{
"NDC": [
{
"NDCCode": "61047-770-10",
"PackageDescription": "113.4 g in 1 TUBE (61047-770-10)",
"NDC11Code": "61047-0770-10",
"ProductNDC": "61047-770",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Close Up Anticavity Toothpaste",
"NonProprietaryName": "Anticavity Toothpaste",
"DosageFormName": "GEL",
"RouteName": "DENTAL",
"StartMarketingDate": "20100325",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "KIK Custom Products",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": ".27",
"StrengthUnit": "g/113.4g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "12579-770-10",
"PackageDescription": "58000 TABLET, FILM COATED in 1 DRUM (12579-770-10)",
"NDC11Code": "12579-0770-10",
"ProductNDC": "12579-770",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Riluzole",
"DosageFormName": "TABLET, FILM COATED",
"StartMarketingDate": "20130515",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Sanofi Winthrop Industrie",
"SubstanceName": "RILUZOLE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "16571-770-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (16571-770-10) ",
"NDC11Code": "16571-0770-10",
"ProductNDC": "16571-770",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fosinopril Sodium",
"NonProprietaryName": "Fosinopril Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110330",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091163",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "FOSINOPRIL SODIUM",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-03-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20110330",
"SamplePackage": "N",
"IndicationAndUsage": "Fosinopril sodium tablets are indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics.Fosinopril sodium tablets are indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics with or without digitalis (see DOSAGE AND ADMINISTRATION).In using fosinopril sodium tablets, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that fosinopril sodium tablets do not have a similar risk (see WARNINGS).In considering use of fosinopril sodium tablets, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see WARNINGS: Head and Neck Angioedema and Intestinal Angioedema).",
"Description": "Fosinopril sodium tablets, USP are the sodium salt of fosinopril, the ester prodrug of an angiotensin-converting enzyme (ACE) inhibitor, fosinoprilat. It contains a phosphinate group capable of specific binding to the active site of angiotensin-converting enzyme. Fosinopril sodium is designated chemically as: L-proline, 4-cyclohexyl-1-[[[2-methyl-1-(1-oxopropoxy) propoxy] (4-phenylbutyl) phosphinyl] acetyl]-, sodium salt, trans-.Fosinopril sodium, USP is a white to almost white powder. It is soluble in water (100 mg/mL), methanol, and ethanol and slightly soluble in hexane.Its structural formula is. Its molecular formula is C30H45NNaO7P, and its molecular weight is 585.65.Fosinopril sodium, USP is available for oral administration as 10 mg, 20 mg, and 40 mg tablets. Inactive ingredients include: anhydrous lactose, crospovidone, microcrystalline cellulose, povidone, and sodium stearyl fumarate."
},
{
"NDCCode": "31722-770-32",
"PackageDescription": "6 BLISTER PACK in 1 CARTON (31722-770-32) / 10 CAPSULE in 1 BLISTER PACK",
"NDC11Code": "31722-0770-32",
"ProductNDC": "31722-770",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pomalidomide",
"NonProprietaryName": "Pomalidomide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20260228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210236",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "POMALIDOMIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Thalidomide Analog [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260228",
"SamplePackage": "N",
"IndicationAndUsage": "Pomalidomide is a thalidomide analogue indicated for the treatment of adult patients: 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 (RS)-4-Amino-2-(2,6-dioxo-piperidin-3-yl)-1H-isoindoline-1,3-dione and it has the following chemical structure. The molecular formula for pomalidomide is C 13H 11N 3O 4and the gram molecular weight is 273.24. Pomalidomide is a pale yellow to yellow color powder. Soluble in dimethylformamide and in dimethylsulfoxide. 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: black iron oxide, gelatin, mannitol, microcrystalline cellulose, potassium hydroxide, pregelatinized starch, propylene glycol, shellac, sodium stearyl fumarate, strong ammonia solution and titanium dioxide. In addition, the 2 mg and 3 mg capsules also contain iron oxide red. The 2 mg capsule also contains iron oxide yellow. The botanical source for pregelatinized starch is corn starch."
},
{
"NDCCode": "41520-770-26",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (41520-770-26) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK",
"NDC11Code": "41520-0770-26",
"ProductNDC": "41520-770",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Careone Allergy And Cough Severe Sinus Congestion",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20160706",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "American Sales Company",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "325; 10; 6.25; 5",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2019-08-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20160706",
"SamplePackage": "N"
},
{
"NDCCode": "49884-770-54",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (49884-770-54) / 10 TABLET in 1 BLISTER PACK (49884-770-52) ",
"NDC11Code": "49884-0770-54",
"ProductNDC": "49884-770",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tolvaptan",
"NonProprietaryName": "Tolvaptan",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220310",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206119",
"LabelerName": "Par Health USA, LLC",
"SubstanceName": "TOLVAPTAN",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Vasopressin V2 Receptor Antagonist [EPC], Vasopressin V2 Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220310",
"SamplePackage": "N",
"IndicationAndUsage": "Tolvaptan tablets are indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia (serum sodium <125 mEq/L or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction), including patients with heart failure and Syndrome of Inappropriate Antidiuretic Hormone (SIADH). Limitations of Use. Patients requiring intervention to raise serum sodium urgently to prevent or to treat serious neurological symptoms should not be treated with tolvaptan tablets. It has not been established that raising serum sodium with tolvaptan tablets provides a symptomatic benefit to patients.",
"Description": "Tolvaptan is (±)-4'-[(7-chloro-2,3,4,5-tetrahydro-5-hydroxy-1H-1-benzazepin-1-yl) carbonyl]-o-tolu-m-toluidide. The empirical formula is C26H25ClN2O3. Molecular weight is 448.94. The chemical structure is. Tolvaptan tablets for oral use contain 15 mg or 30 mg of tolvaptan. Inactive ingredients include corn starch, FD&C Blue #2/indigo carmine aluminum lake, hydroxypropyl cellulose, lactose monohydrate, low substituted hydroxypropyl cellulose, magnesium stearate and microcrystalline cellulose."
},
{
"NDCCode": "60429-770-10",
"PackageDescription": "1000 TABLET in 1 BOTTLE (60429-770-10) ",
"NDC11Code": "60429-0770-10",
"ProductNDC": "60429-770",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Topiramate",
"NonProprietaryName": "Topiramate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110708",
"EndMarketingDate": "20220531",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079162",
"LabelerName": "Golden State Medical Supply, Inc.",
"SubstanceName": "TOPIRAMATE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2022-06-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20110708",
"EndMarketingDatePackage": "20220531",
"SamplePackage": "N"
},
{
"NDCCode": "62257-770-10",
"PackageDescription": "1000 mL in 1 CARTRIDGE (62257-770-10)",
"NDC11Code": "62257-0770-10",
"ProductNDC": "62257-770",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antibacterial",
"NonProprietaryName": "Chloroxylenol",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140409",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "ABC Compounding Co., Inc.",
"SubstanceName": "CHLOROXYLENOL",
"StrengthNumber": "3",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "for hand-washing to decrease bacteria on the skin."
},
{
"NDCCode": "65841-770-10",
"PackageDescription": "1000 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (65841-770-10) ",
"NDC11Code": "65841-0770-10",
"ProductNDC": "65841-770",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lansoprazole",
"NonProprietaryName": "Lansoprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20130823",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202366",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "LANSOPRAZOLE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-05-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20130823",
"SamplePackage": "N"
},
{
"NDCCode": "65841-770-30",
"PackageDescription": "10 BLISTER PACK in 1 CARTON (65841-770-30) / 10 CAPSULE, DELAYED RELEASE PELLETS in 1 BLISTER PACK",
"NDC11Code": "65841-0770-30",
"ProductNDC": "65841-770",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lansoprazole",
"NonProprietaryName": "Lansoprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE PELLETS",
"RouteName": "ORAL",
"StartMarketingDate": "20130823",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202366",
"LabelerName": "Zydus Lifesciences Limited",
"SubstanceName": "LANSOPRAZOLE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2025-05-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20130823",
"SamplePackage": "N"
},
{
"NDCCode": "67877-770-33",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (67877-770-33) / 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "67877-0770-33",
"ProductNDC": "67877-770",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Levetiracetam",
"NonProprietaryName": "Levetiracetam",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220408",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA216375",
"LabelerName": "Ascend Laboratories, LLC",
"SubstanceName": "LEVETIRACETAM",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220528",
"SamplePackage": "N",
"IndicationAndUsage": "Levetiracetam tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1) Levetiracetam tablets are indicated for adjunctive therapy for the treatment of: Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2) Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3).",
"Description": "Levetiracetam,USP is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white) tablets. The chemical name of levetiracetam, USP, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam, USP is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam, USP is a white to almost white powder. It is very soluble in water, soluble in acetonitrile, practically insoluble in hexane. Levetiracetam tablets, USP contain the labeled amount of levetiracetam, USP. Inactive ingredients: colloidal silicon dioxide, magnesium stearate, maize starch, polyethylene glycol, polyvinyl alcohol, povidone, sodium starch glycolate, talc, titanium dioxide and additional agents listed below: 250 mg tablets: FD&C blue #2 indigo carmine aluminum lake 500 mg tablets: iron oxide yellow 750 mg tablets: iron oxide yellow, iron oxide red. Meets USP Dissolution Test 3."
},
{
"NDCCode": "70010-770-10",
"PackageDescription": "1000 TABLET, COATED in 1 BOTTLE (70010-770-10) ",
"NDC11Code": "70010-0770-10",
"ProductNDC": "70010-770",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methocarbamol",
"NonProprietaryName": "Methocarbamol Tablets",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20180702",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209312",
"LabelerName": "Granules Pharmaceuticals Inc.",
"SubstanceName": "METHOCARBAMOL",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
"Status": "Active",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20200201",
"SamplePackage": "N",
"IndicationAndUsage": "Methocarbamol tablets, USP are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.",
"Description": "Methocarbamol tablet, USP, a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is 1,2-Propanediol,3-(2-methoxyphenoxy)-,1-Carbamate,(±)-(or) (±)-3-(o-Methoxyphenoxy)-1,2-Propanediol 1-carbamate and has the empirical formula C 11H 15NO 5. Its molecular weight is 241.24g/mol. The structural formula is shown below. Methocarbamol is a white powder, sparingly soluble in water and in chloroform, soluble in alcohol (only with heating), insoluble in benzene and in n-hexane. Methocarbamol tablets, USP are available as 500 mg and 750 mg tablets for oral administration. Methocarbamol tablets, USP 500 mg are light orange colored, round shaped film coated tablets debossed with \"G\" above the score line on one side and \"500\" on other side. Methocarbamol tablets, USP 750 mg are light orange colored, caplet shaped film coated tablets debossed with \"G\" on one side and \"750\" on other side. Methocarbamol tablets, USP 500 mg and 750 mg contain the following inactive ingredients: colloidal silicon dioxide, maize starch, povidone, sodium lauryl sulfate, sodium starch glycolate, and stearic acid. The tabets are coated with Aquarius Prime which contains FD&C yellow 6, hydroxypropylcellulose, hypromellose, polysorbate 80, propylene glycol, and titanium dioxide."
},
{
"NDCCode": "72288-770-10",
"PackageDescription": "1 BOTTLE in 1 CARTON (72288-770-10) / 30 mL in 1 BOTTLE (72288-770-00) ",
"NDC11Code": "72288-0770-10",
"ProductNDC": "72288-770",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Infants Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "SUSPENSION/ DROPS",
"RouteName": "ORAL",
"StartMarketingDate": "20260806",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075217",
"LabelerName": "Amazon.com Services LLC",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "50",
"StrengthUnit": "mg/1.25mL",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260806",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily: 1 reduces fever, 2 relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches."
},
{
"NDCCode": "76420-770-01",
"PackageDescription": "1 KIT in 1 CARTON (76420-770-01) * 10 mL in 1 VIAL, SINGLE-DOSE (0003-0293-05) * .3 mL in 1 AMPULE (39822-9900-2) * 2.2 g in 1 PACKET (10819-3883-3) * 10 mL in 1 AMPULE (63323-201-10)",
"NDC11Code": "76420-0770-01",
"ProductNDC": "76420-770",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Interarticular Joint Kit",
"NonProprietaryName": "Ammonia, Lidocaine Hydrochloride Anhydrous, Triamcinolone Acetonide, Povidone-iodine",
"DosageFormName": "KIT",
"RouteName": "INFILTRATION; INTRA-ARTICULAR; INTRAMUSCULAR; RESPIRATORY (INHALATION); TOPICAL",
"StartMarketingDate": "20140205",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA014901",
"LabelerName": "Asclemed USA, Inc.",
"Status": "Deprecated",
"LastUpdate": "2017-07-27"
},
{
"NDCCode": "79109-770-10",
"PackageDescription": "1000 L in 1 CONTAINER (79109-770-10)",
"NDC11Code": "79109-0770-10",
"ProductNDC": "79109-770",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "GEL",
"StartMarketingDate": "20200801",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "ROLDAN INDUSTRIES",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "L/100L",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20211231"
},
{
"NDCCode": "0089-0233-10",
"PackageDescription": "100 TABLET, MULTILAYER in 1 BOTTLE (0089-0233-10)",
"NDC11Code": "00089-0233-10",
"ProductNDC": "0089-0233",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Norgesic Forte",
"NonProprietaryName": "Orphenadrine Citrate, Aspirin And Caffeine",
"DosageFormName": "TABLET, MULTILAYER",
"RouteName": "ORAL",
"StartMarketingDate": "19640304",
"EndMarketingDate": "20151231",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA013416",
"LabelerName": "3M Pharmaceuticals",
"SubstanceName": "ORPHENADRINE CITRATE; ASPIRIN; CAFFEINE",
"StrengthNumber": "50; 770; 60",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2016-01-01"
},
{
"NDCCode": "11673-770-14",
"PackageDescription": "1 TUBE in 1 CARTON (11673-770-14) / 14 g in 1 TUBE",
"NDC11Code": "11673-0770-14",
"ProductNDC": "11673-770",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Antibiotic And Pain Relief",
"NonProprietaryName": "Neomycin Sulfate, Polymyxin B Sulfate, And Pramoxine Hydrochloride",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240131",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M004",
"LabelerName": "Target Corporation",
"SubstanceName": "POLYMYXIN B SULFATE; NEOMYCIN SULFATE; PRAMOXINE HYDROCHLORIDE",
"StrengthNumber": "10000; 3.5; 10",
"StrengthUnit": "[USP'U]/g; mg/g; mg/g",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]",
"Status": "Active",
"LastUpdate": "2024-02-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240131",
"SamplePackage": "N",
"IndicationAndUsage": "first aid to prevent infection and for the temporary relief of pain or discomfort in minor: 1 cuts, 2 scapes, 3 burns."
},
{
"NDCCode": "16571-770-09",
"PackageDescription": "90 TABLET in 1 BOTTLE (16571-770-09) ",
"NDC11Code": "16571-0770-09",
"ProductNDC": "16571-770",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fosinopril Sodium",
"NonProprietaryName": "Fosinopril Sodium",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110330",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091163",
"LabelerName": "Rising Pharma Holdings, Inc.",
"SubstanceName": "FOSINOPRIL SODIUM",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2024-03-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20110330",
"SamplePackage": "N",
"IndicationAndUsage": "Fosinopril sodium tablets are indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics.Fosinopril sodium tablets are indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics with or without digitalis (see DOSAGE AND ADMINISTRATION).In using fosinopril sodium tablets, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that fosinopril sodium tablets do not have a similar risk (see WARNINGS).In considering use of fosinopril sodium tablets, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see WARNINGS: Head and Neck Angioedema and Intestinal Angioedema).",
"Description": "Fosinopril sodium tablets, USP are the sodium salt of fosinopril, the ester prodrug of an angiotensin-converting enzyme (ACE) inhibitor, fosinoprilat. It contains a phosphinate group capable of specific binding to the active site of angiotensin-converting enzyme. Fosinopril sodium is designated chemically as: L-proline, 4-cyclohexyl-1-[[[2-methyl-1-(1-oxopropoxy) propoxy] (4-phenylbutyl) phosphinyl] acetyl]-, sodium salt, trans-.Fosinopril sodium, USP is a white to almost white powder. It is soluble in water (100 mg/mL), methanol, and ethanol and slightly soluble in hexane.Its structural formula is. Its molecular formula is C30H45NNaO7P, and its molecular weight is 585.65.Fosinopril sodium, USP is available for oral administration as 10 mg, 20 mg, and 40 mg tablets. Inactive ingredients include: anhydrous lactose, crospovidone, microcrystalline cellulose, povidone, and sodium stearyl fumarate."
},
{
"NDCCode": "21695-726-30",
"PackageDescription": "30 TABLET, MULTILAYER in 1 BOTTLE (21695-726-30)",
"NDC11Code": "21695-0726-30",
"ProductNDC": "21695-726",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Orphenadrine Citrate, Aspirin And Caffeine",
"NonProprietaryName": "Orphenadrine Citrate, Aspirin And Caffeine",
"DosageFormName": "TABLET, MULTILAYER",
"RouteName": "ORAL",
"StartMarketingDate": "19961231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074654",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "ORPHENADRINE CITRATE; ASPIRIN; CAFFEINE",
"StrengthNumber": "50; 770; 60",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Symptomatic relief of mild to moderate pain of acute musculoskeletal disorders. The orphenadrine component is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions.The mode of action of orphenadrine has not been clearly identified, but may be related to its analgesic properties. Orphenadrine Citrate, Aspirin, and Caffeine Tablets do not directly relax tense skeletal muscles in man.",
"Description": "Each tablet, for oral administration, contains Orphenadrine Citrate USP, 25 mg or 50 mg, Aspirin USP, 385 mg or 770 mg, Caffeine USP, 30 mg or 60 mg. Orphenadrine citrate, N, N-Dimethyl-2-[(o-methyl-α-phenylbenzyl)oxy]ethylamine citrate (1:1), is a centrally acting (brain stem) compound. It occurs as a white, practically odorless, crystalline powder, having a bitter taste. Its molecular formula is C18H23NO.C6H8O7 with a molecular weight of 461.51. The structural formula is shown below. Aspirin, salicylic acid acetate, is a non-opiate analgesic, anti-inflammatory and antipyretic agent. It occurs as a white, crystalline tabular or needle like powder and is odorless or has a faint odor. Its molecular formula is C9H8O4, with a molecular weight of 180.16. The structural formula is shown below. Caffeine, 1,3,7-trimethylxanthine, is a central nervous system stimulant which occurs as a white powder or white glistening needles. It also has a bitter taste. Its molecular formula is C8H10N4O2, with a molecular weight of 194.19. The structural formula is shown below. Each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C Blue No. 1, FD&C Yellow No. 10, anhydrous lactose, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid, and sodium lauryl sulfate."
},
{
"NDCCode": "21695-726-45",
"PackageDescription": "45 TABLET, MULTILAYER in 1 BOTTLE (21695-726-45)",
"NDC11Code": "21695-0726-45",
"ProductNDC": "21695-726",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Orphenadrine Citrate, Aspirin And Caffeine",
"NonProprietaryName": "Orphenadrine Citrate, Aspirin And Caffeine",
"DosageFormName": "TABLET, MULTILAYER",
"RouteName": "ORAL",
"StartMarketingDate": "19961231",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074654",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "ORPHENADRINE CITRATE; ASPIRIN; CAFFEINE",
"StrengthNumber": "50; 770; 60",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Symptomatic relief of mild to moderate pain of acute musculoskeletal disorders. The orphenadrine component is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions.The mode of action of orphenadrine has not been clearly identified, but may be related to its analgesic properties. Orphenadrine Citrate, Aspirin, and Caffeine Tablets do not directly relax tense skeletal muscles in man.",
"Description": "Each tablet, for oral administration, contains Orphenadrine Citrate USP, 25 mg or 50 mg, Aspirin USP, 385 mg or 770 mg, Caffeine USP, 30 mg or 60 mg. Orphenadrine citrate, N, N-Dimethyl-2-[(o-methyl-α-phenylbenzyl)oxy]ethylamine citrate (1:1), is a centrally acting (brain stem) compound. It occurs as a white, practically odorless, crystalline powder, having a bitter taste. Its molecular formula is C18H23NO.C6H8O7 with a molecular weight of 461.51. The structural formula is shown below. Aspirin, salicylic acid acetate, is a non-opiate analgesic, anti-inflammatory and antipyretic agent. It occurs as a white, crystalline tabular or needle like powder and is odorless or has a faint odor. Its molecular formula is C9H8O4, with a molecular weight of 180.16. The structural formula is shown below. Caffeine, 1,3,7-trimethylxanthine, is a central nervous system stimulant which occurs as a white powder or white glistening needles. It also has a bitter taste. Its molecular formula is C8H10N4O2, with a molecular weight of 194.19. The structural formula is shown below. Each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C Blue No. 1, FD&C Yellow No. 10, anhydrous lactose, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid, and sodium lauryl sulfate."
},
{
"NDCCode": "21695-770-01",
"PackageDescription": "1 BLISTER PACK in 1 POUCH (21695-770-01) > 1 KIT in 1 BLISTER PACK",
"NDC11Code": "21695-0770-01",
"ProductNDC": "21695-770",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tri-sprintec",
"NonProprietaryName": "Norgestimate And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20110125",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075808",
"LabelerName": "Rebel Distributors Corp",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Tri-Sprintec Tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Tri-Sprintec Tablets are indicated for the treatment of moderate acne vulgaris in females, ≥15 years of age, who have no known contraindications to oral contraceptive therapy, desire contraception, have achieved menarche and are unresponsive to topical anti-acne medications. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. In four clinical trials with norgestimate and ethinyl estradiol, the use-efficacy pregnancy rate ranged from 0.68 to 1.47 per 100 women-years. In total, 4,756 subjects completed 45,244 cycles and a total of 42 pregnancies were reported. This represents an overall use-efficacy rate of 1.21 per 100 women-years. One of these 4 studies was a randomized comparative clinical trial in which 4,633 subjects completed 22,312 cycles. Of the 2,312 patients on norgestimate and ethinyl estradiol, 8 pregnancies were reported. This represents an overall use-efficacy pregnancy rate of 0.94 per 100 women-years. In two double-blind, placebo-controlled, six month, multicenter clinical trials, norgestimate and ethinyl estradiol showed a statistically significant decrease in inflammatory lesion count and total lesion count (TABLE II). The adverse reaction profile of norgestimate and ethinyl estradiol from these two controlled clinical trials is consistent with what has been noted from previous studies involving norgestimate and ethinyl estradiol and are the known risks associated with oral contraceptives.",
"Description": "Tri-Sprintec® Tablets are a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol. Each gray tablet contains 0.18 mg of the progestational compound, norgestimate (18, 19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-oxime, (17α)-(+)-) and 0.035 mg of the estrogenic compound, ethinyl estradiol (19-nor-17α-pregna, 1,3,5(10)-trien-20-yne-3, 17-diol), and the inactive ingredients include anhydrous lactose, lactose monohydrate, lake blend black LB 636 (ingredients include aluminum sulfate solution, aluminum-chloride solution, FD&C blue no. 2, FD&C red no. 40, FD&C yellow no. 6, sodium bicarbonate and sodium carbonate), magnesium stearate, and pregelatinized starch. Each light blue tablet contains 0.215 mg of the progestational compound norgestimate (18, 19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-,oxime, (17α)-(+)-) and 0.035 mg of the estrogenic compound, ethinyl estradiol (19-nor-17α-pregna, 1,3,5(10)-trien-20-yne-3, 17-diol), and the inactive ingredients include anhydrous lactose, FD&C blue no. 2 aluminum lake, (ingredients include aluminum sulfate solution, aluminum-chloride solution, sodium bicarbonate and sodium carbonate), lactose monohydrate, magnesium stearate, and pregelatinized starch. Each blue tablet contains 0.25 mg of the progestational compound norgestimate (18, 19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime, (17α)-(+)-) and 0.035 mg of the estrogenic compound, ethinyl estradiol (19-nor-17α-pregna, 1,3,5(10)-trien-20-yne-3, 17-diol), and the inactive ingredients include anhydrous lactose, FD&C blue no. 2 aluminum lake, (ingredients include aluminum sulfate solution, aluminum-chloride solution, sodium bicarbonate and sodium carbonate), lactose monohydrate, magnesium stearate, and pregelatinized starch. Each white tablet contains only inert ingredients as follows: anhydrous lactose, hypromellose, magnesium stearate, and microcrystalline cellulose. The structural formula is as follows."
},
{
"NDCCode": "36800-770-05",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (36800-770-05) > 225 TABLET, COATED in 1 BOTTLE, PLASTIC",
"NDC11Code": "36800-0770-05",
"ProductNDC": "36800-770",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Pain Relief",
"ProprietaryNameSuffix": "Extra Strength",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140331",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part343",
"LabelerName": "TopCo Associates LLC",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2022-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20140331",
"EndMarketingDatePackage": "20220930",
"SamplePackage": "N"
},
{
"NDCCode": "37808-770-08",
"PackageDescription": "236 mL in 1 BOTTLE (37808-770-08) ",
"NDC11Code": "37808-0770-08",
"ProductNDC": "37808-770",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Heb Stomach Relief",
"ProprietaryNameSuffix": "Max Strength",
"NonProprietaryName": "Bismuth Subsalicylate",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20190423",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M008",
"LabelerName": "HEB",
"SubstanceName": "BISMUTH SUBSALICYLATE",
"StrengthNumber": "1050",
"StrengthUnit": "mg/30mL",
"Status": "Active",
"LastUpdate": "2025-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190423",
"SamplePackage": "N",
"IndicationAndUsage": "relieves: 1 travelers’ diarrhea, 2 diarrhea, 3 upset stomach due to overindulgence in food and drink, including:, 4 heartburn, 5 indigestion, 6 nausea, 7 gas, 8 belching."
},
{
"NDCCode": "37808-770-16",
"PackageDescription": "473 mL in 1 BOTTLE (37808-770-16) ",
"NDC11Code": "37808-0770-16",
"ProductNDC": "37808-770",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Heb Stomach Relief",
"ProprietaryNameSuffix": "Max Strength",
"NonProprietaryName": "Bismuth Subsalicylate",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20190423",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M008",
"LabelerName": "HEB",
"SubstanceName": "BISMUTH SUBSALICYLATE",
"StrengthNumber": "1050",
"StrengthUnit": "mg/30mL",
"Status": "Active",
"LastUpdate": "2025-10-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190423",
"SamplePackage": "N",
"IndicationAndUsage": "relieves: 1 travelers’ diarrhea, 2 diarrhea, 3 upset stomach due to overindulgence in food and drink, including:, 4 heartburn, 5 indigestion, 6 nausea, 7 gas, 8 belching."
},
{
"NDCCode": "41163-770-21",
"PackageDescription": "1 TUBE in 1 CARTON (41163-770-21) / 85 g in 1 TUBE",
"NDC11Code": "41163-0770-21",
"ProductNDC": "41163-770",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Equaline Muscle Rub",
"NonProprietaryName": "Menthol, Methyl Salicylate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140103",
"EndMarketingDate": "20231031",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "United Natural Foods, Inc. dba UNFI",
"SubstanceName": "MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE",
"StrengthNumber": "10; 15",
"StrengthUnit": "g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2023-11-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20140103",
"EndMarketingDatePackage": "20231031",
"SamplePackage": "N"
},
{
"NDCCode": "42291-770-50",
"PackageDescription": "500 TABLET in 1 BOTTLE (42291-770-50) ",
"NDC11Code": "42291-0770-50",
"ProductNDC": "42291-770",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Prednisone",
"NonProprietaryName": "Prednisone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20200422",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211575",
"LabelerName": "AvKARE",
"SubstanceName": "PREDNISONE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20200422",
"SamplePackage": "N"
},
{
"NDCCode": "50268-770-15",
"PackageDescription": "50 BLISTER PACK in 1 BOX (50268-770-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-770-11) ",
"NDC11Code": "50268-0770-15",
"ProductNDC": "50268-770",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline",
"NonProprietaryName": "Sertraline",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20240206",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077670",
"LabelerName": "AvPAK",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240206",
"SamplePackage": "N",
"IndicationAndUsage": "Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies ( 14)] : : 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).",
"Description": "Sertraline hydrochloride tablet USP contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C 17H 17NCl 2HCl is represented by the following structural formula:. Sertraline hydrochloride is white to off white crystalline powder that is sparingly soluble in methanol and dimethyl formamide. Sertraline hydrochloride tablets USP for oral administration contain 28.0 mg, 56.0 mg, and 111.9 mg sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: D&C Yellow #10 (in 25 mg tablet), dibasic calcium phosphate anhydrous, FD&C Blue #1 (in 25 mg tablet), FD&C Blue #2 (in 50 mg tablet), FD&C Red #40 (in 25 mg tablet), hydroxypropyl cellulose, hypromellose, iron oxide yellow (in 100 mg tablet), magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate , titanium dioxide and vanillin. Sertraline hydrochloride tablets USP are coated with vanillin flavored film coating material. Vanillin is a flavoring agent that possess vanilla like fragrance."
},
{
"NDCCode": "50474-770-09",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (50474-770-09) / 1 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "50474-0770-09",
"ProductNDC": "50474-770",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Briviact",
"NonProprietaryName": "Brivaracetam",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160512",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205836",
"LabelerName": "UCB, Inc.",
"SubstanceName": "BRIVARACETAM",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Epoxide Hydrolase Inhibitors [MoA]",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160512",
"EndMarketingDatePackage": "20301129",
"SamplePackage": "N",
"IndicationAndUsage": "BRIVIACT is indicated for the treatment of partial-onset seizures in patients 1 month of age and older.",
"Description": "The chemical name of BRIVIACT (brivaracetam) is (2S)-2-[(4R)-2-oxo-4-propyltetrahydro-1 H-pyrrol-1-yl] butanamide. Its molecular formula is C 11H 20N 2O 2and its molecular weight is 212.29. The chemical structure is:. Brivaracetam is a white to off-white crystalline powder. It is very soluble in water, buffer (pH 1.2, 4.5, and 7.4), ethanol, methanol, and glacial acetic acid. It is freely soluble in acetonitrile and acetone and soluble in toluene. It is very slightly soluble in n-hexane. Tablets. BRIVIACT tablets are for oral administration and contain the following inactive ingredients: croscarmellose sodium, lactose monohydrate, betadex (β-cyclodextrin), anhydrous lactose, magnesium stearate, and film coating agents specified below. 10 mg tablets: polyvinyl alcohol, talc, polyethylene glycol 3350, titanium dioxide 25 mg and 100 mg tablets: polyvinyl alcohol, talc, polyethylene glycol 3350, titanium dioxide, yellow iron oxide, black iron oxide 50 mg tablets: polyvinyl alcohol, talc, polyethylene glycol 3350, titanium dioxide, yellow iron oxide, red iron oxide 75 mg tablets: polyvinyl alcohol, talc, polyethylene glycol 3350, titanium dioxide, yellow iron oxide, red iron oxide, black iron oxide. Oral Solution. BRIVIACT oral solution contains 10 mg of brivaracetam per mL. The inactive ingredients are sodium citrate, anhydrous citric acid, methylparaben, sodium carboxymethylcellulose, sucralose, sorbitol solution, glycerin, raspberry flavor, and purified water. Injection. BRIVIACT injection is a clear, colorless liquid provided as a sterile, preservative-free solution. BRIVIACT injection contains 10 mg brivaracetam per mL for intravenous administration. One vial contains 50 mg of brivaracetam drug substance. It contains the following inactive ingredients: sodium acetate, trihydrate (1.64 mg/mL), glacial acetic acid (for pH adjustment to 5.5), sodium chloride (9.00 mg/mL), and water for injection."
},
{
"NDCCode": "50474-770-14",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (50474-770-14) / 14 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "50474-0770-14",
"ProductNDC": "50474-770",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Briviact",
"NonProprietaryName": "Brivaracetam",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160512",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205836",
"LabelerName": "UCB, Inc.",
"SubstanceName": "BRIVARACETAM",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Epoxide Hydrolase Inhibitors [MoA]",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160512",
"SamplePackage": "Y",
"IndicationAndUsage": "BRIVIACT is indicated for the treatment of partial-onset seizures in patients 1 month of age and older.",
"Description": "The chemical name of BRIVIACT (brivaracetam) is (2S)-2-[(4R)-2-oxo-4-propyltetrahydro-1 H-pyrrol-1-yl] butanamide. Its molecular formula is C 11H 20N 2O 2and its molecular weight is 212.29. The chemical structure is:. Brivaracetam is a white to off-white crystalline powder. It is very soluble in water, buffer (pH 1.2, 4.5, and 7.4), ethanol, methanol, and glacial acetic acid. It is freely soluble in acetonitrile and acetone and soluble in toluene. It is very slightly soluble in n-hexane. Tablets. BRIVIACT tablets are for oral administration and contain the following inactive ingredients: croscarmellose sodium, lactose monohydrate, betadex (β-cyclodextrin), anhydrous lactose, magnesium stearate, and film coating agents specified below. 10 mg tablets: polyvinyl alcohol, talc, polyethylene glycol 3350, titanium dioxide 25 mg and 100 mg tablets: polyvinyl alcohol, talc, polyethylene glycol 3350, titanium dioxide, yellow iron oxide, black iron oxide 50 mg tablets: polyvinyl alcohol, talc, polyethylene glycol 3350, titanium dioxide, yellow iron oxide, red iron oxide 75 mg tablets: polyvinyl alcohol, talc, polyethylene glycol 3350, titanium dioxide, yellow iron oxide, red iron oxide, black iron oxide. Oral Solution. BRIVIACT oral solution contains 10 mg of brivaracetam per mL. The inactive ingredients are sodium citrate, anhydrous citric acid, methylparaben, sodium carboxymethylcellulose, sucralose, sorbitol solution, glycerin, raspberry flavor, and purified water. Injection. BRIVIACT injection is a clear, colorless liquid provided as a sterile, preservative-free solution. BRIVIACT injection contains 10 mg brivaracetam per mL for intravenous administration. One vial contains 50 mg of brivaracetam drug substance. It contains the following inactive ingredients: sodium acetate, trihydrate (1.64 mg/mL), glacial acetic acid (for pH adjustment to 5.5), sodium chloride (9.00 mg/mL), and water for injection."
},
{
"NDCCode": "50474-770-66",
"PackageDescription": "1 BOTTLE in 1 CARTON (50474-770-66) / 60 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "50474-0770-66",
"ProductNDC": "50474-770",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Briviact",
"NonProprietaryName": "Brivaracetam",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20160512",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA205836",
"LabelerName": "UCB, Inc.",
"SubstanceName": "BRIVARACETAM",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Epoxide Hydrolase Inhibitors [MoA]",
"DEASchedule": "CV",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20160512",
"SamplePackage": "N",
"IndicationAndUsage": "BRIVIACT is indicated for the treatment of partial-onset seizures in patients 1 month of age and older.",
"Description": "The chemical name of BRIVIACT (brivaracetam) is (2S)-2-[(4R)-2-oxo-4-propyltetrahydro-1 H-pyrrol-1-yl] butanamide. Its molecular formula is C 11H 20N 2O 2and its molecular weight is 212.29. The chemical structure is:. Brivaracetam is a white to off-white crystalline powder. It is very soluble in water, buffer (pH 1.2, 4.5, and 7.4), ethanol, methanol, and glacial acetic acid. It is freely soluble in acetonitrile and acetone and soluble in toluene. It is very slightly soluble in n-hexane. Tablets. BRIVIACT tablets are for oral administration and contain the following inactive ingredients: croscarmellose sodium, lactose monohydrate, betadex (β-cyclodextrin), anhydrous lactose, magnesium stearate, and film coating agents specified below. 10 mg tablets: polyvinyl alcohol, talc, polyethylene glycol 3350, titanium dioxide 25 mg and 100 mg tablets: polyvinyl alcohol, talc, polyethylene glycol 3350, titanium dioxide, yellow iron oxide, black iron oxide 50 mg tablets: polyvinyl alcohol, talc, polyethylene glycol 3350, titanium dioxide, yellow iron oxide, red iron oxide 75 mg tablets: polyvinyl alcohol, talc, polyethylene glycol 3350, titanium dioxide, yellow iron oxide, red iron oxide, black iron oxide. Oral Solution. BRIVIACT oral solution contains 10 mg of brivaracetam per mL. The inactive ingredients are sodium citrate, anhydrous citric acid, methylparaben, sodium carboxymethylcellulose, sucralose, sorbitol solution, glycerin, raspberry flavor, and purified water. Injection. BRIVIACT injection is a clear, colorless liquid provided as a sterile, preservative-free solution. BRIVIACT injection contains 10 mg brivaracetam per mL for intravenous administration. One vial contains 50 mg of brivaracetam drug substance. It contains the following inactive ingredients: sodium acetate, trihydrate (1.64 mg/mL), glacial acetic acid (for pH adjustment to 5.5), sodium chloride (9.00 mg/mL), and water for injection."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>61047-770-10</NDCCode>
<PackageDescription>113.4 g in 1 TUBE (61047-770-10)</PackageDescription>
<NDC11Code>61047-0770-10</NDC11Code>
<ProductNDC>61047-770</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Close Up Anticavity Toothpaste</ProprietaryName>
<NonProprietaryName>Anticavity Toothpaste</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20100325</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>KIK Custom Products</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>.27</StrengthNumber>
<StrengthUnit>g/113.4g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>12579-770-10</NDCCode>
<PackageDescription>58000 TABLET, FILM COATED in 1 DRUM (12579-770-10)</PackageDescription>
<NDC11Code>12579-0770-10</NDC11Code>
<ProductNDC>12579-770</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Riluzole</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<StartMarketingDate>20130515</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Sanofi Winthrop Industrie</LabelerName>
<SubstanceName>RILUZOLE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>16571-770-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (16571-770-10) </PackageDescription>
<NDC11Code>16571-0770-10</NDC11Code>
<ProductNDC>16571-770</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fosinopril Sodium</ProprietaryName>
<NonProprietaryName>Fosinopril Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110330</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091163</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>FOSINOPRIL SODIUM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-03-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fosinopril sodium tablets are indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics.Fosinopril sodium tablets are indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics with or without digitalis (see DOSAGE AND ADMINISTRATION).In using fosinopril sodium tablets, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that fosinopril sodium tablets do not have a similar risk (see WARNINGS).In considering use of fosinopril sodium tablets, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see WARNINGS: Head and Neck Angioedema and Intestinal Angioedema).</IndicationAndUsage>
<Description>Fosinopril sodium tablets, USP are the sodium salt of fosinopril, the ester prodrug of an angiotensin-converting enzyme (ACE) inhibitor, fosinoprilat. It contains a phosphinate group capable of specific binding to the active site of angiotensin-converting enzyme. Fosinopril sodium is designated chemically as: L-proline, 4-cyclohexyl-1-[[[2-methyl-1-(1-oxopropoxy) propoxy] (4-phenylbutyl) phosphinyl] acetyl]-, sodium salt, trans-.Fosinopril sodium, USP is a white to almost white powder. It is soluble in water (100 mg/mL), methanol, and ethanol and slightly soluble in hexane.Its structural formula is. Its molecular formula is C30H45NNaO7P, and its molecular weight is 585.65.Fosinopril sodium, USP is available for oral administration as 10 mg, 20 mg, and 40 mg tablets. Inactive ingredients include: anhydrous lactose, crospovidone, microcrystalline cellulose, povidone, and sodium stearyl fumarate.</Description>
</NDC>
<NDC>
<NDCCode>31722-770-32</NDCCode>
<PackageDescription>6 BLISTER PACK in 1 CARTON (31722-770-32) / 10 CAPSULE in 1 BLISTER PACK</PackageDescription>
<NDC11Code>31722-0770-32</NDC11Code>
<ProductNDC>31722-770</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pomalidomide</ProprietaryName>
<NonProprietaryName>Pomalidomide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260228</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210236</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>POMALIDOMIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Thalidomide Analog [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260228</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pomalidomide is a thalidomide analogue indicated for the treatment of adult patients: 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 (RS)-4-Amino-2-(2,6-dioxo-piperidin-3-yl)-1H-isoindoline-1,3-dione and it has the following chemical structure. The molecular formula for pomalidomide is C 13H 11N 3O 4and the gram molecular weight is 273.24. Pomalidomide is a pale yellow to yellow color powder. Soluble in dimethylformamide and in dimethylsulfoxide. 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: black iron oxide, gelatin, mannitol, microcrystalline cellulose, potassium hydroxide, pregelatinized starch, propylene glycol, shellac, sodium stearyl fumarate, strong ammonia solution and titanium dioxide. In addition, the 2 mg and 3 mg capsules also contain iron oxide red. The 2 mg capsule also contains iron oxide yellow. The botanical source for pregelatinized starch is corn starch.</Description>
</NDC>
<NDC>
<NDCCode>41520-770-26</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (41520-770-26) > 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>41520-0770-26</NDC11Code>
<ProductNDC>41520-770</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Careone Allergy And Cough Severe Sinus Congestion</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160706</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>American Sales Company</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>325; 10; 6.25; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-08-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160706</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>49884-770-54</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (49884-770-54) / 10 TABLET in 1 BLISTER PACK (49884-770-52) </PackageDescription>
<NDC11Code>49884-0770-54</NDC11Code>
<ProductNDC>49884-770</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tolvaptan</ProprietaryName>
<NonProprietaryName>Tolvaptan</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220310</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206119</ApplicationNumber>
<LabelerName>Par Health USA, LLC</LabelerName>
<SubstanceName>TOLVAPTAN</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Vasopressin V2 Receptor Antagonist [EPC], Vasopressin V2 Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220310</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tolvaptan tablets are indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia (serum sodium <125 mEq/L or less marked hyponatremia that is symptomatic and has resisted correction with fluid restriction), including patients with heart failure and Syndrome of Inappropriate Antidiuretic Hormone (SIADH). Limitations of Use. Patients requiring intervention to raise serum sodium urgently to prevent or to treat serious neurological symptoms should not be treated with tolvaptan tablets. It has not been established that raising serum sodium with tolvaptan tablets provides a symptomatic benefit to patients.</IndicationAndUsage>
<Description>Tolvaptan is (±)-4'-[(7-chloro-2,3,4,5-tetrahydro-5-hydroxy-1H-1-benzazepin-1-yl) carbonyl]-o-tolu-m-toluidide. The empirical formula is C26H25ClN2O3. Molecular weight is 448.94. The chemical structure is. Tolvaptan tablets for oral use contain 15 mg or 30 mg of tolvaptan. Inactive ingredients include corn starch, FD&C Blue #2/indigo carmine aluminum lake, hydroxypropyl cellulose, lactose monohydrate, low substituted hydroxypropyl cellulose, magnesium stearate and microcrystalline cellulose.</Description>
</NDC>
<NDC>
<NDCCode>60429-770-10</NDCCode>
<PackageDescription>1000 TABLET in 1 BOTTLE (60429-770-10) </PackageDescription>
<NDC11Code>60429-0770-10</NDC11Code>
<ProductNDC>60429-770</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Topiramate</ProprietaryName>
<NonProprietaryName>Topiramate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110708</StartMarketingDate>
<EndMarketingDate>20220531</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079162</ApplicationNumber>
<LabelerName>Golden State Medical Supply, Inc.</LabelerName>
<SubstanceName>TOPIRAMATE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-06-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20110708</StartMarketingDatePackage>
<EndMarketingDatePackage>20220531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62257-770-10</NDCCode>
<PackageDescription>1000 mL in 1 CARTRIDGE (62257-770-10)</PackageDescription>
<NDC11Code>62257-0770-10</NDC11Code>
<ProductNDC>62257-770</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antibacterial</ProprietaryName>
<NonProprietaryName>Chloroxylenol</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140409</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>ABC Compounding Co., Inc.</LabelerName>
<SubstanceName>CHLOROXYLENOL</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>for hand-washing to decrease bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>65841-770-10</NDCCode>
<PackageDescription>1000 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (65841-770-10) </PackageDescription>
<NDC11Code>65841-0770-10</NDC11Code>
<ProductNDC>65841-770</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lansoprazole</ProprietaryName>
<NonProprietaryName>Lansoprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE PELLETS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130823</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202366</ApplicationNumber>
<LabelerName>Zydus Lifesciences Limited</LabelerName>
<SubstanceName>LANSOPRAZOLE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130823</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>65841-770-30</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 CARTON (65841-770-30) / 10 CAPSULE, DELAYED RELEASE PELLETS in 1 BLISTER PACK</PackageDescription>
<NDC11Code>65841-0770-30</NDC11Code>
<ProductNDC>65841-770</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lansoprazole</ProprietaryName>
<NonProprietaryName>Lansoprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE PELLETS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130823</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202366</ApplicationNumber>
<LabelerName>Zydus Lifesciences Limited</LabelerName>
<SubstanceName>LANSOPRAZOLE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130823</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>67877-770-33</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (67877-770-33) / 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>67877-0770-33</NDC11Code>
<ProductNDC>67877-770</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Levetiracetam</ProprietaryName>
<NonProprietaryName>Levetiracetam</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220408</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA216375</ApplicationNumber>
<LabelerName>Ascend Laboratories, LLC</LabelerName>
<SubstanceName>LEVETIRACETAM</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220528</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Levetiracetam tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1) Levetiracetam tablets are indicated for adjunctive therapy for the treatment of: Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2) Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3).</IndicationAndUsage>
<Description>Levetiracetam,USP is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white) tablets. The chemical name of levetiracetam, USP, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam, USP is chemically unrelated to existing antiepileptic drugs (AEDs). It has the following structural formula. Levetiracetam, USP is a white to almost white powder. It is very soluble in water, soluble in acetonitrile, practically insoluble in hexane. Levetiracetam tablets, USP contain the labeled amount of levetiracetam, USP. Inactive ingredients: colloidal silicon dioxide, magnesium stearate, maize starch, polyethylene glycol, polyvinyl alcohol, povidone, sodium starch glycolate, talc, titanium dioxide and additional agents listed below: 250 mg tablets: FD&C blue #2 indigo carmine aluminum lake 500 mg tablets: iron oxide yellow 750 mg tablets: iron oxide yellow, iron oxide red. Meets USP Dissolution Test 3.</Description>
</NDC>
<NDC>
<NDCCode>70010-770-10</NDCCode>
<PackageDescription>1000 TABLET, COATED in 1 BOTTLE (70010-770-10) </PackageDescription>
<NDC11Code>70010-0770-10</NDC11Code>
<ProductNDC>70010-770</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methocarbamol</ProprietaryName>
<NonProprietaryName>Methocarbamol Tablets</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180702</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209312</ApplicationNumber>
<LabelerName>Granules Pharmaceuticals Inc.</LabelerName>
<SubstanceName>METHOCARBAMOL</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methocarbamol tablets, USP are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.</IndicationAndUsage>
<Description>Methocarbamol tablet, USP, a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is 1,2-Propanediol,3-(2-methoxyphenoxy)-,1-Carbamate,(±)-(or) (±)-3-(o-Methoxyphenoxy)-1,2-Propanediol 1-carbamate and has the empirical formula C 11H 15NO 5. Its molecular weight is 241.24g/mol. The structural formula is shown below. Methocarbamol is a white powder, sparingly soluble in water and in chloroform, soluble in alcohol (only with heating), insoluble in benzene and in n-hexane. Methocarbamol tablets, USP are available as 500 mg and 750 mg tablets for oral administration. Methocarbamol tablets, USP 500 mg are light orange colored, round shaped film coated tablets debossed with "G" above the score line on one side and "500" on other side. Methocarbamol tablets, USP 750 mg are light orange colored, caplet shaped film coated tablets debossed with "G" on one side and "750" on other side. Methocarbamol tablets, USP 500 mg and 750 mg contain the following inactive ingredients: colloidal silicon dioxide, maize starch, povidone, sodium lauryl sulfate, sodium starch glycolate, and stearic acid. The tabets are coated with Aquarius Prime which contains FD&C yellow 6, hydroxypropylcellulose, hypromellose, polysorbate 80, propylene glycol, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>72288-770-10</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (72288-770-10) / 30 mL in 1 BOTTLE (72288-770-00) </PackageDescription>
<NDC11Code>72288-0770-10</NDC11Code>
<ProductNDC>72288-770</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Infants Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>SUSPENSION/ DROPS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260806</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075217</ApplicationNumber>
<LabelerName>Amazon.com Services LLC</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1.25mL</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260806</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily: 1 reduces fever, 2 relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>76420-770-01</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (76420-770-01) * 10 mL in 1 VIAL, SINGLE-DOSE (0003-0293-05) * .3 mL in 1 AMPULE (39822-9900-2) * 2.2 g in 1 PACKET (10819-3883-3) * 10 mL in 1 AMPULE (63323-201-10)</PackageDescription>
<NDC11Code>76420-0770-01</NDC11Code>
<ProductNDC>76420-770</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Interarticular Joint Kit</ProprietaryName>
<NonProprietaryName>Ammonia, Lidocaine Hydrochloride Anhydrous, Triamcinolone Acetonide, Povidone-iodine</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>INFILTRATION; INTRA-ARTICULAR; INTRAMUSCULAR; RESPIRATORY (INHALATION); TOPICAL</RouteName>
<StartMarketingDate>20140205</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA014901</ApplicationNumber>
<LabelerName>Asclemed USA, Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2017-07-27</LastUpdate>
</NDC>
<NDC>
<NDCCode>79109-770-10</NDCCode>
<PackageDescription>1000 L in 1 CONTAINER (79109-770-10)</PackageDescription>
<NDC11Code>79109-0770-10</NDC11Code>
<ProductNDC>79109-770</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<StartMarketingDate>20200801</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>ROLDAN INDUSTRIES</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>L/100L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0089-0233-10</NDCCode>
<PackageDescription>100 TABLET, MULTILAYER in 1 BOTTLE (0089-0233-10)</PackageDescription>
<NDC11Code>00089-0233-10</NDC11Code>
<ProductNDC>0089-0233</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Norgesic Forte</ProprietaryName>
<NonProprietaryName>Orphenadrine Citrate, Aspirin And Caffeine</NonProprietaryName>
<DosageFormName>TABLET, MULTILAYER</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19640304</StartMarketingDate>
<EndMarketingDate>20151231</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA013416</ApplicationNumber>
<LabelerName>3M Pharmaceuticals</LabelerName>
<SubstanceName>ORPHENADRINE CITRATE; ASPIRIN; CAFFEINE</SubstanceName>
<StrengthNumber>50; 770; 60</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Methylxanthine [EPC],Xanthines [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-01-01</LastUpdate>
</NDC>
<NDC>
<NDCCode>11673-770-14</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (11673-770-14) / 14 g in 1 TUBE</PackageDescription>
<NDC11Code>11673-0770-14</NDC11Code>
<ProductNDC>11673-770</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Antibiotic And Pain Relief</ProprietaryName>
<NonProprietaryName>Neomycin Sulfate, Polymyxin B Sulfate, And Pramoxine Hydrochloride</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240131</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M004</ApplicationNumber>
<LabelerName>Target Corporation</LabelerName>
<SubstanceName>POLYMYXIN B SULFATE; NEOMYCIN SULFATE; PRAMOXINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10000; 3.5; 10</StrengthNumber>
<StrengthUnit>[USP'U]/g; mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-02-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240131</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>first aid to prevent infection and for the temporary relief of pain or discomfort in minor: 1 cuts, 2 scapes, 3 burns.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>16571-770-09</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE (16571-770-09) </PackageDescription>
<NDC11Code>16571-0770-09</NDC11Code>
<ProductNDC>16571-770</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fosinopril Sodium</ProprietaryName>
<NonProprietaryName>Fosinopril Sodium</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110330</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091163</ApplicationNumber>
<LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
<SubstanceName>FOSINOPRIL SODIUM</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-03-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110330</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Fosinopril sodium tablets are indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics.Fosinopril sodium tablets are indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics with or without digitalis (see DOSAGE AND ADMINISTRATION).In using fosinopril sodium tablets, consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that fosinopril sodium tablets do not have a similar risk (see WARNINGS).In considering use of fosinopril sodium tablets, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see WARNINGS: Head and Neck Angioedema and Intestinal Angioedema).</IndicationAndUsage>
<Description>Fosinopril sodium tablets, USP are the sodium salt of fosinopril, the ester prodrug of an angiotensin-converting enzyme (ACE) inhibitor, fosinoprilat. It contains a phosphinate group capable of specific binding to the active site of angiotensin-converting enzyme. Fosinopril sodium is designated chemically as: L-proline, 4-cyclohexyl-1-[[[2-methyl-1-(1-oxopropoxy) propoxy] (4-phenylbutyl) phosphinyl] acetyl]-, sodium salt, trans-.Fosinopril sodium, USP is a white to almost white powder. It is soluble in water (100 mg/mL), methanol, and ethanol and slightly soluble in hexane.Its structural formula is. Its molecular formula is C30H45NNaO7P, and its molecular weight is 585.65.Fosinopril sodium, USP is available for oral administration as 10 mg, 20 mg, and 40 mg tablets. Inactive ingredients include: anhydrous lactose, crospovidone, microcrystalline cellulose, povidone, and sodium stearyl fumarate.</Description>
</NDC>
<NDC>
<NDCCode>21695-726-30</NDCCode>
<PackageDescription>30 TABLET, MULTILAYER in 1 BOTTLE (21695-726-30)</PackageDescription>
<NDC11Code>21695-0726-30</NDC11Code>
<ProductNDC>21695-726</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Orphenadrine Citrate, Aspirin And Caffeine</ProprietaryName>
<NonProprietaryName>Orphenadrine Citrate, Aspirin And Caffeine</NonProprietaryName>
<DosageFormName>TABLET, MULTILAYER</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19961231</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074654</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>ORPHENADRINE CITRATE; ASPIRIN; CAFFEINE</SubstanceName>
<StrengthNumber>50; 770; 60</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Symptomatic relief of mild to moderate pain of acute musculoskeletal disorders. The orphenadrine component is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions.The mode of action of orphenadrine has not been clearly identified, but may be related to its analgesic properties. Orphenadrine Citrate, Aspirin, and Caffeine Tablets do not directly relax tense skeletal muscles in man.</IndicationAndUsage>
<Description>Each tablet, for oral administration, contains Orphenadrine Citrate USP, 25 mg or 50 mg, Aspirin USP, 385 mg or 770 mg, Caffeine USP, 30 mg or 60 mg. Orphenadrine citrate, N, N-Dimethyl-2-[(o-methyl-α-phenylbenzyl)oxy]ethylamine citrate (1:1), is a centrally acting (brain stem) compound. It occurs as a white, practically odorless, crystalline powder, having a bitter taste. Its molecular formula is C18H23NO.C6H8O7 with a molecular weight of 461.51. The structural formula is shown below. Aspirin, salicylic acid acetate, is a non-opiate analgesic, anti-inflammatory and antipyretic agent. It occurs as a white, crystalline tabular or needle like powder and is odorless or has a faint odor. Its molecular formula is C9H8O4, with a molecular weight of 180.16. The structural formula is shown below. Caffeine, 1,3,7-trimethylxanthine, is a central nervous system stimulant which occurs as a white powder or white glistening needles. It also has a bitter taste. Its molecular formula is C8H10N4O2, with a molecular weight of 194.19. The structural formula is shown below. Each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C Blue No. 1, FD&C Yellow No. 10, anhydrous lactose, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid, and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
<NDCCode>21695-726-45</NDCCode>
<PackageDescription>45 TABLET, MULTILAYER in 1 BOTTLE (21695-726-45)</PackageDescription>
<NDC11Code>21695-0726-45</NDC11Code>
<ProductNDC>21695-726</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Orphenadrine Citrate, Aspirin And Caffeine</ProprietaryName>
<NonProprietaryName>Orphenadrine Citrate, Aspirin And Caffeine</NonProprietaryName>
<DosageFormName>TABLET, MULTILAYER</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19961231</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074654</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>ORPHENADRINE CITRATE; ASPIRIN; CAFFEINE</SubstanceName>
<StrengthNumber>50; 770; 60</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Symptomatic relief of mild to moderate pain of acute musculoskeletal disorders. The orphenadrine component is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions.The mode of action of orphenadrine has not been clearly identified, but may be related to its analgesic properties. Orphenadrine Citrate, Aspirin, and Caffeine Tablets do not directly relax tense skeletal muscles in man.</IndicationAndUsage>
<Description>Each tablet, for oral administration, contains Orphenadrine Citrate USP, 25 mg or 50 mg, Aspirin USP, 385 mg or 770 mg, Caffeine USP, 30 mg or 60 mg. Orphenadrine citrate, N, N-Dimethyl-2-[(o-methyl-α-phenylbenzyl)oxy]ethylamine citrate (1:1), is a centrally acting (brain stem) compound. It occurs as a white, practically odorless, crystalline powder, having a bitter taste. Its molecular formula is C18H23NO.C6H8O7 with a molecular weight of 461.51. The structural formula is shown below. Aspirin, salicylic acid acetate, is a non-opiate analgesic, anti-inflammatory and antipyretic agent. It occurs as a white, crystalline tabular or needle like powder and is odorless or has a faint odor. Its molecular formula is C9H8O4, with a molecular weight of 180.16. The structural formula is shown below. Caffeine, 1,3,7-trimethylxanthine, is a central nervous system stimulant which occurs as a white powder or white glistening needles. It also has a bitter taste. Its molecular formula is C8H10N4O2, with a molecular weight of 194.19. The structural formula is shown below. Each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, croscarmellose sodium, FD&C Blue No. 1, FD&C Yellow No. 10, anhydrous lactose, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid, and sodium lauryl sulfate.</Description>
</NDC>
<NDC>
<NDCCode>21695-770-01</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 POUCH (21695-770-01) > 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>21695-0770-01</NDC11Code>
<ProductNDC>21695-770</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tri-sprintec</ProprietaryName>
<NonProprietaryName>Norgestimate And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20110125</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075808</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Tri-Sprintec Tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Tri-Sprintec Tablets are indicated for the treatment of moderate acne vulgaris in females, ≥15 years of age, who have no known contraindications to oral contraceptive therapy, desire contraception, have achieved menarche and are unresponsive to topical anti-acne medications. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. In four clinical trials with norgestimate and ethinyl estradiol, the use-efficacy pregnancy rate ranged from 0.68 to 1.47 per 100 women-years. In total, 4,756 subjects completed 45,244 cycles and a total of 42 pregnancies were reported. This represents an overall use-efficacy rate of 1.21 per 100 women-years. One of these 4 studies was a randomized comparative clinical trial in which 4,633 subjects completed 22,312 cycles. Of the 2,312 patients on norgestimate and ethinyl estradiol, 8 pregnancies were reported. This represents an overall use-efficacy pregnancy rate of 0.94 per 100 women-years. In two double-blind, placebo-controlled, six month, multicenter clinical trials, norgestimate and ethinyl estradiol showed a statistically significant decrease in inflammatory lesion count and total lesion count (TABLE II). The adverse reaction profile of norgestimate and ethinyl estradiol from these two controlled clinical trials is consistent with what has been noted from previous studies involving norgestimate and ethinyl estradiol and are the known risks associated with oral contraceptives.</IndicationAndUsage>
<Description>Tri-Sprintec® Tablets are a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol. Each gray tablet contains 0.18 mg of the progestational compound, norgestimate (18, 19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-oxime, (17α)-(+)-) and 0.035 mg of the estrogenic compound, ethinyl estradiol (19-nor-17α-pregna, 1,3,5(10)-trien-20-yne-3, 17-diol), and the inactive ingredients include anhydrous lactose, lactose monohydrate, lake blend black LB 636 (ingredients include aluminum sulfate solution, aluminum-chloride solution, FD&C blue no. 2, FD&C red no. 40, FD&C yellow no. 6, sodium bicarbonate and sodium carbonate), magnesium stearate, and pregelatinized starch. Each light blue tablet contains 0.215 mg of the progestational compound norgestimate (18, 19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-,oxime, (17α)-(+)-) and 0.035 mg of the estrogenic compound, ethinyl estradiol (19-nor-17α-pregna, 1,3,5(10)-trien-20-yne-3, 17-diol), and the inactive ingredients include anhydrous lactose, FD&C blue no. 2 aluminum lake, (ingredients include aluminum sulfate solution, aluminum-chloride solution, sodium bicarbonate and sodium carbonate), lactose monohydrate, magnesium stearate, and pregelatinized starch. Each blue tablet contains 0.25 mg of the progestational compound norgestimate (18, 19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime, (17α)-(+)-) and 0.035 mg of the estrogenic compound, ethinyl estradiol (19-nor-17α-pregna, 1,3,5(10)-trien-20-yne-3, 17-diol), and the inactive ingredients include anhydrous lactose, FD&C blue no. 2 aluminum lake, (ingredients include aluminum sulfate solution, aluminum-chloride solution, sodium bicarbonate and sodium carbonate), lactose monohydrate, magnesium stearate, and pregelatinized starch. Each white tablet contains only inert ingredients as follows: anhydrous lactose, hypromellose, magnesium stearate, and microcrystalline cellulose. The structural formula is as follows.</Description>
</NDC>
<NDC>
<NDCCode>36800-770-05</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (36800-770-05) > 225 TABLET, COATED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>36800-0770-05</NDC11Code>
<ProductNDC>36800-770</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Pain Relief</ProprietaryName>
<ProprietaryNameSuffix>Extra Strength</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140331</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part343</ApplicationNumber>
<LabelerName>TopCo Associates LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140331</StartMarketingDatePackage>
<EndMarketingDatePackage>20220930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>37808-770-08</NDCCode>
<PackageDescription>236 mL in 1 BOTTLE (37808-770-08) </PackageDescription>
<NDC11Code>37808-0770-08</NDC11Code>
<ProductNDC>37808-770</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Heb Stomach Relief</ProprietaryName>
<ProprietaryNameSuffix>Max Strength</ProprietaryNameSuffix>
<NonProprietaryName>Bismuth Subsalicylate</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190423</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M008</ApplicationNumber>
<LabelerName>HEB</LabelerName>
<SubstanceName>BISMUTH SUBSALICYLATE</SubstanceName>
<StrengthNumber>1050</StrengthNumber>
<StrengthUnit>mg/30mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190423</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves: 1 travelers’ diarrhea, 2 diarrhea, 3 upset stomach due to overindulgence in food and drink, including:, 4 heartburn, 5 indigestion, 6 nausea, 7 gas, 8 belching.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>37808-770-16</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (37808-770-16) </PackageDescription>
<NDC11Code>37808-0770-16</NDC11Code>
<ProductNDC>37808-770</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Heb Stomach Relief</ProprietaryName>
<ProprietaryNameSuffix>Max Strength</ProprietaryNameSuffix>
<NonProprietaryName>Bismuth Subsalicylate</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190423</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M008</ApplicationNumber>
<LabelerName>HEB</LabelerName>
<SubstanceName>BISMUTH SUBSALICYLATE</SubstanceName>
<StrengthNumber>1050</StrengthNumber>
<StrengthUnit>mg/30mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-10-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190423</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>relieves: 1 travelers’ diarrhea, 2 diarrhea, 3 upset stomach due to overindulgence in food and drink, including:, 4 heartburn, 5 indigestion, 6 nausea, 7 gas, 8 belching.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>41163-770-21</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (41163-770-21) / 85 g in 1 TUBE</PackageDescription>
<NDC11Code>41163-0770-21</NDC11Code>
<ProductNDC>41163-770</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Equaline Muscle Rub</ProprietaryName>
<NonProprietaryName>Menthol, Methyl Salicylate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140103</StartMarketingDate>
<EndMarketingDate>20231031</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>United Natural Foods, Inc. dba UNFI</LabelerName>
<SubstanceName>MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE</SubstanceName>
<StrengthNumber>10; 15</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-11-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20140103</StartMarketingDatePackage>
<EndMarketingDatePackage>20231031</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>42291-770-50</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (42291-770-50) </PackageDescription>
<NDC11Code>42291-0770-50</NDC11Code>
<ProductNDC>42291-770</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Prednisone</ProprietaryName>
<NonProprietaryName>Prednisone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200422</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211575</ApplicationNumber>
<LabelerName>AvKARE</LabelerName>
<SubstanceName>PREDNISONE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200422</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50268-770-15</NDCCode>
<PackageDescription>50 BLISTER PACK in 1 BOX (50268-770-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-770-11) </PackageDescription>
<NDC11Code>50268-0770-15</NDC11Code>
<ProductNDC>50268-770</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline</ProprietaryName>
<NonProprietaryName>Sertraline</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240206</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077670</ApplicationNumber>
<LabelerName>AvPAK</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240206</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sertraline hydrochloride tablets are indicated for the treatment of the following [See Clinical Studies ( 14)] : : 1 Major depressive disorder (MDD), 2 Obsessive-compulsive disorder (OCD), 3 Panic disorder (PD), 4 Posttraumatic stress disorder (PTSD), 5 Social anxiety disorder (SAD), 6 Premenstrual dysphoric disorder (PMDD).</IndicationAndUsage>
<Description>Sertraline hydrochloride tablet USP contains sertraline hydrochloride, an SSRI. Sertraline hydrochloride has a molecular weight of 342.7 and has the following chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine hydrochloride. The empirical formula C 17H 17NCl 2HCl is represented by the following structural formula:. Sertraline hydrochloride is white to off white crystalline powder that is sparingly soluble in methanol and dimethyl formamide. Sertraline hydrochloride tablets USP for oral administration contain 28.0 mg, 56.0 mg, and 111.9 mg sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: D&C Yellow #10 (in 25 mg tablet), dibasic calcium phosphate anhydrous, FD&C Blue #1 (in 25 mg tablet), FD&C Blue #2 (in 50 mg tablet), FD&C Red #40 (in 25 mg tablet), hydroxypropyl cellulose, hypromellose, iron oxide yellow (in 100 mg tablet), magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate , titanium dioxide and vanillin. Sertraline hydrochloride tablets USP are coated with vanillin flavored film coating material. Vanillin is a flavoring agent that possess vanilla like fragrance.</Description>
</NDC>
<NDC>
<NDCCode>50474-770-09</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (50474-770-09) / 1 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>50474-0770-09</NDC11Code>
<ProductNDC>50474-770</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Briviact</ProprietaryName>
<NonProprietaryName>Brivaracetam</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160512</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205836</ApplicationNumber>
<LabelerName>UCB, Inc.</LabelerName>
<SubstanceName>BRIVARACETAM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Epoxide Hydrolase Inhibitors [MoA]</Pharm_Classes>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160512</StartMarketingDatePackage>
<EndMarketingDatePackage>20301129</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BRIVIACT is indicated for the treatment of partial-onset seizures in patients 1 month of age and older.</IndicationAndUsage>
<Description>The chemical name of BRIVIACT (brivaracetam) is (2S)-2-[(4R)-2-oxo-4-propyltetrahydro-1 H-pyrrol-1-yl] butanamide. Its molecular formula is C 11H 20N 2O 2and its molecular weight is 212.29. The chemical structure is:. Brivaracetam is a white to off-white crystalline powder. It is very soluble in water, buffer (pH 1.2, 4.5, and 7.4), ethanol, methanol, and glacial acetic acid. It is freely soluble in acetonitrile and acetone and soluble in toluene. It is very slightly soluble in n-hexane. Tablets. BRIVIACT tablets are for oral administration and contain the following inactive ingredients: croscarmellose sodium, lactose monohydrate, betadex (β-cyclodextrin), anhydrous lactose, magnesium stearate, and film coating agents specified below. 10 mg tablets: polyvinyl alcohol, talc, polyethylene glycol 3350, titanium dioxide 25 mg and 100 mg tablets: polyvinyl alcohol, talc, polyethylene glycol 3350, titanium dioxide, yellow iron oxide, black iron oxide 50 mg tablets: polyvinyl alcohol, talc, polyethylene glycol 3350, titanium dioxide, yellow iron oxide, red iron oxide 75 mg tablets: polyvinyl alcohol, talc, polyethylene glycol 3350, titanium dioxide, yellow iron oxide, red iron oxide, black iron oxide. Oral Solution. BRIVIACT oral solution contains 10 mg of brivaracetam per mL. The inactive ingredients are sodium citrate, anhydrous citric acid, methylparaben, sodium carboxymethylcellulose, sucralose, sorbitol solution, glycerin, raspberry flavor, and purified water. Injection. BRIVIACT injection is a clear, colorless liquid provided as a sterile, preservative-free solution. BRIVIACT injection contains 10 mg brivaracetam per mL for intravenous administration. One vial contains 50 mg of brivaracetam drug substance. It contains the following inactive ingredients: sodium acetate, trihydrate (1.64 mg/mL), glacial acetic acid (for pH adjustment to 5.5), sodium chloride (9.00 mg/mL), and water for injection.</Description>
</NDC>
<NDC>
<NDCCode>50474-770-14</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (50474-770-14) / 14 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>50474-0770-14</NDC11Code>
<ProductNDC>50474-770</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Briviact</ProprietaryName>
<NonProprietaryName>Brivaracetam</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160512</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205836</ApplicationNumber>
<LabelerName>UCB, Inc.</LabelerName>
<SubstanceName>BRIVARACETAM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Epoxide Hydrolase Inhibitors [MoA]</Pharm_Classes>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160512</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>BRIVIACT is indicated for the treatment of partial-onset seizures in patients 1 month of age and older.</IndicationAndUsage>
<Description>The chemical name of BRIVIACT (brivaracetam) is (2S)-2-[(4R)-2-oxo-4-propyltetrahydro-1 H-pyrrol-1-yl] butanamide. Its molecular formula is C 11H 20N 2O 2and its molecular weight is 212.29. The chemical structure is:. Brivaracetam is a white to off-white crystalline powder. It is very soluble in water, buffer (pH 1.2, 4.5, and 7.4), ethanol, methanol, and glacial acetic acid. It is freely soluble in acetonitrile and acetone and soluble in toluene. It is very slightly soluble in n-hexane. Tablets. BRIVIACT tablets are for oral administration and contain the following inactive ingredients: croscarmellose sodium, lactose monohydrate, betadex (β-cyclodextrin), anhydrous lactose, magnesium stearate, and film coating agents specified below. 10 mg tablets: polyvinyl alcohol, talc, polyethylene glycol 3350, titanium dioxide 25 mg and 100 mg tablets: polyvinyl alcohol, talc, polyethylene glycol 3350, titanium dioxide, yellow iron oxide, black iron oxide 50 mg tablets: polyvinyl alcohol, talc, polyethylene glycol 3350, titanium dioxide, yellow iron oxide, red iron oxide 75 mg tablets: polyvinyl alcohol, talc, polyethylene glycol 3350, titanium dioxide, yellow iron oxide, red iron oxide, black iron oxide. Oral Solution. BRIVIACT oral solution contains 10 mg of brivaracetam per mL. The inactive ingredients are sodium citrate, anhydrous citric acid, methylparaben, sodium carboxymethylcellulose, sucralose, sorbitol solution, glycerin, raspberry flavor, and purified water. Injection. BRIVIACT injection is a clear, colorless liquid provided as a sterile, preservative-free solution. BRIVIACT injection contains 10 mg brivaracetam per mL for intravenous administration. One vial contains 50 mg of brivaracetam drug substance. It contains the following inactive ingredients: sodium acetate, trihydrate (1.64 mg/mL), glacial acetic acid (for pH adjustment to 5.5), sodium chloride (9.00 mg/mL), and water for injection.</Description>
</NDC>
<NDC>
<NDCCode>50474-770-66</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (50474-770-66) / 60 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>50474-0770-66</NDC11Code>
<ProductNDC>50474-770</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Briviact</ProprietaryName>
<NonProprietaryName>Brivaracetam</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160512</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA205836</ApplicationNumber>
<LabelerName>UCB, Inc.</LabelerName>
<SubstanceName>BRIVARACETAM</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Epoxide Hydrolase Inhibitors [MoA]</Pharm_Classes>
<DEASchedule>CV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160512</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>BRIVIACT is indicated for the treatment of partial-onset seizures in patients 1 month of age and older.</IndicationAndUsage>
<Description>The chemical name of BRIVIACT (brivaracetam) is (2S)-2-[(4R)-2-oxo-4-propyltetrahydro-1 H-pyrrol-1-yl] butanamide. Its molecular formula is C 11H 20N 2O 2and its molecular weight is 212.29. The chemical structure is:. Brivaracetam is a white to off-white crystalline powder. It is very soluble in water, buffer (pH 1.2, 4.5, and 7.4), ethanol, methanol, and glacial acetic acid. It is freely soluble in acetonitrile and acetone and soluble in toluene. It is very slightly soluble in n-hexane. Tablets. BRIVIACT tablets are for oral administration and contain the following inactive ingredients: croscarmellose sodium, lactose monohydrate, betadex (β-cyclodextrin), anhydrous lactose, magnesium stearate, and film coating agents specified below. 10 mg tablets: polyvinyl alcohol, talc, polyethylene glycol 3350, titanium dioxide 25 mg and 100 mg tablets: polyvinyl alcohol, talc, polyethylene glycol 3350, titanium dioxide, yellow iron oxide, black iron oxide 50 mg tablets: polyvinyl alcohol, talc, polyethylene glycol 3350, titanium dioxide, yellow iron oxide, red iron oxide 75 mg tablets: polyvinyl alcohol, talc, polyethylene glycol 3350, titanium dioxide, yellow iron oxide, red iron oxide, black iron oxide. Oral Solution. BRIVIACT oral solution contains 10 mg of brivaracetam per mL. The inactive ingredients are sodium citrate, anhydrous citric acid, methylparaben, sodium carboxymethylcellulose, sucralose, sorbitol solution, glycerin, raspberry flavor, and purified water. Injection. BRIVIACT injection is a clear, colorless liquid provided as a sterile, preservative-free solution. BRIVIACT injection contains 10 mg brivaracetam per mL for intravenous administration. One vial contains 50 mg of brivaracetam drug substance. It contains the following inactive ingredients: sodium acetate, trihydrate (1.64 mg/mL), glacial acetic acid (for pH adjustment to 5.5), sodium chloride (9.00 mg/mL), and water for injection.</Description>
</NDC>
</NDCList>