{
"NDC": [
{
"NDCCode": "0115-1864-18",
"PackageDescription": "30 PACKET in 1 CARTON (0115-1864-18) / 1 FOR SUSPENSION in 1 PACKET (0115-1864-30) ",
"NDC11Code": "00115-1864-18",
"ProductNDC": "0115-1864",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Colesevelam Hydrochloride",
"NonProprietaryName": "Colesevelam Hydrochloride",
"DosageFormName": "FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20230120",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212886",
"LabelerName": "Amneal Pharmaceuticals of New York LLC",
"SubstanceName": "COLESEVELAM HYDROCHLORIDE",
"StrengthNumber": "3.75",
"StrengthUnit": "g/1",
"Pharm_Classes": "Bile Acid Sequestrant [EPC], Bile-acid Binding Activity [MoA]",
"Status": "Active",
"LastUpdate": "2023-01-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230120",
"SamplePackage": "N",
"IndicationAndUsage": "Colesevelam hydrochloride is a bile acid sequestrant indicated as an adjunct to diet and exercise to: 1 reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia (1.1)., 2 reduce LDL-C levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia (HeFH), unable to reach LDL-C target levels despite an adequate trial of diet and lifestyle modification (1.1). .",
"Description": "Colesevelam hydrochloride is a non-absorbed, polymeric, lipid-lowering and glucose-lowering agent for oral administration. Colesevelam hydrochloride is a high-capacity bile acid-binding molecule. Colesevelam hydrochloride is poly (allylamine hydrochloride) cross-linked with epichlorohydrin and alkylated with 1-bromodecane and (6-bromohexyl)-trimethylammonium bromide. The chemical name (IUPAC) of colesevelam hydrochloride is 1-Hexaminium, N,N,N-trimethyl-6-(2-propenylamino)-, chloride, polymer with (chloromethyl) oxirane, 2-propen-4-amine and N-2-propenyl-1-decanamine, hydrochloride. The chemical structure of colesevelam hydrochloride is represented by the following formula. wherein (a) represents allyl amine monomer units that have not been alkylated by either of the 1-bromodecane or (6-bromohexyl)-trimethylammonium bromide alkylating agents or cross-linked by epichlorohydrin; (b) represents allyl amine units that have undergone cross-linking with epichlorohydrin; (c) represents allyl amine units that have been alkylated with a decyl group; (d) represents allyl amine units that have been alkylated with a (6-trimethylammonium) hexyl group, and m represents a number ≥ 100 to indicate an extended polymer network. A small amount of the amines are dialkylated and are not depicted in the formula above. No regular order of the groups is implied by the structure; cross-linking and alkylation are expected to occur randomly along the polymer chains. A large amount of the amines are protonated. The polymer is depicted in the hydrochloride form; a small amount of the halides are bromide. Colesevelam hydrochloride is hydrophilic and insoluble in water. Colesevelam hydrochloride for oral suspension is a lemon-flavored, off-white to pale yellow powder containing yellow granules packaged in a packet containing 3.75 gram colesevelam hydrochloride. In addition, each packet contains the following inactive ingredients: lemon flavor, magnesium aluminum silicate, maltodextrin, medium-chain triglycerides, propylene glycol alginate, silicon dioxide and sucralose."
},
{
"NDCCode": "0115-5212-18",
"PackageDescription": "30 SUSPENSION in 1 CARTON (0115-5212-18) ",
"NDC11Code": "00115-5212-18",
"ProductNDC": "0115-5212",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Colestipol Hydrochloride",
"NonProprietaryName": "Colestipol Hydrochloride",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20060502",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077277",
"LabelerName": "Amneal Pharmaceuticals of New York LLC",
"SubstanceName": "COLESTIPOL HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "g/1",
"Pharm_Classes": "Bile Acid Sequestrant [EPC], Bile-acid Binding Activity [MoA]",
"Status": "Active",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20060502",
"SamplePackage": "N",
"IndicationAndUsage": "Since no drug is innocuous, strict attention should be paid to the indications and contraindications, particularly when selecting drugs for chronic long-term use. Colestipol hydrochloride for oral suspension is indicated as adjunctive therapy to diet for the reduction of elevated serum total and low-density lipoprotein (LDL) cholesterol in patients with primary hypercholesterolemia (elevated low density lipoproteins [LDL] cholesterol) who do not respond adequately to diet. Generally, colestipol hydrochloride for oral suspension has no clinically significant effect on serum triglycerides, but with its use triglyceride levels may be raised in some patients. Therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Treatment should begin and continue with dietary therapy (see NCEP guidelines). A minimum of six months of intensive dietary therapy and counseling should be carried out prior to initiation of drug therapy. Shorter periods may be considered in patients with severe elevations of LDL-C or with definite CHD. According to the NCEP guidelines, the goal of treatment is to lower LDL-C, and LDL-C is to be used to initiate and assess treatment response. Only if LDL-C levels are not available, should the Total-C be used to monitor therapy. The NCEP treatment guidelines are shown below.",
"Description": "Colestipol hydrochloride for oral suspension, USP contains colestipol hydrochloride USP, which is a lipid lowering agent for oral use. Colestipol hydrochloride is an insoluble, high molecular weight basic anion-exchange copolymer of diethylenetriamine and 1-chloro-2, 3-epoxypropane, with approximately 1 out of 5 amine nitrogens protonated (chloride form). It is a light yellow water-insoluble resin which is hygroscopic and swells when suspended in water or aqueous fluids. Colestipol hydrochloride for oral suspension, USP is tasteless and odorless. The inactive ingredient is silicon dioxide. One dose (1 packet or 1 level scoopful) of colestipol hydrochloride for oral suspension, USP contains 5 grams of colestipol hydrochloride, USP."
},
{
"NDCCode": "42582-115-18",
"PackageDescription": "500 CAPSULE in 1 BOTTLE, PLASTIC (42582-115-18)",
"NDC11Code": "42582-0115-18",
"ProductNDC": "42582-115",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20160413",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090007",
"LabelerName": "Bi-Coastal Pharma International LLC",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2016-12-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160413",
"SamplePackage": "N",
"IndicationAndUsage": "Gabapentin Capsules are indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.",
"Description": "The active ingredient in Gabapentin Capsules, USP is gabapentin, USP which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin, USP is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Gabapentin Capsules, USP contain 100 mg, 300 mg or 400 mg of gabapentin, USP and the following inactive ingredients: lactose monohydrate, corn starch, and talc. The 100 mg capsule shell contains gelatin and titanium dioxide. The 300 mg capsule shell contains gelatin, titanium dioxide, and yellow iron oxide. The 400 mg capsule shell contains gelatin, red iron oxide, titanium dioxide, and yellow iron oxide. The imprinting ink contains FD&C Blue No. 2, propylene glycol and shellac."
},
{
"NDCCode": "57664-115-18",
"PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (57664-115-18)",
"NDC11Code": "57664-0115-18",
"ProductNDC": "57664-115",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gemfibrozil",
"NonProprietaryName": "Gemfibrozil",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090701",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079239",
"LabelerName": "Caraco Pharmaceutical Laboratories, Ltd.",
"SubstanceName": "GEMFIBROZIL",
"StrengthNumber": "600",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2018-03-15",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "71863-115-18",
"PackageDescription": "180 g in 1 BOTTLE (71863-115-18) ",
"NDC11Code": "71863-0115-18",
"ProductNDC": "71863-115",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Betaine Anhydrous",
"NonProprietaryName": "Betaine Anhydrous",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20220128",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210508",
"LabelerName": "Eton Pharmaceuticals, Inc.",
"SubstanceName": "BETAINE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Pharm_Classes": "Methylating Activity [MoA], Methylating Agent [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220128",
"SamplePackage": "N",
"IndicationAndUsage": "Betaine Anhydrous for Oral Solution is indicated for the treatment of homocystinuria to decrease elevated homocysteine blood concentrations in pediatric and adult patients. Included within the category of homocystinuria are: Cystathionine beta-synthase (CBS) deficiency 5,10-methylenetetrahydrofolate reductase (MTHFR) deficiency Cobalamin cofactor metabolism (cbl) defect.",
"Description": "Betaine Anhydrous for Oral Solution is an agent for the treatment of homocystinuria. It contains. no ingredients other than anhydrous betaine. Betaine Anhydrous for Oral Solution is a white, granular, hygroscopic powder, which is diluted in water and administered orally. The chemical name of betaine anhydrous powder is trimethylglycine. It has a molecular weight of 117.15. The structural formula is:."
},
{
"NDCCode": "43742-1864-1",
"PackageDescription": "960 mL in 1 BOTTLE, PLASTIC (43742-1864-1) ",
"NDC11Code": "43742-1864-01",
"ProductNDC": "43742-1864",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Hepatitis A Nosode, Hepatitis B Nosode, Hepatitis C Nosode",
"DosageFormName": "LIQUID",
"StartMarketingDate": "20210406",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Deseret Biologicals, Inc.",
"SubstanceName": "HEPATITIS A VIRUS; HEPATITIS B VIRUS; HEPATITIS C VIRUS",
"StrengthNumber": "10; 10; 10",
"StrengthUnit": "[hp_M]/mL; [hp_M]/mL; [hp_M]/mL",
"Status": "Unfinished",
"LastUpdate": "2023-01-18",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "06-APR-21"
},
{
"NDCCode": "0115-1566-01",
"PackageDescription": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0115-1566-01) ",
"NDC11Code": "00115-1566-01",
"ProductNDC": "0115-1566",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20180330",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA208607",
"LabelerName": "Impax Generics",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "18",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2018-04-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231",
"StartMarketingDatePackage": "20180330",
"SamplePackage": "N"
},
{
"NDCCode": "0115-1736-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1736-01) ",
"NDC11Code": "00115-1736-01",
"ProductNDC": "0115-1736",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20160920",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205105",
"LabelerName": "Amneal Pharmaceuticals of New York LLC",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160920",
"SamplePackage": "N",
"IndicationAndUsage": "Methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 15 years of age. Limitations of Use. The use of methylphenidate hydrochloride extended-release capsules is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g. weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7). Use in Specific Populations (8.4)].",
"Description": "Methylphenidate hydrochloride extended-release capsules contains methylphenidate hydrochloride, USP, a CNS stimulant. The extended-release capsules comprise both immediate-release (IR) and extended-release (ER) beads such that 30% of the dose is provided by the IR component and 70% of the dose is provided by the ER component. Methylphenidate hydrochloride extended-release capsules are available in six strengths containing 10 mg (3 mg IR; 7 mg ER), 20 mg (6 mg IR; 14 mg ER), 30 mg (9 mg IR; 21 mg ER), 40 mg (12 mg IR; 28 mg ER), 50 mg (15 mg IR; 35 mg ER), or 60 mg (18 mg IR; 42 mg ER) of methylphenidate hydrochloride, USP for oral administration. Chemically, methylphenidate hydrochloride, USP is d,l (racemic)-threo-methyl α-phenyl-2-piperidineacetate hydrochloride. Its empirical formula is C14H19NO2HCl. Its structural formula is. Methylphenidate hydrochloride, USP is a white, odorless, crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Methylphenidate hydrochloride extended-release capsules also contain the following inactive ingredients: Sugar spheres, povidone, hydroxypropylmethylcellulose and polyethylene glycol, ethyl cellulose, cetyl alcohol, sodium lauryl sulfate, dibutyl sebacate, gelatin and titanium dioxide. The imprinting ink for all strengths includes: D&C Yellow #10, ethanol, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, iron oxide black, methanol, N-Butyl alcohol, propylene glycol, and shellac glaze. The individual capsules contain the following color agents. 10 mg capsules: FD&C Blue No. 2, FDA/E172 Yellow Iron Oxide. 20 mg capsules: D&C Red No. 28, FD&C Blue No. 1, FD&C Green No. 3. 30 mg capsules: FDA/E172 Black Iron Oxide, FDA/E172 Red Iron Oxide, FDA/E172 Yellow Iron Oxide. 40 mg capsules: D&C Yellow No. 10, FD&C Red No. 40. 50 mg capsules: D&C Red No. 28, FD&C Green No. 3, FDA/E172 Black Iron Oxide."
},
{
"NDCCode": "0115-1737-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1737-01) ",
"NDC11Code": "00115-1737-01",
"ProductNDC": "0115-1737",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20160920",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205105",
"LabelerName": "Amneal Pharmaceuticals of New York LLC",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160920",
"SamplePackage": "N",
"IndicationAndUsage": "Methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 15 years of age. Limitations of Use. The use of methylphenidate hydrochloride extended-release capsules is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g. weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7). Use in Specific Populations (8.4)].",
"Description": "Methylphenidate hydrochloride extended-release capsules contains methylphenidate hydrochloride, USP, a CNS stimulant. The extended-release capsules comprise both immediate-release (IR) and extended-release (ER) beads such that 30% of the dose is provided by the IR component and 70% of the dose is provided by the ER component. Methylphenidate hydrochloride extended-release capsules are available in six strengths containing 10 mg (3 mg IR; 7 mg ER), 20 mg (6 mg IR; 14 mg ER), 30 mg (9 mg IR; 21 mg ER), 40 mg (12 mg IR; 28 mg ER), 50 mg (15 mg IR; 35 mg ER), or 60 mg (18 mg IR; 42 mg ER) of methylphenidate hydrochloride, USP for oral administration. Chemically, methylphenidate hydrochloride, USP is d,l (racemic)-threo-methyl α-phenyl-2-piperidineacetate hydrochloride. Its empirical formula is C14H19NO2HCl. Its structural formula is. Methylphenidate hydrochloride, USP is a white, odorless, crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Methylphenidate hydrochloride extended-release capsules also contain the following inactive ingredients: Sugar spheres, povidone, hydroxypropylmethylcellulose and polyethylene glycol, ethyl cellulose, cetyl alcohol, sodium lauryl sulfate, dibutyl sebacate, gelatin and titanium dioxide. The imprinting ink for all strengths includes: D&C Yellow #10, ethanol, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, iron oxide black, methanol, N-Butyl alcohol, propylene glycol, and shellac glaze. The individual capsules contain the following color agents. 10 mg capsules: FD&C Blue No. 2, FDA/E172 Yellow Iron Oxide. 20 mg capsules: D&C Red No. 28, FD&C Blue No. 1, FD&C Green No. 3. 30 mg capsules: FDA/E172 Black Iron Oxide, FDA/E172 Red Iron Oxide, FDA/E172 Yellow Iron Oxide. 40 mg capsules: D&C Yellow No. 10, FD&C Red No. 40. 50 mg capsules: D&C Red No. 28, FD&C Green No. 3, FDA/E172 Black Iron Oxide."
},
{
"NDCCode": "0115-1738-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1738-01) ",
"NDC11Code": "00115-1738-01",
"ProductNDC": "0115-1738",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20160920",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205105",
"LabelerName": "Amneal Pharmaceuticals of New York LLC",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160920",
"SamplePackage": "N",
"IndicationAndUsage": "Methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 15 years of age. Limitations of Use. The use of methylphenidate hydrochloride extended-release capsules is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g. weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7). Use in Specific Populations (8.4)].",
"Description": "Methylphenidate hydrochloride extended-release capsules contains methylphenidate hydrochloride, USP, a CNS stimulant. The extended-release capsules comprise both immediate-release (IR) and extended-release (ER) beads such that 30% of the dose is provided by the IR component and 70% of the dose is provided by the ER component. Methylphenidate hydrochloride extended-release capsules are available in six strengths containing 10 mg (3 mg IR; 7 mg ER), 20 mg (6 mg IR; 14 mg ER), 30 mg (9 mg IR; 21 mg ER), 40 mg (12 mg IR; 28 mg ER), 50 mg (15 mg IR; 35 mg ER), or 60 mg (18 mg IR; 42 mg ER) of methylphenidate hydrochloride, USP for oral administration. Chemically, methylphenidate hydrochloride, USP is d,l (racemic)-threo-methyl α-phenyl-2-piperidineacetate hydrochloride. Its empirical formula is C14H19NO2HCl. Its structural formula is. Methylphenidate hydrochloride, USP is a white, odorless, crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Methylphenidate hydrochloride extended-release capsules also contain the following inactive ingredients: Sugar spheres, povidone, hydroxypropylmethylcellulose and polyethylene glycol, ethyl cellulose, cetyl alcohol, sodium lauryl sulfate, dibutyl sebacate, gelatin and titanium dioxide. The imprinting ink for all strengths includes: D&C Yellow #10, ethanol, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, iron oxide black, methanol, N-Butyl alcohol, propylene glycol, and shellac glaze. The individual capsules contain the following color agents. 10 mg capsules: FD&C Blue No. 2, FDA/E172 Yellow Iron Oxide. 20 mg capsules: D&C Red No. 28, FD&C Blue No. 1, FD&C Green No. 3. 30 mg capsules: FDA/E172 Black Iron Oxide, FDA/E172 Red Iron Oxide, FDA/E172 Yellow Iron Oxide. 40 mg capsules: D&C Yellow No. 10, FD&C Red No. 40. 50 mg capsules: D&C Red No. 28, FD&C Green No. 3, FDA/E172 Black Iron Oxide."
},
{
"NDCCode": "0115-1739-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1739-01) ",
"NDC11Code": "00115-1739-01",
"ProductNDC": "0115-1739",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20160920",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205105",
"LabelerName": "Amneal Pharmaceuticals of New York LLC",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160920",
"SamplePackage": "N",
"IndicationAndUsage": "Methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 15 years of age. Limitations of Use. The use of methylphenidate hydrochloride extended-release capsules is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g. weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7). Use in Specific Populations (8.4)].",
"Description": "Methylphenidate hydrochloride extended-release capsules contains methylphenidate hydrochloride, USP, a CNS stimulant. The extended-release capsules comprise both immediate-release (IR) and extended-release (ER) beads such that 30% of the dose is provided by the IR component and 70% of the dose is provided by the ER component. Methylphenidate hydrochloride extended-release capsules are available in six strengths containing 10 mg (3 mg IR; 7 mg ER), 20 mg (6 mg IR; 14 mg ER), 30 mg (9 mg IR; 21 mg ER), 40 mg (12 mg IR; 28 mg ER), 50 mg (15 mg IR; 35 mg ER), or 60 mg (18 mg IR; 42 mg ER) of methylphenidate hydrochloride, USP for oral administration. Chemically, methylphenidate hydrochloride, USP is d,l (racemic)-threo-methyl α-phenyl-2-piperidineacetate hydrochloride. Its empirical formula is C14H19NO2HCl. Its structural formula is. Methylphenidate hydrochloride, USP is a white, odorless, crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Methylphenidate hydrochloride extended-release capsules also contain the following inactive ingredients: Sugar spheres, povidone, hydroxypropylmethylcellulose and polyethylene glycol, ethyl cellulose, cetyl alcohol, sodium lauryl sulfate, dibutyl sebacate, gelatin and titanium dioxide. The imprinting ink for all strengths includes: D&C Yellow #10, ethanol, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, iron oxide black, methanol, N-Butyl alcohol, propylene glycol, and shellac glaze. The individual capsules contain the following color agents. 10 mg capsules: FD&C Blue No. 2, FDA/E172 Yellow Iron Oxide. 20 mg capsules: D&C Red No. 28, FD&C Blue No. 1, FD&C Green No. 3. 30 mg capsules: FDA/E172 Black Iron Oxide, FDA/E172 Red Iron Oxide, FDA/E172 Yellow Iron Oxide. 40 mg capsules: D&C Yellow No. 10, FD&C Red No. 40. 50 mg capsules: D&C Red No. 28, FD&C Green No. 3, FDA/E172 Black Iron Oxide."
},
{
"NDCCode": "0115-1740-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1740-01) ",
"NDC11Code": "00115-1740-01",
"ProductNDC": "0115-1740",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20160920",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205105",
"LabelerName": "Amneal Pharmaceuticals of New York LLC",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160920",
"SamplePackage": "N",
"IndicationAndUsage": "Methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 15 years of age. Limitations of Use. The use of methylphenidate hydrochloride extended-release capsules is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g. weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7). Use in Specific Populations (8.4)].",
"Description": "Methylphenidate hydrochloride extended-release capsules contains methylphenidate hydrochloride, USP, a CNS stimulant. The extended-release capsules comprise both immediate-release (IR) and extended-release (ER) beads such that 30% of the dose is provided by the IR component and 70% of the dose is provided by the ER component. Methylphenidate hydrochloride extended-release capsules are available in six strengths containing 10 mg (3 mg IR; 7 mg ER), 20 mg (6 mg IR; 14 mg ER), 30 mg (9 mg IR; 21 mg ER), 40 mg (12 mg IR; 28 mg ER), 50 mg (15 mg IR; 35 mg ER), or 60 mg (18 mg IR; 42 mg ER) of methylphenidate hydrochloride, USP for oral administration. Chemically, methylphenidate hydrochloride, USP is d,l (racemic)-threo-methyl α-phenyl-2-piperidineacetate hydrochloride. Its empirical formula is C14H19NO2HCl. Its structural formula is. Methylphenidate hydrochloride, USP is a white, odorless, crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Methylphenidate hydrochloride extended-release capsules also contain the following inactive ingredients: Sugar spheres, povidone, hydroxypropylmethylcellulose and polyethylene glycol, ethyl cellulose, cetyl alcohol, sodium lauryl sulfate, dibutyl sebacate, gelatin and titanium dioxide. The imprinting ink for all strengths includes: D&C Yellow #10, ethanol, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, iron oxide black, methanol, N-Butyl alcohol, propylene glycol, and shellac glaze. The individual capsules contain the following color agents. 10 mg capsules: FD&C Blue No. 2, FDA/E172 Yellow Iron Oxide. 20 mg capsules: D&C Red No. 28, FD&C Blue No. 1, FD&C Green No. 3. 30 mg capsules: FDA/E172 Black Iron Oxide, FDA/E172 Red Iron Oxide, FDA/E172 Yellow Iron Oxide. 40 mg capsules: D&C Yellow No. 10, FD&C Red No. 40. 50 mg capsules: D&C Red No. 28, FD&C Green No. 3, FDA/E172 Black Iron Oxide."
},
{
"NDCCode": "0115-1741-01",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1741-01) ",
"NDC11Code": "00115-1741-01",
"ProductNDC": "0115-1741",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20160920",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA205105",
"LabelerName": "Amneal Pharmaceuticals of New York LLC",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-06-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160920",
"SamplePackage": "N",
"IndicationAndUsage": "Methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 15 years of age. Limitations of Use. The use of methylphenidate hydrochloride extended-release capsules is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g. weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7). Use in Specific Populations (8.4)].",
"Description": "Methylphenidate hydrochloride extended-release capsules contains methylphenidate hydrochloride, USP, a CNS stimulant. The extended-release capsules comprise both immediate-release (IR) and extended-release (ER) beads such that 30% of the dose is provided by the IR component and 70% of the dose is provided by the ER component. Methylphenidate hydrochloride extended-release capsules are available in six strengths containing 10 mg (3 mg IR; 7 mg ER), 20 mg (6 mg IR; 14 mg ER), 30 mg (9 mg IR; 21 mg ER), 40 mg (12 mg IR; 28 mg ER), 50 mg (15 mg IR; 35 mg ER), or 60 mg (18 mg IR; 42 mg ER) of methylphenidate hydrochloride, USP for oral administration. Chemically, methylphenidate hydrochloride, USP is d,l (racemic)-threo-methyl α-phenyl-2-piperidineacetate hydrochloride. Its empirical formula is C14H19NO2HCl. Its structural formula is. Methylphenidate hydrochloride, USP is a white, odorless, crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Methylphenidate hydrochloride extended-release capsules also contain the following inactive ingredients: Sugar spheres, povidone, hydroxypropylmethylcellulose and polyethylene glycol, ethyl cellulose, cetyl alcohol, sodium lauryl sulfate, dibutyl sebacate, gelatin and titanium dioxide. The imprinting ink for all strengths includes: D&C Yellow #10, ethanol, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, iron oxide black, methanol, N-Butyl alcohol, propylene glycol, and shellac glaze. The individual capsules contain the following color agents. 10 mg capsules: FD&C Blue No. 2, FDA/E172 Yellow Iron Oxide. 20 mg capsules: D&C Red No. 28, FD&C Blue No. 1, FD&C Green No. 3. 30 mg capsules: FDA/E172 Black Iron Oxide, FDA/E172 Red Iron Oxide, FDA/E172 Yellow Iron Oxide. 40 mg capsules: D&C Yellow No. 10, FD&C Red No. 40. 50 mg capsules: D&C Red No. 28, FD&C Green No. 3, FDA/E172 Black Iron Oxide."
},
{
"NDCCode": "0115-3511-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (0115-3511-01) ",
"NDC11Code": "00115-3511-01",
"ProductNDC": "0115-3511",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pyridostigmine Bromide",
"NonProprietaryName": "Pyridostigmine Bromide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20030424",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040502",
"LabelerName": "Amneal Pharmaceuticals of New York LLC",
"SubstanceName": "PYRIDOSTIGMINE BROMIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20030424",
"SamplePackage": "N",
"IndicationAndUsage": "Pyridostigmine bromide tablets are useful in the treatment of myasthenia gravis.",
"Description": "Pyridostigmine bromide, USP is an orally active cholinesterase inhibitor. Chemically, pyridostigmine bromide is 3-hydroxy-1-methylpyridinium bromide dimethylcarbamate. Its structural formula is. Pyridostigmine bromide tablets, USP is available as a 60 mg tablet for oral administration. The tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose anhydrous, magnesium stearate and stearic acid."
},
{
"NDCCode": "0115-3511-02",
"PackageDescription": "500 TABLET in 1 BOTTLE (0115-3511-02) ",
"NDC11Code": "00115-3511-02",
"ProductNDC": "0115-3511",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pyridostigmine Bromide",
"NonProprietaryName": "Pyridostigmine Bromide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20030424",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040502",
"LabelerName": "Amneal Pharmaceuticals of New York LLC",
"SubstanceName": "PYRIDOSTIGMINE BROMIDE",
"StrengthNumber": "60",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-10-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20030424",
"SamplePackage": "N",
"IndicationAndUsage": "Pyridostigmine bromide tablets are useful in the treatment of myasthenia gravis.",
"Description": "Pyridostigmine bromide, USP is an orally active cholinesterase inhibitor. Chemically, pyridostigmine bromide is 3-hydroxy-1-methylpyridinium bromide dimethylcarbamate. Its structural formula is. Pyridostigmine bromide tablets, USP is available as a 60 mg tablet for oral administration. The tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose anhydrous, magnesium stearate and stearic acid."
},
{
"NDCCode": "0115-5445-13",
"PackageDescription": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0115-5445-13) ",
"NDC11Code": "00115-5445-13",
"ProductNDC": "0115-5445",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bupropion Hydrochloride",
"NonProprietaryName": "Bupropion Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20041203",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076711",
"LabelerName": "Amneal Pharmaceuticals of New York LLC",
"SubstanceName": "BUPROPION HYDROCHLORIDE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2024-05-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20041203",
"SamplePackage": "N",
"IndicationAndUsage": "Bupropion hydrochloride extended-release tablets (SR) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies (14)]. The efficacy of bupropion hydrochloride extended-release tablets (SR) in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see Clinical Studies (14)].",
"Description": "Bupropion hydrochloride, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNOHCl. The structural formula is. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. Bupropion hydrochloride extended-release tablets (SR) are supplied for oral administration as 200 mg, film-coated, extended-release tablets. Each tablet contains 200 mg of bupropion hydrochloride and the inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, magnesium stearate, and microcrystalline cellulose. The film-coating material contains FD&C Yellow No. 6, hypromellose type 2910/ 3cP, 6cP and 50cP, polyethylene glycol, polydextrose, titanium dioxide, and triacetin. This product meets USP Dissolution Test #3."
},
{
"NDCCode": "0115-7037-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (0115-7037-01) ",
"NDC11Code": "00115-7037-01",
"ProductNDC": "0115-7037",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methitest",
"NonProprietaryName": "Methyltestosterone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19741017",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA080767",
"LabelerName": "Amneal Pharmaceuticals of New York LLC",
"SubstanceName": "METHYLTESTOSTERONE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]",
"DEASchedule": "CIII",
"Status": "Active",
"LastUpdate": "2025-06-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19741017",
"SamplePackage": "N",
"IndicationAndUsage": "1. Males. Androgens are indicated for replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone: 1 Primary hypogonadism (congenita or acquired) — Testicular failure due to cryptohidism, bilateral torsion, orchitis, vanishing testis syndrome, or orchidectomy., 2 Hypogonadotropic hypogonadism (congenital or acquired) — Gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. (Appropriate adrenal cortical and thyroid hormone replacement therapy are still necessary, however, and are actually of primary importance.) If the above conditions occur prior to puberty, androgen replacement therapy will be needed during the adolescent years for development of secondary sexual characteristics. Prolonged androgen treatment will be required to maintain sexual characteristics in these and other males who develop testosterone deficiency after puberty. .",
"Description": "METHITEST (methyltestosterone) tablets, USP contain methyltestosterone USP, a synthetic androgen. Androgens are steroids that develop and maintain primary and secondary male sex characteristics. METHITEST (methyltestosterone) tablets, USP are to be taken orally. Androgens are derivatives of cyclopentanoperhydrophenanthrena. Endogenous androgens are C-19 steroids with a side chain at C-17, and with two angular methyl groups. Testosterone is the primary endogenous androgen. In their active form, all drugs in the class have a 17-beta-hydroxy group. 17-alpha alkylation (methyltestosterone) increases the pharmacologic activity per unit weight compared to testosterone when given orally. Methyltestosterone is the 17α-methyl derivative of testosterone, the true testicular hormone. Chemically, methyltestosterone is 17b-hydroxy-17-methylandrost-4-en-3-one, with the empirical formula C20H30O2, a molecular weight of 302.5, and the following structural formula. C20H30O2 M.W. 302.46 (CAS-58-18-4) 17 β-Hydroxy-17-methylandrost-4-en-3-one. Methyltestosterone, USP is a white to creamy-white, odorless, slightly hydroscopic powder. It is practically insoluble in water, and is soluble in alcohol and other organic solvents. METHITEST (methyltestosterone) tablets, USP contain methyltestosterone, USP and acacia, lactose monohydrate, confectioner’s sugar, corn starch, powdered cellulose, sodium lauryl sulfate, magnesium stearate, pregelatinized starch, and guar gum."
},
{
"NDCCode": "0430-0115-20",
"PackageDescription": "48 BOTTLE in 1 CASE (0430-0115-20) > 60 TABLET, DELAYED RELEASE in 1 BOTTLE",
"NDC11Code": "00430-0115-20",
"ProductNDC": "0430-0115",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doryx",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20110921",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050795",
"LabelerName": "Warner Chilcott (US), LLC",
"SubstanceName": "DOXYCYCLINE HYCLATE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2015-12-18"
},
{
"NDCCode": "10356-115-10",
"PackageDescription": "99 g in 1 TUBE (10356-115-10) ",
"NDC11Code": "10356-0115-10",
"ProductNDC": "10356-115",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aquaphor Healing Fast Relief Diaper Rash",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170331",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Beiersdorf Inc",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": "40",
"StrengthUnit": "g/100g",
"Status": "Active",
"LastUpdate": "2025-12-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170331",
"SamplePackage": "N",
"IndicationAndUsage": "Uses helps treat and prevent diaper rash protects chafed skin associated with diaper rash and helps protect from wetness."
},
{
"NDCCode": "10356-115-29",
"PackageDescription": "4 g in 1 TUBE (10356-115-29) ",
"NDC11Code": "10356-0115-29",
"ProductNDC": "10356-115",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aquaphor Healing Fast Relief Diaper Rash",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170331",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Beiersdorf Inc",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": "40",
"StrengthUnit": "g/100g",
"Status": "Active",
"LastUpdate": "2025-12-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170331",
"SamplePackage": "N",
"IndicationAndUsage": "Uses helps treat and prevent diaper rash protects chafed skin associated with diaper rash and helps protect from wetness."
},
{
"NDCCode": "24510-115-10",
"PackageDescription": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (24510-115-10) ",
"NDC11Code": "24510-0115-10",
"ProductNDC": "24510-115",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Xtampza",
"ProprietaryNameSuffix": "Er",
"NonProprietaryName": "Oxycodone",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20160510",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208090",
"LabelerName": "Collegium Pharmaceutical, Inc.",
"SubstanceName": "OXYCODONE",
"StrengthNumber": "13.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-01-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160510",
"SamplePackage": "N",
"IndicationAndUsage": "XTAMPZA ER is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids.",
"Description": "XTAMPZA ER (oxycodone) extended-release capsules are an opioid agonist for oral use. The capsules contain microspheres formulated with oxycodone base and are supplied in strengths of 9 mg (equivalent to 10 mg oxycodone HCl), 13.5 mg (equivalent to 15 mg oxycodone HCl), 18 mg (equivalent to 20 mg oxycodone HCl), 27 mg (equivalent to 30 mg oxycodone HCl), and 36 mg (equivalent to 40 mg oxycodone HCl) capsules. The capsule strengths describe the amount of oxycodone base per capsule. The structural formula for oxycodone is as follows. C18H21NO4 MW 315.37 g/mol. The chemical name is 4,5 α-Epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one. Oxycodone base is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone is present as myristate salt in the XTAMPZA ER formulation. Each XTAMPZA ER capsule contains either 9, 13.5, 18, 27, or 36 mg of oxycodone (equivalent to 10, 15, 20, 30, or 40 mg of oxycodone HCl, respectively) and the following inactive ingredients: myristic acid, yellow beeswax, carnauba wax, stearoyl polyoxyl-32 glycerides, magnesium stearate, and colloidal silicon dioxide. The capsule shells collectively contain titanium dioxide, hypromellose, and water. Additionally, the 9 mg and 18 mg strength capsule shells contain yellow iron oxide, the 13.5 and 36 mg strength capsule shells contain red iron oxide, and the 27 mg strength capsule shells contain black iron oxide."
},
{
"NDCCode": "24510-115-20",
"PackageDescription": "20 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (24510-115-20) ",
"NDC11Code": "24510-0115-20",
"ProductNDC": "24510-115",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Xtampza",
"ProprietaryNameSuffix": "Er",
"NonProprietaryName": "Oxycodone",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20160510",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208090",
"LabelerName": "Collegium Pharmaceutical, Inc.",
"SubstanceName": "OXYCODONE",
"StrengthNumber": "13.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Full Opioid Agonists [MoA], Opioid Agonist [EPC]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2026-01-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160510",
"SamplePackage": "N",
"IndicationAndUsage": "XTAMPZA ER is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids.",
"Description": "XTAMPZA ER (oxycodone) extended-release capsules are an opioid agonist for oral use. The capsules contain microspheres formulated with oxycodone base and are supplied in strengths of 9 mg (equivalent to 10 mg oxycodone HCl), 13.5 mg (equivalent to 15 mg oxycodone HCl), 18 mg (equivalent to 20 mg oxycodone HCl), 27 mg (equivalent to 30 mg oxycodone HCl), and 36 mg (equivalent to 40 mg oxycodone HCl) capsules. The capsule strengths describe the amount of oxycodone base per capsule. The structural formula for oxycodone is as follows. C18H21NO4 MW 315.37 g/mol. The chemical name is 4,5 α-Epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one. Oxycodone base is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone is present as myristate salt in the XTAMPZA ER formulation. Each XTAMPZA ER capsule contains either 9, 13.5, 18, 27, or 36 mg of oxycodone (equivalent to 10, 15, 20, 30, or 40 mg of oxycodone HCl, respectively) and the following inactive ingredients: myristic acid, yellow beeswax, carnauba wax, stearoyl polyoxyl-32 glycerides, magnesium stearate, and colloidal silicon dioxide. The capsule shells collectively contain titanium dioxide, hypromellose, and water. Additionally, the 9 mg and 18 mg strength capsule shells contain yellow iron oxide, the 13.5 and 36 mg strength capsule shells contain red iron oxide, and the 27 mg strength capsule shells contain black iron oxide."
},
{
"NDCCode": "25000-115-03",
"PackageDescription": "30 TABLET in 1 BOTTLE (25000-115-03)",
"NDC11Code": "25000-0115-03",
"ProductNDC": "25000-115",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120704",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091237",
"LabelerName": "MARKSANS PHARMA LIMITED",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2015-11-18"
},
{
"NDCCode": "25000-115-14",
"PackageDescription": "1000 TABLET in 1 BOTTLE (25000-115-14)",
"NDC11Code": "25000-0115-14",
"ProductNDC": "25000-115",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120704",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091237",
"LabelerName": "MARKSANS PHARMA LIMITED",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2015-11-18"
},
{
"NDCCode": "25000-115-30",
"PackageDescription": "6 BAG in 1 BOX (25000-115-30) > 6500 TABLET in 1 BAG",
"NDC11Code": "25000-0115-30",
"ProductNDC": "25000-115",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20120704",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091237",
"LabelerName": "MARKSANS PHARMA LIMITED",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2015-11-18"
},
{
"NDCCode": "48087-0115-0",
"PackageDescription": "50 kg in 1 DRUM (48087-0115-0) ",
"NDC11Code": "48087-0115-00",
"ProductNDC": "48087-0115",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Oxcarbazepine",
"DosageFormName": "POWDER",
"StartMarketingDate": "20150418",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "F.I.S. FABBRICA ITALIANA SINTETICI S.P.A.",
"SubstanceName": "OXCARBAZEPINE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2021-12-08",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "18-APR-15"
},
{
"NDCCode": "49781-115-15",
"PackageDescription": "15 g in 1 BOTTLE, WITH APPLICATOR (49781-115-15)",
"NDC11Code": "49781-0115-15",
"ProductNDC": "49781-115",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Salicylic Acid",
"NonProprietaryName": "Liquid Wart Remover",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20011001",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part358F",
"LabelerName": "Cardinal Health",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": ".17",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2015-11-18"
},
{
"NDCCode": "51224-115-20",
"PackageDescription": "20 BOTTLE in 1 CARTON (51224-115-20) > 50 mL in 1 BOTTLE (51224-115-01) ",
"NDC11Code": "51224-0115-20",
"ProductNDC": "51224-115",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dexmedetomidine Hydrochloride In Sodium Chloride",
"NonProprietaryName": "Dexmedetomidine Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20201123",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA212857",
"LabelerName": "TAGI Pharma, Inc.",
"SubstanceName": "DEXMEDETOMIDINE HYDROCHLORIDE",
"StrengthNumber": "4",
"StrengthUnit": "ug/mL",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2023-12-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20201123",
"SamplePackage": "N"
},
{
"NDCCode": "57844-115-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (57844-115-01) ",
"NDC11Code": "57844-0115-01",
"ProductNDC": "57844-115",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Adderall",
"NonProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, And Amphetamine Sulfate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040422",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE",
"StrengthNumber": "3.75; 3.75; 3.75; 3.75",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2024-06-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140630",
"SamplePackage": "N",
"IndicationAndUsage": "Adderall® (Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets (Mixed salts of a single entity amphetamine product)) is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy.",
"Description": "A single-entity amphetamine product combining the neutral sulfate salts of dextroamphetamine and amphetamine, with the dextro isomer of amphetamine saccharate and d, l-amphetamine aspartate. Inactive Ingredients: colloidal silicon dioxide, compressible sugar (sucrose and maltodextrin), corn starch, magnesium stearate, microcrystalline cellulose and saccharin sodium. Colors: Adderall® 5 mg is a white to off-white tablet, which contains no color additives. Adderall ® 7.5 mg and 10 mg contain FD&C Blue #1 Aluminum Lake as a color additive. Adderall ® 12.5 mg, 15 mg, 20 mg and 30 mg contain FD&C Yellow #6 Aluminum Lake as a color additive."
},
{
"NDCCode": "58103-115-50",
"PackageDescription": "50 kg in 1 DRUM (58103-115-50) ",
"NDC11Code": "58103-0115-50",
"ProductNDC": "58103-115",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "POWDER",
"StartMarketingDate": "20180905",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "SPI Pharma, Inc.",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "92",
"StrengthUnit": "kg/100kg",
"Status": "Unfinished",
"LastUpdate": "2023-01-24",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "05-SEP-18"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>0115-1864-18</NDCCode>
<PackageDescription>30 PACKET in 1 CARTON (0115-1864-18) / 1 FOR SUSPENSION in 1 PACKET (0115-1864-30) </PackageDescription>
<NDC11Code>00115-1864-18</NDC11Code>
<ProductNDC>0115-1864</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Colesevelam Hydrochloride</ProprietaryName>
<NonProprietaryName>Colesevelam Hydrochloride</NonProprietaryName>
<DosageFormName>FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230120</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212886</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
<SubstanceName>COLESEVELAM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>3.75</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>Bile Acid Sequestrant [EPC], Bile-acid Binding Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230120</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Colesevelam hydrochloride is a bile acid sequestrant indicated as an adjunct to diet and exercise to: 1 reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia (1.1)., 2 reduce LDL-C levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia (HeFH), unable to reach LDL-C target levels despite an adequate trial of diet and lifestyle modification (1.1). .</IndicationAndUsage>
<Description>Colesevelam hydrochloride is a non-absorbed, polymeric, lipid-lowering and glucose-lowering agent for oral administration. Colesevelam hydrochloride is a high-capacity bile acid-binding molecule. Colesevelam hydrochloride is poly (allylamine hydrochloride) cross-linked with epichlorohydrin and alkylated with 1-bromodecane and (6-bromohexyl)-trimethylammonium bromide. The chemical name (IUPAC) of colesevelam hydrochloride is 1-Hexaminium, N,N,N-trimethyl-6-(2-propenylamino)-, chloride, polymer with (chloromethyl) oxirane, 2-propen-4-amine and N-2-propenyl-1-decanamine, hydrochloride. The chemical structure of colesevelam hydrochloride is represented by the following formula. wherein (a) represents allyl amine monomer units that have not been alkylated by either of the 1-bromodecane or (6-bromohexyl)-trimethylammonium bromide alkylating agents or cross-linked by epichlorohydrin; (b) represents allyl amine units that have undergone cross-linking with epichlorohydrin; (c) represents allyl amine units that have been alkylated with a decyl group; (d) represents allyl amine units that have been alkylated with a (6-trimethylammonium) hexyl group, and m represents a number ≥ 100 to indicate an extended polymer network. A small amount of the amines are dialkylated and are not depicted in the formula above. No regular order of the groups is implied by the structure; cross-linking and alkylation are expected to occur randomly along the polymer chains. A large amount of the amines are protonated. The polymer is depicted in the hydrochloride form; a small amount of the halides are bromide. Colesevelam hydrochloride is hydrophilic and insoluble in water. Colesevelam hydrochloride for oral suspension is a lemon-flavored, off-white to pale yellow powder containing yellow granules packaged in a packet containing 3.75 gram colesevelam hydrochloride. In addition, each packet contains the following inactive ingredients: lemon flavor, magnesium aluminum silicate, maltodextrin, medium-chain triglycerides, propylene glycol alginate, silicon dioxide and sucralose.</Description>
</NDC>
<NDC>
<NDCCode>0115-5212-18</NDCCode>
<PackageDescription>30 SUSPENSION in 1 CARTON (0115-5212-18) </PackageDescription>
<NDC11Code>00115-5212-18</NDC11Code>
<ProductNDC>0115-5212</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Colestipol Hydrochloride</ProprietaryName>
<NonProprietaryName>Colestipol Hydrochloride</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060502</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077277</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
<SubstanceName>COLESTIPOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>Bile Acid Sequestrant [EPC], Bile-acid Binding Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20060502</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Since no drug is innocuous, strict attention should be paid to the indications and contraindications, particularly when selecting drugs for chronic long-term use. Colestipol hydrochloride for oral suspension is indicated as adjunctive therapy to diet for the reduction of elevated serum total and low-density lipoprotein (LDL) cholesterol in patients with primary hypercholesterolemia (elevated low density lipoproteins [LDL] cholesterol) who do not respond adequately to diet. Generally, colestipol hydrochloride for oral suspension has no clinically significant effect on serum triglycerides, but with its use triglyceride levels may be raised in some patients. Therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Treatment should begin and continue with dietary therapy (see NCEP guidelines). A minimum of six months of intensive dietary therapy and counseling should be carried out prior to initiation of drug therapy. Shorter periods may be considered in patients with severe elevations of LDL-C or with definite CHD. According to the NCEP guidelines, the goal of treatment is to lower LDL-C, and LDL-C is to be used to initiate and assess treatment response. Only if LDL-C levels are not available, should the Total-C be used to monitor therapy. The NCEP treatment guidelines are shown below.</IndicationAndUsage>
<Description>Colestipol hydrochloride for oral suspension, USP contains colestipol hydrochloride USP, which is a lipid lowering agent for oral use. Colestipol hydrochloride is an insoluble, high molecular weight basic anion-exchange copolymer of diethylenetriamine and 1-chloro-2, 3-epoxypropane, with approximately 1 out of 5 amine nitrogens protonated (chloride form). It is a light yellow water-insoluble resin which is hygroscopic and swells when suspended in water or aqueous fluids. Colestipol hydrochloride for oral suspension, USP is tasteless and odorless. The inactive ingredient is silicon dioxide. One dose (1 packet or 1 level scoopful) of colestipol hydrochloride for oral suspension, USP contains 5 grams of colestipol hydrochloride, USP.</Description>
</NDC>
<NDC>
<NDCCode>42582-115-18</NDCCode>
<PackageDescription>500 CAPSULE in 1 BOTTLE, PLASTIC (42582-115-18)</PackageDescription>
<NDC11Code>42582-0115-18</NDC11Code>
<ProductNDC>42582-115</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160413</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090007</ApplicationNumber>
<LabelerName>Bi-Coastal Pharma International LLC</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2016-12-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160413</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gabapentin Capsules are indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.</IndicationAndUsage>
<Description>The active ingredient in Gabapentin Capsules, USP is gabapentin, USP which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C9H17NO2 and the molecular weight is 171.24. The structural formula of gabapentin is. Gabapentin, USP is a white to off-white crystalline solid with a pKa1 of 3.7 and a pKa2 of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Gabapentin Capsules, USP contain 100 mg, 300 mg or 400 mg of gabapentin, USP and the following inactive ingredients: lactose monohydrate, corn starch, and talc. The 100 mg capsule shell contains gelatin and titanium dioxide. The 300 mg capsule shell contains gelatin, titanium dioxide, and yellow iron oxide. The 400 mg capsule shell contains gelatin, red iron oxide, titanium dioxide, and yellow iron oxide. The imprinting ink contains FD&C Blue No. 2, propylene glycol and shellac.</Description>
</NDC>
<NDC>
<NDCCode>57664-115-18</NDCCode>
<PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (57664-115-18)</PackageDescription>
<NDC11Code>57664-0115-18</NDC11Code>
<ProductNDC>57664-115</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gemfibrozil</ProprietaryName>
<NonProprietaryName>Gemfibrozil</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090701</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079239</ApplicationNumber>
<LabelerName>Caraco Pharmaceutical Laboratories, Ltd.</LabelerName>
<SubstanceName>GEMFIBROZIL</SubstanceName>
<StrengthNumber>600</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator-activated Receptor alpha Agonists [MoA],PPAR alpha [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-03-15</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>71863-115-18</NDCCode>
<PackageDescription>180 g in 1 BOTTLE (71863-115-18) </PackageDescription>
<NDC11Code>71863-0115-18</NDC11Code>
<ProductNDC>71863-115</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Betaine Anhydrous</ProprietaryName>
<NonProprietaryName>Betaine Anhydrous</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220128</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210508</ApplicationNumber>
<LabelerName>Eton Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>BETAINE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Pharm_Classes>Methylating Activity [MoA], Methylating Agent [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220128</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Betaine Anhydrous for Oral Solution is indicated for the treatment of homocystinuria to decrease elevated homocysteine blood concentrations in pediatric and adult patients. Included within the category of homocystinuria are: Cystathionine beta-synthase (CBS) deficiency 5,10-methylenetetrahydrofolate reductase (MTHFR) deficiency Cobalamin cofactor metabolism (cbl) defect.</IndicationAndUsage>
<Description>Betaine Anhydrous for Oral Solution is an agent for the treatment of homocystinuria. It contains. no ingredients other than anhydrous betaine. Betaine Anhydrous for Oral Solution is a white, granular, hygroscopic powder, which is diluted in water and administered orally. The chemical name of betaine anhydrous powder is trimethylglycine. It has a molecular weight of 117.15. The structural formula is:.</Description>
</NDC>
<NDC>
<NDCCode>43742-1864-1</NDCCode>
<PackageDescription>960 mL in 1 BOTTLE, PLASTIC (43742-1864-1) </PackageDescription>
<NDC11Code>43742-1864-01</NDC11Code>
<ProductNDC>43742-1864</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Hepatitis A Nosode, Hepatitis B Nosode, Hepatitis C Nosode</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<StartMarketingDate>20210406</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Deseret Biologicals, Inc.</LabelerName>
<SubstanceName>HEPATITIS A VIRUS; HEPATITIS B VIRUS; HEPATITIS C VIRUS</SubstanceName>
<StrengthNumber>10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_M]/mL; [hp_M]/mL; [hp_M]/mL</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2023-01-18</LastUpdate>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>06-APR-21</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>0115-1566-01</NDCCode>
<PackageDescription>100 TABLET, EXTENDED RELEASE in 1 BOTTLE (0115-1566-01) </PackageDescription>
<NDC11Code>00115-1566-01</NDC11Code>
<ProductNDC>0115-1566</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methylphenidate Hydrochloride</ProprietaryName>
<NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180330</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA208607</ApplicationNumber>
<LabelerName>Impax Generics</LabelerName>
<SubstanceName>METHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>18</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2018-04-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0115-1736-01</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1736-01) </PackageDescription>
<NDC11Code>00115-1736-01</NDC11Code>
<ProductNDC>0115-1736</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methylphenidate Hydrochloride</ProprietaryName>
<NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
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<IndicationAndUsage>Methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 15 years of age. Limitations of Use. The use of methylphenidate hydrochloride extended-release capsules is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g. weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7). Use in Specific Populations (8.4)].</IndicationAndUsage>
<Description>Methylphenidate hydrochloride extended-release capsules contains methylphenidate hydrochloride, USP, a CNS stimulant. The extended-release capsules comprise both immediate-release (IR) and extended-release (ER) beads such that 30% of the dose is provided by the IR component and 70% of the dose is provided by the ER component. Methylphenidate hydrochloride extended-release capsules are available in six strengths containing 10 mg (3 mg IR; 7 mg ER), 20 mg (6 mg IR; 14 mg ER), 30 mg (9 mg IR; 21 mg ER), 40 mg (12 mg IR; 28 mg ER), 50 mg (15 mg IR; 35 mg ER), or 60 mg (18 mg IR; 42 mg ER) of methylphenidate hydrochloride, USP for oral administration. Chemically, methylphenidate hydrochloride, USP is d,l (racemic)-threo-methyl α-phenyl-2-piperidineacetate hydrochloride. Its empirical formula is C14H19NO2HCl. Its structural formula is. Methylphenidate hydrochloride, USP is a white, odorless, crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Methylphenidate hydrochloride extended-release capsules also contain the following inactive ingredients: Sugar spheres, povidone, hydroxypropylmethylcellulose and polyethylene glycol, ethyl cellulose, cetyl alcohol, sodium lauryl sulfate, dibutyl sebacate, gelatin and titanium dioxide. The imprinting ink for all strengths includes: D&C Yellow #10, ethanol, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, iron oxide black, methanol, N-Butyl alcohol, propylene glycol, and shellac glaze. The individual capsules contain the following color agents. 10 mg capsules: FD&C Blue No. 2, FDA/E172 Yellow Iron Oxide. 20 mg capsules: D&C Red No. 28, FD&C Blue No. 1, FD&C Green No. 3. 30 mg capsules: FDA/E172 Black Iron Oxide, FDA/E172 Red Iron Oxide, FDA/E172 Yellow Iron Oxide. 40 mg capsules: D&C Yellow No. 10, FD&C Red No. 40. 50 mg capsules: D&C Red No. 28, FD&C Green No. 3, FDA/E172 Black Iron Oxide.</Description>
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<IndicationAndUsage>Methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 15 years of age. Limitations of Use. The use of methylphenidate hydrochloride extended-release capsules is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g. weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7). Use in Specific Populations (8.4)].</IndicationAndUsage>
<Description>Methylphenidate hydrochloride extended-release capsules contains methylphenidate hydrochloride, USP, a CNS stimulant. The extended-release capsules comprise both immediate-release (IR) and extended-release (ER) beads such that 30% of the dose is provided by the IR component and 70% of the dose is provided by the ER component. Methylphenidate hydrochloride extended-release capsules are available in six strengths containing 10 mg (3 mg IR; 7 mg ER), 20 mg (6 mg IR; 14 mg ER), 30 mg (9 mg IR; 21 mg ER), 40 mg (12 mg IR; 28 mg ER), 50 mg (15 mg IR; 35 mg ER), or 60 mg (18 mg IR; 42 mg ER) of methylphenidate hydrochloride, USP for oral administration. Chemically, methylphenidate hydrochloride, USP is d,l (racemic)-threo-methyl α-phenyl-2-piperidineacetate hydrochloride. Its empirical formula is C14H19NO2HCl. Its structural formula is. Methylphenidate hydrochloride, USP is a white, odorless, crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Methylphenidate hydrochloride extended-release capsules also contain the following inactive ingredients: Sugar spheres, povidone, hydroxypropylmethylcellulose and polyethylene glycol, ethyl cellulose, cetyl alcohol, sodium lauryl sulfate, dibutyl sebacate, gelatin and titanium dioxide. The imprinting ink for all strengths includes: D&C Yellow #10, ethanol, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, iron oxide black, methanol, N-Butyl alcohol, propylene glycol, and shellac glaze. The individual capsules contain the following color agents. 10 mg capsules: FD&C Blue No. 2, FDA/E172 Yellow Iron Oxide. 20 mg capsules: D&C Red No. 28, FD&C Blue No. 1, FD&C Green No. 3. 30 mg capsules: FDA/E172 Black Iron Oxide, FDA/E172 Red Iron Oxide, FDA/E172 Yellow Iron Oxide. 40 mg capsules: D&C Yellow No. 10, FD&C Red No. 40. 50 mg capsules: D&C Red No. 28, FD&C Green No. 3, FDA/E172 Black Iron Oxide.</Description>
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<IndicationAndUsage>Methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 15 years of age. Limitations of Use. The use of methylphenidate hydrochloride extended-release capsules is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g. weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7). Use in Specific Populations (8.4)].</IndicationAndUsage>
<Description>Methylphenidate hydrochloride extended-release capsules contains methylphenidate hydrochloride, USP, a CNS stimulant. The extended-release capsules comprise both immediate-release (IR) and extended-release (ER) beads such that 30% of the dose is provided by the IR component and 70% of the dose is provided by the ER component. Methylphenidate hydrochloride extended-release capsules are available in six strengths containing 10 mg (3 mg IR; 7 mg ER), 20 mg (6 mg IR; 14 mg ER), 30 mg (9 mg IR; 21 mg ER), 40 mg (12 mg IR; 28 mg ER), 50 mg (15 mg IR; 35 mg ER), or 60 mg (18 mg IR; 42 mg ER) of methylphenidate hydrochloride, USP for oral administration. Chemically, methylphenidate hydrochloride, USP is d,l (racemic)-threo-methyl α-phenyl-2-piperidineacetate hydrochloride. Its empirical formula is C14H19NO2HCl. Its structural formula is. Methylphenidate hydrochloride, USP is a white, odorless, crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Methylphenidate hydrochloride extended-release capsules also contain the following inactive ingredients: Sugar spheres, povidone, hydroxypropylmethylcellulose and polyethylene glycol, ethyl cellulose, cetyl alcohol, sodium lauryl sulfate, dibutyl sebacate, gelatin and titanium dioxide. The imprinting ink for all strengths includes: D&C Yellow #10, ethanol, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, iron oxide black, methanol, N-Butyl alcohol, propylene glycol, and shellac glaze. The individual capsules contain the following color agents. 10 mg capsules: FD&C Blue No. 2, FDA/E172 Yellow Iron Oxide. 20 mg capsules: D&C Red No. 28, FD&C Blue No. 1, FD&C Green No. 3. 30 mg capsules: FDA/E172 Black Iron Oxide, FDA/E172 Red Iron Oxide, FDA/E172 Yellow Iron Oxide. 40 mg capsules: D&C Yellow No. 10, FD&C Red No. 40. 50 mg capsules: D&C Red No. 28, FD&C Green No. 3, FDA/E172 Black Iron Oxide.</Description>
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<IndicationAndUsage>Methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 15 years of age. Limitations of Use. The use of methylphenidate hydrochloride extended-release capsules is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g. weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7). Use in Specific Populations (8.4)].</IndicationAndUsage>
<Description>Methylphenidate hydrochloride extended-release capsules contains methylphenidate hydrochloride, USP, a CNS stimulant. The extended-release capsules comprise both immediate-release (IR) and extended-release (ER) beads such that 30% of the dose is provided by the IR component and 70% of the dose is provided by the ER component. Methylphenidate hydrochloride extended-release capsules are available in six strengths containing 10 mg (3 mg IR; 7 mg ER), 20 mg (6 mg IR; 14 mg ER), 30 mg (9 mg IR; 21 mg ER), 40 mg (12 mg IR; 28 mg ER), 50 mg (15 mg IR; 35 mg ER), or 60 mg (18 mg IR; 42 mg ER) of methylphenidate hydrochloride, USP for oral administration. Chemically, methylphenidate hydrochloride, USP is d,l (racemic)-threo-methyl α-phenyl-2-piperidineacetate hydrochloride. Its empirical formula is C14H19NO2HCl. Its structural formula is. Methylphenidate hydrochloride, USP is a white, odorless, crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Methylphenidate hydrochloride extended-release capsules also contain the following inactive ingredients: Sugar spheres, povidone, hydroxypropylmethylcellulose and polyethylene glycol, ethyl cellulose, cetyl alcohol, sodium lauryl sulfate, dibutyl sebacate, gelatin and titanium dioxide. The imprinting ink for all strengths includes: D&C Yellow #10, ethanol, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, iron oxide black, methanol, N-Butyl alcohol, propylene glycol, and shellac glaze. The individual capsules contain the following color agents. 10 mg capsules: FD&C Blue No. 2, FDA/E172 Yellow Iron Oxide. 20 mg capsules: D&C Red No. 28, FD&C Blue No. 1, FD&C Green No. 3. 30 mg capsules: FDA/E172 Black Iron Oxide, FDA/E172 Red Iron Oxide, FDA/E172 Yellow Iron Oxide. 40 mg capsules: D&C Yellow No. 10, FD&C Red No. 40. 50 mg capsules: D&C Red No. 28, FD&C Green No. 3, FDA/E172 Black Iron Oxide.</Description>
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<IndicationAndUsage>Methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 15 years of age. Limitations of Use. The use of methylphenidate hydrochloride extended-release capsules is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g. weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7). Use in Specific Populations (8.4)].</IndicationAndUsage>
<Description>Methylphenidate hydrochloride extended-release capsules contains methylphenidate hydrochloride, USP, a CNS stimulant. The extended-release capsules comprise both immediate-release (IR) and extended-release (ER) beads such that 30% of the dose is provided by the IR component and 70% of the dose is provided by the ER component. Methylphenidate hydrochloride extended-release capsules are available in six strengths containing 10 mg (3 mg IR; 7 mg ER), 20 mg (6 mg IR; 14 mg ER), 30 mg (9 mg IR; 21 mg ER), 40 mg (12 mg IR; 28 mg ER), 50 mg (15 mg IR; 35 mg ER), or 60 mg (18 mg IR; 42 mg ER) of methylphenidate hydrochloride, USP for oral administration. Chemically, methylphenidate hydrochloride, USP is d,l (racemic)-threo-methyl α-phenyl-2-piperidineacetate hydrochloride. Its empirical formula is C14H19NO2HCl. Its structural formula is. Methylphenidate hydrochloride, USP is a white, odorless, crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Methylphenidate hydrochloride extended-release capsules also contain the following inactive ingredients: Sugar spheres, povidone, hydroxypropylmethylcellulose and polyethylene glycol, ethyl cellulose, cetyl alcohol, sodium lauryl sulfate, dibutyl sebacate, gelatin and titanium dioxide. The imprinting ink for all strengths includes: D&C Yellow #10, ethanol, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, iron oxide black, methanol, N-Butyl alcohol, propylene glycol, and shellac glaze. The individual capsules contain the following color agents. 10 mg capsules: FD&C Blue No. 2, FDA/E172 Yellow Iron Oxide. 20 mg capsules: D&C Red No. 28, FD&C Blue No. 1, FD&C Green No. 3. 30 mg capsules: FDA/E172 Black Iron Oxide, FDA/E172 Red Iron Oxide, FDA/E172 Yellow Iron Oxide. 40 mg capsules: D&C Yellow No. 10, FD&C Red No. 40. 50 mg capsules: D&C Red No. 28, FD&C Green No. 3, FDA/E172 Black Iron Oxide.</Description>
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<IndicationAndUsage>Methylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 15 years of age. Limitations of Use. The use of methylphenidate hydrochloride extended-release capsules is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g. weight loss) than patients 6 years and older at the same dosage [see Warnings and Precautions (5.7). Use in Specific Populations (8.4)].</IndicationAndUsage>
<Description>Methylphenidate hydrochloride extended-release capsules contains methylphenidate hydrochloride, USP, a CNS stimulant. The extended-release capsules comprise both immediate-release (IR) and extended-release (ER) beads such that 30% of the dose is provided by the IR component and 70% of the dose is provided by the ER component. Methylphenidate hydrochloride extended-release capsules are available in six strengths containing 10 mg (3 mg IR; 7 mg ER), 20 mg (6 mg IR; 14 mg ER), 30 mg (9 mg IR; 21 mg ER), 40 mg (12 mg IR; 28 mg ER), 50 mg (15 mg IR; 35 mg ER), or 60 mg (18 mg IR; 42 mg ER) of methylphenidate hydrochloride, USP for oral administration. Chemically, methylphenidate hydrochloride, USP is d,l (racemic)-threo-methyl α-phenyl-2-piperidineacetate hydrochloride. Its empirical formula is C14H19NO2HCl. Its structural formula is. Methylphenidate hydrochloride, USP is a white, odorless, crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Methylphenidate hydrochloride extended-release capsules also contain the following inactive ingredients: Sugar spheres, povidone, hydroxypropylmethylcellulose and polyethylene glycol, ethyl cellulose, cetyl alcohol, sodium lauryl sulfate, dibutyl sebacate, gelatin and titanium dioxide. The imprinting ink for all strengths includes: D&C Yellow #10, ethanol, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, iron oxide black, methanol, N-Butyl alcohol, propylene glycol, and shellac glaze. The individual capsules contain the following color agents. 10 mg capsules: FD&C Blue No. 2, FDA/E172 Yellow Iron Oxide. 20 mg capsules: D&C Red No. 28, FD&C Blue No. 1, FD&C Green No. 3. 30 mg capsules: FDA/E172 Black Iron Oxide, FDA/E172 Red Iron Oxide, FDA/E172 Yellow Iron Oxide. 40 mg capsules: D&C Yellow No. 10, FD&C Red No. 40. 50 mg capsules: D&C Red No. 28, FD&C Green No. 3, FDA/E172 Black Iron Oxide.</Description>
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<LastUpdate>2025-10-18</LastUpdate>
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<IndicationAndUsage>Pyridostigmine bromide tablets are useful in the treatment of myasthenia gravis.</IndicationAndUsage>
<Description>Pyridostigmine bromide, USP is an orally active cholinesterase inhibitor. Chemically, pyridostigmine bromide is 3-hydroxy-1-methylpyridinium bromide dimethylcarbamate. Its structural formula is. Pyridostigmine bromide tablets, USP is available as a 60 mg tablet for oral administration. The tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose anhydrous, magnesium stearate and stearic acid.</Description>
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<IndicationAndUsage>Pyridostigmine bromide tablets are useful in the treatment of myasthenia gravis.</IndicationAndUsage>
<Description>Pyridostigmine bromide, USP is an orally active cholinesterase inhibitor. Chemically, pyridostigmine bromide is 3-hydroxy-1-methylpyridinium bromide dimethylcarbamate. Its structural formula is. Pyridostigmine bromide tablets, USP is available as a 60 mg tablet for oral administration. The tablet contains the following inactive ingredients: colloidal silicon dioxide, lactose anhydrous, magnesium stearate and stearic acid.</Description>
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<NDCCode>0115-5445-13</NDCCode>
<PackageDescription>60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0115-5445-13) </PackageDescription>
<NDC11Code>00115-5445-13</NDC11Code>
<ProductNDC>0115-5445</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bupropion Hydrochloride</ProprietaryName>
<NonProprietaryName>Bupropion Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20041203</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076711</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
<SubstanceName>BUPROPION HYDROCHLORIDE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminoketone [EPC], Dopamine Uptake Inhibitors [MoA], Increased Dopamine Activity [PE], Increased Norepinephrine Activity [PE], Norepinephrine Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-05-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20041203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bupropion hydrochloride extended-release tablets (SR) are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies (14)]. The efficacy of bupropion hydrochloride extended-release tablets (SR) in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see Clinical Studies (14)].</IndicationAndUsage>
<Description>Bupropion hydrochloride, an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1-propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C13H18ClNOHCl. The structural formula is. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. Bupropion hydrochloride extended-release tablets (SR) are supplied for oral administration as 200 mg, film-coated, extended-release tablets. Each tablet contains 200 mg of bupropion hydrochloride and the inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, magnesium stearate, and microcrystalline cellulose. The film-coating material contains FD&C Yellow No. 6, hypromellose type 2910/ 3cP, 6cP and 50cP, polyethylene glycol, polydextrose, titanium dioxide, and triacetin. This product meets USP Dissolution Test #3.</Description>
</NDC>
<NDC>
<NDCCode>0115-7037-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0115-7037-01) </PackageDescription>
<NDC11Code>00115-7037-01</NDC11Code>
<ProductNDC>0115-7037</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methitest</ProprietaryName>
<NonProprietaryName>Methyltestosterone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19741017</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA080767</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
<SubstanceName>METHYLTESTOSTERONE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Androgen Receptor Agonists [MoA], Androgen [EPC], Androstanes [CS]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-06-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19741017</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>1. Males. Androgens are indicated for replacement therapy in conditions associated with a deficiency or absence of endogenous testosterone: 1 Primary hypogonadism (congenita or acquired) — Testicular failure due to cryptohidism, bilateral torsion, orchitis, vanishing testis syndrome, or orchidectomy., 2 Hypogonadotropic hypogonadism (congenital or acquired) — Gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation. (Appropriate adrenal cortical and thyroid hormone replacement therapy are still necessary, however, and are actually of primary importance.) If the above conditions occur prior to puberty, androgen replacement therapy will be needed during the adolescent years for development of secondary sexual characteristics. Prolonged androgen treatment will be required to maintain sexual characteristics in these and other males who develop testosterone deficiency after puberty. .</IndicationAndUsage>
<Description>METHITEST (methyltestosterone) tablets, USP contain methyltestosterone USP, a synthetic androgen. Androgens are steroids that develop and maintain primary and secondary male sex characteristics. METHITEST (methyltestosterone) tablets, USP are to be taken orally. Androgens are derivatives of cyclopentanoperhydrophenanthrena. Endogenous androgens are C-19 steroids with a side chain at C-17, and with two angular methyl groups. Testosterone is the primary endogenous androgen. In their active form, all drugs in the class have a 17-beta-hydroxy group. 17-alpha alkylation (methyltestosterone) increases the pharmacologic activity per unit weight compared to testosterone when given orally. Methyltestosterone is the 17α-methyl derivative of testosterone, the true testicular hormone. Chemically, methyltestosterone is 17b-hydroxy-17-methylandrost-4-en-3-one, with the empirical formula C20H30O2, a molecular weight of 302.5, and the following structural formula. C20H30O2 M.W. 302.46 (CAS-58-18-4) 17 β-Hydroxy-17-methylandrost-4-en-3-one. Methyltestosterone, USP is a white to creamy-white, odorless, slightly hydroscopic powder. It is practically insoluble in water, and is soluble in alcohol and other organic solvents. METHITEST (methyltestosterone) tablets, USP contain methyltestosterone, USP and acacia, lactose monohydrate, confectioner’s sugar, corn starch, powdered cellulose, sodium lauryl sulfate, magnesium stearate, pregelatinized starch, and guar gum.</Description>
</NDC>
<NDC>
<NDCCode>0430-0115-20</NDCCode>
<PackageDescription>48 BOTTLE in 1 CASE (0430-0115-20) > 60 TABLET, DELAYED RELEASE in 1 BOTTLE</PackageDescription>
<NDC11Code>00430-0115-20</NDC11Code>
<ProductNDC>0430-0115</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doryx</ProprietaryName>
<NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110921</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050795</ApplicationNumber>
<LabelerName>Warner Chilcott (US), LLC</LabelerName>
<SubstanceName>DOXYCYCLINE HYCLATE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2015-12-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>10356-115-10</NDCCode>
<PackageDescription>99 g in 1 TUBE (10356-115-10) </PackageDescription>
<NDC11Code>10356-0115-10</NDC11Code>
<ProductNDC>10356-115</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aquaphor Healing Fast Relief Diaper Rash</ProprietaryName>
<NonProprietaryName>Zinc Oxide</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170331</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Beiersdorf Inc</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170331</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses helps treat and prevent diaper rash protects chafed skin associated with diaper rash and helps protect from wetness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10356-115-29</NDCCode>
<PackageDescription>4 g in 1 TUBE (10356-115-29) </PackageDescription>
<NDC11Code>10356-0115-29</NDC11Code>
<ProductNDC>10356-115</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aquaphor Healing Fast Relief Diaper Rash</ProprietaryName>
<NonProprietaryName>Zinc Oxide</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170331</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Beiersdorf Inc</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170331</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses helps treat and prevent diaper rash protects chafed skin associated with diaper rash and helps protect from wetness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>24510-115-10</NDCCode>
<PackageDescription>100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (24510-115-10) </PackageDescription>
<NDC11Code>24510-0115-10</NDC11Code>
<ProductNDC>24510-115</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Xtampza</ProprietaryName>
<ProprietaryNameSuffix>Er</ProprietaryNameSuffix>
<NonProprietaryName>Oxycodone</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160510</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208090</ApplicationNumber>
<LabelerName>Collegium Pharmaceutical, Inc.</LabelerName>
<SubstanceName>OXYCODONE</SubstanceName>
<StrengthNumber>13.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-01-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160510</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>XTAMPZA ER is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids.</IndicationAndUsage>
<Description>XTAMPZA ER (oxycodone) extended-release capsules are an opioid agonist for oral use. The capsules contain microspheres formulated with oxycodone base and are supplied in strengths of 9 mg (equivalent to 10 mg oxycodone HCl), 13.5 mg (equivalent to 15 mg oxycodone HCl), 18 mg (equivalent to 20 mg oxycodone HCl), 27 mg (equivalent to 30 mg oxycodone HCl), and 36 mg (equivalent to 40 mg oxycodone HCl) capsules. The capsule strengths describe the amount of oxycodone base per capsule. The structural formula for oxycodone is as follows. C18H21NO4 MW 315.37 g/mol. The chemical name is 4,5 α-Epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one. Oxycodone base is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone is present as myristate salt in the XTAMPZA ER formulation. Each XTAMPZA ER capsule contains either 9, 13.5, 18, 27, or 36 mg of oxycodone (equivalent to 10, 15, 20, 30, or 40 mg of oxycodone HCl, respectively) and the following inactive ingredients: myristic acid, yellow beeswax, carnauba wax, stearoyl polyoxyl-32 glycerides, magnesium stearate, and colloidal silicon dioxide. The capsule shells collectively contain titanium dioxide, hypromellose, and water. Additionally, the 9 mg and 18 mg strength capsule shells contain yellow iron oxide, the 13.5 and 36 mg strength capsule shells contain red iron oxide, and the 27 mg strength capsule shells contain black iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>24510-115-20</NDCCode>
<PackageDescription>20 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (24510-115-20) </PackageDescription>
<NDC11Code>24510-0115-20</NDC11Code>
<ProductNDC>24510-115</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Xtampza</ProprietaryName>
<ProprietaryNameSuffix>Er</ProprietaryNameSuffix>
<NonProprietaryName>Oxycodone</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160510</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208090</ApplicationNumber>
<LabelerName>Collegium Pharmaceutical, Inc.</LabelerName>
<SubstanceName>OXYCODONE</SubstanceName>
<StrengthNumber>13.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Full Opioid Agonists [MoA], Opioid Agonist [EPC]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-01-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160510</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>XTAMPZA ER is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids.</IndicationAndUsage>
<Description>XTAMPZA ER (oxycodone) extended-release capsules are an opioid agonist for oral use. The capsules contain microspheres formulated with oxycodone base and are supplied in strengths of 9 mg (equivalent to 10 mg oxycodone HCl), 13.5 mg (equivalent to 15 mg oxycodone HCl), 18 mg (equivalent to 20 mg oxycodone HCl), 27 mg (equivalent to 30 mg oxycodone HCl), and 36 mg (equivalent to 40 mg oxycodone HCl) capsules. The capsule strengths describe the amount of oxycodone base per capsule. The structural formula for oxycodone is as follows. C18H21NO4 MW 315.37 g/mol. The chemical name is 4,5 α-Epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one. Oxycodone base is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone is present as myristate salt in the XTAMPZA ER formulation. Each XTAMPZA ER capsule contains either 9, 13.5, 18, 27, or 36 mg of oxycodone (equivalent to 10, 15, 20, 30, or 40 mg of oxycodone HCl, respectively) and the following inactive ingredients: myristic acid, yellow beeswax, carnauba wax, stearoyl polyoxyl-32 glycerides, magnesium stearate, and colloidal silicon dioxide. The capsule shells collectively contain titanium dioxide, hypromellose, and water. Additionally, the 9 mg and 18 mg strength capsule shells contain yellow iron oxide, the 13.5 and 36 mg strength capsule shells contain red iron oxide, and the 27 mg strength capsule shells contain black iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>25000-115-03</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (25000-115-03)</PackageDescription>
<NDC11Code>25000-0115-03</NDC11Code>
<ProductNDC>25000-115</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120704</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091237</ApplicationNumber>
<LabelerName>MARKSANS PHARMA LIMITED</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2015-11-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>25000-115-14</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (25000-115-14)</PackageDescription>
<NDC11Code>25000-0115-14</NDC11Code>
<ProductNDC>25000-115</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120704</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091237</ApplicationNumber>
<LabelerName>MARKSANS PHARMA LIMITED</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2015-11-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>25000-115-30</NDCCode>
<PackageDescription>6 BAG in 1 BOX (25000-115-30) > 6500 TABLET in 1 BAG</PackageDescription>
<NDC11Code>25000-0115-30</NDC11Code>
<ProductNDC>25000-115</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120704</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091237</ApplicationNumber>
<LabelerName>MARKSANS PHARMA LIMITED</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2015-11-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>48087-0115-0</NDCCode>
<PackageDescription>50 kg in 1 DRUM (48087-0115-0) </PackageDescription>
<NDC11Code>48087-0115-00</NDC11Code>
<ProductNDC>48087-0115</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Oxcarbazepine</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20150418</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>F.I.S. FABBRICA ITALIANA SINTETICI S.P.A.</LabelerName>
<SubstanceName>OXCARBAZEPINE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2021-12-08</LastUpdate>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>18-APR-15</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>49781-115-15</NDCCode>
<PackageDescription>15 g in 1 BOTTLE, WITH APPLICATOR (49781-115-15)</PackageDescription>
<NDC11Code>49781-0115-15</NDC11Code>
<ProductNDC>49781-115</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Salicylic Acid</ProprietaryName>
<NonProprietaryName>Liquid Wart Remover</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20011001</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part358F</ApplicationNumber>
<LabelerName>Cardinal Health</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>.17</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2015-11-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>51224-115-20</NDCCode>
<PackageDescription>20 BOTTLE in 1 CARTON (51224-115-20) > 50 mL in 1 BOTTLE (51224-115-01) </PackageDescription>
<NDC11Code>51224-0115-20</NDC11Code>
<ProductNDC>51224-115</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dexmedetomidine Hydrochloride In Sodium Chloride</ProprietaryName>
<NonProprietaryName>Dexmedetomidine Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20201123</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA212857</ApplicationNumber>
<LabelerName>TAGI Pharma, Inc.</LabelerName>
<SubstanceName>DEXMEDETOMIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>ug/mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-12-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201123</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>57844-115-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (57844-115-01) </PackageDescription>
<NDC11Code>57844-0115-01</NDC11Code>
<ProductNDC>57844-115</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Adderall</ProprietaryName>
<NonProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, And Amphetamine Sulfate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140630</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040422</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE</SubstanceName>
<StrengthNumber>3.75; 3.75; 3.75; 3.75</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-06-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140630</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adderall® (Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets (Mixed salts of a single entity amphetamine product)) is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy.</IndicationAndUsage>
<Description>A single-entity amphetamine product combining the neutral sulfate salts of dextroamphetamine and amphetamine, with the dextro isomer of amphetamine saccharate and d, l-amphetamine aspartate. Inactive Ingredients: colloidal silicon dioxide, compressible sugar (sucrose and maltodextrin), corn starch, magnesium stearate, microcrystalline cellulose and saccharin sodium. Colors: Adderall® 5 mg is a white to off-white tablet, which contains no color additives. Adderall ® 7.5 mg and 10 mg contain FD&C Blue #1 Aluminum Lake as a color additive. Adderall ® 12.5 mg, 15 mg, 20 mg and 30 mg contain FD&C Yellow #6 Aluminum Lake as a color additive.</Description>
</NDC>
<NDC>
<NDCCode>58103-115-50</NDCCode>
<PackageDescription>50 kg in 1 DRUM (58103-115-50) </PackageDescription>
<NDC11Code>58103-0115-50</NDC11Code>
<ProductNDC>58103-115</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20180905</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>SPI Pharma, Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>92</StrengthNumber>
<StrengthUnit>kg/100kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2023-01-24</LastUpdate>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>05-SEP-18</StartMarketingDatePackage>
</NDC>
</NDCList>