{
"NDC": [
{
"NDCCode": "51642-273-65",
"PackageDescription": "99 g in 1 CARTON (51642-273-65) ",
"NDC11Code": "51642-0273-65",
"ProductNDC": "51642-273",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Eczema Nourish Medicated Cleansing Bar",
"NonProprietaryName": "Colloidal Oatmeal Skin Protectant",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260707",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Vanguard Soap, LLC",
"SubstanceName": "OATMEAL",
"StrengthNumber": "1",
"StrengthUnit": "g/100g",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]",
"Status": "Active",
"LastUpdate": "2026-07-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260707",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieves itching and irritation from eczema, psoriasis, rashes, and minor skin irritations."
},
{
"NDCCode": "35000-273-65",
"PackageDescription": "2 TUBE in 1 CARTON (35000-273-65) / 144 g in 1 TUBE",
"NDC11Code": "35000-0273-65",
"ProductNDC": "35000-273",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Colgate Total Sf Fresh Mint Stripe",
"NonProprietaryName": "Stannous Fluoride",
"DosageFormName": "PASTE, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20241018",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M021",
"LabelerName": "COLGATE PALMOLIVE COMPANY",
"SubstanceName": "STANNOUS FLUORIDE",
"StrengthNumber": "1.1",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2026-06-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241018",
"SamplePackage": "N",
"IndicationAndUsage": "aids in the prevention of cavities. helps prevent gingivitis. helps interfere with harmful effects of plaque associated with gingivitis. builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact."
},
{
"NDCCode": "51048-027-08",
"PackageDescription": "273 mL in 1 BOTTLE, PLASTIC (51048-027-08) ",
"NDC11Code": "51048-0027-08",
"ProductNDC": "51048-027",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dop Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20090309",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Omega & Delta Co",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "65",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20200406",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: For handwashing to decrease bacteria on the skin."
},
{
"NDCCode": "51642-074-42",
"PackageDescription": "99 g in 1 CARTON (51642-074-42) ",
"NDC11Code": "51642-0074-42",
"ProductNDC": "51642-074",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Eczenourish Eczema And Psoriasis Soothing Oat",
"NonProprietaryName": "Colloidal Oatmeal",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260801",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Vanguard Soap, LLC",
"SubstanceName": "OATMEAL",
"StrengthNumber": "1",
"StrengthUnit": "g/100g",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]",
"Status": "Active",
"LastUpdate": "2026-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260801",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily protects and helps relieve minor skin irritation and itching due to: rashes, eczema, poison ivy, poison oak, poison sumac, and insect bites."
},
{
"NDCCode": "51642-881-74",
"PackageDescription": "99 g in 1 CARTON (51642-881-74) ",
"NDC11Code": "51642-0881-74",
"ProductNDC": "51642-881",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Eczema Nourish Medicated Cleansing Bar",
"NonProprietaryName": "Colloidal Oatmeal Skin Protectant Soap",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260707",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Vanguard Soap, LLC",
"SubstanceName": "OATMEAL",
"StrengthNumber": "1",
"StrengthUnit": "g/100g",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260707",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieves itching and irritation from eczema, psoriasis, rashes, and minor skin irritations."
},
{
"NDCCode": "0093-3090-56",
"PackageDescription": "30 TABLET in 1 BOTTLE (0093-3090-56) ",
"NDC11Code": "00093-3090-56",
"ProductNDC": "0093-3090",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Armodafinil",
"NonProprietaryName": "Armodafinil",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20161129",
"EndMarketingDate": "20270930",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021875",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "ARMODAFINIL",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20161129",
"EndMarketingDatePackage": "20270930",
"SamplePackage": "N",
"IndicationAndUsage": "Armodafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD). Limitations of Use. In OSA, armodafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating armodafinil tablets for excessive sleepiness.",
"Description": "Armodafinil is a wakefulness‑promoting agent for oral administration. Armodafinil is the R-enantiomer of modafinil which is a 1:1 mixture of the R- and S-enantiomers. The chemical name for armodafinil is 2‑[(R)-(diphenylmethyl)sulfinyl]acetamide. The molecular formula is C15H15NO2S and the molecular weight is 273.35. The chemical structure is. Armodafinil is a white to off-white, crystalline powder that is slightly soluble in water, sparingly soluble in acetone, and soluble in methanol. Armodafinil tablets contain 50, 150, 200 or 250 mg of armodafinil and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinized starch."
},
{
"NDCCode": "0093-3092-56",
"PackageDescription": "30 TABLET in 1 BOTTLE (0093-3092-56) ",
"NDC11Code": "00093-3092-56",
"ProductNDC": "0093-3092",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Armodafinil",
"NonProprietaryName": "Armodafinil",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20161129",
"EndMarketingDate": "20270831",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021875",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "ARMODAFINIL",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20161129",
"EndMarketingDatePackage": "20270831",
"SamplePackage": "N",
"IndicationAndUsage": "Armodafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD). Limitations of Use. In OSA, armodafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating armodafinil tablets for excessive sleepiness.",
"Description": "Armodafinil is a wakefulness‑promoting agent for oral administration. Armodafinil is the R-enantiomer of modafinil which is a 1:1 mixture of the R- and S-enantiomers. The chemical name for armodafinil is 2‑[(R)-(diphenylmethyl)sulfinyl]acetamide. The molecular formula is C15H15NO2S and the molecular weight is 273.35. The chemical structure is. Armodafinil is a white to off-white, crystalline powder that is slightly soluble in water, sparingly soluble in acetone, and soluble in methanol. Armodafinil tablets contain 50, 150, 200 or 250 mg of armodafinil and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinized starch."
},
{
"NDCCode": "0093-3093-56",
"PackageDescription": "30 TABLET in 1 BOTTLE (0093-3093-56) ",
"NDC11Code": "00093-3093-56",
"ProductNDC": "0093-3093",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Armodafinil",
"NonProprietaryName": "Armodafinil",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20161129",
"EndMarketingDate": "20260630",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021875",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "ARMODAFINIL",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Deprecated",
"LastUpdate": "2026-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20161129",
"EndMarketingDatePackage": "20260630",
"SamplePackage": "N",
"IndicationAndUsage": "Armodafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD). Limitations of Use. In OSA, armodafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating armodafinil tablets for excessive sleepiness.",
"Description": "Armodafinil is a wakefulness‑promoting agent for oral administration. Armodafinil is the R-enantiomer of modafinil which is a 1:1 mixture of the R- and S-enantiomers. The chemical name for armodafinil is 2‑[(R)-(diphenylmethyl)sulfinyl]acetamide. The molecular formula is C15H15NO2S and the molecular weight is 273.35. The chemical structure is. Armodafinil is a white to off-white, crystalline powder that is slightly soluble in water, sparingly soluble in acetone, and soluble in methanol. Armodafinil tablets contain 50, 150, 200 or 250 mg of armodafinil and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinized starch."
},
{
"NDCCode": "0093-3094-56",
"PackageDescription": "30 TABLET in 1 BOTTLE (0093-3094-56) ",
"NDC11Code": "00093-3094-56",
"ProductNDC": "0093-3094",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Armodafinil",
"NonProprietaryName": "Armodafinil",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20161129",
"EndMarketingDate": "20280531",
"MarketingCategoryName": "NDA AUTHORIZED GENERIC",
"ApplicationNumber": "NDA021875",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "ARMODAFINIL",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2025-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20161129",
"EndMarketingDatePackage": "20280531",
"SamplePackage": "N",
"IndicationAndUsage": "Armodafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD). Limitations of Use. In OSA, armodafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating armodafinil tablets for excessive sleepiness.",
"Description": "Armodafinil is a wakefulness‑promoting agent for oral administration. Armodafinil is the R-enantiomer of modafinil which is a 1:1 mixture of the R- and S-enantiomers. The chemical name for armodafinil is 2‑[(R)-(diphenylmethyl)sulfinyl]acetamide. The molecular formula is C15H15NO2S and the molecular weight is 273.35. The chemical structure is. Armodafinil is a white to off-white, crystalline powder that is slightly soluble in water, sparingly soluble in acetone, and soluble in methanol. Armodafinil tablets contain 50, 150, 200 or 250 mg of armodafinil and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinized starch."
},
{
"NDCCode": "0187-0938-01",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (0187-0938-01) ",
"NDC11Code": "00187-0938-01",
"ProductNDC": "0187-0938",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tasmar",
"NonProprietaryName": "Tolcapone",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20040727",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020697",
"LabelerName": "Bausch Health US LLC",
"SubstanceName": "TOLCAPONE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Catechol O-Methyltransferase Inhibitors [MoA], Catechol-O-Methyltransferase Inhibitor [EPC]",
"Status": "Active",
"LastUpdate": "2021-01-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20040727",
"SamplePackage": "N",
"IndicationAndUsage": "TASMAR is indicated as an adjunct to levodopa and carbidopa for the treatment of the signs and symptoms of idiopathic Parkinson's disease. Because of the risk of potentially fatal, acute fulminant liver failure, TASMAR (tolcapone) should ordinarily be used in patients with Parkinson's disease on l-dopa/carbidopa who are experiencing symptom fluctuations and are not responding satisfactorily to or are not appropriate candidates for other adjunctive therapies. Because of the risk of liver injury and because TASMAR, when it is effective, provides an observable symptomatic benefit, the patient who fails to show substantial clinical benefit within 3 weeks of initiation of treatment, should be withdrawn from TASMAR. The effectiveness of TASMAR was demonstrated in randomized controlled trials in patients receiving concomitant levodopa therapy with carbidopa or another aromatic amino acid decarboxylase inhibitor who experienced end of dose wearing-off phenomena as well as in patients who did not experience such phenomena (see CLINICAL PHARMACOLOGY: Clinical Studies).",
"Description": "TASMAR is available as tablets containing 100 mg tolcapone. Tolcapone, an inhibitor of catechol-O-methyltransferase (COMT), is used in the treatment of Parkinson's disease as an adjunct to levodopa/carbidopa therapy. It is a yellow, odorless, non-hygroscopic, crystalline compound with a relative molecular mass of 273.25. The chemical name of tolcapone is 3,4-dihydroxy-4'-methyl-5-nitrobenzophenone. Its empirical formula is C14H11NO5 and its structural formula is. Inactive ingredients: Core: microcrystalline cellulose, lactose monohydrate, anhydrous dibasic calcium phosphate, sodium starch glycolate, povidone, talc, magnesium stearate, and purified water. Film Coating: hypromellose, titanium dioxide, talc, ethylcellulose, triacetin, sodium lauryl sulfate, yellow iron oxide, red iron oxide, and purified water."
},
{
"NDCCode": "0264-7389-60",
"PackageDescription": "4 CONTAINER in 1 CASE (0264-7389-60) > 3000 mL in 1 CONTAINER",
"NDC11Code": "00264-7389-60",
"ProductNDC": "0264-7389",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lactated Ringers Irrigation",
"NonProprietaryName": "Sodium Chloride, Sodium Lactate, Potassium Chloride And Calcium Chloride",
"DosageFormName": "SOLUTION",
"RouteName": "IRRIGATION",
"StartMarketingDate": "20140902",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018681",
"LabelerName": "B. Braun Medical Inc.",
"SubstanceName": "SODIUM CHLORIDE; SODIUM LACTATE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE",
"StrengthNumber": "600; 310; 30; 20",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
"Status": "Active",
"LastUpdate": "2021-08-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140902",
"SamplePackage": "N",
"IndicationAndUsage": "Lactated Ringer’s Irrigation is indicated for all general irrigation, washing and rinsing purposes which permit use of a sterile, nonpyrogenic electrolyte solution.",
"Description": "Lactated Ringer’s Irrigation is a sterile, nonpyrogenic solution of electrolytes in water for injection intended only for sterile irrigation, washing and rinsing purposes. The composition is based on a modification of the injectable formula originally known as Hartmann’s Solution. Each 100 mL of Lactated Ringer’s Irrigation contains: Sodium chloride 600 mg; sodium lactate, anhydrous 310 mg; potassium chloride 30 mg; calcium chloride, dihydrate 20 mg. The pH is 6.75 (6.0 — 7.5). The solution is isotonic (273 mOsmol/liter, calc.) and has the following electrolyte content (mEq/liter): Sodium (Na+) 130; potassium (K+) 4; calcium (Ca++) 3; chloride (Cl¯) 109 and lactate (CH3CH(OH)COO¯) 28. Contains sodium hydroxide and may contain hydrochloric acid for pH adjustment. The solution contains no bacteriostatic or antimicrobial agent or added buffer and is intended only for use as a single-dose or short procedure irrigation. When smaller volumes are required, the unused portion should be discarded. Lactated Ringer’s Irrigation may be classified as a sterile irrigant, wash, rinse and pharmaceutical vehicle. Calcium Chloride, USP is chemically designated calcium chloride, dihydrate (CaCl2 2H2O), white fragments or granules freely soluble in water. Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Sodium Lactate, USP is chemically designated C3H5NaO3, a 60% aqueous solution miscible in water. It has the following structural formula. Water for Injection, USP is chemically designated H2O. The plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary. Not made with natural rubber latex, PVC or DEHP."
},
{
"NDCCode": "0338-0114-04",
"PackageDescription": "12 BOTTLE, PLASTIC in 1 CARTON (0338-0114-04) / 1000 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "00338-0114-04",
"ProductNDC": "0338-0114",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lactated Ringers",
"NonProprietaryName": "Sodium Chloride, Sodium Lactate, Potassium Chloride, Calcium Chloride",
"DosageFormName": "IRRIGANT",
"RouteName": "IRRIGATION",
"StartMarketingDate": "19820219",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018494",
"LabelerName": "Baxter Healthcare Corporation",
"SubstanceName": "SODIUM CHLORIDE; SODIUM LACTATE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE",
"StrengthNumber": "600; 310; 30; 20",
"StrengthUnit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL",
"Pharm_Classes": "Acidifying Activity [MoA], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19820219",
"SamplePackage": "N",
"IndicationAndUsage": "Isotonic solution for irrigation only. Not for injection.",
"Description": "Lactated Ringer’s Irrigation. Each 100 mL contains: 600 mg Sodium Chloride, USP, 310 mg Sodium Lactate, 30 mg Potassium Chloride, USP, 20 mg Calcium Chloride, USP. No antimicrobial agent has been added. pH 6.5 (6.0 to 7.5). Osmolarity 273 mOsmol/L (calc.). Sterile, nonpyrogenic. Pour Bottle."
},
{
"NDCCode": "0338-0137-27",
"PackageDescription": "3000 mL in 1 BAG (0338-0137-27) ",
"NDC11Code": "00338-0137-27",
"ProductNDC": "0338-0137",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lactated Ringers",
"NonProprietaryName": "Sodium Chloride, Soldium Lactate, Potassium Chloride And Calcium Chloride",
"DosageFormName": "IRRIGANT",
"RouteName": "IRRIGATION",
"StartMarketingDate": "19840403",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018921",
"LabelerName": "Baxter Healthcare Company",
"SubstanceName": "SODIUM CHLORIDE; SODIUM LACTATE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE",
"StrengthNumber": "6; 3.1; 300; 200",
"StrengthUnit": "g/1000mL; g/1000mL; mg/1000mL; mg/1000mL",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19840403",
"SamplePackage": "N",
"IndicationAndUsage": "Lactated Ringer’s Irrigation is indicated for use as an arthroscopic irrigating fluid with endoscopic instruments during arthroscopic procedures requiring distension and irrigation of the knee, shoulder, elbow, or other bone joints.",
"Description": "Lactated Ringer’s Irrigation is a sterile, nonpyrogenic, isotonic solution in a single dose ARTHROMATIC plastic container for use as an arthroscopic irrigating solution. Each liter contains 6.0 g Sodium Chloride, USP, (NaCl), 3.1 g Sodium Lactate (C3H5NaO3), 300 mg Potassium Chloride, USP, (KCl), and 200 mg Calcium Chloride, USP, (CaCl22H2O). pH 6.5 (6.0 to 7.5). Milliequivalents per liter: Sodium - 130, Potassium - 4, Calcium - 3, Chloride - 109, Lactate - 28. Osmolarity 273 mOsmol/L (calc.). No antimicrobial agent has been added. The ARTHROMATIC plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexylphthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies."
},
{
"NDCCode": "0338-0137-29",
"PackageDescription": "5000 mL in 1 BAG (0338-0137-29) ",
"NDC11Code": "00338-0137-29",
"ProductNDC": "0338-0137",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lactated Ringers",
"NonProprietaryName": "Sodium Chloride, Soldium Lactate, Potassium Chloride And Calcium Chloride",
"DosageFormName": "IRRIGANT",
"RouteName": "IRRIGATION",
"StartMarketingDate": "19840403",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018921",
"LabelerName": "Baxter Healthcare Company",
"SubstanceName": "SODIUM CHLORIDE; SODIUM LACTATE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE",
"StrengthNumber": "6; 3.1; 300; 200",
"StrengthUnit": "g/1000mL; g/1000mL; mg/1000mL; mg/1000mL",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19840403",
"SamplePackage": "N",
"IndicationAndUsage": "Lactated Ringer’s Irrigation is indicated for use as an arthroscopic irrigating fluid with endoscopic instruments during arthroscopic procedures requiring distension and irrigation of the knee, shoulder, elbow, or other bone joints.",
"Description": "Lactated Ringer’s Irrigation is a sterile, nonpyrogenic, isotonic solution in a single dose ARTHROMATIC plastic container for use as an arthroscopic irrigating solution. Each liter contains 6.0 g Sodium Chloride, USP, (NaCl), 3.1 g Sodium Lactate (C3H5NaO3), 300 mg Potassium Chloride, USP, (KCl), and 200 mg Calcium Chloride, USP, (CaCl22H2O). pH 6.5 (6.0 to 7.5). Milliequivalents per liter: Sodium - 130, Potassium - 4, Calcium - 3, Chloride - 109, Lactate - 28. Osmolarity 273 mOsmol/L (calc.). No antimicrobial agent has been added. The ARTHROMATIC plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexylphthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies."
},
{
"NDCCode": "0378-3431-93",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (0378-3431-93) ",
"NDC11Code": "00378-3431-93",
"ProductNDC": "0378-3431",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Armodafinil",
"NonProprietaryName": "Armodafinil",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200043",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "ARMODAFINIL",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2024-07-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160601",
"SamplePackage": "N",
"IndicationAndUsage": "Armodafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD). Limitations of Use. In OSA, armodafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating armodafinil tablets for excessive sleepiness.",
"Description": "Armodafinil tablets are a wakefulness-promoting agent for oral administration. Armodafinil is the R-enantiomer of modafinil which is a 1:1 mixture of the R- and S-enantiomers. The chemical name for armodafinil is R-(-)-2-[(Diphenylmethyl)sulfinyl]acetamide. The molecular formula is C15H15NO2S and the molecular weight is 273.35. The chemical structure is:. Armodafinil is a white to off-white powder that is slightly soluble in water, sparingly soluble in acetone, and soluble in methanol. Armodafinil tablets contain 50, 150, or 250 mg of armodafinil and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate and povidone."
},
{
"NDCCode": "0378-3432-93",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (0378-3432-93) ",
"NDC11Code": "00378-3432-93",
"ProductNDC": "0378-3432",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Armodafinil",
"NonProprietaryName": "Armodafinil",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200043",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "ARMODAFINIL",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2024-07-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160601",
"SamplePackage": "N",
"IndicationAndUsage": "Armodafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD). Limitations of Use. In OSA, armodafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating armodafinil tablets for excessive sleepiness.",
"Description": "Armodafinil tablets are a wakefulness-promoting agent for oral administration. Armodafinil is the R-enantiomer of modafinil which is a 1:1 mixture of the R- and S-enantiomers. The chemical name for armodafinil is R-(-)-2-[(Diphenylmethyl)sulfinyl]acetamide. The molecular formula is C15H15NO2S and the molecular weight is 273.35. The chemical structure is:. Armodafinil is a white to off-white powder that is slightly soluble in water, sparingly soluble in acetone, and soluble in methanol. Armodafinil tablets contain 50, 150, or 250 mg of armodafinil and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate and povidone."
},
{
"NDCCode": "0378-3433-93",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (0378-3433-93) ",
"NDC11Code": "00378-3433-93",
"ProductNDC": "0378-3433",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Armodafinil",
"NonProprietaryName": "Armodafinil",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA200043",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "ARMODAFINIL",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2024-07-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160601",
"SamplePackage": "N",
"IndicationAndUsage": "Armodafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD). Limitations of Use. In OSA, armodafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating armodafinil tablets for excessive sleepiness.",
"Description": "Armodafinil tablets are a wakefulness-promoting agent for oral administration. Armodafinil is the R-enantiomer of modafinil which is a 1:1 mixture of the R- and S-enantiomers. The chemical name for armodafinil is R-(-)-2-[(Diphenylmethyl)sulfinyl]acetamide. The molecular formula is C15H15NO2S and the molecular weight is 273.35. The chemical structure is:. Armodafinil is a white to off-white powder that is slightly soluble in water, sparingly soluble in acetone, and soluble in methanol. Armodafinil tablets contain 50, 150, or 250 mg of armodafinil and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate and povidone."
},
{
"NDCCode": "0480-2601-21",
"PackageDescription": "21 CAPSULE in 1 BOTTLE (0480-2601-21) ",
"NDC11Code": "00480-2601-21",
"ProductNDC": "0480-2601",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pomalidomide",
"NonProprietaryName": "Pomalidomide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20260302",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209956",
"LabelerName": "Teva Pharmaceuticals, Inc.",
"SubstanceName": "POMALIDOMIDE",
"StrengthNumber": "3",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Thalidomide Analog [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260302",
"SamplePackage": "N",
"IndicationAndUsage": "Pomalidomide is a thalidomide analogue indicated for the treatment of adult patients: 1 in combination with dexamethasone, for patients with multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy (1.1)., 2 with AIDS-related Kaposi sarcoma (KS) after failure of highly active antiretroviral therapy (HAART) or in patients with KS who are HIV-negative. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s) (1.2). .",
"Description": "Pomalidomide is a thalidomide analog. The chemical name is (RS)-4-Amino-2-(2,6-dioxo-piperidin-3-yl)-isoindoline-1,3-dione and it has the following chemical structure. The molecular formula for pomalidomide is C13H11N3O4 and the gram molecular weight is 273.24. Pomalidomide is a yellow crystalline powder. It has limited to low solubility into organic solvents and it has low solubility in all pH solutions (about 0.01 mg/mL). Pomalidomide has a chiral carbon atom which exists as a racemic mixture of the R(+) and S(-) enantiomers. Pomalidomide is available in 1 mg, 2 mg, 3 mg, and 4 mg capsules for oral administration. Each capsule contains pomalidomide as the active ingredient and the following inactive ingredients. 1 mg – black iron oxide, gelatin, mannitol, potassium hydroxide, pregelatinized starch (maize), propylene glycol, shellac, titanium dioxide, and yellow iron oxide. 2 mg – black iron oxide, gelatin, mannitol, potassium hydroxide, pregelatinized starch (maize), propylene glycol, red iron oxide, shellac, titanium dioxide, and yellow iron oxide. 3 mg – black iron oxide, FD&C Blue No. 1, gelatin, mannitol, potassium hydroxide, pregelatinized starch (maize), propylene glycol, shellac, titanium dioxide, and yellow iron oxide. 4 mg – black iron oxide, FD&C Blue No. 1, FD&C Red No. 40, gelatin, mannitol, potassium hydroxide, pregelatinized starch (maize), propylene glycol, shellac, and titanium dioxide."
},
{
"NDCCode": "0480-4018-21",
"PackageDescription": "21 CAPSULE in 1 BOTTLE (0480-4018-21) ",
"NDC11Code": "00480-4018-21",
"ProductNDC": "0480-4018",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pomalidomide",
"NonProprietaryName": "Pomalidomide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20260302",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209956",
"LabelerName": "Teva Pharmaceuticals, Inc.",
"SubstanceName": "POMALIDOMIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Thalidomide Analog [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260302",
"SamplePackage": "N",
"IndicationAndUsage": "Pomalidomide is a thalidomide analogue indicated for the treatment of adult patients: 1 in combination with dexamethasone, for patients with multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy (1.1)., 2 with AIDS-related Kaposi sarcoma (KS) after failure of highly active antiretroviral therapy (HAART) or in patients with KS who are HIV-negative. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s) (1.2). .",
"Description": "Pomalidomide is a thalidomide analog. The chemical name is (RS)-4-Amino-2-(2,6-dioxo-piperidin-3-yl)-isoindoline-1,3-dione and it has the following chemical structure. The molecular formula for pomalidomide is C13H11N3O4 and the gram molecular weight is 273.24. Pomalidomide is a yellow crystalline powder. It has limited to low solubility into organic solvents and it has low solubility in all pH solutions (about 0.01 mg/mL). Pomalidomide has a chiral carbon atom which exists as a racemic mixture of the R(+) and S(-) enantiomers. Pomalidomide is available in 1 mg, 2 mg, 3 mg, and 4 mg capsules for oral administration. Each capsule contains pomalidomide as the active ingredient and the following inactive ingredients. 1 mg – black iron oxide, gelatin, mannitol, potassium hydroxide, pregelatinized starch (maize), propylene glycol, shellac, titanium dioxide, and yellow iron oxide. 2 mg – black iron oxide, gelatin, mannitol, potassium hydroxide, pregelatinized starch (maize), propylene glycol, red iron oxide, shellac, titanium dioxide, and yellow iron oxide. 3 mg – black iron oxide, FD&C Blue No. 1, gelatin, mannitol, potassium hydroxide, pregelatinized starch (maize), propylene glycol, shellac, titanium dioxide, and yellow iron oxide. 4 mg – black iron oxide, FD&C Blue No. 1, FD&C Red No. 40, gelatin, mannitol, potassium hydroxide, pregelatinized starch (maize), propylene glycol, shellac, and titanium dioxide."
},
{
"NDCCode": "0480-4022-21",
"PackageDescription": "21 CAPSULE in 1 BOTTLE (0480-4022-21) ",
"NDC11Code": "00480-4022-21",
"ProductNDC": "0480-4022",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pomalidomide",
"NonProprietaryName": "Pomalidomide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20260302",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209956",
"LabelerName": "Teva Pharmaceuticals, Inc.",
"SubstanceName": "POMALIDOMIDE",
"StrengthNumber": "2",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Thalidomide Analog [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260302",
"SamplePackage": "N",
"IndicationAndUsage": "Pomalidomide is a thalidomide analogue indicated for the treatment of adult patients: 1 in combination with dexamethasone, for patients with multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy (1.1)., 2 with AIDS-related Kaposi sarcoma (KS) after failure of highly active antiretroviral therapy (HAART) or in patients with KS who are HIV-negative. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s) (1.2). .",
"Description": "Pomalidomide is a thalidomide analog. The chemical name is (RS)-4-Amino-2-(2,6-dioxo-piperidin-3-yl)-isoindoline-1,3-dione and it has the following chemical structure. The molecular formula for pomalidomide is C13H11N3O4 and the gram molecular weight is 273.24. Pomalidomide is a yellow crystalline powder. It has limited to low solubility into organic solvents and it has low solubility in all pH solutions (about 0.01 mg/mL). Pomalidomide has a chiral carbon atom which exists as a racemic mixture of the R(+) and S(-) enantiomers. Pomalidomide is available in 1 mg, 2 mg, 3 mg, and 4 mg capsules for oral administration. Each capsule contains pomalidomide as the active ingredient and the following inactive ingredients. 1 mg – black iron oxide, gelatin, mannitol, potassium hydroxide, pregelatinized starch (maize), propylene glycol, shellac, titanium dioxide, and yellow iron oxide. 2 mg – black iron oxide, gelatin, mannitol, potassium hydroxide, pregelatinized starch (maize), propylene glycol, red iron oxide, shellac, titanium dioxide, and yellow iron oxide. 3 mg – black iron oxide, FD&C Blue No. 1, gelatin, mannitol, potassium hydroxide, pregelatinized starch (maize), propylene glycol, shellac, titanium dioxide, and yellow iron oxide. 4 mg – black iron oxide, FD&C Blue No. 1, FD&C Red No. 40, gelatin, mannitol, potassium hydroxide, pregelatinized starch (maize), propylene glycol, shellac, and titanium dioxide."
},
{
"NDCCode": "0480-4035-21",
"PackageDescription": "21 CAPSULE in 1 BOTTLE (0480-4035-21) ",
"NDC11Code": "00480-4035-21",
"ProductNDC": "0480-4035",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pomalidomide",
"NonProprietaryName": "Pomalidomide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20260302",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209956",
"LabelerName": "Teva Pharmaceuticals, Inc.",
"SubstanceName": "POMALIDOMIDE",
"StrengthNumber": "4",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Thalidomide Analog [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260302",
"SamplePackage": "N",
"IndicationAndUsage": "Pomalidomide is a thalidomide analogue indicated for the treatment of adult patients: 1 in combination with dexamethasone, for patients with multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy (1.1)., 2 with AIDS-related Kaposi sarcoma (KS) after failure of highly active antiretroviral therapy (HAART) or in patients with KS who are HIV-negative. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s) (1.2). .",
"Description": "Pomalidomide is a thalidomide analog. The chemical name is (RS)-4-Amino-2-(2,6-dioxo-piperidin-3-yl)-isoindoline-1,3-dione and it has the following chemical structure. The molecular formula for pomalidomide is C13H11N3O4 and the gram molecular weight is 273.24. Pomalidomide is a yellow crystalline powder. It has limited to low solubility into organic solvents and it has low solubility in all pH solutions (about 0.01 mg/mL). Pomalidomide has a chiral carbon atom which exists as a racemic mixture of the R(+) and S(-) enantiomers. Pomalidomide is available in 1 mg, 2 mg, 3 mg, and 4 mg capsules for oral administration. Each capsule contains pomalidomide as the active ingredient and the following inactive ingredients. 1 mg – black iron oxide, gelatin, mannitol, potassium hydroxide, pregelatinized starch (maize), propylene glycol, shellac, titanium dioxide, and yellow iron oxide. 2 mg – black iron oxide, gelatin, mannitol, potassium hydroxide, pregelatinized starch (maize), propylene glycol, red iron oxide, shellac, titanium dioxide, and yellow iron oxide. 3 mg – black iron oxide, FD&C Blue No. 1, gelatin, mannitol, potassium hydroxide, pregelatinized starch (maize), propylene glycol, shellac, titanium dioxide, and yellow iron oxide. 4 mg – black iron oxide, FD&C Blue No. 1, FD&C Red No. 40, gelatin, mannitol, potassium hydroxide, pregelatinized starch (maize), propylene glycol, shellac, and titanium dioxide."
},
{
"NDCCode": "0781-2354-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (0781-2354-01) ",
"NDC11Code": "00781-2354-01",
"ProductNDC": "0781-2354",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pomalidomide",
"NonProprietaryName": "Pomalidomide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20260901",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA220741",
"LabelerName": "Sandoz Inc",
"SubstanceName": "POMALIDOMIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Thalidomide Analog [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-09-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260901",
"EndMarketingDatePackage": "20260901",
"SamplePackage": "N",
"IndicationAndUsage": "Pomalidomide capsules are a thalidomide analogue indicated for the treatment of adult patients: 1 in combination with dexamethasone, for patients with multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy (1.1).",
"Description": "Pomalidomide is a thalidomide analog. The chemical name is 4-Amino-2-(2,6-dioxo-3-piperidyl)isoindoline-1,3-dione and it has the following chemical structure. The molecular formula for pomalidomide is C13H11N3O4 and the gram molecular weight is 273.25. Pomalidomide is a light yellow to yellow colored powder. It is soluble in dimethyl sulfoxide and in dimethylformamide, insoluble in water. It has limited to low solubility into organic solvents, and it is insoluble in all pH solutions (about 0.10 mg/mL). Pomalidomide has a chiral carbon atom which exists as a racemic mixture of the R (+) and S (-) enantiomers. Pomalidomide capsules are available in 1-mg, 2-mg, 3-mg, and 4-mg capsules for oral administration. Each capsule contains pomalidomide as the active ingredient and the following inactive ingredients: anhydrous lactose, isomalt, and sodium stearyl fumarate. The 1-mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, iron oxide yellow, and white ink. The 2-mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, iron oxide yellow, iron oxide red, and white ink. The 3-mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, iron oxide yellow, and white ink. The 4-mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, and white ink."
},
{
"NDCCode": "0781-2354-27",
"PackageDescription": "21 CAPSULE in 1 BOTTLE (0781-2354-27) ",
"NDC11Code": "00781-2354-27",
"ProductNDC": "0781-2354",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pomalidomide",
"NonProprietaryName": "Pomalidomide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20260901",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA220741",
"LabelerName": "Sandoz Inc",
"SubstanceName": "POMALIDOMIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Thalidomide Analog [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260901",
"SamplePackage": "N",
"IndicationAndUsage": "Pomalidomide capsules are a thalidomide analogue indicated for the treatment of adult patients: 1 in combination with dexamethasone, for patients with multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy (1.1).",
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<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-09-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260707</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves itching and irritation from eczema, psoriasis, rashes, and minor skin irritations.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0093-3090-56</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (0093-3090-56) </PackageDescription>
<NDC11Code>00093-3090-56</NDC11Code>
<ProductNDC>0093-3090</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Armodafinil</ProprietaryName>
<NonProprietaryName>Armodafinil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161129</StartMarketingDate>
<EndMarketingDate>20270930</EndMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021875</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>ARMODAFINIL</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20161129</StartMarketingDatePackage>
<EndMarketingDatePackage>20270930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Armodafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD). Limitations of Use. In OSA, armodafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating armodafinil tablets for excessive sleepiness.</IndicationAndUsage>
<Description>Armodafinil is a wakefulness‑promoting agent for oral administration. Armodafinil is the R-enantiomer of modafinil which is a 1:1 mixture of the R- and S-enantiomers. The chemical name for armodafinil is 2‑[(R)-(diphenylmethyl)sulfinyl]acetamide. The molecular formula is C15H15NO2S and the molecular weight is 273.35. The chemical structure is. Armodafinil is a white to off-white, crystalline powder that is slightly soluble in water, sparingly soluble in acetone, and soluble in methanol. Armodafinil tablets contain 50, 150, 200 or 250 mg of armodafinil and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinized starch.</Description>
</NDC>
<NDC>
<NDCCode>0093-3092-56</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (0093-3092-56) </PackageDescription>
<NDC11Code>00093-3092-56</NDC11Code>
<ProductNDC>0093-3092</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Armodafinil</ProprietaryName>
<NonProprietaryName>Armodafinil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161129</StartMarketingDate>
<EndMarketingDate>20270831</EndMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021875</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>ARMODAFINIL</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20161129</StartMarketingDatePackage>
<EndMarketingDatePackage>20270831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Armodafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD). Limitations of Use. In OSA, armodafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating armodafinil tablets for excessive sleepiness.</IndicationAndUsage>
<Description>Armodafinil is a wakefulness‑promoting agent for oral administration. Armodafinil is the R-enantiomer of modafinil which is a 1:1 mixture of the R- and S-enantiomers. The chemical name for armodafinil is 2‑[(R)-(diphenylmethyl)sulfinyl]acetamide. The molecular formula is C15H15NO2S and the molecular weight is 273.35. The chemical structure is. Armodafinil is a white to off-white, crystalline powder that is slightly soluble in water, sparingly soluble in acetone, and soluble in methanol. Armodafinil tablets contain 50, 150, 200 or 250 mg of armodafinil and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinized starch.</Description>
</NDC>
<NDC>
<NDCCode>0093-3093-56</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (0093-3093-56) </PackageDescription>
<NDC11Code>00093-3093-56</NDC11Code>
<ProductNDC>0093-3093</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Armodafinil</ProprietaryName>
<NonProprietaryName>Armodafinil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161129</StartMarketingDate>
<EndMarketingDate>20260630</EndMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021875</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>ARMODAFINIL</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2026-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20161129</StartMarketingDatePackage>
<EndMarketingDatePackage>20260630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Armodafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD). Limitations of Use. In OSA, armodafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating armodafinil tablets for excessive sleepiness.</IndicationAndUsage>
<Description>Armodafinil is a wakefulness‑promoting agent for oral administration. Armodafinil is the R-enantiomer of modafinil which is a 1:1 mixture of the R- and S-enantiomers. The chemical name for armodafinil is 2‑[(R)-(diphenylmethyl)sulfinyl]acetamide. The molecular formula is C15H15NO2S and the molecular weight is 273.35. The chemical structure is. Armodafinil is a white to off-white, crystalline powder that is slightly soluble in water, sparingly soluble in acetone, and soluble in methanol. Armodafinil tablets contain 50, 150, 200 or 250 mg of armodafinil and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinized starch.</Description>
</NDC>
<NDC>
<NDCCode>0093-3094-56</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (0093-3094-56) </PackageDescription>
<NDC11Code>00093-3094-56</NDC11Code>
<ProductNDC>0093-3094</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Armodafinil</ProprietaryName>
<NonProprietaryName>Armodafinil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161129</StartMarketingDate>
<EndMarketingDate>20280531</EndMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021875</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>ARMODAFINIL</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20161129</StartMarketingDatePackage>
<EndMarketingDatePackage>20280531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Armodafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD). Limitations of Use. In OSA, armodafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating armodafinil tablets for excessive sleepiness.</IndicationAndUsage>
<Description>Armodafinil is a wakefulness‑promoting agent for oral administration. Armodafinil is the R-enantiomer of modafinil which is a 1:1 mixture of the R- and S-enantiomers. The chemical name for armodafinil is 2‑[(R)-(diphenylmethyl)sulfinyl]acetamide. The molecular formula is C15H15NO2S and the molecular weight is 273.35. The chemical structure is. Armodafinil is a white to off-white, crystalline powder that is slightly soluble in water, sparingly soluble in acetone, and soluble in methanol. Armodafinil tablets contain 50, 150, 200 or 250 mg of armodafinil and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinized starch.</Description>
</NDC>
<NDC>
<NDCCode>0187-0938-01</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (0187-0938-01) </PackageDescription>
<NDC11Code>00187-0938-01</NDC11Code>
<ProductNDC>0187-0938</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tasmar</ProprietaryName>
<NonProprietaryName>Tolcapone</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040727</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020697</ApplicationNumber>
<LabelerName>Bausch Health US LLC</LabelerName>
<SubstanceName>TOLCAPONE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Catechol O-Methyltransferase Inhibitors [MoA], Catechol-O-Methyltransferase Inhibitor [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-01-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20040727</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>TASMAR is indicated as an adjunct to levodopa and carbidopa for the treatment of the signs and symptoms of idiopathic Parkinson's disease. Because of the risk of potentially fatal, acute fulminant liver failure, TASMAR (tolcapone) should ordinarily be used in patients with Parkinson's disease on l-dopa/carbidopa who are experiencing symptom fluctuations and are not responding satisfactorily to or are not appropriate candidates for other adjunctive therapies. Because of the risk of liver injury and because TASMAR, when it is effective, provides an observable symptomatic benefit, the patient who fails to show substantial clinical benefit within 3 weeks of initiation of treatment, should be withdrawn from TASMAR. The effectiveness of TASMAR was demonstrated in randomized controlled trials in patients receiving concomitant levodopa therapy with carbidopa or another aromatic amino acid decarboxylase inhibitor who experienced end of dose wearing-off phenomena as well as in patients who did not experience such phenomena (see CLINICAL PHARMACOLOGY: Clinical Studies).</IndicationAndUsage>
<Description>TASMAR is available as tablets containing 100 mg tolcapone. Tolcapone, an inhibitor of catechol-O-methyltransferase (COMT), is used in the treatment of Parkinson's disease as an adjunct to levodopa/carbidopa therapy. It is a yellow, odorless, non-hygroscopic, crystalline compound with a relative molecular mass of 273.25. The chemical name of tolcapone is 3,4-dihydroxy-4'-methyl-5-nitrobenzophenone. Its empirical formula is C14H11NO5 and its structural formula is. Inactive ingredients: Core: microcrystalline cellulose, lactose monohydrate, anhydrous dibasic calcium phosphate, sodium starch glycolate, povidone, talc, magnesium stearate, and purified water. Film Coating: hypromellose, titanium dioxide, talc, ethylcellulose, triacetin, sodium lauryl sulfate, yellow iron oxide, red iron oxide, and purified water.</Description>
</NDC>
<NDC>
<NDCCode>0264-7389-60</NDCCode>
<PackageDescription>4 CONTAINER in 1 CASE (0264-7389-60) > 3000 mL in 1 CONTAINER</PackageDescription>
<NDC11Code>00264-7389-60</NDC11Code>
<ProductNDC>0264-7389</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lactated Ringers Irrigation</ProprietaryName>
<NonProprietaryName>Sodium Chloride, Sodium Lactate, Potassium Chloride And Calcium Chloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>IRRIGATION</RouteName>
<StartMarketingDate>20140902</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018681</ApplicationNumber>
<LabelerName>B. Braun Medical Inc.</LabelerName>
<SubstanceName>SODIUM CHLORIDE; SODIUM LACTATE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE</SubstanceName>
<StrengthNumber>600; 310; 30; 20</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2021-08-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140902</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lactated Ringer’s Irrigation is indicated for all general irrigation, washing and rinsing purposes which permit use of a sterile, nonpyrogenic electrolyte solution.</IndicationAndUsage>
<Description>Lactated Ringer’s Irrigation is a sterile, nonpyrogenic solution of electrolytes in water for injection intended only for sterile irrigation, washing and rinsing purposes. The composition is based on a modification of the injectable formula originally known as Hartmann’s Solution. Each 100 mL of Lactated Ringer’s Irrigation contains: Sodium chloride 600 mg; sodium lactate, anhydrous 310 mg; potassium chloride 30 mg; calcium chloride, dihydrate 20 mg. The pH is 6.75 (6.0 — 7.5). The solution is isotonic (273 mOsmol/liter, calc.) and has the following electrolyte content (mEq/liter): Sodium (Na+) 130; potassium (K+) 4; calcium (Ca++) 3; chloride (Cl¯) 109 and lactate (CH3CH(OH)COO¯) 28. Contains sodium hydroxide and may contain hydrochloric acid for pH adjustment. The solution contains no bacteriostatic or antimicrobial agent or added buffer and is intended only for use as a single-dose or short procedure irrigation. When smaller volumes are required, the unused portion should be discarded. Lactated Ringer’s Irrigation may be classified as a sterile irrigant, wash, rinse and pharmaceutical vehicle. Calcium Chloride, USP is chemically designated calcium chloride, dihydrate (CaCl2 2H2O), white fragments or granules freely soluble in water. Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Sodium Lactate, USP is chemically designated C3H5NaO3, a 60% aqueous solution miscible in water. It has the following structural formula. Water for Injection, USP is chemically designated H2O. The plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary. Not made with natural rubber latex, PVC or DEHP.</Description>
</NDC>
<NDC>
<NDCCode>0338-0114-04</NDCCode>
<PackageDescription>12 BOTTLE, PLASTIC in 1 CARTON (0338-0114-04) / 1000 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>00338-0114-04</NDC11Code>
<ProductNDC>0338-0114</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lactated Ringers</ProprietaryName>
<NonProprietaryName>Sodium Chloride, Sodium Lactate, Potassium Chloride, Calcium Chloride</NonProprietaryName>
<DosageFormName>IRRIGANT</DosageFormName>
<RouteName>IRRIGATION</RouteName>
<StartMarketingDate>19820219</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018494</ApplicationNumber>
<LabelerName>Baxter Healthcare Corporation</LabelerName>
<SubstanceName>SODIUM CHLORIDE; SODIUM LACTATE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE</SubstanceName>
<StrengthNumber>600; 310; 30; 20</StrengthNumber>
<StrengthUnit>mg/100mL; mg/100mL; mg/100mL; mg/100mL</StrengthUnit>
<Pharm_Classes>Acidifying Activity [MoA], Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19820219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Isotonic solution for irrigation only. Not for injection.</IndicationAndUsage>
<Description>Lactated Ringer’s Irrigation. Each 100 mL contains: 600 mg Sodium Chloride, USP, 310 mg Sodium Lactate, 30 mg Potassium Chloride, USP, 20 mg Calcium Chloride, USP. No antimicrobial agent has been added. pH 6.5 (6.0 to 7.5). Osmolarity 273 mOsmol/L (calc.). Sterile, nonpyrogenic. Pour Bottle.</Description>
</NDC>
<NDC>
<NDCCode>0338-0137-27</NDCCode>
<PackageDescription>3000 mL in 1 BAG (0338-0137-27) </PackageDescription>
<NDC11Code>00338-0137-27</NDC11Code>
<ProductNDC>0338-0137</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lactated Ringers</ProprietaryName>
<NonProprietaryName>Sodium Chloride, Soldium Lactate, Potassium Chloride And Calcium Chloride</NonProprietaryName>
<DosageFormName>IRRIGANT</DosageFormName>
<RouteName>IRRIGATION</RouteName>
<StartMarketingDate>19840403</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018921</ApplicationNumber>
<LabelerName>Baxter Healthcare Company</LabelerName>
<SubstanceName>SODIUM CHLORIDE; SODIUM LACTATE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE</SubstanceName>
<StrengthNumber>6; 3.1; 300; 200</StrengthNumber>
<StrengthUnit>g/1000mL; g/1000mL; mg/1000mL; mg/1000mL</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19840403</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lactated Ringer’s Irrigation is indicated for use as an arthroscopic irrigating fluid with endoscopic instruments during arthroscopic procedures requiring distension and irrigation of the knee, shoulder, elbow, or other bone joints.</IndicationAndUsage>
<Description>Lactated Ringer’s Irrigation is a sterile, nonpyrogenic, isotonic solution in a single dose ARTHROMATIC plastic container for use as an arthroscopic irrigating solution. Each liter contains 6.0 g Sodium Chloride, USP, (NaCl), 3.1 g Sodium Lactate (C3H5NaO3), 300 mg Potassium Chloride, USP, (KCl), and 200 mg Calcium Chloride, USP, (CaCl22H2O). pH 6.5 (6.0 to 7.5). Milliequivalents per liter: Sodium - 130, Potassium - 4, Calcium - 3, Chloride - 109, Lactate - 28. Osmolarity 273 mOsmol/L (calc.). No antimicrobial agent has been added. The ARTHROMATIC plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexylphthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.</Description>
</NDC>
<NDC>
<NDCCode>0338-0137-29</NDCCode>
<PackageDescription>5000 mL in 1 BAG (0338-0137-29) </PackageDescription>
<NDC11Code>00338-0137-29</NDC11Code>
<ProductNDC>0338-0137</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lactated Ringers</ProprietaryName>
<NonProprietaryName>Sodium Chloride, Soldium Lactate, Potassium Chloride And Calcium Chloride</NonProprietaryName>
<DosageFormName>IRRIGANT</DosageFormName>
<RouteName>IRRIGATION</RouteName>
<StartMarketingDate>19840403</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018921</ApplicationNumber>
<LabelerName>Baxter Healthcare Company</LabelerName>
<SubstanceName>SODIUM CHLORIDE; SODIUM LACTATE; POTASSIUM CHLORIDE; CALCIUM CHLORIDE</SubstanceName>
<StrengthNumber>6; 3.1; 300; 200</StrengthNumber>
<StrengthUnit>g/1000mL; g/1000mL; mg/1000mL; mg/1000mL</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19840403</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lactated Ringer’s Irrigation is indicated for use as an arthroscopic irrigating fluid with endoscopic instruments during arthroscopic procedures requiring distension and irrigation of the knee, shoulder, elbow, or other bone joints.</IndicationAndUsage>
<Description>Lactated Ringer’s Irrigation is a sterile, nonpyrogenic, isotonic solution in a single dose ARTHROMATIC plastic container for use as an arthroscopic irrigating solution. Each liter contains 6.0 g Sodium Chloride, USP, (NaCl), 3.1 g Sodium Lactate (C3H5NaO3), 300 mg Potassium Chloride, USP, (KCl), and 200 mg Calcium Chloride, USP, (CaCl22H2O). pH 6.5 (6.0 to 7.5). Milliequivalents per liter: Sodium - 130, Potassium - 4, Calcium - 3, Chloride - 109, Lactate - 28. Osmolarity 273 mOsmol/L (calc.). No antimicrobial agent has been added. The ARTHROMATIC plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexylphthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.</Description>
</NDC>
<NDC>
<NDCCode>0378-3431-93</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (0378-3431-93) </PackageDescription>
<NDC11Code>00378-3431-93</NDC11Code>
<ProductNDC>0378-3431</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Armodafinil</ProprietaryName>
<NonProprietaryName>Armodafinil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200043</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ARMODAFINIL</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-07-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Armodafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD). Limitations of Use. In OSA, armodafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating armodafinil tablets for excessive sleepiness.</IndicationAndUsage>
<Description>Armodafinil tablets are a wakefulness-promoting agent for oral administration. Armodafinil is the R-enantiomer of modafinil which is a 1:1 mixture of the R- and S-enantiomers. The chemical name for armodafinil is R-(-)-2-[(Diphenylmethyl)sulfinyl]acetamide. The molecular formula is C15H15NO2S and the molecular weight is 273.35. The chemical structure is:. Armodafinil is a white to off-white powder that is slightly soluble in water, sparingly soluble in acetone, and soluble in methanol. Armodafinil tablets contain 50, 150, or 250 mg of armodafinil and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate and povidone.</Description>
</NDC>
<NDC>
<NDCCode>0378-3432-93</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (0378-3432-93) </PackageDescription>
<NDC11Code>00378-3432-93</NDC11Code>
<ProductNDC>0378-3432</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Armodafinil</ProprietaryName>
<NonProprietaryName>Armodafinil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200043</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ARMODAFINIL</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-07-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Armodafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD). Limitations of Use. In OSA, armodafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating armodafinil tablets for excessive sleepiness.</IndicationAndUsage>
<Description>Armodafinil tablets are a wakefulness-promoting agent for oral administration. Armodafinil is the R-enantiomer of modafinil which is a 1:1 mixture of the R- and S-enantiomers. The chemical name for armodafinil is R-(-)-2-[(Diphenylmethyl)sulfinyl]acetamide. The molecular formula is C15H15NO2S and the molecular weight is 273.35. The chemical structure is:. Armodafinil is a white to off-white powder that is slightly soluble in water, sparingly soluble in acetone, and soluble in methanol. Armodafinil tablets contain 50, 150, or 250 mg of armodafinil and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate and povidone.</Description>
</NDC>
<NDC>
<NDCCode>0378-3433-93</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (0378-3433-93) </PackageDescription>
<NDC11Code>00378-3433-93</NDC11Code>
<ProductNDC>0378-3433</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Armodafinil</ProprietaryName>
<NonProprietaryName>Armodafinil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA200043</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ARMODAFINIL</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2024-07-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Armodafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD). Limitations of Use. In OSA, armodafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating armodafinil tablets for excessive sleepiness.</IndicationAndUsage>
<Description>Armodafinil tablets are a wakefulness-promoting agent for oral administration. Armodafinil is the R-enantiomer of modafinil which is a 1:1 mixture of the R- and S-enantiomers. The chemical name for armodafinil is R-(-)-2-[(Diphenylmethyl)sulfinyl]acetamide. The molecular formula is C15H15NO2S and the molecular weight is 273.35. The chemical structure is:. Armodafinil is a white to off-white powder that is slightly soluble in water, sparingly soluble in acetone, and soluble in methanol. Armodafinil tablets contain 50, 150, or 250 mg of armodafinil and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate and povidone.</Description>
</NDC>
<NDC>
<NDCCode>0480-2601-21</NDCCode>
<PackageDescription>21 CAPSULE in 1 BOTTLE (0480-2601-21) </PackageDescription>
<NDC11Code>00480-2601-21</NDC11Code>
<ProductNDC>0480-2601</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pomalidomide</ProprietaryName>
<NonProprietaryName>Pomalidomide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260302</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209956</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>POMALIDOMIDE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Thalidomide Analog [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260302</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pomalidomide is a thalidomide analogue indicated for the treatment of adult patients: 1 in combination with dexamethasone, for patients with multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy (1.1)., 2 with AIDS-related Kaposi sarcoma (KS) after failure of highly active antiretroviral therapy (HAART) or in patients with KS who are HIV-negative. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s) (1.2). .</IndicationAndUsage>
<Description>Pomalidomide is a thalidomide analog. The chemical name is (RS)-4-Amino-2-(2,6-dioxo-piperidin-3-yl)-isoindoline-1,3-dione and it has the following chemical structure. The molecular formula for pomalidomide is C13H11N3O4 and the gram molecular weight is 273.24. Pomalidomide is a yellow crystalline powder. It has limited to low solubility into organic solvents and it has low solubility in all pH solutions (about 0.01 mg/mL). Pomalidomide has a chiral carbon atom which exists as a racemic mixture of the R(+) and S(-) enantiomers. Pomalidomide is available in 1 mg, 2 mg, 3 mg, and 4 mg capsules for oral administration. Each capsule contains pomalidomide as the active ingredient and the following inactive ingredients. 1 mg – black iron oxide, gelatin, mannitol, potassium hydroxide, pregelatinized starch (maize), propylene glycol, shellac, titanium dioxide, and yellow iron oxide. 2 mg – black iron oxide, gelatin, mannitol, potassium hydroxide, pregelatinized starch (maize), propylene glycol, red iron oxide, shellac, titanium dioxide, and yellow iron oxide. 3 mg – black iron oxide, FD&C Blue No. 1, gelatin, mannitol, potassium hydroxide, pregelatinized starch (maize), propylene glycol, shellac, titanium dioxide, and yellow iron oxide. 4 mg – black iron oxide, FD&C Blue No. 1, FD&C Red No. 40, gelatin, mannitol, potassium hydroxide, pregelatinized starch (maize), propylene glycol, shellac, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0480-4018-21</NDCCode>
<PackageDescription>21 CAPSULE in 1 BOTTLE (0480-4018-21) </PackageDescription>
<NDC11Code>00480-4018-21</NDC11Code>
<ProductNDC>0480-4018</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pomalidomide</ProprietaryName>
<NonProprietaryName>Pomalidomide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260302</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209956</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>POMALIDOMIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Thalidomide Analog [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260302</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pomalidomide is a thalidomide analogue indicated for the treatment of adult patients: 1 in combination with dexamethasone, for patients with multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy (1.1)., 2 with AIDS-related Kaposi sarcoma (KS) after failure of highly active antiretroviral therapy (HAART) or in patients with KS who are HIV-negative. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s) (1.2). .</IndicationAndUsage>
<Description>Pomalidomide is a thalidomide analog. The chemical name is (RS)-4-Amino-2-(2,6-dioxo-piperidin-3-yl)-isoindoline-1,3-dione and it has the following chemical structure. The molecular formula for pomalidomide is C13H11N3O4 and the gram molecular weight is 273.24. Pomalidomide is a yellow crystalline powder. It has limited to low solubility into organic solvents and it has low solubility in all pH solutions (about 0.01 mg/mL). Pomalidomide has a chiral carbon atom which exists as a racemic mixture of the R(+) and S(-) enantiomers. Pomalidomide is available in 1 mg, 2 mg, 3 mg, and 4 mg capsules for oral administration. Each capsule contains pomalidomide as the active ingredient and the following inactive ingredients. 1 mg – black iron oxide, gelatin, mannitol, potassium hydroxide, pregelatinized starch (maize), propylene glycol, shellac, titanium dioxide, and yellow iron oxide. 2 mg – black iron oxide, gelatin, mannitol, potassium hydroxide, pregelatinized starch (maize), propylene glycol, red iron oxide, shellac, titanium dioxide, and yellow iron oxide. 3 mg – black iron oxide, FD&C Blue No. 1, gelatin, mannitol, potassium hydroxide, pregelatinized starch (maize), propylene glycol, shellac, titanium dioxide, and yellow iron oxide. 4 mg – black iron oxide, FD&C Blue No. 1, FD&C Red No. 40, gelatin, mannitol, potassium hydroxide, pregelatinized starch (maize), propylene glycol, shellac, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0480-4022-21</NDCCode>
<PackageDescription>21 CAPSULE in 1 BOTTLE (0480-4022-21) </PackageDescription>
<NDC11Code>00480-4022-21</NDC11Code>
<ProductNDC>0480-4022</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pomalidomide</ProprietaryName>
<NonProprietaryName>Pomalidomide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260302</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209956</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>POMALIDOMIDE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Thalidomide Analog [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260302</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pomalidomide is a thalidomide analogue indicated for the treatment of adult patients: 1 in combination with dexamethasone, for patients with multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy (1.1)., 2 with AIDS-related Kaposi sarcoma (KS) after failure of highly active antiretroviral therapy (HAART) or in patients with KS who are HIV-negative. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s) (1.2). .</IndicationAndUsage>
<Description>Pomalidomide is a thalidomide analog. The chemical name is (RS)-4-Amino-2-(2,6-dioxo-piperidin-3-yl)-isoindoline-1,3-dione and it has the following chemical structure. The molecular formula for pomalidomide is C13H11N3O4 and the gram molecular weight is 273.24. Pomalidomide is a yellow crystalline powder. It has limited to low solubility into organic solvents and it has low solubility in all pH solutions (about 0.01 mg/mL). Pomalidomide has a chiral carbon atom which exists as a racemic mixture of the R(+) and S(-) enantiomers. Pomalidomide is available in 1 mg, 2 mg, 3 mg, and 4 mg capsules for oral administration. Each capsule contains pomalidomide as the active ingredient and the following inactive ingredients. 1 mg – black iron oxide, gelatin, mannitol, potassium hydroxide, pregelatinized starch (maize), propylene glycol, shellac, titanium dioxide, and yellow iron oxide. 2 mg – black iron oxide, gelatin, mannitol, potassium hydroxide, pregelatinized starch (maize), propylene glycol, red iron oxide, shellac, titanium dioxide, and yellow iron oxide. 3 mg – black iron oxide, FD&C Blue No. 1, gelatin, mannitol, potassium hydroxide, pregelatinized starch (maize), propylene glycol, shellac, titanium dioxide, and yellow iron oxide. 4 mg – black iron oxide, FD&C Blue No. 1, FD&C Red No. 40, gelatin, mannitol, potassium hydroxide, pregelatinized starch (maize), propylene glycol, shellac, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0480-4035-21</NDCCode>
<PackageDescription>21 CAPSULE in 1 BOTTLE (0480-4035-21) </PackageDescription>
<NDC11Code>00480-4035-21</NDC11Code>
<ProductNDC>0480-4035</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pomalidomide</ProprietaryName>
<NonProprietaryName>Pomalidomide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260302</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209956</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>POMALIDOMIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Thalidomide Analog [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260302</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pomalidomide is a thalidomide analogue indicated for the treatment of adult patients: 1 in combination with dexamethasone, for patients with multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy (1.1)., 2 with AIDS-related Kaposi sarcoma (KS) after failure of highly active antiretroviral therapy (HAART) or in patients with KS who are HIV-negative. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s) (1.2). .</IndicationAndUsage>
<Description>Pomalidomide is a thalidomide analog. The chemical name is (RS)-4-Amino-2-(2,6-dioxo-piperidin-3-yl)-isoindoline-1,3-dione and it has the following chemical structure. The molecular formula for pomalidomide is C13H11N3O4 and the gram molecular weight is 273.24. Pomalidomide is a yellow crystalline powder. It has limited to low solubility into organic solvents and it has low solubility in all pH solutions (about 0.01 mg/mL). Pomalidomide has a chiral carbon atom which exists as a racemic mixture of the R(+) and S(-) enantiomers. Pomalidomide is available in 1 mg, 2 mg, 3 mg, and 4 mg capsules for oral administration. Each capsule contains pomalidomide as the active ingredient and the following inactive ingredients. 1 mg – black iron oxide, gelatin, mannitol, potassium hydroxide, pregelatinized starch (maize), propylene glycol, shellac, titanium dioxide, and yellow iron oxide. 2 mg – black iron oxide, gelatin, mannitol, potassium hydroxide, pregelatinized starch (maize), propylene glycol, red iron oxide, shellac, titanium dioxide, and yellow iron oxide. 3 mg – black iron oxide, FD&C Blue No. 1, gelatin, mannitol, potassium hydroxide, pregelatinized starch (maize), propylene glycol, shellac, titanium dioxide, and yellow iron oxide. 4 mg – black iron oxide, FD&C Blue No. 1, FD&C Red No. 40, gelatin, mannitol, potassium hydroxide, pregelatinized starch (maize), propylene glycol, shellac, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0781-2354-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (0781-2354-01) </PackageDescription>
<NDC11Code>00781-2354-01</NDC11Code>
<ProductNDC>0781-2354</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pomalidomide</ProprietaryName>
<NonProprietaryName>Pomalidomide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260901</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA220741</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>POMALIDOMIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Thalidomide Analog [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-09-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260901</StartMarketingDatePackage>
<EndMarketingDatePackage>20260901</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pomalidomide capsules are a thalidomide analogue indicated for the treatment of adult patients: 1 in combination with dexamethasone, for patients with multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy (1.1).</IndicationAndUsage>
<Description>Pomalidomide is a thalidomide analog. The chemical name is 4-Amino-2-(2,6-dioxo-3-piperidyl)isoindoline-1,3-dione and it has the following chemical structure. The molecular formula for pomalidomide is C13H11N3O4 and the gram molecular weight is 273.25. Pomalidomide is a light yellow to yellow colored powder. It is soluble in dimethyl sulfoxide and in dimethylformamide, insoluble in water. It has limited to low solubility into organic solvents, and it is insoluble in all pH solutions (about 0.10 mg/mL). Pomalidomide has a chiral carbon atom which exists as a racemic mixture of the R (+) and S (-) enantiomers. Pomalidomide capsules are available in 1-mg, 2-mg, 3-mg, and 4-mg capsules for oral administration. Each capsule contains pomalidomide as the active ingredient and the following inactive ingredients: anhydrous lactose, isomalt, and sodium stearyl fumarate. The 1-mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, iron oxide yellow, and white ink. The 2-mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, iron oxide yellow, iron oxide red, and white ink. The 3-mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, iron oxide yellow, and white ink. The 4-mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, and white ink.</Description>
</NDC>
<NDC>
<NDCCode>0781-2354-27</NDCCode>
<PackageDescription>21 CAPSULE in 1 BOTTLE (0781-2354-27) </PackageDescription>
<NDC11Code>00781-2354-27</NDC11Code>
<ProductNDC>0781-2354</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pomalidomide</ProprietaryName>
<NonProprietaryName>Pomalidomide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260901</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA220741</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>POMALIDOMIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Thalidomide Analog [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pomalidomide capsules are a thalidomide analogue indicated for the treatment of adult patients: 1 in combination with dexamethasone, for patients with multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy (1.1).</IndicationAndUsage>
<Description>Pomalidomide is a thalidomide analog. The chemical name is 4-Amino-2-(2,6-dioxo-3-piperidyl)isoindoline-1,3-dione and it has the following chemical structure. The molecular formula for pomalidomide is C13H11N3O4 and the gram molecular weight is 273.25. Pomalidomide is a light yellow to yellow colored powder. It is soluble in dimethyl sulfoxide and in dimethylformamide, insoluble in water. It has limited to low solubility into organic solvents, and it is insoluble in all pH solutions (about 0.10 mg/mL). Pomalidomide has a chiral carbon atom which exists as a racemic mixture of the R (+) and S (-) enantiomers. Pomalidomide capsules are available in 1-mg, 2-mg, 3-mg, and 4-mg capsules for oral administration. Each capsule contains pomalidomide as the active ingredient and the following inactive ingredients: anhydrous lactose, isomalt, and sodium stearyl fumarate. The 1-mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, iron oxide yellow, and white ink. The 2-mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, iron oxide yellow, iron oxide red, and white ink. The 3-mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, iron oxide yellow, and white ink. The 4-mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, and white ink.</Description>
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<IndicationAndUsage>Pomalidomide capsules are a thalidomide analogue indicated for the treatment of adult patients: 1 in combination with dexamethasone, for patients with multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy (1.1).</IndicationAndUsage>
<Description>Pomalidomide is a thalidomide analog. The chemical name is 4-Amino-2-(2,6-dioxo-3-piperidyl)isoindoline-1,3-dione and it has the following chemical structure. The molecular formula for pomalidomide is C13H11N3O4 and the gram molecular weight is 273.25. Pomalidomide is a light yellow to yellow colored powder. It is soluble in dimethyl sulfoxide and in dimethylformamide, insoluble in water. It has limited to low solubility into organic solvents, and it is insoluble in all pH solutions (about 0.10 mg/mL). Pomalidomide has a chiral carbon atom which exists as a racemic mixture of the R (+) and S (-) enantiomers. Pomalidomide capsules are available in 1-mg, 2-mg, 3-mg, and 4-mg capsules for oral administration. Each capsule contains pomalidomide as the active ingredient and the following inactive ingredients: anhydrous lactose, isomalt, and sodium stearyl fumarate. The 1-mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, iron oxide yellow, and white ink. The 2-mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, iron oxide yellow, iron oxide red, and white ink. The 3-mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, iron oxide yellow, and white ink. The 4-mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, and white ink.</Description>
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<IndicationAndUsage>Pomalidomide capsules are a thalidomide analogue indicated for the treatment of adult patients: 1 in combination with dexamethasone, for patients with multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy (1.1).</IndicationAndUsage>
<Description>Pomalidomide is a thalidomide analog. The chemical name is 4-Amino-2-(2,6-dioxo-3-piperidyl)isoindoline-1,3-dione and it has the following chemical structure. The molecular formula for pomalidomide is C13H11N3O4 and the gram molecular weight is 273.25. Pomalidomide is a light yellow to yellow colored powder. It is soluble in dimethyl sulfoxide and in dimethylformamide, insoluble in water. It has limited to low solubility into organic solvents, and it is insoluble in all pH solutions (about 0.10 mg/mL). Pomalidomide has a chiral carbon atom which exists as a racemic mixture of the R (+) and S (-) enantiomers. Pomalidomide capsules are available in 1-mg, 2-mg, 3-mg, and 4-mg capsules for oral administration. Each capsule contains pomalidomide as the active ingredient and the following inactive ingredients: anhydrous lactose, isomalt, and sodium stearyl fumarate. The 1-mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, iron oxide yellow, and white ink. The 2-mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, iron oxide yellow, iron oxide red, and white ink. The 3-mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, iron oxide yellow, and white ink. The 4-mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, and white ink.</Description>
</NDC>
<NDC>
<NDCCode>0781-2366-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (0781-2366-01) </PackageDescription>
<NDC11Code>00781-2366-01</NDC11Code>
<ProductNDC>0781-2366</ProductNDC>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Thalidomide Analog [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-09-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260901</StartMarketingDatePackage>
<EndMarketingDatePackage>20260901</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pomalidomide capsules are a thalidomide analogue indicated for the treatment of adult patients: 1 in combination with dexamethasone, for patients with multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy (1.1).</IndicationAndUsage>
<Description>Pomalidomide is a thalidomide analog. The chemical name is 4-Amino-2-(2,6-dioxo-3-piperidyl)isoindoline-1,3-dione and it has the following chemical structure. The molecular formula for pomalidomide is C13H11N3O4 and the gram molecular weight is 273.25. Pomalidomide is a light yellow to yellow colored powder. It is soluble in dimethyl sulfoxide and in dimethylformamide, insoluble in water. It has limited to low solubility into organic solvents, and it is insoluble in all pH solutions (about 0.10 mg/mL). Pomalidomide has a chiral carbon atom which exists as a racemic mixture of the R (+) and S (-) enantiomers. Pomalidomide capsules are available in 1-mg, 2-mg, 3-mg, and 4-mg capsules for oral administration. Each capsule contains pomalidomide as the active ingredient and the following inactive ingredients: anhydrous lactose, isomalt, and sodium stearyl fumarate. The 1-mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, iron oxide yellow, and white ink. The 2-mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, iron oxide yellow, iron oxide red, and white ink. The 3-mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, iron oxide yellow, and white ink. The 4-mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, and white ink.</Description>
</NDC>
<NDC>
<NDCCode>0781-2366-27</NDCCode>
<PackageDescription>21 CAPSULE in 1 BOTTLE (0781-2366-27) </PackageDescription>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA220741</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>POMALIDOMIDE</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Thalidomide Analog [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pomalidomide capsules are a thalidomide analogue indicated for the treatment of adult patients: 1 in combination with dexamethasone, for patients with multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy (1.1).</IndicationAndUsage>
<Description>Pomalidomide is a thalidomide analog. The chemical name is 4-Amino-2-(2,6-dioxo-3-piperidyl)isoindoline-1,3-dione and it has the following chemical structure. The molecular formula for pomalidomide is C13H11N3O4 and the gram molecular weight is 273.25. Pomalidomide is a light yellow to yellow colored powder. It is soluble in dimethyl sulfoxide and in dimethylformamide, insoluble in water. It has limited to low solubility into organic solvents, and it is insoluble in all pH solutions (about 0.10 mg/mL). Pomalidomide has a chiral carbon atom which exists as a racemic mixture of the R (+) and S (-) enantiomers. Pomalidomide capsules are available in 1-mg, 2-mg, 3-mg, and 4-mg capsules for oral administration. Each capsule contains pomalidomide as the active ingredient and the following inactive ingredients: anhydrous lactose, isomalt, and sodium stearyl fumarate. The 1-mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, iron oxide yellow, and white ink. The 2-mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, iron oxide yellow, iron oxide red, and white ink. The 3-mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, iron oxide yellow, and white ink. The 4-mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, and white ink.</Description>
</NDC>
<NDC>
<NDCCode>0781-2369-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (0781-2369-01) </PackageDescription>
<NDC11Code>00781-2369-01</NDC11Code>
<ProductNDC>0781-2369</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pomalidomide</ProprietaryName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA220741</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>POMALIDOMIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Thalidomide Analog [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-09-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260901</StartMarketingDatePackage>
<EndMarketingDatePackage>20260901</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pomalidomide capsules are a thalidomide analogue indicated for the treatment of adult patients: 1 in combination with dexamethasone, for patients with multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy (1.1).</IndicationAndUsage>
<Description>Pomalidomide is a thalidomide analog. The chemical name is 4-Amino-2-(2,6-dioxo-3-piperidyl)isoindoline-1,3-dione and it has the following chemical structure. The molecular formula for pomalidomide is C13H11N3O4 and the gram molecular weight is 273.25. Pomalidomide is a light yellow to yellow colored powder. It is soluble in dimethyl sulfoxide and in dimethylformamide, insoluble in water. It has limited to low solubility into organic solvents, and it is insoluble in all pH solutions (about 0.10 mg/mL). Pomalidomide has a chiral carbon atom which exists as a racemic mixture of the R (+) and S (-) enantiomers. Pomalidomide capsules are available in 1-mg, 2-mg, 3-mg, and 4-mg capsules for oral administration. Each capsule contains pomalidomide as the active ingredient and the following inactive ingredients: anhydrous lactose, isomalt, and sodium stearyl fumarate. The 1-mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, iron oxide yellow, and white ink. The 2-mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, iron oxide yellow, iron oxide red, and white ink. The 3-mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, iron oxide yellow, and white ink. The 4-mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, and white ink.</Description>
</NDC>
<NDC>
<NDCCode>0781-2369-27</NDCCode>
<PackageDescription>21 CAPSULE in 1 BOTTLE (0781-2369-27) </PackageDescription>
<NDC11Code>00781-2369-27</NDC11Code>
<ProductNDC>0781-2369</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<ApplicationNumber>ANDA220741</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>POMALIDOMIDE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Thalidomide Analog [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pomalidomide capsules are a thalidomide analogue indicated for the treatment of adult patients: 1 in combination with dexamethasone, for patients with multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy (1.1).</IndicationAndUsage>
<Description>Pomalidomide is a thalidomide analog. The chemical name is 4-Amino-2-(2,6-dioxo-3-piperidyl)isoindoline-1,3-dione and it has the following chemical structure. The molecular formula for pomalidomide is C13H11N3O4 and the gram molecular weight is 273.25. Pomalidomide is a light yellow to yellow colored powder. It is soluble in dimethyl sulfoxide and in dimethylformamide, insoluble in water. It has limited to low solubility into organic solvents, and it is insoluble in all pH solutions (about 0.10 mg/mL). Pomalidomide has a chiral carbon atom which exists as a racemic mixture of the R (+) and S (-) enantiomers. Pomalidomide capsules are available in 1-mg, 2-mg, 3-mg, and 4-mg capsules for oral administration. Each capsule contains pomalidomide as the active ingredient and the following inactive ingredients: anhydrous lactose, isomalt, and sodium stearyl fumarate. The 1-mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, iron oxide yellow, and white ink. The 2-mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, iron oxide yellow, iron oxide red, and white ink. The 3-mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, iron oxide yellow, and white ink. The 4-mg capsule shell contains gelatin, titanium dioxide, FD&C blue 2, and white ink.</Description>
</NDC>
<NDC>
<NDCCode>0781-8029-31</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (0781-8029-31) </PackageDescription>
<NDC11Code>00781-8029-31</NDC11Code>
<ProductNDC>0781-8029</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Armodafinil</ProprietaryName>
<NonProprietaryName>Armodafinil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161201</StartMarketingDate>
<EndMarketingDate>20270930</EndMarketingDate>
<MarketingCategoryName>NDA AUTHORIZED GENERIC</MarketingCategoryName>
<ApplicationNumber>NDA021875</ApplicationNumber>
<LabelerName>Sandoz Inc</LabelerName>
<SubstanceName>ARMODAFINIL</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-11-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20161201</StartMarketingDatePackage>
<EndMarketingDatePackage>20270930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Armodafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD). Limitations of Use. In OSA, armodafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating armodafinil tablets for excessive sleepiness.</IndicationAndUsage>
<Description>Armodafinil tablets are a wakefulness‑promoting agent for oral administration. Armodafinil is the R-enantiomer of modafinil which is a 1:1 mixture of the R- and S-enantiomers. The chemical name for armodafinil is 2‑[(R)-(diphenylmethyl)sulfinyl]acetamide. The molecular formula is C15H15NO2S and the molecular weight is 273.35. The chemical structure is. Armodafinil is a white to off-white, crystalline powder that is slightly soluble in water, sparingly soluble in acetone, and soluble in methanol. Armodafinil tablets contain 50, 150, 200 or 250 mg of armodafinil and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinized starch.</Description>
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