{
"NDC": [
{
"NDCCode": "0480-3478-68",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (0480-3478-68) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK (0480-3478-19) / .1 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00480-3478-68",
"ProductNDC": "0480-3478",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Naloxone Hydrochloride",
"NonProprietaryName": "Naloxone Hydrochloride",
"DosageFormName": "SPRAY, METERED",
"RouteName": "NASAL",
"StartMarketingDate": "20240923",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209522",
"LabelerName": "Teva Pharmaceuticals, Inc.",
"SubstanceName": "NALOXONE HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/.1mL",
"Pharm_Classes": "Opioid Antagonist [EPC], Opioid Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2024-10-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240923",
"SamplePackage": "N",
"IndicationAndUsage": "to “revive” someone during an overdose from many prescription pain medications or street drugs such as heroin. this medicine can save a life."
},
{
"NDCCode": "54868-3478-0",
"PackageDescription": "30 CAPSULE in 1 BOTTLE, PLASTIC (54868-3478-0)",
"NDC11Code": "54868-3478-00",
"ProductNDC": "54868-3478",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cefaclor",
"NonProprietaryName": "Cefaclor",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19960124",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA064156",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "CEFACLOR",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Cefaclor is indicated in the treatment of the following infections when caused by susceptible strains of the designated microorganisms. Otitis media caused by Streptococcus pneumoniae, Haemophilus influenzae, staphylococci, and Streptococcus pyogenes. Note: β-lactamase-negative, ampicillin-resistant (BLNAR) strains of Haemophilus influenzae should be considered resistant to cefaclor despite apparent in vitro susceptibility of some BLNAR strains. Lower respiratory tract infections, including pneumonia caused by Streptococcus pneumoniae, Haemophilus influenzae, and Streptococcus. Note: β-lactamase-negative, ampicillin-resistant (BLNAR) strains of Haemophilus influenzae should be considered resistant to cefaclor despite apparent in vitro susceptibility of some BLNAR strains. Pharyngitis and Tonsillitis, caused by Streptococcus pyogenes. Note: Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cefaclor is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cefaclor in the subsequent prevention of rheumatic fever are not available at present. Urinary tract infections, including pyelonephritis and cystitis, caused by Escherichia coli, Proteus mirabilis, Klebsiella spp., and coagulase-negative staphylococci. Skin and skin structure infections caused by Staphylococcus aureus and Streptococcus pyogenes. Appropriate culture and susceptibility studies should be performed to determine susceptibility of the causative organism to cefaclor. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefaclor Capsules and Cefaclor for Oral Suspension and other antibacterial drugs, Cefaclor Capsules and Cefaclor for Oral Suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Cefaclor, USP is a semisynthetic cephalosporin antibiotic for oral administration. It is chemically designated as 3-chloro-7-D-(2-phenylglycinamido)-3-cephem-4-carboxylic acid monohydrate. The chemical formula for cefaclor is C15H14ClN3O4SH2O and the molecular weight is 385.82. Each capsule contains cefaclor monohydrate equivalent to 250 mg (0.68 mmol) or 500 mg (1.36 mmol) anhydrous cefaclor. The capsules also contain colloidal silicon dioxide, croscarmellose sodium, D&C Yellow No. 10, D&C Red No. 28, edible printing ink, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, pregelatinized starch, sicomet black oxide and titanium dioxide. After mixing, each 5 mL of Cefaclor for Oral Suspension will contain cefaclor monohydrate equivalent to 125 mg (0.34 mmol), 187 mg (0.51 mmol), 250 mg (0.68 mmol), or 375 mg (1.0 mmol) anhydrous cefaclor. The suspensions also contain citric acid, colloidal silicon dioxide, FD&C Red No. 40, flavor, simethicone emulsion, sodium benzoate, sodium citrate, sucrose, and xanthan gum."
},
{
"NDCCode": "54868-3478-1",
"PackageDescription": "15 CAPSULE in 1 BOTTLE, PLASTIC (54868-3478-1)",
"NDC11Code": "54868-3478-01",
"ProductNDC": "54868-3478",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cefaclor",
"NonProprietaryName": "Cefaclor",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19960124",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA064156",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "CEFACLOR",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Cefaclor is indicated in the treatment of the following infections when caused by susceptible strains of the designated microorganisms. Otitis media caused by Streptococcus pneumoniae, Haemophilus influenzae, staphylococci, and Streptococcus pyogenes. Note: β-lactamase-negative, ampicillin-resistant (BLNAR) strains of Haemophilus influenzae should be considered resistant to cefaclor despite apparent in vitro susceptibility of some BLNAR strains. Lower respiratory tract infections, including pneumonia caused by Streptococcus pneumoniae, Haemophilus influenzae, and Streptococcus. Note: β-lactamase-negative, ampicillin-resistant (BLNAR) strains of Haemophilus influenzae should be considered resistant to cefaclor despite apparent in vitro susceptibility of some BLNAR strains. Pharyngitis and Tonsillitis, caused by Streptococcus pyogenes. Note: Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cefaclor is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cefaclor in the subsequent prevention of rheumatic fever are not available at present. Urinary tract infections, including pyelonephritis and cystitis, caused by Escherichia coli, Proteus mirabilis, Klebsiella spp., and coagulase-negative staphylococci. Skin and skin structure infections caused by Staphylococcus aureus and Streptococcus pyogenes. Appropriate culture and susceptibility studies should be performed to determine susceptibility of the causative organism to cefaclor. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefaclor Capsules and Cefaclor for Oral Suspension and other antibacterial drugs, Cefaclor Capsules and Cefaclor for Oral Suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Cefaclor, USP is a semisynthetic cephalosporin antibiotic for oral administration. It is chemically designated as 3-chloro-7-D-(2-phenylglycinamido)-3-cephem-4-carboxylic acid monohydrate. The chemical formula for cefaclor is C15H14ClN3O4SH2O and the molecular weight is 385.82. Each capsule contains cefaclor monohydrate equivalent to 250 mg (0.68 mmol) or 500 mg (1.36 mmol) anhydrous cefaclor. The capsules also contain colloidal silicon dioxide, croscarmellose sodium, D&C Yellow No. 10, D&C Red No. 28, edible printing ink, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, pregelatinized starch, sicomet black oxide and titanium dioxide. After mixing, each 5 mL of Cefaclor for Oral Suspension will contain cefaclor monohydrate equivalent to 125 mg (0.34 mmol), 187 mg (0.51 mmol), 250 mg (0.68 mmol), or 375 mg (1.0 mmol) anhydrous cefaclor. The suspensions also contain citric acid, colloidal silicon dioxide, FD&C Red No. 40, flavor, simethicone emulsion, sodium benzoate, sodium citrate, sucrose, and xanthan gum."
},
{
"NDCCode": "54868-3478-2",
"PackageDescription": "20 CAPSULE in 1 BOTTLE, PLASTIC (54868-3478-2)",
"NDC11Code": "54868-3478-02",
"ProductNDC": "54868-3478",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cefaclor",
"NonProprietaryName": "Cefaclor",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19960124",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA064156",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "CEFACLOR",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Cefaclor is indicated in the treatment of the following infections when caused by susceptible strains of the designated microorganisms. Otitis media caused by Streptococcus pneumoniae, Haemophilus influenzae, staphylococci, and Streptococcus pyogenes. Note: β-lactamase-negative, ampicillin-resistant (BLNAR) strains of Haemophilus influenzae should be considered resistant to cefaclor despite apparent in vitro susceptibility of some BLNAR strains. Lower respiratory tract infections, including pneumonia caused by Streptococcus pneumoniae, Haemophilus influenzae, and Streptococcus. Note: β-lactamase-negative, ampicillin-resistant (BLNAR) strains of Haemophilus influenzae should be considered resistant to cefaclor despite apparent in vitro susceptibility of some BLNAR strains. Pharyngitis and Tonsillitis, caused by Streptococcus pyogenes. Note: Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cefaclor is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cefaclor in the subsequent prevention of rheumatic fever are not available at present. Urinary tract infections, including pyelonephritis and cystitis, caused by Escherichia coli, Proteus mirabilis, Klebsiella spp., and coagulase-negative staphylococci. Skin and skin structure infections caused by Staphylococcus aureus and Streptococcus pyogenes. Appropriate culture and susceptibility studies should be performed to determine susceptibility of the causative organism to cefaclor. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefaclor Capsules and Cefaclor for Oral Suspension and other antibacterial drugs, Cefaclor Capsules and Cefaclor for Oral Suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Cefaclor, USP is a semisynthetic cephalosporin antibiotic for oral administration. It is chemically designated as 3-chloro-7-D-(2-phenylglycinamido)-3-cephem-4-carboxylic acid monohydrate. The chemical formula for cefaclor is C15H14ClN3O4SH2O and the molecular weight is 385.82. Each capsule contains cefaclor monohydrate equivalent to 250 mg (0.68 mmol) or 500 mg (1.36 mmol) anhydrous cefaclor. The capsules also contain colloidal silicon dioxide, croscarmellose sodium, D&C Yellow No. 10, D&C Red No. 28, edible printing ink, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, pregelatinized starch, sicomet black oxide and titanium dioxide. After mixing, each 5 mL of Cefaclor for Oral Suspension will contain cefaclor monohydrate equivalent to 125 mg (0.34 mmol), 187 mg (0.51 mmol), 250 mg (0.68 mmol), or 375 mg (1.0 mmol) anhydrous cefaclor. The suspensions also contain citric acid, colloidal silicon dioxide, FD&C Red No. 40, flavor, simethicone emulsion, sodium benzoate, sodium citrate, sucrose, and xanthan gum."
},
{
"NDCCode": "54868-3478-3",
"PackageDescription": "10 CAPSULE in 1 BOTTLE, PLASTIC (54868-3478-3)",
"NDC11Code": "54868-3478-03",
"ProductNDC": "54868-3478",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cefaclor",
"NonProprietaryName": "Cefaclor",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "19960124",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA064156",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "CEFACLOR",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Cefaclor is indicated in the treatment of the following infections when caused by susceptible strains of the designated microorganisms. Otitis media caused by Streptococcus pneumoniae, Haemophilus influenzae, staphylococci, and Streptococcus pyogenes. Note: β-lactamase-negative, ampicillin-resistant (BLNAR) strains of Haemophilus influenzae should be considered resistant to cefaclor despite apparent in vitro susceptibility of some BLNAR strains. Lower respiratory tract infections, including pneumonia caused by Streptococcus pneumoniae, Haemophilus influenzae, and Streptococcus. Note: β-lactamase-negative, ampicillin-resistant (BLNAR) strains of Haemophilus influenzae should be considered resistant to cefaclor despite apparent in vitro susceptibility of some BLNAR strains. Pharyngitis and Tonsillitis, caused by Streptococcus pyogenes. Note: Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cefaclor is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cefaclor in the subsequent prevention of rheumatic fever are not available at present. Urinary tract infections, including pyelonephritis and cystitis, caused by Escherichia coli, Proteus mirabilis, Klebsiella spp., and coagulase-negative staphylococci. Skin and skin structure infections caused by Staphylococcus aureus and Streptococcus pyogenes. Appropriate culture and susceptibility studies should be performed to determine susceptibility of the causative organism to cefaclor. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefaclor Capsules and Cefaclor for Oral Suspension and other antibacterial drugs, Cefaclor Capsules and Cefaclor for Oral Suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Cefaclor, USP is a semisynthetic cephalosporin antibiotic for oral administration. It is chemically designated as 3-chloro-7-D-(2-phenylglycinamido)-3-cephem-4-carboxylic acid monohydrate. The chemical formula for cefaclor is C15H14ClN3O4SH2O and the molecular weight is 385.82. Each capsule contains cefaclor monohydrate equivalent to 250 mg (0.68 mmol) or 500 mg (1.36 mmol) anhydrous cefaclor. The capsules also contain colloidal silicon dioxide, croscarmellose sodium, D&C Yellow No. 10, D&C Red No. 28, edible printing ink, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, pregelatinized starch, sicomet black oxide and titanium dioxide. After mixing, each 5 mL of Cefaclor for Oral Suspension will contain cefaclor monohydrate equivalent to 125 mg (0.34 mmol), 187 mg (0.51 mmol), 250 mg (0.68 mmol), or 375 mg (1.0 mmol) anhydrous cefaclor. The suspensions also contain citric acid, colloidal silicon dioxide, FD&C Red No. 40, flavor, simethicone emulsion, sodium benzoate, sodium citrate, sucrose, and xanthan gum."
},
{
"NDCCode": "68094-480-60",
"PackageDescription": "500 TABLET, COATED in 1 BOTTLE (68094-480-60) ",
"NDC11Code": "68094-0480-60",
"ProductNDC": "68094-480",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20240215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205096",
"LabelerName": "Precision Dose, Inc.",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "1000",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Active",
"LastUpdate": "2025-12-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240215",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.",
"Description": "Metformin hydrochloride tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C4H11N5 ∙ HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride tablets, USP contain 500 mg, 850 mg or 1,000 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 662.88 mg, 779.86 mg metformin base, respectively. Each tablet contains the inactive ingredients povidone and magnesium stearate. In addition, the coating for the 500 mg, 850 mg and 1,000 mg tablets contains hypromellose and polyethylene glycol."
},
{
"NDCCode": "68094-480-70",
"PackageDescription": "1000 TABLET, COATED in 1 BOTTLE (68094-480-70) ",
"NDC11Code": "68094-0480-70",
"ProductNDC": "68094-480",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Metformin Hydrochloride",
"NonProprietaryName": "Metformin Hydrochloride",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20240215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205096",
"LabelerName": "Precision Dose, Inc.",
"SubstanceName": "METFORMIN HYDROCHLORIDE",
"StrengthNumber": "1000",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Biguanide [EPC], Biguanides [CS]",
"Status": "Active",
"LastUpdate": "2025-12-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240215",
"SamplePackage": "N",
"IndicationAndUsage": "Metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.",
"Description": "Metformin hydrochloride tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C4H11N5 ∙ HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride tablets, USP contain 500 mg, 850 mg or 1,000 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 662.88 mg, 779.86 mg metformin base, respectively. Each tablet contains the inactive ingredients povidone and magnesium stearate. In addition, the coating for the 500 mg, 850 mg and 1,000 mg tablets contains hypromellose and polyethylene glycol."
},
{
"NDCCode": "0220-3478-41",
"PackageDescription": "6 [hp_C] in 1 TUBE (0220-3478-41) ",
"NDC11Code": "00220-3478-41",
"ProductNDC": "0220-3478",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Myristica Sebifera",
"NonProprietaryName": "Virola Sebifera Resin",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "19830303",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Boiron",
"SubstanceName": "VIROLA SEBIFERA RESIN",
"StrengthNumber": "6",
"StrengthUnit": "[hp_C]/6[hp_C]",
"Status": "Active",
"LastUpdate": "2025-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19830303",
"SamplePackage": "N",
"IndicationAndUsage": "Relieves pain from boils *."
},
{
"NDCCode": "22840-3478-2",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (22840-3478-2) ",
"NDC11Code": "22840-3478-02",
"ProductNDC": "22840-3478",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Privet Pollen",
"NonProprietaryName": "Ligustrum Vulgare",
"DosageFormName": "SOLUTION",
"RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19810915",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101833",
"LabelerName": "Greer Laboratories, Inc.",
"SubstanceName": "LIGUSTRUM VULGARE POLLEN",
"StrengthNumber": "20000",
"StrengthUnit": "[PNU]/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]",
"Status": "Active",
"LastUpdate": "2025-06-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19810915",
"SamplePackage": "N",
"IndicationAndUsage": "Non-Standardized Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergies to one or more of the specific non-standardized allergens., 2 Immunotherapy for the reduction of allergen-induced allergic symptoms confirmed by appropriate positive skin tests or by in vitro testing for allergen-specific IgE antibodies.",
"Description": "Non-Standardized Allergenic Extracts are sterile solutions used for percutaneous testing, intradermal testing, or subcutaneous immunotherapy. Aqueous extracts contain the soluble extractants of the source material in water for injection, 0.5% sodium chloride, 0.54% sodium bicarbonate, and 0.4% phenol. Glycerinated extracts contain the soluable extractants of the source material in water for injection and 50% glycerin, 0.25% sodium chloride, 0.27% sodium bicarbonate, and 0.2% phenol. The pH of the extracts range from 6 to 9. Certain food extracts (Barley, Oat, Pineapple, Rye, Spinach, and Wheat), labeled “For Diagnostic Use Only”, contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Source materials used in the manufacture of allergenic extracts are collected from natural sources or from laboratory cultures. Non-Standardized Allergenic Extracts appear as clear and colorless to dark brown solutions that should be free of particulate matter. Extracts are labeled either as weight-to-volume based on the weight of the source material to the volume of the extracting fluid, or as PNU/milliliter with one PNU representing 0.00001 mg of protein nitrogen per milliliter."
},
{
"NDCCode": "22840-3478-4",
"PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (22840-3478-4) ",
"NDC11Code": "22840-3478-04",
"ProductNDC": "22840-3478",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Privet Pollen",
"NonProprietaryName": "Ligustrum Vulgare",
"DosageFormName": "SOLUTION",
"RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19810915",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101833",
"LabelerName": "Greer Laboratories, Inc.",
"SubstanceName": "LIGUSTRUM VULGARE POLLEN",
"StrengthNumber": "20000",
"StrengthUnit": "[PNU]/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]",
"Status": "Active",
"LastUpdate": "2025-06-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19810915",
"SamplePackage": "N",
"IndicationAndUsage": "Non-Standardized Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergies to one or more of the specific non-standardized allergens., 2 Immunotherapy for the reduction of allergen-induced allergic symptoms confirmed by appropriate positive skin tests or by in vitro testing for allergen-specific IgE antibodies.",
"Description": "Non-Standardized Allergenic Extracts are sterile solutions used for percutaneous testing, intradermal testing, or subcutaneous immunotherapy. Aqueous extracts contain the soluble extractants of the source material in water for injection, 0.5% sodium chloride, 0.54% sodium bicarbonate, and 0.4% phenol. Glycerinated extracts contain the soluable extractants of the source material in water for injection and 50% glycerin, 0.25% sodium chloride, 0.27% sodium bicarbonate, and 0.2% phenol. The pH of the extracts range from 6 to 9. Certain food extracts (Barley, Oat, Pineapple, Rye, Spinach, and Wheat), labeled “For Diagnostic Use Only”, contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Source materials used in the manufacture of allergenic extracts are collected from natural sources or from laboratory cultures. Non-Standardized Allergenic Extracts appear as clear and colorless to dark brown solutions that should be free of particulate matter. Extracts are labeled either as weight-to-volume based on the weight of the source material to the volume of the extracting fluid, or as PNU/milliliter with one PNU representing 0.00001 mg of protein nitrogen per milliliter."
},
{
"NDCCode": "37662-3478-1",
"PackageDescription": "200 PELLET in 1 VIAL, GLASS (37662-3478-1) ",
"NDC11Code": "37662-3478-01",
"ProductNDC": "37662-3478",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aluminium Iodatum",
"NonProprietaryName": "Aluminium Iodatum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230629",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "ALUMINUM IODIDE",
"StrengthNumber": "1",
"StrengthUnit": "[hp_M]/1",
"Status": "Active",
"LastUpdate": "2023-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230629",
"SamplePackage": "N"
},
{
"NDCCode": "37662-3478-2",
"PackageDescription": "500 PELLET in 1 VIAL, GLASS (37662-3478-2) ",
"NDC11Code": "37662-3478-02",
"ProductNDC": "37662-3478",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aluminium Iodatum",
"NonProprietaryName": "Aluminium Iodatum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230629",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "ALUMINUM IODIDE",
"StrengthNumber": "1",
"StrengthUnit": "[hp_M]/1",
"Status": "Active",
"LastUpdate": "2023-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230629",
"SamplePackage": "N"
},
{
"NDCCode": "37662-3478-3",
"PackageDescription": "3000 PELLET in 1 BOTTLE, GLASS (37662-3478-3) ",
"NDC11Code": "37662-3478-03",
"ProductNDC": "37662-3478",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aluminium Iodatum",
"NonProprietaryName": "Aluminium Iodatum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230629",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "ALUMINUM IODIDE",
"StrengthNumber": "1",
"StrengthUnit": "[hp_M]/1",
"Status": "Active",
"LastUpdate": "2023-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230629",
"SamplePackage": "N"
},
{
"NDCCode": "37662-3478-4",
"PackageDescription": "10000 PELLET in 1 BOTTLE, GLASS (37662-3478-4) ",
"NDC11Code": "37662-3478-04",
"ProductNDC": "37662-3478",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aluminium Iodatum",
"NonProprietaryName": "Aluminium Iodatum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230629",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "ALUMINUM IODIDE",
"StrengthNumber": "1",
"StrengthUnit": "[hp_M]/1",
"Status": "Active",
"LastUpdate": "2023-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230629",
"SamplePackage": "N"
},
{
"NDCCode": "50090-3478-0",
"PackageDescription": "1 BOTTLE in 1 CARTON (50090-3478-0) > 59 mL in 1 BOTTLE",
"NDC11Code": "50090-3478-00",
"ProductNDC": "50090-3478",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sunmark Lice Treatment",
"NonProprietaryName": "Permethrin",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150803",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076090",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "PERMETHRIN",
"StrengthNumber": "1",
"StrengthUnit": "mg/100mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20180614",
"SamplePackage": "N"
},
{
"NDCCode": "55154-3478-9",
"PackageDescription": "6 BLISTER PACK in 1 CARTON (55154-3478-9) > 5 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "55154-3478-09",
"ProductNDC": "55154-3478",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Simvastatin",
"NonProprietaryName": "Simvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20061220",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077752",
"LabelerName": "Cardinal Health",
"SubstanceName": "SIMVASTATIN",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-05-17"
},
{
"NDCCode": "60505-3478-3",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (60505-3478-3) ",
"NDC11Code": "60505-3478-03",
"ProductNDC": "60505-3478",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amlodipine And Atorvastatin",
"NonProprietaryName": "Amlodipine And Atorvastatin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200729",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205199",
"LabelerName": "Apotex Corp.",
"SubstanceName": "AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE",
"StrengthNumber": "5; 10",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200729",
"SamplePackage": "N",
"IndicationAndUsage": "Amlodipine and atorvastatin tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine. Hypertension. Amlodipine is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including amlodipine. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Amlodipine may be used alone or in combination with other antihypertensive agents. Coronary Artery Disease (CAD). Chronic Stable Angina. Amlodipine is indicated for the symptomatic treatment of chronic stable angina. Amlodipine may be used alone or in combination with other antianginal agents. Vasospastic Angina (Prinzmetal’s or Variant Angina). Amlodipine is indicated for the treatment of confirmed or suspected vasospastic angina. Amlodipine may be used as monotherapy or in combination with other antianginal agents. Angiographically Documented CAD. In patients with recently documented CAD by angiography and without heart failure or an ejection fraction < 40%, amlodipine is indicated to reduce the risk of hospitalization for angina and to reduce the risk of a coronary revascularization procedure. Atorvastatin. Atorvastatin is indicated: 1 To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHDMI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHDNon-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD, 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:Adults with primary hyperlipidemia.Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH)., 4 As an adjunct to diet for the treatment of adults with:Primary dysbetalipoproteinemiaHypertriglyceridemia.",
"Description": "Amlodipine and atorvastatin tablets, USP combine the calcium channel blocker amlodipine besylate with the HMG CoA-reductase inhibitor atorvastatin calcium. Amlodipine besylate, USP is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(o-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its molecular formula is C20H25ClN2O5 C6H6O3S. Atorvastatin calcium, USP in the form of propylene glycol solvate, is chemically described as calcium bis((3R,5R)-7-[3-(anilinocarbonyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoate) propylene glycol solvate. Its molecular formula is C66H68CaF2N4O10 * C3H8O2. The structural formulae for amlodipine besylate and atorvastatin calcium propylene glycol solvate are shown below. Amlodipine and atorvastatin tablets, USP for oral administration contains amlodipine besylate, a white or almost white powder, and atorvastatin calcium a white to off-white solid. Amlodipine besylate, USP has a molecular weight of 567.1 g/mol and atorvastatin calcium propylene glycol solvate, USP has a molecular weight of 1231.46 g/mol. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Atorvastatin calcium is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Each film-coated tablet also contains calcium acetate, colloidal silicon dioxide, croscarmellose sodium, ferric oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. In addition, the 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg and 10 mg/80 mg strengths also contain FD&C Blue #2. USP Dissolution Test Pending."
},
{
"NDCCode": "68071-3478-3",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (68071-3478-3) ",
"NDC11Code": "68071-3478-03",
"ProductNDC": "68071-3478",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sucralfate",
"NonProprietaryName": "Sucralfate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200217",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074415",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "SUCRALFATE",
"StrengthNumber": "1",
"StrengthUnit": "g/1",
"Pharm_Classes": "Aluminum Complex [EPC], Organometallic Compounds [CS]",
"Status": "Active",
"LastUpdate": "2025-01-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230803",
"SamplePackage": "N",
"IndicationAndUsage": "Sucralfate tablets are indicated in: 1 Short-term treatment (up to 8 weeks) of active duodenal ulcer. While healing with sucralfate may occur during the first week or two, treatment should be continued for 4 to 8 weeks unless healing has been demonstrated by x-ray or endoscopic examination., 2 Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers.",
"Description": "Sucralfate is an α-D-glucopyranoside, β-D-fructofuranosyl-, octakis-(hydrogen sulfate), aluminum complex. It has the following structural formula. Tablets for oral administration contain 1 g of sucralfate, USP. Also contain: povidone, magnesium stearate, and colloidal silicon dioxide. Therapeutic category: antiulcer."
},
{
"NDCCode": "70518-3478-0",
"PackageDescription": "30 TABLET, FILM COATED in 1 BLISTER PACK (70518-3478-0) ",
"NDC11Code": "70518-3478-00",
"ProductNDC": "70518-3478",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropinirole",
"NonProprietaryName": "Ropinirole",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220817",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090135",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "ROPINIROLE HYDROCHLORIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220817",
"SamplePackage": "N",
"IndicationAndUsage": "Ropinirole tablets are a non-ergoline dopamine agonist indicated for the treatment of Parkinson’s disease (PD) and moderate-to-severe primary Restless Legs Syndrome (RLS). ( 1.1, 1.2).",
"Description": "Ropinirole Tablets, USP contain ropinirole, a non-ergoline dopamine agonist, as the hydrochloride salt. The chemical name of ropinirole hydrochloride, USP is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the empirical formula is C 16H 24N 2OHCl. The molecular weight is 296.84 g/mol (260.38 as the free base). The structural formula is. Ropinirole hydrochloride, USP is a pale cream to yellow powder with a melting range of 243°C to 250°C and a solubility of 133 mg/mL in water. Each circular, beveled edged, biconvex film-coated tablet contains ropinirole hydrochloride, USP equivalent to ropinirole, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, or 5 mg. Inactive ingredients consist of citric acid anhydrous powder, croscarmellose sodium, lactose anhydrous, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The ingredients of the film coating for each tablet are as follows. 0.25 mg:Hypromellose, polyethylene glycol, talc and titanium dioxide. 0.5 mg:FD&C Blue no. 2 aluminum lake, ferric oxide red, ferric oxide yellow, hypromellose, polyethylene glycol, talc and titanium dioxide. 1 mg:FD&C Blue no. 2 aluminum lake, ferric oxide black, ferric oxide yellow, hypromellose, polyethylene glycol, talc and titanium dioxide. 2 mg:Ferric oxide red, hypromellose, polyethylene glycol, talc and titanium dioxide. 3 mg:Carmine, FD&C Blue no. 2 aluminum lake, FD&C Yellow no. 6 aluminum lake, hypromellose, polyethylene glycol, talc and titanium dioxide. 4 mg:Ferric oxide black, ferric oxide red, ferric oxide yellow, hypromellose, polyethylene glycol, talc and titanium dioxide. 5 mg:FD&C Blue no. 1 aluminum lake, FD&C Blue no. 2 aluminum lake, hypromellose, polyethylene glycol, talc and titanium dioxide. The product meets USP Dissolution Test 2."
},
{
"NDCCode": "70518-3478-1",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3478-1) ",
"NDC11Code": "70518-3478-01",
"ProductNDC": "70518-3478",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropinirole",
"NonProprietaryName": "Ropinirole",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220817",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090135",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "ROPINIROLE HYDROCHLORIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230220",
"SamplePackage": "N",
"IndicationAndUsage": "Ropinirole tablets are a non-ergoline dopamine agonist indicated for the treatment of Parkinson’s disease (PD) and moderate-to-severe primary Restless Legs Syndrome (RLS). ( 1.1, 1.2).",
"Description": "Ropinirole Tablets, USP contain ropinirole, a non-ergoline dopamine agonist, as the hydrochloride salt. The chemical name of ropinirole hydrochloride, USP is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the empirical formula is C 16H 24N 2OHCl. The molecular weight is 296.84 g/mol (260.38 as the free base). The structural formula is. Ropinirole hydrochloride, USP is a pale cream to yellow powder with a melting range of 243°C to 250°C and a solubility of 133 mg/mL in water. Each circular, beveled edged, biconvex film-coated tablet contains ropinirole hydrochloride, USP equivalent to ropinirole, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, or 5 mg. Inactive ingredients consist of citric acid anhydrous powder, croscarmellose sodium, lactose anhydrous, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The ingredients of the film coating for each tablet are as follows. 0.25 mg:Hypromellose, polyethylene glycol, talc and titanium dioxide. 0.5 mg:FD&C Blue no. 2 aluminum lake, ferric oxide red, ferric oxide yellow, hypromellose, polyethylene glycol, talc and titanium dioxide. 1 mg:FD&C Blue no. 2 aluminum lake, ferric oxide black, ferric oxide yellow, hypromellose, polyethylene glycol, talc and titanium dioxide. 2 mg:Ferric oxide red, hypromellose, polyethylene glycol, talc and titanium dioxide. 3 mg:Carmine, FD&C Blue no. 2 aluminum lake, FD&C Yellow no. 6 aluminum lake, hypromellose, polyethylene glycol, talc and titanium dioxide. 4 mg:Ferric oxide black, ferric oxide red, ferric oxide yellow, hypromellose, polyethylene glycol, talc and titanium dioxide. 5 mg:FD&C Blue no. 1 aluminum lake, FD&C Blue no. 2 aluminum lake, hypromellose, polyethylene glycol, talc and titanium dioxide. The product meets USP Dissolution Test 2."
},
{
"NDCCode": "70518-3478-2",
"PackageDescription": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3478-2) ",
"NDC11Code": "70518-3478-02",
"ProductNDC": "70518-3478",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropinirole",
"NonProprietaryName": "Ropinirole",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220817",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090135",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "ROPINIROLE HYDROCHLORIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250618",
"SamplePackage": "N",
"IndicationAndUsage": "Ropinirole tablets are a non-ergoline dopamine agonist indicated for the treatment of Parkinson’s disease (PD) and moderate-to-severe primary Restless Legs Syndrome (RLS). ( 1.1, 1.2).",
"Description": "Ropinirole Tablets, USP contain ropinirole, a non-ergoline dopamine agonist, as the hydrochloride salt. The chemical name of ropinirole hydrochloride, USP is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the empirical formula is C 16H 24N 2OHCl. The molecular weight is 296.84 g/mol (260.38 as the free base). The structural formula is. Ropinirole hydrochloride, USP is a pale cream to yellow powder with a melting range of 243°C to 250°C and a solubility of 133 mg/mL in water. Each circular, beveled edged, biconvex film-coated tablet contains ropinirole hydrochloride, USP equivalent to ropinirole, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, or 5 mg. Inactive ingredients consist of citric acid anhydrous powder, croscarmellose sodium, lactose anhydrous, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The ingredients of the film coating for each tablet are as follows. 0.25 mg:Hypromellose, polyethylene glycol, talc and titanium dioxide. 0.5 mg:FD&C Blue no. 2 aluminum lake, ferric oxide red, ferric oxide yellow, hypromellose, polyethylene glycol, talc and titanium dioxide. 1 mg:FD&C Blue no. 2 aluminum lake, ferric oxide black, ferric oxide yellow, hypromellose, polyethylene glycol, talc and titanium dioxide. 2 mg:Ferric oxide red, hypromellose, polyethylene glycol, talc and titanium dioxide. 3 mg:Carmine, FD&C Blue no. 2 aluminum lake, FD&C Yellow no. 6 aluminum lake, hypromellose, polyethylene glycol, talc and titanium dioxide. 4 mg:Ferric oxide black, ferric oxide red, ferric oxide yellow, hypromellose, polyethylene glycol, talc and titanium dioxide. 5 mg:FD&C Blue no. 1 aluminum lake, FD&C Blue no. 2 aluminum lake, hypromellose, polyethylene glycol, talc and titanium dioxide. The product meets USP Dissolution Test 2."
},
{
"NDCCode": "70518-3478-3",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3478-3) ",
"NDC11Code": "70518-3478-03",
"ProductNDC": "70518-3478",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ropinirole",
"NonProprietaryName": "Ropinirole",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220817",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090135",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "ROPINIROLE HYDROCHLORIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260309",
"SamplePackage": "N",
"IndicationAndUsage": "Ropinirole tablets are a non-ergoline dopamine agonist indicated for the treatment of Parkinson’s disease (PD) and moderate-to-severe primary Restless Legs Syndrome (RLS). ( 1.1, 1.2).",
"Description": "Ropinirole Tablets, USP contain ropinirole, a non-ergoline dopamine agonist, as the hydrochloride salt. The chemical name of ropinirole hydrochloride, USP is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the empirical formula is C 16H 24N 2OHCl. The molecular weight is 296.84 g/mol (260.38 as the free base). The structural formula is. Ropinirole hydrochloride, USP is a pale cream to yellow powder with a melting range of 243°C to 250°C and a solubility of 133 mg/mL in water. Each circular, beveled edged, biconvex film-coated tablet contains ropinirole hydrochloride, USP equivalent to ropinirole, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, or 5 mg. Inactive ingredients consist of citric acid anhydrous powder, croscarmellose sodium, lactose anhydrous, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The ingredients of the film coating for each tablet are as follows. 0.25 mg:Hypromellose, polyethylene glycol, talc and titanium dioxide. 0.5 mg:FD&C Blue no. 2 aluminum lake, ferric oxide red, ferric oxide yellow, hypromellose, polyethylene glycol, talc and titanium dioxide. 1 mg:FD&C Blue no. 2 aluminum lake, ferric oxide black, ferric oxide yellow, hypromellose, polyethylene glycol, talc and titanium dioxide. 2 mg:Ferric oxide red, hypromellose, polyethylene glycol, talc and titanium dioxide. 3 mg:Carmine, FD&C Blue no. 2 aluminum lake, FD&C Yellow no. 6 aluminum lake, hypromellose, polyethylene glycol, talc and titanium dioxide. 4 mg:Ferric oxide black, ferric oxide red, ferric oxide yellow, hypromellose, polyethylene glycol, talc and titanium dioxide. 5 mg:FD&C Blue no. 1 aluminum lake, FD&C Blue no. 2 aluminum lake, hypromellose, polyethylene glycol, talc and titanium dioxide. The product meets USP Dissolution Test 2."
},
{
"NDCCode": "0053-0480-48",
"PackageDescription": "1 KIT in 1 CARTON (0053-0480-48) * 1 INJECTION, SUSPENSION in 1 VIAL, GLASS (0053-0099-01) ",
"NDC11Code": "00053-0480-48",
"ProductNDC": "0053-0480",
"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",
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"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": "0054-0480-13",
"PackageDescription": "30 TABLET in 1 BOTTLE (0054-0480-13) ",
"NDC11Code": "00054-0480-13",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"ApplicationNumber": "ANDA207486",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
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"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]",
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"LastUpdate": "2026-08-17",
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"StartMarketingDatePackage": "20210212",
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"IndicationAndUsage": "Everolimus is a kinase inhibitor indicated for the treatment of: : 1 Adults with advanced renal cell carcinoma (RCC) after failure of treatment with sunitinib or sorafenib. (1.3), 2 Adults with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery. (1.4).",
"Description": "Everolimus is a kinase inhibitor. The chemical name of everolimus is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18-dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.04,9]-hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.22 g/mol. The structural formula is: 1 ."
},
{
"NDCCode": "0054-0480-14",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (0054-0480-14) > 28 TABLET in 1 BLISTER PACK",
"NDC11Code": "00054-0480-14",
"ProductNDC": "0054-0480",
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"LastUpdate": "2023-12-23",
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"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20200608",
"SamplePackage": "N"
},
{
"NDCCode": "0135-0480-01",
"PackageDescription": "1 TUBE in 1 CARTON (0135-0480-01) / 118 g in 1 TUBE",
"NDC11Code": "00135-0480-01",
"ProductNDC": "0135-0480",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sensodyne Pronamel",
"ProprietaryNameSuffix": "Mineral Boost Whitening Action",
"NonProprietaryName": "Potassium Nitrate And Sodium Fluoride",
"DosageFormName": "PASTE",
"RouteName": "ORAL",
"StartMarketingDate": "20210104",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M021",
"LabelerName": "Haleon US Holdings LLC",
"SubstanceName": "POTASSIUM NITRATE; SODIUM FLUORIDE",
"StrengthNumber": "50; 1.15",
"StrengthUnit": "mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2026-09-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210104",
"SamplePackage": "N",
"IndicationAndUsage": "builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact. aids in the prevention of dental cavities."
},
{
"NDCCode": "0135-0480-02",
"PackageDescription": "1 TUBE in 1 CARTON (0135-0480-02) / 77 g in 1 TUBE",
"NDC11Code": "00135-0480-02",
"ProductNDC": "0135-0480",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sensodyne Pronamel",
"ProprietaryNameSuffix": "Mineral Boost Whitening Action",
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"DosageFormName": "PASTE",
"RouteName": "ORAL",
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"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M021",
"LabelerName": "Haleon US Holdings LLC",
"SubstanceName": "POTASSIUM NITRATE; SODIUM FLUORIDE",
"StrengthNumber": "50; 1.15",
"StrengthUnit": "mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2026-09-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210104",
"SamplePackage": "N",
"IndicationAndUsage": "builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact. aids in the prevention of dental cavities."
},
{
"NDCCode": "0178-0480-08",
"PackageDescription": "227 g in 1 BOTTLE, PLASTIC (0178-0480-08) ",
"NDC11Code": "00178-0480-08",
"ProductNDC": "0178-0480",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Avar",
"NonProprietaryName": "Sulfacetamide Sodium, Sulfur",
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"StartMarketingDate": "20110915",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Mission Pharmacal Company",
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"StrengthNumber": "100; 50",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Sulfonamide Antibacterial [EPC], Sulfonamides [CS]",
"Status": "Active",
"LastUpdate": "2026-01-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20110915",
"SamplePackage": "N"
},
{
"NDCCode": "0363-0480-11",
"PackageDescription": "184 g in 1 TUBE (0363-0480-11)",
"NDC11Code": "00363-0480-11",
"ProductNDC": "0363-0480",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Oil-free Daily Face",
"NonProprietaryName": "Salicylic Acid",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140915",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333D",
"LabelerName": "Walgreen Company",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": "2",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "for the treatment of acne."
},
{
"NDCCode": "0378-0480-01",
"PackageDescription": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0480-01) ",
"NDC11Code": "00378-0480-01",
"ProductNDC": "0378-0480",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nifedipine",
"NonProprietaryName": "Nifedipine",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20000314",
"EndMarketingDate": "20191130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090649",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "NIFEDIPINE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-12-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20000314",
"EndMarketingDatePackage": "20191130",
"SamplePackage": "N"
}
]
}
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<PackageDescription>2 BLISTER PACK in 1 CARTON (0480-3478-68) / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK (0480-3478-19) / .1 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
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<ProprietaryName>Naloxone Hydrochloride</ProprietaryName>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240923</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>to “revive” someone during an overdose from many prescription pain medications or street drugs such as heroin. this medicine can save a life.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>54868-3478-0</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE, PLASTIC (54868-3478-0)</PackageDescription>
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<StrengthUnit>mg/1</StrengthUnit>
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<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
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<IndicationAndUsage>Cefaclor is indicated in the treatment of the following infections when caused by susceptible strains of the designated microorganisms. Otitis media caused by Streptococcus pneumoniae, Haemophilus influenzae, staphylococci, and Streptococcus pyogenes. Note: β-lactamase-negative, ampicillin-resistant (BLNAR) strains of Haemophilus influenzae should be considered resistant to cefaclor despite apparent in vitro susceptibility of some BLNAR strains. Lower respiratory tract infections, including pneumonia caused by Streptococcus pneumoniae, Haemophilus influenzae, and Streptococcus. Note: β-lactamase-negative, ampicillin-resistant (BLNAR) strains of Haemophilus influenzae should be considered resistant to cefaclor despite apparent in vitro susceptibility of some BLNAR strains. Pharyngitis and Tonsillitis, caused by Streptococcus pyogenes. Note: Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cefaclor is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cefaclor in the subsequent prevention of rheumatic fever are not available at present. Urinary tract infections, including pyelonephritis and cystitis, caused by Escherichia coli, Proteus mirabilis, Klebsiella spp., and coagulase-negative staphylococci. Skin and skin structure infections caused by Staphylococcus aureus and Streptococcus pyogenes. Appropriate culture and susceptibility studies should be performed to determine susceptibility of the causative organism to cefaclor. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefaclor Capsules and Cefaclor for Oral Suspension and other antibacterial drugs, Cefaclor Capsules and Cefaclor for Oral Suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Cefaclor, USP is a semisynthetic cephalosporin antibiotic for oral administration. It is chemically designated as 3-chloro-7-D-(2-phenylglycinamido)-3-cephem-4-carboxylic acid monohydrate. The chemical formula for cefaclor is C15H14ClN3O4SH2O and the molecular weight is 385.82. Each capsule contains cefaclor monohydrate equivalent to 250 mg (0.68 mmol) or 500 mg (1.36 mmol) anhydrous cefaclor. The capsules also contain colloidal silicon dioxide, croscarmellose sodium, D&C Yellow No. 10, D&C Red No. 28, edible printing ink, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, pregelatinized starch, sicomet black oxide and titanium dioxide. After mixing, each 5 mL of Cefaclor for Oral Suspension will contain cefaclor monohydrate equivalent to 125 mg (0.34 mmol), 187 mg (0.51 mmol), 250 mg (0.68 mmol), or 375 mg (1.0 mmol) anhydrous cefaclor. The suspensions also contain citric acid, colloidal silicon dioxide, FD&C Red No. 40, flavor, simethicone emulsion, sodium benzoate, sodium citrate, sucrose, and xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>54868-3478-1</NDCCode>
<PackageDescription>15 CAPSULE in 1 BOTTLE, PLASTIC (54868-3478-1)</PackageDescription>
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<ProductNDC>54868-3478</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cefaclor</ProprietaryName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
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<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>CEFACLOR</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Cefaclor is indicated in the treatment of the following infections when caused by susceptible strains of the designated microorganisms. Otitis media caused by Streptococcus pneumoniae, Haemophilus influenzae, staphylococci, and Streptococcus pyogenes. Note: β-lactamase-negative, ampicillin-resistant (BLNAR) strains of Haemophilus influenzae should be considered resistant to cefaclor despite apparent in vitro susceptibility of some BLNAR strains. Lower respiratory tract infections, including pneumonia caused by Streptococcus pneumoniae, Haemophilus influenzae, and Streptococcus. Note: β-lactamase-negative, ampicillin-resistant (BLNAR) strains of Haemophilus influenzae should be considered resistant to cefaclor despite apparent in vitro susceptibility of some BLNAR strains. Pharyngitis and Tonsillitis, caused by Streptococcus pyogenes. Note: Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cefaclor is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cefaclor in the subsequent prevention of rheumatic fever are not available at present. Urinary tract infections, including pyelonephritis and cystitis, caused by Escherichia coli, Proteus mirabilis, Klebsiella spp., and coagulase-negative staphylococci. Skin and skin structure infections caused by Staphylococcus aureus and Streptococcus pyogenes. Appropriate culture and susceptibility studies should be performed to determine susceptibility of the causative organism to cefaclor. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefaclor Capsules and Cefaclor for Oral Suspension and other antibacterial drugs, Cefaclor Capsules and Cefaclor for Oral Suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Cefaclor, USP is a semisynthetic cephalosporin antibiotic for oral administration. It is chemically designated as 3-chloro-7-D-(2-phenylglycinamido)-3-cephem-4-carboxylic acid monohydrate. The chemical formula for cefaclor is C15H14ClN3O4SH2O and the molecular weight is 385.82. Each capsule contains cefaclor monohydrate equivalent to 250 mg (0.68 mmol) or 500 mg (1.36 mmol) anhydrous cefaclor. The capsules also contain colloidal silicon dioxide, croscarmellose sodium, D&C Yellow No. 10, D&C Red No. 28, edible printing ink, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, pregelatinized starch, sicomet black oxide and titanium dioxide. After mixing, each 5 mL of Cefaclor for Oral Suspension will contain cefaclor monohydrate equivalent to 125 mg (0.34 mmol), 187 mg (0.51 mmol), 250 mg (0.68 mmol), or 375 mg (1.0 mmol) anhydrous cefaclor. The suspensions also contain citric acid, colloidal silicon dioxide, FD&C Red No. 40, flavor, simethicone emulsion, sodium benzoate, sodium citrate, sucrose, and xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>54868-3478-2</NDCCode>
<PackageDescription>20 CAPSULE in 1 BOTTLE, PLASTIC (54868-3478-2)</PackageDescription>
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<ProductNDC>54868-3478</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cefaclor</ProprietaryName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
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<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>CEFACLOR</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Cefaclor is indicated in the treatment of the following infections when caused by susceptible strains of the designated microorganisms. Otitis media caused by Streptococcus pneumoniae, Haemophilus influenzae, staphylococci, and Streptococcus pyogenes. Note: β-lactamase-negative, ampicillin-resistant (BLNAR) strains of Haemophilus influenzae should be considered resistant to cefaclor despite apparent in vitro susceptibility of some BLNAR strains. Lower respiratory tract infections, including pneumonia caused by Streptococcus pneumoniae, Haemophilus influenzae, and Streptococcus. Note: β-lactamase-negative, ampicillin-resistant (BLNAR) strains of Haemophilus influenzae should be considered resistant to cefaclor despite apparent in vitro susceptibility of some BLNAR strains. Pharyngitis and Tonsillitis, caused by Streptococcus pyogenes. Note: Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cefaclor is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cefaclor in the subsequent prevention of rheumatic fever are not available at present. Urinary tract infections, including pyelonephritis and cystitis, caused by Escherichia coli, Proteus mirabilis, Klebsiella spp., and coagulase-negative staphylococci. Skin and skin structure infections caused by Staphylococcus aureus and Streptococcus pyogenes. Appropriate culture and susceptibility studies should be performed to determine susceptibility of the causative organism to cefaclor. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefaclor Capsules and Cefaclor for Oral Suspension and other antibacterial drugs, Cefaclor Capsules and Cefaclor for Oral Suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Cefaclor, USP is a semisynthetic cephalosporin antibiotic for oral administration. It is chemically designated as 3-chloro-7-D-(2-phenylglycinamido)-3-cephem-4-carboxylic acid monohydrate. The chemical formula for cefaclor is C15H14ClN3O4SH2O and the molecular weight is 385.82. Each capsule contains cefaclor monohydrate equivalent to 250 mg (0.68 mmol) or 500 mg (1.36 mmol) anhydrous cefaclor. The capsules also contain colloidal silicon dioxide, croscarmellose sodium, D&C Yellow No. 10, D&C Red No. 28, edible printing ink, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, pregelatinized starch, sicomet black oxide and titanium dioxide. After mixing, each 5 mL of Cefaclor for Oral Suspension will contain cefaclor monohydrate equivalent to 125 mg (0.34 mmol), 187 mg (0.51 mmol), 250 mg (0.68 mmol), or 375 mg (1.0 mmol) anhydrous cefaclor. The suspensions also contain citric acid, colloidal silicon dioxide, FD&C Red No. 40, flavor, simethicone emulsion, sodium benzoate, sodium citrate, sucrose, and xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>54868-3478-3</NDCCode>
<PackageDescription>10 CAPSULE in 1 BOTTLE, PLASTIC (54868-3478-3)</PackageDescription>
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<ProductNDC>54868-3478</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cefaclor</ProprietaryName>
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<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA064156</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>CEFACLOR</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Cefaclor is indicated in the treatment of the following infections when caused by susceptible strains of the designated microorganisms. Otitis media caused by Streptococcus pneumoniae, Haemophilus influenzae, staphylococci, and Streptococcus pyogenes. Note: β-lactamase-negative, ampicillin-resistant (BLNAR) strains of Haemophilus influenzae should be considered resistant to cefaclor despite apparent in vitro susceptibility of some BLNAR strains. Lower respiratory tract infections, including pneumonia caused by Streptococcus pneumoniae, Haemophilus influenzae, and Streptococcus. Note: β-lactamase-negative, ampicillin-resistant (BLNAR) strains of Haemophilus influenzae should be considered resistant to cefaclor despite apparent in vitro susceptibility of some BLNAR strains. Pharyngitis and Tonsillitis, caused by Streptococcus pyogenes. Note: Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cefaclor is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cefaclor in the subsequent prevention of rheumatic fever are not available at present. Urinary tract infections, including pyelonephritis and cystitis, caused by Escherichia coli, Proteus mirabilis, Klebsiella spp., and coagulase-negative staphylococci. Skin and skin structure infections caused by Staphylococcus aureus and Streptococcus pyogenes. Appropriate culture and susceptibility studies should be performed to determine susceptibility of the causative organism to cefaclor. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefaclor Capsules and Cefaclor for Oral Suspension and other antibacterial drugs, Cefaclor Capsules and Cefaclor for Oral Suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Cefaclor, USP is a semisynthetic cephalosporin antibiotic for oral administration. It is chemically designated as 3-chloro-7-D-(2-phenylglycinamido)-3-cephem-4-carboxylic acid monohydrate. The chemical formula for cefaclor is C15H14ClN3O4SH2O and the molecular weight is 385.82. Each capsule contains cefaclor monohydrate equivalent to 250 mg (0.68 mmol) or 500 mg (1.36 mmol) anhydrous cefaclor. The capsules also contain colloidal silicon dioxide, croscarmellose sodium, D&C Yellow No. 10, D&C Red No. 28, edible printing ink, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, pregelatinized starch, sicomet black oxide and titanium dioxide. After mixing, each 5 mL of Cefaclor for Oral Suspension will contain cefaclor monohydrate equivalent to 125 mg (0.34 mmol), 187 mg (0.51 mmol), 250 mg (0.68 mmol), or 375 mg (1.0 mmol) anhydrous cefaclor. The suspensions also contain citric acid, colloidal silicon dioxide, FD&C Red No. 40, flavor, simethicone emulsion, sodium benzoate, sodium citrate, sucrose, and xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>68094-480-60</NDCCode>
<PackageDescription>500 TABLET, COATED in 1 BOTTLE (68094-480-60) </PackageDescription>
<NDC11Code>68094-0480-60</NDC11Code>
<ProductNDC>68094-480</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205096</ApplicationNumber>
<LabelerName>Precision Dose, Inc.</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Metformin hydrochloride tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C4H11N5 ∙ HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride tablets, USP contain 500 mg, 850 mg or 1,000 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 662.88 mg, 779.86 mg metformin base, respectively. Each tablet contains the inactive ingredients povidone and magnesium stearate. In addition, the coating for the 500 mg, 850 mg and 1,000 mg tablets contains hypromellose and polyethylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>68094-480-70</NDCCode>
<PackageDescription>1000 TABLET, COATED in 1 BOTTLE (68094-480-70) </PackageDescription>
<NDC11Code>68094-0480-70</NDC11Code>
<ProductNDC>68094-480</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Metformin Hydrochloride</ProprietaryName>
<NonProprietaryName>Metformin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205096</ApplicationNumber>
<LabelerName>Precision Dose, Inc.</LabelerName>
<SubstanceName>METFORMIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Biguanide [EPC], Biguanides [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>Metformin hydrochloride tablets, USP contain the antihyperglycemic agent metformin, which is a biguanide, in the form of monohydrochloride. The chemical name of metformin hydrochloride is N,N-dimethylimidodicarbonimidic diamide hydrochloride. The structural formula is as shown below. Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C4H11N5 ∙ HCl and a molecular weight of 165.63. It is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin hydrochloride tablets, USP contain 500 mg, 850 mg or 1,000 mg of metformin hydrochloride, which is equivalent to 389.93 mg, 662.88 mg, 779.86 mg metformin base, respectively. Each tablet contains the inactive ingredients povidone and magnesium stearate. In addition, the coating for the 500 mg, 850 mg and 1,000 mg tablets contains hypromellose and polyethylene glycol.</Description>
</NDC>
<NDC>
<NDCCode>0220-3478-41</NDCCode>
<PackageDescription>6 [hp_C] in 1 TUBE (0220-3478-41) </PackageDescription>
<NDC11Code>00220-3478-41</NDC11Code>
<ProductNDC>0220-3478</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Myristica Sebifera</ProprietaryName>
<NonProprietaryName>Virola Sebifera Resin</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19830303</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Boiron</LabelerName>
<SubstanceName>VIROLA SEBIFERA RESIN</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_C]/6[hp_C]</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19830303</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Relieves pain from boils *.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>22840-3478-2</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (22840-3478-2) </PackageDescription>
<NDC11Code>22840-3478-02</NDC11Code>
<ProductNDC>22840-3478</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Privet Pollen</ProprietaryName>
<NonProprietaryName>Ligustrum Vulgare</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19810915</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101833</ApplicationNumber>
<LabelerName>Greer Laboratories, Inc.</LabelerName>
<SubstanceName>LIGUSTRUM VULGARE POLLEN</SubstanceName>
<StrengthNumber>20000</StrengthNumber>
<StrengthUnit>[PNU]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19810915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Non-Standardized Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergies to one or more of the specific non-standardized allergens., 2 Immunotherapy for the reduction of allergen-induced allergic symptoms confirmed by appropriate positive skin tests or by in vitro testing for allergen-specific IgE antibodies.</IndicationAndUsage>
<Description>Non-Standardized Allergenic Extracts are sterile solutions used for percutaneous testing, intradermal testing, or subcutaneous immunotherapy. Aqueous extracts contain the soluble extractants of the source material in water for injection, 0.5% sodium chloride, 0.54% sodium bicarbonate, and 0.4% phenol. Glycerinated extracts contain the soluable extractants of the source material in water for injection and 50% glycerin, 0.25% sodium chloride, 0.27% sodium bicarbonate, and 0.2% phenol. The pH of the extracts range from 6 to 9. Certain food extracts (Barley, Oat, Pineapple, Rye, Spinach, and Wheat), labeled “For Diagnostic Use Only”, contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Source materials used in the manufacture of allergenic extracts are collected from natural sources or from laboratory cultures. Non-Standardized Allergenic Extracts appear as clear and colorless to dark brown solutions that should be free of particulate matter. Extracts are labeled either as weight-to-volume based on the weight of the source material to the volume of the extracting fluid, or as PNU/milliliter with one PNU representing 0.00001 mg of protein nitrogen per milliliter.</Description>
</NDC>
<NDC>
<NDCCode>22840-3478-4</NDCCode>
<PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (22840-3478-4) </PackageDescription>
<NDC11Code>22840-3478-04</NDC11Code>
<ProductNDC>22840-3478</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Privet Pollen</ProprietaryName>
<NonProprietaryName>Ligustrum Vulgare</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19810915</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101833</ApplicationNumber>
<LabelerName>Greer Laboratories, Inc.</LabelerName>
<SubstanceName>LIGUSTRUM VULGARE POLLEN</SubstanceName>
<StrengthNumber>20000</StrengthNumber>
<StrengthUnit>[PNU]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19810915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Non-Standardized Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergies to one or more of the specific non-standardized allergens., 2 Immunotherapy for the reduction of allergen-induced allergic symptoms confirmed by appropriate positive skin tests or by in vitro testing for allergen-specific IgE antibodies.</IndicationAndUsage>
<Description>Non-Standardized Allergenic Extracts are sterile solutions used for percutaneous testing, intradermal testing, or subcutaneous immunotherapy. Aqueous extracts contain the soluble extractants of the source material in water for injection, 0.5% sodium chloride, 0.54% sodium bicarbonate, and 0.4% phenol. Glycerinated extracts contain the soluable extractants of the source material in water for injection and 50% glycerin, 0.25% sodium chloride, 0.27% sodium bicarbonate, and 0.2% phenol. The pH of the extracts range from 6 to 9. Certain food extracts (Barley, Oat, Pineapple, Rye, Spinach, and Wheat), labeled “For Diagnostic Use Only”, contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Source materials used in the manufacture of allergenic extracts are collected from natural sources or from laboratory cultures. Non-Standardized Allergenic Extracts appear as clear and colorless to dark brown solutions that should be free of particulate matter. Extracts are labeled either as weight-to-volume based on the weight of the source material to the volume of the extracting fluid, or as PNU/milliliter with one PNU representing 0.00001 mg of protein nitrogen per milliliter.</Description>
</NDC>
<NDC>
<NDCCode>37662-3478-1</NDCCode>
<PackageDescription>200 PELLET in 1 VIAL, GLASS (37662-3478-1) </PackageDescription>
<NDC11Code>37662-3478-01</NDC11Code>
<ProductNDC>37662-3478</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aluminium Iodatum</ProprietaryName>
<NonProprietaryName>Aluminium Iodatum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230629</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>ALUMINUM IODIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_M]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230629</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>37662-3478-2</NDCCode>
<PackageDescription>500 PELLET in 1 VIAL, GLASS (37662-3478-2) </PackageDescription>
<NDC11Code>37662-3478-02</NDC11Code>
<ProductNDC>37662-3478</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aluminium Iodatum</ProprietaryName>
<NonProprietaryName>Aluminium Iodatum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230629</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>ALUMINUM IODIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_M]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230629</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>37662-3478-3</NDCCode>
<PackageDescription>3000 PELLET in 1 BOTTLE, GLASS (37662-3478-3) </PackageDescription>
<NDC11Code>37662-3478-03</NDC11Code>
<ProductNDC>37662-3478</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aluminium Iodatum</ProprietaryName>
<NonProprietaryName>Aluminium Iodatum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230629</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>ALUMINUM IODIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_M]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230629</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>37662-3478-4</NDCCode>
<PackageDescription>10000 PELLET in 1 BOTTLE, GLASS (37662-3478-4) </PackageDescription>
<NDC11Code>37662-3478-04</NDC11Code>
<ProductNDC>37662-3478</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aluminium Iodatum</ProprietaryName>
<NonProprietaryName>Aluminium Iodatum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230629</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>ALUMINUM IODIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_M]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230629</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50090-3478-0</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (50090-3478-0) > 59 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>50090-3478-00</NDC11Code>
<ProductNDC>50090-3478</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sunmark Lice Treatment</ProprietaryName>
<NonProprietaryName>Permethrin</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150803</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076090</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>PERMETHRIN</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180614</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>55154-3478-9</NDCCode>
<PackageDescription>6 BLISTER PACK in 1 CARTON (55154-3478-9) > 5 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>55154-3478-09</NDC11Code>
<ProductNDC>55154-3478</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Simvastatin</ProprietaryName>
<NonProprietaryName>Simvastatin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20061220</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077752</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>SIMVASTATIN</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-05-17</LastUpdate>
</NDC>
<NDC>
<NDCCode>60505-3478-3</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (60505-3478-3) </PackageDescription>
<NDC11Code>60505-3478-03</NDC11Code>
<ProductNDC>60505-3478</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amlodipine And Atorvastatin</ProprietaryName>
<NonProprietaryName>Amlodipine And Atorvastatin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200729</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA205199</ApplicationNumber>
<LabelerName>Apotex Corp.</LabelerName>
<SubstanceName>AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM TRIHYDRATE</SubstanceName>
<StrengthNumber>5; 10</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200729</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Amlodipine and atorvastatin tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine. Hypertension. Amlodipine is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including amlodipine. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Amlodipine may be used alone or in combination with other antihypertensive agents. Coronary Artery Disease (CAD). Chronic Stable Angina. Amlodipine is indicated for the symptomatic treatment of chronic stable angina. Amlodipine may be used alone or in combination with other antianginal agents. Vasospastic Angina (Prinzmetal’s or Variant Angina). Amlodipine is indicated for the treatment of confirmed or suspected vasospastic angina. Amlodipine may be used as monotherapy or in combination with other antianginal agents. Angiographically Documented CAD. In patients with recently documented CAD by angiography and without heart failure or an ejection fraction < 40%, amlodipine is indicated to reduce the risk of hospitalization for angina and to reduce the risk of a coronary revascularization procedure. Atorvastatin. Atorvastatin is indicated: 1 To reduce the risk of: Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHDMI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHDNon-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD, 2 As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:Adults with primary hyperlipidemia.Adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH)., 3 As an adjunct to other LDL-C-lowering therapies, or alone if such treatments are unavailable, to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH)., 4 As an adjunct to diet for the treatment of adults with:Primary dysbetalipoproteinemiaHypertriglyceridemia.</IndicationAndUsage>
<Description>Amlodipine and atorvastatin tablets, USP combine the calcium channel blocker amlodipine besylate with the HMG CoA-reductase inhibitor atorvastatin calcium. Amlodipine besylate, USP is chemically described as 3-ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(o-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. Its molecular formula is C20H25ClN2O5 C6H6O3S. Atorvastatin calcium, USP in the form of propylene glycol solvate, is chemically described as calcium bis((3R,5R)-7-[3-(anilinocarbonyl)-5-(4-fluorophenyl)-2-isopropyl-4-phenyl-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoate) propylene glycol solvate. Its molecular formula is C66H68CaF2N4O10 * C3H8O2. The structural formulae for amlodipine besylate and atorvastatin calcium propylene glycol solvate are shown below. Amlodipine and atorvastatin tablets, USP for oral administration contains amlodipine besylate, a white or almost white powder, and atorvastatin calcium a white to off-white solid. Amlodipine besylate, USP has a molecular weight of 567.1 g/mol and atorvastatin calcium propylene glycol solvate, USP has a molecular weight of 1231.46 g/mol. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Atorvastatin calcium is insoluble in aqueous solutions of pH 4 and below. Atorvastatin calcium is slightly soluble in distilled water, pH 7.4 phosphate buffer, and acetonitrile; slightly soluble in ethanol; and freely soluble in methanol. Each film-coated tablet also contains calcium acetate, colloidal silicon dioxide, croscarmellose sodium, ferric oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. In addition, the 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg and 10 mg/80 mg strengths also contain FD&C Blue #2. USP Dissolution Test Pending.</Description>
</NDC>
<NDC>
<NDCCode>68071-3478-3</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (68071-3478-3) </PackageDescription>
<NDC11Code>68071-3478-03</NDC11Code>
<ProductNDC>68071-3478</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sucralfate</ProprietaryName>
<NonProprietaryName>Sucralfate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200217</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074415</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>SUCRALFATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>Aluminum Complex [EPC], Organometallic Compounds [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230803</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sucralfate tablets are indicated in: 1 Short-term treatment (up to 8 weeks) of active duodenal ulcer. While healing with sucralfate may occur during the first week or two, treatment should be continued for 4 to 8 weeks unless healing has been demonstrated by x-ray or endoscopic examination., 2 Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers.</IndicationAndUsage>
<Description>Sucralfate is an α-D-glucopyranoside, β-D-fructofuranosyl-, octakis-(hydrogen sulfate), aluminum complex. It has the following structural formula. Tablets for oral administration contain 1 g of sucralfate, USP. Also contain: povidone, magnesium stearate, and colloidal silicon dioxide. Therapeutic category: antiulcer.</Description>
</NDC>
<NDC>
<NDCCode>70518-3478-0</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BLISTER PACK (70518-3478-0) </PackageDescription>
<NDC11Code>70518-3478-00</NDC11Code>
<ProductNDC>70518-3478</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ropinirole</ProprietaryName>
<NonProprietaryName>Ropinirole</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220817</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090135</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>ROPINIROLE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220817</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ropinirole tablets are a non-ergoline dopamine agonist indicated for the treatment of Parkinson’s disease (PD) and moderate-to-severe primary Restless Legs Syndrome (RLS). ( 1.1, 1.2).</IndicationAndUsage>
<Description>Ropinirole Tablets, USP contain ropinirole, a non-ergoline dopamine agonist, as the hydrochloride salt. The chemical name of ropinirole hydrochloride, USP is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the empirical formula is C 16H 24N 2OHCl. The molecular weight is 296.84 g/mol (260.38 as the free base). The structural formula is. Ropinirole hydrochloride, USP is a pale cream to yellow powder with a melting range of 243°C to 250°C and a solubility of 133 mg/mL in water. Each circular, beveled edged, biconvex film-coated tablet contains ropinirole hydrochloride, USP equivalent to ropinirole, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, or 5 mg. Inactive ingredients consist of citric acid anhydrous powder, croscarmellose sodium, lactose anhydrous, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The ingredients of the film coating for each tablet are as follows. 0.25 mg:Hypromellose, polyethylene glycol, talc and titanium dioxide. 0.5 mg:FD&C Blue no. 2 aluminum lake, ferric oxide red, ferric oxide yellow, hypromellose, polyethylene glycol, talc and titanium dioxide. 1 mg:FD&C Blue no. 2 aluminum lake, ferric oxide black, ferric oxide yellow, hypromellose, polyethylene glycol, talc and titanium dioxide. 2 mg:Ferric oxide red, hypromellose, polyethylene glycol, talc and titanium dioxide. 3 mg:Carmine, FD&C Blue no. 2 aluminum lake, FD&C Yellow no. 6 aluminum lake, hypromellose, polyethylene glycol, talc and titanium dioxide. 4 mg:Ferric oxide black, ferric oxide red, ferric oxide yellow, hypromellose, polyethylene glycol, talc and titanium dioxide. 5 mg:FD&C Blue no. 1 aluminum lake, FD&C Blue no. 2 aluminum lake, hypromellose, polyethylene glycol, talc and titanium dioxide. The product meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>70518-3478-1</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3478-1) </PackageDescription>
<NDC11Code>70518-3478-01</NDC11Code>
<ProductNDC>70518-3478</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ropinirole</ProprietaryName>
<NonProprietaryName>Ropinirole</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220817</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090135</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>ROPINIROLE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230220</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ropinirole tablets are a non-ergoline dopamine agonist indicated for the treatment of Parkinson’s disease (PD) and moderate-to-severe primary Restless Legs Syndrome (RLS). ( 1.1, 1.2).</IndicationAndUsage>
<Description>Ropinirole Tablets, USP contain ropinirole, a non-ergoline dopamine agonist, as the hydrochloride salt. The chemical name of ropinirole hydrochloride, USP is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the empirical formula is C 16H 24N 2OHCl. The molecular weight is 296.84 g/mol (260.38 as the free base). The structural formula is. Ropinirole hydrochloride, USP is a pale cream to yellow powder with a melting range of 243°C to 250°C and a solubility of 133 mg/mL in water. Each circular, beveled edged, biconvex film-coated tablet contains ropinirole hydrochloride, USP equivalent to ropinirole, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, or 5 mg. Inactive ingredients consist of citric acid anhydrous powder, croscarmellose sodium, lactose anhydrous, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The ingredients of the film coating for each tablet are as follows. 0.25 mg:Hypromellose, polyethylene glycol, talc and titanium dioxide. 0.5 mg:FD&C Blue no. 2 aluminum lake, ferric oxide red, ferric oxide yellow, hypromellose, polyethylene glycol, talc and titanium dioxide. 1 mg:FD&C Blue no. 2 aluminum lake, ferric oxide black, ferric oxide yellow, hypromellose, polyethylene glycol, talc and titanium dioxide. 2 mg:Ferric oxide red, hypromellose, polyethylene glycol, talc and titanium dioxide. 3 mg:Carmine, FD&C Blue no. 2 aluminum lake, FD&C Yellow no. 6 aluminum lake, hypromellose, polyethylene glycol, talc and titanium dioxide. 4 mg:Ferric oxide black, ferric oxide red, ferric oxide yellow, hypromellose, polyethylene glycol, talc and titanium dioxide. 5 mg:FD&C Blue no. 1 aluminum lake, FD&C Blue no. 2 aluminum lake, hypromellose, polyethylene glycol, talc and titanium dioxide. The product meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>70518-3478-2</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3478-2) </PackageDescription>
<NDC11Code>70518-3478-02</NDC11Code>
<ProductNDC>70518-3478</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ropinirole</ProprietaryName>
<NonProprietaryName>Ropinirole</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220817</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090135</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>ROPINIROLE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250618</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ropinirole tablets are a non-ergoline dopamine agonist indicated for the treatment of Parkinson’s disease (PD) and moderate-to-severe primary Restless Legs Syndrome (RLS). ( 1.1, 1.2).</IndicationAndUsage>
<Description>Ropinirole Tablets, USP contain ropinirole, a non-ergoline dopamine agonist, as the hydrochloride salt. The chemical name of ropinirole hydrochloride, USP is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the empirical formula is C 16H 24N 2OHCl. The molecular weight is 296.84 g/mol (260.38 as the free base). The structural formula is. Ropinirole hydrochloride, USP is a pale cream to yellow powder with a melting range of 243°C to 250°C and a solubility of 133 mg/mL in water. Each circular, beveled edged, biconvex film-coated tablet contains ropinirole hydrochloride, USP equivalent to ropinirole, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, or 5 mg. Inactive ingredients consist of citric acid anhydrous powder, croscarmellose sodium, lactose anhydrous, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The ingredients of the film coating for each tablet are as follows. 0.25 mg:Hypromellose, polyethylene glycol, talc and titanium dioxide. 0.5 mg:FD&C Blue no. 2 aluminum lake, ferric oxide red, ferric oxide yellow, hypromellose, polyethylene glycol, talc and titanium dioxide. 1 mg:FD&C Blue no. 2 aluminum lake, ferric oxide black, ferric oxide yellow, hypromellose, polyethylene glycol, talc and titanium dioxide. 2 mg:Ferric oxide red, hypromellose, polyethylene glycol, talc and titanium dioxide. 3 mg:Carmine, FD&C Blue no. 2 aluminum lake, FD&C Yellow no. 6 aluminum lake, hypromellose, polyethylene glycol, talc and titanium dioxide. 4 mg:Ferric oxide black, ferric oxide red, ferric oxide yellow, hypromellose, polyethylene glycol, talc and titanium dioxide. 5 mg:FD&C Blue no. 1 aluminum lake, FD&C Blue no. 2 aluminum lake, hypromellose, polyethylene glycol, talc and titanium dioxide. The product meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>70518-3478-3</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3478-3) </PackageDescription>
<NDC11Code>70518-3478-03</NDC11Code>
<ProductNDC>70518-3478</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ropinirole</ProprietaryName>
<NonProprietaryName>Ropinirole</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220817</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090135</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>ROPINIROLE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260309</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ropinirole tablets are a non-ergoline dopamine agonist indicated for the treatment of Parkinson’s disease (PD) and moderate-to-severe primary Restless Legs Syndrome (RLS). ( 1.1, 1.2).</IndicationAndUsage>
<Description>Ropinirole Tablets, USP contain ropinirole, a non-ergoline dopamine agonist, as the hydrochloride salt. The chemical name of ropinirole hydrochloride, USP is 4-[2-(dipropylamino)ethyl]-1,3-dihydro-2H-indol-2-one and the empirical formula is C 16H 24N 2OHCl. The molecular weight is 296.84 g/mol (260.38 as the free base). The structural formula is. Ropinirole hydrochloride, USP is a pale cream to yellow powder with a melting range of 243°C to 250°C and a solubility of 133 mg/mL in water. Each circular, beveled edged, biconvex film-coated tablet contains ropinirole hydrochloride, USP equivalent to ropinirole, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, or 5 mg. Inactive ingredients consist of citric acid anhydrous powder, croscarmellose sodium, lactose anhydrous, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The ingredients of the film coating for each tablet are as follows. 0.25 mg:Hypromellose, polyethylene glycol, talc and titanium dioxide. 0.5 mg:FD&C Blue no. 2 aluminum lake, ferric oxide red, ferric oxide yellow, hypromellose, polyethylene glycol, talc and titanium dioxide. 1 mg:FD&C Blue no. 2 aluminum lake, ferric oxide black, ferric oxide yellow, hypromellose, polyethylene glycol, talc and titanium dioxide. 2 mg:Ferric oxide red, hypromellose, polyethylene glycol, talc and titanium dioxide. 3 mg:Carmine, FD&C Blue no. 2 aluminum lake, FD&C Yellow no. 6 aluminum lake, hypromellose, polyethylene glycol, talc and titanium dioxide. 4 mg:Ferric oxide black, ferric oxide red, ferric oxide yellow, hypromellose, polyethylene glycol, talc and titanium dioxide. 5 mg:FD&C Blue no. 1 aluminum lake, FD&C Blue no. 2 aluminum lake, hypromellose, polyethylene glycol, talc and titanium dioxide. The product meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>0053-0480-48</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (0053-0480-48) * 1 INJECTION, SUSPENSION in 1 VIAL, GLASS (0053-0099-01) </PackageDescription>
<NDC11Code>00053-0480-48</NDC11Code>
<ProductNDC>0053-0480</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>0054-0480-13</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (0054-0480-13) </PackageDescription>
<NDC11Code>00054-0480-13</NDC11Code>
<ProductNDC>0054-0480</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Everolimus</ProprietaryName>
<NonProprietaryName>Everolimus</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200608</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207486</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>EVEROLIMUS</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210212</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Everolimus is a kinase inhibitor indicated for the treatment of: : 1 Adults with advanced renal cell carcinoma (RCC) after failure of treatment with sunitinib or sorafenib. (1.3), 2 Adults with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery. (1.4).</IndicationAndUsage>
<Description>Everolimus is a kinase inhibitor. The chemical name of everolimus is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18-dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.04,9]-hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone. The molecular formula is C53H83NO14 and the molecular weight is 958.22 g/mol. The structural formula is: 1 .</Description>
</NDC>
<NDC>
<NDCCode>0054-0480-14</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (0054-0480-14) > 28 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00054-0480-14</NDC11Code>
<ProductNDC>0054-0480</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Everolimus</ProprietaryName>
<NonProprietaryName>Everolimus</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200608</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA207486</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>EVEROLIMUS</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<Status>Deprecated</Status>
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