{
"NDC": [
{
"NDCCode": "0168-0243-15",
"PackageDescription": "1 TUBE in 1 CARTON (0168-0243-15) > 15 g in 1 TUBE",
"NDC11Code": "00168-0243-15",
"ProductNDC": "0168-0243",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diflorasone Diacetate",
"NonProprietaryName": "Diflorasone Diacetate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "19990427",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075374",
"LabelerName": "E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.",
"SubstanceName": "DIFLORASONE DIACETATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-05-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "19990427",
"SamplePackage": "N"
},
{
"NDCCode": "0168-0243-30",
"PackageDescription": "1 TUBE in 1 CARTON (0168-0243-30) > 30 g in 1 TUBE",
"NDC11Code": "00168-0243-30",
"ProductNDC": "0168-0243",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diflorasone Diacetate",
"NonProprietaryName": "Diflorasone Diacetate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "19990427",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075374",
"LabelerName": "E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.",
"SubstanceName": "DIFLORASONE DIACETATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-05-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "19990427",
"SamplePackage": "N"
},
{
"NDCCode": "0168-0243-60",
"PackageDescription": "1 TUBE in 1 CARTON (0168-0243-60) > 60 g in 1 TUBE",
"NDC11Code": "00168-0243-60",
"ProductNDC": "0168-0243",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Diflorasone Diacetate",
"NonProprietaryName": "Diflorasone Diacetate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "19990427",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075374",
"LabelerName": "E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.",
"SubstanceName": "DIFLORASONE DIACETATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-05-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "19990427",
"SamplePackage": "N"
},
{
"NDCCode": "0245-0243-15",
"PackageDescription": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (0245-0243-15)",
"NDC11Code": "00245-0243-15",
"ProductNDC": "0245-0243",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Potassium Chloride",
"NonProprietaryName": "Potassium Chloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19860417",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019123",
"LabelerName": "Upsher-Smith Laboratories, Inc.",
"SubstanceName": "POTASSIUM CHLORIDE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-11-01"
},
{
"NDCCode": "24658-243-15",
"PackageDescription": "15 TABLET in 1 BOTTLE (24658-243-15)",
"NDC11Code": "24658-0243-15",
"ProductNDC": "24658-243",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisinopril",
"NonProprietaryName": "Lisinopril",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20090202",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076063",
"LabelerName": "Blu Pharmaceuticals, LLC",
"SubstanceName": "LISINOPRIL",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-05-09"
},
{
"NDCCode": "43353-243-15",
"PackageDescription": "15 TABLET in 1 BOTTLE (43353-243-15) ",
"NDC11Code": "43353-0243-15",
"ProductNDC": "43353-243",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zolpidem Tartrate",
"NonProprietaryName": "Zolpidem Tartrate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20070905",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077903",
"LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
"SubstanceName": "ZOLPIDEM TARTRATE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Depression [PE], GABA A Agonists [MoA], Pyridines [CS], gamma-Aminobutyric Acid-ergic Agonist [EPC]",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20161006",
"SamplePackage": "N",
"IndicationAndUsage": "Zolpidem tartrate tablets, USP a gamma-amino butyric acid (GABA) A receptor positive modulator, is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation.",
"Description": "Zolpidem tartrate, a gamma-aminobutyric acid (GABA) A receptor positive modulator of the imidazopyridine class. Zolpidem tartrate is available in 5 mg and 10 mg strength tablets for oral administration. Chemically, zolpidem is N,N,6-trimethyl-2-p-tolylimidazo[1,2-a] pyridine-3-acetamide L-(+)-tartrate (2:1). It has the following structure:. Zolpidem tartrate, USP is a white to off-white crystalline powder that is sparingly soluble in water, alcohol, and propylene glycol. It has a molecular weight of 764.88. Each zolpidem tartrate tablet, USP includes the following inactive ingredients: hypromellose, lactose monohydrate, microcrystalline cellulose, magnesium stearate, polyethylene glycol, sodium starch glycolate, titanium dioxide and ferric oxide red; the 10 mg tablet also contains ferric oxide yellow."
},
{
"NDCCode": "63187-243-15",
"PackageDescription": "15 TABLET in 1 BOTTLE, PLASTIC (63187-243-15) ",
"NDC11Code": "63187-0243-15",
"ProductNDC": "63187-243",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prednisone",
"NonProprietaryName": "Prednisone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20030314",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA084283",
"LabelerName": "Proficient Rx LP",
"SubstanceName": "PREDNISONE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2022-06-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140901",
"SamplePackage": "N",
"IndicationAndUsage": "Prednisone tablets and solutions are indicated in the following conditions.",
"Description": "Each tablet for oral administration contains. Prednisone.............................................................50 mg."
},
{
"NDCCode": "63361-243-15",
"PackageDescription": "10 SYRINGE in 1 PACKAGE (63361-243-15) / .5 mL in 1 SYRINGE (63361-243-88) ",
"NDC11Code": "63361-0243-15",
"ProductNDC": "63361-243",
"ProductTypeName": "VACCINE",
"ProprietaryName": "Vaxelis",
"NonProprietaryName": "Diphtheria And Tetanus Toxoids And Acellular Pertussis, Inactivated Poliovirus, Haemophilus B Conjugate And Hepatitis B Vaccine",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "INTRAMUSCULAR",
"StartMarketingDate": "20181221",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA125563",
"LabelerName": "MSP Vaccine Company",
"SubstanceName": "CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS PERTACTIN ANTIGEN; BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN; POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED); HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN; HAEMOPHILUS INFLUENZAE TYPE B CAPSULAR POLYSACCHARIDE MENINGOCOCCAL OUTER MEMBRANE PROTEIN CONJUGATE ANTIGEN",
"StrengthNumber": "15; 5; 20; 20; 3; 5; 29; 7; 26; 10; 3",
"StrengthUnit": "[Lf]/.5mL; [Lf]/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; [D'ag'U]/.5mL; [D'ag'U]/.5mL; [D'ag'U]/.5mL; ug/.5mL; ug/.5mL",
"Pharm_Classes": "Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Diphtheria Toxoid [CS], Haemophilus Vaccines [CS], Hepatitis B Vaccines [CS], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Clostridium Tetani Vaccine [EPC], Inactivated Corynebacterium Diphtheriae Vaccine [EPC], Inactivated Haemophilus Influenzae B Vaccine [EPC], Inactivated Hepatitis B Virus Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Pertussis Vaccine [CS], Pertussis Vaccine [CS], Pertussis Vaccine [CS], Poliovirus Vaccines [CS], Poliovirus Vaccines [CS], Poliovirus Vaccines [CS], Tetanus Toxoid [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS]",
"Status": "Active",
"LastUpdate": "2026-05-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20181221",
"SamplePackage": "N",
"IndicationAndUsage": "VAXELIS® is a vaccine indicated for active immunization to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae (H. influenzae) type b. VAXELIS is approved for use as a 3-dose series in children 6 weeks through 4 years of age (prior to the 5th birthday).",
"Description": "VAXELIS (Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine) is a sterile injectable suspension for intramuscular use. Each 0.5 mL dose is formulated to contain 15 Lf diphtheria toxoid, 5 Lf tetanus toxoid, acellular pertussis antigens [20 mcg detoxified pertussis toxin (PT), 20 mcg filamentous hemagglutinin (FHA), 3 mcg pertactin (PRN), 5 mcg fimbriae types 2 and 3 (FIM)], inactivated polioviruses [29 D-antigen units (DU) Type 1 (Mahoney), 7 DU Type 2 (MEF-1), 26 DU Type 3 (Saukett)], 3 mcg polyribosylribitol phosphate (PRP) of H. influenzae type b covalently bound to 50 mcg of the outer membrane protein complex (OMPC) of Neisseria meningitidis serogroup B, and 10 mcg hepatitis B surface antigen (HBsAg). Each 0.5 mL dose contains 319 mcg aluminum from aluminum salts used as adjuvants. Other ingredients per 0.5 mL dose include <0.0056% polysorbate 80 and the following residuals from the manufacturing process: ≤14 mcg formaldehyde, ≤50 ng glutaraldehyde, ≤50 ng bovine serum albumin, <5 ng of neomycin, <200 ng streptomycin sulfate, <25 ng polymyxin B sulfate, ≤0.125 μg ammonium thiocyanate and ≤0.1 mcg yeast protein (maximum 1% relative to HBsAg protein). Corynebacterium diphtheriae is grown in modified Mueller's growth medium. (3) After purification by ammonium sulfate fractionation, the diphtheria toxin is detoxified with formaldehyde and diafiltered. Clostridium tetani is grown in modified Mueller-Miller casamino acid medium without beef heart infusion. (4) Tetanus toxin is detoxified with formaldehyde and purified by ammonium sulfate fractionation and diafiltration. Diphtheria and tetanus toxoids are individually adsorbed onto aluminum phosphate. The acellular pertussis vaccine antigens are produced from Bordetella pertussis cultures grown in Stainer-Scholte medium (5) modified by the addition of casamino acids and dimethyl-beta-cyclodextrin. PT, FHA and PRN are isolated separately from the supernatant culture medium. FIM are extracted and copurified from the bacterial cells. The pertussis antigens are purified by sequential filtration, salt-precipitation, ultrafiltration and chromatography. PT is detoxified with glutaraldehyde. FHA is treated with formaldehyde and the residual aldehydes are removed by ultrafiltration. The individual antigens are adsorbed separately onto aluminum phosphate. The Type 1, Type 2, and Type 3 polioviruses are individually grown in Vero cells. The viral harvests are concentrated and purified, then inactivated with formaldehyde to produce monovalent suspensions of each serotype. Specified quantities of monovalent suspensions of each serotype are mixed to produce the trivalent poliovirus concentrate. The HBsAg antigen is harvested and purified from fermentation cultures of a recombinant strain of the yeast Saccharomyces cerevisiae containing the gene for the adw subtype of HBsAg. The recombinant Saccharomyces cerevisiae is grown in a fermentation medium which consists of an extract of yeast, soy peptone, dextrose, amino acids, and mineral salts. The HBsAg protein is released from the yeast cells by cell disruption and purified by a series of physical and chemical methods which includes ion and hydrophobic chromatography, and diafiltration. The purified protein is treated in phosphate buffer with formaldehyde and then co-precipitated with alum (potassium aluminum sulfate) to form bulk vaccine adjuvanted with amorphous aluminum hydroxyphosphate sulfate. The purified PRP of H. influenzae type b (Haemophilus b, Ross strain) is conjugated to an OMPC of the B11 strain of N. meningitidis serogroup B. H. influenzae type b is grown in a fermentation medium which includes an extract of yeast, nicotinamide adenine dinucleotide, hemin chloride, soy peptone, dextrose, and mineral salts. The PRP is purified from the culture broth by purification procedures which include ethanol fractionation, enzyme digestion, phenol extraction and diafiltration. N. meningitidis serogroup B is grown in a fermentation medium which includes an extract of yeast, amino acids and mineral salts. The OMPC is purified by detergent extraction, ultracentrifugation, diafiltration and sterile filtration. PRP is conjugated to OMPC by chemical coupling and the PRP-OMPC is then adsorbed onto an amorphous aluminum hydroxyphosphate sulfate adjuvant. The adsorbed diphtheria, tetanus, and acellular pertussis antigens are combined with aluminum phosphate (as adjuvant) and water for injection into an intermediate concentrate. The individual HBsAg and PRP-OMPC adjuvanted bulks are added followed by the trivalent poliovirus concentrate, to produce VAXELIS. Both diphtheria and tetanus toxoids induce at least 2 neutralizing units per mL of serum in the guinea pig potency test. The potency of the acellular pertussis antigens PT, FHA, and FIM is evaluated by the antibody response of immunized mice to detoxified forms as measured by enzyme-linked immunosorbent assay (ELISA). The potency of the acellular pertussis antigen PRN is measured by an in vitro PRN antigenicity ELISA. The potency of the inactivated poliovirus antigens is determined using an in vitro D-antigen ELISA for each serotype. The potency of the HBsAg component is measured relative to a standard by an in vitro immunoassay. The potency of the PRP-OMPC component is measured by quantitating the polysaccharide concentration using a high-performance liquid chromatography (HPLC) method. VAXELIS does not contain a preservative. The syringe plunger stopper and syringe tip cap are not made with natural rubber latex."
},
{
"NDCCode": "66794-243-15",
"PackageDescription": "1 BOTTLE in 1 CARTON (66794-243-15) / 100 mL in 1 BOTTLE",
"NDC11Code": "66794-0243-15",
"ProductNDC": "66794-243",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ampicillin And Sulbactam",
"NonProprietaryName": "Ampicillin And Sulbactam",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20190520",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090578",
"LabelerName": "Piramal Critical Care Inc",
"SubstanceName": "AMPICILLIN SODIUM; SULBACTAM SODIUM",
"StrengthNumber": "100; 50",
"StrengthUnit": "mg/mL; mg/mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-04-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190520",
"SamplePackage": "N",
"IndicationAndUsage": "Ampicillin and Sulbactam for Injection, USP is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below. Skin and Skin Structure Infections caused by beta-lactamase producing strains of Staphylococcus aureus, Escherichia coli,* Klebsiella spp.* (including K. pneumoniae*), Proteus mirabilis,* Bacteroides fragilis,* Enterobacter spp.,* and Acinetobacter calcoaceticus.*. NOTE: For information on use in pediatric patients (see PRECAUTIONS-Pediatric Useand CLINICAL STUDIESsections). Intra-Abdominal Infections caused by beta-lactamase producing strains of Escherichia coli, Klebsiella spp. (including K. pneumoniae*), Bacteroides spp. (including B. fragilis), and Enterobacter spp.*. Gynecological Infections caused by beta-lactamase producing strains of Escherichia coli,* and Bacteroides spp.* (including B. fragilis*). * Efficacy for this organism in this organ system was studied in fewer than 10 infections. While ampicillin and sulbactam for injection, USP is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with ampicillin and sulbactam for injection, USP due to its ampicillin content. Therefore, mixed infections caused by ampicillin-susceptible organisms and beta-lactamase producing organisms susceptible to ampicillin and sulbactam for injection, USP should not require the addition of another antibacterial. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify the organisms causing infection and to determine their susceptibility to ampicillin and sulbactam for injection, USP. Therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies when there is reason to believe the infection may involve any of the beta-lactamase producing organisms listed above in the indicated organ systems. Once the results are known, therapy should be adjusted if appropriate. To reduce the development of drug-resistant bacteria and maintain effectiveness of ampicillin and sulbactam for injection, USP and other antibacterial drugs, ampicillin and sulbactam for injection, USP should be used only to treat 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": "Ampicillin and Sulbactam for Injection is an injectable antibacterial combination consisting of the semisynthetic antibacterial ampicillin sodium and the beta-lactamase inhibitor sulbactam sodium for intravenous and intramuscular administration. Ampicillin sodium is derived from the penicillin nucleus, 6-aminopenicillanic acid. Chemically, it is monosodium (2S, 5R, 6R)-6-[(R)-2-amino-2-phenylacetamido]3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate and has a molecular weight of 371.39. Its chemical formula is C 16H 18N 3NaO 4S. The structural formula is:. Sulbactam sodium is a derivative of the basic penicillin nucleus. Chemically, sulbactam sodium is sodium penicillinate sulfone; sodium (2S, 5R)-3,3-dimethyl-7-oxo-4-thia1-azabicyclo [3.2.0] heptane-2-carboxylate 4,4-dioxide. Its chemical formula is C 8H 10NNaO 5S with a molecular weight of 255.22. The structural formula is:. Ampicillin and Sulbactam for Injection, ampicillin sodium/sulbactam sodium parenteral combination, is available as a white to off-white dry powder for reconstitution. Ampicillin and Sulbactam for Injection, USP dry powder is freely soluble in aqueous diluents to yield pale yellow to yellow solutions containing ampicillin sodium and sulbactam sodium equivalent to 250 mg ampicillin per mL and 125 mg sulbactam per mL. The pH of the solutions is between 8.0 and 10.0. Dilute solutions (up to 30 mg ampicillin and 15 mg sulbactam per mL) are essentially colorless to pale yellow. The pH of dilute solutions remains the same. Ampicillin and Sulbactam for Injection pharmacy bulk package is a vial containing a sterile preparation of ampicillin sodium and sulbactam sodium for parenteral use that contains many single doses. The Pharmacy Bulk Package is for use in a pharmacy admixture setting; it provides many single doses of Ampicillin and Sulbactam for Injection, USP for addition to suitable parenteral fluids in the preparation of admixtures for intravenous infusion (see DIRECTIONS FOR USE, Directions for Proper Use of Pharmacy Bulk Package)."
},
{
"NDCCode": "71335-0243-5",
"PackageDescription": "15 TABLET in 1 BOTTLE (71335-0243-5) ",
"NDC11Code": "71335-0243-05",
"ProductNDC": "71335-0243",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Warfarin Sodium",
"NonProprietaryName": "Warfarin Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150407",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040616",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "WARFARIN SODIUM",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-07-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211227",
"SamplePackage": "N",
"IndicationAndUsage": "Warfarin sodium tablets are indicated for: 1 Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE)., 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement., 3 Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.",
"Description": "Warfarin sodium tablets, USP contain warfarin sodium, an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. The chemical name of warfarin sodium is 3-(α-acetonylbenzyl)-4-hydroxycoumarin sodium salt, which is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its structural formula may be represented as follows. C19H15NaO4 M.W. 330.31. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Each tablet, for oral administration, contains 1 mg, 2 mg, 2.5 mg, 3 mg, 4 mg, 5 mg, 6 mg, 7.5 mg or 10 mg warfarin sodium, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The 1 mg also contains FD&C red no. 40. The 2 mg also contains FD&C blue no. 2 aluminum lake and FD&C red no. 40 aluminum lake. The 2.5 mg also contains D&C yellow no. 10 aluminum lake and FD&C blue no. 1 aluminum lake. The 3 mg also contains FD&C yellow no. 6 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, and D&C yellow no. 10 aluminum lake. The 4 mg also contains FD&C blue no. 1 aluminum lake and FD&C blue no. 2 aluminum lake. The 5 mg also contains FD&C yellow no. 6 aluminum lake, FD&C red no. 40 aluminum lake and D&C yellow no. 10 aluminum lake. The 6 mg also contains D&C yellow no. 10 aluminum lake and FD&C blue no. 1 aluminum lake. The 7.5 mg also contains D&C yellow no. 10 aluminum lake and FD&C yellow no. 6 aluminum lake."
},
{
"NDCCode": "0168-0002-15",
"PackageDescription": "1 TUBE in 1 CARTON (0168-0002-15) / 15 g in 1 TUBE",
"NDC11Code": "00168-0002-15",
"ProductNDC": "0168-0002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triamcinolone Acetonide",
"NonProprietaryName": "Triamcinolone Acetonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19780309",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA085692",
"LabelerName": "E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC",
"SubstanceName": "TRIAMCINOLONE ACETONIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19780309",
"SamplePackage": "N",
"IndicationAndUsage": "Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Triamcinolone Acetonide Cream USP contains Triamcinolone Acetonide [Pregna-1,4-diene-3,20-dione, 9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis- (oxy)]-, (11β,16α)-], with the empirical formula C24H31FO6 and molecular weight 434.50. CAS 76-25-5. Triamcinolone Acetonide Cream USP, 0.025% contains: 0.25 mg of Triamcinolone Acetonide per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water. Triamcinolone Acetonide Cream USP, 0.1% contains: 1 mg of Triamcinolone Acetonide per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water. Triamcinolone Acetonide Cream USP, 0.5% contains: 5 mg of Triamcinolone Acetonide per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water."
},
{
"NDCCode": "0168-0003-15",
"PackageDescription": "1 TUBE in 1 CARTON (0168-0003-15) / 15 g in 1 TUBE",
"NDC11Code": "00168-0003-15",
"ProductNDC": "0168-0003",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triamcinolone Acetonide",
"NonProprietaryName": "Triamcinolone Acetonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19780309",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA085692",
"LabelerName": "E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC",
"SubstanceName": "TRIAMCINOLONE ACETONIDE",
"StrengthNumber": ".25",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19780309",
"SamplePackage": "N",
"IndicationAndUsage": "Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Triamcinolone Acetonide Cream USP contains Triamcinolone Acetonide [Pregna-1,4-diene-3,20-dione, 9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis- (oxy)]-, (11β,16α)-], with the empirical formula C24H31FO6 and molecular weight 434.50. CAS 76-25-5. Triamcinolone Acetonide Cream USP, 0.025% contains: 0.25 mg of Triamcinolone Acetonide per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water. Triamcinolone Acetonide Cream USP, 0.1% contains: 1 mg of Triamcinolone Acetonide per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water. Triamcinolone Acetonide Cream USP, 0.5% contains: 5 mg of Triamcinolone Acetonide per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water."
},
{
"NDCCode": "0168-0004-15",
"PackageDescription": "1 TUBE in 1 CARTON (0168-0004-15) / 15 g in 1 TUBE",
"NDC11Code": "00168-0004-15",
"ProductNDC": "0168-0004",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triamcinolone Acetonide",
"NonProprietaryName": "Triamcinolone Acetonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19780309",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA085692",
"LabelerName": "E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC",
"SubstanceName": "TRIAMCINOLONE ACETONIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19780309",
"SamplePackage": "N",
"IndicationAndUsage": "Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Triamcinolone Acetonide Cream USP contains Triamcinolone Acetonide [Pregna-1,4-diene-3,20-dione, 9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis- (oxy)]-, (11β,16α)-], with the empirical formula C24H31FO6 and molecular weight 434.50. CAS 76-25-5. Triamcinolone Acetonide Cream USP, 0.025% contains: 0.25 mg of Triamcinolone Acetonide per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water. Triamcinolone Acetonide Cream USP, 0.1% contains: 1 mg of Triamcinolone Acetonide per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water. Triamcinolone Acetonide Cream USP, 0.5% contains: 5 mg of Triamcinolone Acetonide per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water."
},
{
"NDCCode": "0168-0006-15",
"PackageDescription": "15 g in 1 TUBE (0168-0006-15) ",
"NDC11Code": "00168-0006-15",
"ProductNDC": "0168-0006",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Triamcinolone Acetonide",
"NonProprietaryName": "Triamcinolone Acetonide",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "19780214",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA085691",
"LabelerName": "E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC",
"SubstanceName": "TRIAMCINOLONE ACETONIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19780214",
"SamplePackage": "N",
"IndicationAndUsage": "Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. Triamcinolone Acetonide Ointment USP contains Triamcinolone Acetonide [Pregna-1,4-diene-3,20-dione,9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis-(oxy)]-, (11β,16α)-], with the molecular formula C24H31FO6 and molecular weight 434.51. CAS 76-25-5. Triamcinolone Acetonide Ointment USP, 0.025% contains: 0.25 mg of triamcinolone acetonide per gram in a base containing white petrolatum and mineral oil. Triamcinolone Acetonide Ointment USP, 0.1% contains: 1 mg triamcinolone acetonide per gram in a base containing white petrolatum and mineral oil."
},
{
"NDCCode": "0168-0007-15",
"PackageDescription": "15 g in 1 TUBE (0168-0007-15) ",
"NDC11Code": "00168-0007-15",
"ProductNDC": "0168-0007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nystatin",
"NonProprietaryName": "Nystatin",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "19820923",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062124",
"LabelerName": "E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.",
"SubstanceName": "NYSTATIN",
"StrengthNumber": "100000",
"StrengthUnit": "[USP'U]/g",
"Pharm_Classes": "Polyene Antifungal [EPC], Polyenes [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-06-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "19820923",
"SamplePackage": "N",
"IndicationAndUsage": "Nystatin Ointment is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida [Monilia]albicans and other Candida species.",
"Description": "Nystatin Ointment USP, for topical use only, contains 100,000 USP Nystatin Units per gram, in a polyethylene and mineral oil base. The structural formula is as follows."
},
{
"NDCCode": "0168-0033-15",
"PackageDescription": "15 g in 1 TUBE (0168-0033-15) ",
"NDC11Code": "00168-0033-15",
"ProductNDC": "0168-0033",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Betamethasone Valerate",
"NonProprietaryName": "Betamethasone Valerate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "19830831",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018865",
"LabelerName": "E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC",
"SubstanceName": "BETAMETHASONE VALERATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19830831",
"SamplePackage": "N",
"IndicationAndUsage": "Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Betamethasone Valerate Cream, Ointment and Lotion contain betamethasone valerate USP, a synthetic adrenocorticosteroid for dermatologic use. Betamethasone, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Betamethasone valerate is a white to practically white odorless crystalline powder practically insoluble in water, freely soluble in acetone and chloroform, soluble in alcohol, and slightly soluble in benzene and ether. Chemically, it is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1, 4-diene-3,20-dione 17-valerate. The structural formula is:. Each gram of the 0.1% Cream contains 1.2 mg betamethasone valerate (equivalent to 1 mg betamethasone) in a soft, white, hydrophilic cream of purified water, mineral oil, white petrolatum, polyoxyl 20 cetostearyl ether, cetostearyl alcohol, monobasic sodium phosphate and phosphoric acid or sodium hydroxide (to adjust pH, if required); chlorocresol is present as a preservative. Each gram of the 0.1% Ointment contains 1.2 mg betamethasone valerate (equivalent to 1 mg betamethasone) in an ointment base of white petrolatum and mineral oil. Each gram of the 0.1% Lotion contains 1.2 mg betamethasone valerate (equivalent to 1 mg betamethasone) in a vehicle of isopropyl alcohol and water slightly thickened with carbomer 934P. Sodium hydroxide is used to adjust pH."
},
{
"NDCCode": "0168-0040-15",
"PackageDescription": "15 g in 1 TUBE (0168-0040-15) ",
"NDC11Code": "00168-0040-15",
"ProductNDC": "0168-0040",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Betamethasone Valerate",
"NonProprietaryName": "Betamethasone Valerate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19830831",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018861",
"LabelerName": "E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC",
"SubstanceName": "BETAMETHASONE VALERATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19830831",
"SamplePackage": "N",
"IndicationAndUsage": "Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Betamethasone Valerate Cream, Ointment and Lotion contain betamethasone valerate USP, a synthetic adrenocorticosteroid for dermatologic use. Betamethasone, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Betamethasone valerate is a white to practically white odorless crystalline powder practically insoluble in water, freely soluble in acetone and chloroform, soluble in alcohol, and slightly soluble in benzene and ether. Chemically, it is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1, 4-diene-3,20-dione 17-valerate. The structural formula is:. Each gram of the 0.1% Cream contains 1.2 mg betamethasone valerate (equivalent to 1 mg betamethasone) in a soft, white, hydrophilic cream of purified water, mineral oil, white petrolatum, polyoxyl 20 cetostearyl ether, cetostearyl alcohol, monobasic sodium phosphate and phosphoric acid or sodium hydroxide (to adjust pH, if required); chlorocresol is present as a preservative. Each gram of the 0.1% Ointment contains 1.2 mg betamethasone valerate (equivalent to 1 mg betamethasone) in an ointment base of white petrolatum and mineral oil. Each gram of the 0.1% Lotion contains 1.2 mg betamethasone valerate (equivalent to 1 mg betamethasone) in a vehicle of isopropyl alcohol and water slightly thickened with carbomer 934P. Sodium hydroxide is used to adjust pH."
},
{
"NDCCode": "0168-0054-15",
"PackageDescription": "1 TUBE in 1 CARTON (0168-0054-15) > 15 g in 1 TUBE",
"NDC11Code": "00168-0054-15",
"ProductNDC": "0168-0054",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nystatin",
"NonProprietaryName": "Nystatin",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19790201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062129",
"LabelerName": "E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.",
"SubstanceName": "NYSTATIN",
"StrengthNumber": "100000",
"StrengthUnit": "[USP'U]/g",
"Pharm_Classes": "Polyene Antifungal [EPC], Polyenes [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-06-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "19790201",
"SamplePackage": "N",
"IndicationAndUsage": "Nystatin cream is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. This cream is not indicated for systemic, oral, intravaginal or ophthalmic use.",
"Description": "Nystatin is a polyene antifungal antibiotic obtained from Streptomyces nursei. Structural formula. Molecular Weight 926.13. Molecular Formula C47H75NO17. Nystatin cream is for dermatologic use. Nystatin cream for topical use, contains 100,000 USP nystatin units per gram in an aqueous, vanishing cream base containing Polysorbate 60, Aluminum Hydroxide Compressed Gel, Titanium Dioxide, Glyceryl Monostearate, Polyethylene Glycol 400 Monostearate, Simethicone Emulsion, Sorbic Acid, Propylene Glycol, Ethylenediamine, Polyoxyethylene Fatty Alcohol Ether, Sorbitol Solution, Methylparaben, Propylparaben, Hydrochloric Acid, White Petrolatum, and Purified Water."
},
{
"NDCCode": "0168-0055-15",
"PackageDescription": "1 TUBE in 1 CARTON (0168-0055-15) / 15 g in 1 TUBE",
"NDC11Code": "00168-0055-15",
"ProductNDC": "0168-0055",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Betamethasone Dipropionate",
"NonProprietaryName": "Betamethasone Dipropionate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19840626",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019137",
"LabelerName": "E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC",
"SubstanceName": "BETAMETHASONE DIPROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19840626",
"SamplePackage": "N",
"IndicationAndUsage": "Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Betamethasone Dipropionate Cream, Ointment and Lotion contain betamethasone dipropionate USP, a synthetic adrenocorticosteroid, for dermatologic use. Betamethasone, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Betamethasone dipropionate is a white to cream white odorless crystalline powder insoluble in water. Chemically, it is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate. The structural formula is. Each gram of the 0.05% Cream contains 0.64 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone) in a soft, white, hydrophilic cream of purified water, mineral oil, white petrolatum, polyoxyl 20 cetostearyl ether, cetostearyl alcohol, monobasic sodium phosphate (monohydrate); chlorocresol is present as a preservative. Sodium hydroxide or phosphoric acid solution to adjust pH, if required. Each gram of the 0.05% Ointment contains 0.64 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone) in an ointment base of mineral oil and white petrolatum. Each gram of the 0.05% Lotion contains 0.64 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone) in a vehicle of isopropyl alcohol and purified water slightly thickened with carbomer 934P. Sodium hydroxide solution to adjust pH, if required."
},
{
"NDCCode": "0168-0056-15",
"PackageDescription": "1 TUBE in 1 CARTON (0168-0056-15) / 15 g in 1 TUBE",
"NDC11Code": "00168-0056-15",
"ProductNDC": "0168-0056",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Betamethasone Dipropionate",
"NonProprietaryName": "Betamethasone Dipropionate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "19840904",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019141",
"LabelerName": "E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC",
"SubstanceName": "BETAMETHASONE DIPROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19840904",
"SamplePackage": "N",
"IndicationAndUsage": "Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Betamethasone dipropionate ointment, USP contain betamethasone dipropionate USP, a synthetic adrenocorticosteroid, for dermatologic use. Betamethasone, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Betamethasone dipropionate is a white to cream white odorless crystalline powder insoluble in water. Chemically, it is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate. The structural formula is. Molecular Formula: C28H37FO7. Molecular Weight: 504.60. Each gram of the 0.05% Ointment contains 0.64 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone) in an ointment base of mineral oil and white petrolatum."
},
{
"NDCCode": "0168-0058-15",
"PackageDescription": "15 g in 1 TUBE (0168-0058-15)",
"NDC11Code": "00168-0058-15",
"ProductNDC": "0168-0058",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluocinolone Acetonide",
"NonProprietaryName": "Fluocinolone Acetonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19821216",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088170",
"LabelerName": "E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.",
"SubstanceName": "FLUOCINOLONE ACETONIDE",
"StrengthNumber": ".1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "0168-0060-15",
"PackageDescription": "15 g in 1 TUBE (0168-0060-15)",
"NDC11Code": "00168-0060-15",
"ProductNDC": "0168-0060",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluocinolone Acetonide",
"NonProprietaryName": "Fluocinolone Acetonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19821216",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088169",
"LabelerName": "E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.",
"SubstanceName": "FLUOCINOLONE ACETONIDE",
"StrengthNumber": ".25",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "0168-0064-15",
"PackageDescription": "15 g in 1 TUBE (0168-0064-15) ",
"NDC11Code": "00168-0064-15",
"ProductNDC": "0168-0064",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluocinolone Acetonide",
"NonProprietaryName": "Fluocinolone Acetonide",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "19821216",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA088168",
"LabelerName": "E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC",
"SubstanceName": "FLUOCINOLONE ACETONIDE",
"StrengthNumber": ".25",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-02-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19821216",
"SamplePackage": "N",
"IndicationAndUsage": "Fluocinolone Acetonide ointment is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Fluocinolone Acetonide Ointment 0.025% is intended for topical administration. The active component is the corticosteroid Fluocinolone Acetonide USP (Pregna-1,4-diene-3,20-dione, 6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-, (6α,11β,16α)-. It has an empirical formula of. C24H30F2O6 and a molecular weight of 452.49 (CAS Registry Number 67-73-2). Each gram of the ointment contains 0.25 mg Fluocinolone Acetonide in a base containing White Petrolatum."
},
{
"NDCCode": "0168-0071-15",
"PackageDescription": "15 g in 1 TUBE (0168-0071-15)",
"NDC11Code": "00168-0071-15",
"ProductNDC": "0168-0071",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gentamicin Sulfate",
"NonProprietaryName": "Gentamicin Sulfate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19840705",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062531",
"LabelerName": "E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc.",
"SubstanceName": "GENTAMICIN SULFATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-18",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0168-0078-15",
"PackageDescription": "15 g in 1 TUBE (0168-0078-15)",
"NDC11Code": "00168-0078-15",
"ProductNDC": "0168-0078",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gentamicin Sulfate",
"NonProprietaryName": "Gentamicin Sulfate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100317",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062533",
"LabelerName": "E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.",
"SubstanceName": "GENTAMICIN",
"StrengthNumber": "1",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Primary skin infections: Impetigo contagiosa, superficial folliculitis, ecthyma, furunculosis, sycosis barbae, and pyoderma gangrenosum. Secondary skin infections: Infectious eczematoid dermatitis, pustular acne, pustular psoriasis, infected seborrheic dermatitis, infected contact dermatitis (including poison ivy), infected excoriations, and bacterial super-infections of fungal or viral infections. Please Note: Gentamicin sulfate is a bactericidal agent that is not effective against viruses or fungi in skin infections. Gentamicin sulfate is useful in the treatment of infected skin cysts and certain other skin abscesses when preceded by incision and drainage to permit adequate contact between the antibiotic and the infecting bacteria. Good results have been obtained in the treatment of infected stasis and other skin ulcers, infected superficial burns, paronychia, infected insect bites and stings, infected lacerations and abrasions, and wounds from minor surgery. Patients sensitive to neomycin can be treated with gentamicin sulfate, although regular observation of patients sensitive to topical antibiotics is advisable when such patients are treated with any topical antibiotic. Gentamicin Sulfate Ointment helps retain moisture and has been useful in infection on dry eczematous or psoriatic skin. Gentamicin Sulfate Ointment may be used in children over one year of age as well as in adults.",
"Description": "Gentamicin Sulfate Ointment is a wide spectrum antibiotic preparation for topical administration. Each gram contains 1.0 mg of Gentamicin in a base of White Petrolatum with Methylparaben and Propylparaben as preservatives."
},
{
"NDCCode": "0168-0081-15",
"PackageDescription": "15 g in 1 TUBE (0168-0081-15) ",
"NDC11Code": "00168-0081-15",
"ProductNDC": "0168-0081",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nystatin And Triamcinolone Acetonide",
"NonProprietaryName": "Nystatin And Triamcinolone Acetonide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19851008",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062599",
"LabelerName": "E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.",
"SubstanceName": "NYSTATIN; TRIAMCINOLONE ACETONIDE",
"StrengthNumber": "100000; 1",
"StrengthUnit": "[USP'U]/g; mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-06-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "19851008",
"SamplePackage": "N",
"IndicationAndUsage": "Nystatin and triamcinolone acetonide cream is indicated for the treatment of cutaneous candidiasis. It has been demonstrated that the nystatin-steroid combination provides greater benefit than the nystatin component alone during the first few days of treatment.",
"Description": "Nystatin and triamcinolone acetonide cream for dermatologic use contains the antifungal agent nystatin and the synthetic corticosteroid triamcinolone acetonide. Nystatin is a polyene antimycotic obtained from Streptomyces noursei. It is a yellow to light tan powder with a cereal-like odor, very slightly soluble in water, and slightly to sparingly soluble in alcohol. It has a molecular formula of C47H75NO17 and a molecular weight of 926.13. Structural formula. Triamcinolone acetonide is designated chemically as 9-fluoro-11β,16α,17, 21-tetrahydroxypregna-1,4-diene-3, 20-dione cyclic 16, 17-acetal with acetone. The white to cream crystalline powder has a slight odor, is practically insoluble in water, and very soluble in alcohol. It has a molecular formula of C24H31FO6 and a molecular weight of 434.50. Structural formula:. Nystatin and triamcinolone acetonide cream is a soft, smooth cream having a light yellow to tan color. Each gram of nystatin and triamcinolone acetonide cream USP contains 100,000 USP Nystatin Units and 1 mg of triamcinolone acetonide in a cream base containing polyoxyethylene fatty alcohol ether, white petrolatum, glyceryl monostearate, polyethylene glycol 400 monostearate, sorbitol solution, simethicone emulsion, propylene glycol, aluminum hydroxide gel, polysorbate 60, titanium dioxide, and purified water with benzyl alcohol as a preservative. Sodium hydroxide to adjust pH."
},
{
"NDCCode": "0168-0089-15",
"PackageDescription": "15 g in 1 TUBE (0168-0089-15) ",
"NDC11Code": "00168-0089-15",
"ProductNDC": "0168-0089",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Nystatin And Triamcinolone Acetonide",
"NonProprietaryName": "Nystatin And Triamcinolone Acetonide",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "19851009",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062602",
"LabelerName": "E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.",
"SubstanceName": "NYSTATIN; TRIAMCINOLONE ACETONIDE",
"StrengthNumber": "100000; 1",
"StrengthUnit": "[USP'U]/g; mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]",
"Status": "Deprecated",
"LastUpdate": "2024-06-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "19851009",
"SamplePackage": "N",
"IndicationAndUsage": "Nystatin and triamcinolone acetonide ointment is indicated for the treatment of cutaneous candidiasis. It has been demonstrated that the nystatin-steroid combination provides greater benefit than the nystatin component alone during the first few days of treatment .",
"Description": "Nystatin and triamcinolone acetonide ointment, USP for dermatologic use contains the antifungal agent nystatin and the synthetic corticosteroid triamcinolone acetonide. Nystatin is a polyene antimycotic obtained from Streptomyces noursei. It is a yellow to light tan powder with a cereal-like odor, very slightly soluble in water, and slightly to sparingly soluble in alcohol. It has a molecular formula of C47H75NO17 and a molecular weight of 926.13. Triamcinolone acetonide is designated chemically as 9-fluoro-11β,16α,17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione cyclic 16, 17-acetal with acetone. The white to cream crystalline powder has a slight odor, is practically insoluble in water, and very soluble in alcohol. It has a molecular formula of C24H31FO6 and a molecular weight of 434.50. Each gram of nystatin and triamcinolone acetonide ointment contains 100,000 USP nystatin units and 1 mg of triamcinolone acetonide in a base of polyethylene and mineral oil."
},
{
"NDCCode": "0168-0099-15",
"PackageDescription": "1 TUBE in 1 CARTON (0168-0099-15) / 15 g in 1 TUBE",
"NDC11Code": "00168-0099-15",
"ProductNDC": "0168-0099",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ketoconazole",
"NonProprietaryName": "Ketoconazole",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20040428",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076294",
"LabelerName": "E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC",
"SubstanceName": "KETOCONAZOLE",
"StrengthNumber": "20",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20040428",
"SamplePackage": "N",
"IndicationAndUsage": "Ketoconazole Cream 2% is indicated for the topical treatment of tinea corporis, tinea cruris and tinea pedis caused by Trichophyton rubrum, T. mentagrophytes and Epidermophyton floccosum; in the treatment of tinea (pityriasis) versicolor caused by Malassezia furfur (Pityrosporum orbiculare); in the treatment of cutaneous candidiasis caused by Candida spp. and in the treatment of seborrheic dermatitis.",
"Description": "Ketoconazole Cream 2%, for topical administration only, contains the broad-spectrum synthetic antifungal agent, ketoconazole 2%, formulated in an aqueous cream vehicle consisting of propylene glycol, stearyl and cetyl alcohols, sorbitan monostearate, polysorbate 60, isopropyl myristate, sodium sulfite anhydrous, polysorbate 80 and purified water. Ketoconazole is cis-1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazine and has the following structural formula."
},
{
"NDCCode": "0168-0133-15",
"PackageDescription": "15 g in 1 TUBE (0168-0133-15) ",
"NDC11Code": "00168-0133-15",
"ProductNDC": "0168-0133",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clotrimazole",
"NonProprietaryName": "Clotrimazole",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20080902",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078338",
"LabelerName": "E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.",
"SubstanceName": "CLOTRIMAZOLE",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-09-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20080902",
"SamplePackage": "N",
"IndicationAndUsage": "Clotrimazole Cream is indicated for the topical treatment of candidiasis due to Candida albicans and tinea versicolor due to Malassezia furfur. Clotrimazole is also available as a nonprescription item which is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis.",
"Description": "Clotrimazole Cream USP 1% contains clotrimazole, a synthetic antifungal agent having the chemical name {1-(o-Chloro-α, α-diphenylbenzyl)imidazole}; the molecular formula C22H17ClN2; a molecular weight of 344.84; and the structural formula:. Clotrimazole is an odorless, white crystalline substance. It is practically insoluble in water, sparingly soluble in ether and very soluble in polyethylene glycol 400, ethanol and chloroform. Each gram of Clotrimazole cream contains 10 mg clotrimazole, dispersed in a vanishing cream base of sorbitan monostearate, polysorbate 60, cetyl esters wax, cetostearyl alcohol, octyldodecanol, purified water, and benzyl alcohol (1%) as preservative."
},
{
"NDCCode": "0168-0135-15",
"PackageDescription": "15 g in 1 TUBE (0168-0135-15) ",
"NDC11Code": "00168-0135-15",
"ProductNDC": "0168-0135",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluocinonide",
"NonProprietaryName": "Fluocinonide",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "19941230",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA072933",
"LabelerName": "Fougera Pharmaceuticals Inc.",
"SubstanceName": "FLUOCINONIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-06-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "19941230",
"SamplePackage": "N",
"IndicationAndUsage": "Fluocinonide Gel USP, 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.",
"Description": "Fluocinonide Gel USP, 0.05% is intended for topical administration. The active component is the corticosteroid Fluocinonide, which is the 21-acetate ester of fluocinolone acetonide. The chemical name of Fluocinonide is Pregna-1,4-diene-3,20-dione,21-(acetyloxy)-6,9-difluoro-11-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(6α,11β,16α)-). It has a molecular formula of C26H32F2O7 and a molecular weight of 494.53. It has the following structural formula. Each gram of Fluocinonide Gel USP, 0.05% contains: fluocinonide 0.5 mg in a gel base consisting of propylene glycol, propyl gallate, edetate disodium, and carbomer 980. Sodium hydroxide solution is added to adjust pH, if required. This clear, colorless thixotropic vehicle is greaseless, non-staining and completely water miscible. In this formulation, the active ingredient is totally in solution."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>0168-0243-15</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0168-0243-15) > 15 g in 1 TUBE</PackageDescription>
<NDC11Code>00168-0243-15</NDC11Code>
<ProductNDC>0168-0243</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diflorasone Diacetate</ProprietaryName>
<NonProprietaryName>Diflorasone Diacetate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19990427</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075374</ApplicationNumber>
<LabelerName>E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.</LabelerName>
<SubstanceName>DIFLORASONE DIACETATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-05-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19990427</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0168-0243-30</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0168-0243-30) > 30 g in 1 TUBE</PackageDescription>
<NDC11Code>00168-0243-30</NDC11Code>
<ProductNDC>0168-0243</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diflorasone Diacetate</ProprietaryName>
<NonProprietaryName>Diflorasone Diacetate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19990427</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075374</ApplicationNumber>
<LabelerName>E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.</LabelerName>
<SubstanceName>DIFLORASONE DIACETATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-05-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19990427</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0168-0243-60</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0168-0243-60) > 60 g in 1 TUBE</PackageDescription>
<NDC11Code>00168-0243-60</NDC11Code>
<ProductNDC>0168-0243</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Diflorasone Diacetate</ProprietaryName>
<NonProprietaryName>Diflorasone Diacetate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19990427</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075374</ApplicationNumber>
<LabelerName>E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.</LabelerName>
<SubstanceName>DIFLORASONE DIACETATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-05-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19990427</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0245-0243-15</NDCCode>
<PackageDescription>500 TABLET, EXTENDED RELEASE in 1 BOTTLE (0245-0243-15)</PackageDescription>
<NDC11Code>00245-0243-15</NDC11Code>
<ProductNDC>0245-0243</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Potassium Chloride</ProprietaryName>
<NonProprietaryName>Potassium Chloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19860417</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019123</ApplicationNumber>
<LabelerName>Upsher-Smith Laboratories, Inc.</LabelerName>
<SubstanceName>POTASSIUM CHLORIDE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Potassium Compounds [Chemical/Ingredient],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-11-01</LastUpdate>
</NDC>
<NDC>
<NDCCode>24658-243-15</NDCCode>
<PackageDescription>15 TABLET in 1 BOTTLE (24658-243-15)</PackageDescription>
<NDC11Code>24658-0243-15</NDC11Code>
<ProductNDC>24658-243</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisinopril</ProprietaryName>
<NonProprietaryName>Lisinopril</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090202</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076063</ApplicationNumber>
<LabelerName>Blu Pharmaceuticals, LLC</LabelerName>
<SubstanceName>LISINOPRIL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-05-09</LastUpdate>
</NDC>
<NDC>
<NDCCode>43353-243-15</NDCCode>
<PackageDescription>15 TABLET in 1 BOTTLE (43353-243-15) </PackageDescription>
<NDC11Code>43353-0243-15</NDC11Code>
<ProductNDC>43353-243</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Zolpidem Tartrate</ProprietaryName>
<NonProprietaryName>Zolpidem Tartrate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070905</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077903</ApplicationNumber>
<LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
<SubstanceName>ZOLPIDEM TARTRATE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Depression [PE], GABA A Agonists [MoA], Pyridines [CS], gamma-Aminobutyric Acid-ergic Agonist [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20161006</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Zolpidem tartrate tablets, USP a gamma-amino butyric acid (GABA) A receptor positive modulator, is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation.</IndicationAndUsage>
<Description>Zolpidem tartrate, a gamma-aminobutyric acid (GABA) A receptor positive modulator of the imidazopyridine class. Zolpidem tartrate is available in 5 mg and 10 mg strength tablets for oral administration. Chemically, zolpidem is N,N,6-trimethyl-2-p-tolylimidazo[1,2-a] pyridine-3-acetamide L-(+)-tartrate (2:1). It has the following structure:. Zolpidem tartrate, USP is a white to off-white crystalline powder that is sparingly soluble in water, alcohol, and propylene glycol. It has a molecular weight of 764.88. Each zolpidem tartrate tablet, USP includes the following inactive ingredients: hypromellose, lactose monohydrate, microcrystalline cellulose, magnesium stearate, polyethylene glycol, sodium starch glycolate, titanium dioxide and ferric oxide red; the 10 mg tablet also contains ferric oxide yellow.</Description>
</NDC>
<NDC>
<NDCCode>63187-243-15</NDCCode>
<PackageDescription>15 TABLET in 1 BOTTLE, PLASTIC (63187-243-15) </PackageDescription>
<NDC11Code>63187-0243-15</NDC11Code>
<ProductNDC>63187-243</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prednisone</ProprietaryName>
<NonProprietaryName>Prednisone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030314</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA084283</ApplicationNumber>
<LabelerName>Proficient Rx LP</LabelerName>
<SubstanceName>PREDNISONE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-06-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Prednisone tablets and solutions are indicated in the following conditions.</IndicationAndUsage>
<Description>Each tablet for oral administration contains. Prednisone.............................................................50 mg.</Description>
</NDC>
<NDC>
<NDCCode>63361-243-15</NDCCode>
<PackageDescription>10 SYRINGE in 1 PACKAGE (63361-243-15) / .5 mL in 1 SYRINGE (63361-243-88) </PackageDescription>
<NDC11Code>63361-0243-15</NDC11Code>
<ProductNDC>63361-243</ProductNDC>
<ProductTypeName>VACCINE</ProductTypeName>
<ProprietaryName>Vaxelis</ProprietaryName>
<NonProprietaryName>Diphtheria And Tetanus Toxoids And Acellular Pertussis, Inactivated Poliovirus, Haemophilus B Conjugate And Hepatitis B Vaccine</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>INTRAMUSCULAR</RouteName>
<StartMarketingDate>20181221</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA125563</ApplicationNumber>
<LabelerName>MSP Vaccine Company</LabelerName>
<SubstanceName>CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS TOXOID ANTIGEN (GLUTARALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED); BORDETELLA PERTUSSIS PERTACTIN ANTIGEN; BORDETELLA PERTUSSIS FIMBRIAE 2/3 ANTIGEN; POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED); POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED); HEPATITIS B VIRUS SUBTYPE ADW HBSAG SURFACE PROTEIN ANTIGEN; HAEMOPHILUS INFLUENZAE TYPE B CAPSULAR POLYSACCHARIDE MENINGOCOCCAL OUTER MEMBRANE PROTEIN CONJUGATE ANTIGEN</SubstanceName>
<StrengthNumber>15; 5; 20; 20; 3; 5; 29; 7; 26; 10; 3</StrengthNumber>
<StrengthUnit>[Lf]/.5mL; [Lf]/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; ug/.5mL; [D'ag'U]/.5mL; [D'ag'U]/.5mL; [D'ag'U]/.5mL; ug/.5mL; ug/.5mL</StrengthUnit>
<Pharm_Classes>Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Actively Acquired Immunity [PE], Diphtheria Toxoid [CS], Haemophilus Vaccines [CS], Hepatitis B Vaccines [CS], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Bordetella Pertussis Vaccine [EPC], Inactivated Clostridium Tetani Vaccine [EPC], Inactivated Corynebacterium Diphtheriae Vaccine [EPC], Inactivated Haemophilus Influenzae B Vaccine [EPC], Inactivated Hepatitis B Virus Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Inactivated Poliovirus Vaccine [EPC], Pertussis Vaccine [CS], Pertussis Vaccine [CS], Pertussis Vaccine [CS], Poliovirus Vaccines [CS], Poliovirus Vaccines [CS], Poliovirus Vaccines [CS], Tetanus Toxoid [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS], Vaccines, Inactivated [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181221</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>VAXELIS® is a vaccine indicated for active immunization to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae (H. influenzae) type b. VAXELIS is approved for use as a 3-dose series in children 6 weeks through 4 years of age (prior to the 5th birthday).</IndicationAndUsage>
<Description>VAXELIS (Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine) is a sterile injectable suspension for intramuscular use. Each 0.5 mL dose is formulated to contain 15 Lf diphtheria toxoid, 5 Lf tetanus toxoid, acellular pertussis antigens [20 mcg detoxified pertussis toxin (PT), 20 mcg filamentous hemagglutinin (FHA), 3 mcg pertactin (PRN), 5 mcg fimbriae types 2 and 3 (FIM)], inactivated polioviruses [29 D-antigen units (DU) Type 1 (Mahoney), 7 DU Type 2 (MEF-1), 26 DU Type 3 (Saukett)], 3 mcg polyribosylribitol phosphate (PRP) of H. influenzae type b covalently bound to 50 mcg of the outer membrane protein complex (OMPC) of Neisseria meningitidis serogroup B, and 10 mcg hepatitis B surface antigen (HBsAg). Each 0.5 mL dose contains 319 mcg aluminum from aluminum salts used as adjuvants. Other ingredients per 0.5 mL dose include <0.0056% polysorbate 80 and the following residuals from the manufacturing process: ≤14 mcg formaldehyde, ≤50 ng glutaraldehyde, ≤50 ng bovine serum albumin, <5 ng of neomycin, <200 ng streptomycin sulfate, <25 ng polymyxin B sulfate, ≤0.125 μg ammonium thiocyanate and ≤0.1 mcg yeast protein (maximum 1% relative to HBsAg protein). Corynebacterium diphtheriae is grown in modified Mueller's growth medium. (3) After purification by ammonium sulfate fractionation, the diphtheria toxin is detoxified with formaldehyde and diafiltered. Clostridium tetani is grown in modified Mueller-Miller casamino acid medium without beef heart infusion. (4) Tetanus toxin is detoxified with formaldehyde and purified by ammonium sulfate fractionation and diafiltration. Diphtheria and tetanus toxoids are individually adsorbed onto aluminum phosphate. The acellular pertussis vaccine antigens are produced from Bordetella pertussis cultures grown in Stainer-Scholte medium (5) modified by the addition of casamino acids and dimethyl-beta-cyclodextrin. PT, FHA and PRN are isolated separately from the supernatant culture medium. FIM are extracted and copurified from the bacterial cells. The pertussis antigens are purified by sequential filtration, salt-precipitation, ultrafiltration and chromatography. PT is detoxified with glutaraldehyde. FHA is treated with formaldehyde and the residual aldehydes are removed by ultrafiltration. The individual antigens are adsorbed separately onto aluminum phosphate. The Type 1, Type 2, and Type 3 polioviruses are individually grown in Vero cells. The viral harvests are concentrated and purified, then inactivated with formaldehyde to produce monovalent suspensions of each serotype. Specified quantities of monovalent suspensions of each serotype are mixed to produce the trivalent poliovirus concentrate. The HBsAg antigen is harvested and purified from fermentation cultures of a recombinant strain of the yeast Saccharomyces cerevisiae containing the gene for the adw subtype of HBsAg. The recombinant Saccharomyces cerevisiae is grown in a fermentation medium which consists of an extract of yeast, soy peptone, dextrose, amino acids, and mineral salts. The HBsAg protein is released from the yeast cells by cell disruption and purified by a series of physical and chemical methods which includes ion and hydrophobic chromatography, and diafiltration. The purified protein is treated in phosphate buffer with formaldehyde and then co-precipitated with alum (potassium aluminum sulfate) to form bulk vaccine adjuvanted with amorphous aluminum hydroxyphosphate sulfate. The purified PRP of H. influenzae type b (Haemophilus b, Ross strain) is conjugated to an OMPC of the B11 strain of N. meningitidis serogroup B. H. influenzae type b is grown in a fermentation medium which includes an extract of yeast, nicotinamide adenine dinucleotide, hemin chloride, soy peptone, dextrose, and mineral salts. The PRP is purified from the culture broth by purification procedures which include ethanol fractionation, enzyme digestion, phenol extraction and diafiltration. N. meningitidis serogroup B is grown in a fermentation medium which includes an extract of yeast, amino acids and mineral salts. The OMPC is purified by detergent extraction, ultracentrifugation, diafiltration and sterile filtration. PRP is conjugated to OMPC by chemical coupling and the PRP-OMPC is then adsorbed onto an amorphous aluminum hydroxyphosphate sulfate adjuvant. The adsorbed diphtheria, tetanus, and acellular pertussis antigens are combined with aluminum phosphate (as adjuvant) and water for injection into an intermediate concentrate. The individual HBsAg and PRP-OMPC adjuvanted bulks are added followed by the trivalent poliovirus concentrate, to produce VAXELIS. Both diphtheria and tetanus toxoids induce at least 2 neutralizing units per mL of serum in the guinea pig potency test. The potency of the acellular pertussis antigens PT, FHA, and FIM is evaluated by the antibody response of immunized mice to detoxified forms as measured by enzyme-linked immunosorbent assay (ELISA). The potency of the acellular pertussis antigen PRN is measured by an in vitro PRN antigenicity ELISA. The potency of the inactivated poliovirus antigens is determined using an in vitro D-antigen ELISA for each serotype. The potency of the HBsAg component is measured relative to a standard by an in vitro immunoassay. The potency of the PRP-OMPC component is measured by quantitating the polysaccharide concentration using a high-performance liquid chromatography (HPLC) method. VAXELIS does not contain a preservative. The syringe plunger stopper and syringe tip cap are not made with natural rubber latex.</Description>
</NDC>
<NDC>
<NDCCode>66794-243-15</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (66794-243-15) / 100 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>66794-0243-15</NDC11Code>
<ProductNDC>66794-243</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ampicillin And Sulbactam</ProprietaryName>
<NonProprietaryName>Ampicillin And Sulbactam</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20190520</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090578</ApplicationNumber>
<LabelerName>Piramal Critical Care Inc</LabelerName>
<SubstanceName>AMPICILLIN SODIUM; SULBACTAM SODIUM</SubstanceName>
<StrengthNumber>100; 50</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-04-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190520</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ampicillin and Sulbactam for Injection, USP is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below. Skin and Skin Structure Infections caused by beta-lactamase producing strains of Staphylococcus aureus, Escherichia coli,* Klebsiella spp.* (including K. pneumoniae*), Proteus mirabilis,* Bacteroides fragilis,* Enterobacter spp.,* and Acinetobacter calcoaceticus.*. NOTE: For information on use in pediatric patients (see PRECAUTIONS-Pediatric Useand CLINICAL STUDIESsections). Intra-Abdominal Infections caused by beta-lactamase producing strains of Escherichia coli, Klebsiella spp. (including K. pneumoniae*), Bacteroides spp. (including B. fragilis), and Enterobacter spp.*. Gynecological Infections caused by beta-lactamase producing strains of Escherichia coli,* and Bacteroides spp.* (including B. fragilis*). * Efficacy for this organism in this organ system was studied in fewer than 10 infections. While ampicillin and sulbactam for injection, USP is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with ampicillin and sulbactam for injection, USP due to its ampicillin content. Therefore, mixed infections caused by ampicillin-susceptible organisms and beta-lactamase producing organisms susceptible to ampicillin and sulbactam for injection, USP should not require the addition of another antibacterial. Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify the organisms causing infection and to determine their susceptibility to ampicillin and sulbactam for injection, USP. Therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies when there is reason to believe the infection may involve any of the beta-lactamase producing organisms listed above in the indicated organ systems. Once the results are known, therapy should be adjusted if appropriate. To reduce the development of drug-resistant bacteria and maintain effectiveness of ampicillin and sulbactam for injection, USP and other antibacterial drugs, ampicillin and sulbactam for injection, USP should be used only to treat 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>Ampicillin and Sulbactam for Injection is an injectable antibacterial combination consisting of the semisynthetic antibacterial ampicillin sodium and the beta-lactamase inhibitor sulbactam sodium for intravenous and intramuscular administration. Ampicillin sodium is derived from the penicillin nucleus, 6-aminopenicillanic acid. Chemically, it is monosodium (2S, 5R, 6R)-6-[(R)-2-amino-2-phenylacetamido]3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate and has a molecular weight of 371.39. Its chemical formula is C 16H 18N 3NaO 4S. The structural formula is:. Sulbactam sodium is a derivative of the basic penicillin nucleus. Chemically, sulbactam sodium is sodium penicillinate sulfone; sodium (2S, 5R)-3,3-dimethyl-7-oxo-4-thia1-azabicyclo [3.2.0] heptane-2-carboxylate 4,4-dioxide. Its chemical formula is C 8H 10NNaO 5S with a molecular weight of 255.22. The structural formula is:. Ampicillin and Sulbactam for Injection, ampicillin sodium/sulbactam sodium parenteral combination, is available as a white to off-white dry powder for reconstitution. Ampicillin and Sulbactam for Injection, USP dry powder is freely soluble in aqueous diluents to yield pale yellow to yellow solutions containing ampicillin sodium and sulbactam sodium equivalent to 250 mg ampicillin per mL and 125 mg sulbactam per mL. The pH of the solutions is between 8.0 and 10.0. Dilute solutions (up to 30 mg ampicillin and 15 mg sulbactam per mL) are essentially colorless to pale yellow. The pH of dilute solutions remains the same. Ampicillin and Sulbactam for Injection pharmacy bulk package is a vial containing a sterile preparation of ampicillin sodium and sulbactam sodium for parenteral use that contains many single doses. The Pharmacy Bulk Package is for use in a pharmacy admixture setting; it provides many single doses of Ampicillin and Sulbactam for Injection, USP for addition to suitable parenteral fluids in the preparation of admixtures for intravenous infusion (see DIRECTIONS FOR USE, Directions for Proper Use of Pharmacy Bulk Package).</Description>
</NDC>
<NDC>
<NDCCode>71335-0243-5</NDCCode>
<PackageDescription>15 TABLET in 1 BOTTLE (71335-0243-5) </PackageDescription>
<NDC11Code>71335-0243-05</NDC11Code>
<ProductNDC>71335-0243</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Warfarin Sodium</ProprietaryName>
<NonProprietaryName>Warfarin Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150407</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040616</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>WARFARIN SODIUM</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Vitamin K Antagonist [EPC], Vitamin K Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Warfarin sodium tablets are indicated for: 1 Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE)., 2 Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement., 3 Reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.</IndicationAndUsage>
<Description>Warfarin sodium tablets, USP contain warfarin sodium, an anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors. The chemical name of warfarin sodium is 3-(α-acetonylbenzyl)-4-hydroxycoumarin sodium salt, which is a racemic mixture of the R- and S-enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its structural formula may be represented as follows. C19H15NaO4 M.W. 330.31. Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether. Each tablet, for oral administration, contains 1 mg, 2 mg, 2.5 mg, 3 mg, 4 mg, 5 mg, 6 mg, 7.5 mg or 10 mg warfarin sodium, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The 1 mg also contains FD&C red no. 40. The 2 mg also contains FD&C blue no. 2 aluminum lake and FD&C red no. 40 aluminum lake. The 2.5 mg also contains D&C yellow no. 10 aluminum lake and FD&C blue no. 1 aluminum lake. The 3 mg also contains FD&C yellow no. 6 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, and D&C yellow no. 10 aluminum lake. The 4 mg also contains FD&C blue no. 1 aluminum lake and FD&C blue no. 2 aluminum lake. The 5 mg also contains FD&C yellow no. 6 aluminum lake, FD&C red no. 40 aluminum lake and D&C yellow no. 10 aluminum lake. The 6 mg also contains D&C yellow no. 10 aluminum lake and FD&C blue no. 1 aluminum lake. The 7.5 mg also contains D&C yellow no. 10 aluminum lake and FD&C yellow no. 6 aluminum lake.</Description>
</NDC>
<NDC>
<NDCCode>0168-0002-15</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0168-0002-15) / 15 g in 1 TUBE</PackageDescription>
<NDC11Code>00168-0002-15</NDC11Code>
<ProductNDC>0168-0002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Triamcinolone Acetonide</ProprietaryName>
<NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19780309</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA085692</ApplicationNumber>
<LabelerName>E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC</LabelerName>
<SubstanceName>TRIAMCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19780309</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Triamcinolone Acetonide Cream USP contains Triamcinolone Acetonide [Pregna-1,4-diene-3,20-dione, 9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis- (oxy)]-, (11β,16α)-], with the empirical formula C24H31FO6 and molecular weight 434.50. CAS 76-25-5. Triamcinolone Acetonide Cream USP, 0.025% contains: 0.25 mg of Triamcinolone Acetonide per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water. Triamcinolone Acetonide Cream USP, 0.1% contains: 1 mg of Triamcinolone Acetonide per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water. Triamcinolone Acetonide Cream USP, 0.5% contains: 5 mg of Triamcinolone Acetonide per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water.</Description>
</NDC>
<NDC>
<NDCCode>0168-0003-15</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0168-0003-15) / 15 g in 1 TUBE</PackageDescription>
<NDC11Code>00168-0003-15</NDC11Code>
<ProductNDC>0168-0003</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Triamcinolone Acetonide</ProprietaryName>
<NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19780309</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA085692</ApplicationNumber>
<LabelerName>E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC</LabelerName>
<SubstanceName>TRIAMCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19780309</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Triamcinolone Acetonide Cream USP contains Triamcinolone Acetonide [Pregna-1,4-diene-3,20-dione, 9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis- (oxy)]-, (11β,16α)-], with the empirical formula C24H31FO6 and molecular weight 434.50. CAS 76-25-5. Triamcinolone Acetonide Cream USP, 0.025% contains: 0.25 mg of Triamcinolone Acetonide per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water. Triamcinolone Acetonide Cream USP, 0.1% contains: 1 mg of Triamcinolone Acetonide per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water. Triamcinolone Acetonide Cream USP, 0.5% contains: 5 mg of Triamcinolone Acetonide per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water.</Description>
</NDC>
<NDC>
<NDCCode>0168-0004-15</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0168-0004-15) / 15 g in 1 TUBE</PackageDescription>
<NDC11Code>00168-0004-15</NDC11Code>
<ProductNDC>0168-0004</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Triamcinolone Acetonide</ProprietaryName>
<NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19780309</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA085692</ApplicationNumber>
<LabelerName>E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC</LabelerName>
<SubstanceName>TRIAMCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19780309</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Triamcinolone Acetonide Cream USP contains Triamcinolone Acetonide [Pregna-1,4-diene-3,20-dione, 9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis- (oxy)]-, (11β,16α)-], with the empirical formula C24H31FO6 and molecular weight 434.50. CAS 76-25-5. Triamcinolone Acetonide Cream USP, 0.025% contains: 0.25 mg of Triamcinolone Acetonide per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water. Triamcinolone Acetonide Cream USP, 0.1% contains: 1 mg of Triamcinolone Acetonide per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water. Triamcinolone Acetonide Cream USP, 0.5% contains: 5 mg of Triamcinolone Acetonide per gram in a base containing Emulsifying Wax, Cetyl Alcohol, Isopropyl Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified Water.</Description>
</NDC>
<NDC>
<NDCCode>0168-0006-15</NDCCode>
<PackageDescription>15 g in 1 TUBE (0168-0006-15) </PackageDescription>
<NDC11Code>00168-0006-15</NDC11Code>
<ProductNDC>0168-0006</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Triamcinolone Acetonide</ProprietaryName>
<NonProprietaryName>Triamcinolone Acetonide</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19780214</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA085691</ApplicationNumber>
<LabelerName>E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC</LabelerName>
<SubstanceName>TRIAMCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19780214</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. Triamcinolone Acetonide Ointment USP contains Triamcinolone Acetonide [Pregna-1,4-diene-3,20-dione,9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis-(oxy)]-, (11β,16α)-], with the molecular formula C24H31FO6 and molecular weight 434.51. CAS 76-25-5. Triamcinolone Acetonide Ointment USP, 0.025% contains: 0.25 mg of triamcinolone acetonide per gram in a base containing white petrolatum and mineral oil. Triamcinolone Acetonide Ointment USP, 0.1% contains: 1 mg triamcinolone acetonide per gram in a base containing white petrolatum and mineral oil.</Description>
</NDC>
<NDC>
<NDCCode>0168-0007-15</NDCCode>
<PackageDescription>15 g in 1 TUBE (0168-0007-15) </PackageDescription>
<NDC11Code>00168-0007-15</NDC11Code>
<ProductNDC>0168-0007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nystatin</ProprietaryName>
<NonProprietaryName>Nystatin</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19820923</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062124</ApplicationNumber>
<LabelerName>E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.</LabelerName>
<SubstanceName>NYSTATIN</SubstanceName>
<StrengthNumber>100000</StrengthNumber>
<StrengthUnit>[USP'U]/g</StrengthUnit>
<Pharm_Classes>Polyene Antifungal [EPC], Polyenes [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-06-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19820923</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nystatin Ointment is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida [Monilia]albicans and other Candida species.</IndicationAndUsage>
<Description>Nystatin Ointment USP, for topical use only, contains 100,000 USP Nystatin Units per gram, in a polyethylene and mineral oil base. The structural formula is as follows.</Description>
</NDC>
<NDC>
<NDCCode>0168-0033-15</NDCCode>
<PackageDescription>15 g in 1 TUBE (0168-0033-15) </PackageDescription>
<NDC11Code>00168-0033-15</NDC11Code>
<ProductNDC>0168-0033</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Betamethasone Valerate</ProprietaryName>
<NonProprietaryName>Betamethasone Valerate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19830831</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018865</ApplicationNumber>
<LabelerName>E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC</LabelerName>
<SubstanceName>BETAMETHASONE VALERATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19830831</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Betamethasone Valerate Cream, Ointment and Lotion contain betamethasone valerate USP, a synthetic adrenocorticosteroid for dermatologic use. Betamethasone, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Betamethasone valerate is a white to practically white odorless crystalline powder practically insoluble in water, freely soluble in acetone and chloroform, soluble in alcohol, and slightly soluble in benzene and ether. Chemically, it is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1, 4-diene-3,20-dione 17-valerate. The structural formula is:. Each gram of the 0.1% Cream contains 1.2 mg betamethasone valerate (equivalent to 1 mg betamethasone) in a soft, white, hydrophilic cream of purified water, mineral oil, white petrolatum, polyoxyl 20 cetostearyl ether, cetostearyl alcohol, monobasic sodium phosphate and phosphoric acid or sodium hydroxide (to adjust pH, if required); chlorocresol is present as a preservative. Each gram of the 0.1% Ointment contains 1.2 mg betamethasone valerate (equivalent to 1 mg betamethasone) in an ointment base of white petrolatum and mineral oil. Each gram of the 0.1% Lotion contains 1.2 mg betamethasone valerate (equivalent to 1 mg betamethasone) in a vehicle of isopropyl alcohol and water slightly thickened with carbomer 934P. Sodium hydroxide is used to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>0168-0040-15</NDCCode>
<PackageDescription>15 g in 1 TUBE (0168-0040-15) </PackageDescription>
<NDC11Code>00168-0040-15</NDC11Code>
<ProductNDC>0168-0040</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Betamethasone Valerate</ProprietaryName>
<NonProprietaryName>Betamethasone Valerate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19830831</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018861</ApplicationNumber>
<LabelerName>E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC</LabelerName>
<SubstanceName>BETAMETHASONE VALERATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19830831</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Betamethasone Valerate Cream, Ointment and Lotion contain betamethasone valerate USP, a synthetic adrenocorticosteroid for dermatologic use. Betamethasone, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Betamethasone valerate is a white to practically white odorless crystalline powder practically insoluble in water, freely soluble in acetone and chloroform, soluble in alcohol, and slightly soluble in benzene and ether. Chemically, it is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1, 4-diene-3,20-dione 17-valerate. The structural formula is:. Each gram of the 0.1% Cream contains 1.2 mg betamethasone valerate (equivalent to 1 mg betamethasone) in a soft, white, hydrophilic cream of purified water, mineral oil, white petrolatum, polyoxyl 20 cetostearyl ether, cetostearyl alcohol, monobasic sodium phosphate and phosphoric acid or sodium hydroxide (to adjust pH, if required); chlorocresol is present as a preservative. Each gram of the 0.1% Ointment contains 1.2 mg betamethasone valerate (equivalent to 1 mg betamethasone) in an ointment base of white petrolatum and mineral oil. Each gram of the 0.1% Lotion contains 1.2 mg betamethasone valerate (equivalent to 1 mg betamethasone) in a vehicle of isopropyl alcohol and water slightly thickened with carbomer 934P. Sodium hydroxide is used to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>0168-0054-15</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0168-0054-15) > 15 g in 1 TUBE</PackageDescription>
<NDC11Code>00168-0054-15</NDC11Code>
<ProductNDC>0168-0054</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nystatin</ProprietaryName>
<NonProprietaryName>Nystatin</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19790201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062129</ApplicationNumber>
<LabelerName>E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.</LabelerName>
<SubstanceName>NYSTATIN</SubstanceName>
<StrengthNumber>100000</StrengthNumber>
<StrengthUnit>[USP'U]/g</StrengthUnit>
<Pharm_Classes>Polyene Antifungal [EPC], Polyenes [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-06-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19790201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nystatin cream is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. This cream is not indicated for systemic, oral, intravaginal or ophthalmic use.</IndicationAndUsage>
<Description>Nystatin is a polyene antifungal antibiotic obtained from Streptomyces nursei. Structural formula. Molecular Weight 926.13. Molecular Formula C47H75NO17. Nystatin cream is for dermatologic use. Nystatin cream for topical use, contains 100,000 USP nystatin units per gram in an aqueous, vanishing cream base containing Polysorbate 60, Aluminum Hydroxide Compressed Gel, Titanium Dioxide, Glyceryl Monostearate, Polyethylene Glycol 400 Monostearate, Simethicone Emulsion, Sorbic Acid, Propylene Glycol, Ethylenediamine, Polyoxyethylene Fatty Alcohol Ether, Sorbitol Solution, Methylparaben, Propylparaben, Hydrochloric Acid, White Petrolatum, and Purified Water.</Description>
</NDC>
<NDC>
<NDCCode>0168-0055-15</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0168-0055-15) / 15 g in 1 TUBE</PackageDescription>
<NDC11Code>00168-0055-15</NDC11Code>
<ProductNDC>0168-0055</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Betamethasone Dipropionate</ProprietaryName>
<NonProprietaryName>Betamethasone Dipropionate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19840626</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019137</ApplicationNumber>
<LabelerName>E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC</LabelerName>
<SubstanceName>BETAMETHASONE DIPROPIONATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19840626</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Betamethasone Dipropionate Cream, Ointment and Lotion contain betamethasone dipropionate USP, a synthetic adrenocorticosteroid, for dermatologic use. Betamethasone, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Betamethasone dipropionate is a white to cream white odorless crystalline powder insoluble in water. Chemically, it is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate. The structural formula is. Each gram of the 0.05% Cream contains 0.64 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone) in a soft, white, hydrophilic cream of purified water, mineral oil, white petrolatum, polyoxyl 20 cetostearyl ether, cetostearyl alcohol, monobasic sodium phosphate (monohydrate); chlorocresol is present as a preservative. Sodium hydroxide or phosphoric acid solution to adjust pH, if required. Each gram of the 0.05% Ointment contains 0.64 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone) in an ointment base of mineral oil and white petrolatum. Each gram of the 0.05% Lotion contains 0.64 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone) in a vehicle of isopropyl alcohol and purified water slightly thickened with carbomer 934P. Sodium hydroxide solution to adjust pH, if required.</Description>
</NDC>
<NDC>
<NDCCode>0168-0056-15</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0168-0056-15) / 15 g in 1 TUBE</PackageDescription>
<NDC11Code>00168-0056-15</NDC11Code>
<ProductNDC>0168-0056</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Betamethasone Dipropionate</ProprietaryName>
<NonProprietaryName>Betamethasone Dipropionate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19840904</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019141</ApplicationNumber>
<LabelerName>E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC</LabelerName>
<SubstanceName>BETAMETHASONE DIPROPIONATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19840904</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Betamethasone dipropionate ointment, USP contain betamethasone dipropionate USP, a synthetic adrenocorticosteroid, for dermatologic use. Betamethasone, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Betamethasone dipropionate is a white to cream white odorless crystalline powder insoluble in water. Chemically, it is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate. The structural formula is. Molecular Formula: C28H37FO7. Molecular Weight: 504.60. Each gram of the 0.05% Ointment contains 0.64 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone) in an ointment base of mineral oil and white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>0168-0058-15</NDCCode>
<PackageDescription>15 g in 1 TUBE (0168-0058-15)</PackageDescription>
<NDC11Code>00168-0058-15</NDC11Code>
<ProductNDC>0168-0058</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluocinolone Acetonide</ProprietaryName>
<NonProprietaryName>Fluocinolone Acetonide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19821216</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088170</ApplicationNumber>
<LabelerName>E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.</LabelerName>
<SubstanceName>FLUOCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0168-0060-15</NDCCode>
<PackageDescription>15 g in 1 TUBE (0168-0060-15)</PackageDescription>
<NDC11Code>00168-0060-15</NDC11Code>
<ProductNDC>0168-0060</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluocinolone Acetonide</ProprietaryName>
<NonProprietaryName>Fluocinolone Acetonide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19821216</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088169</ApplicationNumber>
<LabelerName>E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.</LabelerName>
<SubstanceName>FLUOCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0168-0064-15</NDCCode>
<PackageDescription>15 g in 1 TUBE (0168-0064-15) </PackageDescription>
<NDC11Code>00168-0064-15</NDC11Code>
<ProductNDC>0168-0064</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluocinolone Acetonide</ProprietaryName>
<NonProprietaryName>Fluocinolone Acetonide</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19821216</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA088168</ApplicationNumber>
<LabelerName>E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC</LabelerName>
<SubstanceName>FLUOCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>.25</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19821216</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluocinolone Acetonide ointment is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Fluocinolone Acetonide Ointment 0.025% is intended for topical administration. The active component is the corticosteroid Fluocinolone Acetonide USP (Pregna-1,4-diene-3,20-dione, 6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-, (6α,11β,16α)-. It has an empirical formula of. C24H30F2O6 and a molecular weight of 452.49 (CAS Registry Number 67-73-2). Each gram of the ointment contains 0.25 mg Fluocinolone Acetonide in a base containing White Petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>0168-0071-15</NDCCode>
<PackageDescription>15 g in 1 TUBE (0168-0071-15)</PackageDescription>
<NDC11Code>00168-0071-15</NDC11Code>
<ProductNDC>0168-0071</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gentamicin Sulfate</ProprietaryName>
<NonProprietaryName>Gentamicin Sulfate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19840705</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062531</ApplicationNumber>
<LabelerName>E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc.</LabelerName>
<SubstanceName>GENTAMICIN SULFATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-18</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0168-0078-15</NDCCode>
<PackageDescription>15 g in 1 TUBE (0168-0078-15)</PackageDescription>
<NDC11Code>00168-0078-15</NDC11Code>
<ProductNDC>0168-0078</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gentamicin Sulfate</ProprietaryName>
<NonProprietaryName>Gentamicin Sulfate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100317</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062533</ApplicationNumber>
<LabelerName>E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.</LabelerName>
<SubstanceName>GENTAMICIN</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Primary skin infections: Impetigo contagiosa, superficial folliculitis, ecthyma, furunculosis, sycosis barbae, and pyoderma gangrenosum. Secondary skin infections: Infectious eczematoid dermatitis, pustular acne, pustular psoriasis, infected seborrheic dermatitis, infected contact dermatitis (including poison ivy), infected excoriations, and bacterial super-infections of fungal or viral infections. Please Note: Gentamicin sulfate is a bactericidal agent that is not effective against viruses or fungi in skin infections. Gentamicin sulfate is useful in the treatment of infected skin cysts and certain other skin abscesses when preceded by incision and drainage to permit adequate contact between the antibiotic and the infecting bacteria. Good results have been obtained in the treatment of infected stasis and other skin ulcers, infected superficial burns, paronychia, infected insect bites and stings, infected lacerations and abrasions, and wounds from minor surgery. Patients sensitive to neomycin can be treated with gentamicin sulfate, although regular observation of patients sensitive to topical antibiotics is advisable when such patients are treated with any topical antibiotic. Gentamicin Sulfate Ointment helps retain moisture and has been useful in infection on dry eczematous or psoriatic skin. Gentamicin Sulfate Ointment may be used in children over one year of age as well as in adults.</IndicationAndUsage>
<Description>Gentamicin Sulfate Ointment is a wide spectrum antibiotic preparation for topical administration. Each gram contains 1.0 mg of Gentamicin in a base of White Petrolatum with Methylparaben and Propylparaben as preservatives.</Description>
</NDC>
<NDC>
<NDCCode>0168-0081-15</NDCCode>
<PackageDescription>15 g in 1 TUBE (0168-0081-15) </PackageDescription>
<NDC11Code>00168-0081-15</NDC11Code>
<ProductNDC>0168-0081</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nystatin And Triamcinolone Acetonide</ProprietaryName>
<NonProprietaryName>Nystatin And Triamcinolone Acetonide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19851008</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062599</ApplicationNumber>
<LabelerName>E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.</LabelerName>
<SubstanceName>NYSTATIN; TRIAMCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>100000; 1</StrengthNumber>
<StrengthUnit>[USP'U]/g; mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-06-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19851008</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nystatin and triamcinolone acetonide cream is indicated for the treatment of cutaneous candidiasis. It has been demonstrated that the nystatin-steroid combination provides greater benefit than the nystatin component alone during the first few days of treatment.</IndicationAndUsage>
<Description>Nystatin and triamcinolone acetonide cream for dermatologic use contains the antifungal agent nystatin and the synthetic corticosteroid triamcinolone acetonide. Nystatin is a polyene antimycotic obtained from Streptomyces noursei. It is a yellow to light tan powder with a cereal-like odor, very slightly soluble in water, and slightly to sparingly soluble in alcohol. It has a molecular formula of C47H75NO17 and a molecular weight of 926.13. Structural formula. Triamcinolone acetonide is designated chemically as 9-fluoro-11β,16α,17, 21-tetrahydroxypregna-1,4-diene-3, 20-dione cyclic 16, 17-acetal with acetone. The white to cream crystalline powder has a slight odor, is practically insoluble in water, and very soluble in alcohol. It has a molecular formula of C24H31FO6 and a molecular weight of 434.50. Structural formula:. Nystatin and triamcinolone acetonide cream is a soft, smooth cream having a light yellow to tan color. Each gram of nystatin and triamcinolone acetonide cream USP contains 100,000 USP Nystatin Units and 1 mg of triamcinolone acetonide in a cream base containing polyoxyethylene fatty alcohol ether, white petrolatum, glyceryl monostearate, polyethylene glycol 400 monostearate, sorbitol solution, simethicone emulsion, propylene glycol, aluminum hydroxide gel, polysorbate 60, titanium dioxide, and purified water with benzyl alcohol as a preservative. Sodium hydroxide to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>0168-0089-15</NDCCode>
<PackageDescription>15 g in 1 TUBE (0168-0089-15) </PackageDescription>
<NDC11Code>00168-0089-15</NDC11Code>
<ProductNDC>0168-0089</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Nystatin And Triamcinolone Acetonide</ProprietaryName>
<NonProprietaryName>Nystatin And Triamcinolone Acetonide</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19851009</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062602</ApplicationNumber>
<LabelerName>E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.</LabelerName>
<SubstanceName>NYSTATIN; TRIAMCINOLONE ACETONIDE</SubstanceName>
<StrengthNumber>100000; 1</StrengthNumber>
<StrengthUnit>[USP'U]/g; mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Polyene Antifungal [EPC], Polyenes [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-06-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19851009</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Nystatin and triamcinolone acetonide ointment is indicated for the treatment of cutaneous candidiasis. It has been demonstrated that the nystatin-steroid combination provides greater benefit than the nystatin component alone during the first few days of treatment .</IndicationAndUsage>
<Description>Nystatin and triamcinolone acetonide ointment, USP for dermatologic use contains the antifungal agent nystatin and the synthetic corticosteroid triamcinolone acetonide. Nystatin is a polyene antimycotic obtained from Streptomyces noursei. It is a yellow to light tan powder with a cereal-like odor, very slightly soluble in water, and slightly to sparingly soluble in alcohol. It has a molecular formula of C47H75NO17 and a molecular weight of 926.13. Triamcinolone acetonide is designated chemically as 9-fluoro-11β,16α,17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione cyclic 16, 17-acetal with acetone. The white to cream crystalline powder has a slight odor, is practically insoluble in water, and very soluble in alcohol. It has a molecular formula of C24H31FO6 and a molecular weight of 434.50. Each gram of nystatin and triamcinolone acetonide ointment contains 100,000 USP nystatin units and 1 mg of triamcinolone acetonide in a base of polyethylene and mineral oil.</Description>
</NDC>
<NDC>
<NDCCode>0168-0099-15</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0168-0099-15) / 15 g in 1 TUBE</PackageDescription>
<NDC11Code>00168-0099-15</NDC11Code>
<ProductNDC>0168-0099</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ketoconazole</ProprietaryName>
<NonProprietaryName>Ketoconazole</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20040428</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076294</ApplicationNumber>
<LabelerName>E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC</LabelerName>
<SubstanceName>KETOCONAZOLE</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20040428</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ketoconazole Cream 2% is indicated for the topical treatment of tinea corporis, tinea cruris and tinea pedis caused by Trichophyton rubrum, T. mentagrophytes and Epidermophyton floccosum; in the treatment of tinea (pityriasis) versicolor caused by Malassezia furfur (Pityrosporum orbiculare); in the treatment of cutaneous candidiasis caused by Candida spp. and in the treatment of seborrheic dermatitis.</IndicationAndUsage>
<Description>Ketoconazole Cream 2%, for topical administration only, contains the broad-spectrum synthetic antifungal agent, ketoconazole 2%, formulated in an aqueous cream vehicle consisting of propylene glycol, stearyl and cetyl alcohols, sorbitan monostearate, polysorbate 60, isopropyl myristate, sodium sulfite anhydrous, polysorbate 80 and purified water. Ketoconazole is cis-1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazine and has the following structural formula.</Description>
</NDC>
<NDC>
<NDCCode>0168-0133-15</NDCCode>
<PackageDescription>15 g in 1 TUBE (0168-0133-15) </PackageDescription>
<NDC11Code>00168-0133-15</NDC11Code>
<ProductNDC>0168-0133</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clotrimazole</ProprietaryName>
<NonProprietaryName>Clotrimazole</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20080902</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078338</ApplicationNumber>
<LabelerName>E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CLOTRIMAZOLE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-09-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080902</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clotrimazole Cream is indicated for the topical treatment of candidiasis due to Candida albicans and tinea versicolor due to Malassezia furfur. Clotrimazole is also available as a nonprescription item which is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis.</IndicationAndUsage>
<Description>Clotrimazole Cream USP 1% contains clotrimazole, a synthetic antifungal agent having the chemical name {1-(o-Chloro-α, α-diphenylbenzyl)imidazole}; the molecular formula C22H17ClN2; a molecular weight of 344.84; and the structural formula:. Clotrimazole is an odorless, white crystalline substance. It is practically insoluble in water, sparingly soluble in ether and very soluble in polyethylene glycol 400, ethanol and chloroform. Each gram of Clotrimazole cream contains 10 mg clotrimazole, dispersed in a vanishing cream base of sorbitan monostearate, polysorbate 60, cetyl esters wax, cetostearyl alcohol, octyldodecanol, purified water, and benzyl alcohol (1%) as preservative.</Description>
</NDC>
<NDC>
<NDCCode>0168-0135-15</NDCCode>
<PackageDescription>15 g in 1 TUBE (0168-0135-15) </PackageDescription>
<NDC11Code>00168-0135-15</NDC11Code>
<ProductNDC>0168-0135</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluocinonide</ProprietaryName>
<NonProprietaryName>Fluocinonide</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19941230</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA072933</ApplicationNumber>
<LabelerName>Fougera Pharmaceuticals Inc.</LabelerName>
<SubstanceName>FLUOCINONIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-06-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19941230</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fluocinonide Gel USP, 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.</IndicationAndUsage>
<Description>Fluocinonide Gel USP, 0.05% is intended for topical administration. The active component is the corticosteroid Fluocinonide, which is the 21-acetate ester of fluocinolone acetonide. The chemical name of Fluocinonide is Pregna-1,4-diene-3,20-dione,21-(acetyloxy)-6,9-difluoro-11-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(6α,11β,16α)-). It has a molecular formula of C26H32F2O7 and a molecular weight of 494.53. It has the following structural formula. Each gram of Fluocinonide Gel USP, 0.05% contains: fluocinonide 0.5 mg in a gel base consisting of propylene glycol, propyl gallate, edetate disodium, and carbomer 980. Sodium hydroxide solution is added to adjust pH, if required. This clear, colorless thixotropic vehicle is greaseless, non-staining and completely water miscible. In this formulation, the active ingredient is totally in solution.</Description>
</NDC>
</NDCList>