMUNIS STEM; PASSIFLORA INCARNATA FLOWERING TOP; BERBERIS VULGARIS ROOT BARK; BOS TAURUS COLON; BEEF LIVER; BOS TAURUS LYMPH VESSEL; BOS TAURUS PANCREAS; TRIBASIC CALCIUM PHOSPHATE</SubstanceName>
<StrengthNumber>15; 6; 10; 9; 6; 12; 7; 12; 6; 7; 12; 12; 6; 9; 9; 9; 6; 8; 9; 12; 7; 7; 7; 7; 15</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Meat Proteins [EXT], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Plant Proteins [CS], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19880815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63479-0103-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, GLASS (63479-0103-1) </PackageDescription>
<NDC11Code>63479-0103-01</NDC11Code>
<ProductNDC>63479-0103</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>A03</ProprietaryName>
<ProprietaryNameSuffix>Ultra Antitox</ProprietaryNameSuffix>
<NonProprietaryName>Alfalfa, American Ginseng, Apis Mellifica, Asparagus Officinalis, Avena Sativa, Baryta Iodata, Berberis Vulgaris, Bryonia, Carduus Marianus, Chamomilla, Chelidonium Majus, Conium Maculatum, Ferrum Iodatum, Lapis Albus, Lycopodium Clavatum, Natrum Carbonicum, Passiflora Incarnata, Scrophularia Nodosa, Solidago Virgaurea, Taraxacum Officinale, Uva Ursi</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>19941215</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Apex Energetics Inc.</LabelerName>
<SubstanceName>BRYONIA ALBA ROOT; APIS MELLIFERA; ASPARAGUS; AVENA SATIVA FLOWERING TOP; ALFALFA; AMERICAN GINSENG; FERROUS IODIDE; SODIUM CARBONATE; BARIUM IODIDE; PASSIFLORA INCARNATA FLOWERING TOP; CONIUM MACULATUM FLOWERING TOP; LYCOPODIUM CLAVATUM SPORE; SCROPHULARIA NODOSA; TARAXACUM OFFICINALE; CALCIUM HEXAFLUOROSILICATE; ARCTOSTAPHYLOS UVA-URSI LEAF; MATRICARIA CHAMOMILLA; SOLIDAGO VIRGAUREA FLOWERING TOP; BERBERIS VULGARIS ROOT BARK; MILK THISTLE; CHELIDONIUM MAJUS</SubstanceName>
<StrengthNumber>15; 6; 2; 1; 1; 2; 12; 6; 12; 1; 12; 6; 3; 1; 15; 1; 1; 1; 1; 1; 1</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Standardized Insect Venom Allergenic Extract [EPC], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19941215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63479-0104-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, GLASS (63479-0104-1) </PackageDescription>
<NDC11Code>63479-0104-01</NDC11Code>
<ProductNDC>63479-0104</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>A04</ProprietaryName>
<ProprietaryNameSuffix>Deep Antitox</ProprietaryNameSuffix>
<NonProprietaryName>Allium Cepa, Allium Sativum, Aloe Socotrina, Arsenicum Iodatum, Asterias Rubens, Baptisia Tinctoria, Calcarea Iodata, Candida Albicans, Carbo Vegetabilis, Chelidonium Majus, Cina, Cinchona Officinalis, Colchicum Autumnale, Echinacea Angustifolia, Echinacea Purpurea, Indolum, Lac Vaccinum, Lacticum Acidum, Millefolium, Saccharum Officinale, Sarcolacticum Acidum, Scrophularia Nodosa, Skatolum, Solidago Virgaurea, Sulphur, Uricum Acidum</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>19941215</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Apex Energetics Inc.</LabelerName>
<SubstanceName>ONION; ECHINACEA ANGUSTIFOLIA WHOLE; SUCROSE; SCROPHULARIA NODOSA; CANDIDA ALBICANS; CALCIUM IODIDE; ACTIVATED CHARCOAL; CHELIDONIUM MAJUS; ARTEMISIA CINA PRE-FLOWERING TOP; COLCHICUM AUTUMNALE BULB; ECHINACEA PURPUREA; ACHILLEA MILLEFOLIUM; COW MILK; SULFUR; URIC ACID; CINCHONA OFFICINALIS BARK; BAPTISIA TINCTORIA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; GARLIC; ALOE; ARSENIC TRIIODIDE; ASTERIAS RUBENS; INDOLE; LACTIC ACID, DL-; LACTIC ACID, L-; SKATOLE</SubstanceName>
<StrengthNumber>1; 1; 200; 30; 200; 30; 12; 30; 3; 30; 1; 1; 200; 12; 15; 3; 15; 1; 1; 15; 15; 8; 30; 200; 200; 30</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Fungal Proteins [CS], Increased Coagulation Factor Activity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Milk Proteins [CS], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Plant Proteins [CS], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19941215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63479-0105-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, GLASS (63479-0105-1) </PackageDescription>
<NDC11Code>63479-0105-01</NDC11Code>
<ProductNDC>63479-0105</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>A05</ProprietaryName>
<ProprietaryNameSuffix>Heavy Antitox</ProprietaryNameSuffix>
<NonProprietaryName>Allium Cepa, Allium Sativum, Aluminium Metallicum, Apis Mellifica, Argentum Metallicum, Aurum Metallicum, Belladonna, Berberis Vulgaris, Cadmium Metallicum, Chelidonium Majus, Cuprum Metallicum, Fagus Sylvatica, Formalinum, Formicum Acidum, Hypericum Perforatum, Ichthyolum, Mercurius Corrosivus, Mercurius Solubilis, Niccolum Metallicum, Plumbum Metallicum, Selenium Metallicum, Silicea, Solidago Virgaurea, Stannum Metallicum, Thiosinaminum</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>19941215</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Apex Energetics Inc.</LabelerName>
<SubstanceName>APIS MELLIFERA; GOLD; HYPERICUM PERFORATUM; ICHTHAMMOL; MERCURIUS SOLUBILIS; LEAD; GARLIC; ALUMINUM; ATROPA BELLADONNA; FORMALDEHYDE; FORMIC ACID; SILVER; CHELIDONIUM MAJUS; COPPER; SILICON DIOXIDE; CADMIUM; FAGUS SYLVATICA NUT; BERBERIS VULGARIS ROOT BARK; MERCURIC CHLORIDE; SOLIDAGO VIRGAUREA FLOWERING TOP; TIN; ALLYLTHIOUREA; ONION; NICKEL; SELENIUM</SubstanceName>
<StrengthNumber>4; 30; 3; 10; 60; 60; 1; 30; 4; 30; 12; 60; 1; 60; 30; 60; 2; 1; 200; 1; 30; 12; 1; 15; 15</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Dietary Proteins [CS], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Inhibit Ovum Fertilization [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Plant Proteins [CS], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], Standardized Insect Venom Allergenic Extract [EPC], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19941215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For temporary relief of minor:. spasms*. fatigue*. headache*. congestion*. dry skin*. nervous irritability*. *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63479-0106-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, GLASS (63479-0106-1) </PackageDescription>
<NDC11Code>63479-0106-01</NDC11Code>
<ProductNDC>63479-0106</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>A06</ProprietaryName>
<ProprietaryNameSuffix>Revitalization</ProprietaryNameSuffix>
<NonProprietaryName>Avena Sativa, Bone Marrow Suis, Bos Taurus Adrenal Gland, Bos Taurus Artery, Bos Taurus Colon, Bos Taurus Kidney, Bos Taurus Liver, Bos Taurus Lymph Vessel, Bos Taurus Pancreas, Bos Taurus Pituitarum Posterium, Bos Taurus Placenta, Bos Taurus Skin, Bos Taurus Thymus, Gentiana Lutea, Glycyrrhiza Glabra, Hamamelis Virginiana, Hydrofluoricum Acidum, Kali Phosphoricum, Procaine, Sus Scrofa Spleen</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>19881215</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Apex Energetics Inc.</LabelerName>
<SubstanceName>AVENA SATIVA FLOWERING TOP; BEEF KIDNEY; BEEF LIVER; BOS TAURUS ADRENAL GLAND; BOS TAURUS ARTERY; BOS TAURUS COLON; BOS TAURUS LYMPH VESSEL; BOS TAURUS PANCREAS; BOS TAURUS PITUITARY GLAND, POSTERIOR; BOS TAURUS PLACENTA; BOS TAURUS SKIN; BOS TAURUS THYMUS; GENTIANA LUTEA ROOT; GLYCYRRHIZA GLABRA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYDROFLUORIC ACID; POTASSIUM PHOSPHATE, DIBASIC; PROCAINE; SUS SCROFA BONE MARROW; SUS SCROFA SPLEEN</SubstanceName>
<StrengthNumber>4; 7; 7; 7; 7; 7; 7; 7; 7; 15; 7; 7; 6; 6; 9; 30; 10; 8; 7; 7</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cells, Epidermal [EXT], Dietary Proteins [CS], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Meat Proteins [EXT], Non-Standardized Animal Skin Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Plant Proteins [CS], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-02-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19881215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For temporary relief of minor. fatigue*. irritability*. lack of appetite*. nervous exhaustion*. *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63479-0109-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, GLASS (63479-0109-1) </PackageDescription>
<NDC11Code>63479-0109-01</NDC11Code>
<ProductNDC>63479-0109</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>A09</ProprietaryName>
<ProprietaryNameSuffix>Female Balance</ProprietaryNameSuffix>
<NonProprietaryName>Argentum Nitricum, Atropinum Sulphuricum, Aurum Muriaticum Natronatum, Bos Taurus Ovary, Bos Taurus Pancreas, Bos Taurus Pituitarum Posterium, Bos Taurus Uterus, Cimicifuga Racemosa, Estrone, Helonias Dioica, Progesterone, Pulsatilla Vulgaris, Sabina, Sepia, Sequoiadendron Giganteum Whole, Sus Scrofa Pineal Gland, Sus Scrofa Spleen, Thiosinaminum, Thyroidinum, Viburnum Opulus</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>19880815</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Apex Energetics Inc.</LabelerName>
<SubstanceName>JUNIPERUS SABINA LEAFY TWIG; SUS SCROFA SPLEEN; ALLYLTHIOUREA; THYROID, UNSPECIFIED; BOS TAURUS OVARY; BOS TAURUS PANCREAS; SILVER NITRATE; ESTRONE; SEPIA OFFICINALIS JUICE; SUS SCROFA PINEAL GLAND; CHAMAELIRIUM LUTEUM ROOT; PROGESTERONE; SEQUOIADENDRON GIGANTEUM WHOLE; VIBURNUM OPULUS BARK; ATROPINE SULFATE; SODIUM TETRACHLOROAURATE; BOS TAURUS PITUITARY GLAND; BOS TAURUS UTERUS; BLACK COHOSH; PULSATILLA VULGARIS</SubstanceName>
<StrengthNumber>12; 7; 8; 7; 7; 7; 9; 9; 30; 9; 8; 9; 9; 8; 10; 12; 9; 7; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA], Progesterone [CS], Progesterone [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19880815</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For temporary relief of minor: menstrual irregularity*. headache*. fatigue*. menstrual cramps*. backache during menstruation*. irritability*. *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.</IndicationAndUsage>
</NDC>
</NDCList>