{
"NDC": [
{
"NDCCode": "0310-3080-01",
"PackageDescription": "1 SYRINGE, GLASS in 1 CARTON (0310-3080-01) / .8 mL in 1 SYRINGE, GLASS (0310-3080-25) ",
"NDC11Code": "00310-3080-01",
"ProductNDC": "0310-3080",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Saphnelo",
"NonProprietaryName": "Anifrolumab-fnia",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20260424",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761451",
"LabelerName": "AstraZeneca Pharmaceuticals LP",
"SubstanceName": "ANIFROLUMAB",
"StrengthNumber": "120",
"StrengthUnit": "mg/.8mL",
"Pharm_Classes": "Type I Interferon Receptor Antagonist [EPC], Type I Interferon Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-10-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260424",
"SamplePackage": "N",
"IndicationAndUsage": "SAPHNELO is indicated for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE), who are receiving standard therapy. Limitations of Use. The efficacy of SAPHNELO has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. Use of SAPHNELO is not recommended in these situations.",
"Description": "Anifrolumab-fnia is a type I interferon (IFN) receptor antagonist, immunoglobulin G1 kappa (IgG1κ) monoclonal antibody that is produced in mouse myeloma cells (NS0) by recombinant DNA technology. The molecular weight is approximately 148 kDa. Intravenous Infusion. SAPHNELO (anifrolumab-fnia) injection is a sterile, preservative‑free, clear to opalescent, colorless to slightly yellow, solution in a single-dose vial for intravenous use. Each 2 mL single-dose vial contains 300 mg (150 mg/mL) of anifrolumab-fnia, histidine (3 mg), L-histidine hydrochloride monohydrate (6 mg), lysine hydrochloride (18 mg), polysorbate 80 (1 mg), trehalose (89 mg), and Water for Injection, USP. The pH is 5.9. Subcutaneous Injection. SAPHNELO (anifrolumab-fnia) injection is a sterile, preservative-free, clear to opalescent, colorless to slightly yellow, solution in a prefilled syringe or autoinjector for subcutaneous injection. Each 0.8 mL single-dose prefilled syringe or autoinjector delivers 120 mg of anifrolumab-fnia, histidine (1 mg), L-histidine hydrochloride monohydrate (3 mg), lysine hydrochloride (7 mg), polysorbate 80 (0.4 mg), trehalose (36 mg), and Water for Injection, USP. The pH is 5.9."
},
{
"NDCCode": "0310-3080-02",
"PackageDescription": "1 SYRINGE, GLASS in 1 CARTON (0310-3080-02) / .8 mL in 1 SYRINGE, GLASS (0310-3080-75) ",
"NDC11Code": "00310-3080-02",
"ProductNDC": "0310-3080",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Saphnelo",
"NonProprietaryName": "Anifrolumab-fnia",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20260424",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761451",
"LabelerName": "AstraZeneca Pharmaceuticals LP",
"SubstanceName": "ANIFROLUMAB",
"StrengthNumber": "120",
"StrengthUnit": "mg/.8mL",
"Pharm_Classes": "Type I Interferon Receptor Antagonist [EPC], Type I Interferon Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-10-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260424",
"SamplePackage": "N",
"IndicationAndUsage": "SAPHNELO is indicated for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE), who are receiving standard therapy. Limitations of Use. The efficacy of SAPHNELO has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. Use of SAPHNELO is not recommended in these situations.",
"Description": "Anifrolumab-fnia is a type I interferon (IFN) receptor antagonist, immunoglobulin G1 kappa (IgG1κ) monoclonal antibody that is produced in mouse myeloma cells (NS0) by recombinant DNA technology. The molecular weight is approximately 148 kDa. Intravenous Infusion. SAPHNELO (anifrolumab-fnia) injection is a sterile, preservative‑free, clear to opalescent, colorless to slightly yellow, solution in a single-dose vial for intravenous use. Each 2 mL single-dose vial contains 300 mg (150 mg/mL) of anifrolumab-fnia, histidine (3 mg), L-histidine hydrochloride monohydrate (6 mg), lysine hydrochloride (18 mg), polysorbate 80 (1 mg), trehalose (89 mg), and Water for Injection, USP. The pH is 5.9. Subcutaneous Injection. SAPHNELO (anifrolumab-fnia) injection is a sterile, preservative-free, clear to opalescent, colorless to slightly yellow, solution in a prefilled syringe or autoinjector for subcutaneous injection. Each 0.8 mL single-dose prefilled syringe or autoinjector delivers 120 mg of anifrolumab-fnia, histidine (1 mg), L-histidine hydrochloride monohydrate (3 mg), lysine hydrochloride (7 mg), polysorbate 80 (0.4 mg), trehalose (36 mg), and Water for Injection, USP. The pH is 5.9."
},
{
"NDCCode": "0310-3080-95",
"PackageDescription": "1 SYRINGE, GLASS in 1 CARTON (0310-3080-95) / .8 mL in 1 SYRINGE, GLASS (0310-3080-25) ",
"NDC11Code": "00310-3080-95",
"ProductNDC": "0310-3080",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Saphnelo",
"NonProprietaryName": "Anifrolumab-fnia",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20260424",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761451",
"LabelerName": "AstraZeneca Pharmaceuticals LP",
"SubstanceName": "ANIFROLUMAB",
"StrengthNumber": "120",
"StrengthUnit": "mg/.8mL",
"Pharm_Classes": "Type I Interferon Receptor Antagonist [EPC], Type I Interferon Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-10-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260424",
"SamplePackage": "Y",
"IndicationAndUsage": "SAPHNELO is indicated for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE), who are receiving standard therapy. Limitations of Use. The efficacy of SAPHNELO has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. Use of SAPHNELO is not recommended in these situations.",
"Description": "Anifrolumab-fnia is a type I interferon (IFN) receptor antagonist, immunoglobulin G1 kappa (IgG1κ) monoclonal antibody that is produced in mouse myeloma cells (NS0) by recombinant DNA technology. The molecular weight is approximately 148 kDa. Intravenous Infusion. SAPHNELO (anifrolumab-fnia) injection is a sterile, preservative‑free, clear to opalescent, colorless to slightly yellow, solution in a single-dose vial for intravenous use. Each 2 mL single-dose vial contains 300 mg (150 mg/mL) of anifrolumab-fnia, histidine (3 mg), L-histidine hydrochloride monohydrate (6 mg), lysine hydrochloride (18 mg), polysorbate 80 (1 mg), trehalose (89 mg), and Water for Injection, USP. The pH is 5.9. Subcutaneous Injection. SAPHNELO (anifrolumab-fnia) injection is a sterile, preservative-free, clear to opalescent, colorless to slightly yellow, solution in a prefilled syringe or autoinjector for subcutaneous injection. Each 0.8 mL single-dose prefilled syringe or autoinjector delivers 120 mg of anifrolumab-fnia, histidine (1 mg), L-histidine hydrochloride monohydrate (3 mg), lysine hydrochloride (7 mg), polysorbate 80 (0.4 mg), trehalose (36 mg), and Water for Injection, USP. The pH is 5.9."
},
{
"NDCCode": "0006-3080-01",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE (0006-3080-01) ",
"NDC11Code": "00006-3080-01",
"ProductNDC": "0006-3080",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isentress",
"NonProprietaryName": "Raltegravir",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20170526",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022145",
"LabelerName": "Merck Sharp & Dohme LLC",
"SubstanceName": "RALTEGRAVIR POTASSIUM",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HIV Integrase Inhibitors [MoA], Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170526",
"SamplePackage": "N",
"IndicationAndUsage": "Adult Patients. ISENTRESS and ISENTRESS HD are human immunodeficiency virus integrase strand transfer inhibitors (HIV-1 INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adult patients (1). Pediatric Patients. ISENTRESS is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients weighing at least 2 kg (1). ISENTRESS HD is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients weighing at least 40 kg (1).",
"Description": "ISENTRESS contains raltegravir potassium, a human immunodeficiency virus integrase strand transfer inhibitor. The chemical name for raltegravir potassium is N-[(4-Fluorophenyl) methyl]-1,6-dihydro-5-hydroxy-1-methyl-2-[1-methyl-1-[[(5-methyl-1,3,4-oxadiazol-2-yl)carbonyl]amino]ethyl]-6-oxo-4-pyrimidinecarboxamide monopotassium salt. The empirical formula is C20H20FKN6O5 and the molecular weight is 482.51. The structural formula is. Raltegravir potassium is a white to off-white powder. It is soluble in water, slightly soluble in methanol, very slightly soluble in ethanol and acetonitrile and insoluble in isopropanol. Each 400 mg film-coated tablet of ISENTRESS for oral administration contains 434.4 mg of raltegravir (as potassium salt), equivalent to 400 mg of raltegravir free phenol and the following inactive ingredients: calcium phosphate dibasic anhydrous, hypromellose 2208, lactose monohydrate, magnesium stearate, microcrystalline cellulose, poloxamer 407 (contains 0.01% butylated hydroxytoluene as antioxidant), sodium stearyl fumarate. In addition, the film coating contains the following inactive ingredients: black iron oxide, polyethylene glycol 3350, polyvinyl alcohol, red iron oxide, talc and titanium dioxide. Each 600 mg film-coated tablet of ISENTRESS HD for oral administration contains 651.6 mg of raltegravir (as potassium salt), equivalent to 600 mg of raltegravir free phenol and the following inactive ingredients: croscarmellose sodium, hypromellose 2910, magnesium stearate, microcrystalline cellulose. The film coating contains the following inactive ingredients: ferrosoferric oxide, hypromellose 2910, iron oxide yellow, lactose monohydrate, triacetin and titanium dioxide. The tablet may also contain trace amount of carnauba wax. Each 100 mg chewable tablet of ISENTRESS for oral administration contains 108.6 mg of raltegravir (as potassium salt), equivalent to 100 mg of raltegravir free phenol and the following inactive ingredients: ammonium hydroxide, crospovidone, ethylcellulose 20 cP, fructose, hydroxypropyl cellulose, hypromellose 2910/6cP, magnesium stearate, mannitol, medium chain triglycerides, monoammonium glycyrrhizinate, natural and artificial flavors (orange, banana, and masking that contains aspartame), oleic acid, PEG 400, red iron oxide, saccharin sodium, sodium citrate dihydrate, sodium stearyl fumarate, sorbitol, sucralose and yellow iron oxide. Each 25 mg chewable tablet of ISENTRESS for oral administration contains 27.16 mg of raltegravir (as potassium salt), equivalent to 25 mg of raltegravir free phenol and the following inactive ingredients: ammonium hydroxide, crospovidone, ethylcellulose 20 cP, fructose, hydroxypropyl cellulose, hypromellose 2910/6cP, magnesium stearate, mannitol, medium chain triglycerides, monoammonium glycyrrhizinate, natural and artificial flavors (orange, banana, and masking that contains aspartame), oleic acid, PEG 400, saccharin sodium, sodium citrate dihydrate, sodium stearyl fumarate, sorbitol, sucralose and yellow iron oxide. Each packet of ISENTRESS for oral suspension 100 mg, contains 108.6 mg of raltegravir (as potassium salt), equivalent to 100 mg of raltegravir free phenol and the following inactive ingredients: ammonium hydroxide, banana with other natural flavors, carboxymethylcellulose sodium, crospovidone, ethylcellulose 20 cP, fructose, hydroxypropyl cellulose, hypromellose 2910/6cP, macrogol/PEG 400, magnesium stearate, maltodextrin, mannitol, medium chain triglycerides, microcrystalline cellulose, monoammonium glycyrrhizinate, oleic acid, sorbitol, sucralose and sucrose."
},
{
"NDCCode": "10742-3080-1",
"PackageDescription": "1 TUBE in 1 BLISTER PACK (10742-3080-1) / 4.2 g in 1 TUBE",
"NDC11Code": "10742-3080-01",
"ProductNDC": "10742-3080",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mentholatum Natural Ice Protect Plus Spf 30",
"ProprietaryNameSuffix": "Protect Plus Spf 30",
"NonProprietaryName": "Avobenzone, Dimethicone, Octinoxate, Octisalate",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240901",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "The Mentholatum Company",
"SubstanceName": "OCTINOXATE; OCTISALATE; AVOBENZONE; DIMETHICONE",
"StrengthNumber": "75; 50; 30; 10",
"StrengthUnit": "mg/g; mg/g; mg/g; mg/g",
"Pharm_Classes": "Skin Barrier Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-03-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240901",
"SamplePackage": "N",
"IndicationAndUsage": "helps prevent sunburn. temporarily protects chapped or cracked lips. protect from the drying effects of wind and cold weather."
},
{
"NDCCode": "36987-3080-1",
"PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (36987-3080-1)",
"NDC11Code": "36987-3080-01",
"ProductNDC": "36987-3080",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "English Walnut",
"NonProprietaryName": "English Walnut",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "JUGLANS REGIA POLLEN",
"StrengthNumber": "20000",
"StrengthUnit": "[PNU]/mL",
"Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
"Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
},
{
"NDCCode": "37662-3080-1",
"PackageDescription": "200 PELLET in 1 VIAL, GLASS (37662-3080-1) ",
"NDC11Code": "37662-3080-01",
"ProductNDC": "37662-3080",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Strontium Phosphoricum",
"NonProprietaryName": "Strontium Phosphoricum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230501",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "STRONTIUM PHOSPHATE",
"StrengthNumber": "200",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2023-05-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230501",
"SamplePackage": "N"
},
{
"NDCCode": "48951-3080-1",
"PackageDescription": "1 BOTTLE, DROPPER in 1 BAG (48951-3080-1) > 7 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "48951-3080-01",
"ProductNDC": "48951-3080",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Chelidonium Rosa",
"NonProprietaryName": "Chelidonium Rosa",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20090901",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Uriel Pharmacy Inc.",
"SubstanceName": "FERRIC OXIDE RED; SEDUM ROSEUM WHOLE; CHELIDONIUM MAJUS ROOT; RUTA GRAVEOLENS FLOWERING TOP; SILICON DIOXIDE; LARIX DECIDUA RESIN",
"StrengthNumber": "3; 3; 4; 4; 6; 6",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2019-10-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20090901",
"SamplePackage": "N"
},
{
"NDCCode": "53002-3080-1",
"PackageDescription": "5 TABLET, FILM COATED in 1 BOTTLE (53002-3080-1) ",
"NDC11Code": "53002-3080-01",
"ProductNDC": "53002-3080",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cyclobenzaprine Hydrochloride",
"NonProprietaryName": "Cyclobenzaprine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160722",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090478",
"LabelerName": "RPK Pharmaceuticals, Inc.",
"SubstanceName": "CYCLOBENZAPRINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20171001",
"SamplePackage": "N",
"IndicationAndUsage": "Cyclobenzaprine HCl tablets USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine HCl should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine HCl has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.",
"Description": "Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the empirical formula C20H21NHCl and a molecular weight of 311.9. It has a melting point of 217˚C, and a pKa of 8.47 at 25˚C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl, USP is designated chemically as 3-(5H –dibenzo[a,d]cyclohepten-5-ylidene)-N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine HCl USP, 5 mg is supplied as a 5 mg tablet for oral administration. Cyclobenzaprine HCl USP, 10 mg is supplied as a 10 mg tablet for oral administration. Cyclobenzaprine HCl tablets USP, 5 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry beige (hypromellose 6cP, titanium dioxide, PEG 400, iron oxide yellow and iron oxide red). Cyclobenzaprine HCl tablets USP, 10 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry yellow (hypromellose 3cp, hypromellose 6cp, titanium dioxide, PEG 400, iron oxide yellow and polysorbate 80)."
},
{
"NDCCode": "59762-3080-1",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (59762-3080-1) ",
"NDC11Code": "59762-3080-01",
"ProductNDC": "59762-3080",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Azithromycin",
"NonProprietaryName": "Azithromycin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19960612",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050730",
"LabelerName": "Greenstone LLC",
"SubstanceName": "AZITHROMYCIN DIHYDRATE",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Macrolide Antimicrobial [EPC],Macrolides [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-03-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "19960612",
"SamplePackage": "N"
},
{
"NDCCode": "62991-3080-1",
"PackageDescription": "5 g in 1 JAR (62991-3080-1)",
"NDC11Code": "62991-3080-01",
"ProductNDC": "62991-3080",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Levocetirizine Dihydrochloride",
"DosageFormName": "POWDER",
"StartMarketingDate": "20140821",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "LETCO MEDICAL, LLC",
"SubstanceName": "LEVOCETIRIZINE DIHYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "70518-3080-1",
"PackageDescription": "30 POUCH in 1 BOX (70518-3080-1) > 1 TABLET in 1 POUCH (70518-3080-2) ",
"NDC11Code": "70518-3080-01",
"ProductNDC": "70518-3080",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Biktarvy",
"NonProprietaryName": "Bictegravir Sodium, Emtricitabine, And Tenofovir Alafenamide Fumarate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20210428",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA210251",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE",
"StrengthNumber": "50; 200; 25",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS], Nucleosides [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-06-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20210714",
"SamplePackage": "N"
},
{
"NDCCode": "71335-3080-1",
"PackageDescription": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-3080-1) ",
"NDC11Code": "71335-3080-01",
"ProductNDC": "71335-3080",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Morphine Sulfate",
"NonProprietaryName": "Morphine Sulfate",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20120511",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078761",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "MORPHINE SULFATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-02-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260213",
"SamplePackage": "N",
"IndicationAndUsage": "Morphine sulfate extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations[see Warnings and Precautions (5.1)], reserve morphine sulfate extended-release tabletsfor use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Morphine sulfate extended-release tabletsare not indicated as an as-needed (prn) analgesic.",
"Description": "Morphine sulfate extended-release tablets are for oral use and contains morphine sulfate, an opioid agonist.Each tablet contains the following inactive ingredients common to all strengths: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, povidone, stearic acid, talc and titanium dioxide.The tablet strengths describe the amount of morphine per tablet as the pentahydrated sulfate salt (morphine sulfate, USP).The 15 mg tablets also contain: FD&C Blue # 2/Indigo carmine aluminum lake, ferrosoferric oxide, macrogol/PEG 4000 and macrogol/PEG 400The 30 mg tablets also contain: D&C Red # 27/Phloxine aluminum lake, FD&C Blue # 2/Indigo carmine aluminum lake, macrogol/PEG 4000 and macrogol/PEG 400The 60 mg tablets also contain: FD&C Yellow # 6 aluminum lake and macrogol/PEG 4000 and macrogol/PEG 400The 100 mg tablets also contain: FD&C Blue # 2/Indigo carmine aluminum lake, ferrosoferric oxide, ferric oxide yellow, macrogol/PEG 4000 and macrogol/PEG 400The 200 mg tablets also contain: D&C Yellow # 10 aluminum lake, FD&C Blue # 2/Indigo carmine aluminum lake, macrogol/PEG 4000 and macrogol/PEG 400. Morphine sulfate, USP are white, feathery, silky crystals, cubical masses of crystals, or white crystalline powder, soluble in water, freely soluble in hot water, slightly soluble in alcohol but more so in hot alcohol, insoluble in chloroform and in ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its molecular weight is 758.83 and its structural formula is."
},
{
"NDCCode": "0015-3080-60",
"PackageDescription": "100 TABLET in 1 BOTTLE (0015-3080-60) ",
"NDC11Code": "00015-3080-60",
"ProductNDC": "0015-3080",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lysodren",
"NonProprietaryName": "Mitotane",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090601",
"EndMarketingDate": "20210331",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA016885",
"LabelerName": "E.R. Squibb & Sons, L.L.C.",
"SubstanceName": "MITOTANE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 3A4 Inducers [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-04-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20090601",
"EndMarketingDatePackage": "20210331",
"SamplePackage": "N"
},
{
"NDCCode": "0904-5339-60",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0904-5339-60)",
"NDC11Code": "00904-5339-60",
"ProductNDC": "0904-5339",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prenatal Plus Iron",
"NonProprietaryName": "Multivitamin/multimineral Supplement",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110607",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Major Pharmaceuticals",
"SubstanceName": "VITAMIN A ACETATE; .BETA.-CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE; IRON PENTACARBONYL; ZINC OXIDE; CUPRIC OXIDE",
"StrengthNumber": "3080; 920; 120; 400; 22; 1.84; 3; 20; 10; 1; 12; 200; 29; 25; 2",
"StrengthUnit": "[iU]/1; [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2017-11-01"
},
{
"NDCCode": "15338-522-10",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (15338-522-10) ",
"NDC11Code": "15338-0522-10",
"ProductNDC": "15338-522",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prenatal Plus",
"NonProprietaryName": "Vitamin A Acetate, Beta Carotene, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium Carbonate, Ferrous Fumarate, Zinc Oxide, Cupric Oxide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120911",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Apace Packaging, LLC",
"SubstanceName": "VITAMIN A ACETATE; CYANOCOBALAMIN; ASCORBIC ACID; CHOLECALCIFEROL; FOLIC ACID; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; .ALPHA.-TOCOPHEROL ACETATE, DL-; .BETA.-CAROTENE; ZINC OXIDE; CALCIUM CARBONATE; FERROUS FUMARATE; PYRIDOXINE HYDROCHLORIDE; CUPRIC OXIDE",
"StrengthNumber": "3080; 12; 120; 400; 1; 1.84; 3; 20; 22; 920; 25; 200; 27; 10; 2",
"StrengthUnit": "[iU]/1; ug/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Vitamin A [CS],Vitamin A [EPC],Vitamin B 12 [CS],Vitamin B12 [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Vitamin D [CS],Vitamin D [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20170719",
"SamplePackage": "N"
},
{
"NDCCode": "17856-0668-1",
"PackageDescription": "1 TABLET, FILM COATED in 1 POUCH (17856-0668-1)",
"NDC11Code": "17856-0668-01",
"ProductNDC": "17856-0668",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prenatal Plus",
"NonProprietaryName": "Vitamin A Acetate, .beta.-carotene, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium Carbonate, Ferrous Fumarate, Zinc Oxide, Cupric Oxide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20091202",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Atlantic Biologicals Corps",
"SubstanceName": "VITAMIN A ACETATE; .BETA.-CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE; FERROUS FUMARATE; ZINC OXIDE; CUPRIC OXIDE",
"StrengthNumber": "3080; 920; 120; 400; 22; 1.84; 3; 20; 10; 1; 12; 200; 27; 25; 2",
"StrengthUnit": "[iU]/1; [iU]/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Vitamin A [CS],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Vitamin D [CS],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "To provide Vitamin and Mineral supplementation throughout pregnancy and during the postnatal period for both the lactating and non-lactating mother. It is also useful for improving nutritional status prior to conception.",
"Description": "Each Tablet Contains. VITAMINS: Amount per Tablet. Vitamin A (from Acetate and Beta Carotene) ............................. 4000 IU. Vitamin C (Ascorbic Acid) ........................................................... 120 mg. Vitamin D-3 (Cholecalciferol) ....................................................... 400 IU. Vitamin E (dl- Alpha Tocopheryl Acetate) ...................................... 22 IU. Thiamine (Vitamin B-1) (from Thiamine Mononitrate) ................. 1.84 mg. Riboflavin (Vitamin B-2) .................................................................. 3 mg. Niacin (as Niacinamide) ................................................................ 20 mg. Vitamin B-6 (Pyridoxine HCl) ......................................................... 10 mg. Folic Acid ......................................................................................... 1 mg. Vitamin B-12 (Cyanocobalamin) ................................................... 12 mcg. MINERALS: Amount per Tablet. Calcium (as Calcium Carbonate) ................................................. 200 mg. Iron (from Ferrous Fumarate) ........................................................ 27 mg. Zinc (from Zinc Oxide) ................................................................... 25 mg. Copper (from Cupric Oxide) ........................................................... 2 mg. croscarmellose sodium, FD&C Blue #2, FD&C Red #40, FD&C Yellow # 5, FD&C Yellow # 6, macrogol, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, silicon, starch, stearic acid, talc, titanium dioxide Other ingredients."
},
{
"NDCCode": "39328-106-50",
"PackageDescription": "500 TABLET in 1 BOTTLE, PLASTIC (39328-106-50) ",
"NDC11Code": "39328-0106-50",
"ProductNDC": "39328-106",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prenatal Vitamins Plus Low Iron",
"NonProprietaryName": "Prenatal With Ferrous Fum And Folic Acid",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20130401",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Patrin Pharma, Inc.",
"SubstanceName": ".ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; BETA CAROTENE; CALCIUM CARBONATE; CHOLECALCIFEROL; COPPER; CYANOCOBALAMIN; FOLIC ACID; IRON; NIACIN; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE; VITAMIN A ACETATE; ZINC",
"StrengthNumber": "22; 120; 920; 200; 400; 2; 12; 1; 27; 20; 10; 3; 1.84; 3080; 25",
"StrengthUnit": "mg/1; mg/1; [iU]/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Increased Coagulation Factor Activity [PE], Inhibit Ovum Fertilization [PE], Nicotinic Acid [EPC], Nicotinic Acids [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-01-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20130401",
"SamplePackage": "N"
},
{
"NDCCode": "42291-686-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (42291-686-01) ",
"NDC11Code": "42291-0686-01",
"ProductNDC": "42291-686",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prenatal Plus",
"NonProprietaryName": "Vitamin A Acetate, Beta Carotene, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium Carbonate, Ferrous Fumarate, Zinc Oxide, Cupric Oxide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120911",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "AvKARE, Inc.",
"SubstanceName": "VITAMIN A ACETATE; CYANOCOBALAMIN; ASCORBIC ACID; CHOLECALCIFEROL; FOLIC ACID; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; .ALPHA.-TOCOPHEROL ACETATE, DL-; .BETA.-CAROTENE; ZINC OXIDE; CALCIUM CARBONATE; FERROUS FUMARATE; PYRIDOXINE HYDROCHLORIDE; CUPRIC OXIDE",
"StrengthNumber": "3080; 12; 120; 400; 1; 1.84; 3; 20; 22; 920; 25; 200; 27; 10; 2",
"StrengthUnit": "[iU]/1; ug/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Vitamin A [CS],Vitamin A [EPC],Vitamin B 12 [CS],Vitamin B12 [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Vitamin D [CS],Vitamin D [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20170719",
"SamplePackage": "N"
},
{
"NDCCode": "49902-3080-3",
"PackageDescription": "236 mL in 1 BOTTLE, SPRAY (49902-3080-3) ",
"NDC11Code": "49902-3080-03",
"ProductNDC": "49902-3080",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizer-lemonade",
"NonProprietaryName": "Alcohol",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "BB Trading Worldwide Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "80",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200330",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "50090-3080-0",
"PackageDescription": "33 BLISTER PACK in 1 BOX, UNIT-DOSE (50090-3080-0) > 1 TABLET in 1 BLISTER PACK",
"NDC11Code": "50090-3080-00",
"ProductNDC": "50090-3080",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dicyclomine Hydrochloride",
"NonProprietaryName": "Dicyclomine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19991103",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040317",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "DICYCLOMINE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anticholinergic [EPC],Cholinergic Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20170628",
"SamplePackage": "N"
},
{
"NDCCode": "50268-677-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (50268-677-01) ",
"NDC11Code": "50268-0677-01",
"ProductNDC": "50268-677",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prenatal Plus",
"NonProprietaryName": "Vitamin A Acetate, .beta.-carotene, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium Carbonate, Ferrous Fumarate, Zinc Oxide, Cupric Oxide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220316",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "AvPAK",
"SubstanceName": ".ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; BETA CAROTENE; CALCIUM CARBONATE; CHOLECALCIFEROL; CUPRIC OXIDE; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; VITAMIN A ACETATE; ZINC OXIDE",
"StrengthNumber": "9.9; 120; 920; 200; 400; 2; 12; 27; 1; 20; 10; 3; 1.84; 3080; 25",
"StrengthUnit": "mg/1; mg/1; [iU]/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; mg/1",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20220316",
"SamplePackage": "N",
"IndicationAndUsage": "To provide Vitamin and Mineral supplementation throughout pregnancy and during the postnatal period for both the lactating and non-lactating mother. It is also useful for improving nutritional status prior to conception.",
"Description": "Prenatal Plus Vitamin and Mineral Tablet is an orally administered prenatal / postnatal prescription dietary supplement for both lactating and non-lactating mothers and should be administered under the supervision of a licensed medical practitioner."
},
{
"NDCCode": "0053-0310-31",
"PackageDescription": "1 KIT in 1 CARTON (0053-0310-31) * 1 INJECTION, SUSPENSION in 1 VIAL, GLASS (0053-0099-01) ",
"NDC11Code": "00053-0310-31",
"ProductNDC": "0053-0310",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hemgenix",
"NonProprietaryName": "Etranacogene Dezaparvovec",
"DosageFormName": "KIT",
"StartMarketingDate": "20221122",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125772",
"LabelerName": "CSL Behring",
"Status": "Active",
"LastUpdate": "2026-05-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20221122",
"SamplePackage": "N",
"IndicationAndUsage": "HEMGENIX is indicated for treatment of adults with Hemophilia B (congenital Factor IX deficiency) who: 1 Currently use Factor IX prophylaxis therapy, or, 2 Have current or historical life-threatening hemorrhage, or, 3 Have repeated, serious spontaneous bleeding episodes.",
"Description": "HEMGENIX (etranacogene dezaparvovec-drlb) is an adeno-associated viral vector-based gene therapy for intravenous infusion after dilution. HEMGENIX is a non-replicating recombinant AAV5 containing a codon-optimized DNA sequence of the gain-of-function Padua variant of human Factor IX (variant R338L), under control of a liver-specific promotor 1 (LP1). HEMGENIX has a nominal concentration of 1 × 1013 gc/mL. Each vial contains an extractable volume of no less than 10 mL of HEMGENIX and the following excipients: sucrose (50 mg/mL), polysorbate-20 (0.22 mg/mL), potassium chloride (0.2 mg/mL), potassium phosphate (0.2 mg/mL), sodium chloride (8 mg/mL), and sodium phosphate (1.2 mg/mL). HEMGENIX is sterile, clear and colorless suspension, and contains no preservative. After dilution, HEMGENIX should be clear and colorless suspension."
},
{
"NDCCode": "0310-0075-01",
"PackageDescription": "28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-0075-01) ",
"NDC11Code": "00310-0075-01",
"ProductNDC": "0310-0075",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Etcamah",
"NonProprietaryName": "Camizestrant",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260904",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA220359",
"LabelerName": "AstraZeneca Pharmaceuticals LP",
"SubstanceName": "CAMIZESTRANT",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Status": "Active",
"LastUpdate": "2026-09-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260904",
"SamplePackage": "N",
"IndicationAndUsage": "ETCAMAH in combination with a CDK4/6 inhibitor (abemaciclib, palbociclib, or ribociclib) is indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer upon detection of ESR1 mutation during aromatase inhibitor and CDK4/6 inhibitor therapy, based on an FDA-authorized test [see Dosage and Administration (2.1)]. This indication is approved under accelerated approval based on progression-free survival as measured from detection of ESR1 mutation [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).",
"Description": "ETCAMAH tablets contain camizestrant, an estrogen receptor antagonist for oral use. The chemical name is N-[1-(3-fluoropropyl)-3-azetidinyl]-6-[(6S,8R)-8-methyl-7-(2,2,2-trifluoroethyl)-6,7,8,9-tetrahydro-3H-pyrazolo[4,3-f]isoquinolin-6-yl]-3-pyridinamine. Camizestrant is white to brown powder. The molecular formula for camizestrant is C24H28F4N6 and the molecular weight is 476.51 g/mol. The chemical structure for camizestrant is shown below. Each ETCAMAH tablet contains 75 mg camizestrant and the following inactive ingredients: anhydrous dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The tablet film-coating consists of ferric oxide red, ferric oxide yellow, ferrosoferric oxide, polyethylene glycol 3350, polyvinyl alcohol, talc and titanium dioxide."
},
{
"NDCCode": "0310-1105-30",
"PackageDescription": "30 PACKET in 1 BOX (0310-1105-30) / 5 g in 1 PACKET (0310-1105-01) ",
"NDC11Code": "00310-1105-30",
"ProductNDC": "0310-1105",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lokelma",
"NonProprietaryName": "Sodium Zirconium Cyclosilicate",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20180904",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA207078",
"LabelerName": "AstraZeneca Pharmaceuticals LP",
"SubstanceName": "SODIUM ZIRCONIUM CYCLOSILICATE",
"StrengthNumber": "5",
"StrengthUnit": "g/5g",
"Status": "Active",
"LastUpdate": "2025-02-13",
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"IndicationAndUsage": "LOKELMA is indicated for the treatment of hyperkalemia in adults. Limitation of Use. LOKELMA should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action [see Clinical Pharmacology (12.2) and Clinical Studies (14)].",
"Description": "LOKELMA is a powder for oral suspension. The active ingredient in LOKELMA is sodium zirconium cyclosilicate, a potassium binder. Sodium zirconium cyclosilicate is a non-absorbed zirconium silicate that preferentially exchanges potassium for hydrogen and sodium. LOKELMA is an odorless, insoluble white to grey powder for oral suspension. It has a mean particle size of 20 µm and includes no more than 3% of particles with a diameter below 3 µm. Each 5 g of sodium zirconium cyclosilicate contains 400 mg of sodium. The chemical formula of sodium zirconium cyclosilicate is Na~1.5H~0.5ZrSi3O92–3H2O. Figure 1: Crystal Structure of Sodium Zirconium Cyclosilicate."
},
{
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"PackageDescription": "11 PACKET in 1 BOX (0310-1105-39) / 5 g in 1 PACKET (0310-1105-01) ",
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"ProductNDC": "0310-1105",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lokelma",
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"IndicationAndUsage": "LOKELMA is indicated for the treatment of hyperkalemia in adults. Limitation of Use. LOKELMA should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action [see Clinical Pharmacology (12.2) and Clinical Studies (14)].",
"Description": "LOKELMA is a powder for oral suspension. The active ingredient in LOKELMA is sodium zirconium cyclosilicate, a potassium binder. Sodium zirconium cyclosilicate is a non-absorbed zirconium silicate that preferentially exchanges potassium for hydrogen and sodium. LOKELMA is an odorless, insoluble white to grey powder for oral suspension. It has a mean particle size of 20 µm and includes no more than 3% of particles with a diameter below 3 µm. Each 5 g of sodium zirconium cyclosilicate contains 400 mg of sodium. The chemical formula of sodium zirconium cyclosilicate is Na~1.5H~0.5ZrSi3O92–3H2O. Figure 1: Crystal Structure of Sodium Zirconium Cyclosilicate."
},
{
"NDCCode": "0310-1110-30",
"PackageDescription": "30 PACKET in 1 BOX (0310-1110-30) / 10 g in 1 PACKET (0310-1110-01) ",
"NDC11Code": "00310-1110-30",
"ProductNDC": "0310-1110",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"Description": "LOKELMA is a powder for oral suspension. The active ingredient in LOKELMA is sodium zirconium cyclosilicate, a potassium binder. Sodium zirconium cyclosilicate is a non-absorbed zirconium silicate that preferentially exchanges potassium for hydrogen and sodium. LOKELMA is an odorless, insoluble white to grey powder for oral suspension. It has a mean particle size of 20 µm and includes no more than 3% of particles with a diameter below 3 µm. Each 5 g of sodium zirconium cyclosilicate contains 400 mg of sodium. The chemical formula of sodium zirconium cyclosilicate is Na~1.5H~0.5ZrSi3O92–3H2O. Figure 1: Crystal Structure of Sodium Zirconium Cyclosilicate."
},
{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"LabelerName": "AstraZeneca Pharmaceuticals LP",
"SubstanceName": "SODIUM ZIRCONIUM CYCLOSILICATE",
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"IndicationAndUsage": "LOKELMA is indicated for the treatment of hyperkalemia in adults. Limitation of Use. LOKELMA should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action [see Clinical Pharmacology (12.2) and Clinical Studies (14)].",
"Description": "LOKELMA is a powder for oral suspension. The active ingredient in LOKELMA is sodium zirconium cyclosilicate, a potassium binder. Sodium zirconium cyclosilicate is a non-absorbed zirconium silicate that preferentially exchanges potassium for hydrogen and sodium. LOKELMA is an odorless, insoluble white to grey powder for oral suspension. It has a mean particle size of 20 µm and includes no more than 3% of particles with a diameter below 3 µm. Each 5 g of sodium zirconium cyclosilicate contains 400 mg of sodium. The chemical formula of sodium zirconium cyclosilicate is Na~1.5H~0.5ZrSi3O92–3H2O. Figure 1: Crystal Structure of Sodium Zirconium Cyclosilicate."
},
{
"NDCCode": "0310-1745-01",
"PackageDescription": "1 CARTRIDGE in 1 CARTON (0310-1745-01) / .5 mL in 1 CARTRIDGE",
"NDC11Code": "00310-1745-01",
"ProductNDC": "0310-1745",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fasenra",
"NonProprietaryName": "Benralizumab",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20240405",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761070",
"LabelerName": "AstraZeneca Pharmaceuticals LP",
"SubstanceName": "BENRALIZUMAB",
"StrengthNumber": "10",
"StrengthUnit": "mg/.5mL",
"Pharm_Classes": "Interleukin 5 Receptor alpha-directed Antibody Interactions [MoA], Interleukin-5 Receptor alpha-directed Cytolytic Antibody [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-28",
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"StartMarketingDatePackage": "20240603",
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"IndicationAndUsage": "FASENRA is an interleukin-5 receptor alpha-directed cytolytic monoclonal antibody (IgG1, kappa) indicated for: 1 add-on maintenance treatment of adult and pediatric patients aged 6 years and older with severe asthma, and with an eosinophilic phenotype. (1.1), 2 treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA). (1.2), 3 treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (HES) without an identifiable non-hematologic secondary cause. (1.3).",
"Description": "Benralizumab is a humanized monoclonal antibody (IgG1/κ-class) selective for interleukin-5 receptor alpha subunit (IL-5Rα). Benralizumab is produced in Chinese hamster ovary cells by recombinant DNA technology. Benralizumab has a molecular weight of approximately 150 kDa. FASENRA (benralizumab) injection is a sterile, preservative-free, clear to opalescent, colorless to slightly yellow solution for subcutaneous injection. Since benralizumab is a protein, a few translucent or white to off-white particles may be present in the solution. Each 10 mg single-dose prefilled syringe delivers 0.5 mL containing 10 mg benralizumab, L-histidine (0.7 mg); L-histidine hydrochloride monohydrate (1.2 mg); polysorbate 20 (0.03 mg); α,α‑trehalose dihydrate (47 mg); and Water for Injection, USP, at pH of 5.5 – 6.5. The single-dose prefilled syringe contains a 1 mL glass syringe with a staked 29-gauge ½ inch stainless steel needle. Each 30 mg single-dose prefilled syringe or single-dose autoinjector delivers 1 mL containing 30 mg benralizumab, L-histidine (1.4 mg); L-histidine hydrochloride monohydrate (2.3 mg); polysorbate 20 (0.06 mg); α,α‑trehalose dihydrate (95 mg); and Water for Injection, USP, at pH of 5.5 – 6.5. The single-dose prefilled syringe or single-dose autoinjector contains a 1 mL glass syringe with a staked 29-gauge ½ inch stainless steel needle."
},
{
"NDCCode": "0310-2021-01",
"PackageDescription": "15.6 kg in 1 CONTAINER (0310-2021-01) ",
"NDC11Code": "00310-2021-01",
"ProductNDC": "0310-2021",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Tozorakimab",
"DosageFormName": "LIQUID",
"StartMarketingDate": "20260416",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "AstraZeneca Pharmaceuticals LP",
"SubstanceName": "TOZORAKIMAB",
"StrengthNumber": "15.6",
"StrengthUnit": "kg/15.6kg",
"Status": "Unfinished",
"LastUpdate": "2026-04-17",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "16-APR-26"
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<PackageDescription>1 SYRINGE, GLASS in 1 CARTON (0310-3080-01) / .8 mL in 1 SYRINGE, GLASS (0310-3080-25) </PackageDescription>
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<IndicationAndUsage>SAPHNELO is indicated for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE), who are receiving standard therapy. Limitations of Use. The efficacy of SAPHNELO has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. Use of SAPHNELO is not recommended in these situations.</IndicationAndUsage>
<Description>Anifrolumab-fnia is a type I interferon (IFN) receptor antagonist, immunoglobulin G1 kappa (IgG1κ) monoclonal antibody that is produced in mouse myeloma cells (NS0) by recombinant DNA technology. The molecular weight is approximately 148 kDa. Intravenous Infusion. SAPHNELO (anifrolumab-fnia) injection is a sterile, preservative‑free, clear to opalescent, colorless to slightly yellow, solution in a single-dose vial for intravenous use. Each 2 mL single-dose vial contains 300 mg (150 mg/mL) of anifrolumab-fnia, histidine (3 mg), L-histidine hydrochloride monohydrate (6 mg), lysine hydrochloride (18 mg), polysorbate 80 (1 mg), trehalose (89 mg), and Water for Injection, USP. The pH is 5.9. Subcutaneous Injection. SAPHNELO (anifrolumab-fnia) injection is a sterile, preservative-free, clear to opalescent, colorless to slightly yellow, solution in a prefilled syringe or autoinjector for subcutaneous injection. Each 0.8 mL single-dose prefilled syringe or autoinjector delivers 120 mg of anifrolumab-fnia, histidine (1 mg), L-histidine hydrochloride monohydrate (3 mg), lysine hydrochloride (7 mg), polysorbate 80 (0.4 mg), trehalose (36 mg), and Water for Injection, USP. The pH is 5.9.</Description>
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<PackageDescription>1 SYRINGE, GLASS in 1 CARTON (0310-3080-02) / .8 mL in 1 SYRINGE, GLASS (0310-3080-75) </PackageDescription>
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<Description>Anifrolumab-fnia is a type I interferon (IFN) receptor antagonist, immunoglobulin G1 kappa (IgG1κ) monoclonal antibody that is produced in mouse myeloma cells (NS0) by recombinant DNA technology. The molecular weight is approximately 148 kDa. Intravenous Infusion. SAPHNELO (anifrolumab-fnia) injection is a sterile, preservative‑free, clear to opalescent, colorless to slightly yellow, solution in a single-dose vial for intravenous use. Each 2 mL single-dose vial contains 300 mg (150 mg/mL) of anifrolumab-fnia, histidine (3 mg), L-histidine hydrochloride monohydrate (6 mg), lysine hydrochloride (18 mg), polysorbate 80 (1 mg), trehalose (89 mg), and Water for Injection, USP. The pH is 5.9. Subcutaneous Injection. SAPHNELO (anifrolumab-fnia) injection is a sterile, preservative-free, clear to opalescent, colorless to slightly yellow, solution in a prefilled syringe or autoinjector for subcutaneous injection. Each 0.8 mL single-dose prefilled syringe or autoinjector delivers 120 mg of anifrolumab-fnia, histidine (1 mg), L-histidine hydrochloride monohydrate (3 mg), lysine hydrochloride (7 mg), polysorbate 80 (0.4 mg), trehalose (36 mg), and Water for Injection, USP. The pH is 5.9.</Description>
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<Pharm_Classes>Type I Interferon Receptor Antagonist [EPC], Type I Interferon Receptor Antagonists [MoA]</Pharm_Classes>
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<LastUpdate>2026-10-05</LastUpdate>
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<IndicationAndUsage>SAPHNELO is indicated for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE), who are receiving standard therapy. Limitations of Use. The efficacy of SAPHNELO has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. Use of SAPHNELO is not recommended in these situations.</IndicationAndUsage>
<Description>Anifrolumab-fnia is a type I interferon (IFN) receptor antagonist, immunoglobulin G1 kappa (IgG1κ) monoclonal antibody that is produced in mouse myeloma cells (NS0) by recombinant DNA technology. The molecular weight is approximately 148 kDa. Intravenous Infusion. SAPHNELO (anifrolumab-fnia) injection is a sterile, preservative‑free, clear to opalescent, colorless to slightly yellow, solution in a single-dose vial for intravenous use. Each 2 mL single-dose vial contains 300 mg (150 mg/mL) of anifrolumab-fnia, histidine (3 mg), L-histidine hydrochloride monohydrate (6 mg), lysine hydrochloride (18 mg), polysorbate 80 (1 mg), trehalose (89 mg), and Water for Injection, USP. The pH is 5.9. Subcutaneous Injection. SAPHNELO (anifrolumab-fnia) injection is a sterile, preservative-free, clear to opalescent, colorless to slightly yellow, solution in a prefilled syringe or autoinjector for subcutaneous injection. Each 0.8 mL single-dose prefilled syringe or autoinjector delivers 120 mg of anifrolumab-fnia, histidine (1 mg), L-histidine hydrochloride monohydrate (3 mg), lysine hydrochloride (7 mg), polysorbate 80 (0.4 mg), trehalose (36 mg), and Water for Injection, USP. The pH is 5.9.</Description>
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<ProductNDC>0006-3080</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Isentress</ProprietaryName>
<NonProprietaryName>Raltegravir</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170526</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022145</ApplicationNumber>
<LabelerName>Merck Sharp & Dohme LLC</LabelerName>
<SubstanceName>RALTEGRAVIR POTASSIUM</SubstanceName>
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<Pharm_Classes>HIV Integrase Inhibitors [MoA], Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170526</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adult Patients. ISENTRESS and ISENTRESS HD are human immunodeficiency virus integrase strand transfer inhibitors (HIV-1 INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adult patients (1). Pediatric Patients. ISENTRESS is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients weighing at least 2 kg (1). ISENTRESS HD is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients weighing at least 40 kg (1).</IndicationAndUsage>
<Description>ISENTRESS contains raltegravir potassium, a human immunodeficiency virus integrase strand transfer inhibitor. The chemical name for raltegravir potassium is N-[(4-Fluorophenyl) methyl]-1,6-dihydro-5-hydroxy-1-methyl-2-[1-methyl-1-[[(5-methyl-1,3,4-oxadiazol-2-yl)carbonyl]amino]ethyl]-6-oxo-4-pyrimidinecarboxamide monopotassium salt. The empirical formula is C20H20FKN6O5 and the molecular weight is 482.51. The structural formula is. Raltegravir potassium is a white to off-white powder. It is soluble in water, slightly soluble in methanol, very slightly soluble in ethanol and acetonitrile and insoluble in isopropanol. Each 400 mg film-coated tablet of ISENTRESS for oral administration contains 434.4 mg of raltegravir (as potassium salt), equivalent to 400 mg of raltegravir free phenol and the following inactive ingredients: calcium phosphate dibasic anhydrous, hypromellose 2208, lactose monohydrate, magnesium stearate, microcrystalline cellulose, poloxamer 407 (contains 0.01% butylated hydroxytoluene as antioxidant), sodium stearyl fumarate. In addition, the film coating contains the following inactive ingredients: black iron oxide, polyethylene glycol 3350, polyvinyl alcohol, red iron oxide, talc and titanium dioxide. Each 600 mg film-coated tablet of ISENTRESS HD for oral administration contains 651.6 mg of raltegravir (as potassium salt), equivalent to 600 mg of raltegravir free phenol and the following inactive ingredients: croscarmellose sodium, hypromellose 2910, magnesium stearate, microcrystalline cellulose. The film coating contains the following inactive ingredients: ferrosoferric oxide, hypromellose 2910, iron oxide yellow, lactose monohydrate, triacetin and titanium dioxide. The tablet may also contain trace amount of carnauba wax. Each 100 mg chewable tablet of ISENTRESS for oral administration contains 108.6 mg of raltegravir (as potassium salt), equivalent to 100 mg of raltegravir free phenol and the following inactive ingredients: ammonium hydroxide, crospovidone, ethylcellulose 20 cP, fructose, hydroxypropyl cellulose, hypromellose 2910/6cP, magnesium stearate, mannitol, medium chain triglycerides, monoammonium glycyrrhizinate, natural and artificial flavors (orange, banana, and masking that contains aspartame), oleic acid, PEG 400, red iron oxide, saccharin sodium, sodium citrate dihydrate, sodium stearyl fumarate, sorbitol, sucralose and yellow iron oxide. Each 25 mg chewable tablet of ISENTRESS for oral administration contains 27.16 mg of raltegravir (as potassium salt), equivalent to 25 mg of raltegravir free phenol and the following inactive ingredients: ammonium hydroxide, crospovidone, ethylcellulose 20 cP, fructose, hydroxypropyl cellulose, hypromellose 2910/6cP, magnesium stearate, mannitol, medium chain triglycerides, monoammonium glycyrrhizinate, natural and artificial flavors (orange, banana, and masking that contains aspartame), oleic acid, PEG 400, saccharin sodium, sodium citrate dihydrate, sodium stearyl fumarate, sorbitol, sucralose and yellow iron oxide. Each packet of ISENTRESS for oral suspension 100 mg, contains 108.6 mg of raltegravir (as potassium salt), equivalent to 100 mg of raltegravir free phenol and the following inactive ingredients: ammonium hydroxide, banana with other natural flavors, carboxymethylcellulose sodium, crospovidone, ethylcellulose 20 cP, fructose, hydroxypropyl cellulose, hypromellose 2910/6cP, macrogol/PEG 400, magnesium stearate, maltodextrin, mannitol, medium chain triglycerides, microcrystalline cellulose, monoammonium glycyrrhizinate, oleic acid, sorbitol, sucralose and sucrose.</Description>
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<PackageDescription>1 TUBE in 1 BLISTER PACK (10742-3080-1) / 4.2 g in 1 TUBE</PackageDescription>
<NDC11Code>10742-3080-01</NDC11Code>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mentholatum Natural Ice Protect Plus Spf 30</ProprietaryName>
<ProprietaryNameSuffix>Protect Plus Spf 30</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Dimethicone, Octinoxate, Octisalate</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240901</StartMarketingDate>
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<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>The Mentholatum Company</LabelerName>
<SubstanceName>OCTINOXATE; OCTISALATE; AVOBENZONE; DIMETHICONE</SubstanceName>
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<StrengthUnit>mg/g; mg/g; mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Skin Barrier Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>helps prevent sunburn. temporarily protects chapped or cracked lips. protect from the drying effects of wind and cold weather.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>36987-3080-1</NDCCode>
<PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (36987-3080-1)</PackageDescription>
<NDC11Code>36987-3080-01</NDC11Code>
<ProductNDC>36987-3080</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>English Walnut</ProprietaryName>
<NonProprietaryName>English Walnut</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>JUGLANS REGIA POLLEN</SubstanceName>
<StrengthNumber>20000</StrengthNumber>
<StrengthUnit>[PNU]/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
<Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
</NDC>
<NDC>
<NDCCode>37662-3080-1</NDCCode>
<PackageDescription>200 PELLET in 1 VIAL, GLASS (37662-3080-1) </PackageDescription>
<NDC11Code>37662-3080-01</NDC11Code>
<ProductNDC>37662-3080</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Strontium Phosphoricum</ProprietaryName>
<NonProprietaryName>Strontium Phosphoricum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230501</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>STRONTIUM PHOSPHATE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-05-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>48951-3080-1</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 BAG (48951-3080-1) > 7 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>48951-3080-01</NDC11Code>
<ProductNDC>48951-3080</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Chelidonium Rosa</ProprietaryName>
<NonProprietaryName>Chelidonium Rosa</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090901</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Uriel Pharmacy Inc.</LabelerName>
<SubstanceName>FERRIC OXIDE RED; SEDUM ROSEUM WHOLE; CHELIDONIUM MAJUS ROOT; RUTA GRAVEOLENS FLOWERING TOP; SILICON DIOXIDE; LARIX DECIDUA RESIN</SubstanceName>
<StrengthNumber>3; 3; 4; 4; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-10-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>53002-3080-1</NDCCode>
<PackageDescription>5 TABLET, FILM COATED in 1 BOTTLE (53002-3080-1) </PackageDescription>
<NDC11Code>53002-3080-01</NDC11Code>
<ProductNDC>53002-3080</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cyclobenzaprine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cyclobenzaprine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160722</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090478</ApplicationNumber>
<LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CYCLOBENZAPRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cyclobenzaprine HCl tablets USP are indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living. Cyclobenzaprine HCl should be used only for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use is not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted. Cyclobenzaprine HCl has not been found effective in the treatment of spasticity associated with cerebral or spinal cord disease, or in children with cerebral palsy.</IndicationAndUsage>
<Description>Cyclobenzaprine hydrochloride, USP is a white, crystalline tricyclic amine salt with the empirical formula C20H21NHCl and a molecular weight of 311.9. It has a melting point of 217˚C, and a pKa of 8.47 at 25˚C. It is freely soluble in water and alcohol, sparingly soluble in isopropanol, and insoluble in hydrocarbon solvents. If aqueous solutions are made alkaline, the free base separates. Cyclobenzaprine HCl, USP is designated chemically as 3-(5H –dibenzo[a,d]cyclohepten-5-ylidene)-N, N-dimethyl-1-propanamine hydrochloride, and has the following structural formula. Cyclobenzaprine HCl USP, 5 mg is supplied as a 5 mg tablet for oral administration. Cyclobenzaprine HCl USP, 10 mg is supplied as a 10 mg tablet for oral administration. Cyclobenzaprine HCl tablets USP, 5 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry beige (hypromellose 6cP, titanium dioxide, PEG 400, iron oxide yellow and iron oxide red). Cyclobenzaprine HCl tablets USP, 10 mg contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate and opadry yellow (hypromellose 3cp, hypromellose 6cp, titanium dioxide, PEG 400, iron oxide yellow and polysorbate 80).</Description>
</NDC>
<NDC>
<NDCCode>59762-3080-1</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (59762-3080-1) </PackageDescription>
<NDC11Code>59762-3080-01</NDC11Code>
<ProductNDC>59762-3080</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Azithromycin</ProprietaryName>
<NonProprietaryName>Azithromycin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19960612</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050730</ApplicationNumber>
<LabelerName>Greenstone LLC</LabelerName>
<SubstanceName>AZITHROMYCIN DIHYDRATE</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Macrolide Antimicrobial [EPC],Macrolides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-03-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19960612</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62991-3080-1</NDCCode>
<PackageDescription>5 g in 1 JAR (62991-3080-1)</PackageDescription>
<NDC11Code>62991-3080-01</NDC11Code>
<ProductNDC>62991-3080</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Levocetirizine Dihydrochloride</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20140821</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>LETCO MEDICAL, LLC</LabelerName>
<SubstanceName>LEVOCETIRIZINE DIHYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>70518-3080-1</NDCCode>
<PackageDescription>30 POUCH in 1 BOX (70518-3080-1) > 1 TABLET in 1 POUCH (70518-3080-2) </PackageDescription>
<NDC11Code>70518-3080-01</NDC11Code>
<ProductNDC>70518-3080</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Biktarvy</ProprietaryName>
<NonProprietaryName>Bictegravir Sodium, Emtricitabine, And Tenofovir Alafenamide Fumarate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210428</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA210251</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE</SubstanceName>
<StrengthNumber>50; 200; 25</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS], Nucleosides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-06-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210714</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71335-3080-1</NDCCode>
<PackageDescription>90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-3080-1) </PackageDescription>
<NDC11Code>71335-3080-01</NDC11Code>
<ProductNDC>71335-3080</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Morphine Sulfate</ProprietaryName>
<NonProprietaryName>Morphine Sulfate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120511</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078761</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>MORPHINE SULFATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-02-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260213</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Morphine sulfate extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of Use: 1 Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations[see Warnings and Precautions (5.1)], reserve morphine sulfate extended-release tabletsfor use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain., 2 Morphine sulfate extended-release tabletsare not indicated as an as-needed (prn) analgesic.</IndicationAndUsage>
<Description>Morphine sulfate extended-release tablets are for oral use and contains morphine sulfate, an opioid agonist.Each tablet contains the following inactive ingredients common to all strengths: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, povidone, stearic acid, talc and titanium dioxide.The tablet strengths describe the amount of morphine per tablet as the pentahydrated sulfate salt (morphine sulfate, USP).The 15 mg tablets also contain: FD&C Blue # 2/Indigo carmine aluminum lake, ferrosoferric oxide, macrogol/PEG 4000 and macrogol/PEG 400The 30 mg tablets also contain: D&C Red # 27/Phloxine aluminum lake, FD&C Blue # 2/Indigo carmine aluminum lake, macrogol/PEG 4000 and macrogol/PEG 400The 60 mg tablets also contain: FD&C Yellow # 6 aluminum lake and macrogol/PEG 4000 and macrogol/PEG 400The 100 mg tablets also contain: FD&C Blue # 2/Indigo carmine aluminum lake, ferrosoferric oxide, ferric oxide yellow, macrogol/PEG 4000 and macrogol/PEG 400The 200 mg tablets also contain: D&C Yellow # 10 aluminum lake, FD&C Blue # 2/Indigo carmine aluminum lake, macrogol/PEG 4000 and macrogol/PEG 400. Morphine sulfate, USP are white, feathery, silky crystals, cubical masses of crystals, or white crystalline powder, soluble in water, freely soluble in hot water, slightly soluble in alcohol but more so in hot alcohol, insoluble in chloroform and in ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its molecular weight is 758.83 and its structural formula is.</Description>
</NDC>
<NDC>
<NDCCode>0015-3080-60</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0015-3080-60) </PackageDescription>
<NDC11Code>00015-3080-60</NDC11Code>
<ProductNDC>0015-3080</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lysodren</ProprietaryName>
<NonProprietaryName>Mitotane</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090601</StartMarketingDate>
<EndMarketingDate>20210331</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA016885</ApplicationNumber>
<LabelerName>E.R. Squibb & Sons, L.L.C.</LabelerName>
<SubstanceName>MITOTANE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 3A4 Inducers [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-04-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20090601</StartMarketingDatePackage>
<EndMarketingDatePackage>20210331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0904-5339-60</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0904-5339-60)</PackageDescription>
<NDC11Code>00904-5339-60</NDC11Code>
<ProductNDC>0904-5339</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prenatal Plus Iron</ProprietaryName>
<NonProprietaryName>Multivitamin/multimineral Supplement</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110607</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Major Pharmaceuticals</LabelerName>
<SubstanceName>VITAMIN A ACETATE; .BETA.-CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE; IRON PENTACARBONYL; ZINC OXIDE; CUPRIC OXIDE</SubstanceName>
<StrengthNumber>3080; 920; 120; 400; 22; 1.84; 3; 20; 10; 1; 12; 200; 29; 25; 2</StrengthNumber>
<StrengthUnit>[iU]/1; [iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Vitamin A [Chemical/Ingredient],Vitamin A [EPC],Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-11-01</LastUpdate>
</NDC>
<NDC>
<NDCCode>15338-522-10</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (15338-522-10) </PackageDescription>
<NDC11Code>15338-0522-10</NDC11Code>
<ProductNDC>15338-522</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prenatal Plus</ProprietaryName>
<NonProprietaryName>Vitamin A Acetate, Beta Carotene, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium Carbonate, Ferrous Fumarate, Zinc Oxide, Cupric Oxide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120911</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Apace Packaging, LLC</LabelerName>
<SubstanceName>VITAMIN A ACETATE; CYANOCOBALAMIN; ASCORBIC ACID; CHOLECALCIFEROL; FOLIC ACID; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; .ALPHA.-TOCOPHEROL ACETATE, DL-; .BETA.-CAROTENE; ZINC OXIDE; CALCIUM CARBONATE; FERROUS FUMARATE; PYRIDOXINE HYDROCHLORIDE; CUPRIC OXIDE</SubstanceName>
<StrengthNumber>3080; 12; 120; 400; 1; 1.84; 3; 20; 22; 920; 25; 200; 27; 10; 2</StrengthNumber>
<StrengthUnit>[iU]/1; ug/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Vitamin A [CS],Vitamin A [EPC],Vitamin B 12 [CS],Vitamin B12 [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Vitamin D [CS],Vitamin D [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170719</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>17856-0668-1</NDCCode>
<PackageDescription>1 TABLET, FILM COATED in 1 POUCH (17856-0668-1)</PackageDescription>
<NDC11Code>17856-0668-01</NDC11Code>
<ProductNDC>17856-0668</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prenatal Plus</ProprietaryName>
<NonProprietaryName>Vitamin A Acetate, .beta.-carotene, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium Carbonate, Ferrous Fumarate, Zinc Oxide, Cupric Oxide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20091202</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Atlantic Biologicals Corps</LabelerName>
<SubstanceName>VITAMIN A ACETATE; .BETA.-CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM CARBONATE; FERROUS FUMARATE; ZINC OXIDE; CUPRIC OXIDE</SubstanceName>
<StrengthNumber>3080; 920; 120; 400; 22; 1.84; 3; 20; 10; 1; 12; 200; 27; 25; 2</StrengthNumber>
<StrengthUnit>[iU]/1; [iU]/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Vitamin A [CS],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Vitamin D [CS],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>To provide Vitamin and Mineral supplementation throughout pregnancy and during the postnatal period for both the lactating and non-lactating mother. It is also useful for improving nutritional status prior to conception.</IndicationAndUsage>
<Description>Each Tablet Contains. VITAMINS: Amount per Tablet. Vitamin A (from Acetate and Beta Carotene) ............................. 4000 IU. Vitamin C (Ascorbic Acid) ........................................................... 120 mg. Vitamin D-3 (Cholecalciferol) ....................................................... 400 IU. Vitamin E (dl- Alpha Tocopheryl Acetate) ...................................... 22 IU. Thiamine (Vitamin B-1) (from Thiamine Mononitrate) ................. 1.84 mg. Riboflavin (Vitamin B-2) .................................................................. 3 mg. Niacin (as Niacinamide) ................................................................ 20 mg. Vitamin B-6 (Pyridoxine HCl) ......................................................... 10 mg. Folic Acid ......................................................................................... 1 mg. Vitamin B-12 (Cyanocobalamin) ................................................... 12 mcg. MINERALS: Amount per Tablet. Calcium (as Calcium Carbonate) ................................................. 200 mg. Iron (from Ferrous Fumarate) ........................................................ 27 mg. Zinc (from Zinc Oxide) ................................................................... 25 mg. Copper (from Cupric Oxide) ........................................................... 2 mg. croscarmellose sodium, FD&C Blue #2, FD&C Red #40, FD&C Yellow # 5, FD&C Yellow # 6, macrogol, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, silicon, starch, stearic acid, talc, titanium dioxide Other ingredients.</Description>
</NDC>
<NDC>
<NDCCode>39328-106-50</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE, PLASTIC (39328-106-50) </PackageDescription>
<NDC11Code>39328-0106-50</NDC11Code>
<ProductNDC>39328-106</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prenatal Vitamins Plus Low Iron</ProprietaryName>
<NonProprietaryName>Prenatal With Ferrous Fum And Folic Acid</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130401</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Patrin Pharma, Inc.</LabelerName>
<SubstanceName>.ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; BETA CAROTENE; CALCIUM CARBONATE; CHOLECALCIFEROL; COPPER; CYANOCOBALAMIN; FOLIC ACID; IRON; NIACIN; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE; VITAMIN A ACETATE; ZINC</SubstanceName>
<StrengthNumber>22; 120; 920; 200; 400; 2; 12; 1; 27; 20; 10; 3; 1.84; 3080; 25</StrengthNumber>
<StrengthUnit>mg/1; mg/1; [iU]/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Increased Coagulation Factor Activity [PE], Inhibit Ovum Fertilization [PE], Nicotinic Acid [EPC], Nicotinic Acids [CS], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>42291-686-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (42291-686-01) </PackageDescription>
<NDC11Code>42291-0686-01</NDC11Code>
<ProductNDC>42291-686</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prenatal Plus</ProprietaryName>
<NonProprietaryName>Vitamin A Acetate, Beta Carotene, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium Carbonate, Ferrous Fumarate, Zinc Oxide, Cupric Oxide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120911</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>AvKARE, Inc.</LabelerName>
<SubstanceName>VITAMIN A ACETATE; CYANOCOBALAMIN; ASCORBIC ACID; CHOLECALCIFEROL; FOLIC ACID; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; .ALPHA.-TOCOPHEROL ACETATE, DL-; .BETA.-CAROTENE; ZINC OXIDE; CALCIUM CARBONATE; FERROUS FUMARATE; PYRIDOXINE HYDROCHLORIDE; CUPRIC OXIDE</SubstanceName>
<StrengthNumber>3080; 12; 120; 400; 1; 1.84; 3; 20; 22; 920; 25; 200; 27; 10; 2</StrengthNumber>
<StrengthUnit>[iU]/1; ug/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Vitamin A [CS],Vitamin A [EPC],Vitamin B 12 [CS],Vitamin B12 [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Vitamin D [CS],Vitamin D [EPC],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [CS],Cations, Divalent [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170719</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49902-3080-3</NDCCode>
<PackageDescription>236 mL in 1 BOTTLE, SPRAY (49902-3080-3) </PackageDescription>
<NDC11Code>49902-3080-03</NDC11Code>
<ProductNDC>49902-3080</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizer-lemonade</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200330</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>BB Trading Worldwide Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50090-3080-0</NDCCode>
<PackageDescription>33 BLISTER PACK in 1 BOX, UNIT-DOSE (50090-3080-0) > 1 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>50090-3080-00</NDC11Code>
<ProductNDC>50090-3080</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dicyclomine Hydrochloride</ProprietaryName>
<NonProprietaryName>Dicyclomine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19991103</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040317</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>DICYCLOMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC],Cholinergic Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170628</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50268-677-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (50268-677-01) </PackageDescription>
<NDC11Code>50268-0677-01</NDC11Code>
<ProductNDC>50268-677</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prenatal Plus</ProprietaryName>
<NonProprietaryName>Vitamin A Acetate, .beta.-carotene, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Calcium Carbonate, Ferrous Fumarate, Zinc Oxide, Cupric Oxide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220316</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>AvPAK</LabelerName>
<SubstanceName>.ALPHA.-TOCOPHEROL ACETATE, DL-; ASCORBIC ACID; BETA CAROTENE; CALCIUM CARBONATE; CHOLECALCIFEROL; CUPRIC OXIDE; CYANOCOBALAMIN; FERROUS FUMARATE; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE MONONITRATE; VITAMIN A ACETATE; ZINC OXIDE</SubstanceName>
<StrengthNumber>9.9; 120; 920; 200; 400; 2; 12; 27; 1; 20; 10; 3; 1.84; 3080; 25</StrengthNumber>
<StrengthUnit>mg/1; mg/1; [iU]/1; mg/1; [iU]/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; mg/1</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 12 [CS], Vitamin B 6 [Chemical/Ingredient], Vitamin B12 [EPC], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220316</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To provide Vitamin and Mineral supplementation throughout pregnancy and during the postnatal period for both the lactating and non-lactating mother. It is also useful for improving nutritional status prior to conception.</IndicationAndUsage>
<Description>Prenatal Plus Vitamin and Mineral Tablet is an orally administered prenatal / postnatal prescription dietary supplement for both lactating and non-lactating mothers and should be administered under the supervision of a licensed medical practitioner.</Description>
</NDC>
<NDC>
<NDCCode>0053-0310-31</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0053-0310-31) * 1 INJECTION, SUSPENSION in 1 VIAL, GLASS (0053-0099-01) </PackageDescription>
<NDC11Code>00053-0310-31</NDC11Code>
<ProductNDC>0053-0310</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hemgenix</ProprietaryName>
<NonProprietaryName>Etranacogene Dezaparvovec</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20221122</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125772</ApplicationNumber>
<LabelerName>CSL Behring</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-05-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221122</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>HEMGENIX is indicated for treatment of adults with Hemophilia B (congenital Factor IX deficiency) who: 1 Currently use Factor IX prophylaxis therapy, or, 2 Have current or historical life-threatening hemorrhage, or, 3 Have repeated, serious spontaneous bleeding episodes.</IndicationAndUsage>
<Description>HEMGENIX (etranacogene dezaparvovec-drlb) is an adeno-associated viral vector-based gene therapy for intravenous infusion after dilution. HEMGENIX is a non-replicating recombinant AAV5 containing a codon-optimized DNA sequence of the gain-of-function Padua variant of human Factor IX (variant R338L), under control of a liver-specific promotor 1 (LP1). HEMGENIX has a nominal concentration of 1 × 1013 gc/mL. Each vial contains an extractable volume of no less than 10 mL of HEMGENIX and the following excipients: sucrose (50 mg/mL), polysorbate-20 (0.22 mg/mL), potassium chloride (0.2 mg/mL), potassium phosphate (0.2 mg/mL), sodium chloride (8 mg/mL), and sodium phosphate (1.2 mg/mL). HEMGENIX is sterile, clear and colorless suspension, and contains no preservative. After dilution, HEMGENIX should be clear and colorless suspension.</Description>
</NDC>
<NDC>
<NDCCode>0310-0075-01</NDCCode>
<PackageDescription>28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-0075-01) </PackageDescription>
<NDC11Code>00310-0075-01</NDC11Code>
<ProductNDC>0310-0075</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Etcamah</ProprietaryName>
<NonProprietaryName>Camizestrant</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260904</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA220359</ApplicationNumber>
<LabelerName>AstraZeneca Pharmaceuticals LP</LabelerName>
<SubstanceName>CAMIZESTRANT</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-09-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260904</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>ETCAMAH in combination with a CDK4/6 inhibitor (abemaciclib, palbociclib, or ribociclib) is indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer upon detection of ESR1 mutation during aromatase inhibitor and CDK4/6 inhibitor therapy, based on an FDA-authorized test [see Dosage and Administration (2.1)]. This indication is approved under accelerated approval based on progression-free survival as measured from detection of ESR1 mutation [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).</IndicationAndUsage>
<Description>ETCAMAH tablets contain camizestrant, an estrogen receptor antagonist for oral use. The chemical name is N-[1-(3-fluoropropyl)-3-azetidinyl]-6-[(6S,8R)-8-methyl-7-(2,2,2-trifluoroethyl)-6,7,8,9-tetrahydro-3H-pyrazolo[4,3-f]isoquinolin-6-yl]-3-pyridinamine. Camizestrant is white to brown powder. The molecular formula for camizestrant is C24H28F4N6 and the molecular weight is 476.51 g/mol. The chemical structure for camizestrant is shown below. Each ETCAMAH tablet contains 75 mg camizestrant and the following inactive ingredients: anhydrous dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The tablet film-coating consists of ferric oxide red, ferric oxide yellow, ferrosoferric oxide, polyethylene glycol 3350, polyvinyl alcohol, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0310-1105-30</NDCCode>
<PackageDescription>30 PACKET in 1 BOX (0310-1105-30) / 5 g in 1 PACKET (0310-1105-01) </PackageDescription>
<NDC11Code>00310-1105-30</NDC11Code>
<ProductNDC>0310-1105</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lokelma</ProprietaryName>
<NonProprietaryName>Sodium Zirconium Cyclosilicate</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180904</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207078</ApplicationNumber>
<LabelerName>AstraZeneca Pharmaceuticals LP</LabelerName>
<SubstanceName>SODIUM ZIRCONIUM CYCLOSILICATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/5g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-02-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180904</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LOKELMA is indicated for the treatment of hyperkalemia in adults. Limitation of Use. LOKELMA should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action [see Clinical Pharmacology (12.2) and Clinical Studies (14)].</IndicationAndUsage>
<Description>LOKELMA is a powder for oral suspension. The active ingredient in LOKELMA is sodium zirconium cyclosilicate, a potassium binder. Sodium zirconium cyclosilicate is a non-absorbed zirconium silicate that preferentially exchanges potassium for hydrogen and sodium. LOKELMA is an odorless, insoluble white to grey powder for oral suspension. It has a mean particle size of 20 µm and includes no more than 3% of particles with a diameter below 3 µm. Each 5 g of sodium zirconium cyclosilicate contains 400 mg of sodium. The chemical formula of sodium zirconium cyclosilicate is Na~1.5H~0.5ZrSi3O92–3H2O. Figure 1: Crystal Structure of Sodium Zirconium Cyclosilicate.</Description>
</NDC>
<NDC>
<NDCCode>0310-1105-39</NDCCode>
<PackageDescription>11 PACKET in 1 BOX (0310-1105-39) / 5 g in 1 PACKET (0310-1105-01) </PackageDescription>
<NDC11Code>00310-1105-39</NDC11Code>
<ProductNDC>0310-1105</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lokelma</ProprietaryName>
<NonProprietaryName>Sodium Zirconium Cyclosilicate</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180904</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207078</ApplicationNumber>
<LabelerName>AstraZeneca Pharmaceuticals LP</LabelerName>
<SubstanceName>SODIUM ZIRCONIUM CYCLOSILICATE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/5g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-02-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LOKELMA is indicated for the treatment of hyperkalemia in adults. Limitation of Use. LOKELMA should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action [see Clinical Pharmacology (12.2) and Clinical Studies (14)].</IndicationAndUsage>
<Description>LOKELMA is a powder for oral suspension. The active ingredient in LOKELMA is sodium zirconium cyclosilicate, a potassium binder. Sodium zirconium cyclosilicate is a non-absorbed zirconium silicate that preferentially exchanges potassium for hydrogen and sodium. LOKELMA is an odorless, insoluble white to grey powder for oral suspension. It has a mean particle size of 20 µm and includes no more than 3% of particles with a diameter below 3 µm. Each 5 g of sodium zirconium cyclosilicate contains 400 mg of sodium. The chemical formula of sodium zirconium cyclosilicate is Na~1.5H~0.5ZrSi3O92–3H2O. Figure 1: Crystal Structure of Sodium Zirconium Cyclosilicate.</Description>
</NDC>
<NDC>
<NDCCode>0310-1110-30</NDCCode>
<PackageDescription>30 PACKET in 1 BOX (0310-1110-30) / 10 g in 1 PACKET (0310-1110-01) </PackageDescription>
<NDC11Code>00310-1110-30</NDC11Code>
<ProductNDC>0310-1110</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lokelma</ProprietaryName>
<NonProprietaryName>Sodium Zirconium Cyclosilicate</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180904</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207078</ApplicationNumber>
<LabelerName>AstraZeneca Pharmaceuticals LP</LabelerName>
<SubstanceName>SODIUM ZIRCONIUM CYCLOSILICATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>g/10g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-02-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180904</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LOKELMA is indicated for the treatment of hyperkalemia in adults. Limitation of Use. LOKELMA should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action [see Clinical Pharmacology (12.2) and Clinical Studies (14)].</IndicationAndUsage>
<Description>LOKELMA is a powder for oral suspension. The active ingredient in LOKELMA is sodium zirconium cyclosilicate, a potassium binder. Sodium zirconium cyclosilicate is a non-absorbed zirconium silicate that preferentially exchanges potassium for hydrogen and sodium. LOKELMA is an odorless, insoluble white to grey powder for oral suspension. It has a mean particle size of 20 µm and includes no more than 3% of particles with a diameter below 3 µm. Each 5 g of sodium zirconium cyclosilicate contains 400 mg of sodium. The chemical formula of sodium zirconium cyclosilicate is Na~1.5H~0.5ZrSi3O92–3H2O. Figure 1: Crystal Structure of Sodium Zirconium Cyclosilicate.</Description>
</NDC>
<NDC>
<NDCCode>0310-1110-39</NDCCode>
<PackageDescription>11 PACKET in 1 BOX (0310-1110-39) / 10 g in 1 PACKET (0310-1110-01) </PackageDescription>
<NDC11Code>00310-1110-39</NDC11Code>
<ProductNDC>0310-1110</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lokelma</ProprietaryName>
<NonProprietaryName>Sodium Zirconium Cyclosilicate</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180904</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA207078</ApplicationNumber>
<LabelerName>AstraZeneca Pharmaceuticals LP</LabelerName>
<SubstanceName>SODIUM ZIRCONIUM CYCLOSILICATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>g/10g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-02-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190102</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LOKELMA is indicated for the treatment of hyperkalemia in adults. Limitation of Use. LOKELMA should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action [see Clinical Pharmacology (12.2) and Clinical Studies (14)].</IndicationAndUsage>
<Description>LOKELMA is a powder for oral suspension. The active ingredient in LOKELMA is sodium zirconium cyclosilicate, a potassium binder. Sodium zirconium cyclosilicate is a non-absorbed zirconium silicate that preferentially exchanges potassium for hydrogen and sodium. LOKELMA is an odorless, insoluble white to grey powder for oral suspension. It has a mean particle size of 20 µm and includes no more than 3% of particles with a diameter below 3 µm. Each 5 g of sodium zirconium cyclosilicate contains 400 mg of sodium. The chemical formula of sodium zirconium cyclosilicate is Na~1.5H~0.5ZrSi3O92–3H2O. Figure 1: Crystal Structure of Sodium Zirconium Cyclosilicate.</Description>
</NDC>
<NDC>
<NDCCode>0310-1745-01</NDCCode>
<PackageDescription>1 CARTRIDGE in 1 CARTON (0310-1745-01) / .5 mL in 1 CARTRIDGE</PackageDescription>
<NDC11Code>00310-1745-01</NDC11Code>
<ProductNDC>0310-1745</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fasenra</ProprietaryName>
<NonProprietaryName>Benralizumab</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20240405</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761070</ApplicationNumber>
<LabelerName>AstraZeneca Pharmaceuticals LP</LabelerName>
<SubstanceName>BENRALIZUMAB</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/.5mL</StrengthUnit>
<Pharm_Classes>Interleukin 5 Receptor alpha-directed Antibody Interactions [MoA], Interleukin-5 Receptor alpha-directed Cytolytic Antibody [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240603</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>FASENRA is an interleukin-5 receptor alpha-directed cytolytic monoclonal antibody (IgG1, kappa) indicated for: 1 add-on maintenance treatment of adult and pediatric patients aged 6 years and older with severe asthma, and with an eosinophilic phenotype. (1.1), 2 treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA). (1.2), 3 treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (HES) without an identifiable non-hematologic secondary cause. (1.3).</IndicationAndUsage>
<Description>Benralizumab is a humanized monoclonal antibody (IgG1/κ-class) selective for interleukin-5 receptor alpha subunit (IL-5Rα). Benralizumab is produced in Chinese hamster ovary cells by recombinant DNA technology. Benralizumab has a molecular weight of approximately 150 kDa. FASENRA (benralizumab) injection is a sterile, preservative-free, clear to opalescent, colorless to slightly yellow solution for subcutaneous injection. Since benralizumab is a protein, a few translucent or white to off-white particles may be present in the solution. Each 10 mg single-dose prefilled syringe delivers 0.5 mL containing 10 mg benralizumab, L-histidine (0.7 mg); L-histidine hydrochloride monohydrate (1.2 mg); polysorbate 20 (0.03 mg); α,α‑trehalose dihydrate (47 mg); and Water for Injection, USP, at pH of 5.5 – 6.5. The single-dose prefilled syringe contains a 1 mL glass syringe with a staked 29-gauge ½ inch stainless steel needle. Each 30 mg single-dose prefilled syringe or single-dose autoinjector delivers 1 mL containing 30 mg benralizumab, L-histidine (1.4 mg); L-histidine hydrochloride monohydrate (2.3 mg); polysorbate 20 (0.06 mg); α,α‑trehalose dihydrate (95 mg); and Water for Injection, USP, at pH of 5.5 – 6.5. The single-dose prefilled syringe or single-dose autoinjector contains a 1 mL glass syringe with a staked 29-gauge ½ inch stainless steel needle.</Description>
</NDC>
<NDC>
<NDCCode>0310-2021-01</NDCCode>
<PackageDescription>15.6 kg in 1 CONTAINER (0310-2021-01) </PackageDescription>
<NDC11Code>00310-2021-01</NDC11Code>
<ProductNDC>0310-2021</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Tozorakimab</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<StartMarketingDate>20260416</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>AstraZeneca Pharmaceuticals LP</LabelerName>
<SubstanceName>TOZORAKIMAB</SubstanceName>
<StrengthNumber>15.6</StrengthNumber>
<StrengthUnit>kg/15.6kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-04-17</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>16-APR-26</StartMarketingDatePackage>
</NDC>
</NDCList>